Nazione: Irlanda
Lingua: inglese
Fonte: HPRA (Health Products Regulatory Authority)
BENZALKONIUM CHLORIDE
Innothera Ireland Ltd
1.2 %w/w
Vaginal Cream
1983-11-30
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pharmatex 1.2% Vaginal Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Benzalkonium Chloride 1.2% w/w. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Cream Unctuous white vaginal cream with an odour of lavender. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (a) Properties Cream containing benzalkonium chloride, which is a quaternary ammonium disinfectant and spermicidal agent. (b) Indications for use As an adjunct in the control of conception. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Intravaginal. UNIDOSE: The contents of the container should be expelled as deeply as possible into the vagina using the nozzle and exerting sufficient pressure to the walls of the tube to ensure emptying of the contents. Protection is immediate and lasts for 4 hours. MULTIDOSE: The contents of the container should be expelled as deeply as possible into the vagina using the nozzle and crossbar of the device to ensure adequate distribution. Protection is immediate and lasts for 4 hours. 4.3 CONTRAINDICATIONS Use in patients with a known hypersensitivity to benzalkonium chloride. 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE 1. If irritation of vagina or penis occurs the use of product should cease. 2. The product should only be recommended to individuals who understand the appropriate use of the agent. IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 29/11/2006_ _CRN 2030638_ _page number: 1_ 4.5 INTERACTION WITH OTHER MEDICINAL PRODUCTS AND OTHER FORMS OF INTERACTION The spermicide is inactivated by soap and other anionic surfactants even in trace amounts. Bathing or swimming must be avoided as the efficacy of the product is affected. 4.6 Leggi il documento completo