Kedbumin
Loading...Kedbumin Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
There is currently no warning information available for this product. We apologize for any inconvenience.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
For restoration and maintenance of circulating blood volume where volume deficiency is demonstrated and colloid use is appropriate.
KEDBUMIN™ is indicated for severe albumin deficiency caused by illness or active bleeding. When albumin deficiency results from excessive protein loss, the effect of albumin administration will be temporary unless the underlying disorder is reversed.
KEDBUMIN™ is indicated for maintenance of cardiovascular function following the removal of large volumes of ascitic fluid due to cirrhosis [1, 2].
KEDBUMIN™ is indicated as a plasma expander in the fluid management in of severe forms of ovarian hyperstimulation syndrome (OHSS) [3, 4].
KEDBUMIN™ is indicated in conjunction with diuretics to correct fluid volume overload associated with ARDS [5].
KEDBUMIN™ is indicated after > 24 hours post burn in patients experiencing severe albumin depletion in order to favor edema re-absorption [6].
KEDBUMIN™ is indicated in patients undergoing long term dialysis or for those patients who are fluid-overloaded and cannot tolerate substantial volumes of salt solution for therapy of shock or hypotension [7].
KEDBUMIN™ is indicated in cardiopulmonary bypass procedures as part of the priming fluids [8, 9].
History
There is currently no drug history available for this drug.
Other Information
KEDBUMIN™ is a sterile, aqueous solution for single dose intravenous administration. The product contains 0.25 g per mL human albumin and is prepared by cold ethanol fractionation from pooled human plasma obtained from venous blood at FDA-licensed facilities located in the USA. Intermediate source material (albumin paste) is obtained from a U.S. licensed manufacturer. The colloid osmotic effect of KEDBUMIN™ is approximately four times that of blood plasma.
KEDBUMIN™ is a clear, slightly viscous liquid, with a yellow, amber, or green tint. The productis stabilized by the addition of 0.08 mmol sodium caprylate and 0.08 mmol sodium acetyltryptophan per gram of albumin. Additionally, each liter of material contains 130-160 mEq of sodium ion and ≤ 200 µg of aluminum. The product contains no preservatives.
KEDBUMIN™ is heated for ten hours at 60°C. The KEDBUMIN manufacturing process results in viral reduction in in vitro studies (see table below). These reductions are achieved through a combination of process steps including Cohn fractionation and final container heat treatment.
| HIV-1: Human Immunodeficiency Virus Type 1 BVDV: Bovine Viral Diarrhoea Virus PRV: Pseudorabies Virus REO: Reovirus Type 3 PPV: Porcine Parvovirus HAV: Hepatitis A Virus EMCV: Encephalomyocarditis virus |
|||||||
| Mean Reduction Factor (log10) | |||||||
| Enveloped viruses | Non enveloped viruses | ||||||
| Manufacturing Step | HIV-1 | BVDV | PRV | REO | PPV | HAV | EMCV |
| Fractionation of Effluent I to Effluent II +III |
3.4 | 3.5 | 3.9 | 2.1 | 1.0 | 1.4 | |
| Fractionation of Effluent IV-1 to Effluent IV-4 |
3.7 | ||||||
| Ethanol inactication during fraction V precipitation |
>3.71 | >3.38 | |||||
| Depth Filtration of Fraction V suspension | 3.4 | ≥3.4 | 4.9 | 4.2 | 2.0 | ||
| Generation of Albumin paste | 1.5 | ||||||
| Heat treatment | ≥6.06 | >5.17 | >5.07 | 4.62 | >5.0 | ||
| Overall Reduction Factor | ≥16.57 | >10.17 | ≥15.75 | 11.62 | 5.2 | >8.4 | 3.7 |
Sources
Kedbumin Manufacturers
-
Kedrion S.p.a
![Kedbumin (Albumin (Human)) Injection, Solution [Kedrion S.p.a]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Kedbumin | Kedrion S.p.a
Intravenous Administration Only.
2.1 DosageThe 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 after
Paracentesis 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 AdministrationIntravenous 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.
Login To Your Free Account