Kovaltry

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ANNEX I 
 

SUMMARY OF PRODUCT CHARACTERISTICS 
 



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1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 250 IU powder and solvent for solution for injection 
Kovaltry 500 IU powder and solvent for solution for injection 
Kovaltry 1000 IU powder and solvent for solution for injection 
Kovaltry 2000 IU powder and solvent for solution for injection 
Kovaltry 3000 IU powder and solvent for solution for injection 
 
 
2. QUALITATIVE AND QUANTITATIVE COMPOSITION 
 
Kovaltry 250 IU powder and solvent for solution for injection 
Kovaltry contains approximately 250 IU (100 IU / 1 mL) of recombinant human coagulation 
factor VIII (INN: octocog alfa) after reconstitution. 
 
Kovaltry 500 IU powder and solvent for solution for injection 
Kovaltry contains approximately 500 IU  (200 IU / 1 mL) of recombinant human coagulation 
factor VIII (INN: octocog alfa) after reconstitution. 
 
Kovaltry 1000 IU powder and solvent for solution for injection 
Kovaltry contains approximately 1000 IU (400 IU / 1 mL) of recombinant human coagulation 
factor VIII (INN: octocog alfa) after reconstitution. 
 
Kovaltry 2000 IU powder and solvent for solution for injection 
Kovaltry contains approximately 2000 IU (400 IU / 1 mL) of recombinant human coagulation 
factor VIII (INN: octocog alfa) after reconstitution. 
 
Kovaltry 3000 IU powder and solvent for solution for injection 
Kovaltry contains approximately 3000 IU (600 IU / 1 mL) of recombinant human coagulation 
factor VIII (INN: octocog alfa) after reconstitution. 
 
The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific 
activity of Kovaltry is approximately 4000 IU/mg protein. 
 
Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein 
that has 2,332 amino acids. It is produced by recombinant DNA technology in baby hamster kidney 
cells (BHK) into which the human factor VIII gene has been introduced. Kovaltry is prepared without 
the addition of any human or animal derived protein in the cell culture process, purification or final 
formulation.  
 
For the full list of excipients, see section 6.1. 
 
 
3. PHARMACEUTICAL FORM 
 
Powder and solvent for solution for injection 
 
Powder: solid, white to slightly yellow. 
Solvent: water for injections, a clear solution. 
 
 



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4. CLINICAL PARTICULARS 
 
4.1 Therapeutic indications 
 
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII 
deficiency). Kovaltry can be used for all age groups. 
 
4.2 Posology and method of administration 
 
Treatment should be under the supervision of a physician experienced in the treatment of haemophilia. 
 
Treatment monitoring 
 
During the course of treatment, appropriate determination of factor VIII levels is advised to guide the 
dose to be administered and the frequency of repeated infusions. Individual patients may vary in their 
response to factor VIII, demonstrating different half-lives and recoveries. Dose based on bodyweight 
may require adjustment in underweight or overweight patients.  
 
In the case of major surgical interventions in particular, precise monitoring of the substitution therapy 
by means of coagulation analysis (plasma factor VIII activity) is indispensable. 
 
Posology 
 
The dose and duration of the substitution therapy depend on the severity of the factor VIII deficiency, 
on the location and extent of the bleeding and on the patient's clinical condition. 
 
The number of units of factor VIII administered is expressed in International Units (IU), which are 
related to the current WHO standard for factor VIII products. Factor VIII activity in plasma is 
expressed either as a percentage (relative to normal human plasma) or in International Units (relative 
to an International Standard for factor VIII in plasma). 
 
One International Unit (IU) of factor VIII activity is equivalent to that quantity of factor VIII in 
one mL of normal human plasma. 
 
On demand treatment 
 
The calculation of the required dose of factor VIII is based on the empirical finding that 
1 International Unit (IU) factor VIII per kg body weight raises the plasma factor VIII activity by 1.5% 
to 2.5% of normal activity. 
The required dose is determined using the following formula: 
 
Required units = body weight (kg) x desired factor VIII rise (% or IU/dL) x reciprocal of observed 
recovery (i.e. 0.5 for recovery of 2.0%). 
 
The amount to be administered and the frequency of administration should always be targeted to the 
clinical effectiveness required in the individual case. 
 
In the case of the following haemorrhagic events, the factor VIII activity should not fall below the 
given level (in % of normal) in the corresponding period. The following table can be used to guide 
dosing in bleeding episodes and surgery: 
 



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Table 1: Guide for dosing in bleeding episodes and surgery 
Degree of haemorrhage/ 
Type of surgical procedure 

Factor VIII level 
required (%) (IU/dL) 

Frequency of doses (hours)/ 
Duration of therapy (days) 

Haemorrhage 
 
Early haemarthrosis, muscle 
bleeding or oral bleeding 

 
 

20 - 40 

Repeat every 12 to 24 hours. At 
least 1 day, until the bleeding 
episode as indicated by pain is 
resolved or healing is achieved. 

More extensive 
haemarthrosis, muscle 
bleeding or haematoma 

30 - 60 Repeat infusion every 12 - 24 hours 
for 3 - 4 days or more until pain and 
acute disability are resolved. 

Life threatening 
haemorrhages 

60 - 100 Repeat infusion every 8 to 24 hours 
until threat is resolved 

Surgery 
Minor surgery 
including tooth extraction 

 
 

30 - 60 

 
Every 24 hours, at least 1 day, until 
healing is achieved. 

Major surgery 80 - 100 
(pre- and post-

operative) 

Repeat infusion every 8 - 24 hours 
until adequate wound healing, then 
therapy for at least another 7 days to 
maintain a factor VIII activity of 
30% to 60% (IU/dL). 

 
Prophylaxis 
For long term prophylaxis against bleeding in patients with severe haemophilia A, the usual doses for 
adolescents (≥ 12 years age) and adult patients are 20 to 40 IU of Kovaltry per kg body weight two to 
three times per week. 
In some cases, especially in younger patients, shorter dose intervals or higher doses may be necessary. 
 
Paediatric population 
A safety and efficacy study has been performed in children of 012 years (see section 5.1); limited data 
are available for children below 1 year. 
The recommended prophylaxis doses are 20-50 IU/kg twice weekly, three times weekly or every other 
day according to individual requirements. For paediatric patients above the age of 12, the dose 
recommendations are the same as for adults.  
 
Method of administration 
 
Intravenous use. 
 
Kovaltry should be injected intravenously over 2 to 5 minutes depending on the total volume. The rate 
of administration should be determined by the patient’s comfort level (maximal rate of infusion: 
2 mL/min). 
For instructions on reconstitution of the medicinal product before administration, see section 6.6 and 
the package leaflet. 
 
4.3 Contraindications 
 

 Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. 
 Known allergic reactions to mouse or hamster proteins. 

 
4.4 Special warnings and precautions for use 
 
Traceability 
 
In order to improve traceability of biological medicinal products, the name and the batch number of 
the administered product should be clearly recorded. 
 



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Hypersensitivity 
 
Allergic type hypersensitivity reactions are possible with Kovaltry. 
If symptoms of hypersensitivity occur, patients should be advised to discontinue the use of the 
medicinal product immediately and contact their physician. 
Patients should be informed of the early signs of hypersensitivity reactions including hives, 
generalised urticaria, tightness of the chest, wheezing, hypotension, and anaphylaxis. 
 
In case of shock, standard medical treatment for shock should be implemented. 
 
Inhibitors 
 
The formation of neutralising antibodies (inhibitors) to factor VIII is a known complication in the 
management of individuals with haemophilia A. These inhibitors are usually IgG immunoglobulins 
directed against the factor VIII procoagulant activity, which are quantified in Bethesda Units (BU) 
per mL of plasma using the modified assay. The risk of developing inhibitors is correlated to the 
severity of the disease as well as the exposure to factor VIII , this risk being highest within the first 
50 exposure days but continues throughout life although the risk is uncommon. 
 
The clinical relevance of inhibitor development will depend on the titre of the inhibitor, with low titre 
posing less of a risk of insufficient clinical response than high titre inhibitors. 
 
In general, all patients treated with coagulation factor VIII products should be carefully monitored for 
the development of inhibitors by appropriate clinical observations and laboratory tests (see 
section 4.2). 
If the expected factor VIII activity plasma levels are not attained, or if bleeding is not controlled with 
an appropriate dose, testing for factor VIII inhibitor presence should be performed. In patients with 
high levels of inhibitor, factor VIII therapy may not be effective and other therapeutic options should 
be considered. Management of such patients should be directed by physicians with experience in the 
care of haemophilia and factor VIII inhibitors. 
 
Cardiovascular events 
 
In patients with existing cardiovascular risk factors, substitution therapy with FVIII may increase the 
cardiovascular risk. 
 
Catheter-related complications 
 
If a central venous access device (CVAD) is required, risk of CVAD-related complications including 
local infections, bacteraemia and catheter site thrombosis should be considered. 
 
It is strongly recommended that every time that Kovaltry is administered to a patient, the name and 
batch number of the product are recorded in order to maintain a link between the patient and the batch 
of the medicinal product. 
 
Paediatric population 
 
The listed warnings and precautions apply both to adults and children. 
 
Sodium content 
 
This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially 
‘sodium-free’. 
 



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4.5 Interactions with other medicinal products and other forms of interaction 
 
No interactions of human coagulation factor VIII (rDNA) products with other medicinal products have 
been reported. 
 
4.6 Fertility, pregnancy and lactation 
 
Pregnancy 
 
Animal reproduction studies have not been conducted with factor VIII. Based on the rare occurrence 
of haemophilia A in women, experience regarding the use of factor VIII during pregnancy is not 
available.  
Therefore, factor VIII should be used during pregnancy only if clearly indicated. 
 
Breast-feeding 
 
It is unknown whether Kovaltry is excreted in human milk. The excretion in animals has not been 
studied. Therefore, factor VIII should be used during breast-feeding only if clearly indicated. 
 
Fertility 
 
No animal fertility studies have been conducted with Kovaltry and its effect on human fertility has not 
been established in controlled clinical trials. Since Kovaltry is a replacement protein of endogenous 
factor VIII, no adverse effects on fertility are expected. 
 
4.7 Effects on ability to drive or use machines 
 
If patients experience dizziness or other symptoms affecting their ability to concentrate and react, it is 
recommended that they do not drive or use machines until the reaction subsides. 
 
4.8 Undesirable effects 
 
Summary of the safety profile 
 
Hypersensitivity or allergic reactions (which may include angioedema, burning and stinging at the 
infusion site, chills, flushing, generalised urticaria, headache, hives, hypotension, lethargy, nausea, 
restlessness, tachycardia, tightness of the chest, tingling, vomiting, wheezing) have been observed and 
may in some cases progress to severe anaphylaxis (including shock). 
Development of antibodies to mouse and hamster protein with related hypersensitivity reactions may 
occur. 
 
Development of neutralising antibodies (inhibitors) may occur in patients with haemophilia A treated 
with factor VIII (FVIII), including with Kovaltry. If such inhibitors occur, the condition may manifest 
itself as an insufficient clinical response. In such cases, it is recommended that a specialised 
haemophilia centre be contacted. 
 
Tabulated list of adverse reactions 
 
The table presented below is according to the MedDRA system organ classification (SOC and 
Preferred Term Level). Frequencies have been evaluated according to the following convention: very 
common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100) , rare (≥1/10,000 to 
<1/1,000); very rare (<1/10,000). 
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. 
 



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Table 2: Frequency of adverse drug reactions in clinical trials 
MedDRA 
System Organ Class  

Adverse reactions  Frequency  
 

Blood and lymphatic system disorders Lymphadenopathy common 

FVIII inhibition very common (PUPs)* 
uncommon (PTPs)* 

Immune system disorders Hypersensitivity uncommon 
Psychiatric disorders Insomnia common 
Nervous system disorders Headache, dizziness common 

Dysgeusia uncommon 
Cardiac disorders Palpitation, sinus 

tachycardia 
common 

Vascular disorders Flushing uncommon 

Gastrointestinal disorders Abdominal pain, 
abdominal discomfort, 
dyspepsia 

common 

Skin and subcutaneous tissue disorders Pruritus, rash***, 
dermatitis allergic 

common 
 

Urticaria uncommon 

General disorders and administration 
site conditions 

Pyrexia, chest 
discomfort, injection 
site reactions ** 

common 

* Frequency is based on studies with all FVIII products which included patients with severe 
haemophilia A. PTPs = previously-treated patients, PUPs = previously-untreated patients 
** includes injection site extravasation, hematoma, infusion site pain, pruritus, swelling 
*** rash, rash erythematous, rash pruritic 
 
Description of selected adverse reactions 
 
The most frequently reported adverse reactions in PTPs were related to potential hypersensitivity 
reactions, including headache, pyrexia, pruritus, rash, and abdominal discomfort. 
 
Immunogenicity 
The immunogenicity of Kovaltry was evaluated in previously treated patients (PTPs). 
During clinical trials with Kovaltry in approximately 200 pediatric and adult patients diagnosed with 
severe hemophilia A (FVIII:C < 1%) with previous exposure to factor VIII concentrates ≥ 50 ED, one 
case of transient low titer inhibitor occurred in the ongoing LEOPOLD Kids Part A extension study. 
 
Paediatric population 
In completed clinical studies with 71 paediatric previously treated patients, the frequency, type and 
severity of adverse reactions in children were found to be similar to those in adults. 
 
Reporting of suspected adverse reactions 
 
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It 
allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare 
professionals are asked to report any suspected adverse reactions via the national reporting system 
listed in Appendix V. 
 
4.9 Overdose 
 
No symptoms of overdose with recombinant human coagulation factor VIII have been reported. 
 



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5. PHARMACOLOGICAL PROPERTIES 
 
5.1 Pharmacodynamic properties 
 
Pharmacotherapeutic group: antihemorrhagics: blood coagulation factor VIII, ATC code B02BD02. 
 
Mechanism of action 
 
The factor VIII/von Willebrand factor (vWF) complex consists of two molecules (factor VIII and 
vWF) with different physiological functions. When infused into a haemophiliac patient, factor VIII 
binds to vWF in the patient’s circulation. Activated factor VIII acts as a cofactor for activated 
factor IX, accelerating the conversion of factor X to activated factor X. Activated factor X converts 
prothrombin into thrombin. Thrombin then converts fibrinogen into fibrin and a clot can be formed. 
Haemophilia A is a sex-linked hereditary disorder of blood coagulation due to decreased levels of 
factor VIII:C and results in profuse bleeding into joints, muscles or internal organs, either 
spontaneously or as a result of accidental or surgical trauma. By replacement therapy the plasma levels 
of factor VIII are increased, thereby enabling a temporary correction of the factor deficiency and 
correction of the bleeding tendencies. 
 
Of note, annualised bleeding rate (ABR) is not comparable between different factor concentrates and 
between different clinical studies. 
 
Kovaltry does not contain von Willebrand factor. 
 
Pharmacodynamic effects 
 
The activated partial thromboplastin time (aPTT) is prolonged in people with haemophilia. 
Determination of aPTT is a conventional in vitro assay for biological activity of factor VIII. Treatment 
with rFVIII normalizes the aPTT similar to that achieved with plasma-derived factor VIII. 
 
Clinical efficacy and safety 
 
Control and Prevention of Bleeding 
Two multi-centre, open-label, cross-over, uncontrolled, randomised studies in previously treated 
adults/adolescents with severe haemophilia A (< 1%) and one multi-centre, open-label, uncontrolled 
study in previously treated children < 12 years with severe haemophilia A were conducted. 
 
A total of 204 subjects have been included in the clinical trial program, 153 subjects ≥ 12 years and 
51 subjects < 12 years. 140 subjects were treated for at least 12 months, and 55 of these subjects for a 
median of 24 months. 
 
Paediatric population <12 years 
The paediatric trial enrolled 51 PTPs with severe haemophilia A, 26 subjects in the age group 6-
12 years and 25 subjects in the age group <6 years having accumulated a median number of 73 EDs 
(range: 37 to 103 EDs). Subjects were treated with 2 or 3 injections per week or up to every other day at 
a dose of 25 to 50 IU/kg. Consumption for prophylaxis and treatment of bleeds, annualised bleed rates 
and success rate for bleed treatment are presented in Table 3 
 



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Table 3: Consumption and overall success rates (patients treated with prophylaxis only) 
 Younger 

children 
(0 <6  
years) 

Older 
children 
(6 <12  
years) 

Adolescents and adults 
12-65 years 

Total 

 
 

  Study 1 Study 2 
 

2 x/week 
dosing 

Study 2 
 

3 x/week 
dosing 

 

Study 
participants 

25 26 62 28 31 172 

       

Dose/prophylaxis 
injection, IU/kg 
BW 
median (min, 
max) 

36 IU/kg 
(21; 

58 IU/kg) 

32 IU/kg 
(22; 

50 IU/kg) 

31 IU/kg 
(21; 

43 IU/kg) 

30 IU/kg 
(21; 

34 IU/kg) 

37 IU/kg 
(30; 

42 IU/kg) 

32 IU/kg 
(21; 

58 IU/kg) 
 

       

ABR – all bleeds 
(median, Q1,Q3) 

2.0 
(0.0; 6.0) 

0.9 
(0.0; 5.8) 

1.0 
(0.0; 5.1) 

4.0 
(0.0; 8.0) 

2.0 
(0.0; 4.9) 

2.0 
(0.0; 6.1) 

       

Dose/injection for 
bleed treatment 
Median (min; 
max) 

39 IU/kg 
(21;72 IU

/kg) 

32 IU/kg 
(22; 

50 IU/kg) 

29 IU/kg 
(13; 

54 IU/kg) 

28 IU/kg 
(19; 

39 IU/kg) 

31 IU/kg 
(21; 

49 IU/kg) 

31 IU/kg 
(13; 

72 IU/kg) 

Success rate* 92.4% 86.7% 86.3% 95.0% 97.7% 91.4% 

ABR annualised bleed rate 
Q1 first quartile; Q3 third quartile 
BW: Body weight 
*Success rate defined as % of bleeds treated successfully with ≤ 2 infusions 
 
5.2 Pharmacokinetic properties 
 
The pharmacokinetic (PK) profile of Kovaltry was evaluated in PTPs with severe haemophilia A 
following 50 IU/kg in 21 subjects ≥ 18 years, 5 subjects ≥ 12 years and < 18 years and 19 subjects 
< 12 years of age.  
 
A population PK model was developed based on all available factor VIII measurements (from dense 
PK sampling and all recovery samples) throughout the 3 clinical studies allowing calculation of PK 
parameters for subjects in the various studies. The table 4 below provides PK parameters based on the 
population PK model. 
 



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Table 4: PK parameters (geometric mean (%CV)) based on chromogenic assay. * 
PK parameter ≥ 18 years 

N=109 
12-<18 years 

N=23 
6-<12 years 

N=27 
0-<6 years 

N=24 
T1/2 (h) 14.8 (34) 13.3 (24) 14.1 (31) 13.3 (24) 

AUC (IU.h/dL)** 1,858 (38) 1,523 (27) 1,242 (35) 970 (25) 
CL (dL/h/kg) 0.03 (38) 0.03 (27) 0.04 (35) 0.05 (25) 
Vss (dL/kg) 0.56 (14) 0.61 (14) 0.77 (15) 0.92 (11) 

* Based on population PK estimates 
**AUC calculated for a dose of 50 IU/kg 
 
Repeated PK measurements after 6 to 12 months of prophylaxis treatment with Kovaltry did not 
indicate any relevant changes in PK characteristics after long-term treatment. 
 
In an international study involving 41 clinical laboratories, the performance of Kovaltry in FVIII:C 
assays was evaluated and compared to a marketed full length rFVIII product. Consistent results were 
determined for both products. The FVIII:C of Kovaltry can be measured in plasma with a one-stage 
coagulation assay as well as with a chromogenic assay using the routine methods of the laboratory. 
 
The analysis of all recorded incremental recoveries in previously treated patients demonstrated a 
median rise of > 2% (> 2 IU/dL) per IU/kg body weight for Kovaltry. This result is similar to the 
reported values for factor VIII derived from human plasma. There was no relevant change over the 
6-12 months treatment period. 
 
Table 5: Phase III incremental recovery results 
Study participants N=115 
Chromogenic assay results 
Median; (Q1; Q3) (IU/dL / IU/kg) 

2.3 (1.8; 2.6) 

One-stage assay results 
Median; (Q1; Q3) (IU/dL / IU/kg) 

2.2 (1.8; 2.4) 

 
5.3 Preclinical safety data 
 
Non-clinical data reveal no special risk for humans based on safety pharmacology, in vitro 
genotoxicity, and short term repeat-dose toxicity studies. Repeat-dose toxicity studies longer than 
5 days, reproductive toxicity studies, and carcinogenicity studies, have not been performed. Such 
studies are not considered meaningful due to the production of antibodies against the heterologous 
human protein in animals. Also factor VIII is an intrinsic protein and not known to cause any 
reproductive or carcinogenic effects. 
 
 
6. PHARMACEUTICAL PARTICULARS 
 
6.1 List of excipients 
 
Powder 
Sucrose 
Histidine 
Glycine (E 640) 
Sodium chloride 
Calcium chloride dihydrate (E 509) 
Polysorbate 80 (E 433) 
Acetic acid, glacial (for pH adjustment) (E 260) 
 
Solvent 
Water for injections 
 



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6.2 Incompatibilities 
 
In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal 
products. 
 
Only the provided infusion sets should be used for reconstitution and injection because treatment 
failure can occur as a consequence of human recombinant coagulation factor VIII adsorption to the 
internal surfaces of some infusion equipment. 
 
6.3 Shelf life 
 
30 months 
 
The chemical and physical in-use stability after reconstitution has been demonstrated for 3 hours at 
room temperature. 
After reconstitution, from a microbiological point of view, the product should be used immediately. If 
not used immediately, in use storage times and conditions prior to use are the responsibility of the 
user. 
 
Do not refrigerate after reconstitution. 
 
6.4 Special precautions for storage 
 
Store in a refrigerator (2 °C - 8 °C).  
Do not freeze.  
Keep the vial and the pre filled syringe in the outer carton in order to protect from light. 
 
Within its overall shelf life of 30 months the product when kept in its outer carton, may be stored up to 
25 °C for a limited period of 12 months. In this case, the product expires at the end of this 12 month 
period or the expiry date on the product vial, whichever is earlier. The new expiry date must be noted 
on the outer carton. 
 
For storage conditions after reconstitution of the medicinal product, see section 6.3. 
 
6.5 Nature and contents of container and special equipment for use, administration or 

implantation 
 
Each single package of Kovaltry contains: 
• one vial with powder (10 mL clear glass type 1 vial with grey halogenobutyl rubber blend 

stopper and aluminium seal) 
• one pre-filled syringe with 2.5 mL (for 250 IU, 500 IU and 1000 IU) or 5 mL (for 2000 IU and 

3000 IU) solvent (clear glass cylinder type 1 with grey bromobutyl rubber blend stopper) 
• syringe plunger rod 
• vial adapter 
• one venipuncture set 
 
Pack sizes 
 1 single pack. 
 1 multipack with 30 single packs. 
Not all pack sizes may be marketed. 
 
6.6 Special precautions for disposal and other handling 
 
Detailed instructions for preparation and administration are contained in the package leaflet provided 
with Kovaltry. 
 
The reconstituted medicinal product is a clear and colourless solution. 



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Kovaltry powder should only be reconstituted with the supplied solvent (2.5 mL or 5 mL water for 
injections) in the prefilled syringe and the vial adapter. For infusion, the product must be prepared 
under aseptic conditions. If any component of the package is opened or damaged, do not use this 
component. 
After reconstitution the solution is clear. Parenteral medicinal products should be inspected visually 
for particulate matter and discoloration prior to administration. Do not use Kovaltry if you notice 
visible particulate matter or turbidity. 
 
After reconstitution, the solution is drawn back into the syringe. Kovaltry should be reconstituted and 
administered with the components (vial adapter, prefilled syringe, venipuncture set) provided with 
each package. 
 
The reconstituted product must be filtered prior to administration to remove potential particulate 
matter in the solution. Filtering is achieved by using the vial adapter.  
The venipuncture set provided with the product must not be used for drawing blood because it 
contains an in line filter.  
 
For single use only.  
Any unused medicinal product or waste material should be disposed of in accordance with local 
requirements. 
 
 
7. MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
8. MARKETING AUTHORISATION NUMBERS 
 
EU/1/15/1076/002  1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/012 - 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/004 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/014 - 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/006 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/016 - 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/008 - 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/010 - 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/017   30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/018 - 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/019 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/020 - 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/021 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/022 - 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/023 - 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
EU/1/15/1076/024 - 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
 
 
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION 
 
Date of first authorisation: 18 February 2016 
Date of latest renewal: 
 
 



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10. DATE OF REVISION OF THE TEXT 
 
Detailed information on this medicinal product is available on the website of the European Medicines 
Agency http://www.ema.europa.eu.  
 



14 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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 
 

 



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

 
Name and address of the manufacturer of the biological active substance 

Bayer HealthCare LLC 
800 Dwight Way 
Berkeley 
CA 94710 
United States 

Name and address of the manufacturer responsible for batch release 

Bayer AG 
Kaiser-Wilhelm-Allee 
51368 Leverkusen 
Germany 

 
 
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 (PSURs) 

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

 
 
D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND 

EFFECTIVE USE OF THE MEDICINAL PRODUCT 
 
 Risk management plan (RMP) 

 
The marketing authorisation holder (MAH) shall perform the required pharmacovigilance activities 
and interventions detailed in the agreed RMP presented in Module 1.8.2 of the marketing 
authorisation and any agreed subsequent updates of the RMP. 

An updated RMP should be submitted: 

 At the request of the European Medicines Agency; 

 Whenever the risk management system is modified, especially as the result of new 
information being received that may lead to a significant change to the benefit/risk profile or 
as the result of an important (pharmacovigilance or risk minimisation) milestone being 
reached.  

 



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 Obligation to conduct post-authorisation measures 
 
The MAH shall complete, within the stated timeframe, the below measures: 
 

Description Due date 
Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of 
Kovaltry in previously untreated patients, the MAH should submit the results of the 
ongoing study “13400 - Leopold Kids Part B”  

12/2022 

 
Post-authorisation Efficacy Study: In order to investigate the safety and efficacy of 
long term treatment with Kovaltry, the MAH should submit the results of the ongoing 
study “13400 - Leopold Kids extension”  

12/2022  

 
 



17 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

ANNEX III 
 

LABELLING AND PACKAGE LEAFLET 
 



18 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

A. LABELLING 



19 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 250 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 250 IU (100 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



20 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/002 – 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/012 – 1 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 



21 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 250 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



22 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 250 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 250 IU (100 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Multipack with 30 single packs, each containing: 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the 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 WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 



23 

May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/017 – 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/018 – 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 250 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



24 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



25 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 250 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 250 IU (100 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Component of a multipack, can’t be sold separately. 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



26 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/017 – 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/018 – 30 x (Kovaltry 250 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 



27 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 250 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



28 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL WITH POWDER FOR SOLUTION FOR INJECTION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kovaltry 250 IU powder for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
Intravenous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
250 IU (octocog alfa) (100 IU/mL after reconstitution). 
 
 
6. OTHER 
 
Bayer-Logo 
 
 



29 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 500 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 500 IU (200 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



30 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/004 – 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/014 – 1 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 



31 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 500 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



32 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 500 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 500 IU (200 IU / 1 mL)octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Multipack with 30 single packs, each containing: 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the 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 WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 



33 

May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/019 – 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/020 – 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 500 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



34 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



35 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 500 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 500 IU (200 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Component of a multipack, can’t be sold separately. 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



36 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/019 – 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/020 – 30 x (Kovaltry 500 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 



37 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 500 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



38 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL WITH POWDER FOR SOLUTION FOR INJECTION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kovaltry 500 IU powder for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
Intravenous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
500 IU (octocog alfa) (200 IU/mL after reconstitution). 
 
 
6. OTHER 
 
Bayer-Logo 
 
 



39 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 1000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 1000 IU (400 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



40 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/006 – 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/016 – 1 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 



41 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 1000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



42 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 1000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 1000 IU (400 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Multipack with 30 single packs, each containing: 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the 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 WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 



43 

May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/021 – 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/022 – 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 1000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



44 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



45 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 1000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 1000 IU (400 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Component of a multipack, can’t be sold separately. 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



46 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/021 – 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (3 mL)) 
EU/1/15/1076/022 – 30 x (Kovaltry 1000 IU - solvent (2.5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 



47 

14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 1000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



48 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL WITH POWDER FOR SOLUTION FOR INJECTION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kovaltry 1000 IU powder for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
Intravenous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
1000 IU (octocog alfa) (400 IU/mL after reconstitution). 
 
 
6. OTHER 
 
Bayer-Logo 
 



49 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 2000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 2000 IU (400 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



50 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/008 – 1 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 



51 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 2000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



52 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 2000 IU powder and solvent for solution for injection  
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
 2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 2000 IU (400 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Multipack with 30 single packs, each containing: 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the 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 WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 



53 

May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/023 – 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 2000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



54 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



55 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 2000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 2000 IU (400 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Component of a multipack, can’t be sold separately. 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



56 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/023 – 30 x (Kovaltry 2000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 



57 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 2000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



58 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL WITH POWDER FOR SOLUTION FOR INJECTION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kovaltry 2000 IU powder for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
Intravenous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2000 IU (octocog alfa) (400 IU/mL after reconstitution). 
 
 
6. OTHER 
 
Bayer-Logo 
 



59 

 
 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER CARTON OF A SINGLE PACK (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 3000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 3000 IU (600 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



60 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/010 – 1 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 



61 

15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 3000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 
 



62 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
OUTER LABEL OF MULTIPACK WITH 30 SINGLE PACKS (INCLUDING BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 3000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 3000 IU (600 IU / 1 mL)octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Multipack with 30 single packs, each containing: 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the 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 WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 



63 

May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator.  
Do not freeze. 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/024 – 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 3000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
2D barcode carrying the unique identifier included. 
 
 



64 

18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
PC 
SN 
NN 
 



65 

 
PARTICULARS TO APPEAR ON THE OUTER PACKAGING 
 
INNER CARTON OF A MULTIPACK (WITHOUT BLUE BOX) 
 
 
1. NAME OF THE MEDICINAL PRODUCT 
 
Kovaltry 3000 IU powder and solvent for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
 
 
2. STATEMENT OF ACTIVE SUBSTANCE(S) 
 
Kovaltry contains 3000 IU (600 IU / 1 mL) octocog alfa after reconstitution. 
 
 
3. LIST OF EXCIPIENTS 
 
Sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride dihydrate (E 509), 
polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections. 
 
 
4. PHARMACEUTICAL FORM AND CONTENTS 
 
powder and solvent for solution for injection  
 
Component of a multipack, can’t be sold separately. 
 
1 vial with powder, 1 pre-filled syringe with water for injections, 1 vial adapter and 1 venipuncture 
set. 
 
 
5. METHOD AND ROUTE(S) OF ADMINISTRATION 
 
For intravenous use. Single dose administration only. 
Read the package leaflet before use. 
 
For reconstitution read package leaflet before use. 
 

 
 
 



66 

6. SPECIAL WARNING THAT THE MEDICINAL PRODUCT MUST BE STORED OUT 
OF THE SIGHT AND REACH OF CHILDREN 

 
Keep out of the sight and reach of children. 
 
 
7. OTHER SPECIAL WARNING(S), IF NECESSARY 
 
 
8. EXPIRY DATE 
 
EXP 
EXP (End of the 12 month period, if stored up to 25 °C): ................ 
Do not use after this date. 
 
May be stored at temperatures up to 25 °C for up to 12 months within the expiry date indicated on the 
label. Note the new expiry date on the carton. 
After reconstitution, the product must be used within 3 hours. Do not refrigerate after 
reconstitution. 
 
 
9. SPECIAL STORAGE CONDITIONS 
 
Store in a refrigerator. Do not freeze. 
 
Keep the vial and the pre-filled syringe in the outer carton in order to protect from light. 
 
 
10. SPECIAL PRECAUTIONS FOR DISPOSAL OF UNUSED MEDICINAL PRODUCTS 

OR WASTE MATERIALS DERIVED FROM SUCH MEDICINAL PRODUCTS, IF 
APPROPRIATE 

 
Any unused solution must be discarded. 
 
 
11. NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER 
 
Bayer AG 
51368 Leverkusen 
Germany 
 
 
12. MARKETING AUTHORISATION NUMBER(S) 
 
EU/1/15/1076/024 – 30 x (Kovaltry 3000 IU - solvent (5 mL); pre-filled syringe (5 mL)) 
 
 
13. BATCH NUMBER 
 
Lot 
 
 
14. GENERAL CLASSIFICATION FOR SUPPLY 
 
Medicinal product subject to medical prescription. 
 



67 

 
15. INSTRUCTIONS ON USE 
 
 
16. INFORMATION IN BRAILLE 
 
Kovaltry 3000 
 
 
17. UNIQUE IDENTIFIER – 2D BARCODE 
 
 
18. UNIQUE IDENTIFIER - HUMAN READABLE DATA 
 
 



68 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
VIAL WITH POWDER FOR SOLUTION FOR INJECTION 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION 
 
Kovaltry 3000 IU powder for solution for injection 
 
octocog alfa (recombinant human coagulation factor VIII) 
Intravenous use. 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
3000 IU (octocog alfa) (600 IU/mL after reconstitution). 
 
 
6. OTHER 
 
Bayer-Logo 
 
 



69 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE WITH WATER FOR INJECTIONS 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF 

ADMINISTRATION 
 
water for injections 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
2.5 mL [for reconstitution of strengths 250/500/1000 IU] 
 
 
6. OTHER 
 
 
 



70 

 
MINIMUM PARTICULARS TO APPEAR ON SMALL IMMEDIATE PACKAGING UNITS 
 
PRE-FILLED SYRINGE WITH WATER FOR INJECTIONS 
 
 
1. NAME OF THE MEDICINAL PRODUCT AND IF NECESSARY ROUTE(S) OF 

ADMINISTRATION 
 
water for injections 
 
 
2. METHOD OF ADMINISTRATION 
 
 
3. EXPIRY DATE 
 
EXP 
 
 
4. BATCH NUMBER 
 
Lot 
 
 
5. CONTENTS BY WEIGHT, BY VOLUME OR BY UNIT 
 
5 mL [for reconstitution of strengths 2000/3000 IU] 
 
 
6. OTHER 
 
 
 



71 

 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

B. PACKAGE LEAFLET 
 



72 

Package Leaflet: Information for the user 
 

Kovaltry 250 IU powder and solvent for solution for injection 
Kovaltry 500 IU powder and solvent for solution for injection 

Kovaltry 1000 IU powder and solvent for solution for injection 
Kovaltry 2000 IU powder and solvent for solution for injection 
Kovaltry 3000 IU powder and solvent for solution for injection 

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

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

effects not listed in this leaflet. See section 4. 
 
What is in this leaflet 
1. What Kovaltry is and what it is used for 
2. What you need to know before you use Kovaltry 
3. How to use Kovaltry  
4. Possible side effects 
5. How to store Kovaltry  
6. Contents of the pack and other information 
 
 
1. What Kovaltry is and what it is used for 
 
Kovaltry contains the active substance human recombinant coagulation factor VIII, also called octocog 
alfa. Kovaltry is prepared by recombinant technology without addition of any human- or 
animal derived components in the manufacturing process. Factor VIII is a protein naturally found in 
the blood that helps to clot it. 
 
Kovaltry is used to treat and prevent  bleeding in adults, adolescents and children of all ages with 
haemophilia A (hereditary factor VIII deficiency). 
 
 
2. What you need to know before you use Kovaltry 
 
Do not use Kovaltry if you are  
 allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6).  
 allergic to mouse or hamster proteins. 
 
Warnings and precautions  
Talk to your doctor or pharmacist if you have: 
 tightness in the chest, dizziness (including when you get up from sitting or lying down), itchy 

nettle-rash, wheezing, feeling sick or faint. These may be signs of a rare severe sudden allergic 
reaction to Kovaltry. Stop administering the product immediately and seek medical advice 
if this occurs. 

 bleeding that is not being controlled with your usual dose of Kovaltry. The formation of 
inhibitors (antibodies) is a known complication that can occur during treatment with all 
Factor VIII medicines. These inhibitors, especially at high levels, stop the treatment working 
properly, patients receiving Kovaltry will be monitored carefully for the development of these 



73 

inhibitors. If your or your child’s bleeding is not being controlled with Kovaltry, tell your 
doctor immediately. 

 previously developed factor VIII inhibitors to a different product. If you switch factor VIII 
products, you may be at risk of your inhibitor coming back. 

 a confirmed heart disease or are at risk of heart disease.  
 to use a central venous access device for the administration of Kovaltry. You may be at risk of 

device related complications where the catheter is inserted including: 
- local infections 
- bacteria in the blood  
- a blood clot in the blood vessel. 

 
Children and adolescents 
The listed warnings and precautions apply to patients of all ages, adults and children. 
 
Other medicines and Kovaltry 
Tell your doctor or pharmacist if you are using, have recently used or might use any other medicines. 
 
Pregnancy and breast-feeding 
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 using this medicine. 
 
Kovaltry is not likely to affect the fertility in male or female patients, as the active substance is 
naturally occurring in the body. 
 
Driving and using machines 
If you experience dizziness or any other symptoms affecting your ability to concentrate and react, do 
not drive or use machines until the reaction subsides. 
 
Kovaltry contains sodium 
This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium-
free’. 
 
 
3. How to use Kovaltry 
 
Treatment with Kovaltry will be started by a doctor who is experienced in the care of patients with 
haemophilia A. Always use this medicine exactly as your doctor has told you. Check with your doctor 
if you are not sure. 
The number of factor VIII units is expressed in International Units (IU). 
 
Treatment of bleeding 
 To treat a bleed, your doctor will calculate and adjust your dose and how often it should be given, 
depending on factors such as: 
 your weight 
 the severity of your haemophilia A 
 where the bleed is and how serious it is 
 whether you have inhibitors and how high their level is 
 the factor VIII level that is needed. 
 
Prevention of bleeding 
If you are using Kovaltry to prevent bleeding, your doctor will calculate the dose for you. This will 
usually be in the range of 20 to 40 IU of octocog alfa per kg of body weight, injected two or three 
times per week. However, in some cases, especially for younger patients, shorter dose intervals or 
higher doses may be necessary. 
 



74 

Laboratory tests 
Laboratory tests at suitable intervals help to ensure you always have adequate factor VIII levels. For 
major surgery in particular, your blood clotting must be closely monitored. 
 
Use in children and adolescents 
Kovaltry can be used in children of all ages. In children below the age of 12 higher doses or more 
frequent injections than prescribed for adults may be needed. 
 
Patients with inhibitors 
If you have been told by your doctor that you have developed factor VIII inhibitors you may need to 
use a larger dose of Kovaltry to control bleeding. If this dose does not control your bleeding your 
doctor may consider giving you another product. 
Speak to your doctor if you would like further information on this. 
Do not increase the dose of Kovaltry to control your bleeding without checking with  your doctor. 
 
Duration of treatment 
Usually, Kovaltry treatment for haemophilia is needed life-long. 
 
How Kovaltry is given 
Kovaltry is injected into a vein over 2 to 5 minutes depending on the total volume and your comfort 
level and should be used within 3 hours after reconstitution.  
 
How Kovaltry is prepared for administration 
Use only the components (vial adapter, pre filled syringe containing solvent and venipuncture set) 
provided with each package of this medicine. Please contact your doctor if these components cannot 
be used. Do not use if any component of the package is opened or damaged. 
 
The reconstituted product must be filtered by using the vial adapter before administration to remove 
any possible particles in the solution. 
 
Do not use the venipuncture set provided for drawing blood because it contains an in-line filter. 
 
This medicine must not be mixed with other infusion solutions. Do not use solutions containing 
visible particles or that are cloudy. Follow the instructions for use given by your doctor and provided 
at the end of this leaflet. 
 
If you use more Kovaltry than you should 
Tell your doctor if this occurs. No cases of overdose have been reported.  
 
If you forget to use Kovaltry 
Administer your next dose immediately and continue at regular intervals as advised by your doctor.  
Do not use a double dose to make up for a forgotten dose.  
 
If you stop using Kovaltry 
Do not stop using this medicine without checking with your doctor. 
 
If you have any further questions on the use of this medicine, ask your doctor. 
 
 
4. Possible side effects 
 
Like all medicines, this medicine can cause side effects, although not everybody gets them. 
 



75 

The most serious side effects are allergic reactions which may be severe allergic reaction. Stop 
injecting Kovaltry immediately and speak to your doctor at once if such reactions occur. The 
following symptoms could be an early warning of these reactions: 
 chest tightness/general feeling of being unwell  
 dizziness 
 feeling faint upon standing indicating a reduction in blood pressure 
 feeling sick (nausea) 
 
For children not previously treated with factor VIII medicines, inhibitor antibodies (see section 2) may 
form very commonly (more than 1 in 10 patients). For patients who have received previous treatment 
with factor VIII (more than 150 days of treatment) inhibitor antibodies (see section 2) may form 
uncommonly (less than 1 in 100 patients). If this happens your medicine may stop working properly 
and you may experience persistent bleeding. If this happens, please contact your doctor immediately. 
 
Other possible side effects: 
 
Common (may affect up to 1 in 10 users): 
 lymph nodes enlarged (swelling under the skin of the neck, armpit or groin) 
 heart palpitations (feeling your heart beating hard, rapidly, or irregularly) 
 rapid heartbeat 
 stomach pain or discomfort 
 indigestion  
 fever 
 local reactions where you injected the medicine (e.g. bleeding under the skin, intense itching, 

swelling, burning sensation, temporary redness) 
 headache 
 trouble sleeping 
 rash/itchy rash 
 
Uncommon (may affect up to 1 in 100 users): 
 dysgeusia (strange taste) 
 urticaria (itchy rash) 
 flushing (redness of the face) 
 
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. 
 
 
5. How to store Kovaltry 
 
Keep this medicine out of the sight and reach of children. 
 
Do not use this medicine after the expiry date which is stated on labels and cartons. The expiry date 
refers to the last day of that month. 
 
Store in a refrigerator (2 °C – 8 °C). Do not freeze. 
Store this medicine in the original package in order to protect from light. 
 
This medicine may be stored at room temperature (up to 25 °C) for up to 12 months when you keep it 
in its outer carton. If you store it at room temperature it expires after 12 months or at the expiry date if 
this is earlier. 
The new expiry date must be noted on the outer carton when the medicine is removed from the 
refrigerator. 
 



76 

Do not refrigerate the solution after reconstitution. The reconstituted solution must be used within 
3 hours. This product is for single use only. Any unused solution must be discarded. 
 
Do not use this medicine if you notice any particles in the solution or if the solution is cloudy. 
 
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 Kovaltry contains 
 
The active substance is octocog alfa (human coagulation factor VIII). Each vial of Kovaltry contains 
nominally 250, 500, 1000, 2000 or 3000 IU octocog alfa. 
The other ingredients are sucrose, histidine, glycine (E 640), sodium chloride, calcium chloride 
dihydrate (E 509), polysorbate 80 (E 433), acetic acid glacial (E 260) and water for injections.  
 
What Kovaltry looks like and contents of the pack 
 
Kovaltry is provided as a powder and solvent for solution for injection. The powder is dry and white 
to slightly yellow . The solvent is a clear liquid. 
 
Each single pack of Kovaltry contains 
 a glass vial with powder 
 a pre filled syringe with solvent 
 a separate plunger rod 
 a vial adapter 
 a venipuncture set (for injection into a vein). 
 
Kovaltry is available in pack sizes of: 
 1 single pack 
 1 multipack with 30 single packs 
Not all pack sizes may be marketed. 
 
Marketing Authorisation Holder 
Bayer AG 
51368 Leverkusen 
Germany 
 
Manufacturer 
Bayer AG 
Kaiser-Wilhelm-Allee 
51368 Leverkusen 
Germany 
 
 



77 

For any information about this medicine, please contact the local representative of the Marketing 
Authorisation Holder. 
 
België/Belgique/Belgien 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Lietuva 
UAB Bayer 
Tel. +37 05 23 36 868 

България 
Байер България ЕООД 
Tел.: +359-(0)2-424 72 80 

Luxembourg/Luxemburg 
Bayer SA-NV 
Tél/Tel: +32-(0)2-535 63 11 

Česká republika 
Bayer s.r.o. 
Tel: +420 266 101 111 

Magyarország 
Bayer Hungária KFT 
Tel:+36 14 87-41 00 

Danmark 
Bayer A/S 
Tlf: +45 45 23 50 00 

Malta 
Alfred Gera and Sons Ltd. 
Tel: +35 621 44 62 05 

Deutschland 
Bayer Vital GmbH 
Tel: +49 (0)214-30 513 48 

Nederland 
Bayer B.V. 
Tel: +31-(0)297-28 06 66 

Eesti 
Bayer OÜ 
Tel: +372 655 8565 

Norge 
Bayer AS 
Tlf: +47 23 13 05 00 

Ελλάδα 
Bayer Ελλάς ΑΒΕΕ 
Τηλ: +30-210-61 87 500 

Österreich 
Bayer Austria Ges.m.b.H. 
Tel: +43-(0)1-711 46-0 

España 
Bayer Hispania S.L. 
Tel: +34-93-495 65 00 

Polska 
Bayer Sp. z o.o. 
Tel: +48 22 572 35 00 

France 
Bayer HealthCare 
Tél (N° vert): +33-(0)800 87 54 54 

Portugal 
Bayer Portugal, Lda. 
Tel: +351 21 416 42 00 

Hrvatska 
Bayer d.o.o. 
Tel: +385-(0)1-6599 900 

România 
SC Bayer SRL 
Tel: +40 21 529 59 00 

Ireland 
Bayer Limited 
Tel: +353 1 216 3300 

Slovenija 
Bayer d. o. o. 
Tel: +386 (0)1 58 14 400 

Ísland 
Icepharma hf. 
Sími: +354 540 8000 

Slovenská republika 
Bayer spol. s r.o. 
Tel. +421 2 59 21 31 11 

Italia 
Bayer S.p.A. 
Tel: +39 02 397 81 

Suomi/Finland 
Bayer Oy 
Puh/Tel: +358- 20 785 21 

Κύπρος 
NOVAGEM Limited 
Tηλ: +357 22 48 38 58 

Sverige 
Bayer AB 
Tel: +46 (0) 8 580 223 00 

Latvija 
SIA Bayer 
Tel: +371 67 84 55 63 

United Kingdom 
Bayer plc 
Tel: +44-(0)118 206 3000 

 
This leaflet was last revised in 
 
Detailed information on this medicine is available on the website of the European Medicines Agency 
http://www.ema.europa.eu 
 
------------------------------------------------------------------------------------------------------------------------- 
 



78 

Detailed instructions for reconstitution and administration of Kovaltry 
 
You will need alcohol swabs, gauze pads, plasters and tourniquet. These items are not included in the 
Kovaltry package. 
 
1. Wash your hands thoroughly using soap and warm water. 
 
2. Hold an unopened vial and also a syringe in your hands to warm it to a comfortable temperature 

(do not exceed 37 °C). 
 
3. Remove the protective cap from the vial (A).Wipe the rubber stopper on the 

vial with an alcohol swab and allow the stopper to air dry before use. 
 

 
4. Place the powder vial on a firm, non slip surface. Peel off the paper cover on 

the plastic housing of the vial adapter. Do not remove the adapter from the 
plastic housing. Holding the adapter housing, place over the powder vial and 
firmly press down (B). The adapter will snap over the vial cap. Do not 
remove the adapter housing at this point. 

  

5. Hold the pre filled syringe with solvent upright. Grasp the plunger rod as per 
the picture and attach the rod by turning it firmly clockwise into the threaded 
stopper (C). 

 

6. Holding the syringe by the barrel, snap the syringe cap off the tip (D). Do not 
touch the syringe tip with your hand or any surface. Set the syringe aside for 
further use. 

 

 
7. Now remove and discard the adapter housing (E). 
 

 
8. Attach the pre filled syringe to the threaded vial adapter by turning 

clockwise (F). 
 

 
9. Inject the solvent by slowly pushing down on the plunger rod (G). 
 

 
10. Swirl vial gently until all the powder is dissolved (H). Do not shake vial. Be 

sure that the powder is completely dissolved. Look to check there are no 
particles or discoloration before you use the solution. Do not use solutions 
containing visible particles or that are cloudy. 

 
 



79 

11. Hold the vial on the end above the vial adapter and syringe (I). Fill the 
syringe by drawing the plunger out slowly and smoothly. Ensure that the full 
content of the vial is drawn into the syringe. Hold the syringe upright and 
push the plunger until no air is left in the syringe. 

 
 

12. Apply a tourniquet to your arm. 
 
13. Determine the point of injection and clean the skin with an alcohol swab. 
 
14. Puncture the vein and secure the venipuncture set with a plaster. 
 
15. Holding the vial adapter in place, remove the syringe from the vial adapter 

(the adapter should remain attached to the vial). Attach the syringe to the 
venipuncture set (J). Ensure that no blood enters the syringe. 

 

 
16. Remove tourniquet. 
 
17. Inject the solution into a vein over 2 to 5 minutes, keeping an eye on the position of the needle. 

The speed of injection should be based on your comfort, but should not be faster than 2 mL per 
minute. 

 
18. If a further dose is needed, use a new syringe with the powder reconstituted as described above. 
 
19. If no further dose is required, remove the venipuncture set and syringe. Hold a pad firmly over 

the injection site on your outstretched arm for about 2 minutes. Finally, apply a small pressure 
dressing to the injection site and consider if a plaster is necessary. 

 
20. It is recommended that every time you use Kovaltry, you note down the name and the batch 

number of the product. 
 
21. Do not throw away any medicines via wastewater or household waste. Ask your pharmacist or 

physician how to throw away medicines you no longer use. These measures will help protect the 
environment 

 
 
 


	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