Страна: Армения
Язык: английский
Источник: Դեղերի և բժշկական տեխնոլոգիաների փորձագիտական կենտրոնի գործունեության Հայաստանի Հանրապետությունում
dydrogesterone
ABBOTT Biologicals B.V.
dydrogesterone
10mg
tablets film-coated
Prescription
SUMMARY OF PRODUCT CHARACTERISTICS Dydrogesterone Abbott Confidential information 1/10 This information is confidential 1. NAME OF THE MEDICINAL PRODUCT Duphaston 10 mg film-coated tablets 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 10 mg dydrogesterone. Excipient(s) with known effect: Each tablet contains 111.1 mg Lactose monohydrate. For a full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM A round, biconvex, scored, white film-coated tablet, one side with inscription ‘155’ on either side of the score (size 7 mm). The score line is only to facilitate breaking for ease of swallowing and not to divide into equal doses. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS PROGESTERONE DEFICIENCIES • Treatment of dysmenorrhoea • Treatment of endometriosis • Treatment of secondary amenorrhoea • Treatment of irregular cycles • Treatment of dysfunctional uterine bleeding • Treatment of pre-menstrual syndrome • Treatment of threatened abortion • Treatment of habitual abortion • Treatment of infertility due to luteal insufficiency HORMONE REPLACEMENT THERAPY To counteract the effects of unopposed estrogen on the endometrium in hormone replacement therapy for women with disorders due to natural or surgical induced menopause with an intact uterus. SUMMARY OF PRODUCT CHARACTERISTICS Dydrogesterone Abbott Confidential information 2/10 This information is confidential 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Dosages, treatment schedule and duration of treatment may be adapted to the severity of the dysfunction and the clinical response. Dysmenorrhoea: 10 or 20mg mg dydrogesterone per day from day 5 to day 25 of the menstrual cycle. Endometriosis: 10 to 30 mg dydrogesterone per day from day 5 to day 25 of the cycle or continuously. Dysfunctional uterine bleeding: When treatment is started to arrest a bleeding episode, 20 or 30 mg dydrogesterone per day is to be given for up to 10 days For continuous treatment, 10 or 20 mg dydrogesterone per day should be give Прочитать полный документ