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

jubilant draximage inc - albumin aggregated (unii: 799c8vf17r) (albumin aggregated - unii:799c8vf17r) - albumin aggregated 2.5 mg - draximage maa, after radiolabeling with sodium pertechnetate tc 99m, is indicated for: - lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in adults and pediatric patients. - peritoneovenous shunt scintigraphy as an aid in the evaluation of its patency in adult patients. draximage maa is contraindicated in patients with: - severe pulmonary hypertension [see warnings and precautions (5.1)]. - a history of hypersensitivity to albumin human.reactions have included anaphylaxis [see warnings and precautions (5.2)] . risk summary   available data with technetium tc 99m albumin aggregated injection use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects and miscarriage. animal reproduction studies with technetium tc 99m albumin aggregated have not been conducted radiopharmaceuticals have the potential to cause fetal harm depending on the fetal stage of development and the magnitude of the radiation dose. the radiation exposure to the fetus from technetium tc 99m albumin aggregated is expected to be low (less than 0.5 mgy) (see data). the estimated background risk of major birth defects and miscarriage for the indicated population is unknown. all pregnancies have a background risk of birth defects, loss, or other adverse outcomes. in the u.s. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies are 2% to 4% and 15% to 20%, respectively. data human data no adverse fetal effects of radiation risks have been identified for diagnostic procedures involving less than 50 mgy, which represents less than 10 mgy fetal doses. risk summary technetium-99m is present in breast milk. there are no data on the effects of technetium tc 99m albumin aggregated on the breastfed infant or the effects on milk production. draximage maa is used for imaging in infants with lung disease; exposure to technetium-99m via breastmilk is expected to be lower. based on clinical guidelines, exposure of technetium tc 99m albumin aggregated to a breastfed infant may be minimized by advising a lactating woman to temporarily discontinue breastfeeding and to pump and discard breast milk for a minimum of at least 24 hours after administration of technetium tc 99m albumin aggregated injection. the developmental and health benefits of breastfeeding should be considered along with a mother’s clinical need for draximage maa, any potential adverse effects on the breastfed child from technetium tc 99m albumin aggregated or from the underlying maternal condition. draximage maa, after radiolabeling with technetium-99m, is indicated for lung scintigraphy as an adjunct in the evaluation of pulmonary perfusion in pediatric patients (birth to less than 17 years of age). the safety profile of technetium tc 99m albumin aggregated injection in pediatric patients is similar to adults. the safety and efficacy of draximage maa have not been established for peritoneovenous shunt scintigraphy in pediatric patients.  no formal studies of draximage maa in subjects aged 65 and over were performed to determine whether they respond differently from younger adult subjects. other reported clinical experience has not identified differences in responses between the elderly and younger adult patients. in general, dose selection for an elderly patient should be cautious; administering the low end of the particle dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

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

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 10 g in 50 ml - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. albutein® 20% can be used in such cases.1 albutein 20% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid.4,5,6 albutein 20% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics.1,2,7 albutein 20% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when albumin deficit is the result of excessive protein lo

Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin detemir, quantity: 100 u/ml - injection, solution - excipient ingredients: glycerol; sodium hydroxide; dibasic sodium phosphate dihydrate; water for injections; hydrochloric acid; zinc acetate; metacresol; phenol; sodium chloride - treatment of diabetes mellitus. (see 'pharmacology' and 'clinical trials.')

Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin detemir, quantity: 100 u/ml - injection, solution - excipient ingredients: phenol; glycerol; dibasic sodium phosphate dihydrate; metacresol; hydrochloric acid; zinc acetate; water for injections; sodium hydroxide; sodium chloride - treatment of diabetes mellitus. (see 'pharmacology' and 'clinical trials.')

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

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 12.5 g in 50 ml - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used. [1,2,3] acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. albutein 25% can be used in such cases. [1] albutein 25% may be of value in the treatment of shock or hypotension in renal dialysis patients. [1] preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid. [4,5,6] albutein 25% may be used to treat peripheral edema in patients with acute nephrosis who are refractory to cyclophosphamide, corticosteroid therapy or diuretics. [1,2,7] albutein 25% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when albumin deficit is the result of excessi

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

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - albumin human 12.5 g in 250 ml - for restoration and maintenance of circulating blood volume where hypovolemia is demonstrated and colloid use is appropriate. when hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20-25% albumin solutions should be used.1,2,3 acute liver failure is a special situation in which both hypovolemia and hypoalbuminemia can be present. albutein 5% can be used in such cases.1 albutein 5% may be of value in the treatment of shock or hypotension in renal dialysis patients.1 preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass procedures. albumin also may be used in the priming fluid.4,5,6 albutein 5% may be indicated for subjects with hypoalbuminemia who are critically ill and/or actively bleeding. when albumin deficit is the result of excessive protein loss, the effect of albutein 5% administration will be temporary unless the underlying disorder is reversed.7,8,9 septic patients and patients undergoing major surgery may

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 200 g/l - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 50 g/l - blood substitutes and perfusion solutions

Malta - English - Medicines Authority

baxalta innovations gmbh industriestrasse 67, 1221, vienna, austria - albumin, human - solution for infusion - albumin, human 200 g/l - blood substitutes and perfusion solutions

Australia - English - Department of Health (Therapeutic Goods Administration)

novo nordisk pharmaceuticals pty ltd - insulin aspart, quantity: 180 nmol/ml; insulin degludec, quantity: 420 nmol/ml - injection, solution - excipient ingredients: zinc acetate; phenol; hydrochloric acid; sodium chloride; metacresol; water for injections; sodium hydroxide; glycerol - for use in diabetes mellitus in patients aged 6 years and older.