País: Reino Unido
Idioma: inglés
Fuente: MHRA (Medicines & Healthcare Products Regulatory Agency)
Dacarbazine citrate
medac UK
L01AX04
Dacarbazine citrate
500mg
Powder for solution for infusion
Intravenous
No Controlled Drug Status
Valid as a prescribable product
BNF: 08010500; GTIN: 4037353333338
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 Leer el documento completo