국가: 이스라엘
언어: 영어
출처: Ministry of Health
ESTRADIOL AS HEMIHYDRATE
TRUEMED LTD.
G03CA03
PATCHES
ESTRADIOL AS HEMIHYDRATE 3.2 MG
TRANSDERMAL
Required
THERAMEX IRELAND LIMITED, IRELAND
ESTRADIOL
Deficiency symptoms by absence of Estrogen after the menopause or after surgical removal of the ovarians. They comprise hot flushes, insomnia, atrophies of the urogenital system, changes of mood and increasing loss of the bone substance, which can lead to osteoporosis. In women with intact uterus, estrogen substitution must always be supplemented with a sequential gestagen therapy.
2021-11-30
Page 1 of 13 PATIENT LEAFLET IN ACCORDANCE WITH THE PHARMACISTS' REGULATIONS (PREPARATIONS) - 1986 This medicine is dispensed with a doctor’s prescription only Evorel 50 Transdermal patch Active ingredient and its quantity in a dosage unit: estradiol (as hemihydrate) 3.2 mg The transdermal patch delivers 50 mcg estradiol per day. Inactive ingredients and allergens in the 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. This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if it seems to you that their medical condition is similar to yours. 1. WHAT IS THIS MEDICINE INTENDED FOR? To treat symptoms related to oestrogen deficiency in women after menopause or after surgical removal of the ovaries. The symptoms include hot flushes, insomnia, changes in the urogenital system, mood changes and bone loss, which may lead to osteoporosis. In women who have not undergone hysterectomy, oestrogen therapy must be supplemented with sequential gestagen therapy. THERAPEUTIC GROUP: estradiol 2. BEFORE USING THIS MEDICINE DO NOT USE THIS MEDICINE IF: • You are sensitive (allergic) to estradiol or to any of the other ingredients in this medicine (as listed in section 6 "Additional information") • You have, have previously had or are suspected of having BREAST CANCER • You have or are suspected of having A CANCEROUS TUMOUR WHICH IS WORSENED BY OESTROGENS (such as endometrial cancer) • You have untreated THICKENING OF THE LINING OF THE WOMB (endometrial hyperplasia) • You have UNEXPLAINED VAGINAL BLEEDING • You have or have previously had BLOOD CLOTS IN THE VEINS (thrombosis), such as in the legs (deep venous thrombosis) or lungs (pulmonary embolism) • You have a BLOOD CLOTTING DISORDER (such as protein C, protein S or antithrombin deficiency) • You have or have previously h 전체 문서 읽기
1. NAME OF THE MEDICINAL PRODUCT Evorel ® 50 2. QUALITATIVE AND QUANTITATIVE COMPOSITION 3.2 mg of estradiol (as hemihydrate) /patch 3. PHARMACEUTICAL FORM Transdermal patch EVOREL is a square shaped, transparent, self-adhesive transdermal delivery system (patch) of 0.2 mm thickness for application to the skin surface. It consists of a monolayered adhesive matrix throughout which 17β estradiol is uniformly distributed. The adhesive matrix is protected on the outside surface (from clothes etc) by a polyethylene teraphthalate backing foil, while the adhesive surface of the patch is covered by a polyester sheet (the release liner) which is removed before placing the patch on the body surface. This release liner has an S-shaped incision which facilitates easy removal from the patch. EVOREL 50 is marked ‘CE50’, has a surface area of 16 sq. cm and contains 3.2 mg estradiol (as hemihydrate) corresponding to a release rate of 50 micrograms of estradiol in 24 hours. 4. CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS Deficiency symptoms by absence of Estrogen after the menopause or after surgical removal of the ovarians. They comprise hot flushes, insomnia, atrophies of the urogenital system, changes of mood and increasing loss of the bone substance, which can lead to osteoporosis. In women with intact uterus, estrogen substitution must always be supplemented with a sequential gestagen therapy. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION _ADULTS_ Evorel is an oestrogen-only HRT patch applied to the skin twice weekly. For initiation and continuation of treatment of menopausal symptoms, the lowest effective dose for the shortest duration (see also Section 4.4) should be used. For women with an intact uterus progestogen should normally be added to Evorel for the prevention of adverse endometrial effects, e.g. hyperplasia and cancer. The regimen may be either cyclic or continuous sequential. Only progestogens approved for addition to oestrogen treatment may be prescribed (e.g. oral norethisterone, 1mg/day or medroxyproges 전체 문서 읽기