Negara: Indonesia
Bahasa: Bahasa Indonesia
Sumber: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency
DUS, 1 VIAL @ 400 UNIT
2022-07-21
Pharmacode 1. NAME OF THE MEDICINAL PRODUCT Cerezyme 400 U Powder for concentrate for solution for infusion 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vial contains 400 units* of imiglucerase**. After reconstitution, the solution contains 40 units (approximately 1.0 mg) of imiglucerase per ml (400 U/10 ml). * An enzyme unit (U) is defined as the amount of enzyme that catalyses the hydrolysis of one micromole of the synthetic substrate para-nitrophenyl ß-D-glucopyranoside (pNP-Glc) per minute at 37°C. ** Imiglucerase is a modified form of human acid ß-glucosidase and is produced by recombinant DNA technology using a mammalian Chinese Hamster Ovary (CHO) cell culture, with mannose modification for targeting macrophages. Excipients: For a full list of excipients, see section 6.1. This medicinal product contains sodium and is administered in 0.9% sodium chloride intravenous solution (see section 6.6). After reconstitution, the solution contains 1.24 mmol sodium (400 U/10 mL). To be taken into consideration by patients on a controlled sodium diet. 3. PHARMACEUTICAL FORM Powder for concentrate for solution for infusion. Cerezyme is a white to off-white powder. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Cerezyme® (imiglucerase for injection) is indicated for long-term enzyme replacement therapy for pediatric and adult patients with a confirmed diagnosis of type 1 Gaucher disease that result in one or more of the following conditions: a. Anaemia after exclusion of other causes, such as iron deficiency b. Thrombocytopenia c. Bone disease after exclusion of other causes such as Vitamin D deficiency d. Hepatomegaly or splenomegaly 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Disease management should be directed by physicians knowledgeable in the treatment of Gaucher disease. Posology Due to the heterogeneity and the multi-systemic nature of Gaucher disease, dosage should be individualised for each patient based on a comprehensive evaluation of all clinical manifestations of the disease. Once individual pati Baca dokumen lengkapnya