Kogenate Bayer

Country: European Union

Language: English

Source: EMA (European Medicines Agency)

Active ingredient:

Octocog alfa

Available from:

Bayer AG 

ATC code:

B02BD02

INN (International Name):

octocog alfa

Therapeutic group:

Antihemorrhagics

Therapeutic area:

Hemophilia A

Therapeutic indications:

Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor-VIII deficiency).This preparation does not contain von Willebrand factor and is therefore not indicated in von Willebrand's disease.

Product summary:

Revision: 30

Authorization status:

Withdrawn

Authorization date:

2000-08-04

Patient Information leaflet

38
B. PACKAGE LEAFLET
39
PACKAGE LEAFLET: INFORMATION FOR THE USER
KOGENATE BAYER 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOGENATE BAYER 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOGENATE BAYER 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOGENATE BAYER 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
KOGENATE BAYER 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
Recombinant coagulation factor VIII (octocog alfa)
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 or your 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 KOGENATE Bayer is and what it is used for
2.
What you need to know before you use KOGENATE Bayer
3.
How to use KOGENATE Bayer
4.
Possible side effects
5.
How to store KOGENATE Bayer
6.
Contents of the pack and other information
1.
WHAT KOGENATE BAYER IS AND WHAT IT IS USED FOR
KOGENATE Bayer contains the active substance human recombinant
coagulation factor VIII
(octocog alfa).
KOGENATE Bayer is used for treatment and prophylaxis of bleeding in
adults, adolescents and
children of all ages with haemophilia A (congenital factor VIII
deficiency).
This preparation does not contain von Willebrand factor and is
therefore not to be used in von
Willebrand's disease.
2.
WHAT YOU NEED TO KNOW BEFORE YOU USE KOGENATE BAYER
DO NOT USE KOGENATE BAYER
•
if you are allergic to octocog alfa or to any of the other ingredients
of this medicine (listed in
section 6 and end of section 2).
•
if you are allergic to mouse or hamster protein.
If you are unsure about this, ask your doctor.
WARNINGS AND PRECAUTION

Summary of Product characteristics

1
ANNEX I
SUMMARY OF PRODUCT CHARACTERISTICS
2
1.
NAME OF THE MEDICINAL PRODUCT
KOGENATE Bayer 250 IU powder and solvent for solution for injection
KOGENATE Bayer 500 IU powder and solvent for solution for injection
KOGENATE Bayer 1000 IU powder and solvent for solution for injection
KOGENATE Bayer 2000 IU powder and solvent for solution for injection
KOGENATE Bayer 3000 IU powder and solvent for solution for injection
2.
QUALITATIVE AND QUANTITATIVE COMPOSITION
Each vial contains nominally 250/500/1000/2000/3000 IU human
coagulation factor VIII (INN:
octocog alfa).
Human coagulation factor VIII is produced by recombinant DNA
technology (rDNA) in baby hamster
kidney cells containing the human factor VIII gene.
•
One mL KOGENATE Bayer 250 IU contains approximately 100 IU (250 IU /
2.5 mL) of
recombinant human coagulation factor VIII (INN: octocog alfa) after
reconstitution with water
for injections.
•
One mL KOGENATE Bayer 500 IU contains approximately 200 IU (500 IU /
2.5 mL) of
recombinant human coagulation factor VIII (INN: octocog alfa) after
reconstitution with water
for injections.
•
One mL KOGENATE Bayer 1000 IU contains approximately 400 IU (1000 IU /
2.5 mL) of
recombinant human coagulation factor VIII (INN: octocog alfa) after
reconstitution with water
for injections.
•
One mL KOGENATE Bayer 2000 IU contains approximately 400 IU (2000 IU /
5 mL) of
recombinant human coagulation factor VIII (INN: octocog alfa) after
reconstitution with water
for injections.
•
One mL KOGENATE Bayer 3000 IU contains approximately 600 IU (3000 IU /
5 mL) of
recombinant human coagulation factor VIII (INN: octocog alfa) after
reconstitution with water
for injections.
The potency (IU) is determined using the one-stage clotting assay
against the FDA Mega standard
which was calibrated against WHO standard in International Units (IU).
The specific activity of KOGENATE Bayer is approximately 4000 IU/mg
protein.
For the full list of excipients, see section 6.1.
3.
PHARMACEUTICAL FORM
Powder and solvent for solution for inj