ANCOTIL Solution for infusion Ref.[8891] Active ingredients: Flucytosine

Source: Medicines & Healthcare Products Regulatory Agency (GB)  Revision Year: 2019  Publisher: Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

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.

Active Ingredient 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 and aluminium crimping cap. Bottles are in packs of 5.

Marketing authorization holder

Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom

Marketing authorization dates and numbers

PL 46302/0116

27 February 2009

Drugs

Drug Countries
ANCOTIL Austria, Estonia, France, Ireland, Japan, Malta, Netherlands, Poland, United Kingdom

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