FDA (Food and Drug Administration, USA)
- 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.
- Caution where hypervolemia and its consequences or hemodilution could represent a special risk (5.2)
- Do not dilute with water for injections (5.2)
The most common adverse reactions include fever, chills, rash, nausea, vomiting, tachycardia, and hypotension (6).
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.
|Hypovolemia:||Adults: Initial dose 25 g is suggested|
to Cirrhotic Ascites:
|Adults: 6-8 g for every 1000 mL of ascitic
Adults: 50 to 100 g over 4 hours and repeated
|ARDS:||Adults: 25 g over 30 minutes and repeated at 8 hours for 3 days if necessary|
Determined by direct observation of vital sign
|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
- Pediatric use: ages 12-16 years use as in adults (8.4)
|Date First Approved||15-09-2011|
|Marketing authorisation holder||Kedrion S.p.A|