البلد: الاتحاد الأوروبي
اللغة: الإنجليزية
المصدر: EMA (European Medicines Agency)
Octocog alfa
Bayer AG
B02BD02
octocog alfa
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.
Revision: 12
Authorised
2016-02-18
71 B. PACKAGE LEAFLET 72 PACKAGE LEAFLET: INFORMATION FOR THE USER KOVALTRY 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION KOVALTRY 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION KOVALTRY 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION KOVALTRY 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION KOVALTRY 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION octocog alfa (recombinant 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 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 Kovaltry is and what it is used for 2. What you need to know before you use Kovaltry 3. How to use Kovaltry 4. Possible side effects 5. How to store Kovaltry 6. Contents of the pack and other information 1. WHAT KOVALTRY IS AND WHAT IT IS USED FOR Kovaltry contains the active substance human recombinant coagulation factor VIII, also called octocog alfa. Kovaltry is prepared by recombinant technology without addition of any human- or animal derived components in the manufacturing process. Factor VIII is a protein naturally found in the blood that helps to clot it. Kovaltry is used to TREAT AND PREVENT BLEEDING in adults, adolescents and children of all ages with haemophilia A (hereditary factor VIII deficiency). 2. WHAT YOU NEED TO KNOW BEFORE YOU USE KOVALTRY DO NOT USE KOVALTRY if you are • allergic to octocog alfa or to any of the other ingredients of this medicine (listed in section 6). • allergic to mouse or hamster proteins. WARNINGS AND PRECAUTIONS TALK TO YOUR DOCTOR OR PHARMACIST if you have: • tightness in اقرأ الوثيقة كاملة
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Kovaltry 250 I U powder and solvent for solution for injection Kovaltry contains approximately 250 IU (100 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution. Kovaltry 500 IU powder and solvent for solution for injection Kovaltry contains approximately 500 IU (200 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution. Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry contains approximately 1000 IU (400 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution. Kovaltry 2000 IU powder and solvent for solution for injection Kovaltry contains approximately 2000 IU (400 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution. Kovaltry 3000 IU powder and solvent for solution for injection Kovaltry contains approximately 3000 IU (600 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution. The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Kovaltry is approximately 4000 IU/mg protein. Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids. It is produced by recombinant DNA technology in baby hamster kidney cells (BHK) into which the human factor VIII gene has been introduced. Kovaltry is prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation. For the full list of اقرأ الوثيقة كاملة