国: イギリス
言語: 英語
ソース: MHRA (Medicines & Healthcare Products Regulatory Agency)
Estriol
Waymade Healthcare Plc
G03CA04
Estriol
100microgram/1gram
Vaginal cream
Vaginal
No Controlled Drug Status
Invalid to prescribe in NHS primary care
BNF: 07020100
This leaflet was last revised in January 2020 完全なドキュメントを読む
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT ESTRIOL 0.01% w/w Cream GYNEST 0.01% w/w Cream 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Estriol 0.01% w/w Excipients: Arachis oil and Benzoic acid For a full list of excipients, see Section 6.1 3 PHARMACEUTICAL FORM Vaginal Cream. Description of the product: Estriol Cream is a whitish cream. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS 1. Hormone replacement therapy for treatment of atrophic vaginitis and kraurosis in post- menopausal women. 2. Treatment of pruritus vulvae and dyspareunia associated with atrophic vaginal epithelium. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Gynest Cream is an estrogen-only product for intravaginal use. No progestogen needs to be added (but please refer to section 4.4). Guidance on how to start therapy and maintenance Gynest Cream can be started any time after the manifestation of atrophic vaginitis or associated symptoms (eg dyspareunia, pruritus). The recommended initial daily dose is one applicator full per day. A maintenance dose of one applicator full twice a week may be used after restoration of the vaginal mucosa has been achieved. For initiation and continuation of treatment of postmenopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used. Attempts to discontinue medication should be made at three to six month intervals following physical examination. Missed Dose: When a dose is inadvertently forgotten, resume dosing when the omission is realized. Administration: Gynest Cream is to be applied into the vagina, using an applicator. The applicator holds 5ml of cream containing 0.5mg estriol. The filled applicator should be inserted high into the vagina and emptied, preferably in the evening. Remove the cap from a new tube and use the top of the cap to pierce the metal seal on the tube. One end of the applicator is fitted with a plunger. Ensure the plunger is fully inserted into the applicator. Screw the other end of the applicator onto the tube. Sque 完全なドキュメントを読む