البلد: إسرائيل
اللغة: الإنجليزية
المصدر: Ministry of Health
PRASTERONE
DEXCEL LTD, ISRAEL
G03XX01
VAGINAL PESSARIES
PRASTERONE 6.5 MG
INTRAVAGINAL
Required
ENDOCEUTICS INC., CANADA
PRASTERONE
Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms.
2020-03-03
2 SUMMARY OF PRODUCT CHARACTERISTICS 1. NAME OF THE MEDICINAL PRODUCT Intrarosa. 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal pessary contains 6.5 mg of prasterone. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Vaginal pessary White to off-white, bullet-shaped pessary. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Intrarosa is indicated for the treatment of vulvar and vaginal atrophy in postmenopausal women having moderate to severe symptoms. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Posology The recommended dose is 6.5 mg prasterone (one pessary) administered once daily, at bedtime. For the treatment of postmenopausal symptoms, Intrarosa should only be initiated for symptoms that adversely affect quality of life. In all cases, a careful appraisal of the risks and benefits should be reassessed at least every 6 months and Intrarosa should only be continued as long as the benefit outweighs the risk. If a dose is forgotten, it should be taken as soon as the patient remembers. However, if the next dose is due in less than 8 hours, the patient should skip the missed pessary. Two pessaries should not be used to make up for a forgotten dose. _Special populations _ _ _ _Elderly _ No dose adjustment is considered necessary in elderly women. _Patients with renal and/or hepatic impairment _ Since Intrarosa acts locally in the vagina, no dose adjustment is needed for postmenopausal women having renal or hepatic impairment or any other systemic anomaly or disease. 3 _Paediatric population _ There is no relevant use of Intrarosa in female children of any age group for the indication of vulvar and vaginal atrophy due to menopause. Method of administration Vaginal use Intrarosa can be inserted in the vagina with the finger or with an applicator provided within the identified pack. The pessary should be inserted in the vagina as far as it can comfortably go without force. If inserted with an applicator, the following steps should be followed: 1. The applicator should be activated (by p اقرأ الوثيقة كاملة