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SPC, UK: Ancotil 2.5 g/250 ml Solution for Infusion (2014)

Αναφορές

Βιβλιογραφική αναφορά

Στοιχεία εκδότη

Εκδότης :
Meda Pharmaceuticals Ltd.
Διεύθυνση :
Skyway House, Parsonage Road, Takeley, Bishop's Stortford, CM22 6PU, United Kingdom
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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 and Children 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 ...

Contraindications

Ancotil is contra-indicated: in patients who have shown hypersensitivity to flucytosine or any of the excipients. Co-administration with antiviral nucleoside drugs (e.g. brivudine, sorivudine and their ...

Special warnings and precautions for use

The product should be used with great caution in patients with depression of bone marrow function or blood dyscrasias. Blood counts and tests of renal and hepatic function should be performed before and ...

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 ...

Pregnancy and lactation

Teratogenic effects have been seen in rats, in which species flucytosine is metabolised to fluorouracil. The metabolism may differ in man: nevertheless, the use of Ancotil in pregnancy and in women of ...

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 ...

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 ...

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. Bottles are in packs of 5.

Special precautions for disposal and other handling

Ancotil for Infusion is available to hospitals only.

Marketing authorization holder

Meda Pharmaceuticals Ltd. Skyway House Parsonage Road Takeley Bishops Stortford CM22 6PU United Kingdom

Marketing authorization number(s)

PL 15142/0002

Date of first authorization / renewal of the authorization

27 February 2009

Date of revision of the text

21/01/2014