Albumin Human (Flexbumin)

Trade Name : FLEXBUMIN

Baxalta US Inc.

SOLUTION, PLASMA DERIVATIVE

Strength 0.25 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

Wholesalers Suppliers Exporters Doctors MOH Tender Supplies Hospitals Brand CROs Comparator Supplies Generic Cooperate Sourcing Individual Patients Indian Institutional Buyers

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 0.25 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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About GNH

No data

FLEXBUMIN 25% [Albumin (Human)] is indicated for hypovolemia, hypoalbuminemia, cardiopulmonary bypass surgery, and hemolytic disease of the newborn (HDN).
FLEXBUMIN 25%, Albumin (Human) Solution is indicated for:
Limitations of Use: Albumin is not indicated as an intravenous nutrient.()

Hypovolemia ()
Hypoalbuminemia: Burns, Adult Respiratory Distress Syndrome (ARDS) and Nephrosis ()
Cardiopulmonary Bypass Surgery ()
Hemolytic Disease of the Newborn (HDN) ()

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 25% is a solution containing 25 g of albumin per 100 mL.
FLEXBUMIN 25% is a solution containing 25 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 25% is a sterile, nonpyrogenic preparation of albumin in a single dosage form for intravenous administration. Each 100 mL contains 25 g of albumin. It has been adjusted to physiological pH with sodium bicarbonate and/or sodium hydroxide and stabilized with N-acetyltryptophan (0.02M) and sodium caprylate (0.02M). The sodium content is 145 u00b1 15 mEq/L. FLEXBUMIN 25% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. FLEXBUMIN 25% 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 25% 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 25% 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 25% 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.n

No data

No data

FLEXBUMIN 25% 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, 25% Solution FLEXBUMIN 25%
Single Dose Container50 mLNDC 0944-0493-01Code 2G0201
Each 50 mL contains: 12.5 g albumin from venous plasma in buffered diluent and is osmotically equivalent to 250 mL of normal human plasma. It has been stabilized with sodium caprylate and N-acetyltryptophan and heated for 10 hours at 60u00b0C. The sodium content is 145 u00b1 15 mEq/L. Contains no preservative. See accompanying package insert.
Cautions: In patients with marked dehydration, additional fluids must accompany or follow administration of this product. Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Discard partially used container. The patient and physician should discuss the risks and benefits of this product.
Rx Only
Recommended storage: 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 Plastic0740823

Shire Albumin (Human), USP, 25% Solution FLEXBUMIN 25%
50 mL 12 x 50 mL Single-Dose Containers
NDC 0944-0493-01Code 2G0201

Shire
Albumin (Human), USP, 25% Solution FLEXBUMIN 25%
Single Dose Container100 mLNDC 0944-0493-02Code 2G0012
Each 100 mL contains: 25 g albumin from venous plasma in buffered diluent and is osmotically equivalent to 500 mL of normal human plasma. It has been stabilized with sodium caprylate and N-acetyltryptophan and heated for 10 hours at 60u00b0C. The sodium content is 145 u00b1 15 mEq/L. Contains no preservative. See accompanying package insert.
Cautions: In patients with marked dehydration, additional fluids must accompany or follow administration of this product. Check for minute leaks by squeezing bag firmly. If leaks are found, discard bag as sterility may be impaired. Do not use if turbid. Do not begin administration more than 4 hours after the container has been entered. Discard partially used container. The patient and physician should discuss the risks and benefits of this product.
Rx Only
Recommended storage: 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 Plastic0740823

Shire Albumin (Human), USP, 25% Solution FLEXBUMIN 25%
100 mL 6 x 100 mL Single-Dose Containers
NDC 0944-0493-02Code 2G0012

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Albumin Human (Flexbumin)

Trade Name : FLEXBUMIN

SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

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Albumin Human (Flexbumin)

Trade Name : FLEXBUMIN

SOLUTION, PLASMA DERIVATIVE

Delivery Process

Product information is meant for

Disclaimer

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

Packaging and Delivery

About GNH

Similar Products

Desogestrel And Ethinyl Estradiol (Emoquette)

Diphenoxylate Hydrochloride And Atropine Sulfate (Diphenoxylate Hydrochloride And Atropine Sulfate)

Fluoxetine Hydrochloride (Fluoxetine)

Metoprolol Succinate (Metoprolol Succinate)

Losartan Potassium (Losartan Potassium)

Browse Our Services And Processes

Disclaimer

Browse from other international pharmaceuticals

General

US NDC

Canadian DIN

Swiss Drugs

NZ Drugs

FAQ

Can’t find what you’re looking for?

COMPANY

SERVICES

QUICK LINKS

CONTACT US

Can’t find what
you’re looking for?