Buminate 5% (Albumin) - Summary

BUMINATE 5% SUMMARY

BUMINATE 5%, Albumin (Human), 5% Solution, is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin and was prepared from human venous plasma using the Cohn cold ethanol fractionation process. Source material for fractionation may be obtained from another U.S. licensed manufacturer. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and has been stabilized with sodium acetyltryptophanate and sodium caprylate. The sodium content is 145 ± 15 mEq/L. The solution contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. BUMINATE 5%, Albumin (Human), 5% Solution, is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color.

BUMINATE 5% Solution is indicated for the following:

1. Hypovolemia
   Hypovolemia is a possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Its effectiveness in reversing hypovolemia depends largely upon its colloid osmotic pressure. Although crystalloid solutions and colloid-containing plasma substitutes can be used in emergency treatment of shock, Albumin (Human) has a longer intravascular half-life than crystalloid solutions.⁹
   When the hypovolemia is long-standing and hypoalbuminemia exists accompanied by adequate hydration or edema, treatment with BUMINATE 25%, Albumin (Human), 25% Solution, is preferable.^4,6
   When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible.
2. Hypoalbuminemia
   1. General
      Hypoalbuminemia is another possible indication for use of BUMINATE 5%, Albumin (Human), 5% Solution. Hypoalbuminemia can result from one or more of the following:⁵
      1. Inadequate production (malnutrition, burns, major injury, infections, etc.)
      2. Excessive catabolism (burns, major injury, pancreatitis, etc.)
      3. Loss from the body (hemorrhage, excessive renal excretion, burn exudates, etc.)
      4. Redistribution within the body (major surgery, various inflammatory conditions, etc.)
      
      When albumin deficit is the result of excessive protein loss, the effect of administration of albumin will be temporary unless the underlying disorder is reversed. In most cases, increased nutritional replacement of amino acids and/or protein with concurrent treatment of the underlying disorder will restore normal plasma albumin levels more effectively than administration of albumin solutions. Occasionally hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis cannot be quickly reversed and nutritional supplements may fail to restore adequate plasma albumin levels. In these cases, BUMINATE 5%, Albumin (Human), 5% Solution, may be useful.
   2. Burns
      In conjunction with appropriate crystalloid therapy, BUMINATE 5%, Albumin (Human), 5% Solution, may be useful for treatment of protein deficits after the initial 24-hour period following extensive burns.⁴
3. Miscellaneous Indications
   BUMINATE 5%, Albumin (Human), 5% Solution, may be indicated prior to or during cardiopulmonary bypass surgery, though the data do not indicate a clear-cut advantage over crystalloid solutions.^4,6,10

There is no valid reason for use of albumin as an intravenous nutrient.

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NEWS HIGHLIGHTS

Media Articles Related to Buminate 5% (Albumin)

Diabetic Nephropathy - Early intervention is the key
Source: The Doctors Lounge - Nephrology
Dr. Riham explains how annual screening for microalbuminuria in diabetic patients will allow early identification of nephropathy.

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Published Studies Related to Buminate 5% (Albumin)

Effect of modest salt reduction on blood pressure, urinary albumin, and pulse wave velocity in white, black, and Asian mild hypertensives. [2009.09]
A reduction in salt intake lowers blood pressure. However, most previous trials were in whites with few in blacks and Asians...

Effect of candesartan on microalbuminuria and albumin excretion rate in diabetes: three randomized trials. [2009.07.07]
BACKGROUND: Microalbuminuria in diabetes is strongly predictive of nephropathy, end-stage renal disease, and premature cardiovascular morbidity and mortality. Effective preventive therapies are therefore a clinical priority. OBJECTIVE: To determine whether the angiotensin-receptor blocker candesartan compared with placebo affects microalbuminuria incidence or rate of change in albuminuria in type 1 and type 2 diabetes... CONCLUSION: Candesartan, 32 mg/d, for 4.7 years did not prevent microalbuminuria in mainly normotensive patients with type 1 or type 2 diabetes.

Time-dependent variations in ischemia-modified albumin levels in mesenteric ischemia. [2009.06]
OBJECTIVES: The objective was to determine the value of ischemia-modified albumin (IMA) in the diagnosis of mesenteric embolism. The authors investigated whether or not plasma IMA levels rose in the acute period in a rat model of mesenteric ischemia and the related time-dependent changes... CONCLUSIONS: These preliminary findings suggest that serum IMA levels may represent a significant parameter in the early diagnosis of acute mesenteric ischemia and that further studies are necessary. (c) 2009 by the Society for Academic Emergency Medicine.

Albumin versus normal saline for dehydrated term infants with metabolic acidosis due to acute diarrhea. [2009.06]
To compare the efficacy of albumin to normal saline (NS) for initial hydration therapy for dehydrated term infants with severe metabolic acidosis due to acute diarrhea... CONCLUSION: Albumin was not more effective than NS for initial hydration treatment of dehydrated term infants with metabolic acidosis due to acute diarrhea.

Effect of Albumin Administration Prior to Exchange Transfusion in Term Neonates with Hyperbilirubinemia A Randomized Controlled Trial. [2009.05.20]
OBJECTIVE: To determine the role of intravenous administration of human albumin prior to blood exchange in term neonates for reduction of total serum bilirubin (TSB)... CONCLUSION: Infusion of 20% albumin (1 g/kg) one hour prior to blood exchange can significantly reduce the postexchange total serum bilirubin and duration of phototherapy.

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Clinical Trials Related to Buminate 5% (Albumin)

Sibling Oocyte Study of Medium for In Vitro Fertilization/Intracytoplasmic Sperm Injection (IVF/ICSI) With no Human Serum Albumine [Recruiting]
The purpose of this study is to determine if a new medium with no human serum albumine added is as good as the media conventionally used for IVF/ICSI.

Efficacy and Safety of Plasma Exchange With 5% Albutein in Beta-Amyloid Peptide Clearance in Cerebrospinal Fluid [Recruiting]
The purpose of this study is to evaluate the efficacy and safety of plasma exchange with 5% albumin in beta-amyloid peptide clearance in cerebrospinal fluid, and its effects in patients with mild-moderate Alzheimer's disease.

Voluven® in Paediatric Patients [Recruiting]
This study will compare the clinical efficacy and safety of Voluven® and Human Albumin during elective open-heart surgery in pediatric patients.

Use of Immune Globulin Intravenous (Human) To Treat Age-Related Macular Degeneration [Completed]
This study will evaluate visual improvement in patients treated with Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) or placebo who have Age-Related Macular Degeneration (AMD) with occult Choroidal Neovascularization (CNV).

Immune Globulin Intravenous (IGIV) To Treat Relapsing, Remitting Multiple Sclerosis [Completed]
The trial will study 2 doses of Immune Globulin Intravenous (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the number of relapses that occur in a 1 year treatment period.

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