Country: United Kingdom
Bahasa: Inggeris
Sumber: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dacarbazine citrate
medac UK
L01AX04
Dacarbazine citrate
1gram
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 4037353433335
OBJECT 1 DACARBAZINE 100 MG POWDER FOR SOLUTION FOR INJECTION/INFUSION Summary of Product Characteristics Updated 08-Mar-2017 | medac GmbH 1. Name of the medicinal product Dacarbazine medac 100 mg, powder for solution for injection/infusion Dacarbazine medac 200 mg, powder for solution for injection/infusion Dacarbazine medac 500 mg, powder for solution for infusion Dacarbazine medac 1000 mg, powder for solution for infusion 2. Qualitative and quantitative composition Each single-dose vial of Dacarbazine medac 100 mg contains 100 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution Dacarbazine medac 100 mg contains 10 mg/ml dacarbazine. Each single-dose vial of Dacarbazine medac 200 mg contains 200 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution Dacarbazine medac 200 mg contains 10 mg/ml dacarbazine. Each single-dose vial of Dacarbazine medac 500 mg contains 500 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution and final dilution Dacarbazine medac 500 mg contains 1.4 – 2.0 mg/ml dacarbazine. Each single-dose vial of Dacarbazine medac 1000 mg contains 1000 mg dacarbazine (as dacarbazine citrate, formed in situ). After reconstitution and final dilution Dacarbazine medac 1000 mg contains 2.8 - 4.0 mg/ml dacarbazine. For the full list of excipients, see section 6.1. 3. Pharmaceutical form Dacarbazine medac 100 mg (200 mg): Powder for solution for injection/infusion. Dacarbazine medac 500 mg (1000 mg): Powder for solution for infusion. Dacarbazine medac is a white or pale yellow powder. 4. Clinical particulars 4.1 Therapeutic indications Dacarbazine is indicated for the treatment of patients with metastasised 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 Posology The use of dacarbazine should be confined to physicians experienced in Baca dokumen lengkap