Valtropin

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 

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1. NAME OF THE MEDICINAL PRODUCT 
 
Valtropin 5 mg/1.5 ml powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
One vial of powder contains 5 mg somatropin (corresponding to 15 IU). 
 
After reconstitution with 1.5 ml solvent, 1 ml contains: 
somatropin* 3.33 mg (corresponding to 10 IU) 
* produced in Saccharomyces cerevisiae cells by recombinant DNA technology. 
 
For a full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
 
White or almost white powder. The solvent is a clear solution. 
 
After reconstitution with the solvent provided, Valtropin has a pH of approximately 7.5 and an 
osmolality of approximately 320 mOsm/kg. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Paediatric population 
- Long-term treatment of children (2 to 11 years old) and adolescents (12 to 18 years old) with 

growth failure due to an inadequate secretion of normal endogenous growth hormone. 
- Treatment of short stature in children with Turner syndrome, confirmed by chromosome 

analysis. 
- Treatment of growth retardation in pre-pubertal children with chronic renal insufficiency. 
 
Adult patients 
- Replacement therapy in adults with pronounced growth hormone deficiency of either childhood- 

or adult-onset aetiology. 
 
Patients with severe growth hormone deficiency in adulthood are defined as patients with known 
hypothalamic-pituitary pathology and at least one additional known deficiency of a pituitary hormone 
not being prolactin. These patients should undergo a single dynamic test in order to diagnose or 
exclude a growth hormone deficiency. In patients with childhood-onset isolated growth hormone 
deficiency (no evidence of hypothalamic-pituitary disease or cranial irradiation), two dynamic tests 
should be recommended, except for those having low insulin-like growth factor-1 (IGF-1) 
concentrations (< 2 standard deviation score (SDS)), who may be considered for one test. The cut-off 
point of the dynamic test should be strict. 
 
4.2 Posology and method of administration 
 
Therapy with Valtropin should be initiated and monitored by physicians adequately experienced in the 
diagnosis and management of patients with growth hormone deficiency. 
 
Posology 

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The dosage and administration schedule should be individualised for each patient. 
 
Dosage in paediatric population 
 
Growth hormone deficiency in children 
The recommended dosage is 0.025 - 0.035 mg/kg body weight per day. 
 
Children with Turner syndrome 
The recommended dosage is 0.045 - 0.050 mg/kg body weight per day, given as a subcutaneous 
injection. 
 
Pre-pubertal children with chronic renal insufficiency 
The recommended dosage is 0.045 - 0.050 mg/kg body weight per day, given as a subcutaneous 
injection. 
 
Dosage in adult patients 
 
Growth hormone deficiency in adults 
The recommended starting dose is 0.15 - 0.30 mg/day, given as a subcutaneous injection. A lower 
starting dose may be necessary in older and obese patients. 
 
This dose should be gradually increased according to individual patient requirements based on the 
clinical response and serum IGF-1 concentrations. Total daily dose usually does not exceed 1 mg. 
IGF-1 concentrations should be maintained below the upper limit of the age-specific normal range. 
 
The minimum effective dose should be used. 
 
The dosage of somatropin should be decreased in cases of persistent oedema or severe paresthesia, in 
order to avoid the development of carpal tunnel syndrome. 
 
Experience of prolonged treatment (over 5 years) with somatropin in adults is limited. 
 
Special populations 
 
Elderly 
Experience of somatropin treatment in patients above 60 years of age is limited. A lower starting dose 
may be necessary in older patients. Dose requirements may decline with increasing age. 
 
Renal impairment 
Currently available data on renal insufficiency are described in section 4.4, but no recommendation on 
a posology can be made. 
 
Hepatic impairment 
In patients with severe liver dysfunction a reduction of somatropin clearance has been noted. The 
clinical significance of this decrease is unknown. 
 
Method of administration 
 
Valtropin is administered by subcutaneous injection. 
 
The injection sites should be varied in order to avoid lipo-atrophy. 
 
For further information on reconstitution and administration see section 6.6. 
 
4.3 Contraindications 
 

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- Hypersensitivity to the active substance or to any of the excipients (e.g. metacresol) (see 
section 4.4). 

-  Somatropin must not be used when there is any evidence of activity of a tumour. Intracranial 
tumours must be inactive and antitumour therapy must be completed prior to starting GH 
therapy. Treatment should be discontinued if there is evidence of tumour growth. 

- Valtropin should not be used for growth promotion in children with closed epiphyses. 
- Patients with acute critical illness due to complications following open heart or abdominal 

surgery, multiple accidental trauma, or patients having acute respiratory failure. 
 
4.4 Special warnings and precautions for use 
 
The maximum recommended daily dose should not be exceeded (see section 4.2). 
 
Pituitary 
There is no evidence to suspect that growth hormone replacement influences the recurrence rate or 
regrowth of intracranial neoplasms, but standard clinical practice requires regular pituitary imaging in 
patients with a history of pituitary pathology. A baseline scan is recommended in these patients before 
instituting growth hormone replacement therapy. 
 
Tumour control 
If the patient has had a brain tumour, the patient should be re-examined frequently to make sure that 
the tumour has not come back. 
In childhood cancer survivors, a higher risk of a second neoplasm (benign or malignant) has been 
reported in patients treated with somatropin. Intracranial tumours, in particular, were the most 
common of these second neoplasms. 
 
Intracranial hypertension 
In cases of severe or recurrent headache, visual problems, nausea, and/or vomiting, a fundoscopy for 
papilloedema is recommended. If papilloedema is confirmed, a diagnosis of benign intracranial 
hypertension should be considered and, if appropriate, the growth hormone treatment should be 
discontinued. At present, there is insufficient evidence to guide clinical decision making in patients 
with resolved intracranial hypertension. If growth hormone treatment is restarted, careful monitoring 
for symptoms of intracranial hypertension is necessary. 
 
Insulin sensitivity 
Because human growth hormone may induce a state of insulin resistance, patients treated with 
somatropin should be monitored for evidence of glucose intolerance. 
 
Thyroid function 
Growth hormone increases the extrathyroidal conversion of T4 to T3 and may, as such, unmask 
incipient hypothyroidism. Monitoring of thyroid function should therefore be conducted in all patients. 
In patients with hypopituitarism, standard replacement therapy must be closely monitored when 
somatropin therapy is administered. 
 
Slipped capital epiphyse 
Patients with endocrine disorders, including growth hormone deficiency, may develop slipped capital 
epiphyses more frequently. Any child with the onset of a limp during growth hormone therapy should 
be evaluated. 
 
Growth hormone deficiency after epiphyseal closure 
Subjects who had been treated with growth hormone during childhood, until final height was attained, 
should be re-evaluated for growth hormone deficiency after epiphyseal closure before replacement 
therapy is commenced at the doses recommended for adults. 
 
Treatment after the end of growth in children 

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For children, the treatment should be continued until the end of the growth has been reached. It is 
advisable not to exceed the recommended dosage in view of the potential risks of acromegaly, 
hyperglycaemia, and glucosuria. 
 
Prader-Willi syndrome 
Valtropin is not indicated for the treatment of patients with growth failure due to Prader-Willi 
syndrome unless they also have a diagnosis of growth hormone deficiency. There have been reports of 
sleep apnoea and sudden death after initiating growth hormone therapy in patients with Prader-Willi 
syndrome, who had one or more of the following risk factors: severe obesity, history of upper airway 
obstruction or sleep apnoea, or unidentified respiratory infection. 
 
Renal insufficiency 
Before instituting treatment with somatropin for growth retardation secondary to chronic renal 
insufficiency, children should have been followed for one year to verify growth disturbance. 
Conservative treatment for renal insufficiency (which includes control of acidosis, 
hyperparathyroidism, and nutritional status for one year prior to the treatment) should have been 
established and should be maintained during treatment. Treatment with somatropin should be 
discontinued at the time of renal transplantation. 
 
Gender and dosing 
In order to reach the defined treatment goal, men may need lower growth hormone doses than women. 
Oral oestrogen administration increases the dose requirements in women. An increasing sensitivity to 
growth hormone (expressed as change in IGF-1 per growth hormone dose) over time may be observed, 
particularly in men. The accuracy of the growth hormone dose should therefore be controlled every 
6 months. 
 
Turner syndrome 
Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders 
since these patients have an increased risk of ear or hearing disorders. 
 
Pancreatitis in children 
Children treated with somatropin have an increased risk of developing pancreatitis compared to adults 
treated with somatropin. Although rare, pancreatitis should be considered in somatropin-treated 
children who develop abdominal pain. 
 
Accidental intramuscular injection 
After accidental intramuscular injection, hypoglycaemia may appear. Any unwanted reaction should 
be followed. No special treatment is recommended. 
 
 
Sensitivity to metacresol 
Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to 
metacresol. If sensitivity to the accompanying solvent occurs, the vials should be reconstituted with 
water for injections and used as a single use vial (see section 6.3). 
 
4.5 Interaction with other medicinal products and other forms of interaction 
 
Excessive glucocorticoid therapy will inhibit the growth-promoting effect of human growth hormone. 
Patients with co-existing adrenocorticotropic hormone (ACTH) deficiency should have their 
glucocorticoid replacement dose carefully adjusted to avoid an inhibitory effect on growth. 
 
In women taking oral oestrogens, a higher dose of somatropin may be required to achieve the 
treatment goal. 
 
Patients taking insulin for diabetes mellitus should be carefully monitored during treatment with 
somatropin. An adjustment of the insulin dose may be required. 

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Data from an interaction study performed in growth hormone deficient adults, suggests that 
somatropin administration may increase the clearance of compounds known to be metabolised by 
cytochrome P450 isoenzymes. The clearance of compounds metabolised by cytochrome P 450 3A4 
(e.g. sex steroids, corticosteroids, anticonvulsants and cyclosporine) may be especially increased 
resulting in lower plasma levels of these compounds. The clinical significance of this is unknown. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
For Valtropin no clinical data on exposed pregnancies are available. Animal studies are insufficient 
with respect to effects on pregnancy, embryofoetal development, parturition or postnatal development 
(see section 5.3). Therefore Valtropin should not be used during pregnancy unless clearly necessary. 
 
Breast-feeding 
There have been no clinical studies conducted with Valtropin in breast-feeding women. It is not 
known whether somatropin is excreted in human milk. Therefore caution should be exercised when 
Valtropin is administered to breast-feeding women. 
 
Fertility 
No data on fertility are available. Animal data showed no effect on fertility parameters. 
 
4.7 Effects on ability to drive and use machines 
 
Valtropin has no or negligible influence on the ability to drive and use machines. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
The most common frequent adverse reactions are associated with the injection site, of endocrine 
nature, and headache, paresthesia and joint pain and disorder (arthralgia) in adults. 
 
During clinical studies 128 children (98 children with growth hormone deficiency and 30 with Turner 
syndrome) were exposed to Valtropin. The safety profile of Valtropin observed in these clinical 
studies was consistent with that reported with the reference medicinal product used in these studies 
and other somatropin containing medicinal products. 
 
The following adverse reactions and their frequencies have been observed under treatment with 
somatropin based on published information: 
 
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), not known (cannot be estimated from the available 
data), including isolated reports 
 
Tabulated summary of adverse reactions 
 
Neoplasms benign, malignant and 
unspecified (including cysts and polyps) Uncommon: Neoplasm malignant, neoplasm 
Blood and lymphatic system disorders Uncommon: Anaemia 
Immune system disorders Common: Antibody building 

 
Not known: Single case of acute hypersensitivity 
involving urticaria and pruritus 

Endocrine disorders Common: Hypothyroidism  
Metabolism and nutrition disorders Common: Glucose tolerance impaired 
 Common: Mild hyperglycaemia (1% in children; 

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1% - 10% in adults) 
 Uncommon: Hypoglycaemia, hyperphosphatemia 
 Rare: Diabetes mellitus 
 Not known: Insulin resistance 
Psychiatric disorders Uncommon: Personality disorder 
Nervous system disorders Very common: Headache in adults 
 Very common: Paresthesia in adults 
 Common: Hypertonia 
 Common: Insomnia in adults 
 Common: Carpal tunnel syndrome in adults 
 Uncommon: Carpal tunnel syndrome in children 
 Uncommon: Nystagmus 
 Rare: Neuropathy, intracranial pressure increased 
 Rare: Benign intracranial hypertension 
 Rare: Paresthesia in children 
 Very rare: Insomnia in children 
Eye disorders Uncommon: Papilloedema, diplopia 
Ear and labyrinth disorders Uncommon: Vertigo 
Cardiac disorders Common: Hypertension in adults 
 Uncommon: Tachycardia 
 Rare: Hypertension in children 
Respiratory, thoracic and mediastinal 
disorders Common: Dyspnoea in adults 
 Common: Sleep apnoea in adults 
Gastrointestinal disorders Uncommon: Vomiting, abdominal pain, flatulence, nausea
 Rare: Diarrhoea  

Skin and subcutaneous tissue disorders 
Uncommon: Lipodystrophy, skin atrophy, exfoliative 
dermatitis, urticaria, hirsutism, skin hypertrophy 

Musculoskeletal and connective tissue 
disorders Very common: Arthralgia in adults 
 Common: Arthralgia in children 
 Common: Myalgia 
 Uncommon: Muscle atrophy, bone pain 

Renal and urinary disorders 
Uncommon: Urinary incontinence, haematuria, polyuria, 
urine frequency/pollakiuria, urine abnormality 

Reproductive system and breast disorders Uncommon: Genital discharge 
 Uncommon: Gynaecomastia in adults 
 Very rare: Gynaecomastia in children 
General disorders and administration site 
conditions  Very common: Oedema, peripheral oedema in adults 
 Common: Oedema, peripheral oedema in children 
 Common: Injection site reactions, asthenia 

 

Uncommon: Injection site atrophy, injection site 
haemorrhage, injection site mass, hypertrophy, weakness 
in children 

Investigations Rare: Renal function test abnormal 
 
Description of selected adverse reactions 
 

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In a clinical study with Valtropin, 3% of children with growth hormone deficiency developed 
antibodies to somatropin. The binding capacity of these antibodies was low and there was no effect on 
growth rate. Testing for antibodies to somatropin should be carried out in any patient who fails to 
respond to therapy. 
 
Anti-host cell protein (anti-S. cerevisiae) antibodies were uncommon in patients treated with 
Valtropin. The generation of such antibodies with low binding capacity is unlikely to be clinically 
relevant. In contrast to bacteria (E. coli), yeast has not been described to elicit adjuvant effects 
modifying the immunological response. 
 
Paediatric population 
Mild and transient oedema was observed early during the course of treatment with somatropin.  
 
Adult patients 
In adult patients with adult-onset growth hormone deficiency, oedema, muscle pain, joint pain and 
disorders were reported early in therapy and tended to be transient. 
 
4.9 Overdose 
 
Acute overdose could lead initially to hypoglycaemia and subsequently to hyperglycaemia. Long-term 
overdose could result in signs and symptoms of acromegaly consistent with the known effects of 
excess human growth hormone. Treatment is symptomatic and supportive. There is no antidote for 
somatropin overdose. It is recommended to monitor thyroid function following an overdose. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Pituitary and hypothalamic hormones and analogues, somatropin and 
somatropin agonists; ATC code: H01AC01 
 
Somatropin is a polypeptide hormone of recombinant DNA origin. It has 191 amino acid residues and 
a molecular weight of 22,125 daltons. The amino acid sequence of the medicinal product is identical to 
that of human growth hormone of pituitary origin. Valtropin is synthesised in yeast cells 
(Saccharomyces cerevisiae). 
 
The biological effects of somatropin are equivalent to those of human growth hormone of pituitary 
origin. 
 
The most prominent effect of somatropin is that it stimulates the growth plates of long bones. 
Additionally, it promotes cellular protein synthesis and nitrogen retention. 
 
Somatropin stimulates lipid metabolism; it increases plasma fatty acids and high-density lipoprotein 
(HDL)-cholesterols, and decreases total plasma cholesterol. 
 
Somatropin therapy has a beneficial effect on body composition in growth hormone-deficient patients, 
in that body fat stores are reduced and lean body mass is increased. Long-term therapy in growth 
hormone-deficient patients increases bone mineral density. 
 
Somatropin may induce insulin resistance. Large doses of somatropin may impair glucose tolerance. 
 
Clinical studies 
 
The efficacy and safety of Valtropin has been assessed in a randomised, double-blind, parallel, 
controlled Phase III study in children with growth hormone deficiency. There were no relevant 

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differences between Valtropin and the reference medicinal product with regard to height velocity and 
height velocity SDS. 
 
An open single-arm Phase III study investigating the efficacy and safety of treatment with Valtropin in 
girls with short stature associated with Turner syndrome showed a significant effect of study treatment 
on height velocity. 
 
5.2 Pharmacokinetic properties 
 
A double-blind, randomised, single dose, crossover study in 24 healthy volunteers showed that the 
pharmacokinetic profile of Valtropin was comparable to that of the reference medicinal product. 
Subcutaneous administration of 0.073 mg/kg body weight of Valtropin resulted in a Cmax of 
43.97 ng/ml and an AUC0-24 h of 369.90 ng·h/ml. Cmax was reached at 4 h and t½ was 3 h. 
 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special hazard for humans based on conventional studies with Valtropin of 
repeated dose toxicity, genotoxicity and reproductive toxicity studies. 
 
Animal studies with Valtropin are not sufficient to assess the reproductive toxicity potential. From 
reproductive toxicity studies performed with other somatropin medicinal products there is no evidence 
of an increased risk of adverse reactions for the embryo or foetus. 
 
Long-term studies for carcinogenicity have not been performed. There are no specific local tolerance 
studies in animals after subcutaneous injection of Valtropin. However, in single and repeat-dose 
general toxicity studies no adverse reactions at the injection sites were reported. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder: 
Glycine 
Mannitol 
Sodium dihydrogen phosphate anhydrous 
Disodium phosphate anhydrous 
Sodium hydroxide (for pH adjustment) 
Hydrochloric acid (for pH adjustment). 
 
Solvent: 
Metacresol 
Water for injections. 
 
6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
6.3 Shelf life 
 
3 years 
 
After first opening or following reconstitution with the solvent provided: 
After reconstitution with the solvent provided, chemical and physical in-use stability has been 
demonstrated for 21 days at 2°C - 8°C (refrigerator). 

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Following reconstitution with water for injections: 
After reconstitution with water for injections, the medicinal product must be used immediately and 
must be used as a single use vial. If not used immediately, in-use storage times and conditions prior to 
use would normally not be longer than 24 hours at 2°C - 8°C (refrigerator), unless reconstitution has 
taken place in controlled and validated aseptic conditions. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2°C - 8°C). Do not freeze. 
 
For the purpose of transport and/or ambulatory use, the non-reconstituted medicinal product can be 
kept at room temperature (not above 25°C) for one single period of up to 4 weeks before use. 
The date of refrigerator removal and the new expiry date should be written on the outer carton. At the 
end of the new expiry date, the medicinal product should have been used or be disposed of. 
 
For storage conditions of the reconstituted medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
5 mg of powder in a vial (Type I glass) closed with a stopper (butyl rubber) and a flip-off cap 
(aluminium plastic). 
1.5 ml of solvent in a pre-filled syringe (Type I glass) closed with a tip cap (FluroTec coated butyl 
rubber) 
 
Pack size of 1 vial and 1 pre-filled syringe. 
 
6.6 Special precautions for disposal and other handling 
 
Detailed instructions for the handling of the medicinal product are given at the end of the package 
leaflet. 
 
For use and handling 
 
Valtropin should not be reconstituted with the supplied solvent for patients with a known sensitivity to 
metacresol (see section 4.3). If sensitivity to the accompanying solvent occurs, the vials should be 
reconstituted with water for injections and used as a single use vial. 
 
Reconstitution with the solvent provided 
Each vial of Valtropin should be reconstituted using the accompanying solvent. The solvent should not 
be used if it is discoloured or cloudy. The solvent should be injected into the vial by aiming the stream 
of liquid against the glass wall. Following reconstitution, the vial should be swirled with a GENTLE 
rotary motion until the contents are completely dissolved. DO NOT SHAKE. The resulting solution 
should be clear, without particulate matter. If the solution is discoloured, cloudy or contains particulate 
matter, the contents MUST NOT be injected. Before and after every injection, the septum of the vial 
should be wiped with alcohol to prevent contamination of the contents by repeated needle insertions. 
If reconstituted with the solvent, then the solution is for multidose use (see section 6.3). 
 
Reconstitution with water for injections 
After reconstitution with water for injections the medicinal product must be used immediately (see 
section 6.3) and the solution is for single use only. 
 
Administration 
Sterile disposable syringes and needles should be used for administration of Valtropin. The volume of 
the syringe should be small enough so that the prescribed dose can be withdrawn from the vial with 
reasonable accuracy. 

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Disposal 
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
BioPartners GmbH 
Kaiserpassage 11 
D-72764 Reutlingen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/335/001 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation 24.04.2006 
Date of latest renewal 24.04.2011 
 
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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http://www.ema.europa.eu/


 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II 
 

A. MANUFACTURER OF THE BIOLOGICAL ACTIVE 
SUBSTANCE AND MANUFACTURING AUTHORISATION 
HOLDER RESPONSIBLE FOR BATCH RELEASE 

 
B. CONDITIONS OF THE MARKETING AUTHORISATION 

 

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A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 
MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH 
RELEASE 

 
Name and address of the manufacturer of the biological active substance 
 
LG Life Sciences Ltd., Iksan Plant, 601 Yongje-dong, Iksan-si, Jeonbuk-do 570-350, South Korea 
 
Name and address of the manufacturer responsible for batch release 
 
BioPartners GmbH, Kaiserpassage 11, D-72764 Reutlingen, Germany 
 
 
B. CONDITIONS OF THE MARKETING AUTHORISATION 
 
 CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE IMPOSED ON 

THE MARKETING AUTHORISATION HOLDER 
 
Medicinal product subject to restricted medical prescription (See Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
Not applicable. 
 
 OTHER CONDITIONS 
 

Pharmacovigilance system 

The MAH must ensure that the system of pharmacovigilance, as presented in Module 1.8.1. of the 
Marketing Authorisation, is in place and functioning before and whilst the product is on the market. 

Risk Management Plan 

The MAH should submit an updated Risk Management Plan reflecting: New neoplasm, Second 
neoplasm in childhood cancer survivors and Intracranial aneurysm and Intracranial haemorrhage as 
potential risk. The Risk Management plan should be submitted by 9 May 2012. 
 
The MAH commits to performing the studies and additional pharmacovigilance activities detailed in 
the Pharmacovigilance Plan, as agreed in version 3.1 of the Risk Management Plan (RMP) presented 
in Module 1.8.2. of the Marketing Authorisation Application and any subsequent updates of the RMP 
agreed by the CHMP. 

As per the CHMP Guideline on Risk Management Systems for medicinal products for human use, any 
updated RMP should be submitted at the same time as the next Periodic Safety Update Report 
(PSUR). 

In addition, an updated RMP should be submitted 
- When new information is received that may impact on the current Safety Specification, 

Pharmacovigilance Plan or risk minimisation activities 
- Within 60 days of an important (pharmacovigilance or risk minimisation) milestone being 

reached 
- At the request of the European Medicines Agency 
 
 

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ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 

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A. LABELLING 

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PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
CARTON 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Valtropin 5 mg/1.5 ml powder and solvent for solution for injection 
somatropin 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
1 vial of powder contains 5 mg (15 IU) somatropin (3.33 mg/ml somatropin after reconstitution with 
1.5 ml solvent). 
 
 
3. LIST OF EXCIPIENTS 
 
Powder: glycine, mannitol, sodium phosphate monobasic, sodium phosphate dibasic.  
pH adjustment: sodium hydroxide and hydrochloric acid. 
 
Solvent: metacresol (see leaflet for further information) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
Powder and solvent for solution for injection 
1 vial of 5 mg powder 
1 pre-filled syringe of 1.5 ml solvent. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For information on reconstitution and use read the package leaflet. 
Subcutaneous use 
 
 
6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 

OF THE REACH AND SIGHT OF CHILDREN 
 
Keep out of the reach and sight of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP  
 
After reconstitution with the solvent provided: can be stored for 21 days in a refrigerator. 
After reconstitution with water for injections: must be used immediately. 

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9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
 
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 
 
BioPartners GmbH, Kaiserpassage 11, D-72764 Reutlingen, Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/06/335/001 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Valtropin 5 mg/1.5 ml 
 
 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL OF POWDER 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Valtropin 5 mg/1.5 ml powder for solution for injection 
somatropin 
 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 mg (15 IU) 
 
 
6. OTHER 
 
Store in a refrigerator. Do not freeze. 
 
 

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MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE OF SOLVENT 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Solvent for Valtropin  
 
Subcutaneous use 
 
 
2. METHOD OF ADMINISTRATION 
 
Read the package leaflet before use. 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.5 ml (water for injections with metacresol) 
 
 
6. OTHER 
 
Store in a refrigerator. Do not freeze. 
 
 

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B. PACKAGE LEAFLET 
 

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PACKAGE LEAFLET: INFORMATION FOR THE USER 
 

Valtropin 5 mg/1.5 ml powder and solvent for solution for injection 
Somatropin 

 
Read all of this leaflet carefully before you start using this medicine. 
- 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. Do not pass it on to others. It may harm them, even 

if their symptoms are the same as yours. 
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, 

please tell your doctor or pharmacist. 
 
In this leaflet: 
1. What Valtropin is and what it is used for 
2. Before you use Valtropin 
3. How to use Valtropin 
4. Possible side effects 
5. How to store Valtropin 
6. Further information 
 
 
1. WHAT Valtropin IS AND WHAT IT IS USED FOR 
 
Your medicine is called Valtropin. It is a human growth hormone, also called somatropin. It has the 
same structure as the growth hormone that the body produces in the pituitary glands (glands located at 
the base of the brain). Growth hormone regulates the growth and development of cells. When it 
stimulates growth of cells in the long bones of the legs and spine, it causes an increase in height. 
 
Valtropin is used 
- to treat children (2 to 11 years old) and teenagers (12 to 18 years old) who do not develop to 

their normal height because of poor bone growth caused by growth hormone deficiency (relative 
lack of growth hormone), Turner syndrome, or ‘chronic renal insufficiency’ (a condition in 
which the kidneys gradually lose their ability to perform their normal functions, such as the 
removal of wastes and extra fluid from the body). 

- to treat adults with severe growth hormone deficiency who already had growth hormone 
deficiency when they were children or who do not have enough growth hormone during their 
adult years for some other reason. 

 
In this leaflet the patient is addressed as ‘you’. Caregivers administering Valtropin to their children 
should consider that ‘you’ refers to the child. 
 
 
2. BEFORE YOU USE Valtropin 
 
Do not use Valtropin 
- if you are allergic (hypersensitive) to somatropin or any of the other ingredients of the 

powder or solvent of Valtropin, e.g. metacresol (see section 2, ‘Take special care with 
Valtropin – Occurrence of certain side effects’) 

- and tell your doctor if you have an active tumour. Tumours must be inactive and you must 
have finished your anti-tumour treatment before you start your treatment with Valtropin. 

- for growth promotion in children who have already stopped growing 
- if you have had a serious heart or abdominal operation 
- if you are being treated for more than one injury following a serious accident 
- if you have sudden serious breathing problems 
 

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Take special care with Valtropin 
Examinations before starting treatment 
- A specialist doctor trained in hormone disorders must examine you to decide if it is safe to use 

Valtropin. 
- If you have had a brain tumour a specialist doctor trained in hormone disorders must examine 

your pituitary function to decide if it is safe to use Valtropin. 
- Before children are treated for growth hormone deficiency due to kidney problems, the doctor 

should observe the child for one year before starting growth hormone treatment. 
- If adults have been treated with growth hormone during childhood, they should be re-evaluated 

for growth hormone deficiency before starting any further treatment with growth hormones. 
- Patients with Prader-Willi syndrome should not be treated with Valtropin unless they are also 

suffering from growth hormone failure. 
 
During or after serious illness 
- If you have had a brain tumour, you should be re-examined frequently to make sure that the 

tumour has not come back. 
- If you had cancer as a child. A higher risk for having a second tumour (benign and malignant) 

has been reported in patients that survived their cancer and were treated with somatropin. Of 
these second tumours, in particular, brain tumours were the most common. 

- If children have had a kidney transplant, growth hormone treatment will be stopped. 
- If the child has Turner syndrome, the child’s doctor should carefully check for ear infections 

such as otitis media, because Turner syndrome patients have an increased risk of ear or other 
hearing disorders. 

 
Occurrence of certain side effects 
- If symptoms like headache (severe and recurrent), visual changes, nausea and/or vomiting 

occur, please ask your doctor for advice. 
- If you have injected Valtropin by mistake into the muscle instead of under the skin, your blood 

sugar may become too low (hypoglycaemia). Please contact your doctor for further advice. 
- If the child begins to limp under treatment with Valtropin, please ask your doctor for advice. 
- If you are a child and you are treated with somatropin. You have an increased risk of developing 

an inflammation of your pancreas (pancreatitis) compared to adults treated with somatropin. 
Although rare, pancreatitis should be considered in somatropin-treated children who develop 
abdominal pain. 

- Too much growth hormone can cause greater than normal growth of ears, nose, lips, tongue and 
cheekbone (acromegaly), high blood sugar (hyperglycaemia) and presence of sugar in the urine 
(glucosuria). Always use Valtropin as recommended by your doctor. 

- If an allergic reaction to solvent occurs, the vials should be reconstituted with water for 
injections without preservative (metacresol) and used as a single use vial (see section 5 ‘How to 
store Valtropin’). Do not use the supplied solvent if you have a known allergy to metacresol 
preservative. 

 
Monitoring during treatment by your doctor 
- Valtropin may affect the way your body handles sugar from food and drink. Your doctor may 

check the amount of sugar in your urine or blood. 
- Valtropin can affect the amount of thyroid hormone in the blood, so you must have thyroid 

function tests from time to time. If the thyroid is not working properly, Valtropin may not work 
as well as it should. 

 

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Using other medicines 
Please tell your doctor or pharmacist if you are taking or have recently taken any other medicines, 
including medicines obtained without a prescription. 
 
Tell especially your doctor if you are taking 
- adrenal steroid hormone such as cortisone or prednisolone 
- insulin 
- oral oestrogen  
- sex hormones, medicines to treat stress response or inflammation (corticosteroids), medicines to 

treat epilepsy (e.g. carbamazepin)or cyclosporine (a medicine to suppress the immune system). 
 Your doctor may need to adjust the dose of Valtropin or of the other medicine. 
 
Pregnancy 
Valtropin should not be used during pregnancy unless clearly necessary. If you become pregnant, tell 
your doctor immediately. 
 
Breast-feeding 
If you are breast-feeding or intend to breast-feed, please ask your doctor for advice before using 
Valtropin. 
 
Ask your doctor or pharmacist for advice before taking any medicines. 
 
Driving and using machines 
Valtropin has no or negligible effect on the ability to drive and use machines. 
 
Important information about some of the ingredients of Valtropin 
The accompanying solvent of Valtropin contains metacresol. Do not use this solvent if you are allergic 
to metacresol (see section 2, ‘Do not use Valtropin’). If an allergic reaction to the solvent occurs, the 
vials should be reconstituted with water for injections and used as a single use vial (see section 5 ‘How 
to store Valtropin’). 
 
 
3. HOW TO USE Valtropin 
 
Always use Valtropin exactly as your doctor has told you. You should check with your doctor or 
pharmacist if you are not sure. Do not inject Valtropin yourself if you are not sure about the dose. 
 
Dosage 
Your doctor will tell you how much to use. This will vary according to your disease. Please do not 
change the dosage without consulting your doctor. 
 
The accuracy of the Valtropin dose should be checked every 6 months by your doctor. 
 
In general the dosage will be calculated as described below. However, individual doses may vary, and 
the doctor may change your dose based on your specific need. 
 
Children 
 
Growth hormone deficiency in children 
Inject 0.025 - 0.035 milligrams (mg) for each kilogramme of body weight once daily under the skin 
(subcutaneously). 
 
Children with Turner syndrome 
Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin 
(subcutaneously). 
 

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Children before puberty, who suffer from long-term kidney problems 
Inject 0.045 - 0.050 milligrams (mg) for each kilogramme of body weight once daily under the skin 
(subcutaneously). 
 
Adults 
 
Growth hormone deficiency in adults 
Inject 0.15 - 0.30 milligrams (mg) once daily under the skin (subcutaneously). A lower starting dose 
may be necessary if you are older or overweight. 
 
If necessary, your doctor will gradually increase this dose according to your individual requirements 
based on the clinical outcome and measurement of your blood levels of a so called “growth factor” 
(known as IGF-1). The total daily dose usually does not exceed 1 mg. IGF-1 concentrations need to be 
regularly measured and should be maintained below the upper limit of the normal range for your age 
and sex. 
 
Your doctor will always prescribe the minimum effective dose to be used. 
 
Dosage adjustment 
In elderly patients a dose reduction may be necessary. 
 
The dosage of somatropin should be reduced in cases of long lasting swelling (oedema) or severe 
abnormal sensation (paresthesia), in order to avoid the development of a rare side effect called carpal 
tunnel syndrome (hand numbness and pain). 
 
Following use of the medicine for some time, it may be necessary to reduce the dose, particularly in 
men. 
 
When using other medicines the dose of Valtropin or of the other medicine may need to be adjusted 
(see section 2, ‘Using other medicines’). 
 
Administration 
Valtropin is intended for subcutaneous use after reconstitution. This means that after reconstitution of 
the powder with the solvent provided the solution is injected with a short needle into the fatty tissue 
just under the skin. 
 
If you are injecting this medicine yourself you will be instructed how to prepare and give the injection. 
 
Do not inject Valtropin yourself unless you have received training. 
 
Detailed instructions for subcutaneous administration are provided with this leaflet (see section 
‘Information on how to self-inject Valtropin’ at the end of this leaflet). 
 
If you use more Valtropin than you should 
In case more Valtropin was used than recommended, please consult your doctor. 
 
If you have used too much Valtropin, initially your blood sugar may decrease and become too low 
(hypoglycaemia) and subsequently increase and become too high (hyperglycaemia). If you have used 
too much Valtropin over a longer period, this may result in a greater than normal growth of ears, nose, 
lips, tongue and cheekbone (acromegaly). 
 
If you forget to use Valtropin 
Do not take a double dose to make up for forgotten doses. Continue with the prescribed dosage 
regimen. If you have any doubts, please contact your doctor. 
 

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If you stop using Valtropin 
Please ask your doctor for advice before stopping treatment. Interruption or early stopping of 
treatment with Valtropin may impair the success of the growth hormone therapy. 
 
If you have any further questions on the use of this medicine, ask your doctor or pharmacist. 
 
 
4. POSSIBLE SIDE EFFECTS 
 
Like all medicines, Valtropin can cause side effects, although not everybody gets them. 
 
The side effects of medicines are classified as follows: 
 

very common affects more than 1 user in 10 
common affects 1 to 10 users in 100 
uncommon  affects 1 to 10 users in 1,000 
rare affects 1 to 10 users in 10,000 
very rare affects less than 1 user in 10,000 
not known Frequency cannot be estimated from the available data 

 
You may experience any of the following side effects after administration of Valtropin: 
 
Very common Headache in adults 

 
Abnormal sensation, such as pricking, tingling, or 
itchiness (paresthesia) in adults 

 Joint pain (arthralgia) in adults 

 
Tissue swelling caused by accumulation of fluid in tissue 
(oedema) in adults 

Common 
Development of proteins that bind other substances 
(antibody building) 

 Underactive thyroid gland (hypothyroidism) 
 Impaired ability to reduce sugar levels (glucose tolerance) 

 
Mild increase of blood sugar levels (mild hyperglycaemia) 
(1% in children; 1% - 10% in adults) 

 Abnormal increase of muscle tone (hypertonia) 
 Sleeplessness (insomnia) in adults 
 Increased blood pressure (hypertension) in adults 
 Shortness of breath (dyspnoea) in adults 

 
Temporary interruption of breathing during sleep (sleep 
apnoea) in adults 

 

Numbness and tingling in fingers and palm of the hand 
due to squeezed nerve at hand wrist (carpal tunnel 
syndrome) in adults 

 Joint pain (arthralgia) in children 
 Muscle pain (myalgia) 

 
Tissue swelling caused by accumulation of fluid in tissue 
(oedema) in children 

 Injection site reactions, weakness (asthenia) 
Uncommon Increased growth of new tissue (cancer, neoplasm) 
 Lack of red blood cells (anaemia) 
 Too little sugar in the blood (hypoglycaemia), 
 Blood phosphate level above normal (hyperphosphatemia)

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 Personality disorder 
 Rapid uncontrollable movement of the eyes (nystagmus) 
 Swelling of the optic nerve head (papilloedema) 
 Double vision (diplopia) 
 Dizziness (vertigo) 
 Accelerated heart beat (tachycardia) 
 Vomiting 
 Stomach pain (abdominal pain), wind (flatulence) 
 Nausea 

 

Fat tissue decrease (lipodystrophy), thinning of the skin 
(skin atrophy), inflammation and peeling of skin 
(exfoliative dermatitis), swelling similar to after insect 
stings (urticaria), increased growth of male type hair on a 
woman’s body (hirsutism), thickening of skin tissue (skin 
hypertrophy) 

 Decrease in the muscle mass (muscle atrophy), bone pain 

 

Numbness and tingling in fingers and palm of the hand 
due to squeezed nerve at hand wrist (carpal tunnel 
syndrome) in children 

 

Involuntary loss of urine (urinary incontinence), blood in 
the urine (haematuria), passing more urine than normal 
(polyuria, pollakiuria), abnormal urine 

 Genital discharge 

 
Enlargement of the male breast gland (gynaecomastia) in 
adults 

 

Injection site reactions like thinning of skin tissue, a 
copious discharge of blood from the blood vessels, 
thickening 

 Weakness in children 
Rare Sugar disease (diabetes mellitus) 

 

Nerve disorder outside the brain and spinal cord 
(neuropathy), increased pressure in the skull (intracranial 
pressure increased) 

 
High blood pressure in the skull (benign intracranial 
hypertension) 

 
Abnormal sensation of the skin, such as pricking, tingling 
and itchiness (paresthesia) in children 

 Increased blood pressure (hypertension) in children 
 Diarrhoea 
 Abnormal results in kidney function tests 
Very rare Sleeplessness (insomnia) in children 

 
Enlargement of the male breast gland (gynaecomastia) in 
children 

Frequency not known 
 

Single case of acute allergic reaction involving itching and 
swelling similar to insect stings and itching 

 Severe reduction of insulin effects (insulin resistance) 
 
In patients with adult-onset growth hormone deficiency swelling, muscle pain, joint pain and disorders 
have been reported early in therapy with somatropin but these effects tended to be transient (short-
lived). 
 

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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please 
tell your doctor or pharmacist. 
 
 
5. HOW TO STORE Valtropin 
 
 Keep out of the reach and sight of children. 
 Do not use Valtropin after the expiry date which is stated on the labels and the carton after EXP. 

The expiry date refers to the last day of that month. 
 
Storage conditions of the unopened medicine 
 Store in a refrigerator (2°C - 8°C). Do not freeze. 
 The non-reconstituted medicine can be kept at room temperature (not above 25°C) for one 

single period of up to 4 weeks before use. 
 
Shelf-life after reconstitution with solvent 
 After reconstitution with the solvent provided the medicine may be stored in the refrigerator 

(2°C - 8°C) for a maximum of 21 days. 
 

Shelf-life after reconstitution with water for injections (NOT tap water) 
 After reconstitution with water for injections the medicine must be used immediately and as a 

single use vial. 
 
Do not use Valtropin if you notice that the solvent or the reconstituted solution is cloudy or 
discoloured or if contains particulate matters. 
 
Medicines should not be disposed of via waste water or household waste. Ask your pharmacist how to 
dispose of medicines that are no longer required. These measures will help to protect the environment. 
 
 
6. FURTHER INFORMATION 
 
What Valtropin contains 
 
Powder: 
- The active substance is somatropin. One vial of powder contains 5 mg somatropin 

(corresponding to 15 IU). After reconstitution with 1.5 ml solvent, 1 ml contains 3.33 mg 
somatropin (corresponding to 10 IU). 

- The other ingredients are glycine, mannitol, sodium phosphate monobasic, sodium phosphate 
dibasic and for pH (acidity) adjustment sodium hydroxide and hydrochloric acid. 
 

Solvent: 
- The pre-filled syringe contains water for injections and metacresol (see section 2, ‘Important 

information about some of the ingredients of Valtropin’). 
 
What Valtropin looks like and contents of the pack 
 
Valtropin is presented as a powder and solvent for solution for injection. 
 
One pack contains: 

- 5 mg of white to almost white powder in a glass vial closed with a rubber stopper and a cap 
- 1.5 ml of solvent in a pre-filled syringe closed with a tip cap, for reconstitution as a clear 

solution. 
 

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Marketing Authorisation Holder and Manufacturer 
 
BioPartners GmbH 
Kaiserpassage 11 
D-72764 Reutlingen 
Germany 
Tel: +49 (0) 7121 948 7756 
Fax: +49 (0) 7121 346 255 
 
This leaflet was last approved in {MM/YYYY} 
 
Detailed information on this medicine is available on the European Medicines Agency web site: 
http://www.ema.europa.eu 
 
 
---------------------------------------------------------------------------------------------------------------------------
-- 
 
 
INFORMATION ON HOW TO SELF-INJECT Valtropin 
 
Please read the following instructions carefully before using Valtropin. 
 
Introduction 
The following instructions explain how to inject Valtropin yourself. Please read the instructions carefully 
and follow them step by step. Your doctor or his/her assistant will instruct you how to self-inject Valtropin. 
Do not attempt to inject yourself unless you are sure you understand the procedure and requirements of 
self-injection. 
 
General notes 
For patients with a known allergy to metacresol, Valtropin should not be reconstituted with the 
supplied solvent (see section 2, ‘Do not use Valtropin’). If allergy to the accompanying solvent occurs, 
the vials should be reconstituted with water for injections: please fill a syringe with 1.5 ml of water for 
injections and follow the same instructions as for the pre-filled syringe (see section 5 ‘How to store 
Valtropin’). Do not use tap water. 
 
Collect the necessary items before you begin. These are: 
 Supplied in the pack 

 the Valtropin vial with powder for solution for injection 
 the pre-filled syringe with 1.5 ml solvent for solution for injection 
NOT supplied in the pack 
 sterile injection syringe and needles 
 alcohol swabs 
 dry gauze or cotton pad 
 an adhesive plaster 
 disposal box for used syringes and needles. 

 
Preparing the solution 
 
1. Wash your hands thoroughly with soap and water before preparing the medicine. 
2. Take the Valtropin carton out of the refrigerator and take the powder vial and pre-filled syringe 

with solvent out of the box. Check that the medicine is within the expiry date. 

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http://www.ema.europa.eu/


3. Remove the protective plastic cap from the powder vial. 
 

 
 

4. Clean the rubber stopper on the top of the powder vial with an alcohol swab. After cleaning do not 
touch the top of the vial. 
 

 
Vial containing the powder of your medicine 
 

5. Take the pre-filled syringe with solvent supplied in the pack to prepare your medicine. Remove the 
rubber tip cap and firmly attach a needle to the syringe. Your doctor or his/her assistant will tell you 
what size of needle to use. 
 

 
 

6. Remove the needle guard without touching the needle. 
 

 
 

7. Slowly insert the needle straight through the centre of the rubber stopper of the vial. 
 

 
 

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8. Slowly inject all of the solvent (1.5 ml) into the powder vial aiming the stream of liquid against the 
side of the vial. DO NOT aim it at the white powder at the bottom of the vial. 
 

 
 
Before taking the syringe out of the vial, draw in the same amount of air (1.5 ml) as the solvent you 
injected to reduce the pressure in the vial. Withdraw the syringe and replace the needle guard. 
 

9. Swirl the vial GENTLY to completely dissolve the contents. DO NOT SHAKE. 
 

 
Dissolving up your medicine 
 

10. The resulting solution should be clear, without particles. 
 
11. Label the vial with the date on which you prepared the solution. 
 
 
Preparing the injection 
 
12. Clean the rubber stopper on the top of the vial with an alcohol swab again. After cleaning do not 

touch the top of the vial. 
 

 
Vial containing the solution of your medicine 
 

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13. Take the injection syringe and the needle supplied by your pharmacy or hospital, to withdraw the 
solution of medicine. Remove the injection syringe from its sterile packaging and attach the needle to 
the syringe. 
 

 
 

14. Fill the syringe with air by pulling the plunger back to the level that represents your dose as 
prescribed by your doctor. 
 

 
 

15. Remove the needle guard without touching the needle. 
 

 
 

16. Slowly insert the needle straight through the centre of the rubber stopper of the vial. 
 

 
 

17. Gently push the plunger to discharge the air in the syringe into the vial. 

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18. Turn the vial upside down with the needle still in it and hold the vial in one hand. Hold the syringe 
with the needle in the vial pointing up. Ensure that the tip of the needle is in the solution. Using your 
other hand slowly pull back the plunger in a continuous motion to draw the correct dose into the 
syringe ensuring that the needle tip remains in the solution. 
 

 
Withdrawing the right volume of your medicine with the help of the syringe markings 
 

19. Remove the syringe from the needle leaving the needle in the vial without touching the tip of the 
syringe. Withdraw the needle, replace the needle guard and dispose in a closed container. For 
handling the vial see ‘Injecting the solution’, step 32. 
 

 
 

20. Take a new needle (one that is suitable for subcutaneous injection) and place it firmly onto the tip of 
the syringe. 
 

 
Syringe containing your medicine being attached to a new needle 
 

21. Remove the needle guard from the syringe needle and check for air bubbles in the syringe. 
 

 
 

22. If you see any bubbles, pull the plunger slightly back; tap the syringe gently, with the needle pointing 
up, until the bubbles disappear. Push the plunger slowly back up to the correct dose. 
 

 
 

23. Replace the needle guard and place the syringe with the needle on a flat surface. 
 
 

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Injecting the solution 
 
24. Ensure the solution is at room temperature. If the solution is cold, warm the syringe between your 

palms. 
25. Inspect the solution prior to administration: if the solution is discoloured or if you can see any solid 

particles in the liquid the solution MUST NOT be injected. 
26. Select the injection site according to the recommendation of your doctor. It is very important that you 

vary the injection site each time you give the medicine. 
27. Cleanse the injection site with an alcohol swab and wait for the area to dry. 
28. Check that the correct dose of Valtropin solution is in the syringe. Hold the syringe in your hand as 

you would hold a pencil. 
29. Squeeze a big skin fold between your thumb and index finger. Insert the needle into the pinched skin 

at a 45° to 90° angle with a quick, firm motion. This hurts less than pushing the needle in slowly. 
30. Slowly (over a few seconds) inject the solution by gently depressing the plunger until the syringe is 

empty. 
31. Withdraw the needle quickly and apply pressure over the injection site with a dry gauze or cotton pad 

for several seconds. If there is bleeding, cover the injection site with an adhesive plaster. 
32. Dispose the used syringe in a closed container. Be sure to return the vial to the refrigerator. When 

empty, discard the vial as well. For shelf-life after reconstitution see section 5 ‘How to store 
Valtropin’. 
If the powder is reconstituted with water for injections, then the vial is for single use only. Any 
unused solution should be discarded. 

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	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURING AUTHORISATION HOLDER RESPONSIBLE FOR BATCH RELEASE
	B. CONDITIONS OF THE MARKETING AUTHORISATION
	A. LABELLING
	B. PACKAGE LEAFLET