Země: Austrálie
Jazyk: angličtina
Zdroj: Department of Health (Therapeutic Goods Administration)
Oestradiol
Bayer Australia Ltd
Medicine Registered
CLIMARA ® CMI 1 CONSUMER MEDICINE INFORMATION CLIMARA _oestradiol _ WARNING The Women’s Health Initiative (WHI) trial examined the health benefits and risks of combined _oestrogen plus progestogen_ therapy (n=16,608) and _oestrogen-alone_ therapy (n=10,739) in postmenopausal women aged 50 to 79 years. The _oestrogen plus progestogen_ arm of the WHI trial indicated an increased risk of _myocardial infarction (MI), stroke, invasive breast cancer, pulmonary embolism and deep vein _ _thrombosis _in postmenopausal women receiving treatment with combined conjugated equine estrogens (CEE, 0.625 mg/day) and medroxyprogesterone acetate (MPA, 2.5 mg/day) for 5.2 years compared to those receiving placebo. The _oestrogen-alone_ arm of the WHI trial indicated an increased risk of_ stroke and deep vein _ _thrombosis _in hysterectomised women treated with CEE-alone (0.625 mg/day) for 6.8 years compared to those receiving placebo. Other doses of oral conjugated oestrogens with medroxyprogesterone acetate, and other combinations and dosage forms of oestrogens 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. Therefore, the following should be given serious consideration at the time of prescribing: • Oestrogens with or without progestogens should not be prescribed for primary or secondary prevention of cardiovascular diseases. • Oestrogens with or without progestogens should be prescribed at the lowest effective dose for the approved indication. • Oestrogens with or without progestogens should be prescribed for the shortest period possible for the approved indication. • For the prevention of osteoporosis, oestrogen treatment should be considered in light of other available therapies. CLIMARA ® CMI 1_ _ CLIMARA ® (CLIM·AR·RAH) _oestra Přečtěte si celý dokument
Climara PI Feb2012 Page 1 PRODUCT INFORMATION CLIMARA ® WARNING Oestrogens 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 oestrogens (0.625 mg) relative to placebo (see CLINICAL TRIALS and PRECAUTIONS). 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 oestrogens (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (see CLINICAL TRIALS and PRECAUTIONS). The Women’s Health Initiative Memory Study (WHIMS), a sub-study 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 oestrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (see CLINICAL TRIALS and PRECAUTIONS). Other doses of conjugated oestrogens and medroxyprogesterone acetate, and other combinations and dosage forms of oestrogens 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, oestrogens 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. NAME OF THE MEDICINE CLIMARA is a transdermal delivery system containing oestradiol as the Přečtěte si celý dokument