Country: ইউরোপীয় ইউনিয়ন
ভাষা: ইংরেজি
সূত্র: EMA (European Medicines Agency)
lonoctocog alfa
CSL Behring GmbH
B02BD02
lonoctocog alfa
Antihemorrhagics
Hemophilia A
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).Afstyla can be used for all age groups.
Revision: 10
Authorised
2017-01-04
44 B. PACKAGE LEAFLET 45 PACKAGE LEAFLET: INFORMATION FOR THE USER AFSTYLA 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AFSTYLA 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AFSTYLA 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AFSTYLA 1500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AFSTYLA 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AFSTYLA 2500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION AFSTYLA 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION lonoctocog alfa (recombinant, single-chain coagulation factor VIII) READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU OR YOUR CHILD START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR YOU. • Keep this leaflet. You may need to read it again. • If you have further questions, ask your doctor, pharmacist or nurse. • This medicine has been prescribed for you OR YOUR CHILD 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, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4. WHAT IS IN THIS LEAFLET : 1. What AFSTYLA is and what it is used for 2. What you need to know before you OR YOUR CHILD use AFSTYLA 3. How to use AFSTYLA 4. Possible side effects 5. How to store AFSTYLA 6. Contents of the pack and other information 1. WHAT AFSTYLA IS AND WHAT IT IS USED FOR AFSTYLA is a human clotting (coagulation) factor VIII product that is produced by recombinant DNA technology. The active substance in AFSTYLA is lonoctocog alfa. AFSTYLA is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency). Factor VIII is a protein needed for blood to clot. Patients with haemophilia A lack this factor, so blood does not clot as quickly as it should and they have an increased tendency to bleed. AFSTYLA works by replacing the missing factor VIII in haemophilia A patients enabling their blood to clot normally. AFSTYLA can be সম্পূর্ণ নথি পড়ুন
1 ANNEX I SUMMARY OF PRODUCT CHARACTERISTICS 2 1. NAME OF THE MEDICINAL PRODUCT AFSTYLA 250 IU powder and solvent for solution for injection AFSTYLA 500 IU powder and solvent for solution for injection AFSTYLA 1000 IU powder and solvent for solution for injection AFSTYLA 1500 IU powder and solvent for solution for injection AFSTYLA 2000 IU powder and solvent for solution for injection AFSTYLA 2500 IU powder and solvent for solution for injection AFSTYLA 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION AFSTYLA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU recombinant, single-chain coagulation factor VIII _ _ (rVIII- SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections the solution contains 100 IU/ml of rVIII-SingleChain. AFSTYLA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU recombinant, single-chain coagulation factor VIII _ _ (rVIII- SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections the solution contains 200 IU/ml of rVIII-SingleChain. AFSTYLA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU recombinant, single-chain coagulation factor VIII _ _ (rVIII- SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections the solution contains 400 IU/ml of rVIII-SingleChain. AFSTYLA 1500 IU powder and solvent for solution for injection Each vial contains nominally 1500 IU recombinant, single-chain coagulation factor VIII _ _ (rVIII- SingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml water for injections the solution contains 300 IU/ml of rVIII-SingleChain. AFSTYLA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU recombinant, single-chain coagulation factor VIII _ _ (rVIII- SingleChain, INN = lonoctocog alfa). When reconstituted with 5 ml water for injections the solution contains 400 IU সম্পূর্ণ নথি পড়ুন