Ország: Izrael
Nyelv: angol
Forrás: Ministry of Health
RECOMBINANT HUMAN COAGULATION FACTOR VIII
BAYER ISRAEL LTD
B02BD02
POWDER AND SOLVENT FOR SOLUTION FOR INJECTION
RECOMBINANT HUMAN COAGULATION FACTOR VIII 500 IU
I.V
Required
BAYER AG, GERMANY
COAGULATION FACTOR VIII
Treatment and prophylaxis of bleeding in patients with haemophilia A (congenital factor VIII deficiency). Kovaltry can be used for all age groups.
2022-04-30
PMR 89611407 Technical Template (GFJBE/00-N) Pantone: Black PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS (PREPARATIONS) -1986 This medicine is dispensed with a doctor’s prescription only KOVALTRY ® 250 IU KOVALTRY ® 500 IU KOVALTRY ® 1000 IU KOVALTRY ® 2000 IU POWDER AND SOLVENT FOR SOLUTION FOR INJECTION Each vial of powder contains: Nominally 250, 500, 1000, or 2000 IU (International Units) recombinant human coagulation factor VIII (octocog alfa). After reconstitution with water for injection: 1 mL of Kovaltry 250 IU contains approximately 100 IU (250 IU/2.5 mL) of recombinant human coagulation factor VIII (octocog alfa), 1 mL of Kovaltry 500 IU contains approximately 200 IU (500 IU/2.5 mL) of recombinant human coagulation factor VIII (octocog alfa), 1 mL of Kovaltry 1000 IU contains approximately 400 IU (1000 IU/2.5 mL) of recombinant human coagulation factor VIII (octocog alfa), 1 mL of Kovaltry 2000 IU contains approximately 400 IU (2000 IU/5 mL) of recombinant human coagulation factor VIII (octocog alfa). Inactive ingredients and allergens: 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 the treatment of your illness. Do not pass it on to others. It may harm them even if it seems to you that their illness is similar to yours. 1) WHAT IS THIS MEDICINE INTENDED FOR? Kovaltry is used for treatment and prevention of bleeding in adults, adolescents and children of all ages with haemophilia A (congenital factor VIII deficiency). THERAPEUTIC GROUP: Kovaltry belongs to a group of medicines for prevention of bleeding that contains the coagulation factor number VIII. The medicine contains the active substance human recombinant coagulation factor VIII, also called oc Olvassa el a teljes dokumentumot
1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Kovaltry 250 IU powder and solvent for solution for injection Kovaltry 500 IU powder and solvent for solution for injection Kovaltry 1000 IU powder and solvent for solution for injection Kovaltry 2000 IU powder and solvent for solution for injection 2. QUALITATIVE AND QUANTITATIVE COMPOSITION • Kovaltry 250IU powder and solvent for solution for injection Kovaltry contains approximately 250 IU (100 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution • Kovaltry 500IU powder and solvent for solution for injection Kovaltry contains approximately 500 IU (200 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution. • Kovaltry 1000IU powder and solvent for solution for injection Kovaltry contains approximately 1000 IU ( 400 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution . • Kovaltry 2000IU powder and solvent for solution for injection Kovaltry contains approximately 2000 IU (400 IU / 1 mL) of recombinant human coagulation factor VIII (INN: octocog alfa) after reconstitution. The potency (IU) is determined using the European Pharmacopoeia chromogenic assay. The specific activity of Kovaltry is approximately 4000 IU/mg protein. Octocog alfa (Full length recombinant human coagulation factor VIII (rDNA)) is a purified protein that has 2,332 amino acids. It is produced by recombinant DNA technology in baby hamster kidney cells (BHK) into which the human factor VIII gene has been introduced. Kovaltry is prepared without the addition of any human or animal derived protein in the cell culture process, purification or final formulation. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for injection (vial adapter) Powder: solid, white to slightly yellow. Solvent: water for injections, a clear solution. 4. CLINICAL PARTICULARS 4.1 Therapeutic indications Treatment a Olvassa el a teljes dokumentumot