Human Albumin Grifols
Loading...Human Albumin Grifols Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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. Human Albumin Grifols® 25% can be used in such cases.1
Human Albumin Grifols 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
Human Albumin Grifols 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
Human Albumin Grifols 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 Human Albumin Grifols 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 Human Albumin Grifols 25% may be of value in such cases, especially when plasma colloid oncotic pressure is abnormally low.1 In first 24 hours after thermal injury, large volumes of crystalloids are infused to restore the depleted extracellular fluid volume. Beyond 24 hours, Human Albumin Grifols 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
Human Albumin Grifols 25% may be used as a plasma volume expander in fluid management relating to severe forms of ovarian hyperstimulation syndrome.16,17
Human Albumin Grifols 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
Human Albumin Grifols 25% infusions may be indicated in conjunction with diuretics to correct fluid overload and hypoproteinemia associated with ARDS.6,21
Human Albumin Grifols 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
History
There is currently no drug history available for this drug.
Other Information
Human Albumin Grifols 25% is a sterile aqueous solution for single dose intravenous administration containing 25% human albumin (weight/volume). Human Albumin Grifols 25% is prepared by a cold alcohol fractionation method from pooled human plasma obtained from venous blood. The product is stabilized with 0.08 millimole sodium caprylate and 0.08 millimole sodium acetyltryptophanate per gram of protein. The colloid osmotic effect of human albumin 25% is approximately five times that of normal human plasma.
A liter of Human Albumin Grifols 25% solution contains 130-160 milliequivalents of sodium ion. The aluminium content of the solution is not more than 200 micrograms per liter during the shelf life of the product.
The product contains no preservatives. Human Albumin Grifols 25% is manufactured from Source Plasma collected from FDA approved plasmapheresis centers in the United States. Human Albumin Grifols 25% is heated at 60 °C for ten hours against the possibility of transmitting viruses.
Sources
Human Albumin Grifols Manufacturers
-
Grifols Usa, Llc
![Human Albumin Grifols (Albumin (Human)) Solution [Grifols Usa, Llc]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Human Albumin Grifols | Grifols Usa, Llc
For Intravenous Use Only
2.1 DosageAdjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.
The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication Dose Hypovolemia Adults: Initial dose of 25 g.
If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of Human Albumin Grifols 25%.
Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.
For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per min is usually indicated.
For renal dialysis, the initial dose should not exceed 25 g and patients should be carefully observed for signs of fluid overload. Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. Acute nephrosis Adults: 25 g together with diuretic once a day for 7 - 10 days. Hypoalbuminemia Adults: 50 to 75 g
For pre- and post-operative hypoproteinemia: 50 to 75 g.
In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL.
Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. Ovarian hyperstimulation syndrome Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. Neonatal hyperbilirubinemia 1 g per kilogram body weight prior to or during exchange transfusion. Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed. 2.2 AdministrationIntravenous use only
Human Albumin Grifols 25% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle. Do not freeze. Warm product to room temperature before use if large volumes are administered. Human Albumin Grifols 25% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. Do not dilute with sterile water for injections. The product can be diluted in an isotonic solution (e.g., 5% Dextrose in Water or 0.9% sodium chloride) [see Warnings and Precautions (5.7)]. Adjust the infusion rate to the individual circumstances and the indication. -
Grifols Usa, Llc
Human Albumin Grifols | Grifols Usa, Llc
For Intravenous Use Only
2.1 DosageAdjust the concentration, dosage and infusion rate of the albumin preparation to the patient's individual requirements.
The dose required depends on the patient's body weight, severity of injury/illness and on continuing fluid and protein losses. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required.
Indication Dose Hypovolemia Adults: Initial dose of 20 g.
If hemodynamic stability is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of Human Albumin Grifols 20%.
Anemia resulting from hemorrhage should be corrected by administration of compatible red blood cells or compatible whole blood.
For acute liver failure: initial dose of 12 to 25 g. An infusion rate of 1-2 mL per min is usually indicated.
For renal dialysis, the initial dose should not exceed 20 g and patients should be carefully observed for signs of fluid overload. Cardiopulmonary bypass procedures Adults: Initial dose of 25 g. Additional amounts may be administered as clinically indicated. Acute nephrosis Adults: 25 g together with diuretic once a day for 7 - 10 days. Hypoalbuminemia Adults: 50 to 75 g.
For pre- and post-operative hypoproteinemia: 50 to 75 g.
In burns, therapy usually starts with administration of large volumes of crystalloid solution to maintain plasma volume. After 24 hours: initial dose of 25 g and dose adjustment to maintain plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g per 100 mL.
Third space protein loss due to infection: initial dose of 50 to 100 g. An infusion rate of 1-2 mL per minute is usually indicated in the absence of shock. Treatment should always be guided by hemodynamic response. Ovarian hyperstimulation syndrome Adults: 50 g to 100 g over 4 hours and repeated at 4-12 hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. Neonatal hyperbilirubinemia 1 g per kilogram body weight prior to or during exchange transfusion. Adult respiratory distress syndrome (ARDS) Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days, if necessary. Prevention of central volume depletion after paracentesis due to cirrhotic ascites Adults: 8 g for every 1000 mL of ascitic fluid removed. 2.2 AdministrationIntravenous use only
Human Albumin Grifols 20% is a clear and slightly viscous solution. Visually inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. Do not use if the solution is turbid or if there is sediment in the bottle. Do not freeze. Warm product to room temperature before use if large volumes are administered. Human Albumin Grifols 20% contains no preservatives. Do not begin administration more than 4 hours after the container has been entered. Discard unused portion. Do not dilute with sterile water for injection. The product can be diluted in an isotonic solution (e.g., 5% Dextrose in Water or 0.9% sodium chloride) [see Warnings and Precautions (5.7)]. Adjust the infusion rate to the individual circumstances and the indication.
![Human Albumin Grifols (Albumin (Human)) Solution [Grifols Usa, Llc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a43c5ed6-7423-4ee5-8acb-5fccc2d7b6cc&name=huma1-0006-01.jpg)
Login To Your Free Account