United States - English - NLM (National Library of Medicine)

fenwal, inc. - sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sodium acetate (unii: 4550k0sc9b) (acetate ion - unii:569dqm74sc), trisodium citrate dihydrate (unii: b22547b95k) (anhydrous citric acid - unii:xf417d3psl), sodium phosphate, dibasic, unspecified form (unii: gr686lba74) (phosphate ion - unii:nk08v8k8hr), sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr) - rx only for use with the amicus separator only. store at controlled room temperature. protect from freezing. avoid excessive heat. definition of "controlled room temperature": "a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°c (68° to 77°f); that results in a mean kinetic temperature calculated to be not more than 25°c; and that allows for excursions between 15°c and 30°c (59° and 86°f) that are experienced in pharmacies, hospitals, and warehouses. provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°c are permitted as long as they do not exceed 24 hours ... the mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations." reference: united states pharmacopeia, general notices. united states pharmacopeial convention, inc. 12601 twinbrook parkway, rockville, md.

United States - English - NLM (National Library of Medicine)

fenwal, inc. - sodium chloride (unii: 451w47iq8x) (chloride ion - unii:q32zn48698), sodium acetate (unii: 4550k0sc9b) (acetate ion - unii:569dqm74sc), trisodium citrate dihydrate (unii: b22547b95k) (anhydrous citric acid - unii:xf417d3psl), sodium phosphate, dibasic (unii: gr686lba74) (phosphate ion - unii:nk08v8k8hr), sodium phosphate, monobasic, monohydrate (unii: 593yog76rn) (phosphate ion - unii:nk08v8k8hr) - rx only store at controlled room temperature. protect from freezing. avoid excessive heat. definition of "controlled room temperature": "a temperature maintained thermostatically that encompasses the usual and customary working environment of 20° to 25°c (68° to 77°f); that results in a mean kinetic temperature calculated to be not more than 25°c; and that allows for excursions between 15°c and 30°c (59° and 86°f) that are experienced in pharmacies, hospitals, and warehouses. provided the mean kinetic temperature remains in the allowed range, transient spikes up to 40°c are permitted as long as they do not exceed 24 hours ... the mean kinetic temperature is a calculated value that may be used as an isothermal storage temperature that simulates the non isothermal effects of storage temperature variations." reference: united states pharmacopeia, general notices. united states pharmacopeial convention, inc. 12601 twinbrook parkway, rockville, md. dispose of waste in appropriate biohaza

United States - English - NLM (National Library of Medicine)

remedyrepack inc. - olanzapine (unii: n7u69t4szr) (olanzapine - unii:n7u69t4szr) - oral olanzapine tablets are indicated for the treatment of schizophrenia. efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. in adolescent patients with schizophrenia (ages 13 to 17), efficacy was established in one 6-week trial [see clinical studies (14.1)] . when deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents [see warnings and precautions (5.5)] . monotherapy — oral olanzapine tablets are indicated for the acute treatment of manic or mixed episodes associated with bipolar i disorder an

United States - English - NLM (National Library of Medicine)

cadila pharmaceuticals limited - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] .  raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride is 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 hyperpl

United States - English - NLM (National Library of Medicine)

modavar pharmaceuticals llc - raloxifene hydrochloride (unii: 4f86w47br6) (raloxifene - unii:yx9162eo3i) - raloxifene hydrochloride is indicated for the treatment and prevention of osteoporosis in postmenopausal women [see clinical studies (14.1, 14.2)] .  raloxifene hydrochloride is indicated for the reduction in risk of invasive breast cancer in postmenopausal women with osteoporosis [see clinical studies (14.3)] . raloxifene hydrochloride is 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 hyperpl

Singapore - English - HSA (Health Sciences Authority)

grifols asia pacific pte. ltd. - human fibrinogen; human thrombin - solution - human fibrinogen 80 mg/ml; human thrombin 500 iu/ml

Canada - English - Health Canada

instituto grifols s.a. - fibrinogen (human); thrombin (human) - solution - 80mg; 500unit - fibrinogen (human) 80mg; thrombin (human) 500unit - hemostatics

Canada - English - Health Canada

instituto grifols s.a. - fibrinogen (human); thrombin (human) - solution - 160mg; 1000unit - fibrinogen (human) 160mg; thrombin (human) 1000unit - hemostatics

Canada - English - Health Canada

instituto grifols s.a. - thrombin (human); fibrinogen (human) - solution - 1500unit; 240mg - thrombin (human) 1500unit; fibrinogen (human) 240mg - hemostatics

Canada - English - Health Canada

instituto grifols s.a. - fibrinogen (human); thrombin (human) - solution - 400mg; 2500unit - fibrinogen (human) 400mg; thrombin (human) 2500unit - hemostatics