USA - engelsk - NLM (National Library of Medicine)

northstar rx llc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets 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 atypical hyperplasia, one or more first-degree relatives with breast cancer, or a 5-year predicted risk of breast cancer ≥1.66% (based on the modified gail model). among the factors included in the modified gail model are the following: current age, number of first-degree relatives with breast cancer, number of breast biopsies, age at menarche, nulliparity or age of first live birth. healthcare professionals can obtain a gail model risk assessment tool by dialing 1-800-545-5979. currently, no single clinical finding or test result can quantify risk of breast cancer with certainty. after an assessment of the risk of developing breast cancer, the decision regarding therapy with raloxifene hydrochloride tablets should be based upon an individual assessment of the benefits and risks. raloxifene hydrochloride tablets does not eliminate the risk of breast cancer. patients should have breast exams and mammograms before starting raloxifene hydrochloride tablets and should continue regular breast exams and mammograms in keeping with good medical practice after beginning treatment with raloxifene hydrochloride tablets. important limitations of use for breast cancer risk reduction - there are no data available regarding the effect of raloxifene hydrochloride tablets on invasive breast cancer incidence in women with inherited mutations (brca1, brca2) to be able to make specific recommendations on the effectiveness of raloxifene hydrochloride tablets. - raloxifene hydrochloride tablets are not indicated for the treatment of invasive breast cancer or reduction of the risk of recurrence. - raloxifene hydrochloride tablets are not indicated for the reduction in the risk of noninvasive breast cancer. 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 is contraindicated for use in pregnancy, as it may cause fetal harm [see use in specific populations (8.1)] . risk summary raloxifene hydrochloride is contraindicated for use in pregnant women, and is not indicated for use in females of reproductive potential. based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has during all stages of pregnancy [see clinical pharmacology (12.1)] . limited data with raloxifene hydrochloride use in pregnant women are insufficient to inform any drug associated risks for births defects or miscarriage. in rabbits and rats dosed during organogenesis or during gestation and lactation, raloxifene hydrochloride produced multiple adverse reproductive and developmental effects, including abortion; fetal anomalies; and delayed or disrupted parturition leading to maternal and neonatal mortality, at doses less than or similar to the maximum recommended human dose (based on human body surface area comparison). data animal data in the developmental and reproductive toxicity studies conducted with raloxifene hydrochloride, numerous adverse effects were observed in multiple animal species. in rabbits dosed during organogenesis, abortion and a low rate of fetal heart anomalies (ventricular septal defects) occurred at doses ≥0.1 mg/kg (≥0.04 times the human dose based on surface area, mg/m2 ). in rats dosed during organogenesis, retardation of fetal growth and developmental abnormalities (wavy ribs, kidney cavitation) occurred at doses ≥1 mg/kg (≥0.2 times the human dose based on surface area, mg/m2 ). treatment of rats during gestation and lactation with doses of 0.1 to 10 mg/kg (0.02 to 1.6 times the human dose based on surface area, mg/m2 ) produced effects that included delayed and disrupted parturition, decreased neonatal survival and altered physical development, sex- and age-specific reductions in growth and changes in pituitary hormone content, and decreased lymphoid compartment size in offspring. at 10 mg/kg, the disruption of parturition resulted in maternal and progeny morbidity and death. effects in adult offspring (4 months of age) included uterine hypoplasia and reduced fertility; however, no ovarian or vaginal pathology was observed. risk summary raloxifene hydrochloride is not indicated for use in females of reproductive potential. there is no information on the presence of raloxifene in human milk, the effects on the breastfed child, or the effects on milk production. however, based on mechanism of action, raloxifene hydrochloride may block the important functions that estrogen has in mammary tissue during lactation [see clinical pharmacology (12.1)] . safety and effectiveness in pediatric patients have not been established. of the total number of patients in placebo-controlled clinical studies of raloxifene hydrochloride, 61% were 65 and over, while 15.5% were 75 and over. no overall differences in safety or effectiveness were observed between these subjects and younger subjects, and other reported clinical experience has not identified differences in responses between the elderly and younger patients, but greater sensitivity of some older individuals cannot be ruled out. based on clinical trials, there is no need for dose adjustment for geriatric patients [see clinical pharmacology (12.3)] . raloxifene hydrochloride should be used with caution in patients with moderate or severe renal impairment [see warnings and precautions (5.8) and clinical pharmacology (12.3)] . raloxifene hydrochloride should be used with caution in patients with hepatic impairment [see warnings and precautions (5.5) and clinical pharmacology (12.3)] .

USA - engelsk - NLM (National Library of Medicine)

bryant ranch prepack - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride tablets 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 atyp

Den Europæiske Union - engelsk - EMA (European Medicines Agency)

instituto grifols, s.a. - human fibrinogen, human thrombin - hemostasis, surgical - antihemorrhagics - supportive treatment in adults where standard surgical techniques are insufficient:for improvement of haemostasisas suture support in vascular surgery

USA - engelsk - NLM (National Library of Medicine)

grifols usa, llc - fibrinogen human (unii: n94833051k) (fibrinogen human - unii:n94833051k) - vistaseal is indicated as an adjunct to hemostasis for mild to moderate bleeding in adults undergoing surgery when control of bleeding by standard surgical techniques (such as suture, ligature, and cautery) is ineffective or impractical. vistaseal is effective in heparinized patients. - do not inject directly into the circulatory system. [see warnings and precautions (5.1)] - do not use for the treatment of severe or brisk arterial bleeding. in these situations, blood flow will wash away vistaseal and prevent hemostasis. - do not use vistaseal in patients known to have anaphylactic or severe systemic hypersensitivity reactions to the administration of human blood products. [see warnings and precautions (5.2)] - do not use vistaseal for spraying unless the minimum recommended distance from the applicator tip to the bleeding site can be achieved. [see dosage and administration (2.3)] risk summary there are no available data with vistaseal use in pregnant women. animal reproduction studies have not been perfo

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

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

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

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

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

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

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

grifols australia pty ltd - human thrombin, quantity: 500 iu/ml - application - excipient ingredients: - veraseal is used as supportive treatment in adults where standard surgical techniques are insufficient, for improvement of hemostasis.

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

ausmedic australia pty ltd - 36754 - bath, water - a water bath consisting of a heater and thermostat used to heat and maintain water temperature for the purpose of heating therapeutic heat packs.

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

djo global pty ltd - 36754 - bath, water - a bath designed with a heating element and thermostat which uses water as a heating medium. this is used to raise the temperature of objects placed in the bath, or it can be used to supply tempered water to other laboratory equipment using a pump.