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Ancotil 2.5 g/250 ml Solution for Infusion (2014)

Active ingredients: Flucytosine

Product Name and Form

Ancotil 2.5 g/250 ml Solution for Infusion.

Pharmaceutical form

Infusion bottles containing 2.5 g flucytosine Ph. Eur. in 250 ml isotonic sodium chloride solution.

Qualitative and Quantitative Composition

Flucytosine Ph. Eur. 2.5 g in 250 ml.

Chemical substance
Description
Flucytosine

Flucytosine is a fluorinated pyrimidine derivative. It is an antimycotic agent exerting fungistatic and fungicidal activity by interfering with protein and DNA synthesis. Fluorodeoxyuridine interferes with the enzyme thymidylate synthase. Inhibition of thymidylate synthase subsequently causes disruption of DNA synthesis.

List of excipients

Sodium chloride Ph. Eur.
Tromethamine USP
Hydrochloric acid 25%
Water for injections Ph. Eur.

Pack sizes and Marketing

250 ml neutral glass bottle (DIN 58363) with a teflon coated butyl rubber stopper. Bottles are in packs of 5.

Marketing authorization holder
Authorization dates

Meda Pharmaceuticals Ltd.
Skyway House
Parsonage Road
Takeley
Bishop’s Stortford
CM22 6PU
United Kingdom

27 February 2009

Marketing authorization number:

PL 15142/0002