País: Austrália
Língua: inglês
Origem: Department of Health (Therapeutic Goods Administration)
Oestradiol
Aspen Pharmacare Australia Pty Ltd
Medicine Registered
SANDRENA(R) GEL- Consumer Medicine Information Page 1 of 4 SANDRENA® GEL _oestradiol _ CONSUMER MEDICINE INFORMATION (CMI) _ _ _BEFORE ADMINISTRATION OF THIS MEDICINE PLEASE READ THIS LEAFLET CAREFULLY. IF YOU HAVE ANY QUESTIONS OR WORRIES, ASK _ _YOUR DOCTOR OR PHARMACIST _ WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Sandrena®. It does not contain all the available information. It does not take the place to talking to your doctor or pharmacist. KEEP THIS INFORMATION WITH THE PACK. You may wish to read it again. GENERAL ADVICE 1. This medicine has been prescribed only for your current medical problem. It should not be used for other medical conditions. 2. Never give your medicine to anyone else and do not use medicines meant for other people. 3. Tell every doctor treating you what medicines you are taking. Always carry a medical information card stating which medicines you are using. This can be very important if for example you are involved in an accident. 4. Return unused medicines to your pharmacy for disposal. 5. Make sure that other people who live with you or who look after you read this information. A doctor's prescription is required to obtain this medicine. WHAT SANDRENA® IS USED FOR During and after menopause the production of sex hormones produced by the body decreases. Women may then suffer from complaints such as hot flushes, night sweats, vaginal irritation, depression, and loss of sexual desire. Sandrena® can be used for the short-term relief of menopausal complaints. It can also relieve these symptoms in women who have had their ovaries removed. Relief of symptoms usually starts within a few weeks, but optimal results are obtai Leia o documento completo
SANDRENA – Product Information Page 1 of 10 PRODUCT INFORMATION SANDRENA 0.1% GEL NAME OF THE MEDICINE oestradiol 1 mg/g gel. _ _ Chemical name: 17β-oestradiol; Estra-1, 3, 5 (10) - triene-3, 17β - diol C 18 H 24 O 2 . Molecular weight: 272.4. CAS No. 50-28-2 (anhydrous) DESCRIPTION The product is a smooth and opalescent gel, where the active ingredient, oestradiol, is in dissolved form. The gel is packaged into single-dose sachets. Each sachet contains either 0.5 mg or 1.0 mg of oestradiol. It also contains carbomer 934P, triethanolamine, propylene glycol, water - purified and ethanol. PHARMACOLOGY PHARMACODYNAMIC PROPERTIES Sandrena is an alcohol-based, percutaneously applied gel for hormone replacement therapy with oestradiol as its active ingredient. The pharmacodynamics of Sandrena are similar to those of oral oestrogens but the major difference to oral administration lies in the pharmacokinetic profile. The clinical efficacy of Sandrena in the treatment of menopausal symptoms is comparable to that of peroral oestrogen. Combined with medroxyprogesterone acetate, percutaneous oestradiol treatment lowers total cholesterol without reducing the HDL cholesterol level. PHARMACOKINETIC PROPERTIES Sandrena is an alcohol-based oestradiol gel. When applied to the skin the gel evaporates rapidly and oestradiol is absorbed through the skin into circulation. To some extent, however the oestradiol is stored in subcutaneous tissue from where it is released gradually into circulation. Percutaneous administration naturally circumvents the hepatic first-pass metabolism. Because of the change in composition, the new formulation was compared to the old formulation of Sandrena in a bioequivalence study. Twenty-seve Leia o documento completo