Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 VIAL @ 500 IU + 1 PRE-FILLED SYRINGE PELARUT @ 4 ML + 1 VI...
2022-08-16
STF APR 2021 Page 1 of 21 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. DISETUJUI OLEH BPOM: 30 JULI 2022 ID FERO: EREG100383VR12200014-16 STF APR 2021 Page 2 of 21 Treatment monitoring Dur Baca dokumen lengkapnya