Ülke: Avustralya
Dil: İngilizce
Kaynak: Department of Health (Therapeutic Goods Administration)
estradiol, Quantity: 1.17 mg
Novartis Pharmaceuticals Australia Pty Ltd
Drug delivery system, transdermal
Excipient Ingredients: dipropylene glycol; povidone; oleyl alcohol; ethyl acetate; simethicone; dimeticone; xylene; cyclomethicone; toluene; acrylates/VA copolymer; ethylene/vinyl acetate copolymer; 1,1-dichloroethylene, chloroethylene polymer; polyethylene; sodium carbonate; polyethylene terephthalate; polyvinylidene flouride
Transdermal
2 patches, 8 patches
(S4) Prescription Only Medicine
Short term treatment of symptoms of oestrogen deficiency due to the menopause, whether natural or surgically induced. In women with an intact uterus, oestrogen should always be opposed by progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals (see CLINICAL TRAILS and DOSAGE AND ADMINISTRATION). Combination HRT should not be used in hysterectomised women because it is not needed in these women and it may increase the risk of breast cancer.
Visual Identification: Rectangular patch with round corners, comprising an adhesive layer with a translucent polymeric backing on one side and a release liner on the other side.; Container Type: Sachet; Container Material: Al laminated with PE/paper; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2004-02-05
ESTRADOT ® _estradiol_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about the menopause ("change of life"), hormone replacement therapy and Estradot. It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist. The information in this leaflet was last updated on the date listed on the final page. More recent information on the medicine may be available. YOU SHOULD ENSURE THAT YOU SPEAK TO YOUR PHARMACIST OR DOCTOR TO OBTAIN THE MOST UP-TO-DATE INFORMATION ON THE MEDICINE. YOU CAN ALSO DOWNLOAD THE MOST UP-TO- DATE LEAFLET FROM WWW.NOVARTIS.COM.AU. Those updates may contain important information about the medicine and its use of which you should be aware. All medicines have risks and benefits. Your doctor has weighed the risks of you using Estradot against the benefits they expect it will provide. IF YOU HAVE ANY CONCERNS ABOUT USING THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHEN YOU MUST NOT USE ESTRADOT DO NOT USE ESTRADOT OR OTHER ESTROGENS, WITH OR WITHOUT A PROGESTOGEN TO PREVENT HEART ATTACKS, STROKE OR DEMENTIA. A study called the Women's Health Initiative indicated increased risk of heart attack, stroke, breast cancer, and blood clots in the legs or lungs in women receiving treatment with a product containing conjugated estrogens 0.625 mg and the progestogen medroxyprogesterone acetate (MPA). The researchers stopped the study after 5 years when it was determined the risks were greater than the benefits in this group. The Women's Health Initiative Memory Study indicated increased risk of dementia in women aged 65-79 years taking conjugated estrogens and MPA. There are no comparable data currently available for other doses of conjugated estrogens and MPA or other combinations of estrogens and progestogens. Therefore, you should assume the risks will be similar for other medicines containing estrogen and progestogen combinations. Belgenin tamamını okuyun
1 AUSTRALIAN PRODUCT INFORMATION ESTRADOT® ESTRADIOL TRANSDERMAL PATCH WARNING Estrogens with or without progestogens should not be used for the prevention of cardiovascular disease or dementia. The Women’s Health Initiative (WHI) study reported increased risks of stroke and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 6.8 years of treatment with conjugated estrogens (0.625 mg) relative to placebo (See Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The WHI study reported increased risks of myocardial infarction, stroke, invasive breast cancer, pulmonary emboli, and deep vein thrombosis in postmenopausal women (50 to 79 years of age) during 5 years of treatment with conjugated estrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (See Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). The Women’s Health Initiative Memory Study (WHIMS), a substudy of WHI, reported increased risk of developing probable dementia in postmenopausal women 65 years of age or older during 4 to 5.2 years of treatment with conjugated estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (See Section 5.1 PHARMACODYNAMIC PROPERTIES, Clinical Trials and Section 4.4 SPECIAL WARNINGS AND PRECAUTIONS FOR USE). Other doses of conjugated estrogens and medroxyprogesterone acetate, and other combinations and dosage forms of estrogens and progestogens were not studied in the WHI clinical trials and, in the absence of comparable data, these risks should be assumed to be similar. Because of these risks, estrogens with or without progestogens should be prescribed at the lowest effective doses and for the shortest duration consistent with treatment goals and risks for the individual woman. 1 NAME OF THE MEDICINE Estradiol. 2 QUALITATIVE AND QUANTITATIVE COM Belgenin tamamını okuyun