Optivate 250 IU powder and solvent for solution for injection, Human coagulation factor VIII

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FACTOR VIII, HUMAN; VON WILLEBRAND FACTOR, HUMAN

Available from:

Bio Products Laboratory Limited

ATC code:

B02BD02

INN (International Name):

FACTOR VIII, HUMAN; VON WILLEBRAND FACTOR, HUMAN

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

FACTOR VIII, HUMAN 250 IU; VON WILLEBRAND FACTOR, HUMAN 430 IU

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Authorised

Authorization date:

2012-07-11

Patient Information leaflet

1 
OPTLE5 
PACKAGE LEAFLET: INFORMATION FOR THE USER 
OPTIVATE

 250 IU, 500 IU, 1000 IU 
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 

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. 
• 
This medicine has been prescribed for you only. Do not pass it on to
others. It may harm them, even if 
their signs of illness are the same as yours, 
• 
If you get any side effects, talk to your doctor. This includes
any possible side effects not listed in this 
leaflet. 

WHAT IS IN THIS LEAFLET 
1. What Optivate

 is and what it is used for 
2  What you need to know before you use Optivate


3. How to use Optivate


4. Possible side effects 
5. How to store Optivate


6. Contents of the pack and other information 

1.  WHAT OPTIVATE

 IS AND WHAT IT IS USED FOR 

Optivate

 is a high purity factor VIII concentrate from human blood plasma
obtained from screened donors. 
It is a white or pale yellow sterile powder, supplied with sterilised
water for injections.  
Optivate

 is given by injection into a vein (intravenously) and is used to
prevent and treat bleeding in 
patients with haemophilia A (congenital factor VIII deficiency in
the blood).  Your doctor will explain 
further why this medicine has been given to you. 

2. WHAT YOU NEED TO KNOW BEFORE YOU USE OPTIVATE


DO NOT USE OPTIVATE

: 
- if you are allergic (hypersensitive) to the human coagulation factor
VIII or any of the other ingredients of 
this medicine (listed in section 6). 

WARNINGS AND PRECAUTIONS 
- If you have a larger or longer bleed than usual and the bleeding
does not stop after an injection of 
Optivate

, speak to your doctor. 
Some patients with a shortage of factor VIII may develop inhibitors
(ant

Summary of Product characteristics

 
Page 1 of 9 

SUMMARY OF PRODUCT CHARACTERISTICS 

1. 
NAME OF THE MEDICINAL PRODUCT  

Optivate
 
250 IU, 500 IU, 1000 IU, powder and solvent for solution for
injection 
Human coagulation factor VIII _ _

2. 
QUALITATIVE AND QUANTITATIVE COMPOSITION 

Optivate

 is presented as a powder and solvent for solution for injection
containing nominally 250 
IU, 500 IU or 1000 IU human coagulation factor VIII per vial. 

Optivate

 contains approximately 100 IU/mL human coagulation factor VIII when
reconstituted 
with 2.5 mL (250 IU), 5 mL (500 IU) or 10 mL (1000 IU) sterilised
water for injections. 

The potency (IU) is determined using the European Pharmacopoeia
chromogenic assay. The 
specific activity of Optivate

 is approximately 43 IU/mg of protein. 

Optivate

 also contains human von Willebrand factor (VWF by ristocetin
cofactor activity) at a 
concentration of approximately 430 IU, 860 IU or 1720 IU per vial
respectively for the 250 IU, 500 
IU and 1000 IU presentations.  

For the full list of excipients, see section 6.1. 

3. 
PHARMACEUTICAL FORM  

Powder and solvent for solution for injection. 

Product vial containing white or pale yellow powder.  
Solvent vial containing clear colourless liquid. 

4. 
CLINICAL PARTICULARS  

4.1 
THERAPEUTIC INDICATIONS  

Treatment and prophylaxis of bleeding in patients with haemophilia A
(congenital factor VIII 
deficiency).  

4.2 
POSOLOGY AND METHOD OF ADMINISTRATION  

Treatment should be initiated under the supervision of a physician
experienced in the treatment of 
haemophilia. 

Posology 

The dosage and duration of the substitution therapy depend on the
severity of the FVIII deficiency, 
on the location and extent of the bleeding and the patient’s
clinical condition. 

_On demand treatment _

Page 2 of 9 

The number of units of factor VIII administered is expressed in
International Units (IU), which are 
related to the current WHO stan