Immunate 500 IU FVIII/375 IU VWF powder and solvent for solution for injection

Country: Malta

Language: English

Source: Medicines Authority

Active ingredient:

FACTOR VIII, HUMAN, VON WILLEBRAND

Available from:

Takeda Manufacturing Austria AG Industriestrasse 67, A-1221, Vienna, Austria

ATC code:

B02BD06

INN (International Name):

FACTOR VIII, HUMAN 500 IU VON WILLEBRAND FACTOR, HUMAN 375 IU

Pharmaceutical form:

POWDER AND SOLVENT FOR SOLUTION FOR INJECTION

Composition:

FACTOR VIII, HUMAN 500 IU VON WILLEBRAND FACTOR, HUMAN 375 IU

Prescription type:

POM

Therapeutic area:

ANTIHEMORRHAGICS

Authorization status:

Authorised

Authorization date:

2006-02-21

Patient Information leaflet

1
PACKAGE LEAFLET: INFORMATION FOR THE USER
IMMUNATE
500
IU FVIII/
375
IU VWF POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
human coagulation factor
VIII/
human
von Willebrand
factor
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, please 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 Immunate is and what it is used for
2.
What you need to know before you use Immunate
3.
How to use Immunate
4.
Possible side effects
5.
How to store Immunate
6.
Contents of the pack and other information
1.
WHAT IMMUNATE IS AND WHAT IT IS USED FOR
WHAT IMMUNATE IS
Immunate is a coagulation factor VIII / von Willebrand factor complex
made from human plasma. The
coagulation factor VIII in Immunate replaces the factor VIII which is
lacking or is not functioning
properly in haemophilia A. Haemophilia A is a sex-linked, hereditary
blood coagulation defect due to
reduced factor VIII levels. This results in severe bleeding in joints,
muscles and inner organs, either
spontaneously or as a consequence of accidental or surgical traumata.
The administration of Immunate
temporarily corrects the factor VIII deficiency and reduces the
bleeding tendency.
In addition to its role as a Factor VIII protecting protein, von
Willebrand factor (VWF) mediates platelet
adhesion to sites of vascular injury and plays a role in platelet
aggregation.
WHAT IMMUNATE IS USED FOR
Immunate is used for the treatment and prevention of bleeding in
congenital (haemophilia A) or acquired
factor VIII deficiency.
Immunate is also used for the treatment of bleeding in patients with
von Willebrand’s dis

Summary of Product characteristics

1
SUMMARY OF PRODUCT CHARACTERISTICS
1.
NAME OF THE MEDICINAL PRODUCT
Immunate 500 IU FVIII/375 IU VWF powder and solvent for solution for
injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Active Substances: Human coagulation Factor VIII/ Human von Willebrand
Factor
Each vial contains nominally 500 IU human coagulation factor VIII
1
and 375 IU human von
Willebrand factor
2
(VWF:RCo).
Immunate 500 IU FVIII/375 IU VWF contains approximately 100 IU/ml of
human coagulation factor
VIII and 75 IU/ml human von Willebrand factor after reconstitution.
The potency of factor VIII (IU) is determined using the European
Pharmacopoeia chromogenic assay.
The specific activity of Immunate is 70 ± 30 IU FVIII/mg protein
3
. The potency of VWF (IU) is
determined using the European Pharmacopoeia ristocetin co-factor assay
(VWF:RCo).
Produced from the plasma of human donors.
Excipient(s) with known effect
Sodium (9.8 mg per vial).
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for injection.
White or pale yellow powder or friable solid.
4.
CLINICAL PARTICULARS
4.1
THERAPEUTIC INDICATIONS
Treatment and prophylaxis of bleeding in patients with congenital
(haemophilia A) or acquired factor
VIII deficiency.
Treatment of bleeding in patients with von Willebrand's disease with
factor VIII deficiency, if no
specific preparation effective against von Willebrand’s disease is
available, and when desmopressin
(DDAVP) treatment alone is ineffective or contra-indicated.
1
The FVIII potency was determined against the WHO International
Standard for FVIII Concentrates.
2
The ristocetin cofactor activity of human von Willebrand factor was
determined against the WHO International Standard for
von Willebrand Factor, Concentrate.
3
Without stabilizer (albumin), the maximum specific activity at a 1:1
ratio of factor VIII activity to von Willebrand factor-antigen
is 100 IU factor VIII per mg protein.
2
4.2
POSOLOGY AND METHOD OF ADMINISTRATION
Treatment should be under the supervision of a p