Երկիր: Իռլանդիա
Լեզու: անգլերեն
Աղբյուրը: HPRA (Health Products Regulatory Authority)
SULFATHIAZOLE SULFACETAMIDE SULFABENZAMIDE
Janssen-Cilag Ltd
SULFATHIAZOLE SULFACETAMIDE SULFABENZAMIDE
3.42/2.86/3.7 %v/v
Cream
Withdrawn
2007-04-01
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Sultrin Triple Sulfa Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION For excipients, see 6.1. 3 PHARMACEUTICAL FORM Vaginal cream A smooth white to off-white cream with a characteristic fatty odour. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS In the treatment of infections caused by _H. vaginalis _and non-specific bacterial vaginitis and cervicitis. As prophylaxis against post-operative and post-partum local bacterial infections of perineum, vagina and cervix. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravaginal administration. Adults only: One applicatorful inserted twice daily for ten days. If necessary, use may be continued thereafter on a once daily basis. Safety of use in children has not been established. 4.3 CONTRAINDICATIONS Sulphonamide sensitivity. Kidney disease. Known hypersensitivity to peanuts. Throughout pregnancy and during the nursing period because sulphonamides cross the placenta, are excreted in breast milk and may cause kernicterus. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE Sulphathiazole 3.42 % w/w Sulphacetamide 2.86 % w/w Sulphabenzamide 3.70 % w/w 1. This product is intended for intravaginal use only. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 18/01/2007_ _CRN 2032273_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION Contact should be avoided between contraceptive diaphragms or latex condoms and Sultrin Triple Sulfa Cream since the rubber may be damaged. 4.6 PREGNANCY AND LACTATION The safe use of sulphonamides in pregnancy has not been established. The teratogenic potential of most sulphonamides has not been thoroughly investigated in either animals o Կարդացեք ամբողջական փաստաթուղթը