RECOMBINATE ANTIHAEMOPHILIC FACTOR 250 IU International Unit Pdr+Solv for Soln for Inj

Χώρα: Ιρλανδία

Γλώσσα: Αγγλικά

Πηγή: HPRA (Health Products Regulatory Authority)

Δραστική ουσία:

FACTOR VIII, HUMAN RECOMBINANT

Διαθέσιμο από:

Baxter Healthcare Limited

INN (Διεθνής Όνομα):

FACTOR VIII, HUMAN RECOMBINANT

Δοσολογία:

250 IU International Unit

Φαρμακοτεχνική μορφή:

Pdr+Solv for Soln for Inj

Τρόπος διάθεσης:

Product subject to prescription which may not be renewed (A)

Καθεστώς αδειοδότησης:

Authorised

Ημερομηνία της άδειας:

0000-00-00

Φύλλο οδηγιών χρήσης

PACKAGE LEAFLET: INFORMATION FOR THE USER 

Recombinate 250 IU powder and solvent for solution for injection. 
Recombinate 500 IU powder and solvent for solution for injection. 
Recombinate 1000 IU powder and solvent for solution for injection. 
Octocog alfa (recombinant coagulation factor VIII) 

READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS
MEDICINE. 
- 
Keep this leaflet. You may need to read it again. 
- 
If you have any further questions, ask your doctor or pharmacist. 
- 
This medicine has been prescribed for you. Do not pass it on to
others. It may harm them, 
even if their symptoms are the same as yours. 
- 
If any of the side effects gets serious, or if you notice any side
effects not listed in this leaflet, 
please tell your doctor or pharmacist. 

IN THIS LEAFLET:  
1. 
What Recombinate is and what it is used for 
2. 
Before you use Recombinate 
3. 
How to use Recombinate 
4. 
Possible side effects 
5. 
How to store Recombinate 
6. Further 
information 

1. 
WHAT RECOMBINATE IS AND WHAT IT IS USED FOR 

Recombinate belongs to a pharmacotherapeutic group called blood
coagulation factor VIII. 
Recombinate is used in patients with haemophilia A (congenital
factor VIII deficiency) for 
• 
prevention of bleeding 
• 
treatment of bleeding (e.g. muscle bleeding, oral bleeding, bleeding
at the site of surgery). 

The product does not contain von Willebrand factor and is therefore
not to be used in von 
Willebrand’s disease (a special blood coagulation disorder). 

2. 
BEFORE YOU USE RECOMBINATE 

DO NOT  USE RECOMBINATE 

• 
If you are hypersensitive (allergic) to octocog alfa, to mouse,
bovine or hamster proteins or to 
any of the other ingredients of Recombinate. 
If you are unsure about this, ask your doctor. 
2 
TAKE SPECIAL CARE WITH RECOMBINATE 
_WHEN ALLERGIC REACTIONS OCCUR: _
• 
There is a rare chance that you may experience an anaphylactic
reaction (a severe, sudden 
allergic rea

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SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Recombinate 250 IU, powder and solvent for solution for injection.
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
Octocog alfa 25 IU per ml of reconstituted solution
After reconstitution: One vial of 10ml contains 250 IU octocog alfa
Recombinate 250 IU, contains nominally 250 IU octocog alfa, recombinant, coagulation factor VIII per vial.
The product contains approximately 25 IU/ml octocog alfa, recombinant coagulation factor VIII when reconstituted
with 10 ml of sterile water for injections.
The potency is determined using the European Pharmacopoeia chromogenic assay against the FDA Mega Standard
calibrated to the WHO Standard. The specific activity of Recombinate is approximately 4000 - 8000 IU/mg protein.
Recombinate contains recombinant coagulation factor VIII (INN: octocog alfa). Octocog alfa (recombinant coagulation
factor VIII) is a purified protein consisting of 2332 amino acids. It has an amino acid sequence that is comparable to
factor VIII, and post-translational modifications that are similar to the plasma derived molecule. Recombinant
coagulation factor VIII is a glycoprotein that is expressed by genetically engineered mammalian cells derived from a
Chinese Hamster Ovary cell line.
_Excipients: _For a full list of excipients see 6.1.
3 PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White to off-white friable powder. The solvent (sterilised water for injections) is a clear and colourless liquid.
4 CLINICAL PARTICULARS
4.1 THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with Haemophilia A (congenital Factor VIII deficiency).
This product does not contain von Willebrand factor and is therefore not indicated in von Willebrand’s disease.
Recombinate is indicated fo