Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 VIAL SERBUK 500 U + 1 VIAL WFI 10 ML + 1 DISPOSABLE SYRIN...
2022-06-10
SmPC FEIBA 50U/mL 1 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT FEIBA 50 U/ml powder and solvent for solution for infusion. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active substance: Factor VIII Inhibitor Bypassing Activity 1 ml contains 50 U* factor VIII inhibitor bypassing activity. FEIBA 50 U/ml is available in three different presentations: - The presentation 500 U FEIBA contains 500 U factor VIII inhibitor bypassing activity in 200 – 600 mg human plasma protein, - The presentation 1000 U FEIBA contains 1000 U factor VIII inhibitor bypassing activity in 400 – 1,200 mg human plasma protein, - The presentation 2500 U FEIBA contains 2500 U factor VIII inhibitor bypassing activity in 1,000 – 3,000 mg human plasma protein. FEIBA also contains the factors II, IX and X, mainly in non-activated form, as well as activated factor VII. Factor VIII coagulation antigen (F VIII C:Ag) is present at a concentration of up to 0.1 U./1 U. FEIBA. The factors of the kallikrein-kinin system are present in trace amounts only, if at all. * 1 unit of FEIBA shortens the activated partial thromboplastin time (aPTT) of a factor VIII inhibitor plasma by 50% of the buffer value (blank value). Excipients with known effect: 1.8 mmol sodium (40 mg) per vial with 500 U FEIBA. 3.6 mmol sodium (80 mg) per vial with 1000 U FEIBA. 8.9 mmol sodium (200 mg) per vial with 2500 U FEIBA. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Powder and solvent for solution for infusion. White, off-white or pale green powder. The pH value of the ready-to-use solution is between 6.8 and 7.6. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS - Treatment of bleeding in hemophilia A patients with inhibitors. DISETUJUI BPOM: 19 JUNI 2023 ID REG: EREG100235VR12200178 SmPC FEIBA 50U/mL 2 - Treatment of bleeding in hemophilia B patients with inhibitors, if no other specific treatment is available (see section 5.1). - Treatment of bleeding in non-hemophiliacs with acquired inhibitors to factor VIII. - Prophylax Baca dokumen lengkapnya