Šalis: Australija
kalba: anglų
Šaltinis: Department of Health (Therapeutic Goods Administration)
flucytosine, Quantity: 10 mg/mL
iNova Pharmaceuticals (Australia) Pty Ltd
Injection, solution
Excipient Ingredients: sodium chloride; hydrochloric acid; trometamol; water for injections
Intravenous
250mL x 5
(S4) Prescription Only Medicine
INDICATIONS AS AT 15 MARCH 1996: Antocil is indicated in the treatment of generalised candidiasis, cryptococcosis and chromoblastomycosis.
Visual Identification: Clear, colourless liquid; Container Type: Bottle; Container Material: Glass; Container Life Time: 18 Months; Container Temperature: Store below 25 degrees Celsius
Registered
1991-08-23
ANCOTIL ® INJECTION _Flucytosine 1%_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Ancotil. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you using Ancotil against the benefits they expect it will have for you. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT ANCOTIL IS USED FOR This medicine is used to treat: • fungal or yeast infections in your body, which are also known as candidiasis, cryptococcosis or chromoblastomycosis. ASK YOUR DOCTOR IF YOU HAVE ANY QUESTIONS ABOUT WHY ANCOTIL HAS BEEN PRESCRIBED FOR YOU. Your doctor may have prescribed Ancotil for another purpose. Ancotil is not addictive. Ancotil is available only with a doctor's prescription. BEFORE YOU HAVE ANCOTIL _WHEN YOU MUST NOT HAVE IT_ DO NOT HAVE ANCOTIL IF YOU HAVE AN ALLERGY TO: • any medicine containing flucytosine • any of the ingredients listed at the end of this leaflet. Some of the symptoms of an allergic reaction may include skin rash, itching or hives. DO NOT HAVE ANCOTIL IF YOU KNOW THAT YOU DO NOT HAVE ANY ACTIVITY OF THE ENZYME DIHYDROPYRIMIDINE DEHYDROGENASE (DPD) (COMPLETE DPD DEFICIENCY). DO NOT HAVE THIS MEDICINE IF YOU ARE PREGNANT. It may affect your developing baby if you take it during pregnancy. DO NOT BREAST-FEED IF YOU ARE HAVING THIS MEDICINE. It is not known if the active ingredient in Ancotil passes into breast milk and there is a possibility that your baby may be affected. DO NOT HAVE ANCOTIL AFTER THE EXPIRY DATE (EXP) PRINTED ON THE PACK OR IF THE PACKAGING IS TORN OR SHOWS SIGNS OF TAMPERING. If it has expired or is damaged, your pharmacist will dispose of it for you. _BEFORE YOU START TO HAVE IT_ TELL YOUR DOCTOR IF YOU HAVE ALLERGIES TO ANY OTHER MEDICINES, FOODS, PRESERVATIVES OR DYES. TELL YOUR Perskaitykite visą dokumentą
1 AUSTRALIAN PRODUCT INFORMATION – ANCOTIL (FLUCYTOSINE) INJECTION 1 NAME OF THE MEDICINE Flucytosine 2 QUALITATIVE AND QUANTITATIVE COMPOSITION The active ingredient of Ancotil is 5-flucytosine (5-FC), a fluorinated pyrimidine. Ancotil is available as an isotonic infusion solution (1%) containing 0.805% sodium chloride. Ancotil also contains the excipients hydrochloric acid, trometamol and water for injections. 3 PHARMACEUTICAL FORM Ancotil is a clear, colourless liquid. It is a 2.5 g/250 mL (1% w/v) injection administered intravenously. 4 CLINICAL PARTICULARS 4.1 T HERAPEUTIC INDICATIONS Ancotil is indicated in the treatment of generalised candidiasis, cryptococcosis and chromoblastomycosis. 4.2 D OSE AND METHOD OF ADMINISTRATION Intravenous administration of Ancotil using the infusion solution (37.5 – 50 mg per kg) is given as infusions of short duration (20 to 40 minutes). In patients whose renal function is normal, this dose is repeated at six hourly intervals. Special Dosage Instructions: In patients with impaired renal function the interval between individual doses should be increased as follows: Creatinine Clearance Interval between single doses of 50 mg per kg bodyweight (maximum dose) >40 mL per minute 6 hours 40 – 20 mL per minute 12 hours 20 – 10 mL per minute 24 hours <10 mL per minute Determination of serum concentration of 5-FC 12 hours after the initial dose. Further doses are given as required in order to maintain serum concentration of between 25 and 50 micrograms/mL. (A method of determining 5-FC in biological fluids is described by Schoenebeck 3 .) 2 Ancotil can be efficiently eliminated by both haemodialysis and peritoneal dialysis. With both methods, clearance is approximately as good as that of creatinine (see section 5.2 Pharmacokinetic Properties – Excretion). 4.3 C ONTRAINDICATIONS Ancotil should not be administered to patients with: • known hypersensitivity to the medicine or any of the excipients • known complete dihydropyrimidine dehydrogenase (DPD) deficiency (see secti Perskaitykite visą dokumentą