Země: Nový Zéland
Jazyk: angličtina
Zdroj: Medsafe (Medicines Safety Authority)
Clotrimazole 100mg (Micronised)
Bayer New Zealand Limited
Clotrimazole 100 mg (Micronised)
100 mg
Pessary
Active: Clotrimazole 100mg (Micronised) Excipient: Calcium lactate, hydrate Colloidal silicon dioxide Crospovidone Hypromellose Lactic acid Lactose monohydrate Magnesium stearate Maize starch Microcrystalline cellulose
Blister pack, PA/Al/PVC, 6 pessaries
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, PA/Al/PVC - 6 pessaries - 36 months from date of manufacture stored at or below 30°C
1975-03-06
_Canesten 6 Day Pessary _ _CMI _ _8 September 2017_ Consumer Medicine Information 1 CANESTEN CLOTRIMAZOLE THRUSH 6 DAY PESSARY CLOTRIMAZOLE VAGINAL PESSARIES 100 MG WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Canesten ® Clotrimazole Thrush 6 Day Pessary. 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 pharmacist has weighed the risks of you using Canesten ® Clotrimazole Thrush 6 Day Pessary against the benefits they expect it will have for you. If you have any concerns about using this treatment, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT CANESTEN ® CLOTRIMAZOLE THRUSH 6 DAY PESSARY IS USED FOR Canesten ® Clotrimazole Thrush 6 Day Pessary is used to treat a fungal infection in the vagina and vulval area (thrush). This medicine belongs to a group of medicines called azole antifungals. _WHAT IS VAGINAL THRUSH? _ _Candida albicans_ is a yeast fungus that can multiply rapidly and cause symptoms in the vagina when other micro-organisms aren’t present in a normal balance. Some situations which can increase susceptibility to thrush are: diabetes obesity illness fatigue hormonal fluctuations (pregnancy, menstrual cycle, oral contraceptive pill, HRT [hormone replacement therapy]) prolonged use of antibiotics or steroids Thrush may cause the following symptoms: _Canesten 6 Day Pessary _ _CMI _ _8 September 2017_ Consumer Medicine Information 2 vaginal itching vaginal soreness a white odourless discharge from the vagina (like cottage cheese) pain during intercourse The symptoms below are NOT usually signs of thrush: abnormal or irregular vaginal bleeding blood stained discharge vulva or vaginal sores, ulcers or blisters lower abdominal pain pain when passing urine fever or chills foul smelling and/or unusual coloured discharge See your doctor if Přečtěte si celý dokument
_ _ _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 Přečtěte si celý dokument