Recombinate 1000IU powder and solvent for solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

octocog alfa 1000 iu

Available from:

Baxter Healthcare Limited

ATC code:

B02BD02

INN (International Name):

octocog alfa

Pharmaceutical form:

powder and solvent for solution for injection

Authorization status:

Authorised

Authorization date:

2011-07-29

Patient Information leaflet

PACKAGE LEAFLET: INFORMATION  
FOR THE USER
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.
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 reaction) to Recombinate. You should be aware of the early signs of allergic reactions 
such  as  rash,  hive

Summary of Product characteristics

 
Page 1 of 13 
SUMMARY OF PRODUCT CHARACTERISTICS 
1. 
NAME OF THE MEDICINAL PRODUCT 
Recombinate 1000 IU powder and solvent for solution for injection 
2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Octocog alfa   
100 IU per ml of reconstituted solution 
After reconstitution:  One vial of 10 ml contains 1000 IU octocog alfa 
Recombinate 1000 IU, contains nominally 1000 IU octocog alfa, recombinant, coagulation factor VIII 
per vial. 
The product contains approximately 100 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. 
For a full list of excipients, see section 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 colorless 
liquid. 
4. 
CLINICAL PARTICULARS 
4.1 
THERAPEUTIC INDICATIONS 
Treatment  and  prophylaxis  of  bleeding