DRUGS & SUPPLEMENTS
Active ingredient: Albumin Human
Albumin Human uses
1 INDICATIONS AND USAGE
Albumin Human 5% [Albumin ] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery.
Albumin Human 5%, Albumin (Human) Solution is indicated for:
Limitations of Use: Albumin is not indicated as an intravenous nutrient.(1.4)
Albumin Human 5% [Albumin (Human)] is indicated for reversing hypovolemia. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 25% albumin should be used.4,6
Albumin Human 5% is indicated for patients with hypoalbuminemia resulting from one or more of the following:5
Albumin Human 5% is indicated for patients with hypoalbuminemia accompanying severe injuries, infections or severe pancreatitis that cannot be quickly reversed and nutritional supplements fail to restore serum albumin levels.
After the first 24 hours, Albumin Human 5% is indicated in conjunction with appropriate crystalloid therapy, for the treatment of oncotic deficits following extensive burns and to replace protein loss which accompanies any severe burn.4,6
1.3 Cardiopulmonary Bypass Surgery
Preoperative dilution of blood using albumin and crystalloid can be used in cardiopulmonary bypass surgery. Albumin Human 5% is indicated as a component of the pump prime during cardiopulmonary bypass procedures.4,6
1.4 Limitations of Use
Albumin is not indicated as an intravenous nutrient.
2 DOSAGE AND ADMINISTRATION
For intravenous use only.
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. Refer to Table 1 for recommended doses.
Do not exceed 2 g of albumin per kg of body weight for the daily dose. Do not exceed 1 mL/min for patients with normal blood volume. More rapid administration can cause circulatory overload and pulmonary edema.11 [See Warnings and Precautions (5.2) ]
Reversing hypovolemia depends largely upon its ability to draw interstitial fluid into the circulation. It is most effective in patients who are well hydrated. Use 5% protein solutions or dilute 25% albumin with crystalloid solutions in the absence of adequate or excessive hydration.
If albumin deficit is the result of excessive protein loss, the effect of Albumin Human 5% will be temporary unless the underlying disorder is reversed.
CAUTION: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before the administration of fluid from the secondary container is complete.
3 DOSAGE FORMS AND STRENGTHS
Albumin Human 5% is a solution containing 5 g of albumin per 100 mL.
Albumin Human 5% is a solution containing 5 g of albumin per each 100 mL.
5 WARNINGS AND PRECAUTIONS
5.1 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.
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. 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:
Closely monitor hemodynamic parameters after administering Albumin Human 5% for evidence of cardiac or respiratory failure, renal failure or increasing intracranial pressure.
5.4 Blood Pressure
Monitor blood pressure in trauma patients and postoperative surgery patients resuscitated with Albumin Human 5% in order to detect re-bleeding secondary to clot disruption.
Do not dilute Albumin Human 5% 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. [See Dosage and Administration (2.2) ]
5.6 Transmission of Infectious Agents
Albumin Human 5% is a derivative of human blood. Based on effective donor screening and product manufacturing processes, it carries an extremely remote risk for transmission of viral diseases and variant Creutzfeldt-Jakob disease (vCJD). There is a theoretical risk for transmission of 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 Baxalta US Inc. at 1-800-423-2090. The physician should discuss the risks and benefits of this product with the patient.
6 ADVERSE REACTIONS
The most serious adverse reactions are hypersensitivity reaction and pulmonary edema.
The most serious adverse reactions are hypersensitivity reaction (including anaphylactic reaction) and pulmonary edema. (6)
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 www.fda.gov/medwatch.
6.1 Clinical Trials Experience
No sponsor initiated clinical studies have been conducted with Albumin Human 5%.
6.2 Postmarketing Experience
The following adverse reactions have been identified during post-approval use of Albumin Human 5%. 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 Albumin Human 5%:
8 USE IN SPECIFIC POPULATIONS
Pediatric Use: Ensure dose is appropriate for body weight.
No human or animal data are available to indicate the presence or absence of drug-associated risk. It is not known whether Albumin Human 5% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.
No human or animal data are available to indicate the presence or absence of drug-associated risk. It is not known whether Albumin Human 5% is excreted in human milk.
8.4 Pediatric Use
The safety of albumin solutions has been demonstrated in children provided the dose is appropriate for body weight; however, the safety of Albumin Human 5% has not been evaluated in sponsor conducted pediatric studies.
8.5 Geriatric Use
No human or animal data.
Hypervolemia may occur if the dosage and rate of infusion are too high. [See Warnings and Precautions (5.2) ]
Albumin Human 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 ± 15 mEq/L. Albumin Human 5% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. Albumin Human 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.
Albumin Human 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 ± 0.5°C for 10 - 11 hours. This process accomplishes both purification of albumin and reduction of viruses.
In vitro studies demonstrate that the manufacturing process for Albumin Human 5% provides for effective viral reduction. These viral reduction studies, summarized in Table 2, demonstrate viral clearance during the manufacturing process for Albumin Human 5%.
These studies indicate that specific steps in the manufacturing of Albumin Human 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 Albumin Human 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 60°C. 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.1,2,3 Albumin Human 5% contains no blood group isoagglutinins, thereby permitting its administration without regard to the recipient's blood group.
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
Albumin is responsible for 70-80% of the colloid osmotic pressure of normal plasma, thus making it useful in regulating the volume of circulating blood.4,5,6 Albumin is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6
Albumin Human 5% is osmotically equivalent to an equal volume of normal human plasma and will increase circulating plasma volume by an amount approximately equal to volume infused. The degree and duration of volume expansion depends upon the initial blood volume. In patients with decreased blood volume, the effect of infused albumin can persist for many hours; however, in patients with normal blood volume, the duration will be shorter.7,8,9
Total body albumin is estimated to be 350 g for a 70 kg patient, more than 60% located in the extravascular fluid compartment. The half-life of albumin is 15 to 20 days with a turnover of approximately 15 g per day.5
The minimum plasma albumin level necessary to prevent or reverse peripheral edema is unknown. It is recommended that plasma albumin levels be maintained at approximately 2.5 g/dL. This concentration provides a plasma oncotic pressure value of 20 mmHg.4
16 HOW SUPPLIED/STORAGE AND HANDLING
Albumin Human 5% is supplied in a single-dose plastic container:
Room temperature: not exceed 30°C (86°F). Protect from freezing.
17 PATIENT COUNSELING INFORMATION
Baxalta US Inc.
Westlake Village, CA 91362
U.S. License No. 2020
BAXALTA® and Albumin Human® are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.
Albumin Human 5% 250 mL bag label
Albumin (Human), USP,
Albumin Human 5%
Single Dose Containers
Contains: 12.5 g albumin; stabilized with sodium caprylate and
N-acetyltryptophan. The sodium content is 145 ± 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.
Store at room temperature, not to exceed 30°C (86°F). Protect from
Baxalta and Albumin Human are registered trademarks of
Baxalta US Inc.
Westlake Village, CA 91362 USA
U.S. License No. 2020
Albumin Human available forms, composition, doses:
Indications and Usages:
Albumin Human destination | category:
Drugs with same active ingredients (Pharmaceutical companies):
Frequently asked QuestionsCan i drive or operate heavy machine after consuming Albumin Human?
Depending on the reaction of the Albumin Human after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Albumin Human not safe to drive or operate heavy machine after consumption. Meaning that, do not drive or operate heavy duty machines after taking the capsule if the capsule has a strange reaction on your body like dizziness, drowsiness. As prescribed by a pharmacist, it is dangerous to take alcohol while taking medicines as it exposed patients to drowsiness and health risk. Please take note of such effect most especially when taking Primosa capsule. It's advisable to consult your doctor on time for a proper recommendation and medical consultations.Is Albumin Human addictive or habit forming?
Medicines are not designed with the mind of creating an addiction or abuse on the health of the users. Addictive Medicine is categorically called Controlled substances by the government. For instance, Schedule H or X in India and schedule II-V in the US are controlled substances.
Please consult the medicine instruction manual on how to use and ensure it is not a controlled substance.In conclusion, self medication is a killer to your health. Consult your doctor for a proper prescription, recommendation, and guidiance.
Reviewsdrugs.com conducted a study on Albumin Human, and the result of the survey is set out below. It is noteworthy that the product of the survey is based on the perception and impressions of the visitors of the website as well as the views of Albumin Human consumers. We, as a result of this, advice that you do not base your therapeutic or medical decisions on this result, but rather consult your certified medical experts for their recommendations.
Visitor reported usefulNo survey data has been collected yet
Visitor reported side effectsNo survey data has been collected yet
Visitor reported price estimatesNo survey data has been collected yet
Visitor reported frequency of useNo survey data has been collected yet
Visitor reported dosesNo survey data has been collected yet
Visitor reported time for resultsNo survey data has been collected yet
Visitor reported administrationNo survey data has been collected yet
Visitor reported ageNo survey data has been collected yet
The information was verified by Dr. Arunabha Ray, MD Pharmacology