Združene države Amerike - angleščina - NLM (National Library of Medicine)

zydus pharmaceuticals usa inc. - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 10 mg - metastatic breast cancer tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. adjuvant treatment of breast cancer tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whe

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - tamoxifen citrate 15.2mg equivalent to tamoxifen 10 mg;   - film coated tablet - 10 mg - active: tamoxifen citrate 15.2mg equivalent to tamoxifen 10 mg   excipient: hypromellose lactose monohydrate   macrogol 4000 magnesium stearate microcrystalline cellulose povidone sodium starch glycolate titanium dioxide

Nova Zelandija - angleščina - Medsafe (Medicines Safety Authority)

sandoz new zealand limited - tamoxifen citrate 30.4mg equivalent to tamoxifen 20 mg;   - film coated tablet - 20 mg - active: tamoxifen citrate 30.4mg equivalent to tamoxifen 20 mg   excipient: hypromellose lactose monohydrate   macrogol 4000 magnesium stearate microcrystalline cellulose povidone sodium starch glycolate titanium dioxide

Združene države Amerike - angleščina - NLM (National Library of Medicine)

cipla usa inc. - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] . raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)] . the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)] . twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not known. high risk of breast cancer is defined as at least one breast biopsy showing lobular carcinoma in situ (lcis) or

Združene države Amerike - angleščina - NLM (National Library of Medicine)

camber pharmaceuticals inc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment of osteoporosis in postmenopausal women [see clinical studies (14.1)]. raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (vte), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see warnings and precautions (5.1)]. raloxifene hydrochloride tablets are contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers [see use in specific populations (8.1, 8.3)]. raloxifene hydrochloride tablets may cause fetal harm when administered to a pregnant woman. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. in rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ), and hydrocephal

Združene države Amerike - angleščina - NLM (National Library of Medicine)

liberty pharmaceuticals, inc. - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment of osteoporosis in postmenopausal women [see clinical studies (14.1)]. raloxifene hydrochloride tablets are contraindicated in women with active or past history of venous thromboembolism (vte), including deep vein thrombosis, pulmonary embolism, and retinal vein thrombosis [see warnings and precautions (5.1)]. raloxifene hydrochloride tablets are contraindicated in pregnancy, in women who may become pregnant, and in nursing mothers [see use in specific populations (8.1, 8.3)]. raloxifene hydrochloride tablets may cause fetal harm when administered to a pregnant woman. if this drug is used during pregnancy, or if the patient becomes pregnant while taking this drug, the patient should be apprised of the potential hazard to the fetus. in rabbit studies, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred in rabbits at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ), and hydrocephal

Združene države Amerike - angleščina - NLM (National Library of Medicine)

american health packaging - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride 60 mg - raloxifene hydrochloride tablets, usp are indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)]. raloxifene hydrochloride tablets are indicated for the reduction in risk of invasive breast cancer in postmenopausal women at high risk of invasive breast cancer [see clinical studies (14.4)]. the effect in the reduction in the incidence of breast cancer was shown in a study of postmenopausal women at high risk for breast cancer with a 5-year planned duration with a median follow-up of 4.3 years [see clinical studies (14.4)]. twenty-seven percent of the participants received drug for 5 years. the long-term effects and the recommended length of treatment are not

Združene države Amerike - angleščina - NLM (National Library of Medicine)

bryant ranch prepack - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 20 mg - tamoxifen citrate tablets are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. tamoxifen citrate tablets are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen therapy is likely to be beneficial. t

Evropska unija - angleščina - EMA (European Medicines Agency)

teva b.v. - raloxifene hydrochloride - osteoporosis, postmenopausal - sex hormones and modulators of the genital system, - raloxifene is indicated for the treatment and prevention of osteoporosis in postmenopausal women. a significant reduction in the incidence of vertebral, but not hip fractures has been demonstrated.when determining the choice of raloxifene or other therapies, including oestrogens, for an individual postmenopausal woman, consideration should be given to menopausal symptoms, effects on uterine and breast tissues, and cardiovascular risks and benefits.

Združene države Amerike - angleščina - NLM (National Library of Medicine)

a-s medication solutions - tamoxifen citrate (unii: 7frv7310n6) (tamoxifen - unii:094zi81y45) - tamoxifen 10 mg - tamoxifen citrate tablets, usp are effective in the treatment of metastatic breast cancer in women and men. in premenopausal women with metastatic breast cancer, tamoxifen is an alternative to oophorectomy or ovarian irradiation. available evidence indicates that patients whose tumors are estrogen receptor positive are more likely to benefit from tamoxifen therapy. tamoxifen citrate tablets, usp are indicated for the treatment of node-positive breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. in some tamoxifen adjuvant studies, most of the benefit to date has been in the subgroup with four or more positive axillary nodes. tamoxifen citrate tablets, usp are indicated for the treatment of axillary node-negative breast cancer in women following total mastectomy or segmental mastectomy, axillary dissection, and breast irradiation. the estrogen and progesterone receptor values may help to predict whether adjuvant tamoxifen therapy is likely to be beneficial. tamoxifen reduces the occurrence of contralateral breast cancer in patients receiving adjuvant tamoxifen therapy for breast cancer. in women with dcis, following breast surgery and radiation, tamoxifen citrate tablets are indicated to reduce the risk of invasive breast cancer (see boxed warning at the beginning of the label). the decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen therapy. current data from clinical trials support 5 years of adjuvant tamoxifen therapy for patients with breast cancer. tamoxifen citrate tablets are indicated to reduce the incidence of breast cancer in women at high risk for breast cancer. this effect was shown in a study of 5 years planned duration with a median follow-up of 4.2 years. twenty-five percent of the participants received drug for 5 years. the longer-term effects are not known. in this study, there was no impact of tamoxifen on overall or breast cancer-related mortality (see boxed warning at the beginning of the label). tamoxifen citrate tablets are indicated only for high-risk women. “high risk” is defined as women at least 35 years of age with a 5-year predicted risk of breast cancer ≥1.67%, as calculated by the gail model. examples of combinations of factors predicting a 5-year risk ≥1.67% are: age 35 or older and any of the following combination of factors: - one first degree relative with a history of breast cancer, 2 or more benign biopsies, and a history of a breast biopsy showing atypical hyperplasia; or - at least 2 first degree relatives with a history of breast cancer, and a personal history of at least one breast biopsy; or - lcis age 40 or older and any of the following combination of factors: - one first degree relative with a history of breast cancer, 2 or more benign biopsies, age at first live birth 25 or older, and age at menarche 11 or younger; or - at least 2 first degree relatives with a history of breast cancer, and age at first live birth 19 or younger; or - one first degree relative with a history of breast cancer, and a personal history of a breast biopsy showing atypical hyperplasia. age 45 or older and any of the following combination of factors: - at least 2 first degree relatives with a history of breast cancer and age at first live birth 24 or younger; or - one first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, age at menarche 11 or less and age at first live birth 20 or more. age 50 or older and any of the following combination of factors: - at least 2 first degree relatives with a history of breast cancer; or - history of 1 breast biopsy showing atypical hyperplasia, and age at first live birth 30 or older and age at menarche 11 or less; or - history of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 30 or more. age 55 or older and any of the following combination of factors: - one first degree relative with a history of breast cancer with a personal history of a benign breast biopsy, and age at menarche 11 or less; or - history of at least 2 breast biopsies with a history of atypical hyperplasia, and age at first live birth 20 or older. age 60 or older and: - five-year predicted risk of breast cancer ≥1.67%, as calculated by the gail model. for women whose risk factors are not described in the above examples, the gail model is necessary to estimate absolute breast cancer risk. health care professionals can obtain a gail model risk assessment tool by dialing 1-888-838-2872. there are insufficient data available regarding the effect of tamoxifen on breast cancer incidence in women with inherited mutations (brca1, brca2) to be able to make specific recommendations on the effectiveness of tamoxifen citrate in these patients. after an assessment of the risk of developing breast cancer, the decision regarding therapy with tamoxifen for the reduction in breast cancer incidence should be based upon an individual assessment of the benefits and risks of tamoxifen citrate therapy. in the nsabp p-1 trial, tamoxifen treatment lowered the risk of developing breast cancer during the follow-up period of the trial, but did not eliminate breast cancer risk (see table 3 in clinical pharmacology ). tamoxifen citrate tablets are contraindicated in patients with known hypersensitivity to the drug or any of its ingredients. tamoxifen citrate tablets are contraindicated in women who require concomitant coumarin-type anticoagulant therapy or in women with a history of deep-vein thrombosis or pulmonary embolus.