Country: Unjoni Ewropea
Lingwa: Ingliż
Sors: EMA (European Medicines Agency)
Damoctocog alfa pegol
Bayer AG
B02BD02
damoctocog alfa pegol
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in previously treated patients ≥ 12 years of age with haemophilia A (congenital factor VIII deficiency).
Revision: 5
Authorised
2018-11-22
73 B. PACKAGE LEAFLET 74 PACKAGE LEAFLET: INFORMATION FOR THE USER JIVI 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION JIVI 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION JIVI 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION JIVI 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION JIVI 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION PEGylated B-domain deleted recombinant human coagulation factor VIII (damoctocog alfa pegol) 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 Jivi is and what it is used for 2. What you need to know before you use Jivi 3. How to use Jivi 4. Possible side effects 5. How to store Jivi 6. Contents of the pack and other information 1. WHAT JIVI IS AND WHAT IT IS USED FOR Jivi contains the active substance damoctocog alfa pegol. It is produced 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. The protein in damoctocog alfa pegol has been modified (pegylated) to prolong its action in the body. Jivi is used to TREAT AND PREVENT BLEEDING in previously treated adults and adolescents aged from 12 years with haemophilia A (hereditary factor VIII deficiency). It is not for use in children younger than 12 years of age. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE JIVI DO NOT USE JIVI if you are • allergic to damoctocog alfa pegol or any of the other ingredients of this medicine (listed in section 6). • allergic to mou Aqra d-dokument sħiħ
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT Jivi 250 IU powder and solvent for solution for injection Jivi 500 IU powder and solvent for solution for injection Jivi 1000 IU powder and solvent for solution for injection Jivi 2000 IU powder and solvent for solution for injection Jivi 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Jivi 250 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 100 IU (250 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol. Jivi 500 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 200 IU (500 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol. Jivi 1000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 400 IU (1 000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol. Jivi 2000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 800 IU (2 000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol. Jivi 3000 IU powder and solvent for solution for injection After reconstitution with the solvent provided, one mL of solution contains approximately 1 200 IU (3 000 IU/2.5 mL) of human coagulation factor VIII, damoctocog alfa pegol. The potency International Unit (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Jivi is approximately 10 000 IU/mg protein. The active substance, damoctocog alfa pegol, is a site specifically PEGylated B-domain deleted recombinant human coagulation factor VIII, produced in baby hamster kidney cells (BHK), with a 60 kDa branched polyethylene-glycol (two 30 kDa PEG) moiety. The molecular weight of the protein is approximately 234 k Aqra d-dokument sħiħ