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DACARBAZINE Powder for solution for injection or infusion (2017)

Active ingredients: Dacarbazine

Product Name and Form

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.

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.

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.

Chemical substance
Description
Dacarbazine

Dacarbazine is a cytostatic agent. The antineoplastic effect is due to an inhibition of cell growth which is independent of the cell cycle and due to an inhibition of DNA synthesis.

List of excipients

Citric acid, anhydrous
Mannitol

Pack sizes and Marketing

Dacarbazine medac 100 mg (200 mg) is supplied as a sterile powder for solution for injection/infusion in single-dose vials made of amber glass (Type I, Ph.Eur.) and closed with butyl rubber stoppers. Each carton of Dacarbazine medac 100 mg (200 mg) contains 10 vials.

Dacarbazine medac 500 mg (1000 mg) is supplied as a sterile powder for solution for infusion in single-dose vials made of amber glass (Type I, Ph.Eur.) and closed with butyl rubber stoppers. Each carton of Dacarbazine medac 500 mg (1000 mg) contains one vial.

Marketing authorization holder
Authorization dates

medac, Gesellschaft für klinische Spezialpräparate mbH, Theaterstr. 6, 22880 Wedel, Germany

Date of first authorisation: 28 November 1997

Date of last renewal: 24 April 2010

Marketing authorization number:

Dacarbazine medac 100 mg: PL 11587/0008
Dacarbazine medac 200 mg: PL 11587/0009
Dacarbazine medac 500 mg: PL 11587/0010
Dacarbazine medac 1000 mg: PL 11587/0011