Kogenate Bayer 500unit powder and solvent for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Octocog alfa

Available from:

Bayer Plc

INN (International Name):

Octocog alfa

Dosage:

500unit

Pharmaceutical form:

Powder and solvent for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 02110000; GTIN: 5010605950353

Patient Information leaflet

v019_0
Page 1 of 8
Due to regulatory changes, the content of the following Patient
Information Leaflet may vary from the one found in your medicine pack.
Please compare the 'Leaflet prepared/revised date' towards the end of
the leaflet to establish if there have been any changes.
If you have any doubts or queries about your medication, please
contact
your doctor or pharmacist.
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
Willebr

Summary of Product characteristics

OBJECT 1
KOGENATE BAYER POWDER AND SOLVENT FOR SOLUTION
FOR INJECTION
Summary of Product Characteristics Updated 05-Dec-2017 | Bayer plc
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 e