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Albumin (Human)
Overview
What is Albumin (Human)?
ALBUMIN (HUMAN) 25% is a sterile, liquid preparation of albumin derived from large pools of human plasma. All units of human plasma used in the manufacture of ALBUMIN (HUMAN) 25% are provided by FDA approved blood establishments only.
The product is manufactured by cold ethanol fractionation followed by ultra- and diafiltration. The manufacturing process includes final container pasteurization and additional bulk pasteurization at 60 +/- 0.5°C for 10 – 11 hours. The ALBUMIN (HUMAN) 25% manufacturing process provides a significant viral reduction in in vitro studies (table 3). These reductions are achieved through a combination of process steps including Cohn fractionation and final container pasteurization.
No procedure, however, has been shown to be completely effective in removing viral infectivity from derivatives of human plasma. [see Warnings and Precautions, Infection Risk from Human Plasma (5.7)]
Table 3 In vitro reduction factor during ALBUMIN (HUMAN) 25% manufacturing
PRV: Pseudorabies Virus
SBV: Sindbis Virus
HIV-1: Human Immunodeficiency Virus - 1
Reo 3: Reovirus Type 3
PPV: Porcine Parvovirus
HAV: Hepatitis A Virus
ALBUMIN (HUMAN) 25% is a clear, slightly viscous liquid; it is almost colorless or slightly yellow or green.
The composition of ALBUMIN (HUMAN) 25% is as follows:
ALBUMIN (HUMAN) 25% contains no preservatives and components used in its packaging are latex-free.
What does Albumin (Human) look like?
What are the available doses of Albumin (Human)?
12.5 g in 50 mL infusion bottle (3)
25 g in 100 mL infusion bottle (3)
What should I talk to my health care provider before I take Albumin (Human)?
Pregnancy: No human or animal data. Use only if needed. (8.1)
Pediatric use: The product should only be administered to pediatric patients if needed. (8.4)
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How should I use Albumin (Human)?
ALBUMIN (HUMAN) 25% is indicated in the emergency treatment of hypovolemia with or without shock. Its effectiveness in reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. When blood volume deficit is the result of hemorrhage, compatible red blood cells or whole blood should be administered as quickly as possible. [1, 2]
When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 20% - 25% albumin solutions should be used. [
]
General Recommendations
The concentration of the albumin preparation, dosage and the infusion rate should be adjusted to the patient’s individual requirements.
The dose required depends on the body weight of the patient, the severity of trauma or illness and on continuing fluid and protein losses. Measures of adequacy of circulating volume and not plasma albumin levels should be used to determine the dose required.
The daily dose should not exceed 2 g of ALBUMIN (HUMAN) 25% per kg of body weight.
Hypovolemia
In adults, an intravenous infusion of 25 g should be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
In spite of limited information about the efficacy in pediatric subjects, an intravenous infusion of 2.5 to 12.5 g or 0.5 to 1 g/kg body weight may be given. If adequate response (stabilization of circulation) is not achieved within 15 to 30 minutes, an additional dose may be given.
Hemodilution may follow administration of ALBUMIN (HUMAN) 25%. If hemorrhage has occurred, this may result in relative anemia. This condition should be controlled by the supplemental administration of compatible red blood cells or compatible whole blood.
Hypoalbuminemia
In adults, intravenous infusion of 50 to 75 g of ALBUMIN (HUMAN) 25% may be used. Hypoalbuminemia is usually accompanied by a hidden extravascular albumin deficiency of equal magnitude. This total body albumin deficit must be considered when determining the amount of albumin necessary to reverse the hypoalbuminemia.
In burns, therapy usually starts with the administration of large volumes of crystalloid injection to maintain plasma volume. After 24 hours, ALBUMIN (HUMAN) 25% may be added at an initial dose of 25 g with the dose adjusted thereafter to maintain a plasma protein concentration of 2.5 g per 100 mL or a serum protein concentration of 5.2 g/100 mL.
Prevention of Central Volume Depletion after Paracentesis due to Cirrhotic Ascites
In adults, intravenous infusion of 8 g of ALBUMIN (HUMAN) 25% may be given for every 1,000 mL of ascitic fluid removed.
Ovarian Hyperstimulation Syndrome
In adults, as a guideline, doses of 50 – 100 g of ALBUMIN (HUMAN) 25% should be infused over 4 hours and repeated at 4- to 12-hour intervals as necessary, when infusion of normal saline fails to achieve or maintain hemodynamic stability and urine output. [
]
Adult Respiratory Distress Syndrome (ARDS)
In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused over 30 minutes and repeated at 8 hour intervals for 3 days, if necessary. [
]
Induction of Diuresis in Patients with Acute Nephrosis
In adults, a dose of 25 g of ALBUMIN (HUMAN) 25% can be infused, administered with an appropriate diuretic once a day for 7 to 10 days.
Hemolytic Disease of the Newborn
ALBUMIN (HUMAN) 25% may be administered prior to or during exchange transfusion at a dose of 1 g per kilogram body weight. [
]
What interacts with Albumin (Human)?
Sorry No Records found
What are the warnings of Albumin (Human)?
Sorry No Records found
What are the precautions of Albumin (Human)?
Sorry No Records found
What are the side effects of Albumin (Human)?
Sorry No records found
What should I look out for while using Albumin (Human)?
Do not use in individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.
What might happen if I take too much Albumin (Human)?
Sorry No Records found
How should I store and handle Albumin (Human)?
Procedures for proper handling and disposal should be considered. Consideration should be given to handling and disposal according to guidelines issued for cytotoxic drugs. Several guidelines on this subject have been published. Caution should be exercised in the handling and preparation of Fludarabine Phosphate Injection solution. The use of latex gloves and safety glasses is recommended to avoid exposure in case of breakage of the vial or other accidental spillage. If the solution contacts the skin or mucous membranes, wash thoroughly with soap and water; rinse eyes thoroughly with plain water. Avoid exposure by inhalation or by direct contact of the skin or mucous membranes. ALBUMIN (HUMAN) 25% is supplied in 12.5 g in 50 mL or 25.0 g in 100 mL single use bottles. ALBUMIN (HUMAN) 25% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid. ALBUMIN (HUMAN) 25% is supplied in 12.5 g in 50 mL or 25.0 g in 100 mL single use bottles. ALBUMIN (HUMAN) 25% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid. ALBUMIN (HUMAN) 25% is supplied in 12.5 g in 50 mL or 25.0 g in 100 mL single use bottles. ALBUMIN (HUMAN) 25% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid. ALBUMIN (HUMAN) 25% is supplied in 12.5 g in 50 mL or 25.0 g in 100 mL single use bottles. ALBUMIN (HUMAN) 25% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid. ALBUMIN (HUMAN) 25% is supplied in 12.5 g in 50 mL or 25.0 g in 100 mL single use bottles. ALBUMIN (HUMAN) 25% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid. ALBUMIN (HUMAN) 25% is supplied in 12.5 g in 50 mL or 25.0 g in 100 mL single use bottles. ALBUMIN (HUMAN) 25% may be stored for 36 months at +2°C to + 25°C (36°F to 77°F) from the date of manufacture. Store protected from light. Do not freeze. Do not use after expiration date. Do not use if turbid.
Clinical Information
Chemical Structure
No Image foundClinical Pharmacology
Albumin is responsible for 75-80% of the colloid osmotic pressure of normal plasma. Albumin stabilizes circulating blood volume and is a carrier of hormones, enzymes, medicinal products and toxins. [
]
Albumin is a protein with a total extravascular mass of approximately 160 g and an intravascular mass of about 120 g. [
]
Non-Clinical Toxicology
Do not use in individuals who are hypersensitive to albumin preparations, any ingredient in the formulation, or components of the container.Usage with Alcohol:
Hypersensitivity or allergic reactions have been observed, and may in some cases progress to severe anaphylaxis. Epinephrine should be available immediately to treat any acute hypersensitivity reaction.
Reference
This information is obtained from the National Institute of Health's Standard Packaging Label drug database.
"https://dailymed.nlm.nih.gov/dailymed/"
While we update our database periodically, we cannot guarantee it is always updated to the latest version.
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