Land: Tansania
Sprache: Englisch
Quelle: Tanzania Medicinces & Medical Devices Authority
Dacarbazine
MIRACALUS PHARMA PRIVATE LIMITED, INDIA
Alkylating agents list
Dacarbazine
200 mg/vial
Lyophilized Injection
Naprod Life Sciences Private Limited, INDIA
Physical description: A white to yellowish white lyophilized mass; Local technical representative: JILICHEM (T) Limited (5053)
Registered/Compliant
2020-12-24
SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE FINISHED PHARMACEUTICAL PRODUCT: DACARBAZINE FOR INJECTION USP 200MG/VIAL ATC CODE: L01AX04 DISTRIBUTION CATEGORY: POM 2. QUALITATIVE AND QUANTITATIVE COMPOSITION: Each vial contains: Dacarbazine USP 200mg EXCIPIENTS: FOR A FULL LIST OF EXCIPIENTS, SEE SECTION 6.1 3. PHARMACEUTICAL FORM: Lyophilized powder for Injection DESCRIPTION: A white to yellowish lyophilized mass. 4. CLINICAL PARTICULARS: 4.1 THERAPEUTIC INDICATIONS Dacarbazine is indicated for the treatment of patients with metastasized malignant melanoma. Further indications for dacarbazine as part of a combination chemotherapy are: - advanced Hodgkin's disease, - advanced adult soft tissue sarcomas (except mesothelioma, Kaposi sarcoma). 4.2 POSOLOGY AND METHOD OF ADMINISTRATION MALIGNANT MELANOMA The recommended dosage is 2 to 4.5 mg/kg/day for 10 days. Treatment may be repeated at 4-week intervals. An alternate recommended dosage is 250 mg/square meter body surface/day I.V injection for 5 days. Treatment may be repeated every 3 weeks. HODGKIN'S DISEASE The recommended dosage of dacarbazine in the treatment of Hodgkin's disease is 150 mg/square meter body surface/day for 5 days, in combination with other effective drugs. Treatment may be repeated every 4 weeks. An alternative recommended dosage is 375 mg/square meter body surface on day 1, in combination with other effective drugs, to be repeated every 15 days. 4.3 CONTRAINDICATIONS Dacarbazine is contraindicated in patients: - • who have a history of hypersensitivity reactions to dacarbazine or to any of the excipients. • in pregnant or breastfeeding women • in patients with leucopenia and/or thrombocytopenia • in patients with severe liver or kidney diseases. 4.4 WARNING AND PRECAUTIONS It is recommended that dacarbazine should only be administered under the supervision of a physician specialized in oncology, having the facilities for regular monitoring of clinical, biochemical and hematological effects, during and after therapy. If symptoms of Lesen Sie das vollständige Dokument