מדינה: ניו זילנד
שפה: אנגלית
מקור: Medsafe (Medicines Safety Authority)
Clotrimazole 10 mg/g; Hydrocortisone acetate 11.2 mg/g equivalent to 10 mg/g hydrocortisone;
Bayer New Zealand Limited
Clotrimazole 10 mg/g
Topical cream
Active: Clotrimazole 10 mg/g Hydrocortisone acetate 11.2 mg/g equivalent to 10 mg/g hydrocortisone Excipient: Benzyl alcohol Cetostearyl alcohol Hydrochloric acid Tricetereth-4-phosphate Medium-chain triglycerides Purified water Sodium hydroxide
Restricted
Bayer Hispania SL
For dermatophyte and yeast infections of the skin when inflammation is prominent. This includes conditions such as fungal infected dermatitis, intertrigo and Candida nappy rash.
Package - Contents - Shelf Life: Tube, aluminium, with inner lacquer & tube sealing. PE cap - 15 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, with inner lacquer & tube sealing. PE cap - 20 g - 36 months from date of manufacture stored at or below 25°C - Tube, aluminium, with inner lacquer & tube sealing. PE cap - 30 g - 36 months from date of manufacture stored at or below 25°C
2016-05-26
_Canesten Extra CMI _ _31 October 2017_ Consumer Medicine Information 1 CANESTEN ® EXTRA TOPICAL CREAM – CLOTRIMAZOLE 10 MG/G & HYDROCORTISONE 10 MG/G WHAT IS IN THIS LEAFLET This leaflet answers some common questions about CANESTEN EXTRA Clotrimazole and Hydrocortisone Cream. 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 EXTRA cream against the benefits they expect it will have for you. If you have any concerns about this medicine, ask your doctor or pharmacist. KEEP THIS LEAFLET WITH YOUR MEDICINE. You may need to read it again. WHAT IS CANESTEN EXTRA CREAM USED FOR? CANESTEN EXTRA cream is used on the skin to treat and soothe inflamed fungal skin conditions such as: Tinea pedis (athlete’s foot) External symptoms of thrush Jock itch Fungally infected nappy rash Ringworm Fungal skin rash Fungally infected eczema or dermatitis. CANESTEN EXTRA cream is a broad spectrum anti-fungal and anti-inflammatory cream. It contains two active ingredients; clotrimazole and hydrocortisone (as acetate). Clotrimazole belongs to a group of medicines called imidazole antifungals which are used to treat fungal skin infections. Hydrocortisone is a mild steroid which reduces the swelling, redness and itching associated with inflammation of the skin. _Canesten Extra CMI _ _31 October 2017_ Consumer Medicine Information 2 For conditions without inflammation use an antifungal agent without hydrocortisone, such as Canesten clotrimazole antifungal cream. This product should only be used in children under 2 years of age (for example, fungal nappy rash) if a doctor has told you to. ASK YOUR DOCTOR OR PHARMACIST IF YOU HAVE ANY QUESTIONS ABOUT WHETHER THIS MEDICINE IS SUITABLE FOR YOU. CANESTEN EXTRA is a Pharmacist Only Medicine. This medicine is available without a doctor’s prescription, only through your pharmacist. BEFORE USING CANEST קרא את המסמך השלם
_Canesten Extra Data Sheet _ _28 October 2021 _ NEW ZEALAND DATA SHEET Page 1 of 7 1. PRODUCT NAME CANESTEN ® EXTRA TOPICAL CREAM CLOTRIMAZOLE 10 MG/G, HYDROCORTISONE ACETATE 11.2 MG/G 2. QUALITATIVE AND QUANTITATIVE COMPOSITION CANESTEN EXTRA Antifungal Anti-Inflammatory Cream contains 10 mg/g of clotrimazole and 11.2 mg/g of hydrocortisone acetate (equivalent to 10 mg/g hydrocortisone) as active ingredients. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Cream – topical. A white to slightly yellowish cream. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS CANESTEN EXTRA cream is indicated for dermatophyte and yeast infections of the skin when inflammation is prominent. This includes conditions such as fungal infected dermatitis, intertrigo and Candida nappy rash. 4.2 DOSE AND METHOD OF ADMINISTRATION A small amount of CANESTEN EXTRA cream should be applied thinly and evenly with gentle rubbing to the affected area(s) twice daily. Use only until inflammation, itching and redness have subsided, and not for more than 7 days (unless directed by the doctor). Then use an antifungal-only cream such as CANESTEN Clotrimazole Anti-fungal Cream for 14 days after symptoms disappear to avoid recurrence of the infection. _PAEDIATRIC POPULATION _ The risk of systemic absorption, and hence systemic toxicity, is greater in children due to the higher permeation properties of the skin and a larger skin surface to body weight ratio than adults. Do not use on children under 2 years of age except on the advice of a doctor. 4.3 CONTRAINDICATIONS CANESTEN EXTRA cream is contraindicated in the following cases: • hypersensitivity to the active substances or to any of the excipients listed in section 6.1 • use on broken skin • diseases affecting the skin (such as acne, rosacea, perioral dermatitis, lues, tuberculosis, etc.) • in or near the eyes • viral skin diseases (e.g. herpes simplex, chicken pox, etc.) Page 2 of 7 • dermal vaccination reactions 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Be קרא את המסמך השלם