Used by health care professionals for the past 15 years, and thanks to its GALAXY technology, FLEXBUMIN® enables the use of a closed infusion system in albumin therapy.1-10
Available in different
USED BY HEALTHCARE PROFESSIONALS
FOR THE PAST 15 YEARS
and thanks to its GALAXY technology FLEXBUMIN® enables the use of a closed infusion system in albumin therapy. 1-10
DEVICE QUALITY
No latex used in the manufacture of the GALAXY container3
No known risk of aluminium leaching4
Resistance to degradation by oxidation2
CLOSED SYSTEM ASSET
Fully collapsible with self-sealing injection ports1,2
Does not require external venting to empty, thus reducing the risk of external contamination2,6
Sterile albumin solution without the need for port swabbing1
Can limit residual volume wastage and medication error thanks to its collapsible system versus standard bottles11
SUSTAINABILITY
Sustainable for a lower carbon footprint7
Storage at room temperature for 2 years (not to exceed 30°C)1,2
HUMAN ALBUMIN QUALITY
Meets the Quality Standards of Excellence, Assurance and Leadership (QSEAL) albumin quality standards8
FLEXBUMIN®
ADDED BENEFITS
FLEXBUMIN® offers several advantages & benefits compared to albumin in glass5,12
Lower risk of shattering vs. glass12
No risk of interruption of care to clean up broken glass12
Ready for use in about 45 seconds12
Requires up to 48% less shelf space compared with albumin in glass5,*
Weighs up to 56% less than albumin in glass5,*
*50mL FLEXBUMIN GALAXY bag vs. 50mL Human Albumin glass bottles
FLEXBUMIN® provides the choice of a closed infusion system in albumin therapy to help reduce CLABSI risks and patient mortality2,6
In an observational study, 94% of participating nurses (N=36) stated they preferred using FLEXBUMIN® albumin delivery system rather than Human Albumin bottles.12,*
*Based on an observational study performed with a total of 36 practicing nurses evaluating the way of use of FLEXBUMIN® albumin delivery system vs. Human Albumin bottles with attached hangers or accompanying sleeves.12
FLEXBUMIN® has a low carbon footprint compared to glass bottles7,13-15
FLEXBUMIN® IS THE FIRST CARBON-CERTIFIED,
PLASMA DERIVED PRODUCT7
Requires less energy to manufacture13,*
Uses less energy to transport13,*
Is 90% lighter than glass, when empty14,*
Reduces product waste14,*
Reduces institutional disposal costs13,*
Has 28% lower carbon footprint than albumin in glass13,*
Substituting 4 FLEXBUMIN containers (100 mL) for 4 vials of Human Albumin (100 mL) each day for 1 year is equivalent to the CO2 reduction gained from 70 trees grown from seedling to 10 years of age.13
*100 mL FLEXBUMIN bag vs. 100 mL Human Albumin glass bottle
REFERENCES
Flexbumin India Prescribing Information (PI).
Four-layer bag technology - Ref-35896- Baxter - May 2017.
Analysis of Aluminum levels in Flexbumin during stability - Internal Memo - July 2014.
Efficiency Weights and Dimensions of Albumin vs. Flexbumin - Internal Memo - 2017
Maki DG, et al. Impact of Switching from an Open to a Closed Infusion System on Rates of Central Line-Associated Bloodstream Infection: A Meta-analysis of Time-Sequence Cohort Studies in 4 Countries. Infect Control Hosp Epidemiol 2011:32-50-58
Baxalta US Inc. FLEXBUMIN 5%, Albumin (Human) USP, 5% Solution. Package insert. July 2017. Available at:https://www.shirecontent.com/PI/PDFS/FLEXBUMINS USA ENG.adf. Accessed November 2020.
Štrbová P, et al. Residual volumes and final weights in different types of plastic infusion containers. Int J Pharm Sci. 2016:8(3):293-296.
Summary Report of Observations for Flexbumin bags and Buminate bottles. Shire, Data on file-ID: FLEX-005. July 2017.
Albumin packaged as FLEXBUMIN and BUMINATE. Baxter Healthcare Corporation. Data on file. 2012.
Disposal cost assessment. Baxter Healthcare Corporation. Data on file, ref-34896. April 2010.
DOW. Saran PVDC Resins & Films and the Environment, DOW Form No. 190-00500-0305 March 2005.
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Before prescribing and for complete details please consult the India Package Insert. Do not dilute with Sterile Water for Injection. Acceptable diluents include 0.9% Sodium Chloride or 5% Dextrose in Water. Do not mix or add with other medicinal products including blood and blood components, protein hydrolysates or solutions containing alcohol. Do not add supplementary medication. Administer within 4 hours after the container has been entered. Monitor hemodynamic parameters and check for the risk of hypervolemia and cardiovascular overload. Record the name and batch number of the product to maintain a link between the patient and the product. Discard unused portion. Flexbumin® is not indicated as an intravenous nutrient.
Detailed Safety Information
Please consult the Flexbumin® India Prescribing Information before prescribing.
Guidance for use
For intravenous use only. The dose required depends on the patient’s body weight, severity of injury/illness and on continuing fluid and protein losses. Adjust the concentration, dosage, and infusion rate to the patient’s individual requirements. Use adequacy of circulating blood volume, not plasma albumin levels, to determine the dose required. Do not exceed 2 g of albumin per kg of body weight for the daily dose and 1 mL/min for patients with normal blood volume. More rapid administration can cause circulatory overload and pulmonary edema
Contraindications
Patients with a history of Hypersensitivity reaction to albumin preparations or to any of the excipients (N-acetyltryptophan and sodium caprylate). Reactions have included anaphylactic shock, anaphylactic reaction, or hypersensitivity/allergic reactions
Patients with severe anemia or cardiac failure with normal or increased intravascular volume. (See Warnings & Precautions)
Special warnings and precautions for use
Hypersensitivity Reactions: Hypersensitivity reactions (including anaphylactic reactions) have been observed. Discontinue administration immediately if a hypersensitivity reaction (including anaphylactic type reactions) is suspected. In case of shock, implement standard medical treatment for shock. Hypervolemia/Hemodilution: Under conditions where hypervolemia and/or hemodilution may occur adjust dose and rate of infusion to the patient’s volume status. Monitor coagulation and hematology parameters when comparatively large volumes are replaced. Ensure adequate substitution of other blood constituents (coagulation factors, platelets, and erythrocytes). Monitor electrolyte status to maintain the electrolyte balance. Discontinue administration at the first clinical signs of cardiovascular overload (e.g., headache, dyspnea, jugular venous distention, rales and abnormal elevations in systemic or central venous blood pressure). Conditions that pose increased risk of hypervolemia and/or hemodilution include but are not limited to: Heart failure, Hypertension, Esophageal varices, Pulmonary edema, Hemorrhagic diathesis, Severe anemia, Renal failure. Hemodynamics: Closely monitor hemodynamic parameters after administering Flexbumin® for evidence of cardiac or respiratory failure, renal failure, or increasing intracranial pressure. Blood Pressure:
Monitor blood pressure in trauma patients and postoperative surgery patients resuscitated with Flexbumin® in order to detect re-bleeding secondary to clot disruption. Hemolysis: Do not dilute Flexbumin® with Sterile Water for Injection as this can cause hemolysis in recipients. There exists a risk of potentially fatal hemolysis and acute renal failure from the use of Sterile Water for Injection as a diluent for Albumin (Human) in concentrations of 20% or higher. Transmission of Infectious Agents: Flexbumin® is a derivative of human blood. There is a theoretical risk for transmission of viral infections such as Creutzfeldt-Jakob disease (CJD), but if that risk actually exists, the risk of transmission would also be considered extremely remote. No cases of transmission of viral diseases, CJD or vCJD, have ever been identified for licensed albumin. All infections thought by a physician possibly to have been transmitted by this product should be reported by the physician or other healthcare provider to Manufacturer/Importer and via the national reporting system.
Warning: “To be sold by retail on the prescription of a Registered Medical Practitioner Only”
Interactions
No interaction studies of Flexbumin® with other medicinal products have been performed.
Adverse Reactions
Adverse Reactions The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema.
Clinical Trial Experience
No sponsor initiated clinical studies have been conducted with Flexbumin®
Post marketing Experience
The following adverse reactions have been reported in the post approval use of Flexbumin® . Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. The following adverse reactions have been reported in the post approval use of Flexbumin®
Immune System Disorders: Anaphylactic shock, anaphylactic reaction, hypersensitivity/allergic reactions
Respiratory, Thoracic, and Mediastinal Disorders: Pulmonary edema, dyspnea
Gastrointestinal Disorders: Vomiting, nausea
Skin and Subcutaneous Tissue Disorders: Urticaria, rash, pruritus
General Disorders and Administration Site Conditions: Pyrexia, chills
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions to the Manufacturer/Importer and via the national reporting system. The physician should discuss the risks and benefits of this product with the patient. Suspected Adverse Events should be reported to Takeda at: AE.India@takeda.com
“Disclaimer: This information is solely intended for the use of Registered Medical Practitioner and Hospital only. This information should not be used or shared or distributed to any other person / party and should be strictly by the intended parties for the intended purposes only. For more information, please refer to full Prescribing Information.
This material contains copyright protected information, content; the use of which is limited by law and this material cannot be reproduced, replicated, used or modified by any person for their own use or further distribution. TAKEDA and the TAKEDA logo are trademarks or registered trademarks of Takeda Pharmaceutical Company Limited.
Material code: pi-01929 Date of Preparation of SI: 22nd February 2022
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Terms of Use
Welcome to the Takeda website for Flexbumin.in (the “Website”). The information provided on this Website is about Takeda and its products. It is for general information and education purposes only. Please read and review these Terms of Use carefully before accessing and using this Website.
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Disclaimer
FLEXBUMIN® is indicated for hypovolemia, hypoalbuminemia, cardiopulmonary bypass surgery, and hemolytic disease of the new born (HDN).
Registration details may vary between countries. Please consult your local Prescribing information.
This website is intended to provide information to Healthcare Professionals and/or Registered Medical Practitioners only; it should not be used for diagnosing or treating a health problem or disease. Healthcare professionals and registered medical practitioners shall apply their independent medical judgment and patient analysis for assessing any patient and not rely on the material provided on this Website. It contains information on Flexbumin®, which is based on the India Prescribing Information (PI). This website has been developed by Takeda in accordance with industry and legal standards about Flexbumin®. Takeda makes every reasonable effort to include accurate and current information. However, the information provided on the website is not exhaustive. This website is not intended to be used to report adverse events or product quality complaints. If you would like to report an adverse event or product quality complaint, please contact us at AE.India@takeda.com.
This information is solely intended for the use of Registered Medical Practitioner and Hospital only. This information should not be used or shared or distributed to any other person/party and should be strictly by the intended parties for the intended purposes only. For more information please refer to full Prescribing Information
This material contains copyright protected information, content; the use of which is limited by law and this material cannot be reproduced, replicated, used or modified by any person for their own use or further distribution.
FLEXBUMIN® is trademark or registered trademark of Baxalta Incorporated. TAKEDA and the TAKEDA logo are trademarks or registered trademarks of Takeda Pharmaceutical Company Limited.
