देश: न्यूज़ीलैंड
भाषा: अंग्रेज़ी
स्रोत: Medsafe (Medicines Safety Authority)
Estradiol hemihydrate 3.92mg equivalent to estradiol 3.79 mg (50 µg/24h)
Bayer New Zealand Limited
Estradiol hemihydrate 3.92 mg (equivalent to estradiol 3.79 mg (50 µg/24h))
50 mcg/24h
Transdermal patch
Active: Estradiol hemihydrate 3.92mg equivalent to estradiol 3.79 mg (50 µg/24h) Excipient: Acrylates copolymer Ethyl oleate Glyceryl monolaurate Isopropyl myristate
Sachet, aluminium foil, laminated, 4 patches
Prescription
Prescription
Bayer AG
For short-term treatment of complaints associated with the menopause and post-menopause, including signs and symptoms of oestrogen deficiency, whether naturally or surgically induced. Oestrogen replacement therapy in women with an intact uterus should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals. Prevention of postmenopausal osteoporosis.
Package - Contents - Shelf Life: Sachet, aluminium foil, laminated - 4 patches - 36 months from date of manufacture stored at or below 30°C
1994-05-19
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) _oestradiol _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some common questions about Climara. It does not contain all the available information. It does not take th पूरा दस्तावेज़ पढ़ें
CLIMARA DS XV1.0, CCDS 16 Page 1 of 21 NEW ZEALAND DATA SHEET 1 PRODUCT NAME CLIMARA® _estradiol _ 2 QUALITATIVE AND QUANTITATIVE COMPOSITION CLIMARA 25 patch contains 2.0 mg of estradiol (equivalent to 2.0 mg estradiol hemihydrate) releasing a nominal 25 micrograms per 24 hours. CLIMARA 50 patch contains 3.8 mg of estradiol (equivalent to 3.9 mg estradiol hemihydrate) releasing a nominal 50 micrograms per 24 hours. CLIMARA 75 patch contains 5.7 mg of estradiol (equivalent to 5.9 mg estradiol hemihydrate) releasing a nominal 75 micrograms per 24 hours. CLIMARA 100 patch contains 7.6 mg of estradiol (equivalent to 7.8 mg estradiol hemihydrate) releasing a nominal 100 micrograms per 24 hours. For a list of excipients see 6.1 List of excipients. 3 PHARMACEUTICAL FORM The CLIMARA transdermal delivery system is a transparent oval patch containing estradiol in an acrylate adhesive matrix. 4 CLINICAL PARTICULARS 4.1 Therapeutic indications For short-term treatment of complaints associated with the menopause and post-menopause, including signs and symptoms of estrogen deficiency, whether naturally or surgically induced. Estrogen replacement therapy in women with an intact uterus should always be opposed by a progestogen in an adequate dosage regimen to ensure secretory transformation of the endometrium at regular intervals. Prevention of postmenopausal osteoporosis. For further information please refer to 5.1 Pharmacodynamic properties. 4.2 Dose and method of administration Hormonal contraception should be stopped when hormone replacement therapy (HRT) is started and the patient should be advised to take non-hormonal contraceptive precautions, if required. CLIMARA DS XV1.0, CCDS 16 Page 2 of 21 _Dosage Regimen _ Hormone replacement therapy should only be continued for as long as the benefit in alleviation of severe symptoms outweighs the risk for the individual woman. The need for continuing treatment should be reviewed periodically (e.g. at 6-monthly intervals). Treatment should be based on individual considerations (s पूरा दस्तावेज़ पढ़ें