Country: Malasía
Tungumál: enska
Heimild: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
Turoctocog Alfa
NOVO NORDISK PHARMA (MALAYSIA) SDN. BHD.
Turoctocog Alfa
1 vial Vials
Novo Nordisk A/S
NOVOEIGHT ® _Consumer Medication Information Leaflet (RiMUP)_ 250, 500 & 1000 IU _ _ Turoctocog Alfa (human coagulation factor VIII (rDNA)) ______________________________________________________________________________________________ 1 WHAT IS IN THIS LEAFLET 1. What NovoEight ® is used for 2. How NovoEight ® works 3. Before you use NovoEight ® 4. How to use NovoEight ® 5. While you are using it 6. Side effects 7. Storage and disposal of NovoEight ® 8. Product description 9. Manufacturer 10. Product Registration Holder 11. Date of revision 1. WHAT NOVOEIGHT ® IS USED FOR NovoEight ® is used to treat and prevent bleeding episodes in patients with haemophilia A (inborn factor VIII deficiency) and can be used for all age groups. 2. HOW NOVOEIGHT ® WORKS NovoEight ® contains the active substance turoctocog alfa, human coagulation factor VIII. Factor VIII is a protein naturally found in the blood that helps it to clot. In patients with haemophilia A, factor VIII is missing or not working properly. NovoEight ® replaces this faulty or missing ‘factor VIII’ and helps blood to form clots at the site of bleeding. 3. BEFORE YOU USE NOVOEIGHT ® _- WHEN YOU MUST NOT USE IT _ ►If you are allergic to the active substance or to any of the other ingredients of this medicine. ►If you are allergic to hamster proteins. Do not use NovoEight ® if either of the above applies to you. If you are not sure, talk to your doctor before using this medicine. _- BEFORE YOU START TO USE IT _ _ _ Talk to your doctor before using NovoEight ® . _- TAKING OTHER MEDICINES _ Tell your doctor if you are taking, have recently taken or might take any other medicines. 4. HOW TO USE NOVOEIGHT ® _- HOW MUCH TO USE _ Treatment with NovoEight ® will be started by a doctor who is experienced in the care of patients with haemophilia A. Always use this medicine exactly as your doctor has told you. Check with your doctor if you are not sure. Your doctor will calculate your dose for you. This will depend on your weight and what the medicin Lestu allt skjalið
NovoEight ® Professional leaflet EN-Apr-2021_8-9063-00-007-1 Based on EU text: 20200925_EN_N8_05593_ver-13-3 1 1. NAME OF THE MEDICINAL PRODUCT NOVOEIGHT ® 250 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 500 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 1000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each powder vial contains nominally 250, 500 or 1000 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight ® contains approximately 62.5, 125 or 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. The potency (IU) is determined using the European Pharmacopoeia (Ph. Eur) chromogenic assay. The specific activity of NovoEight ® is approximately 8,300 IU/mg protein. Turoctocog alfa (human coagulation factor VIII (rDNA)) is a purified protein that has 1,445 amino acids with an approximate molecular mass of 166 kDA. It is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cells, and prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation. Turoctocog alfa is a B-domain truncated recombinant human coagulation factor VIII (B-domain consists of 21 amino acids of the wild type B-domain) without any other modifications in the amino acid sequence. _Excipient with known effect_ The medicinal product contains 30.5 mg sodium per reconstituted vial. 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. Clear and colourless solution for injection. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). NovoEight ® can be used for all age groups. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Treatment should be under the supervision of a doctor experienced in the treatment of haemophilia. Treatment monitoring During th Lestu allt skjalið