Страна: Южна Африка
Език: английски
Източник: South African Health Products Regulatory Authority (SAHPRA)
Donmed
Synapause Vaginal Cream® RU M1740.021.005 SCHEDULING STATUS: S2 PROPRIETARY NAME (and dosage form): Synapause Vaginal Cream ® (vaginal cream) COMPOSITION Synapause Vaginal Cream contains as active substance 0,1% m/m oestriol in a water emulsion adjusted to pH 4; with chlorhexidine hydrochloride, 0,002% to 0,01% m/m as preservative. PHARMACOLOGICAL CLASSIFICATION A/18.6/Vaginal preparations PHARMACOLOGICAL ACTION Synapause Vaginal Cream contains the natural short acting female hormone, oestriol. Oestriol improves the maturation index of the vaginal epithelium. During the use of Synapause Vaginal Cream, systemic absorption of oestriol occurs. INDICATIONS - Complaints resulting from atrophy of the genitourinary tract in conditions of estrogen deficiency associated with the natural or surgical menopause. - Pre- and postoperative therapy in postmenopausal or ovariectomized women undergoing vaginal surgery. CONTRA-INDICATIONS - Pregnancy. - In patients with previous thromboembolic disorders, cardiovascular disease, thrombophlebitis, disorders of lipid metabolism. - In patients with a history during pregnancy of pruritus, herpes, deteriorating otosclerosis, idiopathic jaundice or liver impairment. - For inhibition of lactation after birth, particularly in women over 35, or following operative delivery. - Undiagnosed vaginal bleeding. - In patients with a family or personal history of malignant neoplastic disease of the breast or genital tract. DOSAGE AND DIRECTIONS FOR USE - Complaints resulting from atrophy of the genitourinary tract in conditions of estrogen deficiency: 1 application per day for 2 to 3 weeks, followed by a maintenance therapy of 1 application twice per week. - Pre- and postoperative therapy in postmenopausal or ovariectomized women undergoing vaginal surgery: 1 appli Прочетете целия документ