Land: Ierland
Taal: Engels
Bron: HPRA (Health Products Regulatory Authority)
ECONAZOLE NITRATE
Bristol-Myers Squibb Pharmaceuticals Ltd
150 Milligram
Pessary
1978-01-30
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Ecostatin Pessaries 150 mg 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each pessary contains Econazole nitrate 150 mg. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Pessary Cream-white to yellowish opaque, oval pessary with a fat-like odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Vulvovaginal candidosis. 4.2 POSOLOGY AND METHOD OF ADMINSTRATION Adults: One pessary to be inserted at bedtime for three consecutive nights. Administration should be continued even if menstruation occurs, and despite the disappearance of signs and symptoms of the infection. The pessary should be inserted high into the vagina while the patient is supine. Although a three-day course of therapy usually suffices, it may be necessary to institute a second course of therapy. Children and infants: Vulvo-vaginal candidosis is not normally a problem in children, therefore there are no specific dosage recommendation. Elderly: No specific dosage recommendations or precautions apply. 4.3 CONTRAINDICATIONS Patients with a history of sensitivity to any of the components of the preparation. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE This preparation is not for oral use. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 16/06/2006_ _CRN 2024319_ _page number: 1_ It is important to ensure the concurrent treatment of partners. Avoid contact between the pessary and contraceptive diaphragms and condoms since the rubber may be damaged by the preparation. 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION None, except see 4.4 above. 4.6 PREGNANCY AND LACTATION There is no evidence of a teratogenic effect in animals. Systemic absorption Lees het volledige document