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Albumin Human (Flexbumin)

Trade Name : Flexbumin

Baxalta US Inc.

INJECTION, SOLUTION, PLASMA DERIVATIVE

Strength 0.05 g/mL

ALBUMIN HUMAN Human Serum Albumin [EPC],Increased Intravascular Volume [PE],Increased Oncotic Pressure [PE],Osmotic Activity [MoA],Serum Albumin [Chemical/Ingredient]

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Product information is meant for

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Disclaimer

Trade Marks displayed in compliance with provisions of: Trademark Act, 1999 u/s 30 and 30 (1) of "Fair use"

GNH India is WHO GDP and ISO 9001 2015 Certified Pharmaceutical Wholesaler/ Supplier/ Exporters/ Importer from India of Albumin Human (Flexbumin) which is also known as Flexbumin and Manufactured by Baxalta US Inc.. It is available in strength of 0.05 g/mL per ml. Read more

Albumin Human (Flexbumin) is supplied for Tenders/ Emergency imports/ Un - licensed, Specials, Orphan drug/ Name patient line/ RLD supplies/ Reference listed drugs/ Comparator Drug/ Bio-Similar/ Innovator samples For Clinical trials.  Click to know price.     Read less

Packaging and Delivery

Validated Cold Chain Shipment

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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About GNH

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

We deliver your medicines through a validated cold chain shipment process. This process is used as these medicines need to manufactured, transported and stored at very specific temperatures, utilizing thermal and refrigerated packaging methods.

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  • No data
  • FLEXBUMIN 5% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery.
  • FLEXBUMIN 5%, Albumin (Human) Solution is indicated for:
  • Limitations of Use: Albumin is not indicated as an intravenous nutrient.()
  • Hypovolemia ()
  • Hypoalbuminemia: Burns ()
  • Cardiopulmonary Bypass Surgery ()
  • For intravenous use only
  • For intravenous use only
  • Adjust dose and rate of infusion based on the patient's clinical status. ()
  • Do not exceed 2 g of albumin per kg body weight for the daily dose. ()
  • Do not exceed 1 mL/min for patients with normal blood volume. ()
  • Do not dilute with Sterile Water for Injection. ()
  • FLEXBUMIN 5% is a solution containing 5 g of albumin per 100 mL.
  • FLEXBUMIN 5% is a solution containing 5 g of albumin per each 100 mL.
  • No data
  • History of hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). ()
  • Severe anemia or cardiac failure with normal or increased intravascular volume. ()
  • No data
  • Hypersensitivity reactions (including anaphylactic reactions) have been observed. If hypersensitivity reaction is suspected, discontinue use and implement appropriate standard medical treatment. ()
  • Under conditions where hypervolemia and/or hemodilution may occur, adjust the dose and rate of infusion to the patient's volume status. When administering large volumes, monitor hemodynamic parameters and ensure adequate substitution of other blood constituents are available (coagulation factors, platelets, and erythrocytes). Monitor electrolyte balance. ()
  • Closely monitor hemodynamic parameters after administration for evidence of cardiac or respiratory failure, renal failure or increasing intracranial pressure. ()
  • Monitor blood pressure in trauma patients and postoperative surgery patients in order to detect re-bleeding secondary to clot disruption. ()
  • Do not dilute with Sterile Water for Injection as this can cause hemolysis in recipients. ()
  • This product is made from human plasma and may contain infectious agents e.g., viruses and, theoretically, the variant Creutzfeldt-Jakob disease agent. ()
  • The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema.
  • The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema. ()
  • To report SUSPECTED ADVERSE REACTIONS, contact Baxalta US Inc., customer service at 1-800-999-1785 or contact the FDA at 1-800-FDA-1088 or
  • Pediatric Use: Ensure dose is appropriate for body weight. ()
  • Hypervolemia may occur if the dosage and rate of infusion are too high. [See]
  • FLEXBUMIN 5% is a sterile, nonpyrogenic preparation of albumin in single dosage form for intravenous administration. Each 100 mL contains 5 g of albumin. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.004M) and sodium caprylate (0.004M). The sodium content is 145 u00b1 15 mEq/L. FLEXBUMIN 5% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 5% is a transparent or slightly opalescent solution which may have a greenish tint or may vary from a pale straw to an amber color and is clear of particulate matter.
  • FLEXBUMIN 5% is manufactured from human plasma by the modified Cohn-Oncley cold ethanol fractionation process, which includes a series of cold-ethanol precipitation, centrifugation and/or filtration steps followed by pasteurization of the final product at 60 u00b1 0.5u00b0C for 10 - 11 hours. This process accomplishes both purification of albumin and reduction of viruses.
  • In vitro
  • These studies indicate that specific steps in the manufacturing of FLEXBUMIN 5% are capable of eliminating/inactivating a wide range of relevant and model viruses. Since the mechanism of virus elimination/inactivation by fractionation and by heating steps is different, the overall manufacturing process of FLEXBUMIN 5% is effective in reducing viral load.
  • The likelihood of the presence of viable hepatitis viruses has been minimized by testing the plasma at three stages for the presence of hepatitis viruses, by fractionation steps with demonstrated virus removal capacity and by heating the product for 10 hours at 60u00b0C. This procedure has been shown to be an effective method of inactivating hepatitis virus in albumin solutions even when those solutions were prepared from plasma known to be infective.FLEXBUMIN 5% contains no blood group isoagglutinins, thereby permitting its administration without regard to the recipient's blood group.
  • No data
  • No data
  • FLEXBUMIN 5% is supplied in a single-dose plastic container:
  • Storage
  • Room temperature: not exceed 30u00b0C (86u00b0F). Protect from freezing.
  • No data
  • Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
  • BAXALTAand FLEXBUMINare trademarks of Baxalta Incorporated, a Takeda company.
  • SHIRE and the Shire Logo are trademarks or registered trademarks of members of the Shire group of companies, now part of Takeda.
  • Shire
  • Albumin (Human), USP, 5% Solution FLEXBUMIN 5%
  • For Intravenous Use Only
  • 250 mL Single Dose Container
  • NDC 0944-0495-05Code 2G0250
  • Contains: 12.5 g albumin; stabilized with sodium caprylate and N-acetyltryptophan. The sodium content is 145 u00b1 15 mEq/L. Contains no preservative. Directions for use: See package insert.
  • Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Discard partially used container.
  • Rx Only
  • Store at room temperature, not to exceed 30u00b0C (86u00b0F). Protect from freezing.
  • BAXALTA and FLEXBUMIN are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
  • Baxalta US Inc.Lexington, MA 02421 USAU.S. License No. 2020
  • PL 2501 Plastic0740818
  • Shire Albumin (Human), USP, 5% Solution FLEXBUMIN 5%
  • 250 mL 2 x 250 mL Single-Dose Containers
  • NDC 0944-0495-05Code 2G0250

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