Malta - engelska - Medicines Authority

pfizer hellas s.a. 243 messoghion ave., neo psychiko 15451, athens, greece - estrogens conjugated - coated tablet - estrogens conjugated 0.625 mg - sex hormones and modulators of the genital system

USA - engelska - NLM (National Library of Medicine)

a-s medication solutions - estrogens, conjugated (unii: iu5qr144qx) (estrogens, conjugated - unii:iu5qr144qx) - limitation of use when prescribing solely for the treatment of moderate to severe symptoms of vulvar and vaginal atrophy due to menopause, topical vaginal products should be considered. limitation of use when prescribing solely for the prevention of postmenopausal osteoporosis, therapy should only be considered for women at significant risk of osteoporosis and non-estrogen medication should be carefully considered premarin therapy is contraindicated in individuals with any of the following conditions: premarin should not be used during pregnancy [see contraindications (4)] . there appears to be little or no increased risk of birth defects in children born to women who have used estrogens and progestins as an oral contraceptive inadvertently during early pregnancy. premarin should not be used during lactation. estrogen administration to nursing women has been shown to decrease the quantity and quality of the breast milk. detectable amounts of estrogens have been identified in the breast milk of mothers receiving estrogen-alone therapy. caution should be exercised when premarin is administered to a nursing woman. estrogen therapy has been used for the induction of puberty in adolescents with some forms of pubertal delay. safety and effectiveness in pediatric patients have not otherwise been established. large and repeated doses of estrogen over an extended time period have been shown to accelerate epiphyseal closure, which could result in short stature if treatment is initiated before the completion of physiologic puberty in normally developing children. if estrogen is administered to patients whose bone growth is not complete, periodic monitoring of bone maturation and effects on epiphyseal centers is recommended during estrogen administration. estrogen treatment of prepubertal girls also induces premature breast development and vaginal cornification, and may induce vaginal bleeding. in boys, estrogen treatment may modify the normal pubertal process and induce gynecomastia. there have not been sufficient numbers of geriatric patients involved in studies utilizing premarin to determine whether those over 65 years of age differ from younger subjects in their response to premarin. the women's health initiative study in the whi estrogen-alone substudy (daily ce 0.625 mg-alone versus placebo), there was a higher relative risk of stroke in women greater than 65 years of age [see clinical studies (14.5)] . in the whi estrogen plus progestin substudy (daily ce [0.625 mg] plus mpa [2.5 mg]), there was a higher relative risk of nonfatal stroke and invasive breast cancer in women greater than 65 years of age [see clinical studies (14.5)] . the women's health initiative memory study in the whims ancillary studies of postmenopausal women 65 to 79 years of age, there was an increased risk of developing probable dementia in women receiving estrogen-alone or estrogen plus progestin when compared to placebo [see warnings and precautions (5.3), and clinical studies (14.6)] . since both ancillary studies were conducted in women 65 to 79 years of age, it is unknown whether these findings apply to younger postmenopausal women8 [see warnings and precautions (5.3), and clinical studies (14.6)]. the effect of renal impairment on the pharmacokinetics of premarin has not been studied. the effect of hepatic impairment on the pharmacokinetics of premarin has not been studied.

USA - engelska - NLM (National Library of Medicine)

bryant ranch prepack - estrogens, esterified (unii: 3asp8q3768) (estrogens, esterified - unii:3asp8q3768), methyltestosterone (unii: v9efu16zif) (methyltestosterone - unii:v9efu16zif) - esterified estrogens and methyltestosterone full and half-strength tablets are indicated in the: esterified estrogens and methyltestosterone full and half-strength tablets should not be used in women with any of the following conditions: methyltestosterone should not be used in: methyltestosterone is classified as a schedule iii controlled substance under the anabolic steroids act of 1990.

Kanada - engelska - Health Canada

pfizer canada ulc - conjugated estrogens; bazedoxifene (bazedoxifene acetate) - tablet (immediate and extended release) - 0.45mg; 20mg - conjugated estrogens 0.45mg; bazedoxifene (bazedoxifene acetate) 20mg - estrogen agonist-antagonists

Storbritannien - engelska - MHRA (Medicines & Healthcare Products Regulatory Agency)

pfizer ltd - bazedoxifene acetate; conjugated oestrogens - modified-release tablet - 20mg ; 450microgram

Australien - engelska - Department of Health (Therapeutic Goods Administration)

pfizer australia pty ltd - conjugated estrogens, quantity: 0.3 mg - 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 - 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.

Kanada - engelska - Health Canada

searchlight pharma inc - esterified estrogens - tablet - 0.625mg - esterified estrogens 0.625mg - estrogens

Kanada - engelska - Health Canada

searchlight pharma inc - esterified estrogens - tablet - 0.3mg - esterified estrogens 0.3mg - estrogens

Kanada - engelska - Health Canada

wyeth canada - conjugated estrogens - tablet - 0.9mg - conjugated estrogens 0.9mg - estrogens

Kanada - engelska - Health Canada

pfizer canada ulc - conjugated estrogens - tablet - 0.3mg - conjugated estrogens 0.3mg - estrogens