Negara: Israel
Bahasa: Inggris
Sumber: Ministry of Health
ESTRADIOL AS HEMIHYDRATE; NORETHISTERONE AS ACETATE
NOVO NORDISK LTD., ISRAEL
G03AA05
FILM COATED TABLETS
ESTRADIOL AS HEMIHYDRATE 1 MG; NORETHISTERONE AS ACETATE 0.5 MG
PER OS
Required
NOVO NORDISK A/S, DENMARK
NORETHISTERONE AND ESTROGEN
NORETHISTERONE AND ESTROGEN
Hormone replacement therapy (HRT) for oestrogen deficiency symptoms in women more than one year after menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of , or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience treating women older than 65 years is limited.
2014-06-30
1 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 THIS MEDICINE IS DISPENSED WITH A DOCTOR’S PRESCRIPTION ONLY ACTIVELLE ® FILM-COATED TABLETS ACTIVE INGREDIENTS: ESTRADIOL AS HEMIHYDRATE 1 MG NORETHISTERONE ACETATE 0.5 MG Inactive ingredients and allergens in this medicine: See section 2 under ‘Important information about some of this medicine’s ingredients’, and 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. This medicine has been prescribed to treat you. Do not pass it on to others. It may harm them, even if it seems to you that their condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? Activelle is intended for: • Relief of symptoms that are due to a drop in the level of the hormome estrogen in postmenopausal women, when at least one year has passed since their last natural period. • Prevention of osteoporosis (bone thinning) in menopausal women who are at high risk of future fractures and who cannot be treated with other medicines for this condition. There is only limited experience of treating women older than 65. THERAPEUTIC GROUP: progestagens and estrogens. continuous, combined therapy. Activelle is a continuous combined hormone replacement therapy (HRT). It contains two types of female hormones, estrogen and progestagen. 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: _ _ • You are SENSITIVE (allergic) to the active ingredients or to any of the other ingredients in this medicine (listed in section 6 ‘Additional information’). • You have, have had, or suspect having BREAST CANCER. • You have, or have had CANCER WHICH IS SENSITIVE TO ESTROGENS, such as cancer of the womb lining (endometrium), or if you are suspected of having this type of cancer. • You have UNEXPLAINED VAGINAL BLEEDING. • You have EXCESSIVE THICKENING O Baca dokumen lengkapnya
Activelle IL SPC JAN21-Notification Page 1 of 13 1. NAME OF THE MEDICINAL PRODUCT Activelle ® 2. QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains: Estradiol 1 mg (as estradiol hemihydrate) and norethisterone acetate 0.5 mg. Excipient with known effect: lactose monohydrate. For the full list of excipients, see section 6.1. 3. PHARMACEUTICAL FORM Film-coated tablets. White film-coated, round, biconvex tablets with a diameter of 6 mm. The tablets are engraved with NOVO 288 on one side and the Apis bull on the other. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Hormone Replacement Therapy (HRT) for oestrogen deficiency symptoms in women with more than 1 year after menopause. Prevention of osteoporosis in postmenopausal women at high risk of future fractures who are intolerant of, or contraindicated for, other medicinal products approved for the prevention of osteoporosis. The experience treating women older than 65 years is limited. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION Activelle is a continuous combined HRT product intended for use in women with an intact uterus. One tablet should be taken orally once a day without interruption, preferably at the same time every day. 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. A switch to a higher dose combination product could be indicated if the response after 3 months is insufficient for symptom relief. In women with amenorrhoea and not taking HRT or women in transition from another continuous combined HRT product, treatment with Activelle may be started on any convenient day. In women in transition from a sequential HRT regimen, treatment should start right after their withdrawal bleeding has ended. If the patient has forgotten to take a tablet, the tablet should be taken as soon as possible within the next 12 hours. If more than 12 hours have passed, the tablet should be discarded. Forgetting a dose may increase the likelih Baca dokumen lengkapnya