Country: United Kingdom
Language: English
Source: MHRA (Medicines & Healthcare Products Regulatory Agency)
Octocog alfa
Bayer Plc
Octocog alfa
1000unit
Powder and solvent for solution for injection
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 02110000; GTIN: 5010605950360
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 Read the complete document
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 Read the complete document