Land: Israel
Språk: engelsk
Kilde: Ministry of Health
TUROCTOCOG ALFA
NOVO NORDISK LTD., ISRAEL
B02BD02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
TUROCTOCOG ALFA 1000 IU / 4 ML
I.V
Required
NOVO NORDISK A/S, DENMARK
COAGULATION FACTOR VIII
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).NovoEight can be used for all age groups.
2020-08-31
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) – 1986 This medicine is dispensed with a doctor's prescription only NOVOEIGHT ® 500 IU NOVOEIGHT ® 1000 IU NOVOEIGHT ® 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION ACTIVE INGREDIENT: TUROCTOCOG ALFA Inactive ingredients and allergens in this medicine: See section 2 under " Important information about some of this medicine's ingredients " and section 6 " Additional information " . READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. This leaflet contains concise information about this medicine. If you have any further questions, consult your doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED 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. THERAPEUTIC GROUP: antihaemorrhagics, blood coagulation factor VIII. 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. 2. BEFORE USING THE MEDICINE DO NOT USE THIS MEDICINE IF: • you are sensitive (allergic) to the active substance or to any of the other ingredients this medicine contains (listed in section 6 " Additional information " ). • you are allergic to hamster proteins. Do not use NovoEight if either of the above applies to you. If you are not sure, consult your doctor before using this medicine. SPECIAL WARNINGS ABOUT USING THIS MEDICINE TALK TO YOUR DOCTOR BEFORE USING NOVOEIGHT. There is a rare chance that you may experience an anaphylactic reaction (a severe, sudden aller Les hele dokumentet
1 1. NAME OF THE MEDICINAL PRODUCT NovoEight ® 500 IU NovoEight ® 1000 IU NovoEight ® 2000 IU 2. QUALITATIVE AND QUANTITATIVE COMPOSITION NovoEight 500 IU. Each powder vial contains nominally 500 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 125 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. NovoEight 1000 IU. Each powder vial contains nominally 1000 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 250 IU/ml of human coagulation factor VIII (rDNA), turoctocog alfa. NovoEight 2000 IU. Each powder vial contains nominally 2000 IU human coagulation factor VIII (rDNA), turoctocog alfa. After reconstitution NovoEight contains approximately 500 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. 2 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment and prophylaxis of bleeding in patients with haemophilia A (congenita Les hele dokumentet