Humalog

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml, solution for injection in vial 
Humalog 100 units/ml, solution for injection in cartridge 
Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen 
Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 100 units of insulin lispro* (equivalent to 3.5mg).   
 
Vial 
Each vial contains 1000 units insulin lispro in 10 ml solution. 
 
Cartridge 
Each cartridge contains 300 units of insulin lispro in 3 ml solution. 
 
KwikPen 
Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution. 
Each KwikPen delivers 1-60 units in steps of 1 unit. 
 
Junior KwikPen 
Each pre-filled pen contains 300 units of insulin lispro in 3 ml solution. 
Each Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units. 
 
*produced in E.coli by recombinant DNA technology. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection. 
 
Clear, colourless, aqueous solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
For the treatment of adults and children with diabetes mellitus who require insulin for the maintenance 
of normal glucose homeostasis. Humalog is also indicated for the initial stabilisation of diabetes 
mellitus.  
 
4.2 Posology and method of administration 
 
Posology 
The dosage should be determined by the physician, according to the requirement of the patient.  
 
Junior KwikPen 
Humalog 100 units/ml Junior KwikPen is suitable for patients who may benefit from finer insulin dose 
adjustments. 
 
Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals.  
 



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Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously 
as compared with soluble insulin. This rapid onset of activity allows a Humalog injection (or, in the 
case of administration by continuous subcutaneous infusion, a Humalog bolus) to be given very close 
to mealtime. The time course of action of any insulin may vary considerably in different individuals or 
at different times in the same individual. The faster onset of action compared to soluble human insulin 
is maintained regardless of injection site. As with all insulin preparations, the duration of action of 
Humalog is dependent on dose, site of injection, blood supply, temperature, and physical activity. 
 
Humalog can be used in conjunction with a longer-acting insulin or oral sulphonylurea agents, on the 
advice of a physician.  
 
Humalog KwikPens 
Humalog KwikPen is available in two strengths. The Humalog 100 units/ml KwikPen (and Humalog 
200 units/ml KwikPen, see separate SmPC) delivers 1 – 60 units in steps of 1 unit in a single injection. 
The Humalog 100 units/ml Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units in a single 
injection. The number of insulin units is shown in the dose window of the pen regardless of 
strength and no dose conversion should be done when transferring a patient to a new strength or to a 
pen with a different dose step.  
 
Special populations 
 
Renal impairment 
Insulin requirements may be reduced in the presence of renal impairment. 
 
Hepatic impairment 
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for 
gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic 
impairment, an increase in insulin resistance may lead to increased insulin requirements. 
 
Paediatric population 
Humalog can be used in adolescents and children (see section 5.1). 
 
Method of administration 
 
Humalog preparations should be given by subcutaneous injection.  
The KwikPen and Junior KwikPen are only suitable for subcutaneous injections. Humalog in 
cartridges is only suitable for subcutaneous injections from a Lilly reusable pen or compatible pump 
systems for continuous subcutaneous insulin infusion (CSII).  
 
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of 
injection sites should be rotated so that the same site is not used more than approximately once a 
month. 
 
When administered subcutaneously care should be taken when injecting Humalog to ensure that a 
blood vessel has not been entered. After injection, the site of injection should not be massaged. 
Patients must be educated to use the proper injection techniques. 
 
Use of Humalog in an insulin infusion pump 
For subcutaneous injection of Humalog using a continuous infusion pump, you may fill the pump 
reservoir from a Humalog 100 units/ml vial. Some pumps are compatible with cartridges that can be 
inserted intact into the pump. 
 
Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before infusing 
insulin lispro, the pump manufacturer’s instructions should be studied to ascertain the suitability for 
the particular pump. Use the correct reservoir and catheter for the pump. When filling the pump 
reservoir avoid damaging it by using the correct needle length on the filling system. The infusion set 
(tubing and cannula) should be changed in accordance with the instructions in the product information 



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supplied with the infusion set. In the event of a hypoglycaemic episode, the infusion should be stopped 
until the episode is resolved. If repeated or severe low blood glucose levels occur consider the need to 
reduce or stop an insulin infusion. A pump malfunction or obstruction of the infusion set can result in 
a rapid rise in glucose levels. If an interruption to insulin flow is suspected, follow the instructions in 
the pump product literature. When used with an insulin infusion pump, Humalog should not be mixed 
with any other insulin. 
 
Intravenous administration of insulin 
If necessary, Humalog may also be administered intravenously, for example: for the control of blood 
glucose levels during ketoacidosis, acute illnesses or during intra and post operative periods. 
Humalog 100 units /ml is available in vials if administration of intravenous injection is necessary.   
 
Intravenous injection of insulin lispro should be carried out following normal clinical practise for 
intravenous injections, for example by an intravenous bolus or by an infusion system. Frequent 
monitoring of the blood glucose levels is required. 
Infusion systems at concentrations from 0.1 units/ml to 1.0 units/ml insulin lispro in 0.9% sodium 
chloride or 5% dextrose are stable at room temperature for 48 hours. It is recommended that the 
system is primed before starting the infusion to the patient. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Hypoglycaemia. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Transferring a patient to another type or brand of insulin  
Transferring a patient to another type or brand of insulin should be done under strict medical 
supervision. Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane,  etc.), 
species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA 
versus animal-source insulin) may result in the need for a change in dosage. For fast-acting insulins, 
any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across 
the whole day, particularly nocturnal/fasting glucose control. 
 
Vial 
When mixing Humalog with a longer acting insulin, the shorter-acting Humalog should be drawn into 
the syringe first, to prevent contamination of the vial by the longer-acting insulin. Mixing of the 
insulins ahead of time or just before the injection should be on advice of the physician. However, a 
consistent routine must be followed. 
 
Hypoglycaemia and hyperglycaemia 
Conditions which may make the early warning symptoms of hypoglycaemia different or less 
pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or 
medications such as beta-blockers. 
 
A few patients who have experienced hypoglycaemic reactions after transfer from animal-source 
insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less 
pronounced or different from those experienced with their previous insulin. Uncorrected 
hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death. 
 



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The use of dosages which are inadequate or discontinuation of treatment, especially in insulin-
dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are 
potentially lethal. 
 
Insulin requirements and dosage adjustment 
Insulin requirements may be increased during illness or emotional disturbances. 
 
Adjustment of dosage may also be necessary if patients undertake increased physical activity or 
change their usual diet. Exercise taken immediately after a meal may increase the risk of 
hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if 
hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human 
insulin. 
 
Combination of Humalog with pioglitazone: 
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, 
especially in patients with risk factors for development of cardiac heart failure. This should be kept in 
mind, if treatment with the combination of pioglitazone and Humalog is considered. If the 
combination is used, patients should be observed for signs and symptoms of heart failure, weight gain 
and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs. 
 
Avoidance of medication errors 
Patients must be instructed to always check the insulin label before each injection to avoid accidental 
mix-ups between the two different strengths of Humalog KwikPen as well as other insulin products. 
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the 
requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who 
are blind or have poor vision must be instructed to always get help/assistance from another person who 
has good vision and is trained in using the insulin device. 
 
Excipients 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially 
“sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as 
oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as 
ritodrine, salbutamol, terbutaline).  
 
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic 
activity, such as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha 
antibiotics, certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake 
inhibitors), certain angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II 
receptor blockers, beta-blockers, octreotide or alcohol.  
 
The physician should be consulted when using other medications in addition to Humalog (see section 
4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on 
pregnancy or on the health of the foetus/newborn.    
 
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational 
diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and 
increase during the second and third trimesters. Patients with diabetes should be advised to inform 



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their doctor if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose 
control, as well as general health, is essential in pregnant patients with diabetes.  
 
Breast-feeding 
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.  
 
Fertility 
Insulin lispro did not induce fertility impairment in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may 
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or 
operating machinery). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is 
particularly important in those who have reduced or absent awareness of the warning signs of 
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes 
may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No 
specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin 
dose and other factors e.g. a patient`s level of diet and exercise. 
 
Tabulated list of adverse reactions 
 
The following related adverse reactions from clinical trials are listed below as MedDRA preferred 
term by system organ class and in order of decreasing incidence (very common: ≥1/10; common: 
≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

MedDRA system 
organ classes 

Very 
common 

Common Uncommon Rare Very 
rare 

Immune system disorders  

Local allergy  X    

Systemic allergy    X  

Skin and subcutaneous tissue disorders 

Lipodystrophy   X   

 
Description of selected adverse reactions 
 
Local allergy  
Local allergy in patients is common. Redness, swelling, and itching can occur at the site of insulin 
injection. This condition usually resolves in a few days to a few weeks. In some instances, this 
condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or 
poor injection technique.  
 
 



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Systemic allergy 
Systemic allergy,  which is rare  but potentially more serious, is a generalised allergy to insulin. It may 
cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast 
pulse, or sweating. Severe cases of generalised allergy may be life-threatening. 
 
Lipodystrophy 
Lipodystrophy at the injection site is uncommon. 
 
Oedema  
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic 
control is improved by intensified insulin therapy. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Insulins have no specific overdose definitions because serum glucose concentrations are a result of 
complex interactions between insulin levels, glucose availability and other metabolic processes. 
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy 
expenditure. 
 
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and 
vomiting. 
 
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or 
saccharated products. 
 
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or 
subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers 
sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously. 
 
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. 
However, glucose solution must be given intravenously if glucagon is not available or if the patient 
fails to respond to glucagon. The patient should be given a meal as soon as consciousness is 
recovered. 
 
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur 
after apparent clinical recovery. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group : Drugs used in diabetes, insulins and analogues for injection, fast-acting, 
ATC code: A10AB04 
 
The primary activity of insulin lispro is the regulation of glucose metabolism. 
 
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues. 
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and 
amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein 
catabolism and amino acid output. 



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Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given 
closer to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 
45 minutes before). Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 
5 hours) when compared to soluble insulin.  
 
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial 
hyperglycaemia with insulin lispro compared to soluble human insulin.  
 
As with all insulin preparations, the time course of insulin lispro action may vary in different 
individuals or at different times in the same individual and is dependent on dose, site of injection, 
blood supply, temperature and physical activity. The typical activity profile following subcutaneous 
injection is illustrated below. 
 

 
 
The above representation reflects the relative amount of glucose over time required to maintain the 
subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of 
these insulins on glucose metabolism over time. 
 
Clinical trials have been performed in children (61 patients aged 2 to 11) and children and adolescents 
(481 patients aged 9 to 19 years), comparing insulin lispro to human soluble insulin. The 
pharmacodynamic profile of insulin lispro in children is similar to that seen in adults.  
 
When used in subcutaneous infusion pumps, treatment with insulin lispro has been shown to result in 
lower glycosylated haemoglobin levels compared to soluble insulin.  In a double-blind, crossover 
study, the reduction in glycosylated haemoglobin levels after 12 weeks dosing was 0.37 percentage 
points with insulin lispro, compared to 0.03 percentage points for soluble insulin (p = 0.004). 
 
In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that 
the addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea alone. The 
reduction of HbA1c would also be expected with other insulin products e.g. soluble or isophane 
insulins. 
 
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of 
episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In some 
studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime 
hypoglycaemia. 
 



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The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment. 
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a 
glucose clamp procedure, were maintained over a wide range of renal function.  
 
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more 
rapid and of a shorter duration. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak 
blood levels 30 to 70 minutes following subcutaneous injection. When considering the clinical 
relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as 
discussed in 5.1). 
 
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients 
with renal impairment. In patients with type 2 diabetes over a wide range of renal function the 
pharmacokinetic differences between insulin lispro and soluble human insulin were generally 
maintained and shown to be independent of renal function.  Insulin lispro maintains more rapid 
absorption and elimination when compared to soluble human insulin in patients with hepatic 
impairment. 
 
5.3 Preclinical safety data 
 
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro 
behaved in a manner that closely resembled human insulin. Studies also demonstrate that the 
dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin. Acute, 
one month and twelve month toxicology studies produced no significant toxicity findings. 
 
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
m-Cresol  
Glycerol 
Dibasic sodium phosphate. 7H2O 
Zinc oxide 
Water for injections 
Hydrochloric acid and sodium hydroxide maybe used to adjust pH. 
 
6.2 Incompatibilities 
 
Cartridge, KwikPen and Junior KwikPen 
These medicinal products should not be mixed with any other insulin or any other medicinal product. 
 
Vial 
This medicinal product must not be mixed with other medicinal products except those mentioned in 
section 6.6. 
 
 
6.3 Shelf life 
 
Before use 
3 years.  
 



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After first use / after cartridge insertion 
28 days. 
 
6.4 Special precautions for storage 
 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
 
Before use 
Store in a refrigerator (2°C - 8°C). 
 
After first use / after cartridge insertion 
 
Vial 
Store in a refrigerator (2°C - 8°C) or below 30°C. 
 
Cartridge 
Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the 
needle attached. 
 
KwikPen and Junior KwikPen 
Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached. 
 
6.5 Nature and contents of container 
 
Vial 
The solution is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and secured 
with aluminium seals. Dimeticone or silicone emulsion may be used to treat the vial stoppers. 
 
10 ml Vial: Packs of 1 or 2 or a multipack of 5 (5 packs of 1). Not all packs may be marketed 
 
Cartridge 
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and 
plunger heads, and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to 
treat the cartridge plungers, and/or the glass cartridges. 
 
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed 
 
KwikPen 
The solution is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and 
plunger heads and are secured with aluminium seals. Dimeticone or silicone emulsion may be used to 
treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a disposable 
pen injector, called the “KwikPen”. Needles are not included. 
 
3 ml KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed 
 
Junior KwikPen 
Type I glass cartridges, sealed with halobutyl disc seals secured with aluminium seals and bromobutyl 
plunger heads. Dimeticone or silicone emulsion may be used to treat the cartridge plunger. The 3 ml 
cartridges are sealed in a disposable pen injector, called the “Junior KwikPen”. Needles are not 
included. 
 
3 ml Junior KwikPen: Packs of 1, 5 or a multipack of 10 (2 packs of 5). Not all packs may be 
marketed 
 
 
 
 



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6.6 Special precautions for disposal and other handling 
 
Instructions for use and handling 
To prevent the possible transmission of disease, each cartridge or pen must be used by one patient 
only, even if the needle on the delivery device is changed.  Patients using vials must never share 
needles or syringes. The patient should discard the needle after every injection. 
 
The Humalog solution should be clear and colourless. Humalog should not be used if it appears 
cloudy, thickened, or slightly coloured or if solid particles are visible. 
 
Do not mix insulin in vials with insulin in cartridges. See section 6.2. 
 
Preparing a dose 
 
Vial 
The vial is to be used in conjunction with an appropriate syringe (100 unit markings). 
 
i) Humalog 
1. Wash your hands.  
 
2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.   
 
3. If the therapeutic regimen requires the injection of basal insulin and Humalog at the same time, 

the two can be mixed in the syringe. If mixing insulins, refer to the instructions for mixing that 
follow in Section (ii) and 6.2.  

 
4. Draw air into the syringe equal to the prescribed Humalog dose. Wipe the top of the vial with a 

swab. Put the needle through the rubber top of the Humalog vial and inject the air into the vial.  
 
5. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand. 
 
6. Making sure the tip of the needle is in the Humalog, withdraw the correct dose into the syringe.  
 
7. Before removing the needle from the vial, check the syringe for air bubbles that reduce the 

amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side 
until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.  

 
8. Remove the needle from the vial and lay the syringe down so that the needle does not touch 

anything. 
 
ii) Mixing Humalog with longer-acting Human Insulins (see section 6.2) 
 
1. Humalog should be mixed with longer-acting human insulins only on the advice of a doctor. 
 
2. Draw air into the syringe equal to the amount of longer-acting insulin being taken. Insert the 

needle into the longer-acting insulin vial and inject the air. Withdraw the needle.  
 
3. Now inject air into the Humalog vial in the same manner, but do not withdraw the needle.  
 
4. Turn the vial and syringe upside down.  
 
5. Making sure the tip of the needle is in the Humalog, withdraw the correct dose of Humalog into 

the syringe.  
 
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the 

amount of Humalog in it. If bubbles are present, hold the syringe straight up and tap its side 
until the bubbles float to the top. Push them out with the plunger and withdraw the correct dose.  



 12 

 
7. Remove the needle from the vial of Humalog and insert it into the vial of the longer-acting 

insulin. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand and 
shake gently. Making sure the tip of the needle is in the insulin, withdraw the dose of longer-
acting insulin. 

 
8. Withdraw the needle and lay the syringe down so that the needle does not touch anything. 
 
Cartridge 
Humalog cartridges are to be used with a Lilly reusable insulin pen and should not be used with any 
other reusable pen as the dosing accuracy has not been established with other pens. 
 
The instructions with each individual pen must be followed for loading the cartridge, attaching the 
needle and administering the insulin injection. 
 
KwikPen and Junior KwikPen 
Before using the pre-filled pen the user manual included in the package leaflet must be read carefully.  
The pre-filled pen has to be used as recommended in the user manual.  
 
Pens should not be used if any part looks broken or damaged. 
 
Injecting a dose 
 
If using a pre-filled or reusable pen refer to the detailed instructions for preparing the pen and injecting 
the dose, the following is a general description. 
  
1. Wash your hands 
 
2. Choose a site for injection. 
 
3. Clean the skin as instructed. 
 
4. Stabilise the skin by spreading it or pinching up a large area. Insert the needle and inject as 

instructed. 
 
5. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not 

rub the area. 
 
6. Dispose of the syringe and needle safely. For an injection device use the outer needle cap, 

unscrew the needle and dispose of it safely. 
 
7. Use of the injection sites should be rotated so that the same is not used more than approximately 

once a month. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/96/007/002 
EU/1/96/007/004 
EU/1/96/007/020 
EU/1/96/007/021 



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EU/1/96/007/023 
EU/1/96/007/031 
EU/1/96/007/032 
EU/1/96/007/043 
EU/1/96/007/044 
EU/1/96/007/045 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 
 
Date of first authorisation: 30th April 1996 
Date of last renewal: 30th April 2006 
 
 
10.  DATE OF REVISION OF THE TEXT 

 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix25 100 units/ml, suspension for injection in vial 
Humalog Mix25 100 units/ml, suspension for injection in cartridge 
Humalog Mix25 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 100 units insulin lispro* (equivalent to 3.5mg).  
 
Humalog Mix25 consists of 25% insulin lispro solution and 75% insulin lispro protamine suspension. 
 
Vial 
Each vial contains 1000 units of insulin lispro in 10 ml suspension. 
 
Cartridge 
Each cartridge contains 300 units of insulin lispro in 3 ml suspension. 
 
KwikPen 
Each pre-filled pen contains 300 units of insulin lispro in 3 ml suspension. 
Each KwikPen delivers 1-60 units in steps of 1 unit. 
 
*produced in E.coli by recombinant DNA technology. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
 
White suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Humalog Mix25 is indicated for the treatment of patients with diabetes mellitus who require insulin 
for the maintenance of normal glucose homeostasis.  
 
4.2 Posology and method of administration 
 
Posology 
 
The dosage should be determined by the physician, according to the requirement of the patient. 
 
Humalog Mix25 may be given shortly before meals. When necessary, Humalog Mix25 can be given 
soon after meals. Humalog Mix25 should only be given by subcutaneous injection. Under no 
circumstances should Humalog Mix25 be given intravenously. 
 
The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous 
administration of Humalog Mix25. This allows Humalog Mix25 to be given very close to mealtime. 
The duration of action of the insulin lispro protamine suspension component of Humalog Mix25 is 
similar to that of a basal insulin (NPH). 
 



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The time course of action of any insulin may vary considerably in different individuals or at different 
times in the same individual. As with all insulin preparations, the duration of action of Humalog 
Mix25 is dependent on dose, site of injection, blood supply, temperature, and physical activity. 
 
Special populations 
 
Renal impairment 
Insulin requirements may be reduced in the presence of renal impairment. 
 
Hepatic impairment 
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for 
gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic 
impairment, an increase in insulin resistance may lead to increased insulin requirements. 
 
Paediatric population 
Administration of Humalog Mix25 to children below 12 years of age should be considered only in 
case of an expected benefit when compared to soluble insulin. 
 
Method of administration 
 
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen.  Use of 
injection sites should be rotated so that the same site is not used more than approximately once a 
month. 
 
When administered subcutaneously care should be taken when injecting Humalog Mix25 to ensure 
that a blood vessel has not been entered. After injection, the site of injection should not be massaged. 
Patients must be educated to use the proper injection techniques. 
 
KwikPen 
The KwikPen delivers 1 – 60 units in steps of 1 unit in a single injection. The needed dose is dialled in 
units. The number of units is shown in the dose window of the pen.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Hypoglycaemia. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Under no circumstances should Humalog Mix25 be given intravenously. 
 
Transferring a patient to another type or brand of insulin  
Transferring a patient to another type or brand of insulin should be done under strict medical 
supervision. Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, etc.), 
species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA 
versus animal-source insulin) may result in the need for a change in dosage.  
 
Hypoglycaemia and hyperglycaemia 
Conditions which may make the early warning symptoms of hypoglycaemia different or less 
pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or 
medications such as beta-blockers. 
 



 16 

A few patients who have experienced hypoglycaemic reactions after transfer from animal-source 
insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less 
pronounced or different from those experienced with their previous insulin. Uncorrected 
hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death. 
 
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin-
dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are 
potentially lethal. 
 
Insulin requirements and dosage adjustment 
Insulin requirements may be increased during illness or emotional disturbances. 
 
Adjustment of dosage may also be necessary if patients undertake increased physical activity or 
change their usual diet.  Exercise taken immediately after a meal may increase the risk of 
hypoglycaemia. 
 
Combination of Humalog Mix25 with pioglitazone 
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, 
especially in patients with risk factors for development of cardiac heart failure. This should be kept in 
mind, if treatment with the combination of pioglitazone and Humalog Mix25 is considered. If the 
combination is used, patients should be observed for signs and symptoms of heart failure, weight gain 
and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs. 
 
Avoidance of medication errors 
Patients must be instructed to always check the insulin label before each injection to avoid accidental 
mix-ups between the two different strengths of Humalog KwikPen as well as other insulin products. 
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the 
requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who 
are blind or have poor vision must be instructed to always get help/assistance from another person who 
has good vision and is trained in using the insulin device. 
 
Excipients 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially 
“sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Insulin requirements may be increased by substances with hyperglycaemic activity, such as oral 
contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as 
ritodrine, salbutamol, terbutaline).  
 
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such 
as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulphate antibiotics, certain 
antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain 
angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-
blockers, octreotide or alcohol.  
 
Mixing Humalog Mix25 with other insulins has not been studied. 
 
The physician should be consulted when using other medications in addition to Humalog Mix25 (see 
section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on 
pregnancy or on the health of the foetus/newborn.    



 17 

 
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational 
diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and 
increase during the second and third trimesters. Patients with diabetes should be advised to inform 
their doctor if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose 
control, as well as general health, is essential in pregnant patients with diabetes.  
 
Breast-feeding 
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.  
 
Fertility 
Insulin lispro did not induce fertility impairment in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may 
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or 
operating machinery). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is 
particularly important in those who have reduced or absent awareness of the warning signs of 
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes 
may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No 
specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin 
dose and other factors e.g. a patient`s level of diet and exercise. 
 
Tabulated list of adverse reactions 
 
The following related adverse reactions from clinical trials are listed below as MedDRA preferred 
term by system organ class and in order of decreasing incidence (very common: ≥1/10; common: 
≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

MedDRA system 
organ classes 

Very 
common 

Common Uncommon Rare Very 
rare 

Immune system disorders  

Local allergy  X    

Systemic allergy    X  

Skin and subcutaneous tissue disorders 

Lipodystrophy   X   

 
Description of selected adverse reactions 
 
Local allergy  
Local allergy in patients is common . Redness, swelling, and itching can occur at the site of insulin 
injection. This condition usually resolves in a few days to a few weeks. In some instances, this 



 18 

condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or 
poor injection technique.  
 
Systemic allergy 
Systemic allergy,  which is rare but potentially more serious, is a generalised allergy to insulin. It may 
cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast 
pulse, or sweating. Severe cases of generalised allergy may be life-threatening. 
 
Lipodystrophy 
Lipodystrophy at the injection site is uncommon . 
 
Oedema  
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic 
control is improved by intensified insulin therapy. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Insulins have no specific overdose definitions because serum glucose concentrations are a result of 
complex interactions between insulin levels, glucose availability and other metabolic processes.  
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy 
expenditure. 
 
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and 
vomiting. 
 
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or 
saccharated products. 
 
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or 
subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers 
sufficiently.  Patients who fail to respond to glucagon must be given glucose solution intravenously. 
 
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.  
However, glucose solution must be given intravenously if glucagon is not available or if the patient 
fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered. 
 
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur 
after apparent clinical recovery. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, intermediate 
or long acting combined with fast acting. ATC Code: A10A D04. 
 
The primary activity of insulin lispro is the regulation of glucose metabolism. 
 
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.  
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and 



 19 

amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein 
catabolism and amino acid output. 
 
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given 
closer to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 45 
minutes before). The rapid onset and early peak of activity of insulin lispro is observed following the 
subcutaneous administration of Humalog Mix25.  Humalog BASAL has an activity profile that is very 
similar to that of a basal insulin (NPH) over a period of approximately 15 hours.  
 
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial 
hyperglycaemia with Humalog Mix25 compared to human insulin mixture 30/70. In one clinical study 
there was a small (0.38 mmol/l) increase in blood glucose levels at night (3a.m.). 
 
In the figure below the pharmacodynamics of Humalog Mix25 and BASAL are illustrated. 

 
The above representation reflects the relative amount of glucose over time required to maintain the 
subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of 
these insulins on glucose metabolism over time. 
 
The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment. 
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a 
glucose clamp procedure, were maintained over a wide range of renal function.  
 
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more 
rapid and of a shorter duration. 
 
In two 8-month open label crossover studies, type 2 diabetes patients who were either new to insulin 
therapy or already using one or two injections of insulin, received 4 months of treatment with 
Humalog Mix25 (used twice daily with metformin) and insulin glargine (used once daily with 
metformin) in a randomised sequence. Detailed information can be found in the following table. 
 

 

0 4 8 12 16 20 24 

Humalog Mix25 
Humalog Basal 

 
 Time, hours 

Hypoglycemic Activity 



 20 

 Insulin-Naive Patients 
n = 78 

Not Insulin-Naive Patients 
n = 97 

Mean total daily insulin dose at endpoint 0.63 units/kg 0.42 units/kg 
Haemoglobin A1c –Reduction

1
  1.30% 

(mean at baseline = 8.7%) 
1.00 % 

(mean at baseline = 8.5%) 
Reduction of the mean of combined 
morning / evening two-hour postprandial 
blood glucose

1
  

3.46 mM 
 

2.48 mM 
 

Reduction of the mean fasting blood 
glucose

1
  

0.55 mM 
 

0.65 mM 
 

Incidence of hypoglycaemia at endpoint 25% 25% 
Bodyweight gain2 2.33 kg 0.96 kg 

1 from baseline to end of Humalog Mix25 treatment 
2 in patients randomised to Humalog Mix25 during the first crossover period 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak 
blood levels 30 to 70 minutes following subcutaneous injection. The pharmacokinetics of insulin 
lispro protamine suspension are consistent with those of an intermediate acting insulin such as NPH. 
The pharmacokinetics of Humalog Mix25 are representative of the individual pharmacokinetic 
properties of the two components. When considering the clinical relevance of these kinetics, it is more 
appropriate to examine the glucose utilisation curves (as discussed in 5.1). 
 
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients 
with renal impairment. In patients with type 2 diabetes over a wide range of renal function  the 
pharmacokinetic differences between insulin lispro and soluble human insulin were generally 
maintained and shown to be independent of renal function.  Insulin lispro maintains more rapid 
absorption and elimination when compared to soluble human insulin in patients with hepatic 
impairment. 
 
5.3 Preclinical safety data 
 
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro 
behaved in a manner that closely resembled human insulin.  Studies also demonstrate that the 
dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin.  Acute, 
one month and twelve month toxicology studies produced no significant toxicity findings. 
 
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.  
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Protamine sulphate 
m-Cresol  
Phenol  
Glycerol 
Dibasic sodium phosphate.7H2O 
Zinc oxide 
Water for injections 
Hydrochloric acid and sodium hydroxide may be used to adjust pH. 
 



 21 

6.2 Incompatibilities 
 
Mixing Humalog Mix25 with other insulins has not been studied. In the absence of compatibility 
studies, this medicinal product must not be mixed with other medicinal products. 
 
6.3 Shelf life 
 
Before use 
3 years.   
 
After first use /after cartridge insertion 
28 days. 
 
6.4 Special precautions for storage 
 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
 
Before use 
Store in a refrigerator (2°C - 8°C). 
 
After first use /after cartridge insertion 
 
Vial 
Store in a refrigerator (2°C - 8°C) or below 30°C. 
 
Cartridge 
Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the 
needle attached. 
 
KwikPen 
Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached. 
 
6.5 Nature and contents of container 
 
Vial 
The suspension is contained in type I flint glass vials, sealed with butyl or halobutyl stoppers and 
secured with aluminium seals.  Dimeticone or silicone emulsion may have been used to treat the vial 
stoppers.  
 
10 ml Vial: Pack of 1. Not all packs may be marketed. 
 
Cartridge 
The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and 
plunger heads and secured with aluminium seals. Dimeticone or silicone emulsion may have been used 
to treat the cartridge plunger, and/or the glass cartridge. 
 
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed. 
 
KwikPen 
The suspension is contained in type I flint glass cartridges, sealed with halobutyl disc seals and 
plunger heads and secured with aluminium seals.  Dimeticone or silicone emulsion may have been 
used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a 
disposable pen injector, called the “KwikPen”.  Needles are not included. 
 
3 ml KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed. 
 
 



 22 

6.6 Special precautions for disposal and other handling 
 
Instructions for use and handling 
 
To prevent the possible transmission of disease, each cartridge or pen must be used by one patient 
only, even if the needle on the delivery device is changed.  Patients using vials must never share 
needles or syringes. The patient should discard the needle after every injection. 
 
The Humalog Mix25 should be examined frequently and should not be used if clumps of material are 
present or if solid white particles stick to the bottom or wall of the container, giving it a frosted 
appearance. 
 
Preparing a dose 
 
Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to resuspend 
the insulin until it appears uniformly cloudy or milky. Cartridges and KwikPens containing Humalog 
Mix25 should be rotated in the palms of the hands ten times and inverted 180° ten times immediately 
before use to resuspend the insulin until it appears uniformly cloudy or milky.   
 
If not, repeat the above procedure until contents are mixed.  Cartridges contain a small glass bead to 
assist mixing.  
 
Do not shake vigorously as this may cause frothing which may interfere with the correct measurement 
of the dose.  
 
Vial 
The vial is to be used in conjunction with an appropriate syringe (100 unit markings). 
 
1. Wash your hands.  
 
2. If using a new vial, flip off the plastic protective cap, but do not remove the stopper.    
 
3. Draw air into the syringe equal to the prescribed Humalog Mix25 dose.  Wipe the top of the vial 

with a swab.  Put the needle through rubber top of the Humalog Mix25 vial and inject the air 
into the vial.  

 
4. Turn the vial and syringe upside down. Hold the vial and syringe firmly in one hand. 
 
5. Making sure the tip of the needle is in the Humalog Mix25, withdraw the correct dose into the 

syringe.  
 
6. Before removing the needle from the vial, check the syringe for air bubbles that reduce the 

amount of Humalog Mix25 in it. If bubbles are present, hold the syringe straight up and tap its 
side until the bubbles float to the top. Push them out with the plunger and withdraw the correct 
dose.  

 
7. Remove the needle from the vial and lay the syringe down so that the needle does not touch 

anything. 
 
Cartridge 
Humalog Mix25 cartridges are to be used with a Lilly reusable insulin pen and should not be used 
with any other reusable pen as the dosing accuracy has not been established with other pens. 
 
The instructions with each individual pen must be followed for loading the cartridge, attaching the 
needle and administering the insulin injection. 
 



 23 

KwikPen 
Before using the KwikPen the user manual included in the package leaflet must be read carefully.  The 
KwikPen has to be used as recommended in the user manual. 
 
Pens should not be used if any part looks broken or damaged. 
 
Injecting a dose 
 
If using a pre-filled or reusable pen refer to the detailed instructions for preparing the pen and injecting 
the dose, the following is a general description. 
 
1. Wash your hands 
 
2. Choose a site for injection. 
 
3. Clean the skin as instructed. 
 
4. Stabilise the skin by spreading it or pinching up a large area.  Insert the needle and inject as 

instructed. 
 
5. Pull the needle out and apply gentle pressure over the injection site for several seconds. Do not 

rub the area. 
 
6. Dispose of the syringe and needle safely. For an injection device use the outer needle cap, 

unscrew the needle and dispose of it safely. 
 
7. Use of the injection sites should be rotated so that the same is not used more than approximately 

once a month. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBERS  
 
EU/1/96/007/005 
EU/1/96/007/008 
EU/1/96/007/024 
EU/1/96/007/033 
EU/1/96/007/034 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF AUTHORISATION 
 
Date of first authorisation: 30th April 1996 
Date of last renewal: 30th April 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 
 



 24 

1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix50 100 units/ml, suspension for injection in cartridge 
Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 100 units insulin lispro* (equivalent to 3.5mg).  
 
Humalog Mix50 consists of 50% insulin lispro solution and 50% insulin lispro protamine suspension. 
 
Cartridge 
Each cartridge contains 300 units of insulin lispro in 3 ml suspension. 
 
KwikPen 
Each pre-filled pen contains 300 units of insulin lispro in 3 ml suspension. 
Each KwikPen delivers 1-60 units in steps of 1 unit. 
 
*produced in E.coli by recombinant DNA technology. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Suspension for injection. 
 
White suspension. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Humalog Mix50 is indicated for the treatment of patients with diabetes mellitus who require insulin for 
the maintenance of normal glucose homeostasis.  
 
4.2 Posology and method of administration 
 
Posology 
 
The dosage should be determined by the physician, according to the requirement of the patient. 
 
Humalog Mix50 may be given shortly before meals. When necessary, Humalog Mix50 can be given 
soon after meals. Humalog Mix50 should only be given by subcutaneous injection. Under no 
circumstances should Humalog Mix50 be given intravenously. 
 
The rapid onset and early peak of activity of Humalog itself is observed following the subcutaneous 
administration of Humalog Mix50. This allows Humalog Mix50 to be given very close to mealtime. 
The duration of action of the insulin lispro protamine suspension component of Humalog Mix50 is 
similar to that of a basal insulin (NPH). 
 
The time course of action of any insulin may vary considerably in different individuals or at different 
times in the same individual. As with all insulin preparations, the duration of action of Humalog Mix50 
is dependent on dose, site of injection, blood supply, temperature, and physical activity. 
 



 25 

Special populations 
 
Renal impairment 
Insulin requirements may be reduced in the presence of renal impairment. 
 
Hepatic impairment 
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for 
gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic 
impairment, an increase in insulin resistance may lead to increased insulin requirements. 
 
Paediatric population 
Administration of Humalog Mix50 to children below 12 years of age should be considered only in 
case of an expected benefit when compared to soluble insulin. 
 
Method of administration 
 
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen.  Use of 
injection sites should be rotated so that the same site is not used more than approximately once a 
month. 
 
When administered subcutaneously care should be taken when injecting Humalog Mix50 to ensure 
that a blood vessel has not been entered. After injection, the site of injection should not be massaged. 
Patients must be educated to use the proper injection techniques. 
 
KwikPen 
The KwikPen delivers 1 – 60 units in steps of 1 unit in a single injection. The needed dose is dialled in 
units. The number of units is shown in the dose window of the pen.  
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Hypoglycaemia. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Under no circumstances should Humalog Mix50 be given intravenously. 
 
Transferring a patient to another type or brand of insulin  
Transferring a patient to another type or brand of insulin should be done under strict medical 
supervision.  Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, etc.), 
species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA 
versus animal-source insulin) may result in the need for a change in dosage. 
 
Hypoglycaemia and hyperglycaemia 
Conditions which may make the early warning symptoms of hypoglycaemia different or less 
pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or 
medications such as beta-blockers. 
 
A few patients who have experienced hypoglycaemic reactions after transfer from animal-source 
insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less 
pronounced or different from those experienced with their previous insulin. Uncorrected 
hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death. 



 26 

 
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin-
dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are 
potentially lethal. 
 
Insulin requirements and dosage adjustment  
Insulin requirements may be increased during illness or emotional disturbances. 
 
Adjustment of dosage may also be necessary if patients undertake increased physical activity or change 
their usual diet. Exercise taken immediately after a meal may increase the risk of hypoglycaemia. 
 
Combination of Humalog Mix50 with pioglitazone 
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, 
especially in patients with risk factors for development of cardiac heart failure. This should be kept in 
mind, if treatment with the combination of pioglitazone and Humalog Mix50 is considered. If the 
combination is used, patients should be observed for signs and symptoms of heart failure, weight gain 
and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs. 
 
Avoidance of medication errors 
Patients must be instructed to always check the insulin label before each injection to avoid accidental 
mix-ups between the two different strengths of Humalog KwikPen as well as other insulin products. 
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the 
requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who 
are blind or have poor vision must be instructed to always get help/assistance from another person who 
has good vision and is trained in using the insulin device. 
 
Excipients 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially 
“sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Insulin requirements may be increased by substances with hyperglycaemic activity, such as oral 
contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as 
ritodrine, salbutamol, terbutaline).  
 
Insulin requirements may be reduced in the presence of substances with hypoglycaemic activity, such 
as oral hypoglycaemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, certain 
antidepressants, (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain 
angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-
blockers, octreotide or alcohol.  
 
Mixing Humalog Mix50 with other insulins has not been studied. 
 
The physician should be consulted when using other medications in addition to Humalog Mix50 (see 
section 4.4). 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on 
pregnancy or on the health of the foetus/newborn.    
 
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational 
diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and 
increase during the second and third trimesters. Patients with diabetes should be advised to inform 



 27 

their doctor if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose 
control, as well as general health, is essential in pregnant patients with diabetes.  
 
Breast-feeding 
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.  
 
Fertility 
Insulin lispro did not induce fertility impairment in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may 
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or 
operating machinery). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving, this is 
particularly important in those who have reduced or absent awareness of the warning signs of 
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
Hypoglycaemia is the most frequent undesirable effect of insulin therapy that a patient with diabetes 
may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, death. No 
specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both the insulin 
dose and other factors e.g. a patient`s level of diet and exercise. 
 
Tabulated list of adverse reactions 
 
The following related adverse reactions from clinical trials are listed below as MedDRA preferred 
term by system organ class and in order of decreasing incidence (very common: ≥1/10; common: 
≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

MedDRA system 
organ classes 

Very 
common 

Common Uncommon Rare Very 
rare 

Immune system disorders  

Local allergy  X    

Systemic allergy    X  

Skin and subcutaneous tissue disorders 

Lipodystrophy   X   

 
Description of selected adverse reactions 
 
Local allergy  
Local allergy in patients is common . Redness, swelling, and itching can occur at the site of insulin 
injection. This condition usually resolves in a few days to a few weeks. In some instances, this 
condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or 
poor injection technique.  
 



 28 

Systemic allergy 
Systemic allergy,  which is rare  but potentially more serious, is a generalised allergy to insulin. It may 
cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast 
pulse, or sweating. Severe cases of generalised allergy may be life-threatening. 
 
Lipodystrophy 
Lipodystrophy at the injection site is uncommon . 
 
Oedema  
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic 
control is improved by intensified insulin therapy. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Insulins have no specific overdose definitions because serum glucose concentrations are a result of 
complex interactions between insulin levels, glucose availability and other metabolic processes.  
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy 
expenditure. 
 
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and 
vomiting. 
 
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or 
saccharated products. 
 
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or 
subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers 
sufficiently.  Patients who fail to respond to glucagon must be given glucose solution intravenously. 
 
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously.  
However, glucose solution must be given intravenously if glucagon is not available or if the patient 
fails to respond to glucagon.  The patient should be given a meal as soon as consciousness is recovered. 
 
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur 
after apparent clinical recovery. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Drugs used in diabetes, insulins and analogues for injection, intermediate 
or long acting combined with fast acting. ATC Code: A10A D04. 
 
The primary activity of insulin lispro is the regulation of glucose metabolism. 
 
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues.  
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and 
amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein 
catabolism and amino acid output. 
 



 29 

Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given closer 
to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin (30 to 45 minutes 
before). The rapid onset and early peak of activity of insulin lispro is observed following the 
subcutaneous administration of Humalog Mix50. Humalog BASAL has an activity profile that is very 
similar to that of a basal insulin (NPH) over a period of approximately 15 hours.  In the figure below 
the pharmacodynamics of Humalog Mix50 and BASAL are illustrated. 
 
 
 
 
 
 
 
 
 
Hypoglycaemic  
activity 

 
                         Time, hours 
 

 
 
The above representation reflects the relative amount of glucose over time required to maintain the 
subject's whole blood glucose concentrations near fasting levels and is an indicator of the effect of 
these insulins on glucose metabolism over time. 
 
The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment. 
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a 
glucose clamp procedure, were maintained over a wide range of renal function.  
 
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more 
rapid and of a shorter duration. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak 
blood levels 30 to 70 minutes following subcutaneous injection. The pharmacokinetics of insulin lispro 
protamine suspension are consistent with those of an intermediate acting insulin such as NPH. The 
pharmacokinetics of Humalog Mix50 are representative of the individual pharmacokinetic properties 
of the two components. When considering the clinical relevance of these kinetics, it is more 
appropriate to examine the glucose utilisation curves (as discussed in 5.1). 
 
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients 
with renal impairment. In patients with type 2 diabetes over a wide range of renal function  the 
pharmacokinetic differences between insulin lispro and soluble human insulin were generally 
maintained and shown to be independent of renal function.  Insulin lispro maintains more rapid 
absorption and elimination when compared to soluble human insulin in patients with hepatic 
impairment. 

0 4 8 12 16 20 24 

Humalog Mix50 
Humalog Basal 



 30 

 
5.3 Preclinical safety data 
 
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro 
behaved in a manner that closely resembled human insulin. Studies also demonstrate that the 
dissociation of binding to the insulin receptor of insulin lispro  is equivalent to human insulin. Acute, 
one month and twelve month toxicology studies produced no significant toxicity findings. 
 
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Protamine sulphate 
m-Cresol  
Phenol  
Glycerol 
Dibasic sodium phosphate.7H2O 
Zinc oxide 
Water for injections 
Hydrochloric acid and sodium hydroxide may be used to adjust pH. 
 
6.2 Incompatibilities 
 
Mixing Humalog Mix50 with other insulins has not been studied. In the absence of compatibility 
studies, this medicinal product must not be mixed with other medicinal products. 
 
6.3 Shelf life 
 
Before use 
3 years.   
 
After first use/ after cartridge insertion 
28 days. 
 
6.4 Special precautions for storage 
 
Do not freeze. Do not expose to excessive heat or direct sunlight. 
 
Before use 
Store in a refrigerator (2°C - 8°C).  
 
After first use/ after cartridge insertion 
 
Cartridge 
Store below 30°C. Do not refrigerate. The pen with the inserted cartridge should not be stored with the 
needle attached. 
 
KwikPen 
Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached. 
 



 31 

6.5 Nature and contents of container  
 
Cartridge 
The suspension is contained in type I flint glass cartridges, sealed with butyl or halobutyl disc seals and 
plunger heads and secured with aluminium seals.  Dimeticone or silicone emulsion may have been 
used to treat the cartridge plunger, and/or the glass cartridge.   
 
3 ml Cartridge: Packs of 5 or 10. Not all packs may be marketed. 
 
KwikPen 
The suspension is contained in type I flint glass cartridges, sealed with halobutyl disc seals and 
plunger heads and secured with aluminium seals.  Dimeticone or silicone emulsion may have been 
used to treat the cartridge plunger, and/or the glass cartridge. The 3 ml cartridges are sealed in a 
disposable pen injector, called the “KwikPen”.  Needles are not included. 
3 ml KwikPen: Packs of 5 or a multipack of 10 (2 packs of 5). Not all packs may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Instructions for use and handling 
 
To prevent the possible transmission of disease, each cartridge or pen must be used by one patient 
only, even if the needle on the delivery device is changed. The patient should discard the needle after 
every injection. 
 
The Humalog Mix50 should be examined frequently and should not be used if clumps of material are 
present or if solid white particles stick to the bottom or wall of the container, giving it a frosted 
appearance. 
 
Preparing a dose 
 
Cartridges  or KwikPens containing Humalog Mix50 should be rotated in the palms of the hands ten 
times and inverted 180° ten times immediately before use to resuspend the insulin until it appears 
uniformly cloudy or milky.  If not, repeat the above procedure until contents are mixed.  Cartridges 
contain a small glass bead to assist mixing.   
 
Do not shake vigorously as this may cause frothing which may interfere with the correct measurement 
of the dose. 
 
Cartridge 
Humalog Mix50 cartridges are to be used with a Lilly reusable insulin pen and should not be used 
with any other reusable pen as the dosing accuracy has not been established with other pens. 
 
The instructions with each individual pen must be followed for loading the cartridge, attaching the 
needle and administering the insulin injection. 
 
KwikPen 
Before using the KwikPen the user manual included in the package leaflet must be read carefully.  The 
KwikPen has to be used as recommended in the user manual. 
 
Pens should not be used if any part looks broken or damaged. 
 
Injecting a dose 
If using a pre-filled or reusable pen refer to the detailed instructions for preparing the pen and injecting 
the dose, the following is a general description. 
 
1. Wash your hands. 
 



 32 

2. Choose a site for injection. 
 
3. Clean the skin as instructed. 
 
4. Stabilise the skin by spreading it or pinching up a large area.  Insert the needle and inject as 

instructed. 
 
5. Pull the needle out and apply gentle pressure over the injection site for several seconds.  Do not 

rub the area. 
 
6. Using the outer needle cap, unscrew the needle and dispose of it safely. 
 
7. Use of injection sites should be rotated so that the same site is not used more than approximately 

once a month. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORIZATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/96/007/006 
EU/1/96/007/025 
EU/1/96/007/035 
EU/1/96/007/036 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 30th April 1996 
Date of last renewal: 30th April 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 



 33 

1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Each ml contains 200 units insulin lispro*(equivalent to 6.9 mg).  
 
Each pre-filled pen contains 600 units of insulin lispro in 3 ml solution. 
 
Each KwikPen delivers 1-60 units in steps of 1 unit. 
 
* produced in E.coli by recombinant DNA technology. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Solution for injection.  
 
Clear, colourless, aqueous solution. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
For the treatment of adults with diabetes mellitus who require insulin for the maintenance of normal 
glucose homeostasis. Humalog 200 units/ml KwikPen is also indicated for the initial stabilisation of 
diabetes mellitus.  
 
4.2 Posology and method of administration 
 
Posology 
 
The dosage should be determined by the physician, according to the requirement of the patient.  
 
Humalog may be given shortly before meals. When necessary Humalog can be given soon after meals.  
 
Humalog takes effect rapidly and has a shorter duration of activity (2 to 5 hours) given subcutaneously 
as compared with soluble insulin. This rapid onset of activity allows a Humalog injection to be given 
very close to mealtime. The time course of action of any insulin may vary considerably in different 
individuals or at different times in the same individual. The faster onset of action compared to soluble 
human insulin is maintained regardless of injection site. The duration of action of Humalog is 
dependent on dose, site of injection, blood supply, temperature, and physical activity. 
 
Humalog can be used in conjunction with a longer-acting insulin or oral sulphonylurea medicinal 
products, on the advice of a physician.  
 
Humalog KwikPens 
Humalog KwikPen is available in two strengths.The Humalog 200 units/ml KwikPen (and Humalog 
100 units/ml KwikPen, see separate SmPC) delivers 1 – 60 units in steps of 1 unit in a single injection. 
The number of insulin units is shown in the dose window of the pen regardless of strength and no 
dose conversion should be done when transferring a patient to a new strength or to a pen with a 
different dose step.  



 34 

Humalog 200 units/ml KwikPen should be reserved for the treatment of patients with diabetes 
requiring daily doses of more than 20 units of rapid-acting insulin. The insulin lispro solution 
containing 200 units/ml should not be withdrawn from the pre-filled pen (the KwikPen) or mixed with 
any other insulin (see section 4.4 and section 6.2). 
 
Special populations 
 
Renal impairment 
Insulin requirements may be reduced in the presence of renal impairment. 
 
Hepatic impairment 
Insulin requirements may be reduced in patients with hepatic impairment due to reduced capacity for 
gluconeogenesis and reduced insulin breakdown; however, in patients with chronic hepatic 
impairment, an increase in insulin resistance may lead to increased insulin requirements. 
 
Method of administration 
 
Humalog solution for injection should be given subcutaneously.  
 
Subcutaneous administration should be in the upper arms, thighs, buttocks, or abdomen. Use of 
injection sites should be rotated so that the same site is not used more than approximately once a 
month. 
 
When administered subcutaneously care should be taken when injecting Humalog to ensure that a 
blood vessel has not been entered. After injection, the site of injection should not be massaged. 
Patients must be educated to use the proper injection techniques. 
 
Humalog 200 units/ml KwikPen solution for injection should not be used in an insulin infusion pump. 
 
Humalog 200 units/ml KwikPen solution for injection should not be used intravenously. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 
Hypoglycaemia. 
 
4.4 Special warnings and precautions for use 
 
Traceability 
In order to improve the traceability of biological medicinal products, the name and the batch number 
of the administered product should be clearly recorded. 
 
Transferring a patient to another type or brand of insulin  
Transferring a patient to another type or brand of insulin should be done under strict medical 
supervision. Changes in strength, brand (manufacturer), type (regular/soluble, NPH/isophane, etc.), 
species (animal, human, human insulin analogue), and/or method of manufacture (recombinant DNA 
versus animal-source insulin) may result in the need for a change in dosage. For fast-acting insulins, 
any patient also on basal insulin must optimise dosage of both insulins to obtain glucose control across 
the whole day, particularly nocturnal/fasting glucose control. 
 
Hypoglycaemia and hyperglycaemia 
Conditions which may make the early warning symptoms of hypoglycaemia different or less 
pronounced include long duration of diabetes, intensified insulin therapy, diabetic nerve disease or 
medicinal products such as beta-blockers. 
 



 35 

A few patients who have experienced hypoglycaemic reactions after transfer from animal-source 
insulin to human insulin have reported that the early warning symptoms of hypoglycaemia were less 
pronounced or different from those experienced with their previous insulin. Uncorrected 
hypoglycaemic or hyperglycaemic reactions can cause loss of consciousness, coma, or death. 
 
The use of dosages which are inadequate or discontinuation of treatment, especially in insulin-
dependent diabetics, may lead to hyperglycaemia and diabetic ketoacidosis; conditions which are 
potentially lethal. 
 
Insulin requirements and dosage adjustment 
Insulin requirements may be increased during illness or emotional disturbances. 
Adjustment of dosage may also be necessary if patients undertake increased physical activity or 
change their usual diet. Exercise taken immediately after a meal may increase the risk of 
hypoglycaemia. A consequence of the pharmacodynamics of rapid-acting insulin analogues is that if 
hypoglycaemia occurs, it may occur earlier after an injection when compared with soluble human 
insulin. 
 
Combination of Humalog with pioglitazone 
Cases of cardiac failure have been reported when pioglitazone was used in combination with insulin, 
especially in patients with risk factors for development of cardiac heart failure. This should be kept in 
mind, if treatment with the combination of pioglitazone and Humalog is considered. If the 
combination is used, patients should be observed for signs and symptoms of heart failure, weight gain 
and oedema. Pioglitazone should be discontinued, if any deterioration in cardiac symptoms occurs. 
 
Avoidance of medication errors when using insulin lispro (200 units/ml) in pre-filled pen: 
The insulin lispro solution for injection containing 200 units/ml must not be transferred from the pre-
filled pen, the KwikPen, to a syringe. The markings on the insulin syringe will not measure the dose 
correctly. Overdose can result causing severe hypoglycemia.  The insulin lispro solution for injection 
containing 200 units/ml must not be transferred from the KwikPen to any other insulin delivery 
device, including insulin infusion pumps. 
Patients must be instructed to always check the insulin label before each injection to avoid accidental 
mix-ups between the two different strengths of Humalog as well as other insulin products. 
 
Patients must visually verify the dialled units on the dose counter of the pen. Therefore, the 
requirement for patients to self-inject is that they can read the dose counter on the pen. Patients who 
are blind or have poor vision must be instructed to always get help/assistance from another person who 
has good vision and is trained in using the insulin device. 
 
Excipients 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e., essentially 
“sodium-free”. 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Insulin requirements may be increased by medicinal products with hyperglycaemic activity, such as 
oral contraceptives, corticosteroids, or thyroid replacement therapy, danazol, beta2 stimulants (such as 
ritodrine, salbutamol, terbutaline).  
Insulin requirements may be reduced in the presence of medicinal products with hypoglycaemic 
activity, such as oral hypoglycemics, salicylates (for example, acetylsalicylic acid), sulpha antibiotics, 
certain antidepressants (monoamine oxidase inhibitors, selective serotonin reuptake inhibitors), certain 
angiotensin converting enzyme inhibitors (captopril, enalapril), angiotensin II receptor blockers, beta-
blockers, octreotide or alcohol.  
 
The physician should be consulted when using other medicinal products in addition to Humalog 
200 units/ml KwikPen (see section 4.4). 
 



 36 

4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
Data on a large number of exposed pregnancies do not indicate any adverse effect of insulin lispro on 
pregnancy or on the health of the foetus/newborn.   
 
It is essential to maintain good control of the insulin-treated (insulin-dependent or gestational 
diabetes) patient throughout pregnancy. Insulin requirements usually fall during the first trimester and 
increase during the second and third trimesters. Patients with diabetes should be advised to inform 
their doctor if they are pregnant or are contemplating pregnancy. Careful monitoring of glucose 
control, as well as general health, is essential in pregnant patients with diabetes.  
 
Breast-feeding 
Patients with diabetes who are breast-feeding may require adjustments in insulin dose, diet or both.  
 
Fertility 
Insulin lispro did not induce fertility impairment in animal studies (see section 5.3). 
 
4.7 Effects on ability to drive and use machines 
 
The patient’s ability to concentrate and react may be impaired as a result of hypoglycaemia. This may 
constitute a risk in situations where these abilities are of special importance (e.g. driving a car or using 
machines). 
 
Patients should be advised to take precautions to avoid hypoglycaemia whilst driving. This is 
particularly important in those who have reduced or absent awareness of the warning signs of 
hypoglycaemia or have frequent episodes of hypoglycaemia. The advisability of driving should be 
considered in these circumstances. 
 
4.8 Undesirable effects 
 
Summary of safety profile 
 
Hypoglycaemia is the most frequent adverse reaction of insulin lispro therapy that a patient with 
diabetes may suffer. Severe hypoglycaemia may lead to loss of consciousness, and in extreme cases, 
death. No specific frequency for hypoglycaemia is presented, since hypoglycaemia is a result of both 
the insulin dose and other factors e.g. a patient`s level of diet and exercise. 
 
Tabulated list of adverse reactions 
 
The following related adverse reactions from clinical trials are listed below as MedDRA preferred 
term by system organ class and in order of decreasing incidence (very common: ≥1/10; common: 
≥1/100 to <1/10; uncommon: ≥1/1,000 to <1/100; rare: ≥1/10,000 to <1/1,000; very rare: <1/10,000). 
 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 

MedDRA system 
organ classes 

Very 
common 

Common Uncommon Rare Very 
rare 

Immune system disorders  

Local allergy  X    

Systemic allergy    X  

Skin and subcutaneous tissue disorders 

Lipodystrophy   X   

 



 37 

Description of selected adverse reactions 
 
Local allergy  
Local allergy in patients is common). Redness, swelling, and itching can occur at the site of insulin 
injection. This condition usually resolves in a few days to a few weeks. In some instances, this 
condition may be related to factors other than insulin, such as irritants in the skin cleansing agent or 
poor injection technique.  
 
Systemic allergy  
Systemic allergy, which is rare but potentially more serious, is a generalised allergy to insulin. It may 
cause a rash over the whole body, shortness of breath, wheezing, reduction in blood pressure, fast 
pulse, or sweating. Severe cases of generalised allergy may be life-threatening. 
 
Lipodystrophy  
Lipodystrophy at the injection site is uncommon. 
 
Oedema  
Cases of oedema have been reported with insulin therapy, particularly if previous poor metabolic 
control is improved by intensified insulin therapy. 
 
Reporting of suspected adverse reactions 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Insulins have no specific overdose definitions because serum glucose concentrations are a result of 
complex interactions between insulin levels, glucose availability and other metabolic processes. 
Hypoglycaemia may occur as a result of an excess of insulin activity relative to food intake and energy 
expenditure. 
 
Hypoglycaemia may be associated with listlessness, confusion, palpitations, headache, sweating and 
vomiting. 
 
Mild hypoglycaemic episodes will respond to oral administration of glucose or other sugar or 
saccharated products. 
 
Correction of moderately severe hypoglycaemia can be accomplished by intramuscular or 
subcutaneous administration of glucagon, followed by oral carbohydrate when the patient recovers 
sufficiently. Patients who fail to respond to glucagon must be given glucose solution intravenously. 
 
If the patient is comatose, glucagon should be administered intramuscularly or subcutaneously. 
However, glucose solution must be given intravenously if glucagon is not available or if the patient 
fails to respond to glucagon. The patient should be given a meal as soon as consciousness is recovered. 
 
Sustained carbohydrate intake and observation may be necessary because hypoglycaemia may recur 
after apparent clinical recovery. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group : Drugs used in diabetes, insulins and analogues for injection, fast-acting, 
ATC code: A10AB04 



 38 

 
The primary activity of insulin lispro is the regulation of glucose metabolism. 
 
In addition, insulins have several anabolic and anti-catabolic actions on a variety of different tissues. 
Within muscle tissue this includes increasing glycogen, fatty acid, glycerol and protein synthesis and 
amino acid uptake, while decreasing glycogenolysis, gluconeogenesis, ketogenesis, lipolysis, protein 
catabolism and amino acid output. 
 
Insulin lispro has a rapid onset of action (approximately 15 minutes), thus allowing it to be given 
closer to a meal (within zero to 15 minutes of the meal) when compared to soluble insulin  
(30 to 45 minutes before). Insulin lispro takes effect rapidly and has a shorter duration of activity (2 to 
5 hours) when compared to soluble insulin.  
 
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated reduced postprandial 
hyperglycaemia with insulin lispro compared to soluble human insulin.  
The time course of insulin lispro action may vary in different individuals or at different times in the 
same individual and is dependent on dose, site of injection, blood supply, temperature and physical 
activity. The typical activity profile following subcutaneous injection is illustrated below. 
 
Figure 1: 

 
 
The above representation (figure 1) reflects the relative amount of glucose over time required to 
maintain the subject's whole blood glucose concentrations near fasting levels and is an indicator of the 
effect of these insulins (100 units/ml) on glucose metabolism over time. 
 
The pharmacodynamic responses of insulin lispro 200 units/ml solution for injection were similar to 
those for insulin lispro 100 units/ml solution for injection after subcutaneous administration of a single 
20 unit dose in healthy subjects as shown in the graph below (figure 2). 



 39 

 
Figure 2: Arithmetic mean glucose infusion rate versus time profiles following subcutaneous 
administration of 20 units of insulin lispro 200 units/ml or insulin lispro 100 units/ml 
 
In patients with type 2 diabetes on maximum doses of sulphonyl urea agents, studies have shown that 
the addition of insulin lispro significantly reduces HbA1c compared to sulphonyl urea alone. The 
reduction of HbA1c would also be expected with other insulin products e.g. soluble or isophane 
insulins. 
 
Clinical trials in patients with type 1 and type 2 diabetes have demonstrated a reduced number of 
episodes of nocturnal hypoglycaemia with insulin lispro compared to soluble human insulin. In some 
studies, reduction of nocturnal hypoglycaemia was associated with increased episodes of daytime 
hypoglycaemia. 
 
The glucodynamic response to insulin lispro is not affected by renal or hepatic function impairment. 
Glucodynamic differences between insulin lispro and soluble human insulin, as measured during a 
glucose clamp procedure, were maintained over a wide range of renal function. 
 
Insulin lispro has been shown to be equipotent to human insulin on a molar basis but its effect is more 
rapid and of a shorter duration. 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetics of insulin lispro reflect a compound that is rapidly absorbed, and achieves peak 
blood levels 30 to 70 minutes following subcutaneous injection. When considering the clinical 
relevance of these kinetics, it is more appropriate to examine the glucose utilisation curves (as 
discussed in 5.1). 
 
Insulin lispro maintains more rapid absorption when compared to soluble human insulin in patients 
with renal impairment. In patients with type 2 diabetes over a wide range of renal function the 
pharmacokinetic differences between insulin lispro and soluble human insulin were generally 
maintained and shown to be independent of renal function.  Insulin lispro maintains more rapid 

0 1 2 3 4 5 6 7 8 
0 

100

200

300

400

500

600

700

800

Time (hr) 

Glucose 

Infusion 

Rate 

(mg/min) 

Insulin lispro 200 units/ml 
Insulin lispro 100 units/ml 

 



 40 

absorption and elimination when compared to soluble human insulin in patients with hepatic 
impairment. 
 
Insulin lispro 200 units/ml solution for injection was bioequivalent to insulin lispro 100 units/ml 
solution for injection after subcutaneous administration of a single 20 unit dose in healthy subjects. 
Time to maximum concentration was also similar between formulations.  
 
5.3 Preclinical safety data 
 
In in vitro tests, including binding to insulin receptor sites and effects on growing cells, insulin lispro 
behaved in a manner that closely resembled human insulin. Studies also demonstrate that the 
dissociation of binding to the insulin receptor of insulin lispro is equivalent to human insulin. Acute, 
one month and twelve month toxicology studies produced no significant toxicity findings. 
 
Insulin lispro did not induce fertility impairment, embryotoxicity or teratogenicity in animal studies.  
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
m-Cresol 
Glycerol 
Trometamol 
Zinc oxide 
Water for injections 
Hydrochloric acid and sodium hydroxide may be used to adjust pH. 
 
6.2 Incompatibilities 
 
This medicinal product should not be mixed with any other insulin or any other medicinal product. 
The solution for injection should not be diluted.  
 
6.3 Shelf life 
 
Before use 
3 years.  
 
After first use 
28 days. 
 
6.4 Special precautions for storage 
 
Do not freeze. Do not expose to excessive heat or direct sunlight. 
 
Before use 
Store in a refrigerator (2°C - 8°C).  
 
After first use 
Store below 30°C. Do not refrigerate. The pre-filled pen should not be stored with the needle attached. 
 
6.5 Nature and contents of container  
 
Type I glass cartridges, sealed with halobutyl disc seals and plunger heads and secured with 
aluminium seals. Dimeticone or silicone emulsion may be used to treat the cartridge plunger, and/or 
the glass cartridge. The 3 ml cartridges which contain 600 units insulin lispro (200 units/ml), are 
sealed in a disposable pen injector, called the “KwikPen”. Needles are not included. 



 41 

 
1 pre-filled pen of 3 ml  
2 pre-filled pens of 3 ml  
5 pre-filled pens of 3 ml  
Multipacks containing 10 (2 packs of 5) pre-filled pens of 3 ml  
 
Not all packs may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Instructions for use and handling 
To prevent the possible transmission of disease, each pen must be used by one patient only, even if the 
needle is changed. The patient should discard the needle after every injection. 
 
The Humalog solution should be clear and colourless. Humalog should not be used if it appears 
cloudy, thickened, or slightly coloured or if solid particles are visible. 
 
Handling of the pre-filled pen 
Before using the KwikPen the user manual included in the package leaflet must be read carefully.  The 
KwikPen has to be used as recommended in the user manual. 
 
Pens should not be used if any part looks broken or damaged. 
 
Any unused product or waste material should be disposed of in accordance with local requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/96/007/039 
EU/1/96/007/040 
EU/1/96/007/041 
EU/1/96/007/042 
 
 
9. DATE OF FIRST AUTHORISATION / RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 30th April 1996 
Date of last renewal: 30th April 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu 



 42 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

 
ANNEX II 

 
A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE 

SUBSTANCE AND MANUFACTURERS RESPONSIBLE 
FOR BATCH RELEASE 

 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY 

AND USE 
  

C. OTHER CONDITIONS AND REQUIREMENTS OF THE 
MARKETING AUTHORISATION 

 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO 

THE SAFE AND EFFECTIVE USE OF THE MEDICINAL 
PRODUCT 

 
 



 43 

A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE 

 
Names and addresses of the manufacturers of the biological active substance 
 
Fermentation  
Eli Lilly and Company, Lilly Technology Center Building 333 and 324, Indianapolis, Indiana, USA 
Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12.3 KM (PR05), 65th Infantry Road, Carolina, 
Puerto Rico 00985 
 
Granule Recovery  
Eli Lilly and Company, Lilly Technology Center Building 130, Indianapolis, Indiana, USA 
Lilly del Caribe, Inc., Puerto Rico Industrial Park, 12.3 KM (PR05), 65th Infantry Road, Carolina, 
Puerto Rico 00985 
 
Names and addresses of the manufacturers responsible for batch release 
 
Vials  
Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain. 
 
Cartridges  
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France. 
Eli Lilly Italia S.p.A., Via  Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
Humalog 100 units/ml KwikPen, Humalog Mix25 100 units/ml KwikPen, Humalog Mix50 100 units/ml 
KwikPen Humalog 200 units/ml KwikPen  
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France. 
Eli Lilly Italia S.p.A., Via  Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
Humalog 100 units/ml Junior KwikPen 
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France.  
 
The printed package leaflet of the medicinal product must state the name and address of the 
manufacturer responsible for the release of the concerned batch 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE  
 
Medicinal product subject to medical prescription  
 
 
C.  OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
 Periodic Safety Update Reports (PSURs) 
 
The requirements for submission of PSURs for this medicinal product are set 
out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 
2001/83/EC and any subsequent updates published on the European medicines web-portal. 
 
 



 44 

D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 
EFFECTIVE USE OF THE MEDICINAL PRODUCT  

 
Risk Management Plan (RMP) 
 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing authorisation 
and any agreed subsequent updates of the RMP. 
 
An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 
 Whenever the risk management system is modified, especially as the result of new information 

being received that may lead to a significant change to the benefit/risk profile or as the result 
of an important (pharmacovigilance or risk minimisation) milestone being reached. 

 
 
 
 
 
 
 



 45 

 
 
 
 
 
 
 
 
 
 
 
 

 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 



 46 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 



 47 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Vial.  Pack of 1 and 2 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml solution for injection in vial 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate 7H0 with m-cresol as a preservative in water 
for injection. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
1 vial of 10 ml 
2 vials of 10 ml  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 



 48 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/96/007/002 
EU/1/96/007/020 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 49 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – Vial 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml solution for injection in vial 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate 7H0 with m-cresol as a preservative in water 
for injection. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
Multipack: 5 vials of 10 ml. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 



 50 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/021  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 



 51 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – Vial 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml solution for injection in vial 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate 7H0 with m-cresol as a preservative in water 
for injection. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
Multipack: 5 (5 packs of 1) vials of 10 ml.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous and intravenous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 52 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/021  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN:  
NN:  
 
 



 53 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog 100 units/ml solution for injection in vial 
Insulin lispro 
Subcutaneous and intravenous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP   
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 54 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON - Cartridges.  Pack of 5 and 10 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml solution for injection in cartridge 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate7H0 with m-cresol as a preservative in water 
for injection. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection 
 
5 cartridges of 3 ml  
10 cartridges of 3 ml 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNINGS, IF NECESSARY 
 
These cartridges are for use with a Lilly 3 ml pen only. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 55 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use cartridges may be used for up to 28 days. Following insertion in a pen, the cartridge and 
pen should be stored below 30C and should not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/96/007/004 
EU/1/96/007/023 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
(To open, lift here and pull) 
CARTON HAS BEEN OPENED 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 56 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog 100 units/ml solution for injection in cartridge 
Insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 57 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Vial. Pack of 1 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix25 100 units/ml suspension for injection in vial 
25% insulin lispro and 75% insulin lispro protamine suspension  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate.7H2O with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection  
1 vial of 10 ml 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNINGS, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 



 58 

Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use, vials may be used for up to 28 days. Vials in use should be stored below 30C. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/005 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 59 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog Mix25 100 units/ml suspension for injection in vial 
25% insulin lispro and 75% insulin lispro protamine suspension 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
10 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 60 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Cartridges. Pack of 5 and 10 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix25 100 units/ml suspension for injection in cartridge 
25% insulin lispro and 75% insulin lispro protamine suspension  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection  
5 cartridges of 3 ml 
10 cartridges of 3 ml 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
These cartridges are for use with a Lilly 3 ml pen only. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 61 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use cartridges may be used for up to 28 days. Following insertion in a pen, the cartridge and 
pen should be stored below 30C and should not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/96/007/008 
EU/1/96/007/024 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
(To open, lift here and pull) 
CARTON HAS BEEN OPENED 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix25 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 62 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
 
 
LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog Mix25 100 units/ml suspension for injection in cartridge 
25% insulin lispro and 75% insulin lispro protamine suspension  
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 63 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Cartridges. Pack of 5 and 10 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix50 100 units/ml suspension for injection in cartridge 
50% insulin lispro and 50% insulin lispro protamine suspension  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection  
5 cartridges of 3 ml 
10 cartridges of 3 ml 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
These cartridges are for use with a Lilly 3 ml pen only. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 64 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use cartridges may be used for up to 28 days. Following insertion in a pen, the cartridge and 
pen should be stored below 30C and should not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/96/007/006 
EU/1/96/007/025 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
(To open, lift here and pull) 
CARTON HAS BEEN OPENED 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix50 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC: 
SN:  
NN:  



 65 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
 
LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog Mix50 100 units/ml suspension for injection in cartridge 
50% insulin lispro and 50% insulin lispro protamine suspension  
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 66 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – KwikPen. Pack of 5 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen. 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol as a preservative in water 
for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
5 pens of 3 ml  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 



 67 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/031 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
If seal is broken before first use, contact pharmacist. 
 
16. INFORMATION IN BRAILLE 
 
Humalog KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



 68 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – KwikPen 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol as a preservative in water 
for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.. 
 
Multipack: 5 pens of 3 ml. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 



 69 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/032 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
If seal is broken before first use, contact pharmacist. 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog KwikPen 
 



 70 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol as a preservative in water 
for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.. 
 
Multipack: 10 (2 packs of 5) pens of 3 ml.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  



 71 

Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/032  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



 72 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog 100 units/ml KwikPen, solution for injection 
Insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 73 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – KwikPen. Pack of 5 
 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix25 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
25% insulin lispro and 75% insulin lispro protamine suspension  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection 
5 pens of 3 ml 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
 
 
8. EXPIRY DATE 
 
EXP  
 



 74 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/033 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
If seal is broken before first use, contact pharmacist. 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix25 KwikPen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 75 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack - KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix25 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
25% insulin lispro and 75% insulin lispro protamine suspension  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection. 
Multipack: 5 pens of 3 ml. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
 
 
8. EXPIRY DATE 
 
EXP  
 



 76 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/034 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
If seal is broken before first use, contact pharmacist. 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix25 KwikPen 



 77 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix25 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
25% insulin lispro and 75% insulin lispro protamine suspension 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection. 
 
Multipack: 10 (2 packs of 5) pens of 3 ml.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 78 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/034  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix25 KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 
 



 79 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog Mix25 100 units/ml KwikPen, suspension for injection 
25% insulin lispro and 75% insulin lispro protamine suspension 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 80 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – KwikPen. Pack of 5 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
50% insulin lispro and 50% insulin lispro protamine suspension  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection.  
5 pens of 3 ml 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
 
 
8. EXPIRY DATE 
 
EXP  
 



 81 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/035 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
If seal is broken before first use, contact pharmacist. 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix50 KwikPen 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN: 
NN:  
 



 82 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack - KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
50% insulin lispro and 50% insulin lispro protamine suspension  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection.. 
Multipack: 5 pens of 3 ml. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTE OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
 
 
8. EXPIRY DATE 
 
EXP  
 



 83 

 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/036 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
If seal is broken before first use, contact pharmacist. 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix50 KwikPen 
 



 84 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
50% insulin lispro and 50% insulin lispro protamine suspension 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml suspension contains 100 units of insulin lispro (equivalent to 3.5mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains protamine sulphate, glycerol, zinc oxide, dibasic sodium phosphate 7 H20 with m-cresol and 
phenol as preservatives in water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Suspension for injection.. 
 
Multipack: 10 (2 packs of 5) pens of 3 ml.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Resuspend carefully. See enclosed package leaflet. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 85 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/036  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog Mix50 KwikPen  
 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  
 



 86 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog Mix50 100 units/ml KwikPen, suspension for injection 
50% insulin lispro and 50% insulin lispro protamine suspension 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml (3.5 mg/ml) 
 
 
6. OTHER 
 



 87 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – KwikPen. Pack of 1, 2 and 5 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 200 units of insulin lispro (equivalent to 6.9 mg)  
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, trometamol, metacresol and water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
1 pen of 3 mL. 
2 pens of 3 mL. 
5 pens of 3 mL. 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Use only in this pen, or severe overdose can result. 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 88 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/96/007/039  1 pen 
EU/1/96/007/040  2 pens 
EU/1/96/007/041  5 pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog 200 units/ml  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 89 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 200 units of insulin lispro (equivalent to 6.9 mg)  
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, trometamol, metacresol and water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
Multipack: 5 pens of 3 ml. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Use only in this pen, or severe overdose can result. 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 90 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/042  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog 200 units/ml  
 



 91 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – KwikPen 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 200 units of insulin lispro (equivalent to 6.9 mg) 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, trometamol, metacresol and water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
Multipack: 10 (2 packs of 5) pens of 3 ml.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
Use only in this pen, or severe overdose can result. 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 92 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Pens in use should be stored below 30C and should 
not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/042  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog 200 units/ml  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN: 
 
 



 93 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog 200 units/ml KwikPen, solution for injection 
Insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml 
 
 
6. OTHER 
 
USE ONLY IN THIS PEN, OR SEVERE OVERDOSE CAN RESULT. 
 
 



 94 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON – Junior KwikPen. Pack of 1 and 5 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen. 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5 mg). 
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate7H0, metacresol and water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
1 pen of 3 mL. 
5 pens of 3 mL. 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
The pen delivers 0.5 – 30 units in steps of 0.5 units. 
 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 95 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Discard after 28 days even if some of the solution 
remains.  Pens in use should be stored below 30C and should not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht 
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBERS  
 
EU/1/96/007/043  1 pen 
EU/1/96/007/044  5 pens 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog 100 units/ml Junior KwikPen  
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 96 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
INTERMEDIATE CARTON (without blue box) component of a multipack – Junior KwikPen  
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen. 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5 mg).  
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate7H0, metacresol and water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.   
 
Multipack: 5 pens of 3 ml. Component of a multipack, can’t be sold separately. 
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
The pen delivers 0.5 – 30 units in steps of 0.5 units. 
 
If seal is broken before first use, contact pharmacist. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 97 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. . Discard after 28 days even if some of the solution 
remains. Pens in use should be stored below 30C and should not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/045  
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog 100 units/ml Junior KwikPen 
 



 98 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING  
 
OUTER CARTON (with blue box) multipack – Junior KwikPen  
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen. 
Insulin lispro  
 
 
2. STATEMENT OF ACTIVE SUBSTANCE 
 
One ml solution contains 100 units of insulin lispro (equivalent to 3.5 mg).  
 
 
3. LIST OF EXCIPIENTS 
 
Contains glycerol, zinc oxide, dibasic sodium phosphate7H0, metacresol and water for injections. 
Sodium hydroxide and/or hydrochloric acid may have been used to adjust acidity. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Solution for injection.  
 
Multipack: 10 (2 packs of 5) pens of 3 ml.  
 
 
5. METHOD AND ROUTES OF ADMINISTRATION 
 
Read the package leaflet before use. 
Subcutaneous use. 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE SIGHT AND REACH OF CHILDREN 
 
Keep out of the sight and reach of children 
 
 
7. OTHER SPECIAL WARNING, IF NECESSARY 
 
The pen delivers 0.5 – 30 units in steps of 0.5 units. 
 
 
8. EXPIRY DATE 
 
EXP  
 
 



 99 

9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator (2°C - 8°C). 
Do not freeze. Do not expose to excessive heat or direct sunlight.  
Once in use pens may be used for up to 28 days. Discard after 28 days even if some of the solution 
remains. Pens in use should be stored below 30C and should not be refrigerated. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Eli Lilly Nederland B.V. 
Papendorpseweg 83, 3528 BJ Utrecht  
The Netherlands 
 
 
12. MARKETING AUTHORISATION NUMBER  
 
EU/1/96/007/045 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
 
16. INFORMATION IN BRAILLE 
 
Humalog 100 units/ml Junior KwikPen   
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC:  
SN:  
NN:  



 100 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
LABEL TEXT 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Humalog 100 units/ml Junior KwikPen, solution for injection 
Insulin lispro 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP  
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3 ml 
 
 
6. OTHER 
 
 
 
 
 



 101 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



 102 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog 100 units/ml, solution for injection in vial 
insulin lispro 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog is and what it is used for 
2. What you need to know before you use Humalog 
3. How to use Humalog 
4. Possible side effects 
5. How to store Humalog 
6. Contents of the pack and other information 
 
 
1. What Humalog is and what it is used for  
 
Humalog is used to treat diabetes. Humalog works more quickly than normal human insulin because 
the insulin molecule has been changed slightly. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It 
works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally 
use Humalog within 15 minutes of a meal. 
 
Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin 
comes with another patient information leaflet to tell you about it. Do not change your insulin unless 
your doctor tells you to. Be very careful if you do change insulin. 
 
Humalog is suitable for use in adults and children.  
 
 
2. What you need to know before you use Humalog  
 
Do NOT use Humalog 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how 

to deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel 

the warning symptoms when your blood sugar is falling too low. Warning signs are listed later 
in this leaflet. You must think carefully about when to have your meals, how often to exercise 
and how much to do. You must also keep a close watch on your blood sugar levels by testing 
your blood glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human 
insulin have reported that the early warning symptoms were less obvious or different. If you 
often have hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 



 103 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse 

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
- Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. 

The time difference between countries may mean that you have to have your injections and 
meals at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke 
who were treated with pioglitazone and insulin experienced the development of heart failure. 
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual 
shortness of breath or rapid increase in weight or localised swelling (oedema). 

 
Other medicines and Humalog 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Humalog 
 
Always check the pack and the vial label for the name and type of the insulin when you get it 
from your pharmacy. Make sure you get the Humalog that your doctor has told you to use. 



 104 

 
Always use Humalog exactly as your doctor has told you. You should check with your doctor if you 
are not sure. 
 
Dosage 
 You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject 

soon after a meal. But your doctor will have told you exactly how much to use, when to use it, 
and how often. These instructions are only for you. Follow them exactly and visit your diabetes 
clinic regularly. 

 If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before. This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

 Inject Humalog under the skin. You should only inject it into a muscle if your doctor has told 
you to. 

 
Preparing Humalog 
 Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if 

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time 
you inject yourself. 

 
Injecting Humalog 
 First wash your hands. 
 Before you make an injection, clean your skin as you have been instructed. Clean the rubber 

stopper on the vial, but do not remove the stopper. 
 Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of 

Humalog you want. Your doctor or clinic will tell you how to do this. Do not share your 
needles and syringes. 

 Inject under the skin, as you were taught. Do not inject directly into a vein. After your injection, 
leave the needle in the skin for five seconds to make sure you have taken the whole dose. Do 
not rub the area you have just injected. Make sure you inject at least half an inch (1 cm) from 
the last injection and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t 
matter which injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog 
injection will still work quicker than soluble human insulin. 

 Your doctor will tell you if you have to mix Humalog with one of the human insulins. For 
example if you do need to inject a mixture, draw the Humalog into the syringe before the long 
acting insulin. Inject the liquid as soon as you have mixed it. Do the same thing every time. You 
should not normally mix Humalog with one of the mixtures of human insulins. You should 
never mix Humalog with insulins produced by other manufacturers or animal insulins. 

 You must not administer Humalog by the intravenous route. Inject Humalog as your physician 
or nurse has taught you. Only your physician can administer Humalog by the intravenous route. 
He will only do this under special circumstances such as surgery or if you are ill and your 
glucose levels are too high. 

 
Using Humalog in an infusion pump 
 Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before 

infusing insulin lispro, the manufacturers instructions should be studied to ascertain the 
suitability or otherwise for the particular pump. Read and follow the instructions in the product 
literature supplied with the infusion pump. 

 Be sure to use the correct reservoir and catheter for your pump. 
 Changing of the infusion set (tubing and needle) must be done according to the instructions in 

the product information supplied with the infusion set. 
 In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is 

resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and 
consider the need to reduce or stop your insulin infusion. 



 105 

 A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. 
If an interruption to insulin flow is suspected, follow the instructions in the product literature 
and if appropriate, notify your doctor or clinic. 

 When used with an insulin infusion pump, Humalog should not be mixed with any other insulin. 
 
If you take more Humalog than you need 
If you take more Humalog than you need, a low blood sugar may occur.  Check your blood sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog 
If you take less Humalog than you need, a high blood sugar may occur.  Check your blood sugar. 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep spare syringes and a spare vial of Humalog. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog. 
If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin 
unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating. 
If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 



 106 

listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness                       • rapid heartbeat 
• nervousness or shakiness   • feeling sick 
• headache                        • cold sweat. 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy  • no appetite 
• flushed face   • fruity smell on the breath 
• thirst    • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 
C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog 
 
Before the first use store your Humalog in a refrigerator (2C – 8C). Do not freeze. Keep your vial in 
use in a refrigerator (2°C – 8°C) or at room temperature up to 30°C and discard after 28 days. Do not 
put it near heat or in the sun.  
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 



 107 

Do not use this medicine if you notice it is coloured or it has solid pieces in it. You must use it only if 
it looks like water. Check this each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog 100 units/ml solution for injection in vial contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 

- The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and 
water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the 
acidity.  

 
What Humalog looks like and contents of the pack 
Humalog 100 units/ml, solution for injection is a sterile, clear, colourless, aqueous solution and 
contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each vial 
contains 1000 units (10 millilitres). Humalog 100 units/ml, solution for injection in vial comes in a 
pack of 1 vial, 2 vials or a multipack of 5 x 1 vial. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog 100 units/ml, solution for injection in vial is made by: 
 Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 



 108 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 109 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog 100 units/ml, solution for injection in cartridge 
insulin lispro 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog is and what it is used for 
2. What you need to know before you use Humalog 
3. How to use Humalog 
4. Possible side effects 
5. How to store Humalog 
6. Contents of the pack and other information 
 
 
1. What Humalog is and what it is used for 
 
Humalog is used to treat diabetes. Humalog works more quickly than normal human insulin because 
the insulin molecule has been changed slightly.  
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It 
works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally 
use Humalog within 15 minutes of a meal.  
 
Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin 
comes with another patient information leaflet to tell you about it. Do not change your insulin unless 
your doctor tells you to. Be very careful if you do change insulin. 
 
Humalog is suitable for use in adults and children.  
 
 
2. What you need to know before you use Humalog  
 
Do NOT use Humalog 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this 
leaflet. You must think carefully about when to have your meals, how often to exercise and how 
much to do. You must also keep a close watch on your blood sugar levels by testing your blood 
glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 



 110 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse 
- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. 

The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who 
were treated with pioglitazone and insulin experienced the development of heart failure. Inform 
your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness 
of breath or rapid increase in weight or localised swelling (oedema). 

 
Other medicines and Humalog 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog  
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Humalog 
 
The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens. 
 



 111 

Always check the pack and the cartridge label for the name and type of the insulin when you get 
it from your pharmacy. Make sure you get the Humalog that your doctor has told you to use. 
 
Always use Humalog exactly as your doctor has told you. You should check with your doctor if you 
are not sure. To prevent the possible transmission of disease, each cartridge must be used by you only, 
even if the needle on the delivery device is changed. 
 
Dosage 
 You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject 

soon after a meal. But your doctor will have told you exactly how much to use, when to use it, 
and how often. These instructions are only for you. Follow them exactly and visit your diabetes 
clinic regularly. 

 If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before. This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

 Inject Humalog under the skin. You should only inject it into a muscle if your doctor has told 
you to. 

 
Preparing Humalog 
 Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if 

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time 
you inject yourself. 

 
Getting the pen ready to use 
 First wash your hands. Disinfect the rubber membrane of the cartridge. 
 You must only use Humalog cartridges in Lilly insulin pens. Please make sure that 

Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 
3 ml cartridge only fits the 3 ml pen. 

 Follow the instructions that come with the pen. Put the cartridge into the pen. 
 You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the 

side of the pen so that any bubbles float to the top. With the pen still pointing up, press the 
injection mechanism. Do this until a drop of Humalog comes out of the needle. There may still 
be some small air bubbles left in the pen. These are harmless, but if the air bubble is too big, it 
may make the dose of your injection less accurate. 

 
Injecting Humalog 
 Before you make an injection, clean your skin as you have been instructed. Inject under the 

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle 
in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area 
you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection 
and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which 
injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will 
still work quicker than soluble human insulin. 

 You must not administer Humalog by the intravenous route. Inject Humalog as your physician 
or nurse has taught you. Only your physician can administer Humalog by the intravenous route. 
He will only do this under special circumstances such as surgery or if you are ill and your 
glucose levels are too high. 

 
After injecting 
 As soon as you have done the injection, take the needle off the pen using the outer needle cap. 

This will keep the Humalog sterile and prevent leaking. It will also stop air going back into the 
pen and the needle clogging up. Do not share your needles. Do not share your pen. Replace the 
cap on your pen. Leave the cartridge in the pen. 

 



 112 

Further injections 
 Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing 

up until a drop of Humalog comes out of the needle. You can see how much Humalog is left by 
looking at the gauge on the side of the cartridge. The distance between each mark on the gauge 
is about 20 units. If there is not enough for your dose, change the cartridge. 

 
Do not mix any other insulin in a Humalog cartridge. Once the cartridge is empty, do not use it 
again.  
 
Using Humalog in an infusion pump 
 Only certain CE-marked insulin infusion pumps may be used to infuse insulin lispro. Before 

infusing insulin lispro, the manufacturers instructions should be studied to ascertain the 
suitability or otherwise for the particular pump. Read and follow the instructions in the product 
literature supplied with the infusion pump. 

 Be sure to use the correct reservoir and catheter for your pump. 
 Changing of the infusion set (tubing and needle) must be done according to the instructions in 

the product information supplied with the infusion set. 
 In the event of a hypoglycaemic episode, the infusion should be stopped until the episode is 

resolved. If repeated or severe low blood glucose levels occur, notify your doctor or clinic and 
consider the need to reduce or stop your insulin infusion. 

 A pump malfunction or obstruction of the infusion set can result in a rapid rise in glucose levels. 
If an interruption to insulin flow is suspected, follow the instructions in the product literature 
and if appropriate, notify your doctor or clinic. 

 When used with an insulin infusion pump, Humalog should not be mixed with any other insulin. 
 
If you take more Humalog than you need 
If you take more Humalog than you need, a low blood sugar may occur.  Check your blood sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog 
If you take less Humalog than you need, a high blood sugar may occur.  Check your blood sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”). 
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case 

you lose your pen or cartridges or they get damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog. 
If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin 
unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 



 113 

4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 
If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat. 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 



 114 

• feeling sleepy • no appetite 
• flushed face  • fruity smell on the breath 
• thirst   • feeling or being sick. 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 
C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog 
 
Before the first use store your Humalog in a refrigerator (2C – 8C). Do not freeze.  
 
Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it 
near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen 
with the inserted cartridge should not be stored with the needle attached. 
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not use this medicine if you notice it is coloured or it has solid pieces in it. You must use it only if 
it looks like water. Check this each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog 100 units/ml solution for injection in cartridge contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 

- The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and 
water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the 
acidity.  

 
What Humalog looks like and contents of the pack 
Humalog 100 units/ml, solution for injection is a sterile, clear, colourless, aqueous solution and 
contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each 
cartridge contains 300 units (3 millilitres). The cartridges come in packs of 5 or10 cartridges. Not all 
pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog 100 units/ml, solution for injection in cartridge is made by: 
 Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, 
 Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 



 115 

For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 



 116 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 117 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog Mix25 100 units/ml, suspension for injection in vial 
insulin lispro 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog Mix25 is and what it is used for 
2. What you need to know before you use Humalog Mix25 
3. How to use Humalog Mix25 
4. Possible side effects 
5. How to store Humalog Mix25 
6. Contents of the pack and other information 
 
 
1. What Humalog Mix25 is and what it is used for 
 
Humalog Mix25 is used to treat diabetes.  Humalog Mix25 is a premixed suspension. Its active 
substance is insulin lispro.  25% of the insulin lispro in Humalog Mix25 is dissolved in water and it 
works more quickly than normal human insulin because the insulin molecule has been changed 
slightly.  75% of the insulin lispro in Humalog Mix25 is available in a suspension together with 
protamine sulphate, so that its action is prolonged. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in 
your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the 
long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should 
normally use Humalog Mix25 within 15 minutes of a meal. 
 
Your doctor may tell you to use Humalog Mix25 as well as a longer-acting insulin. Each kind of 
insulin comes with another patient information leaflet to tell you about it. Do not change your 
insulin unless your doctor tells you to. Be very careful if you do change insulin. 
 
 
2. What you need to know before you use Humalog  Mix25 
 
Do NOT use Humalog Mix25 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this 
leaflet.  You must think carefully about when to have your meals, how often to exercise and how 
much to do. You must also keep a close watch on your blood sugar levels by testing your blood 
glucose often. 



 118 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising them, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse 

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.  

The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke 
who were treated with pioglitazone and insulin experienced the development of heart failure. 
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual 
shortness of breath or rapid increase in weight or localised swelling (oedema). 

 
Other medicines and Humalog Mix25 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog Mix25 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 



 119 

3. How to use Humalog Mix25 
 
Always check the pack and the vial label for the name and type of the insulin when you get it 
from your pharmacy. Make sure you get the Humalog Mix25 that your doctor has told you to 
use. 
 
Always use Humalog Mix25 exactly as your doctor has told you. You should check with your doctor 
if you are not sure. 
Dosage 
• You should normally inject Humalog Mix25 within 15 minutes of a meal.  If you need to, you 

can inject soon after a meal.  But your doctor will have told you exactly how much to use, 
when to use it, and how often.  These instructions are only for you.  Follow them exactly and 
visit your diabetes clinic regularly. 

• If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before.  This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

• Inject Humalog Mix25 under the skin. You should not administer it using a different 
administration route. Under no circumstances should Humalog Mix25 be given intravenously. 

 
Preparing Humalog Mix25 
• Vials containing Humalog Mix25 should be rotated in the palms of the hands before use to 

resuspend insulin until it appears uniformly cloudy or milky. Do not shake vigorously as this 
may cause frothing which may interfere with the correct measurement of the dose. The vials 
should be examined frequently and should not be used if clumps of material are present or if 
solid white particles stick to the bottom or wall of the vial, giving it a frosted appearance. 
Check each time you inject yourself. 

 
Injecting Humalog Mix25 
• First wash your hands. 
• Before you make an injection, clean your skin as you have been instructed. Clean the rubber 

stopper on the vial, but do not remove the stopper. 
• Use a clean, sterile syringe and needle to pierce the rubber stopper and draw in the amount of 

Humalog Mix25 you want.  Your doctor or clinic will tell you how to do this.  Do not share 
your needles and syringes. 

• Inject under the skin, as you were taught.  Do not inject directly into a vein. After your 
injection, leave the needle in the skin for five seconds to make sure you have taken the whole 
dose.  Do not rub the area you have just injected.  Make sure you inject at least half an inch (1 
cm) from the last injection and that you ‘rotate’ the places you inject, as you have been taught. 

 
If you take more Humalog Mix25 than you need 
If you take more Humalog Mix25 than you need, a low blood sugar may occur.  Check your blood 
sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog Mix25 
If you take less Humalog Mix25 than you need, a high blood sugar may occur.  Check your blood 
sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”).  



 120 

 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep spare syringes and a spare vial of Humalog Mix25. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog Mix25. 
If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 
 
If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog Mix25 or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 



 121 

The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness   • rapid heartbeat 
• nervousness or shakiness • feeling sick 
• headache   • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy • no appetite 
• flushed face  • fruity smell on the breath 
• thirst   • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 
C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog  Mix25 
 
Before the first use store your Humalog Mix25 in a refrigerator (2C – 8C). Do not freeze. Keep your 
vial in use in a refrigerator (2°C – 8°C) or at room temperature up to 30°C and discard after 28 days. 
Do not put it near heat or in the sun.  
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not use this medicine if you notice clumps of material are present or if solid white particles stick to 
the bottom or wall of the vial, giving it a frosted appearance. Check each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog Mix25 100 units/ml suspension for injection in vial contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 



 122 

- The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium 
phosphate 7H2O, zinc oxide and water for injection.  Sodium hydroxide or hydrochloric acid 
may have been used to adjust the acidity. 

 
What Humalog Mix25 100 units/ml suspension for injection in vial looks like and contents of the 
pack 
Humalog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains 
100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection. 25% of the 
insulin lispro in Humalog Mix25 is dissolved in water.  75% of the insulin lispro in Humalog Mix25 
is available in a suspension together with protamine sulphate. Each vial contains 1000 units (10 
millilitres).  Humalog Mix25 100 units/ml suspension for injection in vial comes in a pack of 1 vial. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog Mix25 100 units/ml suspension for injection in vial is made by: 
 Lilly S.A., Avda. de la Industria 30, 28108 Alcobendas, Madrid, Spain. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 



 123 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 



 124 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog Mix25 100 units/ml, suspension for injection in cartridge 
insulin lispro 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog Mix25 is and what it is used for 
2. What you need to know before you use Humalog Mix25 
3. How to use Humalog Mix25 
4. Possible side effects 
5. How to store Humalog Mix25 
6. Contents of the pack and other information 
 
 
1. What Humalog Mix25 is and what it is used for 
 
Humalog Mix25 is used to treat diabetes.  Humalog Mix25 is a premixed suspension. Its active 
substance is insulin lispro.  25% of the insulin lispro in Humalog Mix25 is dissolved in water and it 
works more quickly than normal human insulin because the insulin molecule has been changed 
slightly.  75% of the insulin lispro in Humalog Mix25 is available in a suspension together with 
protamine sulphate, so that its action is prolonged. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in 
your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the 
long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should 
normally use Humalog Mix25 within 15 minutes of a meal. 
 
Your doctor may tell you to use Humalog Mix25 as well as a longer-acting insulin. Each kind of 
insulin comes with another patient information leaflet to tell you about it. Do not change your 
insulin unless your doctor tells you to. Be very careful if you do change insulin. 
 
 
2. What you need to know before you use Humalog  Mix25 
 
Do NOT use Humalog Mix25 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25 than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this 
leaflet.  You must think carefully about when to have your meals, how often to exercise and how 
much to do. You must also keep a close watch on your blood sugar levels by testing your blood 
glucose often. 



 125 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising them, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse 

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.  

The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke 
who were treated with pioglitazone and insulin experienced the development of heart failure. 
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual 
shortness of breath or rapid increase in weight or localised swelling (oedema). 

 
Other medicines and Humalog Mix25 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog Mix25 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 



 126 

3. How to use Humalog Mix25 
 
The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens. 
 
Always check the pack and the cartridge label for the name and type of the insulin when you 
get it from your pharmacy. Make sure you get the Humalog Mix25 that your doctor has told 
you to use. 
 
Always use Humalog Mix25 exactly as your doctor has told you. You should check with your doctor 
if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by 
you only, even if the needle on the delivery device is changed. 
 
Dosage 
• You should normally inject Humalog Mix25 within 15 minutes of a meal.  If you need to, you 

can inject soon after a meal.  But your doctor will have told you exactly how much to use, 
when to use it, and how often.  These instructions are only for you.  Follow them exactly and 
visit your diabetes clinic regularly. 

• If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before.  This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

• Inject Humalog Mix25 under the skin. You should not administer it using a different 
administration route. Under no circumstances should Humalog Mix25 be given intravenously. 

 
Preparing Humalog Mix25 
• Cartridges containing Humalog Mix25 should be rotated in the palms of the hands ten times 

and inverted 180° ten times immediately before use to resuspend insulin until it appears 
uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. 
Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may 
cause frothing which may interfere with the correct measurement of the dose. The cartridges 
should be examined frequently and should not be used if clumps of material are present or if 
solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. 
Check each time you inject yourself. 

 
Getting the pen ready to use 
 First wash your hands. Disinfect the rubber membrane of the cartridge. 
 You must only use Humalog Mix25 cartridges in Lilly insulin pens. Please make sure that 

Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 
3 ml cartridge only fits the 3 ml pen. 

 Follow the instructions that come with the pen. Put the cartridge into the pen. 
 You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the 

side of the pen so that any bubbles float to the top. With the pen still pointing up, press the 
injection mechanism. Do this until a drop of Humalog Mix25 comes out of the needle. There 
may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is 
too big, it may make the dose of your injection less accurate. 

 
Injecting Humalog Mix25 
 Before you make an injection, clean your skin as you have been instructed. Inject under the 

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle 
in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area 
you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection 
and that you ‘rotate’ the places you inject, as you have been taught. 

 
After injecting 
 As soon as you have done the injection, take the needle off the pen using the outer needle cap. 

This will keep the Humalog Mix25 sterile and prevent leaking. It will also stop air going back 
into the pen and the needle clogging up. Do not share your needles. Do not share your pen. 
Replace the cap on your pen. Leave the cartridge in the pen. 



 127 

 
Further injections 
 Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing 

up until a drop of Humalog Mix25 comes out of the needle. You can see how much Humalog is 
left by looking at the gauge on the side of the cartridge. The distance between each mark on the 
gauge is about 20 units. If there is not enough for your dose, change the cartridge.  

 
Do not mix any other insulin in a Humalog Mix25 cartridge. Once the cartridge is empty, do not 
use it again. 
 
If you take more Humalog Mix25 than you need 
If you take more Humalog Mix25 than you need, a low blood sugar may occur.  Check your blood 
sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog Mix25 
If you take less Humalog Mix25 than you need, a high blood sugar may occur.  Check your blood 
sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep spare syringes and a spare vial of Humalog Mix25, or a spare pen and cartridges, 
in case you lose your pen or cartridges or they get damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog Mix25. 
If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 
If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 



 128 

Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog Mix25 or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy • no appetite 
• flushed face  • fruity smell on the breath 
• thirst   • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 
C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 



 129 

5. How to store Humalog  Mix25 
 
Before the first use store your Humalog Mix25 in a refrigerator (2C – 8C). Do not freeze.  
 
Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it 
near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen 
with the inserted cartridge should not be stored with the needle attached. 
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not use this medicine if you notice clumps of material are present or if solid white particles stick to 
the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog Mix25 100 units/ml suspension for injection in cartridge contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 

- The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium 
phosphate 7H2O, zinc oxide and water for injection.  Sodium hydroxide or hydrochloric acid 
may have been used to adjust the acidity. 

 
What Humalog Mix25 100 units/ml suspension for injection in cartridge looks like and contents 
of the pack 
Humalog Mix25 100 units/ml suspension for injection is a white, sterile suspension and contains 
100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.  25% of the 
insulin lispro in Humalog Mix25 is dissolved in water.  75% of the insulin lispro in Humalog Mix25 
is available in a suspension together with protamine sulphate. Each cartridge contains 300 units (3 
millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog Mix25 100 units/ml suspension for injection in cartridge is made by: 
 Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, 
 Eli Lilly Italia S.p.A., Via Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 



 130 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 131 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog Mix50 100 units/ml, suspension for injection in cartridge 
insulin lispro 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog Mix50 is and what it is used for 
2. What you need to know before you use Humalog Mix50 
3. How to use Humalog Mix50 
4. Possible side effects 
5. How to store Humalog Mix50 
6. Contents of the pack and other information 
 
 
1. What Humalog Mix50 is and what it is used for 
 
Humalog Mix50 is used to treat diabetes.  Humalog Mix50 is a premixed suspension. Its active 
substance is insulin lispro.  50% of the insulin lispro in Humalog Mix50 is dissolved in water and it 
works more quickly than normal human insulin because the insulin molecule has been changed 
slightly.  50% of the insulin lispro in Humalog Mix50 is available in a suspension together with 
protamine sulphate, so that its action is prolonged. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in 
your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the 
long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should 
normally use Humalog Mix50 within 15 minutes of a meal. 
 
Your doctor may tell you to use Humalog Mix50 as well as a longer-acting insulin. Each kind of 
insulin comes with another patient information leaflet to tell you about it. Do not change your 
insulin unless your doctor tells you to. Be very careful if you do change insulin. 
 
 
2. What you need to know before you use Humalog Mix50 
 
Do NOT use Humalog Mix50 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix50 than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 
Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this 
leaflet.  You must think carefully about when to have your meals, how often to exercise and how 
much to do. You must also keep a close watch on your blood sugar levels by testing your blood 
glucose often. 



 132 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising them, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse 

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.  

The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke 
who were treated with pioglitazone and insulin experienced the development of heart failure. 
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual 
shortness of breath or rapid increase in weight or localised swelling (oedema). 

 
Other medicines and Humalog Mix50 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog Mix50 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 



 133 

3. How to use Humalog Mix50 
 
The 3 ml cartridge is only for use in Lilly 3 ml pens. It is not for use in 1.5 ml pens. 
 
Always check the pack and the cartridge label for the name and type of the insulin when you 
get it from your pharmacy. Make sure you get the Humalog Mix50 that your doctor has told 
you to use. 
 
Always use Humalog Mix50 exactly as your doctor has told you. You should check with your doctor 
if you are not sure. To prevent the possible transmission of disease, each cartridge must be used by 
you only, even if the needle on the delivery device is changed. 
 
Dosage 
• You should normally inject Humalog Mix50 within 15 minutes of a meal.  If you need to, you 

can inject soon after a meal.  But your doctor will have told you exactly how much to use, 
when to use it, and how often.  These instructions are only for you.  Follow them exactly and 
visit your diabetes clinic regularly. 

• If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before.  This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

• Inject Humalog Mix50 under the skin. You should not administer it using a different 
administration route. Under no circumstances should Humalog Mix50 be given intravenously. 

 
Preparing Humalog Mix50 
• Cartridges containing Humalog Mix50 should be rotated in the palms of the hands ten times 

and inverted 180° ten times immediately before use to resuspend insulin until it appears 
uniformly cloudy or milky. If not, repeat the above procedure until contents are mixed. 
Cartridges contain a small glass bead to assist mixing. Do not shake vigorously as this may 
cause frothing which may interfere with the correct measurement of the dose. The cartridges 
should be examined frequently and should not be used if clumps of material are present or if 
solid white particles stick to the bottom or wall of the cartridge, giving it a frosted appearance. 
Check each time you inject yourself. 

 
Getting the pen ready to use 
 First wash your hands. Disinfect the rubber membrane of the cartridge. 
 You must only use Humalog Mix50 cartridges in Lilly insulin pens. Please make sure that 

Humalog or Lilly cartridges are mentioned in the leaflet accompanying your pen. The 
3 ml cartridge only fits the 3 ml pen. 

 Follow the instructions that come with the pen. Put the cartridge into the pen. 
 You will set the dose to 1 or 2 units. Then hold the pen with the needle pointing up and tap the 

side of the pen so that any bubbles float to the top. With the pen still pointing up, press the 
injection mechanism. Do this until a drop of Humalog Mix50 comes out of the needle. There 
may still be some small air bubbles left in the pen. These are harmless, but if the air bubble is 
too big, it may make the dose of your injection less accurate. 

 
Injecting Humalog Mix50 
 Before you make an injection, clean your skin as you have been instructed. Inject under the 

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle 
in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area 
you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection 
and that you ‘rotate’ the places you inject, as you have been taught. 

 
After injecting 
 As soon as you have done the injection, take the needle off the pen using the outer needle cap. 

This will keep the Humalog Mix50 sterile and prevent leaking. It will also stop air going back 
into the pen and the needle clogging up. Do not share your needles. Do not share your pen. 
Replace the cap on your pen. Leave the cartridge in the pen. 



 134 

 
Further injections 
 Before every injection, dial 1 or 2 units and press the injection mechanism with the pen pointing 

up until a drop of Humalog Mix50 comes out of the needle. You can see how much Humalog is 
left by looking at the gauge on the side of the cartridge. The distance between each mark on the 
gauge is about 20 units. If there is not enough for your dose, change the cartridge.  

 
Do not mix any other insulin in a Humalog Mix50 cartridge. Once the cartridge is empty, do not 
use it again. 
 
If you take more Humalog Mix50 than you need 
If you take more Humalog Mix50 than you need, a low blood sugar may occur.  Check your blood 
sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog Mix50 
If you take less Humalog Mix50 than you need, a high blood sugar may occur.  Check your blood 
sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep a spare pen and cartridges, in case you lose your pen or cartridges or they get 
damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog Mix50. 
If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 
If you think you are having this sort of insulin allergy with Humalog Mix50, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 



 135 

Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog Mix50 or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy • no appetite 
• flushed face  • fruity smell on the breath 
• thirst   • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 
C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 



 136 

5. How to store Humalog Mix50 
 
Before the first use store your Humalog Mix50 in a refrigerator (2C – 8C). Do not freeze.  
 
Keep your cartridge in use at room temperature (15° - 30°C) and discard after 28 days. Do not put it 
near heat or in the sun. Do not keep your pen or the cartridges you are using in the fridge. The pen 
with the inserted cartridge should not be stored with the needle attached. 
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not use this medicine if you notice clumps of material are present or if solid white particles stick to 
the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog Mix50 100 units/ml suspension for injection in cartridge contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 

- The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium 
phosphate 7H2O, zinc oxide and water for injection.  Sodium hydroxide or hydrochloric acid 
may have been used to adjust the acidity. 

 
What Humalog Mix50 100 units/ml suspension for injection in cartridge looks like and contents 
of the pack 
Humalog Mix50 100 units/ml suspension for injection is a white, sterile suspension and contains 
100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.  50% of the 
insulin lispro in Humalog Mix50 is dissolved in water.  50% of the insulin lispro in Humalog Mix50 
is available in a suspension together with protamine sulphate. Each cartridge contains 300 units (3 
millilitres). The cartridges come in packs of 5 or 10 cartridges. Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog Mix50 100 units/ml suspension for injection in cartridge is made by: 
 Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, 
 Eli Lilly Italia S.p.A., Via  Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 



 137 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 138 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog 100 units/ml KwikPen, solution for injection in a pre-filled pen 
insulin lispro 

Each KwikPen delivers 1 – 60 units in steps of 1 units. 
 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog KwikPen is and what it is used for 
2. What you need to know before you use Humalog KwikPen 
3. How to use Humalog KwikPen 
4. Possible side effects 
5. How to store Humalog KwikPen 
6. Contents of the pack and other information 
 
 
1. What Humalog KwikPen is and what it is used for 
 
Humalog KwikPen is used to treat diabetes. It works more quickly than normal human insulin because 
the insulin molecule has been changed slightly. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It 
works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally 
use Humalog within 15 minutes of a meal.  
 
Your doctor may tell you to use Humalog KwikPen as well as a longer-acting insulin. Each kind of 
insulin comes with another patient information leaflet to tell you about it. Do not change your insulin 
unless your doctor tells you to. Be very careful if you do change insulin. 
 
Humalog is suitable for use in adults and children.  
 
The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.  
One KwikPen contains multiple doses of insulin.  The KwikPen dials 1 unit at a time.  The number of 
units are displayed in the dose window, always check this before your injection. You can give 
from 1 to 60 units in a single injection.  If your dose is more than 60 units, you will need to give 
yourself more than one injection.  
 
 
2. What you need to know before you use Humalog KwikPen 
 
Do NOT use Humalog KwikPen  
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 
 



 139 

Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this 
leaflet. You must think carefully about when to have your meals, how often to exercise and how 
much to do. You must also keep a close watch on your blood sugar levels by testing your blood 
glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse 
- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. 

The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who 
were treated with pioglitazone and insulin experienced the development of heart failure. Inform 
your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness 
of breath or rapid increase in weight or localised swelling (oedema). 

 This Pen is not recommended for use by the blind or visually impaired without the help of someone 
trained to use the Pen. 

 
Other medicines and Humalog KwikPen 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription  (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 



 140 

 
Important information about some of the ingredients of Humalog KwikPen 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Humalog KwikPen 
 
Always check the pack and the label of the pre-filled pen for the name and type of the insulin 
when you get it from your pharmacy. Make sure you get the Humalog KwikPen that your 
doctor has told you to use. 
 
Always use Humalog KwikPen exactly as your doctor has told you. You should check with your 
doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used by 
you only, even if the needle is changed. 
 
Dosage 
 You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject 

soon after a meal. But your doctor will have told you exactly how much to use, when to use it, 
and how often. These instructions are only for you. Follow them exactly and visit your diabetes 
clinic regularly. 

 If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before. This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

 Humalog KwikPen is only suitable for injecting just under the skin. Speak to your doctor if you 
need to inject your insulin by another method.   

 
Preparing Humalog KwikPen  
 Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if 

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time 
you inject yourself. 

 
Getting the KwikPen ready to use (Please see user manual) 
 First wash your hands. 
 Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions 

carefully. Here are some reminders. 
 Use a clean needle. (Needles are not included). 
 Prime your KwikPen before each use. This checks that insulin comes out and clears the air 

bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these 
are harmless. But if the air bubbles are too large it may affect the insulin dose. 

 
Injecting Humalog  
 Before you make an injection, clean your skin as you have been instructed. Inject under the 

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle 
in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area 
you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection 
and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which 
injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will 
still work quicker than soluble human insulin. 

 You must not administer Humalog by the intravenous route. Inject Humalog as your physician 
or nurse has taught you. Only your physician can administer Humalog by the intravenous route. 
He will only do this under special circumstances such as surgery or if you are ill and your 
glucose levels are too high. 

 



 141 

After injecting 
 As soon as you have done the injection, unscrew the needle from the KwikPen using the outer 

needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen 
and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap 
on your pen. 

 
Further injections 
 Every time you use a KwikPen you must use a new needle. Before every injection, clear any air 

bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing 
up. The scale on the cartridge shows about how many units you have left. 

 Do not mix any other insulin in your disposable pen. Once the KwikPen is empty, do not use it 
again. Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do 
this. 

 
Using Humalog in an infusion pump 
 KwikPen is only suitable for injecting just under the skin.  Do not use the pen to administer 

Humalog by a different way.  Other forms of Humalog 100 unit /ml are available if this is 
necessary.  Speak to your doctor if this applies to you. 

 
If you take more Humalog than you need 
If you take more Humalog than you need, a low blood sugar may occur.  Check your blood sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog 
If you take less Humalog than you need, a high blood sugar may occur.  Check your blood sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep spare syringes and a spare vial of Humalog, or a spare pen and cartridges, in case 
you lose your KwikPen or it gets damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog. 
If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin 
unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 



 142 

 
If you think you are having this sort of insulin allergy with Humalog, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy  • no appetite 
• flushed face   • fruity smell on the breath 
• thirst    • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 



 143 

C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog KwikPen 
 
Before the first use store your Humalog KwikPen in a refrigerator (2C – 8C). Do not freeze.  
 
Keep your Humalog KwikPen in use at room temperature (15° - 30°C) and discard after 28 days. Do 
not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. The 
KwikPen should not be stored with the needle attached. 
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not use this medicine if you notice the solution is coloured or it has solid pieces in it. You must use 
it only if it looks like water. Check this each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog 100 units/ml KwikPen solution for injection contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 

- The other ingredients are m-cresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and 
water for injection. Sodium hydroxide or hydrochloric acid may have been used to adjust the 
acidity.  

 
What Humalog KwikPen looks like and contents of the pack 
Humalog 100 units/ml KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution 
and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. Each 
Humalog KwikPen contains 300 units (3 millilitres). The Humalog KwikPen comes in a pack of 5 pre-
filled pens or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog 
in your pre-filled pen is the same as the Humalog, which comes in separate Humalog cartridges. The 
KwikPen simply has a built in cartridge. When the pre-filled pen is empty you cannot use it again. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog 100 units/ml KwikPen, solution for injection is made by: 
 Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, 
 Eli Lilly Italia S.p.A., Via  Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 



 144 

Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 



 145 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
USER MANUAL 
 
Please see manual text later. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 146 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog Mix25 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
insulin lispro 

Each KwikPen delivers 1 – 60 units in steps of 1 units. 
 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog Mix25 KwikPen is and what it is used for 
2. What you need to know before you use Humalog Mix25 KwikPen  
3. How to use Humalog Mix25 KwikPen 
4. Possible side effects 
5. How to store Humalog Mix25 KwikPen 
6. Contents of the pack and other information 
 
 
1. What Humalog Mix25 KwikPen is and what it is used for 
 
Humalog Mix25 KwikPen is used to treat diabetes.  It is a premixed suspension. Its active substance is 
insulin lispro.  25% of the insulin lispro in Humalog Mix25 KwikPen is dissolved in water and it 
works more quickly than normal human insulin because the insulin molecule has been changed 
slightly.  75% of the insulin lispro in Humalog Mix25 KwikPen is available in a suspension together 
with protamine sulphate, so that its action is prolonged. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in 
your blood. Humalog Mix25 is a substitute for your own insulin and is used to control glucose in the 
long term. Humalog Mix25 works very quickly and longer than soluble insulin. You should 
normally use Humalog Mix25 within 15 minutes of a meal. 
 
Your doctor may tell you to use Humalog Mix25 KwikPen as well as a longer-acting insulin. Each 
kind of insulin comes with another patient information leaflet to tell you about it. Do not change 
your insulin unless your doctor tells you to. Be very careful if you do change insulin. 
 
The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.  
One KwikPen contains multiple doses of insulin.  The KwikPen dials 1 unit at a time. The number of 
units are displayed in the dose window, always check this before your injection. You can give 
from 1 to 60 units in a single injection.  If your dose is more than 60 units, you will need to give 
yourself more than one injection.  
 
 
 
2. What you need to know before you use Humalog  Mix25 KwikPen 
 
Do NOT use Humalog Mix25 KwikPen 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix25 than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 



 147 

 
Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this 
leaflet.  You must think carefully about when to have your meals, how often to exercise and how 
much to do. You must also keep a close watch on your blood sugar levels by testing your blood 
glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising them, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse 

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.  

The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke 
who were treated with pioglitazone and insulin experienced the development of heart failure. 
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual 
shortness of breath or rapid increase in weight or localised swelling (oedema). 

 This Pen is not recommended for use by the blind or visually impaired without the help of 
someone trained to use the Pen. 

 
Other medicines and Humalog Mix25 KwikPen 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 



 148 

Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog Mix25 KwikPen 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Humalog Mix25 KwikPen 
 
Always check the pack and the label of the pre-filled pen for the name and type of the insulin 
when you get it from your pharmacy. Make sure you get the Humalog Mix25 KwikPen that 
your doctor has told you to use. 
 
Always use Humalog Mix25 KwikPen exactly as your doctor has told you. You should check with 
your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used 
by you only, even if the needle is changed. 
 
Dosage 
• You should normally inject Humalog Mix25 within 15 minutes of a meal.  If you need to, you 

can inject soon after a meal.  But your doctor will have told you exactly how much to use, 
when to use it, and how often.  These instructions are only for you.  Follow them exactly and 
visit your diabetes clinic regularly. 

• If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before.  This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

• Humalog Mix25 KwikPen is only suitable for injecting just under the skin. Speak to your 
doctor if you need to inject your insulin by another method.  

 
Preparing Humalog Mix25 KwikPen 
• The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times 

immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, 
repeat the above procedure until contents are mixed.  Cartridges contain a small glass bead to 
assist mixing.  Do not shake vigorously as this may cause frothing which may interfere with 
the correct measurement of the dose. The cartridges should be examined frequently and should 
not be used if clumps of material are present or if solid white particles stick to the bottom or 
wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. 

 
Getting the KwikPen ready to use (Please see user manual) 
 First wash your hands. 
 Read the instructions on how to use your pre-filled insulin pen.  Please follow the instructions 

carefully. Here are some reminders. 
 Use a clean needle.  (Needles are not included). 
 Prime your KwikPen before each use. This checks that insulin comes out and clears the air 

bubbles from your KwikPen.  There may still be some small air bubbles left in the pen - these 
are harmless.  But if the air bubbles are too large it may affect the insulin dose. 

 
Injecting Humalog Mix25 
 Before you make an injection, clean your skin as you have been instructed.  Inject under the 

skin, as you were taught.  Do not inject directly into a vein.  After your injection, leave the 
needle in the skin for five seconds to make sure you have taken the whole dose.  Do not rub the 



 149 

area you have just injected.  Make sure you inject at least half an inch (1 cm) from where you 
last injected and that you ‘rotate’ the places you inject, as you have been taught. 

 
After injecting 
 As soon as you have done the injection, unscrew the needle from the KwikPen using the outer 

needle cap.  This will keep the insulin sterile and stop it leaking.  It also stops air entering the 
pen and your needle clogging.  Do not share your needles.  Do not share your pen.  Replace 
the cap on the pen. 

 
Further injections 
 Every time you use a KwikPen you must use a new needle.  Before every injection, clear any air 

bubbles.  You can see how much insulin is left by holding the KwikPen with the needle 
pointing up.  The scale on the cartridge shows about how many units you have left. 

 Do not mix any other insulin in your disposable pen.  Once the KwikPen is empty, do not use it 
again.  Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do 
this. 

 
If you take more Humalog Mix25 than you need 
If you take more Humalog Mix25 than you need, a low blood sugar may occur.  Check your blood 
sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog Mix25 
If you take less Humalog Mix25 than you need, a high blood sugar may occur.  Check your blood 
sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep spare syringes and a spare vial of Humalog Mix25, or a spare pen and cartridges, 
in case you lose your KwikPen or it gets damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog Mix25. 
If you take less Humalog Mix25 than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 



 150 

If you think you are having this sort of insulin allergy with Humalog Mix25, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog Mix25 or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy • no appetite 
• flushed face  • fruity smell on the breath 
• thirst   • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 



 151 

C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog Mix25 KwikPen 
 
Before the first use store your Humalog Mix25 KwikPen in a refrigerator (2C – 8C). Do not freeze.  
 
Keep your Humalog Mix25 KwikPen in use at room temperature (15° - 30°C) and discard after 28 
days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. 
The KwikPen should not be stored with the needle attached. 
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not use this medicine if you notice clumps of material are present or if solid white particles stick to 
the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog Mix25 100 units/ml KwikPen, suspension for injection contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 

- The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium 
phosphate 7H2O, zinc oxide and water for injection.  Sodium hydroxide or hydrochloric acid 
may have been used to adjust the acidity. 

 
What Humalog Mix25 100 units/ml KwikPen, suspension for injection looks like and contents of 
the pack 
Humalog Mix25 100 units/ KwikPen, suspension for injection is a white, sterile suspension and 
contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.  25% of 
the insulin lispro in Humalog Mix25 is dissolved in water.  75% of the insulin lispro in Humalog 
Mix25 is available in a suspension together with protamine sulphate. Each Humalog Mix25 KwikPen 
contains 300 units (3 millilitres). The Humalog Mix25 KwikPen comes in a pack of 5 pre-filled pens 
or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog Mix25 in 
your KwikPen is the same as the Humalog Mix25, which comes in separate Humalog Mix25 
cartridges. The KwikPen simply has a built in cartridge. When the KwikPen is empty you cannot use 
it again. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog Mix25 100 units/ml KwikPen, suspension for injection is made by: 
 Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, 
 Eli Lilly Italia S.p.A., Via  Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 



 152 

For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 



 153 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
USER MANUAL 
 
Please see manual text later. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 154 

PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Humalog Mix50 100 units/ml KwikPen, suspension for injection in a pre-filled pen 
insulin lispro 

Each KwikPen delivers 1 – 60 units in steps of 1 units. 
 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog Mix50 KwikPen is and what it is used for 
2. What you need to know before you use Humalog Mix50 KwikPen  
3. How to use Humalog Mix50 KwikPen 
4. Possible side effects 
5. How to store Humalog Mix50 KwikPen 
6. Contents of the pack and other information 
 
 
1. What Humalog Mix50 KwikPen is and what it is used for 
 
Humalog Mix50 KwikPen is used to treat diabetes.  It is a premixed suspension. Its active substance is 
insulin lispro.  50% of the insulin lispro in Humalog Mix50 KwikPen is dissolved in water and it 
works more quickly than normal human insulin because the insulin molecule has been changed 
slightly.  50% of the insulin lispro in Humalog Mix50 KwikPen is available in a suspension together 
with protamine sulphate, so that its action is prolonged. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in 
your blood. Humalog Mix50 is a substitute for your own insulin and is used to control glucose in the 
long term. Humalog Mix50 works very quickly and longer than soluble insulin. You should 
normally use Humalog Mix50 within 15 minutes of a meal. 
 
Your doctor may tell you to use Humalog Mix50 KwikPen as well as a longer-acting insulin. Each 
kind of insulin comes with another patient information leaflet to tell you about it. Do not change 
your insulin unless your doctor tells you to. Be very careful if you do change insulin. 
 
The KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin lispro.  
One KwikPen contains multiple doses of insulin.  The KwikPen dials 1 unit at a time.  The number of 
units are displayed in the dose window, always check this before your injection. You can give 
from 1 to 60 units in a single injection.  If your dose is more than 60 units, you will need to give 
yourself more than one injection.  
 
 
2. What you need to know before you use Humalog  Mix50 KwikPen 
 
Do NOT use Humalog Mix50 KwikPen 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog Mix50 than you need). 
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
 



 155 

Warnings and precautions  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed later in this 
leaflet.  You must think carefully about when to have your meals, how often to exercise and how 
much to do. You must also keep a close watch on your blood sugar levels by testing your blood 
glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising them, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes 
nurse 

- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 The amount of insulin you need may also change if you drink alcohol. 
 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad.  

The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke 
who were treated with pioglitazone and insulin experienced the development of heart failure. 
Inform your doctor as soon as possible, if you experience signs of heart failure such as unusual 
shortness of breath or rapid increase in weight or localised swelling (oedema). 

 This Pen is not recommended for use by the blind or visually impaired without the help of 
someone trained to use the Pen. 

 
Other medicines and Humalog Mix50 KwikPen 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics,  
 acetyl salicylic acid,  
 sulpha antibiotics,  
 octreotide,  
 “beta2 stimulants” (for example ritodrine, salbutamol or terbutaline),  
 beta-blockers, or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol,  
 some angiotensin converting enzyme (ACE) inhibitors (for example captopril, enalapril), and  
 angiotensin II receptor blockers. 

 
Please tell your doctor, if you are taking or have recently taken any other medicines, including 
medicines obtained without a prescription (see section “Warnings and precautions”). 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 



 156 

 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog Mix50 KwikPen 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Humalog Mix50 KwikPen 
 
Always check the pack and the label of the pre-filled pen for the name and type of the insulin 
when you get it from your pharmacy. Make sure you get the Humalog Mix50 KwikPen that 
your doctor has told you to use. 
 
Always use Humalog Mix50 KwikPen exactly as your doctor has told you. You should check with 
your doctor if you are not sure. To prevent the possible transmission of disease, each pen must be used 
by you only, even if the needle is changed. 
 
Dosage 
• You should normally inject Humalog Mix50 within 15 minutes of a meal.  If you need to, you 

can inject soon after a meal.  But your doctor will have told you exactly how much to use, 
when to use it, and how often.  These instructions are only for you.  Follow them exactly and 
visit your diabetes clinic regularly. 

• If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before.  This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

• Humalog Mix50 KwikPen is only suitable for injecting just under the skin. Speak to your 
doctor if you need to inject your insulin by another method.    

 
Preparing Humalog Mix50 KwikPen 
• The KwikPen should be rotated in the palms of the hands ten times and inverted 180° ten times 

immediately before use to resuspend insulin until it appears uniformly cloudy or milky. If not, 
repeat the above procedure until contents are mixed.  Cartridges contain a small glass bead to 
assist mixing.  Do not shake vigorously as this may cause frothing which may interfere with 
the correct measurement of the dose. The cartridges should be examined frequently and should 
not be used if clumps of material are present or if solid white particles stick to the bottom or 
wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. 

 
Getting the KwikPen ready to use (Please see user manual) 
 First wash your hands. 
 Read the instructions on how to use your pre-filled insulin pen.  Please follow the instructions 

carefully. Here are some reminders. 
 Use a clean needle.  (Needles are not included). 
 Prime your KwikPen before each use. This checks that insulin comes out and clears the air 

bubbles from your KwikPen.  There may still be some small air bubbles left in the pen - these 
are harmless.  But if the air bubbles are too large it may affect the insulin dose. 

 
Injecting Humalog Mix50 
 Before you make an injection, clean your skin as you have been instructed.  Inject under the 

skin, as you were taught.  Do not inject directly into a vein.  After your injection, leave the 
needle in the skin for five seconds to make sure you have taken the whole dose.  Do not rub the 
area you have just injected.  Make sure you inject at least half an inch (1 cm) from where you 
last injected and that you ‘rotate’ the places you inject, as you have been taught. 

 
After injecting 
 As soon as you have done the injection, unscrew the needle from the KwikPen using the outer 

needle cap.  This will keep the insulin sterile and stop it leaking.  It also stops air entering the 



 157 

pen and your needle clogging.  Do not share your needles.  Do not share your pen.  Replace 
the cap on the pen. 

 
Further injections 
 Every time you use a KwikPen you must use a new needle.  Before every injection, clear any air 

bubbles.  You can see how much insulin is left by holding the KwikPen with the needle 
pointing up.  The scale on the cartridge shows about how many units you have left. 

 Do not mix any other insulin in your disposable pen.  Once the KwikPen is empty, do not use it 
again.  Please get rid of it carefully - your pharmacist or diabetes nurse will tell you how to do 
this. 

 
If you take more Humalog Mix50 than you need 
If you take more Humalog Mix50 than you need, a low blood sugar may occur.  Check your blood 
sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog Mix50 
If you take less Humalog Mix50 than you need, a high blood sugar may occur.  Check your blood 
sugar 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, nausea, vomiting, dehydration, unconsciousness, coma or even 
death (see A and B in section 4 “Possible Side Effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always keep a spare pen and cartridges, in case you lose your KwikPen or it gets damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog Mix50. 
If you take less Humalog Mix50 than you need, a high blood sugar may occur. Do not change your 
insulin unless your doctor tells you to. 
 
If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Systemic allergy is rare ( 1/10,000 to <1/1,000). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 
If you think you are having this sort of insulin allergy with Humalog Mix50, tell your doctor at once. 
 
Local allergy is common ( 1/100 to <1/10).  Some people get redness, swelling or itching around the 
area of the insulin injection. This usually clears up in anything from a few days to a few weeks. If this 
happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon ( 1/1,000 to <1/100). If you notice 
your skin thickening or pitting at the injection site, tell your doctor. 



 158 

 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
A.  Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog Mix50 or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels. 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations, e.g. driving a 
car, in which you or others would be put at risk by hypoglycaemia. 
 
B.  Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy • no appetite 
• flushed face  • fruity smell on the breath 
• thirst   • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 
C.  Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog Mix50 KwikPen 
 
Before the first use store your Humalog Mix50 KwikPen in a refrigerator (2C – 8C). Do not freeze.  
 



 159 

Keep your Humalog Mix50 KwikPen in use at room temperature (15° - 30°C) and discard after 28 
days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the fridge. 
The KwikPen should not be stored with the needle attached. 
 
Keep out of the reach and sight of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Do not use this medicine if you notice clumps of material are present or if solid white particles stick to 
the bottom or wall of the cartridge, giving it a frosted appearance. Check each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog Mix50 100 units/ml KwikPen, suspension for injection contains 
- The active substance is insulin lispro. Insulin lispro is made in the laboratory by a ‘recombinant 

DNA technology’ process. It is a changed form of human insulin and so is different from other 
human and animal insulins. Insulin lispro is closely related to human insulin which is a natural 
hormone made by the pancreas. 

- The other ingredients are protamine sulphate, m-cresol, phenol, glycerol, dibasic sodium 
phosphate 7H2O, zinc oxide and water for injection.  Sodium hydroxide or hydrochloric acid 
may have been used to adjust the acidity. 

 
What Humalog Mix50 100 units/ml KwikPen, suspension for injection looks like and contents of 
the pack 
Humalog Mix50 100 units/ml KwikPen, suspension for injection is a white, sterile suspension and 
contains 100 units of insulin lispro in each millilitre (100 units/ml) suspension for injection.  50% of 
the insulin lispro in Humalog Mix50 is dissolved in water.  50% of the insulin lispro in Humalog 
Mix50 is available in a suspension together with protamine sulphate. Each Humalog Mix50 KwikPen 
contains 300 units (3 millilitres). The Humalog Mix50 KwikPen comes in a pack of 5 pre-filled pens 
or a multipack of 2 x 5 pre-filled pens. Not all pack sizes may be marketed. The Humalog Mix50 in 
your KwikPen is the same as the Humalog Mix50, which comes in separate Humalog Mix50 
cartridges. The KwikPen simply has a built in cartridge. When the KwikPen is empty you cannot use 
it again. 
 
Marketing Authorisation Holder and Manufacturer 
Humalog Mix50 100 units/ml KwikPen, suspension for injection is made by: 
 Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, 
 Eli Lilly Italia S.p.A., Via  Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
The product licence is held by: Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The 
Netherlands. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 



 160 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
USER MANUAL 
 



 161 

Please see manual text later. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 
 



 162 

 USER MANUAL 
KwikPen pre-filled insulin pen 

 
100 units/ml 

 

 
 

 
 
PLEASE READ THIS USER MANUAL BEFORE USE 

 

Read the User Manual before you start taking your insulin and each time you get another KwikPen. 
There may be new information. This information does not take the place of talking to your healthcare 
professional about your medical condition or your treatment. 
 
KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml (300 units, 100 units/ml) of insulin. 
You can give yourself multiple doses using one Pen. The Pen dials 1 unit at a time. You can give from 
1 to 60 units in a single injection. If your dose is more than 60 units, you will need to give yourself 
more than one injection. The plunger only moves a little with each injection, and you may not notice 
that it moves. The plunger will only reach the end of the cartridge when you have used all 300 units in 
the Pen. 
 
Do not share your pen with other people, even if the needle has been changed. Do not reuse or 
share needles with other people. You may give an infection to them or get an infection from 
them. 

This Pen is not recommended for use by the blind or visually impaired without the help of someone 
trained to use the Pen.   
 

KwikPen Parts 
 

Cap Clip 
                Cartridge 

Holder Label    Dose Indicator 
 
 

Dose Knob 

    Pen     
Cap 

Rubber 
Seal 

Plunger  Pen 
Body 

Dose  
Window 

 

 



 163 

 
Pen Needle Parts 

(Needles Not Included) 
  Paper Tab  

 
 
 
 
 

Outer Needle 
Shield 

Inner Needle 
Shield 

Needle  

 
 
 
 
 
 

How to recognize your KwikPen: 
 
  

Humalog 
    Humalog Humalog 

 Mix25   Mix50  
 Solution Suspension 

(cloudy insulin) 
Suspension 

(cloudy insulin) 
Pen colour: Blue Blue Blue 

 
Dose Knob:  

Burgundy 
 

Yellow 
 

Red 

Labels: White with 
Burgundy 
Colour Bar 

White with 
Yellow 

Colour Bar 

White with 
Red 

Colour Bar 
 
Supplies needed to give your injection: 
 
• KwikPen containing your insulin 
• KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles recommended) 
• Swab  
Needles and swab are not included. 
 
Preparing your Pen  
• Wash your hands with soap and water. 
• Check the Pen to make sure you are taking the right type of insulin. This is especially important 

if you use more than 1 type of insulin. 
• Do not use your Pen past the expiration date printed on the Label. After you start using the Pen, 

throw your Pen away after the in-use time specified in the Package Leaflet. 
• Always use a new Needle for each injection to help prevent infections and blocked Needles. 



 164 

 
 

Step 1: 
 
• Pull the Pen Cap straight off. 

– Do not remove the Pen Label. 
• Wipe the Rubber Seal with a swab. 
 
 

 
Step 2: 
 
(For HUMALOG suspensions cloudy insulins only) 
 
• Gently roll the Pen 10 times.  
AND 
• Invert the Pen 10 times. 
 
 
 
Mixing is important to make sure you get the right dose. 
The insulin should look evenly mixed. 
 
 
 
Step 3: 

 

• Check the appearance of the insulin. 
– HUMALOG solution should look clear and colourless. Do not use if it is cloudy, coloured, 

or has particles or clumps in it. 
 

– HUMALOG suspensions - cloudy insulins - should look white after mixing.  Do not use 
if it looks clear or contains any clumps or particles. 

 
Step 4: 

 
• Select a new Needle. 
• Pull off the Paper Tab from the Outer Needle Shield. 
 
 
 

 
Step 5: 
 
• Push the capped Needle straight onto the Pen  

and twist the Needle on until it is tight. 
 

 
 

Step 6: 
 
• Pull off the Outer Needle Shield. Do not throw it away. 
• Pull off the Inner Needle Shield and throw it away. 
 

 



 165 

 
 

Priming your Pen  
Prime before each injection. 
• Priming your Pen means removing the air from the Needle and Cartridge that may collect 

during normal use and ensures that the Pen is working correctly. 
• If you do not prime before each injection, you may get too much or too little insulin. 
 

 
Step 7: 
 
• To prime your Pen, turn the Dose Knob to select 2 units. 
 
 
 

 
Step 8: 
• Hold your Pen with the Needle pointing up. Tap the Cartridge  

Holder gently to collect air bubbles at the top 
 
 
 
 
 
 

Step 9: 

• Continue holding your Pen with Needle pointing 
up. Push the Dose Knob in until it stops, and “0” 
is seen in the Dose Window. Hold the Dose 
Knob in and count to 5 slowly. 

 You should see insulin at the tip of the Needle. 

– If you do not see insulin, repeat the 
priming steps, but not more than 4 times. 

– If you still do not see insulin, change the 
Needle and repeat the priming steps. 

Small air bubbles are normal and will not affect 
your dose. 

 

 

 
Selecting your dose 
 
• You can give from 1 to 60 units in a single injection. 
• If your dose is more than 60 units, you will need to give more than one injection. 

– If you need help deciding how to divide up your dose, ask your healthcare professional. 
– You should use a new Needle for each injection and repeat the priming step. 

 



 166 

Step 10: 

• Turn the Dose Knob to select the 
number of units you need to inject. 
The Dose Indicator should line up 
with your dose. 

– The Pen dials 1 unit at a time. 

– The Dose Knob clicks as you 
turn it. 

– DO NOT dial your dose by 
counting the clicks because 
you may dial the wrong dose. 

– The dose can be corrected by 
turning the Dose Knob in 
either direction until the correct 
dose lines up with the Dose 
Indicator. 

– The even numbers are printed 
on the dial. 

– The odd numbers, after the 
number 1, are shown as full 
lines. 

 

• Always check the number in the 
Dose Window to make sure you 
have dialled the correct dose. 

 

 

 

 

 

 

(Example: 12 units 
shown in the Dose 
Window) 

 

 

 

 

 

 

(Example: 25 units 
shown in the Dose 
Window) 

 
 

• The Pen will not let you dial more than the number of units left in the Pen. 
• If you need to inject more than the number of units left in the Pen, you may either: 

– inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or 
– get a new Pen and inject the full dose. 

• It is normal to see a small amount of insulin left in the Pen that you cannot inject. 
 
Giving your injection 
 
• Inject your insulin as your healthcare professional has shown you. 
• Change (rotate) your injection site for each injection. 
• Do not try to change your dose while injecting. 
 

Step 11: 

• Choose your injection site. 

Your insulin is injected under the skin 
(subcutaneously) of your stomach area, 
buttocks, upper legs or upper arms. 

• Wipe your skin with a swab, and let the 
injection site dry before you inject your 
dose. 

 

 

 

 

 

 

 

 



 167 

Step 12: 

• Insert the Needle into your skin. 

• Push the Dose Knob all the way in. 

• Continue to hold the Dose 
Knob in and slowly count 
to 5 before removing the 
Needle. 

 

Do not try to inject your insulin by turning the 
Dose Knob. You will NOT receive your 
insulin by turning the Dose Knob. 

 
 

Step 13: 

• Pull the Needle out of your skin. 

– A drop of insulin at the Needle 
tip is normal. It will not affect 
your dose. 

• Check the number in the Dose Window 

– If you see “0” in the Dose 
window, you have received the 
full amount you dialled. 

– If you do not see “0” in the Dose 
window, do not redial. Insert the 
needle into your skin and finish 
your injection. 

– If you still do not think you 
received the full amount you 
dialled for your injection, do not 
start over or repeat that 
injection. Monitor your blood 
glucose as instructed by your 
healthcare professional. 

– If you normally need to give 2 
injections for your full dose, be 
sure to give your second 
injection. 

The plunger only moves a little with each 
injection, and you may not notice that it 
moves. 

If you see blood after you take the Needle out 
of your skin, press the injection site lightly 
with a piece of gauze or a swab. Do not rub 
the area. 

 

 

 
 
 
 

5 sec 



 168 

After your injection 
 

 
Step 14: 
• Carefully replace the Outer Needle Shield. 
 
 
 
 

Step 15: 

• Unscrew the capped Needle and dispose 
of it as described below (see Disposing 
of Pens and Needles section). 

• Do not store the Pen with the Needle 
attached to prevent leaking, blocking 
the Needle, and air from entering the 
Pen. 

 

 

Step 16: 

• Replace the Pen Cap by lining up the 
Cap Clip with the Dose Indicator and 
pushing straight on. 

 

 

 

 

Disposing of pens and needles  

 

• Put used Needles in a sharps container or a hard plastic container with a secure lid. Do not 
throw needles directly into your household waste. 

• Do not recycle the filled sharps container. 
• Ask your healthcare professional about options to dispose of the Pen and the sharps container 

properly. 
• The directions regarding needle handling are not intended to replace local, healthcare 

professional or institutional policies. 
 

Storing your pen   

 

Unused pens 

• Store unused Pens in the refrigerator at 2°C to 8°C. 
• Do not freeze your insulin. Do not use if it has been frozen. 
• Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept 

in the refrigerator. 
 
In-use Pen 
• Store the Pen you are currently using at room temperature up to 30°C and away from dust, food 

and liquids, heat and light. 
• Throw away the Pen you are using after the time specified in the Package Leaflet, even if it still 

has insulin left in it. 
 



 169 

General information about the safe and effective use of your pen  

• Keep your Pen and Needles out of the sight and reach of children. 
• Do not use your Pen if any part looks broken or damaged. 
• Always carry an extra Pen in case yours is lost or damaged. 
 
Troubleshooting 
• If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap 

straight off. 
• If the Dose Knob is hard to push: 

– Pushing the Dose Knob more slowly will make it easier to inject. 
– Your Needle may be blocked. Put on a new Needle and prime the Pen. 
– You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen. 

You may need to get a prescription from your healthcare professional. 
 
If you have any questions or problems with your KwikPen, call your healthcare professional for help 
or contact your local Lilly affiliate 
 
Document Revision Date:  



 170 

Package leaflet: Information for the user 
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen 

insulin lispro 
Each KwikPen delivers 1 – 60 units in steps of 1 units. 

 
 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog 200 units/ml KwikPen is and what it is used for 
2. What you need to know before you use Humalog 200 units/ml KwikPen 
3. How to use Humalog 200 units/ml KwikPen 
4. Possible side effects 
5. How to store Humalog 200 units/ml KwikPen 
6. Contents of the pack and other information 
 
 
1. What Humalog 200 units/ml KwikPen is and what it is used for 
 
Humalog 200 units/ml KwikPen is used to treat diabetes. Humalog works more quickly than normal 
human insulin because insulin lispro has been changed slightly in comparison to human insulin. 
Insulin lispro is closely related to human insulin which is a natural hormone made by the pancreas. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It 
works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally 
use Humalog within 15 minutes of a meal.  
 
Your doctor may tell you to use Humalog 200 units/ml KwikPen as well as a longer-acting insulin. 
Each kind of insulin comes with another patient information leaflet to tell you about it. Do not change 
your insulin unless your doctor tells you to.  
 
Humalog 200 units/ml KwikPen should be reserved for the treatment of adults with diabetes requiring 
daily doses of more than 20 units of rapid-acting insulin. 
 
Humalog 200 units/ml KwikPen is a disposable pre-filled pen containing 3 ml (600 units, 
200 units/ml) of insulin lispro.  One KwikPen contains multiple doses of insulin.  The KwikPen dials 
1 unit at a time.  The number of units are displayed in the dose window, always check this before 
your injection. You can give from 1 to 60 units in a single injection.  If your dose is more than 
60 units, you will need to give yourself more than one injection.  
 
 
2. What you need to know before you use Humalog 200 units/ml KwikPen 
 
Do NOT use Humalog 200 units/ml KwikPen  
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see section 3: If you take more Humalog than you need). 
 



 171 

Warnings and precautions  
 The Humalog 200 units/ml solution for injection in your pre-filled pen (the KwikPen) should 

ONLY be injected with this pre-filled pen. Do not transfer the insulin lispro from your 
Humalog 200 units/ml KwikPen to a syringe. The markings on the insulin syringe will not 
measure your dose correctly. A severe overdose can result, causing low blood sugar which may put 
your life in danger.  Do not transfer insulin from your Humalog 200 units/ml KwikPen to any other 
insulin delivery devices like insulin infusion pumps. 

 Do NOT mix the Humalog 200 units/ml solution for injection in your pre-filled pen (the 
KwikPen) with any other insulin or any other medicine. The Humalog 200 units/ml solution for 
injection should not be diluted. 

 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 
warning symptoms when your blood sugar is falling too low. Warning signs are listed in section 4 
of this leaflet. You must think carefully about when to have your meals, how often to exercise and 
how much to do. You must also keep a close watch on your blood sugar levels by testing your 
blood glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse 
- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. 
The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who 
were treated with pioglitazone and insulin experienced the development of heart failure. Inform 
your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness 
of breath or rapid increase in weight or localised swelling (oedema). 

 This Pen is not recommended for use by the blind or visually impaired without the help of someone 
trained to use the Pen. 

 
Other medicines and Humalog 200 units/ml KwikPen 
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics, (e.g. metformin, acarbose, sulphonylurea agents, pioglitazone, 

empagliflozin, DPP-4-inhibitors like sitagliptin or saxagliptine, ), 
 acetyl salicylic acid,  
 sulpha antibiotics,  
 somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you 

make too much growth hormone),  
 “beta2 stimulants”such as salbutamol or terbutaline to treat asthma, or ritodrine used to stop 

premature labor, 
 beta-blockers – to treat high blood pressure., or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol (medicine acting on ovulation),  
 some angiotensin converting (ACE) inhibitors, used to treat certain heart conditions or high 

blood pressure (for example captopril, enalapril), and  
 specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart 

problems  (angiotensin II receptor blockers). 
 
Please tell your doctor, if you are taking, have recently taken or might take any other medicines. (see 
also section “Warnings and precautions”). 
 



 172 

Humalog with alcohol 
 
Your blood sugar levels may either rise or fall if you drink alcohol.  Therefore the amount of insulin 
needed may change. 
 
Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or using machines). You should contact your doctor about the advisability of driving if you have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog 200 units/ml KwikPen 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Humalog 200 units/ml KwikPen 
 
Always check the pack and the label of the pre-filled pen for the name and type of the insulin 
when you get it from your pharmacy. Make sure you get the Humalog 200 units/ml KwikPen 
that your doctor has told you to use. 
 
Always use this medicine exactly as your doctor has told you. You should check with your doctor if 
you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, 
even if the needle is changed. 
 
Humalog 200 units/ml KwikPen is for patients taking more than 20 units of rapid-acting insulin a day. 
 
Do not transfer insulin from your Humalog 200 units/ml KwikPen to a syringe. The markings on 
the insulin syringe will not measure your dose correctly. A severe overdose can result, causing 
low blood sugar which may put your life in danger. 
 
Do not use Humalog 200 units/ml KwikPen solution for injection in an insulin infusion pump. 
 
Dosage 
 You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject 

soon after a meal. But your doctor will have told you exactly how much to use, when to use it, 
and how often. These instructions are only for you. Follow them exactly and visit your diabetes 
clinic regularly. 

 If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before. This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

 Inject Humalog under the skin (subcutaneously).  
 
Preparing Humalog 200 units/ml KwikPen  
 Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if 

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time 
you inject yourself. 

 



 173 

Getting the KwikPen ready to use (Please see user manual) 
 First wash your hands. 
 Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions 

carefully. Here are some reminders. 
 Use a clean needle. (Needles are not included). 
 Prime your KwikPen before each use. This checks that insulin comes out and clears the air 

bubbles from your KwikPen. There may still be some small air bubbles left in the pen - these 
are harmless. But if the air bubbles are too large it may affect the insulin dose. 

 
Injecting Humalog  
 Before you make an injection, clean your skin as you have been instructed. Inject under the 

skin, as you were taught. After your injection, leave the needle in the skin for five seconds to 
make sure you have taken the whole dose. Do not rub the area you have just injected. Make sure 
you inject at least half an inch (1 cm) from the last injection and that you ‘rotate’ the places you 
inject, as you have been taught. It doesn’t matter which injection site you use, either upper arm, 
thigh, buttock or abdomen, your Humalog injection will still work quicker than soluble human 
insulin. 

 Do not inject Humalog 200 units/ml KwikPen solution for injection directly into a vein 
(intravenously). 

 
After injecting 
 As soon as you have done the injection, unscrew the needle from the KwikPen using the outer 

needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering the pen 
and your needle clogging. Do not share your needles. Do not share your pen. Replace the cap 
on your pen. 

 
Further injections 
 Every time you use a KwikPen you must use a new needle. Before every injection, clear any air 

bubbles. You can see how much insulin is left by holding the KwikPen with the needle pointing 
up.  

 Once the KwikPen is empty, do not use it again. Please get rid of it carefully - your pharmacist 
or diabetes nurse will tell you how to do this. 

 
If you take more Humalog than you need 
If you take more Humalog than you need, a low blood sugar may occur.  Check your blood sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog 
If you take less Humalog than you need, a high blood sugar may occur.  Check your blood sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated, they can be 
very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids 
(dehydration), unconsciousness, coma or even death (see section 4 “Possible side effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always carry a spare pen in case you lose your KwikPen or it gets damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 



 174 

If you stop using Humalog. 
If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin 
unless your doctor tells you to. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 
If you think you are having this sort of insulin allergy with Humalog, contact a doctor at once. 
 
Local allergy is common (may affect up to 1 in 10 people).  Some people get redness, swelling or 
itching around the area of the insulin injection. This usually clears up in anything from a few days to a 
few weeks. If this happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If 
you notice your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels (see section 2). 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations such as 
driving a car, in which you or others would be put at risk by hypoglycaemia. 
 



 175 

Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 
• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy   • no appetite 
• flushed face   • fruity smell on the breath 
• thirst    • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse. Get medical help immediately. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog 200 units/ml KwikPen 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Before the first use store your Humalog 200 units/ml KwikPen in a refrigerator (2C – 8C). Do not 
freeze.  
 
Keep your Humalog 200 units/ml KwikPen in use at room temperature (15° - 30°C) and discard after 
28 days. Do not put it near heat or in the sun. Do not keep the KwikPen that you are using in the 
fridge. The KwikPen should not be stored with the needle attached. 
 
Do not use this medicine if you notice the solution is coloured or it has solid pieces in it. You must use 
it only if it looks like water. Check this each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information 
 
What Humalog 200 units/ml KwikPen solution for injection contains 
- The active substance is insulin lispro.  Each ml of solution contains 200 units (U) of insulin 

lispro. Each pre-filled pen (3 ml) contains 600 units (U) of insulin lispro. 
- The other ingredients are metacresol, glycerol, trometamol, zinc oxide and water for injection. 

Sodium hydroxide or hydrochloric acid may have been used to adjust the acidity.  
 
What Humalog 200 units/ml KwikPen looks like and contents of the pack 
Humalog 200 units/ml KwikPen, solution for injection is a sterile, clear, colourless, aqueous solution 
and contains 200 units of insulin lispro in each millilitre (200 units/ml) solution for injection. Each 
Humalog 200 units/ml KwikPen contains 600 units (3 millilitres). The Humalog 200 units/ml 
KwikPen comes in a pack of 1, 2 or 5 pre-filled pens or multipacks of 2 x 5 pre-filled pens. Not all 



 176 

pack sizes may be marketed. The KwikPen simply has a built in cartridge. When the pre-filled pen is 
empty you cannot use it again. 
 
Marketing Authorisation Holder  
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands.  
 
Manufacturer 
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France,  
Eli Lilly Italia S.p.A., Via  Gramsci 731-733, 50019 Sesto Fiorentino, (FI) Italy. 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 



 177 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
USER MANUAL 
 
Please see manual text later. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 178 

USER MANUAL 
Humalog 200 units/ml KwikPen, solution for injection in a pre-filled pen 

insulin lispro  

 

 

PLEASE READ THIS USER MANUAL BEFORE USE 
 
 

 
 
 

Read the User Manual before you start taking Humalog 200 units/ml KwikPen solution for injection 
and each time you get another Humalog 200 units/ml KwikPen. There may be new information. This 
information does not take the place of talking to your healthcare professional about your medical 
condition or your treatment. 

Humalog 200 units/ml KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml (600 units, 
200 units/ml) of insulin lispro solution for injection. You can give yourself multiple doses using one 
Pen. The Pen dials 1 unit at a time. You can inject from 1 to 60 units in a single injection. If your dose 
is more than 60 units, you will need to give yourself more than one injection. The plunger only 
moves a little with each injection, and you may not notice that it moves. The plunger will only reach 
the end of the cartridge when you have used all 600 units in the Pen. 

This pen is designed to allow you to give more doses than other pens you may have used in the 
past. Dial your usual dose as instructed by your healthcare professional. 

Humalog KwikPen is available in two strengths, 100 units/ml and 200 units/ml. Inject Humalog 
200 units/ml ONLY with your Pen. DO NOT transfer insulin from your Pen to another insulin 
delivery device. Syringes and insulin pumps will not dose 200 units/ml insulin correctly. A severe 
overdose can result, causing very low blood sugar which may put your life in danger. 

Do not share your Pen with other people, even if the needle has been changed. Do not reuse or 
share needles with other people.. You may give an infection to them or get an infection from 
them.  

This Pen is not recommended for use by the blind or visually impaired without the help of someone 
trained to use the Pen. 

USE ONLY IN THIS PEN, OR 
SEVERE OVERDOSE CAN RESULT 



 179 

 
KwikPen Parts 

 
 
 Pen Cap  Cartridge Holder Label  Dose Indicator 

 

 
 
 
Dose 
Knob 

Cap 
Clip Rubber Seal   Plunger  Pen Body 

Dose 
Window 

 
Pen Needle Parts 

(Needles Not Included) 
Dose Knob 

with burgundy ring 
  Needle   

  

Outer Needle 
Shield 

 Inner 
Needle 
Shield 

 Paper Tab  

 
How to recognize your Humalog 200 units/ml KwikPen: 

- Pen colour:  Dark grey 
- Dose Knob:  Dark grey with burgundy ring on the end 
- Labels:  Burgundy, “200 units/ml” in yellow box. 

 Yellow warning on cartridge holder 
 
Supplies needed to give your injection: 

 Humalog 200 units/ml KwikPen 
 KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles 

recommended) 
 Swab 

Needles and swab are not included. 
 
 
Preparing your Pen 

 Wash your hands with soap and water. 

 Check the Pen to make sure you are taking the right type of insulin. This is especially important if 
you use more than 1 type of insulin.  

 Do not use your Pen past the expiration date printed on the Label or for more than 28 days after 
you first start using the Pen.  

 Always use a new Needle for each injection to help prevent infections and blocked Needles.  
 
 
 
 
 
 
 

USE ONLY IN THIS PEN OR SEVERE 
OVERDOSE CAN RESULT 



 180 

Step 1: 

Pull the Pen Cap straight off. 

 Do not remove the Pen Label. 

Wipe the Rubber Seal with a swab.  

Humalog 200 units/ml solution for injection 
should look clear and colourless. Do not use if it 
is cloudy, coloured, or has particles or clumps in 
it. 

 

 

 
Step 2: 

Select a new Needle. 

Pull off the Paper Tab from the Outer Needle 
Shield. 

 

 
 

Step 3: 

Push the capped Needle straight onto the Pen 
and twist the Needle on until it is tight. 

 

 
 

Step 4: 

Pull off the Outer Needle Shield. Do not throw 
it away. 

Pull off the Inner Needle Shield and throw it 
away.   

 
 

USE ONLY IN THIS PEN OR  
SEVERE OVERDOSE CAN RESULT 



 181 

Priming your Pen 

Prime before each injection.  

 Priming your Pen means removing the air from the Needle and Cartridge that may collect during 
normal use and ensures that the Pen is working correctly.  

 If you do not prime before each injection, you may get too much or too little insulin.  
 

Step 5: 

To prime your Pen, turn the Dose Knob to select 
2 units. 

 
 

Step 6: 

Hold your Pen with the Needle pointing up. Tap 
the Cartridge Holder gently to collect air bubbles 
at the top. 

 
 

Step 7: 

Continue holding your Pen with Needle pointing 
up. Push the Dose Knob in until it stops, and “0” 
is seen in the Dose Window. Hold the Dose Knob 
in and count to 5 slowly. 

 You should see insulin at the tip of the 
Needle. 

 If you do not see insulin, repeat the 
priming steps, but not more than 
8 times. 

 If you still do not see insulin, change 
the Needle and repeat the priming 
steps. 

Small air bubbles are normal and will not affect 
your dose. 

 

 
 

 



 182 

 
Selecting your dose 

This pen has been designed to deliver the dose that is shown in the window. Dial your usual dose 
as instructed by your healthcare professional. 

 You can give from 1 to 60 units in a single injection.  

 If your dose is more than 60 units, you will need to give more than one injection.  

- If you need help deciding how to divide up your dose, ask your healthcare professional.  
- You should use a new Needle for each injection and repeat the priming step.  
 

Step 8: 

Turn the Dose Knob to select the number of units 
you need to inject. The Dose Indicator should 
line up with your dose. 

 The Pen dials 1 unit at a time. 

 The Dose Knob clicks as you turn it. 

 DO NOT dial your dose by counting 
the clicks because you may dial the 
wrong dose. 

 The dose can be corrected by turning 
the Dose Knob in either direction until 
the correct dose lines up with the Dose 
Indicator. 

 The even numbers are printed on the 
dial.  

 The odd numbers, after the number 1, 
are shown as full lines. 

Always check the number in the Dose Window 
to make sure you have dialled the correct 
dose.  

 
 

 
 

   (Example: 12 units shown in the 
Dose Window) 

 

 
 
 

   (Example: 25 units shown in the 
Dose Window) 

 

 

 The Pen will not let you dial more than the number of units left in the Pen.  

 If you need to inject more than the number of units left in the Pen, you may either:  

- inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or 
- get a new Pen and inject the full dose.  



 183 

Giving your injection 

 Inject your insulin as your healthcare professional has shown you.  

 Change (rotate) your injection site for each injection.  

 Do not try to change your dose while injecting.  

 

Step 9: 

Choose your injection site. 

Humalog 200 units/ml solution for injection is 
injected under the skin (subcutaneously) of your 
stomach area, buttocks, upper legs or upper 
arms. 

Wipe your skin with a swab, and let your skin 
dry before you inject your dose. 

 

 

Step 10: 

Insert the Needle into your skin. 

Push the Dose Knob all the way in.  

 

 

Continue to hold the Dose Knob in 
and slowly count to 5 before 
removing the Needle. 

Do not try to inject your insulin by turning the 
Dose Knob. You will NOT receive your insulin 
by turning the Dose Knob. 

 

 
 

Step 11: 

Pull the Needle out of your skin. 

 A drop of insulin at the Needle tip is 
normal. It will not affect your dose.  

 Check the number in the Dose 
Window.If you see “0” in the Dose 
Window, you have received the full 
amount you dialled.  

 If you do not see “0” in the Dose 
Window, do not redial. Insert the 
needle into your skin and finish your 
injection. 

 If you still do not think you received 
the full amount you dialled for your 
injection, do not start over or repeat 
that injection. Monitor your blood 
glucose as instructed by your 
healthcare professional. 

The plunger only moves a little with each 
injection and you may not notice that it moves. 

 

 



 184 

If you see blood after you take the Needle out of 
your skin, press the injection site lightly with a 
piece of gauze or a swab. Do not rub the area. 

 
After your injection 
 

Step 12: 

Carefully replace the Outer Needle Shield. 

 

 
 

Step 13: 

Unscrew the capped Needle and dispose of it as 
described below (see Disposing of Pens and 
Needles section). 

Do not store the Pen with the Needle attached to 
prevent leaking, blocking the Needle, and air 
from entering the Pen. 

 

 
 

Step 14: 

Replace the Pen Cap by lining up the Cap Clip 
with the Dose Indicator and pushing straight on. 

 

 
 

 
Disposing of Pens and Needles 

 Put used Needles in a sharps container or hard plastic container with a secure lid. Do not 
throw needles directly into your household waste.  

 Do not recycle the filled sharps container. 
 Ask your healthcare professional about options to dispose of the Pen and the sharps container 

properly. 
 The directions regarding needle handling are not intended to replace local, healthcare 

professional or institutional policies. 
 
Storing your Pen 

Unused Pens 

 Store unused Pens in the refrigerator at 2°C to 8°C. 

 Do not freeze Humalog 200 units/ml solution for injection. Do not use if it has been frozen.  

 Unused Pens may be used until the expiration date printed on the Label, if the Pen has been 
kept in the refrigerator.  



 185 

In-use Pen 

 Store the Pen you are currently using at room temperature (up to 30°C) and away from dust, 
food and liquids, heat and light. 

 Throw away the Pen you are using after 28 days, even if it still has insulin left in it. 
 
General information about the safe and effective use of your Pen 

 Keep your Pen and Needles out of the sight and reach of children. 

 Do not use your Pen if any part looks broken or damaged. 

 Always carry an extra Pen in case yours is lost or damaged. 

Troubleshooting 

 If you cannot remove the Pen Cap, gently twist the cap back and forth, and then pull the cap 
straight off. 

 If the Dose Knob is hard to push;  

- Pushing the Dose Knob more slowly will make it easier to inject. 
- Your Needle may be blocked. Put on a new Needle and prime the Pen. 
- You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new 

Pen. You may need to get a prescription from your healthcare professional. 

 Do not transfer insulin from the Pen to a syringe or an insulin pump. Severe overdose 
can result. 

 

If you have any questions or problems with your Humalog 200 units/ml KwikPen, call your healthcare 
professional for help or contact your local Lilly affiliate.  

 
Document revision date:  



 186 

 
Package leaflet: Information for the user 

 
Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen 

insulin lispro 
Each Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units. 

 
Read all of this leaflet carefully before you start using this medicine because it contains 
important information for you. 
- Keep this leaflet. You may need to read it again. 
- If you have any further questions, ask your doctor or pharmacist. 
- This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, 

even if their signs of illness are the same as yours. 
- If you get any side effects, talk to your doctor or pharmacist. This includes any possible side 

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet:  
1. What Humalog Junior KwikPen is and what it is used for 
2. What you need to know before you use Humalog Junior KwikPen 
3. How to use Humalog Junior KwikPen 
4. Possible side effects 
5. How to store Humalog Junior KwikPen 
6. Contents of the pack and other information 
 
 
1. What Humalog Junior KwikPen is and what it is used for 
 
Humalog Junior KwikPen is used to treat diabetes. Humalog works more quickly than normal human 
insulin because insulin lispro has been changed slightly in comparison to human insulin. Insulin lispro 
is closely related to human insulin which is a natural hormone made by the pancreas. 
 
You get diabetes if your pancreas does not make enough insulin to control the level of glucose in your 
blood. Humalog is a substitute for your own insulin and is used to control glucose in the long term. It 
works very quickly and lasts a shorter time than soluble insulin (2 to 5 hours). You should normally 
use Humalog within 15 minutes of a meal.  
 
Your doctor may tell you to use Humalog as well as a longer-acting insulin. Each kind of insulin 
comes with another patient information leaflet to tell you about it. Do not change your insulin unless 
your doctor tells you to.  
 
Humalog is suitable for use in adults and children.  
 
Humalog 100 units/ml Junior KwikPen is a disposable pre-filled pen containing 3 ml (300 units, 
100 units/ml) of insulin lispro.  One KwikPen contains multiple doses of insulin.  The KwikPen dials 
half unit (0.5 unit) at a time. The number of units are displayed in the dose window, always check 
this before your injection. You can give from 0.5 unit to 30 units in a single injection.  If your dose 
is more than 30 units, you will need to give yourself more than one injection.  
 
 
2. What you need to know before you use Humalog Junior KwikPen   
 
Do NOT use Humalog Junior KwikPen  
- if you are allergic to insulin lispro or any of the other ingredients of this medicine (listed in 

section 6). 
- if you think hypoglycaemia (low blood sugar) is starting. Further in this leaflet it tells you how to 

deal with mild hypoglycaemia (see Section 3: If you take more Humalog than you need). 
 



 187 

Warnings and precautions  
 Do NOT mix the Humalog 100 units/ml solution for injection in your pre-filled pen (the 

Junior KwikPen) with any other insulins or any other medicine.  
 If your blood sugar levels are well controlled by your current insulin therapy, you may not feel the 

warning symptoms when your blood sugar is falling too low. Warning signs are listed in section 4 
of this leaflet. You must think carefully about when to have your meals, how often to exercise and 
how much to do. You must also keep a close watch on your blood sugar levels by testing your 
blood glucose often. 

 A few people who have had hypoglycaemia after switching from animal insulin to human insulin 
have reported that the early warning symptoms were less obvious or different. If you often have 
hypoglycaemia or have difficulty recognising it, please discuss this with your doctor. 

 If you answer YES to any of the following questions, tell your doctor, pharmacist or diabetes nurse 
- Have you recently become ill? 
- Do you have trouble with your kidneys or liver? 
-  Are you exercising more than usual? 

 You should also tell your doctor, pharmacist or diabetes nurse if you are planning to go abroad. 
The time difference between countries may mean that you have to have your injections and meals 
at different times from when you are at home. 

 Some patients with long-standing type 2 diabetes mellitus and heart disease or previous stroke who 
were treated with pioglitazone and insulin experienced the development of heart failure. Inform 
your doctor as soon as possible, if you experience signs of heart failure such as unusual shortness 
of breath or rapid increase in weight or localised swelling (oedema). 

 This Pen is not recommended for use by the blind or visually impaired without the help of someone 
trained to use the Pen. 

 
Other medicines and Humalog Junior KwikPen  
Your insulin needs may change if you are taking  

 the contraceptive pill,  
 steroids,  
 thyroid hormone replacement therapy,  
 oral hypoglycaemics, (e.g. metformin, acarbose, sulphonylurea agents, pioglitazone, 

empagliflozin, DPP-4-inhibitors like sitagliptin or saxagliptine, ), 
 acetyl salicylic acid,  
 sulpha antibiotics,  
 somatostatin analogues (such as octreotide, used to treat an uncommon condition in which you 

make too much growth hormone),  
 “beta2 stimulants”such as salbutamol or terbutaline to treat asthma, or ritodrine used to stop 

premature labor, 
 beta-blockers – to treat high blood pressure., or  
 some antidepressants (monoamine oxidase inhibitors or selective serotonin reuptake inhibitors),  
 danazol (medicine acting on ovulation),  
 some angiotensin converting (ACE) inhibitors, used to treat certain heart conditions or high 

blood pressure (for example captopril, enalapril), and  
 specific medicines to treat high blood pressure, kidney damage due to diabetes, and some heart 

problems  (angiotensin II receptor blockers). 
 
Please tell your doctor, if you are taking, have recently taken or might take any other medicines. (see 
also section “Warnings and precautions”). 
 
Humalog with alcohol 
 
Your blood sugar levels may either rise or fall if you drink alcohol.  Therefore the amount of insulin 
needed may change. 
 



 188 

Pregnancy and breast-feeding 
Are you pregnant or thinking about becoming pregnant, or are you breast-feeding? The amount of 
insulin you need usually falls during the first three months of pregnancy and increases for the 
remaining six months. If you are breast-feeding, you may need to alter your insulin intake or diet. 
Ask your doctor for advice. 
 
Driving and using machines 
Your ability to concentrate and react may be reduced if you have hypoglycaemia. Please keep this 
possible problem in mind in all situations where you might put yourself and others at risk (e.g. driving 
a car or operating machinery). You should contact your doctor about the advisability of driving if you 
have: 
 frequent episodes of hypoglycaemia 
 reduced or absent warning signs of hypoglycaemia 
 
Important information about some of the ingredients of Humalog Junior KwikPen 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Humalog Junior KwikPen  
 
Always check the pack and the label of the pre-filled pen for the name and type of the insulin 
when you get it from your pharmacy. Make sure you get the Humalog 100 units/ml Junior 
KwikPen that your doctor has told you to use. 
 
Always use this medicine exactly as your doctor has told you. You should check with your doctor if 
you are not sure. To prevent the possible transmission of disease, each pen must be used by you only, 
even if the needle is changed. 
 
Dosage 
 The number of half units (0.5 units) is shown in the dose window of your pen. The half units 

(0.5 units) are shown as lines between the numbers. 
 Always check the number in the dose window to make sure you have dialled the correct dose. 
 You should normally inject Humalog within 15 minutes of a meal. If you need to, you can inject 

soon after a meal. But your doctor will have told you exactly how much to use, when to use it, 
and how often. These instructions are only for you. Follow them exactly and visit your diabetes 
clinic regularly. 

 If you change the type of insulin you use (for example from a human or animal insulin to a 
Humalog product), you may have to take more or less than before. This might just be for the 
first injection or it may be a gradual change over several weeks or months.  

 Humalog KwikPen is only suitable for injecting just under the skin. Speak to your doctor if you 
need to inject your insulin by another method.   

Preparing Humalog Junior KwikPen  
• Humalog is already dissolved in water, so you do not need to mix it. But you must use it only if 

it looks like water. It must be clear, have no colour and no solid pieces in it. Check each time 
you inject yourself. 

 
Getting the Junior KwikPen ready to use (Please see user manual) 
• First wash your hands. 
• Read the instructions on how to use your pre-filled insulin pen. Please follow the instructions 

carefully. Here are some reminders. 
• Use a clean needle. (Needles are not included). 
• Prime your Junior KwikPen  before each use. This checks that insulin comes out and clears the 

air bubbles from your Junior KwikPen . There may still be some small air bubbles left in the 
pen - these are harmless. But if the air bubbles are too large it may affect the insulin dose. 

 



 189 

Injecting Humalog  
• Before you make an injection, clean your skin as you have been instructed. Inject under the 

skin, as you were taught. Do not inject directly into a vein. After your injection, leave the needle 
in the skin for five seconds to make sure you have taken the whole dose. Do not rub the area 
you have just injected. Make sure you inject at least half an inch (1 cm) from the last injection 
and that you ‘rotate’ the places you inject, as you have been taught. It doesn’t matter which 
injection site you use, either upper arm, thigh, buttock or abdomen, your Humalog injection will 
still work quicker than soluble human insulin. 

• You must not administer Humalog by the intravenous route. Inject Humalog as your physician 
or nurse has taught you. Only your physician can administer Humalog by the intravenous route. 
He will only do this under special circumstances such as surgery or if you are ill and your 
glucose levels are too high. 

 
After injecting 
• As soon as you have done the injection, unscrew the needle from the Junior KwikPen using the 

outer needle cap. This will keep the insulin sterile and stop it leaking. It also stops air entering 
the pen and your needle clogging. Do not share your needles. Do not share your pen. Replace 
the cap on your pen. 

 
Further injections 
• Every time you use a Junior KwikPen you must use a new needle. Before every injection, clear 

any air bubbles. You can see how much insulin is left by holding the Junior KwikPen with the 
needle pointing up. The scale on the cartridge shows about how many units you have left. 

• Once the Junior KwikPen is empty, do not use it again. Please get rid of it carefully - your 
pharmacist or diabetes nurse will tell you how to do this. 

 
Using Humalog in an infusion pump 
• Junior KwikPen is only suitable for injecting just under the skin.  Do not use the pen to 

administer Humalog by a different way.  Other forms of Humalog 100 units/ml are available if 
this is necessary.  Speak to your doctor if this applies to you. 

 
If you take more Humalog than you need 
If you take more Humalog than you need, a low blood sugar may occur.  Check your blood sugar.  
 
If your blood sugar is low (mild hypoglycaemia), eat glucose tablets, sugar or drink a sugary drink. 
Then eat fruit, biscuits, or a sandwich, as your doctor has advised you and have some rest. This will 
often get you over mild hypoglycaemia or a minor insulin overdose. If you get worse and your 
breathing is shallow and your skin gets pale, tell your doctor at once. A glucagon injection can treat 
quite severe hypoglycaemia. Eat glucose or sugar after the glucagon injection. If you do not respond to 
glucagon, you will have to go to hospital. Ask your doctor to tell you about glucagon. 
 
If you forget to use Humalog 
If you take less Humalog than you need, a high blood sugar may occur.  Check your blood sugar 
 
If hypoglycaemia (low blood sugar) or hyperglycaemia (high blood sugar) is not treated they can be 
very serious and cause headaches, feeling sick (nausea), being sick (vomiting), loss of fluids 
(dehydration), unconsciousness, coma or even death (see section 4 “Possible Side Effects”).  
 
Three simple steps to avoid hypoglycaemia or hyperglycaemia are: 
• Always carry a spare pen in case you lose your Junior KwikPen or it gets damaged. 
• Always carry something to show you are diabetic. 
• Always carry sugar with you. 
 
If you stop using Humalog. 
If you take less Humalog than you need, a high blood sugar may occur. Do not change your insulin 
unless your doctor tells you to. 
 



 190 

If you have any further questions on the use of this product, ask your doctor or pharmacist. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Severe allergy is rare (may affect up to 1 in 1,000 people). The symptoms are as follows: 
• rash over the whole body  • blood pressure dropping 
• difficulty in breathing  • heart beating fast 
• wheezing    • sweating 
 
If you think you are having this sort of insulin allergy with Humalog, contact a doctor at once. 
 
Local allergy is common (may affect up to 1 in 10 people).  Some people get redness, swelling or 
itching around the area of the insulin injection. This usually clears up in anything from a few days to a 
few weeks. If this happens to you, tell your doctor. 
 
Lipodystrophy (thickening or pitting of the skin) is uncommon (may affect up to 1 in 100 people). If 
you notice your skin thickening or pitting at the injection site, tell your doctor. 
 
Oedema (e.g. swelling in arms, ankles; fluid retention) has been reported, particularly at the start of 
insulin therapy or during a change in therapy to improve control of your blood glucose. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects 
not listed in this leaflet. You can also report side effects directly via the national reporting system 
listed in Appendix V. By reporting side effects you can help provide more information on the safety of 
this medicine. 
 
Common problems of diabetes 
 
Hypoglycaemia  
Hypoglycaemia (low blood sugar) means there is not enough sugar in the blood. This can be caused if: 
• you take too much Humalog or other insulin; 
• you miss or delay meals or change your diet; 
• you exercise or work too hard just before or after a meal; 
• you have an infection or illness (especially diarrhoea or vomiting); 
• there is a change in your need for insulin; or 
• you have trouble with your kidneys or liver which gets worse. 
 
Alcohol and some medicines can affect your blood sugar levels (see section 2). 
 
The first symptoms of low blood sugar usually come on quickly and include the following: 
• tiredness    • rapid heartbeat 
• nervousness or shakiness  • feeling sick 
• headache    • cold sweat 
 
While you are not confident about recognising your warning symptoms, avoid situations such as 
driving a car, in which you or others would be put at risk by hypoglycaemia. 
 
Hyperglycaemia and diabetic ketoacidosis 
Hyperglycaemia (too much sugar in the blood) means that your body does not have enough insulin. 
Hyperglycaemia can be brought about by: 
• not taking your Humalog or other insulin; 
• taking less insulin than your doctor tells you to; 
• eating a lot more than your diet allows; or 



 191 

• fever, infection or emotional stress. 
 
Hyperglycaemia can lead to diabetic ketoacidosis. The first symptoms come on slowly over many 
hours or days. The symptoms include the following: 
• feeling sleepy  • no appetite 
• flushed face   • fruity smell on the breath 
• thirst    • feeling or being sick 
 
Severe symptoms are heavy breathing and a rapid pulse.  Get medical help immediately. 
 
Illness 
If you are ill, especially if you feel sick or are sick, the amount of insulin you need may change. Even 
when you are not eating normally, you still need insulin. Test your urine or blood, follow your 
‘sick rules’, and tell your doctor. 
 
 
5. How to store Humalog Junior KwikPen 
 
Keep out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on the label and the carton. The expiry 
date refers to the last day of that month.  
 
Before the first use store your Humalog Junior KwikPen in a refrigerator (2C – 8C). Do not freeze.  
 
Keep your Humalog Junior KwikPen in use at room temperature (15° - 30°C) and discard after 28 
days even if some of the solution remains. Do not put it near heat or in the sun. Do not keep the 
Junior KwikPen that you are using in the fridge. The Junior KwikPen should not be stored with the 
needle attached. 
 
Do not use this medicine if you notice the solution is coloured or it has solid pieces in it. You must use 
it only if it looks like water. Check this each time you inject yourself. 
 
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to 
dispose of medicines no longer required. These measures will help to protect the environment. 
 
 
6. Contents of the pack and other information  
 
What Humalog 100 units/ml Junior KwikPen solution for injection contains 
- The active substance is insulin lispro. Each ml of solution contains 100 units (U) of insulin 

lispro.  Each pre-filled pen (3 ml) contains 300 units (U) of insulin lispro. 
- The other ingredients are metacresol, glycerol, dibasic sodium phosphate 7 H2O, zinc oxide and 

water for injections. Sodium hydroxide or hydrochloric acid may have been used to adjust the 
acidity.  

 
What Humalog 100 units/ml Junior KwikPen looks like and contents of the pack 
Humalog 100 units/ml Junior KwikPen, solution for injection is a sterile, clear, colourless, aqueous 
solution and contains 100 units of insulin lispro in each millilitre (100 units/ml) solution for injection. 
Each Humalog Junior KwikPen contains 300 units (3 millilitres). The Humalog Junior KwikPen 
comes in a pack of 1or 5 pre-filled pens or multipacks of 2 x 5 pre-filled pens. Not all pack sizes may 
be marketed. The Junior KwikPen simply has a built in cartridge. When the pre-filled pen is empty 
you cannot use it again. The Junior KwikPen is blue.  The dose knob is blue with raised ridges.  The 
label is white with an orange colour bar and there is an orange to yellow, burgundy colour band. Each 
Junior KwikPen delivers 0.5 – 30 units in steps of 0.5 units. 
 
 



 192 

Marketing Authorisation Holder  
 
Eli Lilly Nederland B.V., Papendorpseweg 83, 3528 BJ Utrecht, The Netherlands. 
 
Manufacturer  
 
Lilly France S.A.S., Rue du Colonel Lilly, 67640 Fegersheim, France, 
 
For any information about this medicinal product, please contact the local representative of the 
Marketing Authorisation Holder: 
 
Belgique/België/Belgien 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 
 

Lietuva 
Eli Lilly Lietuva 
Tel. +370 (5) 2649600 
 

България 
ТП "Ели Лили Недерланд" Б.В. - България 
тел. + 359 2 491 41 40 
 

Luxembourg/Luxemburg 
Eli Lilly Benelux S.A./N.V. 
Tél/Tel: + 32-(0)2 548 84 84 

Česká republika 
ELI LILLY ČR, s.r.o. 
Tel: + 420 234 664 111 
 

Magyarország 
Lilly Hungária Kft. 
Tel: + 36 1 328 5100 

Danmark 
Eli Lilly Danmark A/S  
Tlf: +45 45 26 6000 
 

Malta 
Charles de Giorgio Ltd. 
Tel: + 356 25600 500 

Deutschland 
Lilly Deutschland GmbH 
Tel. + 49-(0) 6172 273 2222 
 

Nederland 
Eli Lilly Nederland B.V.  
Tel: + 31-(0) 30 60 25 800 

Eesti 
Eli Lilly Nederland B.V. 
Tel: +372 6817 280 
 

Norge 
Eli Lilly Norge A.S.  
Tlf: + 47 22 88 18 00 

Ελλάδα 
ΦΑΡΜΑΣΕΡΒ-ΛΙΛΛΥ Α.Ε.Β.Ε.  
Τηλ: +30 210 629 4600 
 

Österreich 
Eli Lilly Ges. m.b.H.  
Tel: + 43-(0) 1 711 780 

España 
Lilly S.A. 
Tel: + 34-91 663 50 00 
 

Polska 
Eli Lilly Polska Sp. z o.o. 
Tel: +48 22 440 33 00 

France 
Lilly France S.A.S. 
Tél: +33-(0) 1 55 49 34 34 
 

Portugal 
Lilly Portugal - Produtos Farmacêuticos, Lda 
Tel: + 351-21-4126600 

Hrvatska 
Eli Lilly Hrvatska d.o.o. 
Tel: +385 1 2350 999 
 

România 
Eli Lilly România S.R.L. 
Tel: + 40 21 4023000 

Ireland 
Eli Lilly and Company (Ireland) Limited 
Tel: + 353-(0) 1 661 4377 
 

Slovenija 
Eli Lilly farmacevtska družba, d.o.o. 
Tel: +386 (0) 1 580 00 10 
 



 193 

Ísland 
Icepharma hf.  
Sími + 354 540 8000 
 

Slovenská republika 
Eli Lilly Slovakia s.r.o. 
Tel: + 421 220 663 111 
 

Italia 
Eli Lilly Italia S.p.A. 
Tel: + 39- 055 42571 
 

Suomi/Finland 
Oy Eli Lilly Finland Ab  
Puh/Tel: + 358-(0) 9 85 45 250 
 

Κύπρος 
Phadisco Ltd  
Τηλ: +357 22 715000 
 

Sverige 
Eli Lilly Sweden AB 
Tel: + 46-(0) 8 7378800 

Latvija 
Eli Lilly (Suisse) S.A Pārstāvniecība Latvijā  
Tel: +371 67364000 
 

United Kingdom 
Eli Lilly and Company Limited 
Tel: + 44-(0) 1256 315000 

 
This leaflet was last revised in {MM/YYYY}. 
 
USER MANUAL 
 
Please see manual text later. 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu/. 



 194 

 
Instructions for Use 

Humalog 100 units/ml Junior KwikPen, solution for injection in a pre-filled pen 
insulin lispro  

 

 
 

 
PLEASE READ THESE INSTRUCTIONS BEFORE USE 

Read the Instructions for Use before you start taking Humalog Junior KwikPen and each time you get 
another Humalog Junior KwikPen. There may be new information. This information does not take the 
place of talking to your healthcare professional about your medical condition or your treatment. 

Humalog 100 units/ml Junior KwikPen (“Pen”) is a disposable pre-filled pen containing 3 ml 
(300 units, 100 units/ml) of insulin lispro solution for injection.  One pen contains multiple doses of 
insulin. 

 

• Your healthcare professional will tell you how many units to give as your dose and how to 
inject your prescribed dose of insulin. 

• The Pen dials half unit (0.5 unit) at a time. You can give from 0.5 unit to 30 units in a single 
injection.  

• Always check the number in the dose window to make sure you have dialed the correct dose. 

• If your dose is more than 30 units, you will need to give yourself more than one injection.  

• The Plunger only moves a little with each injection, and you may not notice that it moves. When 
the Plunger reaches the end of the cartridge, you have used all 300 units in the Pen. 

Do not share your Pen with other people, even if the needle has been changed. Do not reuse or 
share needles with other people. You may give an infection to them or get an infection from 
them. 

This Pen is not recommended for use by the blind or visually impaired without the help of someone 
trained to use the Pen. 

 

Humalog Junior KwikPen Parts 
 Pen Cap  Cartridge Holder  Label Dose Indicator 

 

 
 Cap Clip Rubber Seal Plunger Pen Body Dose 

Window 
Dose 
Knob 

 



 195 

Pen Needle Parts 
(Needles Not Included) 

 Dose Knob 
Blue, with raised ridges 

on end and side 

 
  Paper Tab   

 

 

  

 
Outer Needle 

Shield 
Inner Needle 

Shield 
Needle    

 
 
 
How to recognize your Humalog Junior KwikPen: 
• Pen colour: Blue 

• Dose Knob: Blue, with raised ridges on end and side 

• Label: White with an orange colour bar and orange-to-yellow and burgundy colour band 

 
Supplies needed to give your injection: 
• Humalog Junior KwikPen 

• KwikPen compatible Needle (BD [Becton, Dickinson and Company] Pen Needles recommended) 

• Swab 

Needles and swab are not included. 
 

Preparing your Pen 
• Wash your hands with soap and water. 

• Check the Pen to make sure you are taking the right type of insulin. This is especially important if 
you use more than 1 type of insulin. 

• Do not use your Pen past the expiration date printed on the Label or for more than 28 days after 
you first start using the Pen. 

• Always use a new Needle for each injection to help prevent infections and blocked Needles.  

 
Step 1: 
• Pull the Pen Cap straight off. 

– Do not remove the Pen Label. 

• Wipe the Rubber Seal with a swab. 

Humalog should look clear and colourless. Do not 
use if it is cloudy, coloured, or has particles or clumps 
in it. 

 



 196 

Step 2: 
• Select a new Needle. 

• Pull off the Paper Tab from the Outer Needle 
Shield. 

 

Step 3: 
• Push the capped Needle straight onto the Pen and 

twist the Needle on until it is tight. 

 

Step 4: 
• Pull off the Outer Needle Shield. Do not throw it 

away. 

• Pull off the Inner Needle Shield and throw it 
away. 

 

 
 
Priming your Pen 
Prime before each injection. 
• Priming your Pen means removing the air from the Needle and Cartridge that may collect during 

normal use. It is important to prime your Pen so that it will work correctly. 

• If you do not prime before each injection, you may get too much or too little insulin. 

 
Step 5: 
• To prime your Pen, turn the Dose Knob to select 

2 units. 

 

 
Step 6: 
• Hold your Pen with the Needle pointing up. Tap 

the Cartridge Holder gently to collect air bubbles 
at the top. 

 

Keep Throw 
Away 



 197 

Step 7: 
• Continue holding your Pen with the Needle 

pointing up. Push the Dose Knob in until it stops, 
and “0” is seen in the Dose Window. Hold the 
Dose Knob in and count to 5 slowly. 

You should see insulin at the tip of the Needle. 

– If you do not see insulin, repeat the priming 
steps, but not more than 4 times. 

– If you still do not see insulin, change the 
Needle and repeat the priming steps. 

Small air bubbles are normal and will not affect your 
dose. 

 

 
 

 
 

 
Selecting your dose 
• You can give from half unit (0.5 unit) to 30 units in a single injection. 

Always check the number in the Dose Window to make sure you have dialled the correct dose. 

 

• If your dose is more than 30 units, you will need to give more than one injection. 

–  Talk to your healthcare professional about how to give your dose. 

– Use a new Needle for each injection and repeat the priming step. 

– If you usually need more than 30 units, ask your healthcare professional if a different 
Humalog KwikPen would be better for you. 



 198 

 
Step 8: 
• Turn the Dose Knob to select the number of units 

you need to inject. The Dose Indicator should line 
up with your dose. 

– The Pen dials half unit (0.5 unit) at a time. 

– The Dose Knob clicks as you turn it. 

– DO NOT dial your dose by counting the 
clicks because you may dial the wrong dose. 

– The dose can be corrected by turning the Dose 
Knob in either direction until the correct dose 
lines up with the Dose Indicator. 

– The whole unit numbers are printed on the 
dial. 

 
 
 

– The half units  are shown as  lines between 
the numbers. 

 
 
• Always check the number in the Dose Window 

to make sure you have dialled the correct dose. 

 

 
 
 

 
Example: 4 units 
shown in the  
Dose Window 

 
 

 
Example: 10 ½ (10.5) 
units shown in the 
Dose Window 

 
• The Pen will not let you dial more than the number of units left in the Pen. 

• If you need to inject more than the number of units left in the Pen, you may either: 

– inject the amount left in your Pen and then use a new Pen to give the rest of your dose, or 

– get a new Pen and inject the full dose. 

• It is normal to see a small amount of insulin left in the Pen that you can not inject. 

 
Giving your injection 
• Inject your insulin as your healthcare professional has shown you. 

• Change (rotate) your injection site for each injection. 

• Do not try to change your dose while injecting. 

 
Step 9: 
• Choose your injection site. 

 Humalog is injected under the skin 
(subcutaneously) of your stomach area, 
buttocks, upper legs or upper arms. 

• Wipe your skin with a swab, and let your 
skin dry before you inject your dose. 

 

 

 



 199 

Step 10: 
• Insert the Needle into your skin. 

• Push the Dose Knob all the way in. 

 

• Continue to hold the Dose 
Knob in and slowly count to 5 
before removing the Needle. 

Do not try to inject your insulin by 
turning the Dose Knob. You will 
NOT receive your insulin by 
turning the Dose Knob. 

 

Step 11: 
• Pull the Needle out of your skin. 

– A drop of insulin at the Needle tip is normal. It 
will not affect your dose. 

• Check the number in the Dose Window 

- If you see “0” in the Dose window, you have 
received the full amount you dialled. 

- If you do not see “0” in the Dose window, you 
did not receive your full dose. Do not redial. 
Insert the needle into your skin and finish your 
injection. 

- If you still do not think you received the full 
amount you dialled for your injection, do not 
start over or repeat that injection. Monitor 
your blood glucose and call your healthcare 
professional for further instructions. 

The plunger only moves a little with each injection, 
and you may not notice that it moves. 

If you see blood after you take the Needle out of your 
skin, press the injection site lightly with a piece of 
gauze or a swab. Do not rub the area. 

 

 

5sec 



 200 

 
After your injection 
Step 12: 
• Carefully replace the Outer Needle Shield. 

 

Step 13: 
• Unscrew the capped Needle and dispose of it as 

described below (see Disposing of Pens and 
Needles section). 

• Do not store the Pen with the Needle attached to 
prevent leaking, blocking the Needle, and air 
from entering the Pen. 

 

Step 14: 
• Replace the Pen Cap by lining up the Cap Clip 

with the Dose Indicator and pushing straight on. 

 

 
 
Disposing of Pens and Needles 
• Put used Needles in a sharps container or a hard plastic container with a secure lid. Do not throw 

needles directly into your household waste.  

• Do not recycle the filled sharps container. 

• Ask your healthcare professional about options to dispose of the Pen and the sharps container 
properly. 

• The directions regarding needle handling are not intended to replace local, healthcare professional 
or institutional policies. 

Storing your Pen 
Unused Pens 
• Store unused Pens in the refrigerator at (2 °C to 8 °C). 

• Do not freeze Humalog. Do not use if it has been frozen. 

• Unused Pens may be used until the expiration date printed on the Label, if the Pen has been kept 
in the refrigerator. 

In-use Pen 
• Store the Pen you are currently using at room temperature [up to (30 °C)] and away from dust, 

food and liquids, heat and light. 

• Throw away the Pen you are using after 28 days, even if it still has insulin left in it. 

 
General information about the safe and effective use of your Pen 
• Keep your Pen and Needles out of the sight and reach of children. 

• Do not use your Pen if any part looks broken or damaged. 

• Always carry an extra Pen in case yours is lost or damaged. 



 201 

 
 
Troubleshooting 
• If you can not remove the Pen Cap, gently twist the cap back and forth, and then pull the cap 

straight off. 

• If the Dose Knob is hard to push: 

– Pushing the Dose Knob more slowly will make it easier to inject. 

– Your Needle may be blocked. Put on a new Needle and prime the Pen. 

– You may have dust, food, or liquid inside the Pen. Throw the Pen away and get a new Pen. 
You may need to get a prescription from your healthcare professional. 

If you have any questions or problems with your Humalog 100 units/ml Junior KwikPen, call your 
healthcare professional for help or contact your local Lilly affiliate.  

 
Document revision date:  
 
 
 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURERS OF THE BIOLOGICAL ACTIVE SUBSTANCE ANDMANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE
	C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETINGAUTHORISATION
	D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE ANDEFFECTIVE USE OF THE MEDICINAL PRODUCT
	A. LABELLING
	B. PACKAGE LEAFLET