Dacarbazine 100mg powder for solution for injection vials

Country: United Kingdom

Language: English

Source: MHRA (Medicines & Healthcare Products Regulatory Agency)

Active ingredient:

Dacarbazine citrate

Available from:

medac UK

ATC code:

L01AX04

INN (International Name):

Dacarbazine citrate

Dosage:

100mg

Pharmaceutical form:

Powder for solution for injection

Administration route:

Intravenous

Class:

No Controlled Drug Status

Prescription type:

Valid as a prescribable product

Product summary:

BNF: 08010500; GTIN: 4037353333222

Summary of Product characteristics

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