Ireland - English - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human albumin solution - solution for infusion - 200 gram(s)/litre - albumin

Ireland - English - HPRA (Health Products Regulatory Authority)

instituto grifols s.a. - human albumin solution - solution for infusion - 50 gram(s)/litre - albumin

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: gb distributors, inc.; distributor: n/a - human albumin - solution for injection for infusion (iv) - 0.05

Philippines - English - FDA (Food And Drug Administration)

n/a; importer: gb distributors, inc.; distributor: n/a - human albumin - solution for injection for infusion (iv) - 0.25

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

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - 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 excessive protein loss, the effect of albutein 25% administration will be temporary unless the underlying disorder is reversed.8,9,10 septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,11 treatment with albutein 25% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1 in the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. beyond 24 hours, albutein 25% can be used to maintain plasma colloid osmotic pressure.2,12,13 protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.14,15 albutein 25% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17 albutein 25% is indicated for the treatment of neonatal hyperbilirubinemia. it may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.18,19,20 albutein 25% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ards.6,21 albutein 25% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.2,22,23,24 - hypersensitivity to albumin preparations or to any of the excipients. - severe anemia or cardiac failure with normal or increased intravascular volume.x risk summary there is no data with albutein 25% use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with albutein 25%. it is not known whether albutein 25% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. albutein 25% should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of albutein 25% in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albutein 25% and any potential adverse effects on the breastfed infant from albutein 25%.     no human or animal data. use only if clearly needed. no human or animal data. use only if clearly needed.

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

grifols usa, llc - albumin human (unii: zif514rvzr) (albumin human - unii:zif514rvzr) - 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 loss, the effect of albutein 20% administration will be temporary unless the underlying disorder is reversed.8,9,10  septic patients and patients undergoing major surgery may lose more than half of their circulating plasma volume.1,11 treatment with albutein 20% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1   in the first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. beyond 24 hours, albutein 20% can be used to maintain plasma colloid osmotic pressure.2,12,13  protein loss from the third space due to infection (acute peritonitis, pancreatitis, mediastinitis or extensive cellulitis) may require treatment with an infusion of albumin.14,15 albutein 20% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17 albutein 20% is indicated for the treatment of neonatal hyperbilirubinemia. it may be used prior to or during an exchange procedure in an attempt to bind free bilirubin and enhance its excretion.18,19,20 albutein 20% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ards.6,21 albutein 20% may be used to maintain cardiovascular function following removal of large volumes of ascitic fluid after paracentesis due to cirrhotic ascites.2,22,23,24 - hypersensitivity to albumin preparations or to any of the excipients. - severe anemia or cardiac failure with normal or increased intravascular volume. risk summary   there is no data with albutein 20% use in pregnant women to inform a drug-associated risk. animal reproduction studies have not been conducted with albutein 20%. it is not known whether albutein 20% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. albutein 20% should be given to a pregnant woman only if clearly needed. in the u.s. general population, the estimated background risk of major birth defect and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. risk summary there is no information regarding the presence of albutein 20% in human milk, the effect on the breastfed infant, or the effects on milk production. the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for albutein 20% and any potential adverse effects on the breastfed infant from albutein 20%. no human or animal data.  use only if clearly needed.  no human or animal data.  use only if clearly needed. 

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

grifols uk ltd - albumin solution human - solution for infusion - 50mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

grifols uk ltd - albumin solution human - solution for infusion - 50mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

grifols uk ltd - albumin solution human - solution for infusion - 200mg/1ml

United Kingdom - English - MHRA (Medicines & Healthcare Products Regulatory Agency)

grifols uk ltd - albumin solution human - solution for infusion - 200mg/1ml