Maa: Malesia
Kieli: englanti
Lähde: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Lonoctocog alfa
DKSH MALAYSIA SDN. BHD.
Lonoctocog alfa
6 ml
CSL Behring GmbH
_CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP)_ _ _ AFSTYLA ® _ _ Lonoctocog alfa (250IU, 500IU, 1000IU, 2000IU, 3000IU) 1 WHAT IS IN THIS LEAFLET 1. What AFSTYLA is used for 2. How AFSTYLA _ _ works 3. Before you use AFSTYLA 4. How to use AFSTYLA _5._ _ _ While you are using AFSTYLA _ _ 6. Side effects 7. Storage and Disposal of AFSTYLA 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision 11. Serial number WHAT AFSTYLA IS USED FOR AFSTYLA is an injectable clotting (coagulation) factor VIII product that is produced by recombinant DNA technology. The active substance AFSTYLA is lonoctocog alfa. AFSTYLA is used to treat, prevent, or reduce the frequency of bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency) and can be used for all age groups. It can be used during surgeries too. HOW AFSTYLA WORKS Factor VIII is involved in blood clotting. Lack of this factor means that blood does not clot as quickly as it should so there is an increased tendency to bleed. AFSTYLA works by replacing factor VIII in haemophilia A patients to enable their blood to clot BEFORE YOU USE AFSTYLA - _When you must not use it: _ Do not use AFSTYLA if you have had a life-threatening allergic reaction to AFSTYLA, any of its components or excipients (listed in section “Product Description”), or hamster proteins. _ _ - _Before you start to use it _ Talk to your doctor, pharmacist or nurse before using AFSTYLA. • Allergic (hypersensitivity) reactions are possible. The product contains traces of hamster proteins (see also When you must not use it”). If symptoms of hypersensitivity occur, you should stop using the medicine immediately and contact your doctor. Your doctor should inform you of the early signs of hypersensitivity reactions. These include hives, generalised skin rash, tightness of the chest, wheezing, fall in blood pressure and anaphylaxis (a serious allergic reaction that causes severe difficulty in breathing, or dizziness). • Because of the risk of allerg Lue koko asiakirja
1. NAME OF THE MEDICINAL PRODUCT _AFSTYLA_ 250IU powder and solvent for solution for injection. _AFSTYLA_ 500IU powder and solvent for solution for injection. _AFSTYLA_ 1000IU powder and solvent for solution for injection. _AFSTYLA_ 2000IU powder and solvent for solution for injection. _AFSTYLA_ 3000IU powder and solvent for solution for injection. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION One vial contains nominally 250/500/1000/2000/3000 IU recombinant, single chain coagulation factor VIII _ _ (rVIII-SingleChain, INN = lonoctocog alfa). After reconstitution with 2.5 ml water for injections (250/500/1000 IU) the solution contains 100/200/400 IU/ml of rVIII-SingleChain. When reconstituted with 5 ml water for injections (2000/3000 IU) the solution contains 400/600 IU/ml of rVIII-SingleChain. The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of _AFSTYLA_ is 7400 - 16000 IU/mg protein. _AFSTYLA _ is a single chain recombinant factor VIII produced in Chinese hamster ovary (CHO) cells. It is a construct where most of the B-domain occurring in wild-type, full-length factor VIII and 4 amino acids of the adjacent acidic a3 domain were removed (amino acids 765 to 1652 of full-length factor VIII). The newly formed linkage of the heavy and light chain of factor VIII introduces a new N- glycosylation site. As the furin cleavage site present in wild type factor VIII between the B- domain and the a3 domain was removed, _AFSTYLA_ is expressed as a single chain factor VIII molecule. Excipient with known effect: Sodium approximately 0.23-0.30 mmol/ml (5.4-7.0 mg/ml). For the full list of excipients, see section 6.1 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection. White or slightly yellow powder or friable mass and clear, colourless solvent for solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS _AFSTYLA _ is indicated in adults and pediatrics with hemophilia A (congenital factor VIII deficiency) for: • Control and prevention of Lue koko asiakirja