Țară: Israel
Limbă: engleză
Sursă: Ministry of Health
BIFONAZOLE; FLUOCINONIDE
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
D01AC10
CREAM
FLUOCINONIDE 0.05 W/W; BIFONAZOLE 1.00 W/W
DERMAL
Required
PADAGIS ISRAEL PHARMACEUTICALS LTD, ISRAEL
BIFONAZOLE
BIFONAZOLE
Broad-spectrum drug for relief of inflammatory conditions accompanied by fungal infection, which respond to corticoid therapy.
2014-02-28
PATIENT PACKAGE INSERT IN ACCORDANCE WITH THE PHARMACISTS’ REGULATIONS )PREPARATIONS( – 1986 The medicine is dispensed with a doctor’s prescription only. Comagis Cream Each 100 grams of Comagis Cream contains: 1 gram bifonazole 0.05 grams fluocinonide Inactive and allergenic ingredients in t h e m e d i c i n e – s e e s e c t i o n 2 “ I m p o r t a n t information about some of the ingredients o f t h e medicine” and section 6 “Further information”. Read the leaflet carefully in its entirety before using the medicine. This leaflet contains concise information about the medicine. If you have further questions, refer to the doctor or pharmacist. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar. 1. WHAT IS THE MEDICINE INTENDED FOR? Comagis Cream relieves conditions of i n f l a m m a t i o n a c c o m p a n i e d by f u n g a l infection that respond to corticoid therapy. Therapeutic group: Anti-inflammatory + antifungal. 2. BEFORE USING THE MEDICINE Do not use the medicine: • If you are sensitive )allergic( to the active ingredients or any of the additional ingredients contained in the medicine )see section 6(. • To treat diaper rash. If your infant has diaper rash, refer to the doctor to receive appropriate treatment. • To treat nail or scalp infections. • To treat vaginal infections. • Do not use the medicine on large areas of the body or for a long time. Special warnings regarding use of the medicine • Do not allow the medicine to come in contact with the eyes. • Do not bandage, cover or wrap the treated area in a manner that will create an occlusive dressing, unless directed to do so by a doctor. Before treatment with Comagis Cream, tell the doctor if • you have ever experienced an allergic reaction to any antifungal substance. Drug interactions If you are taking, or have recently taken, other medicines, including non- prescription medicines and nutritional supplements, tel Citiți documentul complet
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Comagis Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Active Ingredients: For 100gram cream: Fluocinonide 0.05g and Bifonazole 1.00g Excipient with known effect: Cetostearyl Alcohol and Benzyl Alcohol. For excipients see section 6.1. 3 PHARMACEUTICAL FORM Cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Broad-spectrum drug for relief of inflammatory conditions accompanied by fungal infection, which respond to corticoid therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Adults A small amount of the cream should be applied to the affected skin area once daily (preferably before retiring), using a gentle, but thorough massage. Children Administration of topical corticosteroids to pediatric patients should be limited to the least amount compatible with an effective therapeutic regimen. Chronic corticosteroid therapy may interfere with the growth and development of pediatric patients. 4.3 CONTRAINDICATIONS • Hypersensitivity to the active substance(s) or to any of the excipients listed in section 6.1 • Treatment of infants with nappy rash. • Treatment of nail and scalp infections. • Treatment of vaginal infections. • Application to large areas of the body or for prolonged periods must be avoided. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This product contains cetostearyl alcohol which may cause local skin reactions (e.g. contact dermatitis). This product contains Benzyl alcohol which may cause allergic reactions and mild local irritation. Patients with a history of hypersensitivity reactions to other imidazole antifungal agents (e.g. econazole, clotrimazole, miconazole) must take bifonazole containing products with caution. – – 2 Systemic absorption of topical corticosteroids has produced reversible hypothalamic- pituitary-adrenal (HPA) axis suppression, manifestations of Cushing's syndrome, hyperglycemia, and glucosuria in some patients. Conditions which augment systemic absorption include the application of the more poten Citiți documentul complet