מדינה: ישראל
שפה: אנגלית
מקור: Ministry of Health
COAGULATION FACTOR VIII
MEGAPHARM LTD
B02BD05
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
COAGULATION FACTOR VIII 1000 IU
I.V
Required
SWEDISH ORPHAN BIOVITRUM AB (PUBL), SWEDEN
COAGULATION FACTOR VII
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency).
2022-08-31
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a physician’s prescription only ELOCTA 250, 500, 1000, 2000, 3000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION THE MEDICINE’S NAME, FORM AND STRENGTH: EACH VIAL OF POWDER CONTAINS: RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 250 IU RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 500 IU RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 1000 IU RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 2000 IU RECOMBINANT HUMAN COAGULATION FACTOR VIII (EFMOROCTOCOG ALFA) 3000 IU AFTER BEING DISSOLVED IN WATER FOR INJECTION: 1 ml of ELOCTA 250 IU contains approximately 83 IU (250 IU / 3 ml) of recombinant human coagulation factor VIII 1 ml of ELOCTA 500 IU contains approximately 167 IU (500 IU / 3 ml) of recombinant human coagulation factor VIII 1 ml of ELOCTA 1000 IU contains approximately 333 IU (1000 IU / 3 ml) of recombinant human coagulation factor VIII 1 ml of ELOCTA 2000 IU contains approximately 667 IU (2000 IU / 3 ml) of recombinant human coagulation factor VIII 1 ml of ELOCTA 3000 IU contains approximately 1000 IU (3000 IU / 3 ml) of recombinant human coagulation factor VIII Inactive and allergenic ingredients: see section 6 “Additional information” and section 2 “Important information about some of the medicine’s ingredients”. READ THIS LEAFLET CAREFULLY IN ITS ENTIRETY BEFORE USING THE MEDICINE. This leaflet contains concise information about the medicine. If you have further questions, consult with your physician or pharmacist. This medicine has been prescribed to treat your illness. Do not pass it on to others. It may harm them, even if it seems to you that their illness is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? ELOCTA is intended for the treatment and prophylaxis of bleeding in patients with hemophilia A (congenital coagulation factor VIII deficiency). THERAPEUTIC GROUP: ELOCTA belongs to a class of bleed קרא את המסמך השלם
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT ELOCTA 250 IU powder and solvent for solution for injection ELOCTA 500 IU powder and solvent for solution for injection ELOCTA 1000 IU powder and solvent for solution for injection ELOCTA 2000 IU powder and solvent for solution for injection ELOCTA 3000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION ELOCTA 250 IU powder and solvent for solution for injection Each vial contains nominally 250 IU (33.3 mcg/vial) efmoroctocog alfa. ELOCTA contains approximately 83 IU/mL of recombinant human coagulation factor VIII, efmoroctocog alfa after reconstitution. ELOCTA 500 IU powder and solvent for solution for injection Each vial contains nominally 500 IU (66.7mcg/vial) efmoroctocog alfa. ELOCTA contains approximately 167 IU/mL of recombinant efmoroctocog alfa after reconstitution. ELOCTA 1000 IU powder and solvent for solution for injection Each vial contains nominally 1000 IU (133.3 mcg/vial) efmoroctocog alfa. ELOCTA contains approximately 333 IU/mL of recombinant efmoroctocog alfa after reconstitution. ELOCTA 2000 IU powder and solvent for solution for injection Each vial contains nominally 2000 IU (266.7 mcg/vial) efmoroctocog alfa. ELOCTA contains approximately 667 IU/mL of recombinant efmoroctocog alfa after reconstitution. ELOCTA 3000 IU powder and solvent for solution for injection Each vial contains nominally 3000 IU (400mcg/vial) efmoroctocog alfa. ELOCTA contains approximately 1000 IU/mL of recombinant efmoroctocog alfa after reconstitution. The potency (International Units (IU)) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of ELOCTA is 4000-10200 IU/mg protein. Efmoroctocog alfa (recombinant human coagulation factor VIII, Fc fusion protein (rFVIIIFc)) has 1,890 amino acids. It is produced by recombinant DNA technology in a human embryonic kidney (HEK) cell line without the addition of any exogenous human- or animal-derived protein in the cell culture proc קרא את המסמך השלם