Optivate 250IU 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

Available from:

BPL Bioproducts Laboratory GmbH Dornhofstraße 34, 63263 Neu-Isenburg,, Germany

ATC code:

B02BD02

INN (International Name):

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

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

PAGE 1 OF 8
PACKAGE LEAFLET
PAGE 2 OF 8
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 or pharmacist. This
includes any possible side
effects not listed in this leaflet. See section 4.
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, a protein that is
needed for blood to clot. The
factor VIII in Optivate is extracted from human blood plasma (the
liquid part of blood).
Optivate is used to prevent and treat bleeding in patients with
haemophilia A (a congenital factor VIII
deficiency in the blood).
Optivate preparation contains human von Willebrand factor.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE OPTIVATE
DO NOT USE OPTIVATE:
-
if you are allergic (hypersensitive) to 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.
-
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 and you or your child will be monitored
carefully for the
development of these inhibi

Summary of Product characteristics

Page 1 of 11
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.
Page 2 of 11
_ _
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 p