国: オーストラリア
言語: 英語
ソース: Department of Health (Therapeutic Goods Administration)
conjugated estrogens, Quantity: 0.3 mg
Pfizer Australia Pty Ltd
conjugated estrogens
Tablet, film coated
Excipient Ingredients: sucrose; hyprolose; macrogol 400; Carnauba Wax; hypromellose; lactose monohydrate; microcrystalline cellulose; magnesium stearate; calcium phosphate; powdered cellulose; titanium dioxide; propylene glycol; purified water; isopropyl alcohol; polysorbate 80; quinoline yellow aluminium lake; indigo carmine aluminium lake
Oral
1 x 28 tablets, 3 x 28 tablets, 4 x 28 tablets, 2 x 28 tablets
(S4) Prescription Only Medicine
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. 1. PREMARIN is indicated as replacement therapy for oestrogen deficiency states associated with climacteric manifested by: a) Moderate to severe vasomotor symptoms associated with oestrogen deficiency in natural and surgical menopause (sweating, hot flushes). Periodic re-evaluation with a view to short term treatment is recommended. b) Atrophic vaginitis. When prescribing solely for the treatment of symptoms of vaginal atrophy, topical vaginal products should be considered. There is no evidence that oestrogens are effective for anxiety or depression without associated vasomotor symptoms, and they should not be used to treat such conditions. 2. PREMARIN is indicated for the prevention of postmenopausal osteoporosis in select patients. When prescribed solely for the prevention of postmenopausal osteoporosis, therapy should only be prescribed for women who are at high risk of osteoporosis and future fracture and who are intolerant of, or contraindicated for, non-oestrogen products approved for prevention of osteoporosis. Life style modifications and the risk benefit profile of PREMARIN should be taken into careful consideration and discussed with the patient, to allow the patient to make an informed decision prior to prescribing. (See PRECAUTIONS and DOSAGE AND ADMINISTRATION). 3. Hypoestrogenic states e.g. female hypogonadism, primary ovarian failure or female castration. See BOXED WARNING, particularly when considering PREMARIN for long-term usage.
Visual Identification: Green, oval, biconvex, coated tablets, marked "0.3" in white.; Container Type: Blister Pack; Container Life Time: 2 Years; Container Temperature: Store below 25 degrees Celsius
Licence status A
2012-05-28
PREMARIN ® _Conjugated estrogens Tablets_ CONSUMER MEDICINE INFORMATION WHAT IS IN THIS LEAFLET This leaflet answers some of the common questions about PREMARIN Tablets. It does not contain all of the available information. It does not take the place of talking to your doctor or pharmacist. All medicines have risks and benefits. Your doctor has weighed the risks of you taking PREMARIN against the benefits this medicine is expected to have for you. IF YOU HAVE ANY CONCERNS ABOUT THIS MEDICINE, ASK YOUR DOCTOR OR PHARMACIST. KEEP THIS LEAFLET WITH THE MEDICINE. You may need to read it again. WHAT PREMARIN IS USED FOR PREMARIN is a type of treatment called hormone replacement therapy (HRT) and contains the hormone estrogen in the form known as conjugated estrogens. PREMARIN helps to relieve the discomfort many women feel during and after menopause, including symptoms such as "hot flushes", sweating and vaginal dryness. It helps to prevent thinning of the bones (osteoporosis), which can cause fractures. PREMARIN is also used to treat women where either the ovary does not function properly or has been removed. If your doctor thinks you will need to take estrogens for a long time, including for the prevention of osteoporosis, he or she will have considered the benefits and risks of other treatments before prescribing PREMARIN for you. _HOW IT WORKS_ Menopause occurs naturally in women, typically between the ages of 45 and 55. During menopause, your body produces less estrogen than it did beforehand. This can cause symptoms such as "hot flushes". Some women also have problems with dryness of the vagina causing discomfort during or after sexual intercourse. Some women develop osteoporosis during or after menopause. This is a thinning of the bones making them weaker and more likely to break, especially the bones of the spine, hip and wrist. Conjugated estrogens are like the hormones produced by the ovaries before menopause. When given during or after menopause, they can help control the symptoms. Estrogen is used treat w 完全なドキュメントを読む
Version: pfppremt10220 Supersedes: pfppremt10417 Page 1 of 21 AUSTRALIAN PRODUCT INFORMATION – PREMARIN ® (CONJUGATED ESTROGENS) WARNING ENDOMETRIAL CANCER Adequate diagnostic measures, including endometrial sampling when indicated, should be undertaken to rule out malignancy in all cases of undiagnosed persistent or recurring abnormal vaginal bleeding (see Section 4.4 Special warnings and precautions for use, Malignant neoplasms, Endometrial cancer). CARDIOVASCULAR AND OTHER RISKS Estrogens with or without progestogens should not be used for the prevention of cardiovascular disease or dementia (see Sections 5.1 Pharmacodynamic properties, Clinical trials and 4.4 Special warnings and precautions for use, Cardiovascular risk and Dementia ). The estrogen-alone substudy of 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 7.1 years of treatment with conjugated estrogens (CE 0.625 mg) relative to placebo (see Sections 5.1 Pharmacodynamic properties, Clinical trials and 4.4 Special warnings and precautions for use, Cardiovascular risk). The estrogen plus progestogen substudy of the WHI 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 5.6 years of treatment with conjugated estrogens combined with medroxyprogesterone acetate (CE 0.625 mg/MPA 2.5 mg) relative to placebo (see Sections 5.1 Pharmacodynamic properties, Clinical trials and 4.4 Special warnings and precautions for use, Cardiovascular risk and Malignant neoplasms, Breast cancer). 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 5.2 years of treatment with CE alone and during 4 years of treatment with CE/MPA relative to placebo. It is unknown whether this finding applies to younger postmeno 完全なドキュメントを読む