Država: Australija
Jezik: engleski
Izvor: Department of Health (Therapeutic Goods Administration)
estradiol valerate, Quantity: 2 mg
Bayer Australia Ltd
Tablet, sugar coated
Excipient Ingredients: magnesium stearate; indigo carmine; macrogol 6000; sucrose; glycol montanate; titanium dioxide; calcium carbonate; povidone; maize starch; lactose monohydrate; glycerol; purified talc
Oral
2 x 28 tablets
Medicine Registered
(S4) Prescription Only Medicine
INDICATIONS AS AT 19 July 2004: Short term treatment of climacteric complaints after the cessation of monthly bleeding, or deficiency symptoms after oophorectomy or radiological castration for non-carcinomatous diseases, such as hot flushes, outbreaks of sweat, sleep disturbances, depressive moods, irritability, headaches, dizziness. Progynova has also a favourable influence on bladder irritation (a not infrequent occurrence in the climacteric), signs of cutaneous and mucosal involution (particularly in the genital region) which normally occur with advancing age.
Visual Identification: Pale blue sugar coated tablet; Container Type: Blister Pack; Container Material: PVC/Al; Container Life Time: 24 Months; Container Temperature: Store below 25 degrees Celsius
Registered
1991-08-19
PROGYNOVA ® CMI 1 CONSUMER MEDICINE INFORMATION PROGYNOVA ® _ _ _estradiol valerate_ WARNING The Women’s Health Initiative (WHI) trial examined the health benefits and risks of combined _estrogen _ _plus progestogen_ therapy (n=16,608) and _ estrogen-alone_ therapy (n=10,739) in postmenopausal women aged 50 to 79 years. The _ estrogen 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 _ estrogen-alone_ arm of the WHI trial indicated an increased risk of_ stroke and deep vein _ _thrombosis _in hysterectomized women treated with CEE-alone (0.625 mg/day) for 6.8 years compared to those receiving placebo. Other doses of oral conjugated estrogens with 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. Therefore, the following should be given serious consideration at the time of prescribing: • Estrogens with or without progestogens should not be prescribed for primary or secondary prevention of cardiovascular diseases. • Estrogens with or without progestogens should be prescribed at the lowest effective dose for the approved indication. • Estrogens with or without progestogens should be prescribed for the shortest period possible for the approved indication. • For the prevention of osteoporosis, estrogen treatment should be considered in light of other available therapies. PROGYNOVA ® CMI 2 PROGYNOVA ® (PRO·GUY·NO·VA) _estradiol valerate _ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about Progynova tablets. It does not contain all of t Pročitajte cijeli dokument
PROGYNOVA PI 1 AUSTRALIAN PRODUCT INFORMATION PROGYNOVA ® (ESTRADIOL VALERATE) TABLETS 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 Clinical trials and 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 estrogen s (0.625 mg) combined with medroxyprogesterone acetate (2.5 mg) relative to placebo (see Clinical trials and 4.4 Special warnings and precautions for use). 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 estrogens, with or without medroxyprogesterone acetate, relative to placebo. It is unknown whether this finding applies to younger postmenopausal women (see Clinical trials and 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 valerate 2 QUALITATIVE AND QUANTITATIVE COMPOSITION PROGYNOVA 1 mg: each tablet contains 1 mg estradiol valerate. PROGYNOVA 2 mg: each tablet contains 2 mg estra Pročitajte cijeli dokument