Država: Nova Zelandija
Jezik: angleščina
Source: Medsafe (Medicines Safety Authority)
Clotrimazole 500mg (micronised)
Bayer New Zealand Limited
Clotrimazole 500 mg (micronised)
500 mg
Pessary
Active: Clotrimazole 500mg (micronised) Excipient: Gelatin Glycerol Liquid paraffin Purified water Quinoline yellow Sunset yellow FCF Titanium dioxide White soft paraffin
Blister pack, PVC/PVdC/PVC blister with aluminium foil lid with heat sealing lacquer, 1 pessary
Restricted
Restricted
Bayer Hispania SL
Canesten Clotrimazole Thrush Treatment Once and 6 Day vaginal pessaries are indicated for the topical treatment of vaginal candidiasis.
Package - Contents - Shelf Life: Blister pack, PVC/PVdC/PVC blister with aluminium foil lid with heat sealing lacquer - 1 pessaries - 36 months from date of manufacture stored at or below 30°C
2011-02-10
_ _ _Canesten Data Sheet _ _4 April 2022_ NEW ZEALAND DATA SHEET Page 1 of 9 RESTRICTED CANESTEN ® CANESTEN CLOTRIMAZOLE THRUSH 6 DAY CREAM, INTERNAL VAGINAL CREAM 10 MG/G (1%) CANESTEN CLOTRIMAZOLE THRUSH 3 DAY CREAM, INTERNAL VAGINAL CREAM 20 MG/G (2%) CANESTEN CLOTRIMAZOLE THRUSH 1 DAY CREAM, INTERNAL VAGINAL CREAM 100 MG/G (10%) CANESTEN CLOTRIMAZOLE THRUSH 6 DAY PESSARY, VAGINAL PESSARY 100 MG CANESTEN CLOTRIMAZOLE THRUSH 1 DAY PESSARY, VAGINAL PESSARY 500 MG CANESTEN CLOTRIMAZOLE THRUSH 1 DAY PESSARY & CREAM, VAGINAL PESSARY 500 MG + TOPICAL CREAM 10 MG/G (1%) 1. NAME OF THE MEDICINAL PRODUCT Clotrimazole 1-(o-chloro- α, α - diphenylbenzyl) imidazole C 22 H 17 ClN 2 Molecular Weight 344.84 Clotrimazole is a colourless, crystalline, weakly alkaline substance, melting point 141°- 145°C, soluble in acetone, chloroform and ethanol and practically insoluble in water. It forms stable salts with both organic and inorganic acids. It is not photosensitive but is slightly hygroscopic, and may be hydrolysed in acid media. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION QUALITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT All formulations: clotrimazole _Canesten Data Sheet _ _4 April 2022_ Page 2 of 9 RESTRICTED QUANTITATIVE COMPOSITION IN TERMS OF THE ACTIVE INGREDIENT Canesten Clotrimazole Thrush 6 Day Cream contains 10 mg/g (1% w/w) of clotrimazole in a vanishing cream base. Canesten Clotrimazole Thrush 3 Day Cream contains 20 mg/g (2% w/w) of clotrimazole in a vanishing cream base. Canesten Clotrimazole Thrush 1 Day Cream contains 100 mg/g (10% w/w) of clotrimazole in a vanishing cream base Canesten Clotrimazole Thrush 6 Day Pessary contains 100 mg of clotrimazole in each pessary. Canesten Clotrimazole Thrush 1 Day Pessary contains 500 mg of clotrimazole in each pessary. Canesten Clotrimazole Thrush 1 Day Pessary & Cream contains 500 mg of clotrimazole in each pessary and 10 mg/g clotrimazole in the cream. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM CANESTEN CLOTRIMAZOLE THRUSH 6 DA Preberite celoten dokument