ANCOTIL Solution for infusion (2019)
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Περιεχόμενα
Name of the medicinal product
Ancotil 2.5 g/250 ml Solution for Infusion.
Qualitative and quantitative composition
Flucytosine Ph. Eur. 2.5 g in 250 ml.
Pharmaceutical form
Infusion bottles containing 2.5 g flucytosine Ph. Eur. in 250 ml isotonic sodium chloride solution.
Therapeutic indications
Ancotil is indicated for the treatment of systemic yeast and fungal infections due to sensitive organisms: such infections include cryptococcosis, candidiasis, chromomycosis and infections due to torulopsis ...
Posology and method of administration
Adults Ancotil for Infusion should be administered using a giving set. It may be administered directly into a vein, through a central venous catheter, or by intra-peritoneal infusion. The recommended daily ...
Contraindications
Ancotil is contra-indicated: in patients who have shown hypersensitivity to flucytosine or any of the excipients. in co-administration with antiviral nucleoside drugs e.g. ganciclovir and valganciclovir, ...
Special warnings and precautions for use
Flucytosine has a narrow therapeutic window and there is a risk of its potential toxicity at high systemic concentrations. The product should be used with great caution in patients with depression of bone ...
Interaction with other medicinal products and other forms of interaction
There is contradictory evidence concerning a drug interaction between Ancotil and cytarabine. Strict monitoring of blood levels is required if the two medicines are given concurrently. Brivudine, sorivudine ...
Fertility, pregnancy and lactation
Contraception in males and females Flucytosine is partially metabolised into 5-fluorouracil, which is genotoxic and considered as a potential human teratogen. Females of childbearing potential under treatment ...
Effects on ability to drive and use machines
Not applicable.
Undesirable effects
Nausea, vomiting, diarrhoea and skin rashes may occur but are usually of a transient nature. Less frequently observed side effects include allergic reactions, Lyells Syndrome, myocardial toxicity and ventricular ...
Overdose
Haemodialysis produces a rapid fall in the serum concentration of Ancotil.
Pharmacodynamic properties
Pharmacotherapeutic group: Antimycotic agent ATC Code: J02AX01 Flucytosine is a fluorinated pyrimidine derivative. It is an antimycotic agent exerting fungistatic and fungicidal activity by interfering ...
Pharmacokinetic properties
Absorption Bioavailability after an oral dose of 2 g varies between individuals and ranges from 76–98%. Peak plasma concentrations are reached within 1–2 hours after oral administration but may be delayed ...
Preclinical safety data
In vitro investigations on mutagenic potential of flucytosine were negative. No studies are available on the carcinogenic potential of Ancotil. Flucytosine has been shown to be teratogenic and embryotoxic ...
List of excipients
Sodium chloride Ph. Eur. Tromethamine USP Hydrochloric acid 25% Water for injections Ph. Eur.
Incompatibilities
Ancotil for Infusion may be given concurrently with other infusions of Sodium Chloride Intravenous infusion (0.9% w/v) BP, Glucose Intravenous Infusion (5% w/v) BP, or Sodium Chloride (0.18% w/v) and Glucose ...
Shelf life
Shelf life: 2 years.
Special precautions for storage
Ancotil for Infusion should be stored between 18°C and 25°C. If stored below 18°C, precipitation of Ancotil substance may occur. Prolonged storage above 25°C could lead to the decomposition of Ancotil ...
Nature and contents of container
250 ml neutral glass bottle (DIN 58363) with a teflon coated butyl rubber stopper and aluminium crimping cap. Bottles are in packs of 5.
Special precautions for disposal and other handling
Ancotil for Infusion is available to hospitals only.
Marketing authorization holder
Mylan Products Ltd., Station Close, Potters Bar, Hertfordshire, EN6 1TL, United Kingdom
Marketing authorization number(s)
PL 46302/0116
Date of first authorization / renewal of the authorization
27 February 2009
Date of revision of the text
April 2019
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