국가: 말레이시아
언어: 영어
출처: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)
ESTRADIOL HEMIHYDRATE (ESTRADIOL)
SYARIKAT WELLCHEM SDN. BHD.
ESTRADIOL HEMIHYDRATE (ESTRADIOL)
80 gm
LABORATOIRES BESINS INTERNATIONAL
OESTRODOSE GEL _CONSUMER MEDICATION INFORMATION LEAFLET (RIMUP) _ Estradiol Hemihydrate (60mg/100g) WHAT IS IN THIS LEAFLET 1. What Oestrodose is used for 2. How Oestrodose works 3. Before you use Oestrodose 4. How to use Oestrodose 5. While you are using it 6. Side effects 7. Storage and Disposal of Oestrodose 8. Product Description 9. Manufacturer and Product Registration Holder 10. Date of Revision WHAT OESTRODOSE IS USED FOR Oestrodose is used for general estrogen therapy that is absorbed through the skin. It contains the female hormone oestrogen. Oestrodose is indicated for estrogen deficiency, following the decrease in ovarian activity: - Blood vessels constriction dilation disorders, hot flushes. - Vaginal dryness and thinning of vaginal wall which may disrupt sexual intercourse. HOW OESTRODOSE WORKS Oestrodose works by replacing the oestrogen in your body. BEFORE YOU USE OESTRODOSE - _When you must not use it _ Do not take Oestrodose: - If you are allergic to estradiol or any of the other ingredients of this medicine. - If you are pregnant. - If you have malignant tumors of the breast or uterus, pituitary tumors. - If you have severe liver, kidney or heart disease, porphyria (a group of diseases in which substances called porphyrins build up, affecting the skin or nervous system) , blood circulation disorders such as blood clots in the veins of the legs or the lungs or a confirmed history of these conditions. - If you have undiagnosed vaginal bleeding. A complete medical and family history should be obtained prior to starting any estrogen therapy. Before commencing therapy, you should have a complete physical and gynaecological examination including blood pressure, breasts, abdomen and pelvic organs and endometrial assessment where necessary. This should be repeated at regular intervals. People with a uterus should be monitored at least annually for signs of thickening of uterus lining or endometrial cancer. Women who have not had their uterus removed. The addition of 10 or more days of progesterone s 전체 문서 읽기
OESTRODOSE 0.06% GEL Metered dose pump _FOR TOPICAL ADMINISTRATION _ _ACTIVE INGREDIENT _ This canister delivers 64 metered doses. Each metered dose (1.25g gel) contains 0.75mg 17 - estradiol. _OTHER INGREDIENTS:_ Carbomer, 95% v/v ethanol, triethanolamine and purified water. _PRODUCT DESCRIPTION:_ Container with pump and cap containing a colourless, transparent gel with an alcoholic odour. _MODE OF ACTION: _ General estrogen therapy via the percutaneous route: Uses the natural estrogen secreted by the ovary: 17 - estradiol _PHARMACOLOGY: _ General estrogen therapy by the percutaneous route, with the following advantages: Use of the estrogen naturally secreted by the ovary, named estradiol 17 ; Avoids the effects of first passage through the liver, which increases angiotensinogen synthesis, VLDL lipoproteins and certain clotting factors considered to favour the development of cardiovascular, thromboembolic and metabolic side-effects. _PHARMACOKINETIC PROPERTIES: _ Percutaneous absorption equal to around 10% of the dose applied: one metered dose delivered 75 g of estradiol. There is a transitory stockage in the corneal of the epidermis. There is slow diffusion into the general circulation via the dermic capillary bed. The plasma level of 17 -estradiol obtained in menopausal women receiving 2 measures per day of Oestrodose is on average 80 pg/ml. The estrone/ estradiol ratio is similar to that seen in non-menopausal genitally active women. _INDICATIONS: _ Indicated in estrogen deficiency following the decrease in ovarian activity: - Vasomotor disorders, hot flushes - Vaginal atrophy and dryness which may disrupt sexual intercourse _RECOMMENDED DOSE: _ Posology and method of administration: OESTRODOSE is presented in bottles supplied with a metered dose pump. Each pressure dose delivers 1.25 gm of gel, containing 0.75 mg of estradiol The mean dose is 2.5 gm of gel per day, i.e. 2 pressure doses for a period of 24 to 28 days. The posology may be readjusted after 2 or 3 cycles of treatment 전체 문서 읽기