País: Nova Zelanda
Idioma: anglès
Font: Medsafe (Medicines Safety Authority)
Ciclopirox 8%
sanofi-aventis new zealand limited
Ciclopirox 8%
8 %
Nail lacquer
Active: Ciclopirox 8% Excipient: Butyl ester of PVM/MA copolymer Ethyl acetate Isopropyl alcohol Nitrogen
Bottle, glass, 1x1.5g, 1.5 g
Pharmacy only
Pharmacy only
Sanofi-Aventis Deutschland GmbH
Package - Contents - Shelf Life: Bottle, glass, 1x1.5g - 1.5 g - 24 months from date of manufacture stored at or below 25°C protect from light 6 months opened stored at or below 25°C protect from light - Bottle, glass, 1x3g - 3 g - 36 months from date of manufacture stored at or below 25°C protect from light 6 months opened stored at or below 25°C protect from light
1993-04-22
BATRAFEN CMI LAQ NZ #17673v6.0 Page 1 Batrafen ® Nail Lacquer (bat-rar-fen) _CICLOPIROX _ _(SICK-LOW-PIR-ROCKS)_ _ _ CONSUMER MEDICINE INFORMATION (CMI) BATRAFEN CMI LAQ #17673v6.0 Page 2 _ _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Batrafen Nail Lacquer. 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 NAIL LACQUER IS USED FOR Batrafen Nail Lacquer is a nail lacquer that is painted onto the fingernails or toenails. Batrafen Nail Lacquer contains ciclopirox, which is an antifungal agent. Batrafen Nail Lacquer is used to treat fungal infections of the fingernails and toenails. Fungal nail infections are hard to treat and a full cure depends on several factors, including how badly damaged the nail is. While Batrafen Nail Lacquer can cure the fungal infection, it cannot repair the damage and so a full cure can be expected in less than one in three people. 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 NAIL LACQUER 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 NAIL LACQUER TO A CHILD OR ADOLES Llegiu el document complet
_Batrafen DS LAQ_ _ _ _#78118v1.0 Page _ _1 _ _ _ DATA SHEET BATRAFEN NAIL LACQUER NAME OF MEDICINE Ciclopirox 8% Nail Lacquer PRESENTATION Batrafen Nail Lacquer contains 80mg/g (8%) of the active ingredient ciclopirox. Ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2-(1H) pyridone (C 12 H 17 NO 2 ). MW: 207.3. The chemical structure is shown below: CAS 29342-05-0 Ciclopirox is a white to slightly yellowish-white, crystalline powder which is odourless to almost odourless. It is freely soluble in dichloromethane and ethanol 96%, very soluble in chloroform, soluble in ether and slightly soluble in water. The pKa value is 7.2. The lacquer is composed of butyl ester of PVM/MA copolymer, ethyl acetate and propyl alcohol. The excipients ethyl acetate and propyl alcohol are solvents that vaporise after application. Batrafen Nail Lacquer is a clear, slightly yellow solution. USES ACTIONS Ciclopirox is a broad spectrum antimycotic with a high penetrating power. It has a fungicidal effect on dermatophytes, yeasts, moulds and other fungi. Ciclopirox is the free acid of ciclopiroxolamine. Ciclopirox has an identical spectrum of activity to ciclopiroxolamine. Ciclopirox is a hydroxypyridone derivative that is structurally unrelated to the imidazole derivatives or other antifungals. Ciclopirox has several mechanisms of action including chelation of polyvalent metal cations (e.g. Fe 3+ and Al 3+ ). It thus inhibits the metal-dependent enzymes, including those responsible for the degradation of peroxides within fungal cells. Batrafen Nail Lacquer has been developed for the treatment of fungal infections of the nails. The active ingredient ciclopirox penetrates the nail plate and reaches the fungal pathogen within 48 hours of application. PHARMACOKINETICS Glucuronidation is the main metabolic pathway for ciclopirox, which is excreted Llegiu el document complet