Data from FDA - Curated by Toby Galbraith - Last updated 15 May 2017

Licensing authority

FDA (Food and Drug Administration, USA)

Indication(s)

KEDBUMIN is a 25% albumin solution indicated for:
- Hypovolemia (1.1) and Hypoalbuminemia (1.2)
- Prevention of central volume depletion after paracentesis due to cirrhotic ascites (1.3)
- Ovarian hyperstimulation syndrome (OHSS) (1.4)
- Adult Respiratory Distress Syndrome (ARDS) (1.5)
- Burns (1.6)
- Hemodialysis patients undergoing long term dialysis (1.7)
- Patients who cannot tolerate substantial volumes of salt solution (1.7)
- Priming as part of a cardiopulmonary bypass fluids (1.8)

Full Prescribing information

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Advisory information

contraindications

- Severe anemia or heart failure in the presence of normal or increased intravascular volume (4).
- Hypersensitivity to albumin, the excipients, or components of the container.

Special warnings and precautions
- Risk of transmission of infectious agents (5.1).
- Caution where hypervolemia and its consequences or hemodilution could represent a special risk (5.2)
- Do not dilute with water for injections (5.2)
Adverse reactions

The most common adverse reactions include fever, chills, rash, nausea, vomiting, tachycardia, and hypotension (6).

Usage information

Dosing and administration

Intravenous Administration Only. KEDBUMIN may be diluted with 5% glucose or 0.9% sodium chloride. Concentration, dosage, and infusion-rate should be adjusted to the patient’s individual requirements and indication (2.1). Daily dosage should not exceed 2g per kg body weight.

Indication: Dose
Hypovolemia: Adults: Initial dose 25 g is suggested
Hypoalbuminemia:

50-75 g

Prevention of
Central Volume
Depletion after
Paracentesis due
to Cirrhotic Ascites:
Adults: 6-8 g for every 1000 mL of ascitic
fluid removed
OHHS:

Adults: 50 to 100 g over 4 hours and repeated
at 4-12 hour intervals as necessary. 10-50 g; single infusion

ARDS: Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days if necessary
Burns:

Determined by direct observation of vital sign
or measurement of either plasma oncotic pressure or protein content

Hemodialysis: 100 mL
Cardiopulmonary Bypass: Estimated from the difference between the desired and actual total serum protein
concentration times the estimated plasma volume (approx 40mL per kg) times 2
Use in special populations
- Pregnancy: no human or animal data. Use only if clearly needed (8.1).
- Pediatric use: ages 12-16 years use as in adults (8.4)

More information

Category Value
Authorisation number BLA125384
Orphan designation No
Product NDC 76179-025
Date First Approved 15-09-2011
Marketing authorisation holder Kedrion S.p.A