Kedrion S.p.a

Kedrion S.p.a Drugs

• Kedbumin
  

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  Kedbumin

  

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  Intravenous Administration Only.

  2.1 Dosage

  The concentration of the albumin preparation, dosage, and infusion-rate should be adjusted to the patient’s individual requirements and indication.

  Indication Dose Hypovolemia Adults: Initial dose of 25 g is suggested. Pediatric dosage should be adjusted based upon on age, weight and clinical conditions Hypoalbuminemia 50-75 g Prevention of Central Volume Depletion afterParacentesis due to Cirrhotic Ascites Adults: 6-8 g for every 1000 mL of ascitic fluid removed OHSS Adults:50-100 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 The amount of albumin required to achieve adequate plasma volume and protein content should be determined by direct observation of vital signs or measurement of either plasma oncotic pressure or protein content Hemodialysis 100 mL Cardiopulmonary Bypass Required dose can be estimated from the difference between the desired and actual total serum protein concentration multiplied by the estimated plasma volume (approximately 40mL per kg) times 2 (to account for extravascular deficit, which absorbs about half of the administered dose)

  2.2 Administration

  Intravenous administration only.

  Inspect visually for particulate matter and discoloration prior to administration, whenever the solution and container permit.

  Do not dilute with sterile water for injection as hemolysis may occur (5.3).

  KEDBUMIN™ may be diluted with 5% glucose or 0.9% sodium chloride.

  Adjust the infusion rate to the rate of removal in plasma exchange.

  Warm the product to room temperature if large volumes are to be administered.

  Do not begin administration > 4 hours after the container has been entered. Discard unused material.

  Record the batch number every time KEDBUMIN™ is administered to a patient.

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