国家: 以色列
语言: 英文
来源: Ministry of Health
ESTRADIOL HEMIHYDRATE
NOVO NORDISK LTD., ISRAEL
G03CA03
FILM COATED TABLETS
ESTRADIOL HEMIHYDRATE 10 MCG
VAGINAL
Not required
NOVO NORDISK A/S, DENMARK
ESTRADIOL
ESTRADIOL
Treatment of atrophic vaginitis due to estrogen deficiency in postmenopausal women.The experience treating women older than 65 years is limited.שינוי משטר מינון: 1/7/2019שינויים בעלון לרופא בסעיף Posology:4.2 Posology and method of administrationVagifem is administered intravaginally as a local oestrogen therapy by use of an applicator. Initial dose: One vaginal tablet daily for two weeks. Maintenance dose: One vaginal tablet twice a week.Treatment may be started on any convenient day.If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided.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.For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains within the normal postmenopausal range, such as Vagifem, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’).
2016-11-30
Page 1 of 12 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 THIS MEDICINE IS DISPENSED WITHOUT A DOCTOR'S PRESCRIPTION VAGIFEM ® 10 MICROGRAMS FILM-COATED VAGINAL TABLETS ACTIVE INGREDIENT: ESTRADIOL 10 MCG (AS HEMIHYDRATE) Inactive ingredients and allergens in this medicine: see section 6 ‘Additional information’. READ THE ENTIRE LEAFLET CAREFULLY BEFORE YOU START USING THIS MEDICINE. THIS LEAFLET CONTAINS CONCISE INFORMATION ABOUT THIS MEDICINE. If you have any further questions, consult your doctor or pharmacist. Use this medicine according to the instructions in the section about dose in this leaflet. Consult your pharmacist if you need further information. Consult your doctor if your symptoms of illness get worse or do not improve after 2 to 4 weeks, or if other symptoms occur. 1. WHAT IS THIS MEDICINE INTENDED FOR? Vagifem 10 micrograms in intended to treat vaginal atrophy that is caused by estrogen deficiency in women after the menopause. The experience of treating women older than 65 years is limited. THERAPEUTIC GROUP: estrogens, natural and semi-synthetic, simple. Vagifem 10 mcg contains estradiol which is a female sex hormone that belongs to a group of hormones called estrogens. The estradiol in Vagifem 10 mcg is exactly the same as the estradiol produced in the ovaries of women. Vagifem 10 mcg belongs to a group of medicines called vaginal hormone replacement therapy (HRT). Vagifem 10 mcg is used to relieve menopausal symptoms in the vagina such as dryness and irritation. This condition is called ‘vaginal atrophy’, it is caused by a drop in the levels of estrogen in your body. This happens naturally after the menopause. Vagifem 10 mcg works by replacing the estrogen which is normally produced in the ovaries of women. It is inserted into your vagina, so the hormone is released where it is needed. This may relieve discomfort in the vagina. Page 2 of 12 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: MEDICAL HISTORY AND ROUTINE MEDICAL CHECK UPS 阅读完整的文件
1 NAME OF THE MEDICINAL PRODUCT Vagifem ® 10 micrograms 2 QUALITATIVE AND QUANTITATIVE COMPOSITION Each vaginal tablet contains: estradiol hemihydrate equivalent to estradiol 10 micrograms. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Vaginal tablet. White, film-coated, biconvex tablet, engraved with NOVO 278 on one side. Diameter 6 mm. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Treatment of atrophic vaginitis due to oestrogen deficiency in postmenopausal women. The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Vagifem 10 mcg is administered intravaginally as a local oestrogen therapy by use of an applicator. Initial dose: One vaginal tablet daily for two weeks. Maintenance dose: One vaginal tablet twice a week. Treatment may be started on any convenient day. If a dose is forgotten, it should be taken as soon as the patient remembers. A double dose should be avoided. 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. For oestrogen products for vaginal application of which the systemic exposure to the oestrogen remains WITHIN the normal postmenopausal range, such as Vagifem 10 mcg, it is not recommended to add a progestagen (but see section 4.4, ‘Special warnings and precautions for use’, ‘Endometrial hyperplasia and carcinoma’). Vagifem 10 mcg may be used in women with or without an intact uterus. Vaginal infections should be treated before start of the Vagifem 10 mcg therapy. Administration: 1. Open the blister pack at the plunger end. 2. Insert the applicator in the vagina until resistance is met (8-10 cm). 3. Release the tablet by pressing the plunger. 4. Withdraw the applicator and discard. 4.3 CONTRAINDICATIONS • Known, past or suspected breast cancer • Known, past or suspected oestrogen-dependent malignant tumours (e.g. endometrial cancer) • Undiagnosed genital bleeding • Untreated endometria 阅读完整的文件