NovoSeven

1 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection 
NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection 
NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection 
NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
NovoSeven 1 mg (50 KIU)  
NovoSeven is presented as powder and solvent for solution for injection containing 1 mg eptacog alfa 
(activated) per vial (corresponds to 50 KIU/vial). 
 
NovoSeven 2 mg (100 KIU) 
NovoSeven is presented as powder and solvent for solution for injection containing 2 mg eptacog alfa 
(activated) per vial (corresponds to 100 KIU/vial). 
 
NovoSeven 5 mg (250 KIU) 
NovoSeven is presented as powder and solvent for solution for injection containing 5 mg eptacog alfa 
(activated) per vial (corresponds to 250 KIU/vial). 
 
NovoSeven 8 mg (400 KIU) 
NovoSeven is presented as powder and solvent for solution for injection containing 8 mg eptacog alfa 
(activated) per vial (corresponds to 400 KIU/vial). 
 
1 KIU equals 1,000 IU (International Units). 
 
Eptacog alfa (activated) is recombinant coagulation factor VIIa (rFVIIa) with a molecular mass of 
approximately 50,000 Daltons produced in baby hamster kidney cells (BHK Cells) by recombinant 
DNA technology. 
 
After reconstitution, the product contains 1 mg/ml eptacog alfa (activated) when reconstituted with 
solvent. 
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection. 
 
White lyophilised powder. Solvent: clear colourless solution. The reconstituted solution has a pH of 
approximately 6.0. 
 
 
4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
NovoSeven is indicated for the treatment of bleeding episodes and for the prevention of bleeding in 
those undergoing surgery or invasive procedures in the following patient groups: 
• in patients with congenital haemophilia with inhibitors to coagulation factors VIII or 

IX > 5 Bethesda Units (BU) 
• in patients with congenital haemophilia who are expected to have a high anamnestic response to 

factor VIII or factor IX administration 
• in patients with acquired haemophilia 



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• in patients with congenital FVII deficiency 
• in patients with Glanzmann’s thrombasthenia with past or present refractoriness to platelet 

transfusions, or where platelets are not readily available. 
 
4.2 Posology and method of administration 
 
Treatment should be initiated under the supervision of a physician experienced in the treatment of 
haemophilia and/or bleeding disorders. 
 
Posology 
 
Haemophilia A or B with inhibitors or expected to have a high anamnestic response 
 
Dose 
NovoSeven should be given as early as possible after the start of a bleeding episode. The 
recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight. 
Following the initial dose of NovoSeven further injections may be repeated. The duration of treatment 
and the interval between injections will vary with the severity of the haemorrhage, the invasive 
procedures or surgery being performed. 
 
Paediatric population  
Current clinical experience does not warrant a general differentiation in dosing between children and 
adults, although children have faster clearance than adults. Therefore, higher doses of rFVIIa may be 
needed in paediatric patients to achieve similar plasma concentrations as in adult patients (see section 
5.2). 
 
Dose interval 
Initially 2 – 3 hours to obtain haemostasis. 
If continued therapy is needed, the dose interval can be increased successively once effective 
haemostasis is achieved to every 4, 6, 8 or 12 hours for as long as treatment is judged as being 
indicated. 
 
Mild to moderate bleeding episodes (including home therapy) 
Early intervention has been shown to be efficacious in the treatment of mild to moderate joint, muscle 
and mucocutaneous bleeds. Two dosing regimens can be recommended: 
 
1) Two to three injections of 90 µg per kg body weight administered at three-hour intervals. 

If further treatment is required, one additional dose of 90 µg per kg body weight can be 
administered. 

2) One single injection of 270 µg per kg body weight. 
 
The duration of home therapy should not exceed 24 hours. Only after consultation with the 
haemophilia treatment centre can continued home treatment be considered. 
 
There is no clinical experience with administration of a single dose of 270 µg per kg body weight in 
elderly patients. 
 
Serious bleeding episodes 
An initial dose of 90 µg per kg body weight is recommended and could be administered on the way to 
the hospital where the patient is usually treated. The following dose varies according to the type and 
severity of the haemorrhage. Dosing frequency should initially be every second hour until clinical 
improvement is observed. If continued therapy is indicated, the dose interval can then be increased to 
3 hours for 1 – 2 days. Thereafter, the dose interval can be increased successively to every 4, 6, 8 or 
12 hours for as long as treatment is judged as being indicated. A major bleeding episode may be 
treated for 2 – 3 weeks but can be extended beyond this if clinically warranted. 
 
Invasive procedure/surgery 



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An initial dose of 90 µg per kg body weight should be given immediately before the intervention. The 
dose should be repeated after 2 hours and then at 2 – 3 hour intervals for the first 24 – 48 hours 
depending on the intervention performed and the clinical status of the patient. In major surgery, the 
dose should be continued at 2 – 4 hour intervals for 6 – 7 days. The dose interval may then be 
increased to 6 – 8 hours for another 2 weeks of treatment.  
Patients undergoing major surgery may be treated for up to 2 – 3 weeks until healing has occurred. 
 
Acquired Haemophilia 
 
Dose and dose interval 
NovoSeven should be given as early as possible after the start of a bleeding episode. The 
recommended initial dose, administered by intravenous bolus injection, is 90 µg per kg body weight. 
Following the initial dose of NovoSeven further injections may be given if required. The duration of 
treatment and the interval between injections will vary with the severity of the haemorrhage, the 
invasive procedures or the surgery being performed. 
The initial dose interval should be 2 – 3 hours. Once haemostasis has been achieved, the dose interval 
can be increased successively to every 4, 6, 8 or 12 hours for as long as treatment is judged to be 
indicated. 
 
Factor VII deficiency 
 
Dose, dose range and dose interval 
The recommended dose range in adults and children for treatment of bleeding episodes and for the 
prevention of bleeding in patients undergoing surgery or invasive procedures is 15 – 30 μg per kg 
body weight every 4 – 6 hours until haemostasis is achieved. Dose and frequency of injections should 
be adapted to each individual. 
 
Paediatric population 
Limited clinical experience in long term prophylaxis has been gathered in the paediatric population 
below 12 years of age, with a severe clinical phenotype (see section 5.1). 
 
Dose and frequency of injections for prophylaxis should be based on clinical response and adapted to 
each individual. 
 
Glanzmann’s thrombasthenia 
 
Dose, dose range and dose interval 
The recommended dose for treatment of bleeding episodes and for the prevention of bleeding in 
patients undergoing surgery or invasive procedures is 90 µg (range 80 – 120 µg) per kg body weight at 
intervals of two hours (1.5 – 2.5 hours). At least three doses should be administered to secure effective 
haemostasis. The recommended route of administration is bolus injection as lack of efficacy may 
appear in connection with continuous infusion. 
 
For those patients who are not refractory, platelets is the first line treatment for Glanzmann’s 
thrombasthenia. 
 
Method of administration 
For instructions on reconstitution of the medicinal product before administration, see section 6.6. 
Administer the solution as an intravenous bolus injection over 2 – 5 minutes. 
 
Monitoring of treatment – laboratory tests 
 
There is no requirement for monitoring of NovoSeven therapy. Severity of bleeding condition and 
clinical response to NovoSeven administration must guide dosing requirements. 
 
After administration of rFVIIa, prothrombin time (PT) and activated partial thromboplastin time 
(aPTT) have been shown to shorten, however no correlation has been demonstrated between PT and 



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aPTT and clinical efficacy of rFVIIa. 
 
4.3 Contraindications 
 
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1 or to mouse, 
hamster or bovine protein. 
 
4.4 Special warnings and precautions for use 
 
In pathological conditions in which tissue factor may be expressed more extensively than considered 
normal, there may be a potential risk of development of thrombotic events or induction of 
Disseminated Intravascular Coagulation (DIC) in association with NovoSeven treatment. 
 
Such situations may include patients with advanced atherosclerotic disease, crush injury, septicaemia 
or DIC. Because of the risk of thromboembolic complications, caution should be exercised when 
administering NovoSeven to patients with a history of coronary heart disease, to patients with liver 
disease, to patients post-operatively, to neonates, or to patients at risk of thromboembolic phenomena 
or disseminated intravascular coagulation. In each of these situations, the potential benefit of treatment 
with NovoSeven should be weighed against the risk of these complications. 
 
As recombinant coagulation factor VIIa NovoSeven may contain trace amounts of mouse IgG, bovine 
IgG and other residual culture proteins (hamster and bovine serum proteins), the remote possibility 
exists that patients treated with the product may develop hypersensitivity to these proteins. In such 
cases treatment with antihistamines i.v. should be considered. 
 
If allergic or anaphylactic-type reactions occur, the administration should be discontinued 
immediately. In case of shock, standard medical treatment for shock should be implemented. Patients 
should be informed of the early signs of hypersensitivity reactions. If such symptoms occur, the 
patient should be advised to discontinue use of the product immediately and contact their physician. 
 
In case of severe bleeds the product should be administered in hospitals preferably specialised in 
treatment of haemophilia patients with coagulation factor VIII or IX inhibitors, or if not possible, in 
close collaboration with a physician specialised in haemophilia treatment. 
 
If bleeding is not kept under control hospital care is mandatory. Patients/carers should inform the 
physician/supervising hospital at the earliest possible opportunity about all usages of NovoSeven. 
 
Factor VII deficient patients should be monitored for prothrombin time and factor VII coagulant 
activity before and after administration of NovoSeven. In case the factor VIIa activity fails to reach the 
expected level or bleeding is not controlled after treatment with the recommended doses, antibody 
formation may be suspected and analysis for antibodies should be performed. Thrombosis has been 
reported in FVII deficient patients receiving NovoSeven during surgery but the risk of thrombosis in 
factor VII deficient patients treated with NovoSeven is unknown (see section 5.1). 
 
4.5 Interaction with other medicinal products and other forms of interaction  
 
The risk of a potential interaction between NovoSeven and coagulation factor concentrates is 
unknown. Simultaneous use of prothrombin complex concentrates, activated or not, should be 
avoided. 
 
Anti-fibrinolytics have been reported to reduce blood loss in association with surgery in haemophilia 
patients, especially in orthopaedic surgery and surgery in regions rich in fibrinolytic activity, such as 
the oral cavity. Experience with concomitant administration of anti-fibrinolytics and rFVIIa treatment 
is however limited. 
 
Based on a non-clinical study (see section 5.3) it is not recommended to combine rFVIIa and rFXIII. 
There are no clinical data available on interaction between rFVIIa and rFXIII. 



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4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
As a precautionary measure, it is preferable to avoid use of NovoSeven during pregnancy. Data on a 
limited number of exposed pregnancies within approved indications indicate no adverse effects of 
rFVIIa on pregnancy or on the health of the foetus/new-born child. To date, no other relevant 
epidemiological data are available. Animal studies do not indicate direct or indirect harmful effects 
with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see 
section 5.3). 
 
Breast-feeding 
 
It is unknown whether rFVIIa is excreted in human breast milk. The excretion of rFVIIa in milk has 
not been studied in animals. A decision on whether to continue/discontinue breast-feeding or to 
continue/discontinue therapy with NovoSeven should be made taking into account the benefit of 
breast-feeding to the child and the benefit of NovoSeven therapy to the woman.  
 
Fertility 
 
Data from non-clinical studies as well as post-marketing data show no indication that rFVIIa has a 
harmful effect on male or female fertility. 
 
4.7 Effects on ability to drive and use machines 
 
No studies on the effect on the ability to drive and use machines have been performed.  
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
The most frequently reported adverse drug reactions are decreased therapeutic response, pyrexia, rash, 
venous thromboembolic events, pruritus and urticaria. These reactions are reported as uncommon 
(≥ 1/1,000, < 1/100). 
 
Tabulated summary of adverse reactions 
 
Table 1 lists adverse reactions reported during clinical trials and from spontaneous (post-marketing) 
reports. Within each frequency grouping, undesirable effects are presented in order of decreasing 
seriousness. Adverse drug reactions reported post-marketing only (i.e. not in clinical trials) are 
presented with a frequency of ‘not known’. 
 
Clinical trials conducted in 484 patients (including 4297 treatment episodes) with haemophilia A and 
B, acquired haemophilia, factor VII deficiency or Glanzmann’s thrombasthenia have shown that 
adverse drug reactions are common (≥ 1/100 to < 1/10). As the total number of treatment episodes in 
clinical trials is below 10,000, the lowest possible frequency of adverse drug reactions that can be 
assigned is rare (> 1/10,000 to < 1/1,000). 
 
The most frequent adverse drug reactions are pyrexia and rash (uncommon: > 1/1,000 to < 1/100), and 
the most serious adverse drug reactions are thromboembolic events. 
The frequencies of both serious and non-serious adverse drug reactions are listed by system organ 
classes in the table below 
 
Table 1 Adverse reactions from clinical trials and spontaneous (post-marketing) reports 
 



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MedDRA system 
organ class 

Uncommon (≥1/1,000 to 
<1/100) 

Rare (≥1/10,000 to <1/1,000) Frequency Not Known 

Blood and 
lymphatic system 
disorders 

 - Disseminated 
intravascular coagulation 
(see section 4.4) 

- Related laboratory 
findings, including 
elevated levels of D-
dimmer and decreased 
levels of AT (see section 
4.4) 

- Coagulopathy 

 

Gastrointestinal 
disorders 

 - Nausea  

General disorders 
and 
administration 
site conditions 

- Therapeutic response 
decreased* 

- Pyrexia 

- Injection site reaction 
including injection site 
pain 

 

Immune system 
disorders 

 - Hypersensitivity (see 
sections 4.3 and 4.4) 

- Anaphylactic reaction 

Investigations  - Increased fibrin 
degradation products 

- Increase of alanine 
aminotransferase, 
alkaline phosphatase, 
lactate dehydrogenase 
and prothrombin 

 

Nervous system 
disorders 

 - Headache  

Skin and 
subcutaneous 
tissue disorders 

- Rash (including 
allergic dermatitis and 
rash erythematous) 

- Pruritus and urticaria 

 - Flushing 

- Angioedema 

Vascular 
disorders 

- Venous 
thromboembolic 
events (deep vein 
thrombosis, 
thrombosis at i.v. site, 
pulmonary embolism, 
thromboembolic 
events of the liver 

- Arterial thromboembolic 
events (myocardial 
infarction, cerebral 
infarction, cerebral 
ischaemia, cerebral 
artery occlusion, 
cerebrovascular accident, 
renal artery thrombosis, 

- Intracardiac thrombus 



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including portal vein 
thrombosis, renal vein 
thrombosis, 
thrombophlebitis, 
superficial 
thrombophlebitis and 
intestinal ischaemia) 

peripheral ischaemia, 
peripheral arterial 
thrombosis and intestinal 
ischaemia) 

- Angina pectoris 

 
* Lack of efficacy (therapeutic response decreased) has been reported. It is important that the dosage 
regimen of NovoSevenis compliant with the recommended dosage as stated in section 4.2. 
 
Description of selected adverse reactions 
 
Inhibitory antibody formation 
 
In post-marketing experience, there have been no reports of inhibitory antibodies against NovoSeven 
or FVII in patients with haemophilia A or B. Development of inhibitory antibodies to NovoSeven has 
been reported in a post-marketing observational registry of patients with congenital FVII deficiency. 
 
In clinical trials of patients with factor VII deficiency, formation of antibodies against NovoSeven and 
FVII is the only adverse drug reaction reported (frequency: common (≥ 1/100 to < 1/10)). In some 
cases, the antibodies showed inhibitory effect in vitro. Risk factors that may have contributed to 
antibody development including previous treatment with human plasma and/or plasma-derived factor 
VII, severe mutation of FVII gene, and overdose of NovoSeven, were present. Patients with factor VII 
deficiency treated with NovoSeven should be monitored for factor VII antibodies (see section 4.4). 
 
Thromboembolic events - arterial and venous 
 
When NovoSeven is administered to patients outside approved indications, arterial thromboembolic 
events are common (≥ 1/100 to < 1/10). A higher risk of arterial thromboembolic adverse events (see 
table: Vascular disorders) (5.6% in patients treated with NovoSeven versus 3.0% in placebo-treated 
patients) has been shown in a meta-analysis of pooled data from placebo-controlled trials conducted 
outside current approved indications in various clinical settings, each of these having distinct patient 
characteristics and hence different underlying risk profiles.  
 
Safety and efficacy of NovoSeven have not been established outside the approved indications and 
therefore NovoSeven should not be used. 
 
Thromboembolic events may lead to cardiac arrest. 
 
Other special populations 
 
Patients with acquired haemophilia 
 
Clinical trials conducted in 61 patients with acquired haemophilia with a total of 100 treatment 
episodes, showed that certain adverse drug reactions were reported more frequently (1% based on 
treatment episodes): Arterial thromboembolic events (cerebral artery occlusion, cerebrovascular 
accident), venous thromboembolic events (pulmonary embolism and deep vein thrombosis), angina 
pectoris, nausea, pyrexia, erythematous rash and investigation of increased levels of fibrin degradation 
products. 
 
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 



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professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
Dose limiting toxicities of NovoSeven have not been investigated in clinical trials. 
 
Four cases of overdose have been reported in patients with haemophilia in 16 years. The only 
complication reported in connection with an overdose was a slight transient increase in blood pressure 
in a 16 year-old patient receiving 24 mg rFVIIa instead of 5.5 mg. 
 
No cases of overdose have been reported in patients with acquired haemophilia or Glanzmann’s 
thrombasthenia. 
 
In patients with factor VII deficiency, where the recommended dose is 15 – 30 µg/kg rFVIIa, one 
episode of overdose has been associated with a thrombotic event (occipital stroke) in an elderly 
(> 80 year) male patient treated with 10 – 20 times the recommended dose. In addition, the 
development of antibodies against NovoSeven and FVII has been associated with overdose in one 
patient with factor VII deficiency. 
 
The dose schedule should not be intentionally increased above the recommended doses due to the 
absence of information on the additional risk that may be incurred. 
 
 
5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: Blood coagulation factors, ATC code: B02BD08 
 
Mechanism of action 
NovoSeven contains activated recombinant coagulation factor VII. The mechanism of action includes 
the binding of factor VIIa to exposed tissue factor. This complex activates factor IX into factor IXa 
and factor X into factor Xa, leading to the initial conversion of small amounts of prothrombin into 
thrombin. Thrombin leads to the activation of platelets and factors V and VIII at the site of injury and 
to the formation of the haemostatic plug by converting fibrinogen into fibrin. Pharmacological doses 
of NovoSeven activate factor X directly on the surface of activated platelets, localized to the site of 
injury, independently of tissue factor. This results in the conversion of prothrombin into large amounts 
of thrombin independently of tissue factor.  
 
Pharmacodynamic effects 
The pharmacodynamic effect of factor VIIa gives rise to an increased local formation of factor Xa, 
thrombin and fibrin. 
 
A theoretical risk for the development of systemic activation of the coagulation system in patients 
suffering from underlying diseases predisposing them to DIC cannot be totally excluded. 
 
In an observational registry (F7HAEM-3578) covering subjects with congenital FVII deficiency, the 
median dose for long term prophylaxis against bleeding in 22 paediatric patients (below 12 years of 
age) with Factor VII deficiency and a severe clinical phenotype was 30 µg/kg (range 17 µg/kg to 
200 µg/kg; the dose most often used was 30 µg/kg in 10 patients) with a median dose frequency of 3 
doses per week (range 1 to 7; the dose frequency most often reported was 3 per week in 13 patients). 
 
In the same registry 3 out of 91 surgical patients experienced thromboembolic events. 
 
An observational registry (F7HAEM-3521) covered 133 subjects with Glanzmann’s thrombasthenia 
treated with NovoSeven. The median dose per infusion for treatment of 333 bleeding episodes was 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


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90 µg/kg (range 28 to 450 µg/kg). NovoSeven was used in 157 surgical procedures, at a median dose 
of 92 µg/kg (up to 270 µg/kg). Treatment with NovoSeven, alone or in combination with 
antifibrinolytics and/or platelets, was defined as effective when bleeding was stopped for at least 6 
hours. The efficacy rates were 81% and 82%, respectively, in patients with positive or negative 
refractoriness to platelet transfusions, and 77% and 85%, respectively, in patients testing positive or 
negative for antibodies to platelets. Positive status indicates at least one positive test at any admission. 
 
5.2 Pharmacokinetic properties  
 
Healthy subjects 
 
Distribution, elimination and linearity 
Using the FVII clotting assay, the pharmacokinetics of rFVIIa were investigated in 35 healthy 
Caucasian and Japanese subjects in a dose-escalation study. Subjects were stratified according to sex 
and ethnic group and dosed with 40, 80 and 160 µg rFVIIa per kg body weight (3 doses each) and/or 
placebo. The pharmacokinetics were similar across sex and ethnic groups.  
The mean steady state volume of distribution ranged from 130 to 165 ml/kg, the mean values of 
clearance ranged from 33.3 to 37.2 ml/h×kg. 
The mean terminal half-life ranged from 3.9 to 6.0 hours. 
The pharmacokinetic profiles indicated dose proportionality. 
 
Haemophilia A and B with inhibitors 
 
Distribution, elimination and linearity 
Using the FVIIa assay, the pharmacokinetic properties of rFVIIa were studied in 12 paediatric (2 – 
12 years) and 5 adult patients in non-bleeding state. 
Mean volume of distribution at steady state was 196 ml/kg in paediatric patients versus 159 ml/kg in 
adults. 
Mean clearance was approximately 50% higher in paediatric patients relative to adults (78 versus 
53 ml/h×kg), whereas the mean terminal half-life was determined to 2.3 hours in both groups. 
Clearance appears related with age, therefore in younger patients clearance may be increased by more 
than 50%. 
Dose proportionality was established in children for the investigated doses of 90 and 180 µg per kg 
body weight, which is in accordance with previous findings at lower doses (17.5 – 70 µg/kg rFVIIa).  
 
Factor VII deficiency 
 
Distribution and elimination 
Single dose pharmacokinetics of rFVIIa, 15 and 30 μg per kg body weight, showed no significant 
difference between the two doses used with regard to dose-independent parameters:  
Volume of distribution at steady state (280 – 290 ml/kg), half-life (2.82 – 3.11 h), total body clearance 
(70.8 – 79.1 ml/h×kg) and mean residence time (3.75 – 3.80 h).  
The mean in vivo plasma recovery was approximately 20%. 
 
Glanzmann’s thrombasthenia 
 
Pharmacokinetics of NovoSeven in patients with Glanzmann’s thrombasthenia have not been 
investigated, but are expected to be similar to the pharmacokinetics in haemophilia A and B patients. 
 
5.3 Preclinical safety data 
 
All findings in the preclinical safety programme were related to the pharmacological effect of rFVIIa. 
 
A potential synergistic effect of combined treatment with rFXIII and rFVIIa in an advanced 
cardiovascular model in cynomolgus monkey resulted in exaggerated pharmacology (thrombosis and 
death) at a lower dose level than when administering the individual compounds. 
 



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6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder 
Sodium chloride 
Calcium chloride dihydrate 
Glycylglycine 
Polysorbate 80 
Mannitol 
Sucrose 
Methionine 
Hydrochloric acid (for pH-adjustment) 
Sodium hydroxide (for pH-adjustment) 
 
Solvent 
Histidine 
Hydrochloric acid (for pH-adjustment) 
Sodium hydroxide (for pH-adjustment) 
Water for injections 
 
6.2 Incompatibilities 
 
NovoSeven must not be mixed with infusion solutions or be given in a drip. 
 
6.3 Shelf life 
 
The shelf life for the product packed for sale is 3 years when the product is stored below 25°C. 
 
In vial 
After reconstitution, chemical and physical stability has been demonstrated for 6 hours at 25°C and 
24 hours at 5°C. 
From a microbiological point of view, the product should be used immediately. If not used 
immediately, storage time and storage conditions prior to use are the responsibility of the user, and 
should not be longer than 24 hours at 2°C – 8°C, unless reconstitution has taken place in controlled 
and validated aseptic conditions. The reconstituted solution should be stored in the vial. 
 
In syringe (50 ml polypropylene) in hospital settings only 
Reconstitution must take place in controlled and validated aseptic conditions by adequately trained 
staff. Under these conditions, chemical and physical stability has been demonstrated for 24 hours at 
25°C when stored in a 50 ml syringe (polypropylene). If not used immediately, the conditions prior to 
use are the responsibility of the user and the in-use storage time must not be longer than as stated 
above. 
 
6.4 Special precautions for storage 
 
– Store powder and solvent below 25°C. 
– Store powder and solvent protected from light. 
– Do not freeze. 
– For storage conditions of the reconstituted medicinal product, see section 6.3. 
 
6.5 Nature and contents of container 
 
The solvent of NovoSeven is provided in either a vial or in a pre-filled syringe. Not all presentations 
may be marketed. 
 



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The NovoSeven 1 mg (50 KIU)/NovoSeven 2 mg (100 KIU) package contains either 
– 1 vial (2 ml) with white powder for solution for injection 
– 1 vial (2 ml) with solvent for reconstitution 
 
or 
 
– 1 vial (2 ml) with white powder for solution for injection 
– 1 pre-filled syringe (3 ml) with solvent for reconstitution 
– 1 plunger rod 
– 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer. 
 
The NovoSeven 5 mg (250 KIU)/NovoSeven 8 mg (400 KIU) package contains either 
– 1 vial (12 ml) with white powder for solution for injection 
– 1 vial (12 ml) with solvent for reconstitution 
 
or 
 
– 1 vial (12 ml) with white powder for solution for injection 
– 1 pre-filled syringe (10 ml) with solvent for reconstitution 
– 1 plunger rod 
– 1 vial adapter, with an integrated particle filter with a pore size of 25 micrometer. 
 
Vial: Type I glass vial closed with a chlorobutyl rubber stopper, covered with an aluminium cap. The 
closed vial is equipped with a polypropylene tamper-evident snap-off cap. 
 
Pre-filled syringe: Type I glass barrel with a polypropylene backstop and bromobutyl rubber plunger. 
The syringe cap consists of bromobutyl rubber and polypropylene tamper evident seal. 
 
Plunger rod: made of polypropylene. 
 
6.6 Special precautions for disposal and other handling 
 
The solvent of NovoSeven is provided in either a vial or in a pre-filled syringe. Not all presentations 
may be marketed. Handling procedures for both presentations are described below. 
 
Powder in vial and solvent in vial: 
 
Always use an aseptic technique. 
 
Reconstitution 
 
• NovoSeven powder and solvent vials should be at room temperature at reconstitution. Remove 

the plastic caps from the two vials. If the caps are loose or missing, do not use the vials. Clean 
the rubber stoppers on the vials with alcohol swabs and allow them to dry before use. Use a 
disposable syringe of an appropriate size and a vial adapter, transfer needle (20 – 26G) or other 
suitable device. If devices other than those supplied by Novo Nordisk are used, ensure the use 
of an adequate filter with a pore size of 25 micrometer. 

 
• Attach the vial adapter to the solvent vial. If using a transfer needle, screw the transfer needle 

tightly onto the syringe. 
 
• Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent 

vial (ml equals cc on the syringe). 
 
• Screw the syringe tightly onto the vial adapter on the solvent vial. If using a transfer needle, 

insert the transfer needle into the rubber stopper of the solvent vial. Inject air into the vial by 
pushing the plunger until you feel a clear resistance. 



 13 

 
• Hold the syringe with the solvent vial upside down. If using a transfer needle, make sure the 

transfer needle tip is in the solvent. Pull the plunger to draw the solvent into the syringe. 
 
• Remove the empty solvent vial. If using a vial adapter, tip the syringe to remove it from the vial. 
 
• Attach the syringe with the vial adapter or transfer needle to the powder vial. If using a transfer 

needle, make sure to penetrate the centre of the rubber stopper. Hold the syringe slightly tilted 
with the vial facing downwards. Push the plunger slowly to inject the solvent into the powder 
vial. Make sure not to aim the stream of solvent directly at the NovoSeven powder as this will 
cause foaming. 

 
• Gently swirl the vial until all the powder is dissolved. Do not shake the vial as this will cause 

foaming. 
 
NovoSeven reconstituted solution is colourless and should be inspected visually for particulate matter 
and discolouration prior to administration. 
 
Do not store reconstituted NovoSeven in plastic syringes, unless as described in section 6.3. 
 
It is recommended to use NovoSeven immediately after reconstitution, unless as described in section 
6.3. 
 
Administration 
 
• Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may 

have been pushed out by the pressure in the syringe). If using a transfer needle, make sure the 
transfer needle tip is in the solution. Hold the syringe with the vial upside down and pull the 
plunger to draw all the solution into the syringe. 

 
• If using a vial adapter, unscrew the vial adapter with the empty vial. If using a transfer needle, 

remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer 
needle off the syringe. 

 
• NovoSeven is now ready for injection. Locate a suitable site, and slowly inject NovoSeven into 

a vein over a period of 2 – 5 minutes without removing the needle from the injection site. 
 
Safely dispose of the syringe, vials and any unused product. Any unused medicinal product or waste 
material should be disposed of in accordance with local requirements. 
 
Powder in vial and solvent in pre-filled syringe: 
 
Always use an aseptic technique. 
 
Reconstitution 
 
• The NovoSeven powder vial and pre-filled syringe with solvent should be at room temperature 

at reconstitution. Remove the plastic cap from the vial. If the cap is loose or missing, do not use 
the vial. Wipe the rubber stopper on the vial with a sterile alcohol swab and allow it to dry for a 
few seconds before use. Do not touch the rubber stopper after wiping it. 

 
• Remove the protective paper from the vial adapter. Do not take the vial adapter out of the 

protective cap. If the protective paper is not fully sealed or it is broken do not use the vial 
adapter. Turn over the protective cap, and snap the vial adapter onto the vial. Lightly squeeze 
the protective cap with the thumb and index finger. Remove the protective cap from the vial 
adapter. 

 



 14 

• Screw the plunger rod clockwise into the plunger inside the pre-filled syringe until resistance is 
felt. Remove the syringe cap from the pre-filled syringe by bending it down until the perforation 
breaks. Do not touch the syringe tip under the syringe cap. If the syringe cap is loose or missing, 
do not use the pre-filled syringe. 

 
• Screw the pre-filled syringe securely onto the vial adapter until resistance is felt. Hold the pre-

filled syringe slightly tilted with the vial pointing downwards. Push the plunger rod to inject all 
the solvent into the vial. Keep the plunger rod pressed down and swirl the vial gently until all 
the powder is dissolved. Do not shake the vial as this will cause foaming. 

 
If a larger dose is needed, repeat the procedure with additional vials, pre-filled syringes and vial 
adapters. 
 
The NovoSeven reconstituted solution is colourless and should be inspected visually for particulate 
matter and discolouration prior to administration. 
 
It is recommended to use NovoSeven immediately after reconstitution. For storage conditions of the 
reconstituted medicinal product, see section 6.3. 
 
Administration 
 
• Keep the plunger rod pushed completely in. Turn the syringe with the vial upside down. Stop 

pushing the plunger rod and let it move back on its own while the reconstituted solution fills the 
syringe. Pull the plunger rod slightly downwards to draw the mixed solution into the syringe. 
 

• While holding the vial upside down, tap the syringe gently to let any air bubbles rise to the top. 
Push the plunger rod slowly until all air bubbles are gone. 

 
 If the entire dose is not required, use the scale on the syringe to see how much mixed solution is 

withdrawn. 
 
• Unscrew the vial adapter with the vial. 
 
• NovoSeven is now ready for injection. Locate a suitable site, and slowly inject NovoSeven into 

a vein over a period of 2 – 5 minutes without removing the needle from the injection site. 
 
Safely dispose of the used materials. Any unused medicinal product or waste material should be 
disposed of in accordance with local requirements. 
 
Procedure for pooling of vials for hospital use only:  
 
During in vitro studies, the chemical and physical in-use stability has been demonstrated for 24 hours 
at 25°C in a 50 ml syringe (polypropylene). Compatibility with the product was demonstrated for the 
system consisting of a 50 ml syringe (polypropylene), a 2 m infusion tube (polyethylene) and an in-
line filter with a 5 micrometer pore size. 
 
Pooling of vials (hospital use only): 
 
• All steps should be completed under controlled and validated aseptic conditions by adequately 

trained staff.  
• If not reconstituted, pooled or used as recommended the in-use times and conditions prior to use 

are the responsibility of the user.  
• Ensure that a vial adapter is used irrespective of presentation. 
• Reconstitute the product as described above under Reconstitution for relevant product 

presentation. Unscrew the empty syringe from the vial adapter and for both presentations ensure 
that a vial adapter is attached to the vial containing reconstituted product.  



 15 

• Repeat the procedure with the appropriate number of additional vials, solvent vials/pre-filled 
syringes and vial adapters. 

• Draw approximately 5 ml of sterile air into the 50 ml syringe (polypropylene). Screw the 
syringe securely onto the vial adapter until resistance is felt. Hold the syringe slightly tilted with 
the vial pointing downwards. Push the plunger rod gently to inject a little air into the vial. Turn 
the syringe with the vial upside down and withdraw the contents of the vial into the syringe. 

• Repeat the above procedure with the remaining vials with reconstituted product, to obtain the 
desired volume in the syringe. 

• An in-line filter with a 5 micrometer pore size must be ensured for administration. Ensure that 
the syringe, the infusion tube and the in-line filter are primed and free of air before 
administration. 

• The syringe with adequately reconstituted product is now ready for administration in a CE-
marked infusion pump (accepting a 50 ml syringe). 

• The infusion pump must only be operated by trained hospital personnel. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
NovoSeven 1 mg (50 KIU)  
EU/1/96/006/004 
EU/1/96/006/008 
 
NovoSeven 2 mg (100 KIU) 
EU/1/96/006/005 
EU/1/96/006/009 
 
NovoSeven 5 mg (250 KIU) 
EU/1/96/006/006 
EU/1/96/006/010 
 
NovoSeven 8 mg (400 KIU) 
EU/1/96/006/007 
EU/1/96/006/011 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 23 February 1996 
Date of latest renewal: 23 February 2006 
 
 
10. DATE OF REVISION OF THE TEXT 
 
 
 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency (EMA) http://www.ema.europa.eu. 
 

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


 16 

 
  



 17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX II  
 
A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND 

MANUFACTURER 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 



 18 

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

 
Name and address of the manufacturer of the biological active substance 
 
Novo Nordisk A/S 
Hallas Allé 
DK-4400 Kalundborg 
Denmark 
 
Name and address of the manufacturer responsible for batch release 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd 
Denmark 
 
 
B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY AND USE 
 
Medicinal product subject to restricted medical prescription (see Annex I: Summary of Product 
Characteristics, section 4.2). 
 
 
C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING 

AUTHORISATION 
 
• Periodic Safety Update Reports (PSUR) 
 
The requirements for submission of periodic safety update reports 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 webportal. 
 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT  
 
• Risk Management Plan (RMP) 
 
The 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. 

 
 
 

  



 19 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 
 

  



 20 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 
 
 

  



 21 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 1 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder  
1 vial of solvent 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze 
Store protected from light 



 22 

 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/004 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 1 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



 23 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 1 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 1 mg/vial (50 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder 
1 pre-filled syringe of solvent with separate plunger rod 
1 vial adapter for reconstitution 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze  



 24 

Store protected from light 
 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/008 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 1 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN:  



 25 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for powder vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
NovoSeven 1 mg 
Powder for injection 
Eptacog alfa (activated) 
IV 
 
 

2. METHOD OF ADMINISTRATION 
 
For single dose injection 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 mg 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 26 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for Solvent vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1.1 ml 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 27 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for pre-filled syringe with solvent 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1 ml 
 
 

6. OTHER 
 
1 
2 
3 
ml 
 
Novo Nordisk A/S 
 
 
  



 28 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 2 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder 
1 vial of solvent  
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze 
Store protected from light 



 29 

 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/005 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 2 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



 30 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 2 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 2 mg/vial (100 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder 
1 pre-filled syringe of solvent with separate plunger rod 
1 vial adapter for reconstitution 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze  



 31 

Store protected from light 
 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/009 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 2 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



 32 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for powder vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
NovoSeven 2 mg 
Powder for injection 
Eptacog alfa (activated) 
IV 
 
 

2. METHOD OF ADMINISTRATION 
 
For single dose injection 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2 mg 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 33 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for Solvent vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.1 ml 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 34 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for pre-filled syringe with solvent 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2 ml 
 
 

6. OTHER 
 
1 
2 
3 
ml 
 
Novo Nordisk A/S 
 
 
  



 35 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 5 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder 
1 vial of solvent 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze 
Store protected from light 



 36 

 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/006 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



 37 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 5 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 5 mg/vial (250 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder 
1 pre-filled syringe of solvent with separate plunger rod 
1 vial adapter for reconstitution 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze 



 38 

Store protected from light 
 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/010 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 5 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



 39 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for powder vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
NovoSeven 5 mg 
Powder for injection 
Eptacog alfa (activated) 
IV 
 
 

2. METHOD OF ADMINISTRATION 
 
For single dose injection 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 mg 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 40 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for Solvent vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5.2 ml 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 41 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for pre-filled syringe with solvent 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 ml  
 
 

6. OTHER 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
ml 
 
Novo Nordisk A/S 
 
 
  



 42 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 8 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder 
1 vial of solvent 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze 
Store protected from light 



 43 

 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/007 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 8 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



 44 

PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
Carton text 

 
 

1. NAME OF THE MEDICINAL PRODUCT 
 
NovoSeven 8 mg 
Powder and solvent for solution for injection 
Eptacog alfa (activated) 
 
 

2. STATEMENT OF ACTIVE SUBSTANCE 
 
Eptacog alfa (activated) 8 mg/vial (400 KIU/vial), 1 mg/ml after reconstitution 
 
 

3. LIST OF EXCIPIENTS 
 
Sodium chloride, calcium chloride dihydrate, glycylglycine, polysorbate 80, mannitol, sucrose, 
methionine, histidine, water for injections 
 
 

4. PHARMACEUTICAL FORM AND CONTENTS 
 
Each pack contains: 
1 vial of powder 
1 pre-filled syringe of solvent with separate plunger rod 
1 vial adapter for reconstitution 
 
 

5. METHOD AND ROUTE OF ADMINISTRATION 
 
Intravenous use. For single dose administration 
Administration should preferably take place immediately after reconstitution 
Read package leaflet before 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 
 
 

8. EXPIRY DATE 
 
EXP/ 
 
 

9. SPECIAL STORAGE CONDITIONS 
 
Store below 25°C 
Do not freeze 



 45 

Store protected from light 
 
 

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 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
 

12. MARKETING AUTHORISATION NUMBER 
 
EU/1/96/006/011 
 
 

13. BATCH NUMBER 
 
Lot: 
 
 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription 
 
 

15. INSTRUCTIONS ON USE 
 
 

16. INFORMATION IN BRAILLE 
 
NovoSeven 8 mg 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included 
 
 
18. UNIQUE IDENTIFIER – HUMAN READABLE DATA 
 
PC: 
SN: 
NN: 
 
 
  



 46 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for powder vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
NovoSeven 8 mg 
Powder for injection 
Eptacog alfa (activated) 
IV 
 
 

2. METHOD OF ADMINISTRATION 
 
For single dose injection 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
8 mg 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 47 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for Solvent vial 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
8.1 ml 
 
 

6. OTHER 
 
Novo Nordisk A/S 
 
 
  



 48 

MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
Label for pre-filled syringe with solvent 

 
 

1. NAME OF THE MEDICINAL PRODUCT AND ROUTE OF ADMINISTRATION 
 
Solvent for NovoSeven 
 
 

2. METHOD OF ADMINISTRATION 
 
 

3. EXPIRY DATE 
 
EXP/ 
 
 

4. BATCH NUMBER 
 
Lot: 
 
 

5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
8 ml 
 
 

6. OTHER 
 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
ml 
 
Novo Nordisk A/S 
 
 

  



 49 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 
 



 50 

Package leaflet: Information for the user 
 

NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection 
NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection 
NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection 
NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection 

 
eptacog alfa (activated) 

 
Read all of this leaflet carefully before you are given this injection 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. 
• 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. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
What is in this leaflet 
1. What NovoSeven is and what it is used for 
2. What you need to know before you use NovoSeven 
3. How to use NovoSeven 
4. Possible side effects 
5. How to store NovoSeven 
6. Contents of the pack and other information 
 
Overleaf: NovoSeven user instructions 
 
 
1. What NovoSeven is and what it is used for 
 
NovoSeven is a blood coagulation factor. It works by making the blood clot at the site of bleeding, 
when the body's own clotting factors are not working. 
 
NovoSeven is used to treat bleeding, and to prevent excessive bleeding after surgery or other 
important treatments. Early treatment with NovoSeven reduces how much you bleed and for how long. 
It works in all types of bleeds, including joint bleeds. This reduces the need for hospitalisation and 
days absent from work and school. 
It is used in certain groups of people: 
• If you were born with haemophilia and do not respond normally to factors VIII or IX treatment 
• If you have acquired haemophilia 
• If you have Factor VII deficiency 
• If you have Glanzmann’s thrombasthenia (a bleeding disorder) and your condition cannot be 

treated effectively with platelet transfusion, or if platelets are not readily available. 
 
 
2. What you need to know before you use NovoSeven 
 
Do not use NovoSeven 
• If you are allergic to eptacog alfa (active compound of NovoSeven) or any of the other 

ingredients in this medicine (listed in section 6). 
• If you are allergic to mouse, hamster or cow proteins (such as cows’ milk). 
 
► If any of these apply to you, do not use NovoSeven. Talk to your doctor. 
 
Warnings and precautions 
Before treatment with NovoSeven, make sure your doctor knows: 



 51 

• If you have just had surgery 
• If you recently had a crush injury 
• If your arteries are narrowed by disease (atherosclerosis) 
• If you have an increased risk of blood clots (thrombosis) 
• If you have severe liver disease 
• If you have a serious blood infection 
• If you are prone to disseminated intravascular coagulation (DIC, a condition where blood clots 

develop throughout the blood stream) you must be carefully monitored. 
 
► If any of these conditions apply to you, talk to your doctor before using the injection. 
 
Other medicines and NovoSeven 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Do not use NovoSeven at the same time as prothrombin complex concentrates or rFXIII. You should 
talk to your doctor before using NovoSeven if you also use Factor VIII or IX products. 
 
There is limited experience of using NovoSeven together with medicines called antifibrinolytic drugs 
(such as aminocaproic acid or tranexamic acid) which are also used to control bleeding. You should 
talk to your doctor before using NovoSeven with these medicines. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before you use NovoSeven. 
 
Driving and using machines  
There are no studies on the effect of NovoSeven on the ability to drive and use machines. However, 
there is no medical reason to think that it would affect your ability. 
 
 
3. How to use NovoSeven 
 
The NovoSeven powder must be reconstituted with its solvent and injected into a vein. See overleaf 
for detailed instructions. 
 
When to treat yourself 
Start treatment of a bleed as early as possible, ideally within 2 hours. 
• In cases of a mild or moderate bleed, you should treat yourself as early as possible, ideally at 

home. 
• In case of a severe bleed you should contact your doctor. Usually severe bleeds are treated at the 

hospital and you can give yourself the first NovoSeven dose on the way there. 
 
Do not treat yourself for longer than 24 hours without consulting your doctor. 
• Each time you use NovoSeven, tell your doctor or hospital as soon as possible. 
• If bleeding is not controlled within 24 hours, contact your doctor immediately. You will usually 

need hospital care. 
 
Dose 
The first dose should be given as early as possible after bleeding has started. Talk to your doctor about 
when to use the injections and how long to keep using them. 
The dose will be worked out by your doctor, based on your body weight, condition and type of bleed. 
To achieve the best results, follow the prescribed dose carefully. Your doctor might change the dose. 
 
If you have haemophilia: 
The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 
2–3 hours until bleeding is controlled. 



 52 

Your doctor may recommend a single dose of 270 micrograms for every 1 kilogram you weigh. There 
is no clinical experience in people over 65 using this single dose. 
 
If you have Factor VII deficiency: 
The usual dose range is 15 to 30 micrograms for every 1 kilogram you weigh, for each injection. 
 
If you have Glanzmann’s thrombasthenia: 
The usual dose is 90 micrograms (range is 80 to 120 micrograms) for every 1 kilogram you weigh, for 
each injection. 
 
If you inject more NovoSeven than you should 
If you inject too much NovoSeven, get medical advice at once. 
 
If you forget an injection of NovoSeven 
If you forget an injection, or if you want to stop the treatment, get your doctor's advice. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects  
Rare (may affect up to 1 in 1,000 treatment episodes) 
• Allergic, hypersensitivity or anaphylactic reactions. Signs may include skin rashes, itching, 

flushing and hives; wheezing or difficulty breathing; feeling faint or dizzy; and severe swelling 
of the lips or throat, or at the injection site. 

• Blood clots in arteries in the heart (which could lead to a heart attack or angina), in the brain 
(which could lead to a stroke) or in the intestine and kidneys. Signs may include severe pain in 
the chest, breathlessness, confusion, difficulty with speech or movement (paralysis) or 
abdominal pain. 

 
Uncommon (may affect up to 1 in 100 treatment episodes) 
• Blood clots in the veins in lungs, legs, liver, kidneys or at site of injection. Signs may include 

difficulty in breathing, red and painful swelling in the leg and abdominal pain. 
• Lack of effect or decreased response to treatment. 
 
► If you notice any of these serious side effects, get medical help immediately. Explain that you 

have been using NovoSeven. 
 
Remind your doctor if you have a history of allergic reactions as you may need to be monitored more 
carefully. In most cases of blood clots, the patients were predisposed to blood clotting disorders. 
 
Other rare side effects 
(may affect up to 1 in 1,000 treatment episodes)  
• Nausea (feeling sick) 
• Headache 
• Changes in some liver and blood tests. 
 
Other uncommon side effects 
(may affect up to 1 in 100 treatment episodes) 
• Allergic skin reactions including rash, itching and hives 
• Fever. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. 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. 

http://www.ema.europa.eu/docs/en_GB/document_library/Template_or_form/2013/03/WC500139752.doc


 53 

 
 
5. How to store NovoSeven 
 
• Keep this medicine out of the sight and reach of children. 
• Do not use this medicine after the expiry date that is stated on the carton. The expiry date refers 

to the last day of that month. 
• Store powder and solvent below 25°C. 
• Store powder and solvent protected from light. 
• Do not freeze. 
• Use NovoSeven at once after mixing the powder with the solvent to avoid infection. If you 

cannot use it immediately, after it has been mixed, you should store it in the vial with the vial 
adapter and syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours. Do 
not freeze the mixed NovoSeven solution and keep it protected from light. Do not store the 
solution without advice from your doctor or nurse. 

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What NovoSeven contains 
• The active substance is recombinant coagulation factor VIIa (activated eptacog alfa). 
• The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, 

glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium 
hydroxide. The ingredients in the solvent are histidine, hydrochloric acid, sodium hydroxide, 
water for injections. 

 
The powder for solution for injection contains: 1 mg/vial (corresponding to 50 KIU/vial), 2 mg/vial 
(corresponding to 100 KIU/vial), 5 mg/vial (corresponding to 250 KIU/vial) or 8 mg/vial 
(corresponding to 400 KIU/vial). 
After reconstitution, 1 ml of the solution contains 1 mg eptacog alfa (activated). 
1 KIU equals 1,000 IU (International Units). 
 
What NovoSeven looks like and contents of the pack 
The powder vial contains white powder and the solvent vial contains a clear colourless solution. The 
reconstituted solution is colourless. Do not use the reconstituted solution if you notice particles in it or 
if it is discoloured. 
 
Each NovoSeven pack contains: 
• 1 vial with white powder for solution for injection 
• 1 vial with solvent for reconstitution 
 
Pack sizes: 1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU) and 8 mg (400 KIU). 
Please refer to outer packaging for present pack size. 
 
Marketing Authorisation Holder and Manufacturer 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
This leaflet was last revised in  
 
Other sources of information 
 



 54 

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

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


 55 

NOVOSEVEN USER INSTRUCTIONS 
 

        
 
Preparing the solution 
 
Wash your hands. NovoSeven powder and solvent vials should be at room temperature at 
reconstitution. Remove the plastic caps from the two vials. If the caps are loose or missing, do not use 
the vials. Clean the rubber stoppers on the vials with alcohol swabs and allow them to dry before use. 
Use a disposable syringe of an appropriate size and a vial adapter, transfer needle (20 – 26G) or other 
suitable device. 
 
A 
Remove the protective paper from the vial adapter without taking it out of the protective cap. Attach 
the vial adapter to the solvent vial. Once attached, remove the protective cap. Take care not to touch 
the spike on the vial adapter. If using a transfer needle, remove transfer needle from the packaging 
without taking it out of the protective cap. Screw the transfer needle tightly onto the syringe. 
 

 
 
B 
Pull the plunger to draw in a volume of air that is equal to the amount of solvent in the solvent vial (ml 
equals cc on the syringe). 
 

 
 
C 
Screw the syringe tightly onto the vial adapter on the solvent vial. If using a transfer needle, remove 
the protective cap and insert the transfer needle into the rubber stopper of the solvent vial. Take care 
not to touch the end of the transfer needle. Inject air into the vial by pushing the plunger until you feel 
a clear resistance. 
 

B 

A 

Plastic cap 

Rubber stopper 

Solvent vial 
Plastic cap 

Rubber stopper 

Powder vial 



 56 

 
 
D 
Hold the syringe with the solvent vial upside down. If you are using a transfer needle, make sure that 
the transfer needle tip is in the solvent. Pull the plunger to draw the solvent into the syringe. 
 

 
 
E 
Remove the empty solvent vial. If you use a vial adapter, tip the syringe to remove it from the vial. 
 

 
 
F 
Attach the syringe with vial adapter or transfer needle to the powder vial. If you use a transfer needle, 
make sure to penetrate the centre of the rubber stopper. Hold the syringe slightly tilted with the vial 
facing downwards. Push the plunger slowly to inject the solvent into the powder vial. Make sure not to 
aim the stream of solvent directly at the NovoSeven powder as this will cause foaming. 
 

 
 
G 
Gently swirl the vial until all the powder is dissolved. Do not shake the vial as this will cause foaming. 
Check the solution for visible particles and discolouration. If you notice either, do not use it. 
NovoSeven reconstituted product is a clear, colourless solution. Keep the vial adapter or transfer 

F 

E 

D 

C 



 57 

needle attached to the vial. 
 

 
 
Although NovoSeven will be stable for 24 hours after it has been mixed, you should use it at once to 
avoid infection. If you do not use it immediately after mixing, you should store the vial with the 
syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours. Do not store the 
solution without your doctor’s advice. 
 
Injecting the solution 
 
H 
Ensure that the plunger is pushed all the way in before turning the syringe upside down (it may have 
been pushed out by the pressure in the syringe). If you use a transfer needle, make sure that the 
transfer needle tip is in the solution. Hold the syringe with the vial upside down and pull the plunger to 
draw all the solution into the syringe. 
 

 
 
I 
If you use a vial adapter, unscrew the vial adapter with the empty vial. If you use a transfer needle, 
remove the transfer needle from the vial, replace the transfer needle cap, and twist the transfer needle 
off the syringe. 
 
NovoSeven is now ready for injection. Follow the injection procedure as instructed by your healthcare 
professional. 
 

 
 
J 
Safely dispose of the syringe, vials, any unused product and other waste materials as instructed by 
your healthcare professional. 
 

I 

H 

G 



 58 

 
 
 
 

J 



 59 

Package leaflet: Information for the user 
 

NovoSeven 1 mg (50 KIU) powder and solvent for solution for injection 
NovoSeven 2 mg (100 KIU) powder and solvent for solution for injection 
NovoSeven 5 mg (250 KIU) powder and solvent for solution for injection 
NovoSeven 8 mg (400 KIU) powder and solvent for solution for injection 

 
eptacog alfa (activated) 

 
Read all of this leaflet carefully before you are given this injection 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. 
• 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. This includes any possible side effects not listed 

in this leaflet. See section 4. 
 
What is in this leaflet 
1. What NovoSeven is and what it is used for 
2. What you need to know before you use NovoSeven 
3. How to use NovoSeven 
4. Possible side effects 
5. How to store NovoSeven 
6. Contents of the pack and other information 
 
Overleaf: Instructions on how to use NovoSeven 
 
 
1. What NovoSeven is and what it is used for 
 
NovoSeven is a blood coagulation factor. It works by making the blood clot at the site of bleeding, 
when the body's own clotting factors are not working. 
 
NovoSeven is used to treat bleeding, and to prevent excessive bleeding after surgery or other 
important treatments. Early treatment with NovoSeven reduces how much you bleed and for how long. 
It works in all types of bleeds, including joint bleeds. This reduces the need for hospitalisation and 
days absent from work and school. 
It is used in certain groups of people: 
• If you were born with haemophilia and do not respond normally to factors VIII or IX treatment 
• If you have acquired haemophilia 
• If you have Factor VII deficiency 
• If you have Glanzmann’s thrombasthenia (a bleeding disorder) and your condition cannot be 

treated effectively with platelet transfusion, or if platelets are not readily available. 
 
 
2. What you need to know before you use NovoSeven 
 
Do not use NovoSeven 
• If you are allergic to eptacog alfa (active compound of NovoSeven) or any of the other 

ingredients in this medicine (listed in section 6). 
• If you are allergic to mouse, hamster or cow proteins (such as cows’ milk). 
 
► If any of these apply to you, do not use NovoSeven. Talk to your doctor. 
 
Warnings and precautions 
Before treatment with NovoSeven, make sure your doctor knows: 



 60 

• If you have just had surgery 
• If you recently had a crush injury 
• If your arteries are narrowed by disease (atherosclerosis) 
• If you have an increased risk of blood clots (thrombosis) 
• If you have severe liver disease 
• If you have a serious blood infection 
• If you are prone to disseminated intravascular coagulation (DIC, a condition where blood clots 

develop throughout the blood stream) you must be carefully monitored. 
 
► If any of these conditions apply to you, talk to your doctor before using the injection. 
 
Other medicines and NovoSeven 
Tell your doctor or pharmacist if you are taking, have recently taken or might take any other 
medicines. 
 
Do not use NovoSeven at the same time as prothrombin complex concentrates or rFXIII. You should 
talk to your doctor before using NovoSeven if you also use Factor VIII or IX products. 
 
There is limited experience of using NovoSeven together with medicines called antifibrinolytic drugs 
(such as aminocaproic acid or tranexamic acid) which are also used to control bleeding. You should 
talk to your doctor before using NovoSeven with these medicines. 
 
Pregnancy, breast-feeding and fertility 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask 
your doctor for advice before you use NovoSeven. 
 
Driving and using machines  
There are no studies on the effect of NovoSeven on the ability to drive and use machines. However, 
there is no medical reason to think that it would affect your ability. 
 
 
3. How to use NovoSeven 
 
The NovoSeven powder must be reconstituted with its solvent and injected into a vein. See overleaf 
for detailed instructions. 
 
When to treat yourself 
Start treatment of a bleed as early as possible, ideally within 2 hours. 
• In cases of a mild or moderate bleed, you should treat yourself as early as possible, ideally at 

home. 
• In case of a severe bleed you should contact your doctor. Usually severe bleeds are treated at the 

hospital and you can give yourself the first NovoSeven dose on the way there. 
 
Do not treat yourself for longer than 24 hours without consulting your doctor. 
• Each time you use NovoSeven, tell your doctor or hospital as soon as possible. 
• If bleeding is not controlled within 24 hours, contact your doctor immediately. You will usually 

need hospital care. 
 
Dose 
The first dose should be given as early as possible after bleeding has started. Talk to your doctor about 
when to use the injections and how long to keep using them. 
The dose will be worked out by your doctor, based on your body weight, condition and type of bleed. 
To achieve the best results, follow the prescribed dose carefully. Your doctor might change the dose. 
 
If you have haemophilia: 
The usual dose is 90 micrograms for every 1 kilogram you weigh; you can repeat the injection every 
2–3 hours until bleeding is controlled. 



 61 

Your doctor may recommend a single dose of 270 micrograms for every 1 kilogram you weigh. There 
is no clinical experience in people over 65 using this single dose. 
 
If you have Factor VII deficiency: 
The usual dose range is 15 to 30 micrograms for every 1 kilogram you weigh, for each injection. 
 
If you have Glanzmann’s thrombasthenia: 
The usual dose is 90 micrograms (range is 80 to 120 micrograms) for every 1 kilogram you weigh, for 
each injection. 
 
If you inject more NovoSeven than you should 
If you inject too much NovoSeven, get medical advice at once. 
 
If you forget an injection of NovoSeven 
If you forget an injection, or if you want to stop the treatment, get your doctor's advice. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 
Serious side effects  
Rare (may affect up to 1 in 1,000 treatment episodes) 
• Allergic, hypersensitivity or anaphylactic reactions. Signs may include skin rashes, itching, 

flushing and hives; wheezing or difficulty breathing; feeling faint or dizzy; and severe swelling 
of the lips or throat, or at the injection site. 

• Blood clots in arteries in the heart (which could lead to a heart attack or angina), in the brain 
(which could lead to a stroke) or in the intestine and kidneys. Signs may include severe pain in 
the chest, breathlessness, confusion, difficulty with speech or movement (paralysis) or 
abdominal pain. 

 
Uncommon (may affect up to 1 in 100 treatment episodes) 
• Blood clots in the veins in lungs, legs, liver, kidneys or at site of injection. Signs may include 

difficulty in breathing, red and painful swelling in the leg and abdominal pain. 
• Lack of effect or decreased response to treatment. 
 
► If you notice any of these serious side effects, get medical help immediately. Explain that you 

have been using NovoSeven. 
 
Remind your doctor if you have a history of allergic reactions as you may need to be monitored more 
carefully. In most cases of blood clots, the patients were predisposed to blood clotting disorders. 
 
Other rare side effects 
(may affect up to 1 in 1,000 treatment episodes)  
• Nausea (feeling sick) 
• Headache 
• Changes in some liver and blood tests. 
 
Other uncommon side effects 
(may affect up to 1 in 100 treatment episodes) 
• Allergic skin reactions including rash, itching and hives 
• Fever. 
 
Reporting of side effects 
If you get any side effects, talk to your doctor. 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. 



 62 

 
 
5. How to store NovoSeven 
 
• Keep this medicine out of the sight and reach of children. 
• Do not use this medicine after the expiry date that is stated on the carton. The expiry date refers 

to the last day of that month. 
• Store powder and solvent below 25°C. 
• Store powder and solvent protected from light. 
• Do not freeze. 
• Use NovoSeven at once after mixing the powder with the solvent to avoid infection. If you 

cannot use it immediately, after it has been mixed, you should store it in the vial with the vial 
adapter and syringe still attached in a refrigerator at 2°C to 8°C for no longer than 24 hours. Do 
not freeze the mixed NovoSeven solution and keep it protected from light. Do not store the 
solution without advice from your doctor or nurse. 

• Do not throw away any medicines via wastewater or household waste. Ask your pharmacist 
how to throw away medicines you no longer use. These measures will help protect the 
environment. 

 
 
6. Contents of the pack and other information 
 
What NovoSeven contains 
• The active substance is recombinant coagulation factor VIIa (activated eptacog alfa). 
• The other ingredients in the powder are sodium chloride, calcium chloride dihydrate, 

glycylglycine, polysorbate 80, mannitol, sucrose, methionine, hydrochloric acid, sodium 
hydroxide. The ingredients in the solvent are histidine, hydrochloric acid, sodium hydroxide, 
water for injections. 

 
The powder for solution for injection contains: 1 mg/vial (corresponding to 50 KIU/vial), 2 mg/vial 
(corresponding to 100 KIU/vial), 5 mg/vial (corresponding to 250 KIU/vial) or 8 mg/vial 
(corresponding to 400 KIU/vial). 
After reconstitution, 1 ml of the solution contains 1 mg eptacog alfa (activated). 
1 KIU equals 1,000 IU (International Units). 
 
What NovoSeven looks like and contents of the pack 
The powder vial contains white powder and the pre-filled syringe contains a clear colourless solution. 
The reconstituted solution is colourless. Do not use the reconstituted solution if you notice particles in 
it or if it is discoloured. 
 
Each NovoSeven pack contains: 
• 1 vial with white powder for solution for injection 
• 1 vial adapter 
• 1 pre-filled syringe with solvent for reconstitution 
• 1 plunger rod 
 
Pack sizes: 1 mg (50 KIU), 2 mg (100 KIU), 5 mg (250 KIU) and 8 mg (400 KIU). 
Please refer to outer packaging for present pack size. 
 
Marketing Authorisation Holder and Manufacturer 
 
Novo Nordisk A/S 
Novo Allé 
DK-2880 Bagsværd, Denmark 
 
This leaflet was last revised in  
 



 63 

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

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


 64 

Instructions on how to use NovoSeven 
 
READ THESE INSTRUCTIONS CAREFULLY BEFORE USING NOVOSEVEN 
 
NovoSeven is supplied as a powder. Before injection (administration) it must be reconstituted with the solvent 
supplied in the syringe. The solvent is a histidine solution. The reconstituted NovoSeven must be injected into 
your vein (intravenous injection). The equipment in this package is designed to reconstitute and inject 
NovoSeven. 
 
You will also need an administration set (tubing and butterfly needle, sterile alcohol swabs, gauze pads and 
plasters). These devices are not included in the NovoSeven package. 
 
Do not use the equipment without proper training from your doctor or nurse. 
 
Always wash your hands and ensure that the area around you is clean. 
 
When you prepare and inject medication directly into the vein, it is important to use a clean and germ free 
(aseptic) technique. Improper technique can introduce germs that can infect the blood. 
 
Do not open the equipment until you are ready to use it. 
 
Do not use the equipment if it has been dropped, or if it is damaged. Use a new package instead. 
 
Do not use the equipment if it is expired. Use a new package instead. The expiry date is printed after ‘EXP’ 
on the outer carton, on the vial, on the vial adapter and on the pre-filled syringe.  
 
Do not use the equipment if you suspect it is contaminated. Use a new package instead. 
 
Do not dispose of any of the items until after you have injected the reconstituted solution. 
 
The equipment is for single use only. 
 
Contents 
 
The package contains: 
 
• 1 vial with NovoSeven powder 
• 1 vial adapter 
• 1 pre-filled syringe with solvent 
• 1 plunger rod (placed under the syringe) 
 
 
 
 



 65 

 Overview 

Plastic cap 
Rubber stopper 

(under plastic cap) 

Vial with NovoSeven powder 

 
 

Vial adapter 

Protective cap 

Spike 
(under protective paper) 

Protective 
paper 

 
 
 

Pre-filled syringe with solvent 

Syringe tip 
(under syringe 

cap) Scale 

Plunger 

Syringe cap 
 

 
 Plunger rod 

Thread 
Wide top 

end 

 
 
 
 
1. Prepare the vial and the syringe 
 

 



 66 

• Take out the number of NovoSeven packages 
you need. 

 
• Check the expiry date. 
 
• Check the name, strength and colour of the 

package, to make sure it contains the correct 
product. 

 
• Wash your hands and dry them properly using a 

clean towel or air dry. 
 
• Take the vial, the vial adapter and the pre-filled 

syringe out of the carton. Leave the plunger rod 
untouched in the carton. 

 
• Bring the vial and the pre-filled syringe to 

room temperature (not above 37°C). You can 
do this by holding them in your hands until they 
feel as warm as your hands. 

 
• Do not use any other way to warm the vial and 

pre-filled syringe. 
 

 A 

 

• Remove the plastic cap from the vial. 
If the plastic cap is loose or missing, do not 
use the vial. 

 
• Wipe the rubber stopper with a sterile alcohol 

swab and allow it to air dry for a few seconds 
before use to ensure that it is as germ free as 
possible. 

 
• Do not touch the rubber stopper with your 

fingers as this can transfer germs. 
 

 
 B 

 

2. Attach the vial adapter 
 
• Remove the protective paper from the vial 

adapter. 
 
If the protective paper is not fully sealed or if 
it is broken, do not use the vial adapter. 
 
Do not take the vial adapter out of the 
protective cap with your fingers. If you touch 
the spike on the vial adapter germs from your 
fingers can be transferred. 
 

 

 
 C 

 

• Place the vial on a flat and solid surface. 
 
• Turn over the protective cap, and snap the vial 

adapter onto the vial.  
 

Once attached, do not remove the vial adapter 
from the vial. 

 



 67 

  D 

 
• Lightly squeeze the protective cap with your 

thumb and index finger as shown. 
 
Remove the protective cap from the vial 
adapter. 

 
Do not lift the vial adapter from the vial when 
removing the protective cap. 

 

 
 E 

 
3. Attach the plunger rod and the syringe 
 
• Grasp the plunger rod by the wide top-end and 

take it out of the carton. Do not touch the sides 
or the thread of the plunger rod. If you touch 
the sides or the thread, germs from your fingers 
can be transferred. 

 
Immediately connect the plunger rod to the 
syringe by turning it clockwise into the plunger 
inside the pre-filled syringe until resistance is 
felt. 

 

 
 F 

 

• Remove the syringe cap from the pre-filled 
syringe by bending it down until the perforation 
breaks. 

 
Do not touch the syringe tip under the syringe 
cap. If you touch the syringe tip, germs from 
your fingers can be transferred. 
 
If the syringe cap is loose or missing, do not 
use the pre-filled syringe. 

 
 G 

 

• Screw the pre-filled syringe securely onto the 
vial adapter until resistance is felt. 

 
 

 H 

 
 

4. Reconstitute the powder with the solvent 
 
• Hold the pre-filled syringe slightly tilted with 

the vial pointing downwards. 
 
• Push the plunger rod to inject all the solvent 

into the vial. 

 



 68 

  I 

 
• Keep the plunger rod pressed down and swirl 

the vial gently until all the powder is dissolved. 
 

Do not shake the vial as this will cause 
foaming. 

 
• Check the reconstituted solution. It must be 

colourless. If you notice visible particles or 
discolouration, do not use it. Use a new 
package instead. 

 
 

 
 J 

 
Use the reconstituted NovoSeven at once to avoid infections. 
 
If you cannot use it at once, see section 5 How to store NovoSeven on the other side of this leaflet. Do not 
store the reconstituted solution without advice from your doctor or nurse. 
 
(I) 
If your dose requires more than one vial, repeat steps A to J with additional vials, vial adapters and pre-filled 
syringes until you have reached your required dose. 
• Keep the plunger rod pushed completely in.  
 
• Turn the syringe with the vial upside down.  
 
• Stop pushing the plunger rod and let it move 

back on its own while the reconstituted solution 
fills the syringe. 

 
• Pull the plunger rod slightly downwards to 

draw the reconstituted solution into the syringe. 
 
• In case you only need part of the reconstituted 

solution, use the scale on the syringe to see how 
much of the solution you withdraw, as instructed 
by your doctor or nurse. 

 
• If, at any point, there is too much air in the 

syringe, inject the air back into the vial. 
 
• While holding the vial upside down, tap the 

syringe gently to let any air bubbles rise to the 
top. 

 
• Push the plunger rod slowly until all air 

bubbles are gone. 
 

 
 K 

 



 69 

• Unscrew the vial adapter with the vial.  
 
• Do not touch the syringe tip. If you touch the 

syringe tip, germs from your fingers can be 
transferred. 

 

 
 L 

 
Injecting NovoSeven with pre-filled syringe via needleless connectors for intravenous (IV) catheters 
 
Caution: The pre-filled syringe is made of glass and is designed to be compatible with standard luer-lock 
connections. Some needleless connectors with an internal spike are incompatible with the pre-filled syringe. 
This incompatibility may prevent administration of the drug and/or result in damage to the needleless 
connector. 
 
Follow the instructions for use for the needleless connector. Administration through a needleless connector may 
require withdrawal of the reconstituted solution into a standard 10 ml sterile luer-lock plastic syringe. This 
should be done right after step J. 
 
 
5. Inject the reconstituted solution 
 
NovoSeven is now ready to inject into your vein.  
 
• Inject the reconstituted solution as instructed by your doctor or nurse. 
 
• Inject slowly over 2 to 5 minutes. 
 
Injecting the solution via a central venous access device (CVAD) such as a central venous catheter or a 
subcutaneous port: 
• Use a clean and germ free (aseptic) technique. Follow the instructions for proper use for your connector 

and CVAD in consultation with your doctor or nurse. 
• Injecting into a CVAD may require using a sterile 10 ml plastic syringe for withdrawal of the 

reconstituted solution. 
• If the CVAD line needs to be flushed before or after NovoSeven injection, use sodium chloride 9 mg/ml 

solution for injection. 
 

Disposal 
 
• After injection, safely dispose of the syringe 

with the administration set, the vial with the vial 
adapter, any unused NovoSeven and other waste 
materials as instructed by your doctor or nurse.  

 
• Do not throw it out with the ordinary household 

waste. 

 
 M 

 
 
Do not disassemble the equipment before disposal.  
 
Do not reuse the equipment. 

 


	SUMMARY OF PRODUCT CHARACTERISTICS
	A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURER 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
	A. LABELLING
	B. PACKAGE LEAFLET