Страна: Нова Зеландия
Език: английски
Източник: Medsafe (Medicines Safety Authority)
Ciclopirox olamine 1%{relative}
sanofi-aventis new zealand limited
Ciclopirox olamine 1% w/w
1% w/w
Topical cream
Active: Ciclopirox olamine 1%{relative}
Tube, 1x20g, 20 g
Pharmacy only
Pharmacy only
Sanofi-Aventis Deutschland GmbH
Package - Contents - Shelf Life: Tube, 1x20g - 20 g - 24 months from date of manufacture stored at or below 30°C
1985-09-12
BATRAFEN CMI CRE & SOL #78119v2.0 Page 1 Batrafen ® Cream and Solution (bat-rar-fen) _CICLOPIROX _ _(SICK-LOW-PIR-ROCKS)_ _ _ CONSUMER MEDICINE INFORMATION (CMI) WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Batrafen. 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 or pharmacist has weighed the risks of you using it 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 BATRAFEN IS USED FOR Batrafen contains ciclopirox, which is an antifungal agent. Batrafen is used to treat fungal infections of the skin. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHY IT HAS BEEN RECOMMENDED FOR YOU. BEFORE YOU USE IT _WHEN YOU MUST NOT USE IT _ DO NOT USE BATRAFEN IF YOU ARE ALLERGIC TO IT OR ANY OF THE INGREDIENTS LISTED AT THE END OF THIS LEAFLET. Some symptoms of an allergic reaction include skin rash, itching, shortness of breath or swelling of the face, lips or tongue, which may cause difficulty in swallowing or breathing. DO NOT GIVE BATRAFEN TO A CHILD. DO NOT USE IT IF YOU ARE PREGNANT OR INTEND TO BECOME PREGNANT. It may affect your developing baby if you use it during pregnancy. DO NOT USE IT IF YOU ARE BREAST- FEEDING OR PLANNING TO BREAST-FEED. Batrafen may pass into breast milk and there is a possibility your baby may be affected. DO NOT USE BATRAFEN CREAM WITH LATEX CONDOMS. It contains a paraffin which can cause leaking or breaking of latex condoms and therefore lose the protection provided by condoms. DO NOT USE IT AFTER THE EXPIRY DA Прочетете целия документ
_Batrafen DS CRE & SOL_ _ _ _#78117v2.0 Page _ _1 _ _ _ DATA SHEET BATRAFEN CREAM AND SOLUTION NAME OF MEDICINE Ciclopirox olamine 1% cream and 1% w/v solution. PRESENTATION Batrafen Cream is a nearly white cream and each gram contains 10mg ciclopirox olamine in an oil- in-water emulsion consisting of 2-octyldodecanol, mineral oil, stearyl alcohol, cetyl alcohol, polysorbate 60, myristyl alcohol, cocamide DEA, sorbitan monostearate, lactic acid, purified water and benzyl alcohol (1%). Batrafen Solution is a clear solution and each ml contains 10mg ciclopirox olamine dissolved in alcoholic aqueous solution. USES ACTIONS Ciclopirox olamine is a broad spectrum antimycotic with a high penetrating power. It has a fungicidal effect on dermatophytes, yeasts, moulds and other fungi. PHARMACOKINETICS Penetration studies in human cadaverous skin from the back, with Batrafen Cream 1% tagged with ciclopirox olamine, showed the presence of 0.8 to 1.6% of the dose in stratum corneum, 1.5 to 6 hours after application. The levels in the dermis were still 10 to 15 times above the minimum inhibitory concentrations. Three grams of the 1% solution were applied topically to an area of about 750 square centimetres on the back of male subjects for 6 hours. During this time the serum concentration rose to 0.008 ± 0.005 μg/mL. Three to 6 hours after removal of the solution, the concentrations had already fallen below the detection limit of 0.003 μg/mL. Of the radioactivity applied, 1.1 ± 0.6% was eliminated in the urine and <0.1% in the faeces; the elimination half life was 3.5 ± 1.1 H on the first day. Excretion was complete on the second and third day. The absorption which can be regarded as equal with the portion of 1.1 ± 0.6% eliminated in the urine, practically ended when the active substance was removed from the skin. INDICATIONS Batraf Прочетете целия документ