Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
BENZALKONIUM CHLORIDE
Innothera Ireland Ltd
18.9 Milligram
Pessary
1983-12-06
PART II SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT Pharmatex 18.9 mg Ovule 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each ovule contains 18.9 mg of benzalkonium chloride. For excipients, see 6.1. 3 PHARMACEUTICAL FORM Pessary White odourless cylindrical pessary, with conical head. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS (a) Properties Ovule 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. One ovule should be inserted intravaginally at least 10 minutes prior to each coitus. 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. 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 PREGNANCY AND LACTATION As benzalkonium chloride is not absorbed, and as diffusion does not occur into the blood or milk of nursing mothers, IRISH MEDICINES BOARD ________________________________________________________________________________________________________________________ _Date Printed 30/11/2006_ _CRN 2030648_ _page number: 1_ nor into the uterine cavity of animals, the use of Pharmatex Ovule in pregnancy or lactation is not contra-indicated. 4.7 EFFECTS ON ABILITY TO DRIVE AND USE MACHINES Not applicable. 4.8 UNDESIRABLE EFFECTS Possibility of allergy. 4.9 Прочитајте комплетан документ