Země: Malajsie
Jazyk: angličtina
Zdroj: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
BIFONAZOLE
BAYER CO. (MALAYSIA) SDN. BHD.
BIFONAZOLE
15 gm
GP GRENZACH PRODUKTIONS GMBH
1 CANESPRO ONCE DAILY BIFONAZOLE ANTI-FUNGAL CREAM 1% W/W Bifonazole 1% CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) WHAT IS IN THIS LEAFLET 1. What Canespro Once Daily Bifonazole Anti-fungal Cream is used for 2. How Canespro Once Daily Bifonazole Anti-fungal Creamworks 3. Before you use Canespro Once Daily Bifonazole Anti-fungal Cream 4. How to use Canespro Once Daily Bifonazole Anti-fungal Cream 5. While you are using it 6. Side effects 7. Storage and Disposal of Canespro Once Daily Bifonazole Anti-fungal Cream 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of revision WHAT CANESPRO ONCE DAILY BIFONAZOLE ANTI-FUNGAL CREAM IS USED FOR Canespro Once Daily Bifonazole Anti- fungal Cream is used to treat athlete’s foot, fungal infection of the hand, ringworks, jock itch, white spots, erythrasma (skin redness) & fungal infection of the skin. HOW CANESPRO ONCE DAILY BIFONAZOLE ANTI-FUNGAL CREAM WORKS The active substance in Canespro Once Daily Bifonazole Anti-fungal Cream is bifonazole. Bifonazole belongs to a group of medicines called imidazoles. The primary mechanism of action of bifonazole is against the division and growing of fungi , on two different levels, thereby distinguishing bifonazole both from other azole derivatives and from other anti-fungals which act only on a single level. Bifonazole alters the permeability of the fungal cell wall and inhibits the activity of enzymes within the cell. It specifically inhibits the biosynthesis of ergosterol required for cell membrane production. BEFORE YOU USE CANE SPRO ONCE DAILY BIFONAZOLE ANTI-FUNGAL CREAM _When you must not use it_ If you are allergic (hypersensitive) to bifonazole or any of the other ingredients of . If you have ever had an allergic reaction to any antifungal product. Patients on warfarin therapy should be monitored when bifonazole is used concomitantly. Some of the excipients may reduce the effectiveness of latex products such as condoms and diaphragms when applied to genital area. The effect is temporary and Přečtěte si celý dokument
Once Daily Bifonazole Anti-Fungal cream 1%w/w For external use only Canespro PRODUCT INSERT FOR MALAYSIA MARKET ACTIVE INGREDIENTS Canespro ® Once Daily Bifonazole Anti-Fungal Cream 1%w/w contains: Bifonazole 1% PRODUCT DESCRIPTION White & soft cream. PHARMACODYNAMIC Pharmacotherapeutic group: Anti-fungals for dermatological use -Bifonazole ATC Code: DD1AC10 MODE OF ACTION Bifonazole is an imidazole derivative with a broad antimycotic spectrum, which includes dermatophytes, yeasts, moulds and other fungi such as _Malassezia furfur_. It is also effective against _Corynebacterium minutissimum_. Bifonazole exerts its anti-fungal action by inhibiting the biosynthesis of ergosterol on two different levels, thereby distinguishing bifonazole both from other azole derivatives and from other anti-fungals which act only on a single level. Inhibition of ergosterol synthesis leads to structural and functional impairment of the cytoplasmic membrane. The resistance situation for bifonazole is favorable. Primary resistant variants of sensitive fungal species are very rare. Investigations so far did not provide any evidence of a development of secondary resistance in primarily sensitive strains. PHARMACOKINETIC Absorption Bifonazole penetrates well into infected skin layers. 6 hours after administration concentrations in the various skin layers reach from 1000 µg/cm 3 in the top layer of the epidermis (stratum corneum) to 5 µg/cm 3 in the stratum papillare. All concentrations determined are thus within a range of reliable antimycotic activity. INDICATIONS • Treatment of skin mycoses caused by dermatophytes, yeasts, moulds, and other fungi (e.g. athlete’s foot, fungal infection of the hand, ringworms, jock itch, white spots, superficial fungal skin infections & other tinea conditions). • Treatment of erythrasma (skin redness). DOSAGE & APPLICATION Posology To achieve a lasting cure, treatment with bifonazole must be carried out reliably and over an adequate period. The usual periods of treatment are summarized in the tab Přečtěte si celý dokument