País: Indonesia
Idioma: indonesio
Fuente: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
MOROCTOCOG ALFA
PFIZER INDONESIA - Indonesia
MOROCTOCOG ALFA
250 IU
SERBUK INJEKSI LIOFILISASI
DUS, 1 VIAL @ 250 IU + 1 PRE-FILLED SYRINGE @ 4 ML + 1 VIAL ADAPT...
WYETH FARMA, S.A. - Spain
2021-05-16
Generic Name: Moroctocog alfa Trade Name: XYNTHA CDS Effective Date: January 18, 2019 Supersedes: NA Approved by BPOM: 2020-0058307 Page 1 of 25 PT. PFIZER INDONESIA LOCAL PRODUCT DOCUMENT Generic Name: Moroctocog alfa Trade Name: XYNTHA CDS Effective Date: January 18, 2019 Supersedes: NA 1. NAME OF THE MEDICINAL PRODUCT XYNTHA *Note: XYNTHA information applies to the product manufactured using the albumin-free process. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Active ingredients Moroctocog alfa (INN) Physical characteristics XYNTHA is a white to off-white cake. Upon reconstitution, XYNTHA appears as a clear to slightly opalescent, colorless solution. Single-use vial containing nominally 250, 500 or 1000 International Units (IUs) of moroctocog alfa (recombinant coagulation factor VIII). 3. PHARMACEUTICAL FORM Single use vial: Powder and solvent for solution for intravenous (IV) injection. 4. CLINICAL PARTICULARS 4.1. THERAPEUTIC INDICATIONS DISETUJUI BPOM 7/4/2021 ID REG : EREG10024112000148 EREG10024112000149 EREG10024112000150 Generic Name: Moroctocog alfa Trade Name: XYNTHA CDS Effective Date: January 18, 2019 Supersedes: NA Approved by BPOM: 2020-0058307 Page 2 of 25 XYNTHA is used for the control and prevention of hemorrhagic episodes and for routine and surgical prophylaxis in patients with haemophilia A (congenital factor VIII deficiency or classic haemophilia). (XYNTHA is appropriate for use in children of all ages.) XYNTHA does not contain von Willebrand factor, and therefore is not indicated in Von Willebrand’s disease. 4.2. POSOLOGY AND METHOD OF ADMINISTRATION Treatment with XYNTHA should be initiated under the supervision of a physician experienced in the treatment of haemophilia A. Dosage and duration of treatment depend on the severity of the factor VIII deficiency, the location and extent of bleeding, and the patient’s clinical condition. Individual patients may vary in their response to factor VIII, achieving different levels of recovery and demonstrating different half-lives. Doses adminis Leer el documento completo