Negara: Irlandia
Bahasa: Inggris
Sumber: HPRA (Health Products Regulatory Authority)
FLUCYTOSINE
Meda Health Sales Ireland Limited
J02AX01
FLUCYTOSINE
2.5/250
Solution for Infusion
Product subject to prescription which may not be renewed (A)
Other antimycotics for systemic use
Authorised
2009-04-24
Patient Information Leaflet ANCOTIL 2.5G/250ML (1G IN 100 ML) SOLUTION FOR INFUSION Flucytosine READ ALL OF THIS LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE BECAUSE IT CONTAINS IMPORTANT INFORMATION FOR US. Keep this leaflet. You may need to read it again. This leaflet tells you about Ancotil. It does not contain all the information about Ancotil. If you have any questions or are unsure of anything ask the doctor or nurse. This medicine has been prescribed for you only. Do not pass it on to others. It may harm them , even if their signs of illness are the same as yours. If you experience any side effect and this becomes serious, tell your doctor or pharmacist. WHAT IS IN THIS LEAFLET: 1. What Ancotil is and what it is used for 2. What you need to know before you are given Ancotil 3. How Ancotil is given 4. Possible side effects 5. How to store Ancotil 6. Contents of the pack and further information 1. WHAT ANCOTIL IS AND WHAT IT IS USED FOR Ancotil Solution for Infusion contains an anti-fungal agent. It is used to treat certain yeast and fungal infections. 2. WHAT YOU NEED TO KNOW BEFORE YOU ARE GIVEN ANCOTIL SOLUTION FOR INFUSION YOU SHOULD NOT BE GIVEN ANCOTIL If you are allergic (hypersensitive) to flucytosine or any of the other ingredients of Ancotil (these are listed in section 6, ‘’Further Information’’). If you are breast-feeding. If you are using any medicine known as an antiviral nucleoside (e.g. brivudine, sorivudine, ganciclovir, valganciclovir). These medicines are usually used to treat chickenpox and shingles. WARNINGS AND PRECAUTIONS Tell your doctor before you start treatment If you have a liver, kidney or blood problem. Your doct Baca dokumen lengkapnya
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ancotil 2.5g/250ml Solution for Infusion 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each infusion bottle contains 2.5 g in 250 ml (1 g in 100 ml) of flucytosine. Each bottle also contains 790mg (34mmol) sodium equivalent to 316mg (14mmol) in 100ml. For a full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Solution for infusion A clear, colourless to slightly yellow sterile aqueous solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Ancotil is indicated for the treatment of systemic yeast and fungal infections due to sensitive organisms: such infections include Cryptococcus, Candidiasis, Chromomycosis and infections due to _Torulopsis glabrata _and _Hansenula_. In the treatment of cryptococcal meningitis and severe systemic candidiasis it is recommended that Ancotil should be given in combination with amphotericin-B. Amphotericin-B may also be given in combination with Ancotil in severe or long-standing infections due to other organisms. In cases of cryptococcal meningitis, where toxicity of amphotericin B, or a combination of flucytosine with amphotericin B is dose limiting, a combination of flucytosine with fluconazole has demonstrated successful cure, but at a lower rate than in combination with amphotericin B. 4.2 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 recommended daily dosage in adults and children is 200mg/kg body-weight divided into four doses over the 24 hours. In patients harbouring extremely sensitive organisms a total daily dose of 100 to 150mg/kg body-weight may be sufficient. Adequa Baca dokumen lengkapnya