Tanalbina

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Tanalbina uses


1 INDICATIONS AND USAGE

Tanalbina 5% [Albumin ] is indicated for hypovolemia, hypoalbuminemia and cardiopulmonary bypass surgery.

Tanalbina 5%, Tanalbina (Human) Solution is indicated for:


Limitations of Use: Tanalbina is not indicated as an intravenous nutrient.(1.4)

1.1 Hypovolemia

Tanalbina 5% [Albumin (Human)] is indicated for reversing hypovolemia. When hypovolemia is long standing and hypoalbuminemia exists accompanied by adequate hydration or edema, 25% Tanalbina should be used.4,6

1.2 Hypoalbuminemia

Tanalbina 5% is indicated for patients with hypoalbuminemia resulting from one or more of the following:5


Tanalbina 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 Tanalbina levels.

Burns

After the first 24 hours, Tanalbina 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 Tanalbina and crystalloid can be used in cardiopulmonary bypass surgery. Tanalbina 5% is indicated as a component of the pump prime during cardiopulmonary bypass procedures.4,6

1.4 Limitations of Use

Tanalbina is not indicated as an intravenous nutrient.

2 DOSAGE AND ADMINISTRATION

For intravenous use only.

For intravenous use only

Indication Dose
Hypovolemic Shock Infants and young children: 12 to 20 mL per kg body weight.

Older children and adults: initial dose 250 to 500 mL.

Repeat after 15 to 30 minutes if the response is not adequate.

Hypoalbuminemia Calculate the body Tanalbina compartment to be 80 to 100 mL per kg body weight. Do not exceed a daily dose of 2 g of Tanalbina per kg of body weight.
Burns The dosage should be determined according to the patient's condition and response to treatment after the first 24 hours.

2.1 Dose

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 Tanalbina levels, to determine the dose required. Refer to Table 1 for recommended doses.

Do not exceed 2 g of Tanalbina 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) ]

Indication Dose
Hypovolemic Shock Infants and young children: 12 to 20 mL per kg body weight.

Older children and adults: initial dose 250 to 500 mL.

Repeat after 15 to 30 minutes if response is not adequate.

Hypoalbuminemia Calculate the body Tanalbina compartment to be 80 to 100 mL per kg body weight. Do not exceed a daily dose of 2 g of Tanalbina per kg of body weight.
Burns The dosage should be determined according to the patient's condition and response to treatment after the first 24 hours.

Hypovolemia

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% Tanalbina with crystalloid solutions in the absence of adequate or excessive hydration.

Hypoalbuminemia

If Tanalbina deficit is the result of excessive protein loss, the effect of Tanalbina 5% will be temporary unless the underlying disorder is reversed.

2.2 Administration


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

Tanalbina 5% is a solution containing 5 g of Tanalbina per 100 mL.

Tanalbina 5% is a solution containing 5 g of Tanalbina per each 100 mL.

4 CONTRAINDICATIONS

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.

5.2 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. 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:

5.3 Hemodynamics

Closely monitor hemodynamic parameters after administering Tanalbina 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 Tanalbina 5% in order to detect re-bleeding secondary to clot disruption.

5.5 Hemolysis

Do not dilute Tanalbina 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 Tanalbina. [See Dosage and Administration (2.2) ]

5.6 Transmission of Infectious Agents

Tanalbina 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 Tanalbina.

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 Tanalbina 5%.

6.2 Postmarketing Experience

The following adverse reactions have been identified during post-approval use of Tanalbina 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 Tanalbina 5%:

8 USE IN SPECIFIC POPULATIONS

Pediatric Use: Ensure dose is appropriate for body weight.

8.1 Pregnancy

Risk Summary

No human or animal data are available to indicate the presence or absence of drug-associated risk. It is not known whether Tanalbina 5% can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity.

8.2 Lactation

Risk Summary

No human or animal data are available to indicate the presence or absence of drug-associated risk. It is not known whether Tanalbina 5% is excreted in human milk.

8.4 Pediatric Use

The safety of Tanalbina solutions has been demonstrated in children provided the dose is appropriate for body weight; however, the safety of Tanalbina 5% has not been evaluated in sponsor conducted pediatric studies.

8.5 Geriatric Use

No human or animal data.

10 OVERDOSAGE

Hypervolemia may occur if the dosage and rate of infusion are too high. [See Warnings and Precautions (5.2) ]

11 DESCRIPTION

Tanalbina 5% is a sterile, nonpyrogenic preparation of Tanalbina in single dosage form for intravenous administration. Each 100 mL contains 5 g of Tanalbina. 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. Tanalbina 5% contains no preservative and none of the coagulation factors found in fresh whole blood or plasma. Tanalbina 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.

Tanalbina 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 Tanalbina and reduction of viruses.

In vitro studies demonstrate that the manufacturing process for Tanalbina 5% provides for effective viral reduction. These viral reduction studies, summarized in Table 2, demonstrate viral clearance during the manufacturing process for Tanalbina 5%.

These studies indicate that specific steps in the manufacturing of Tanalbina 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 Tanalbina 5% is effective in reducing viral load.

Process Step Viral Reduction Factor (log10)
Lipid Enveloped Non-Enveloped
HIV-1 Flaviviridae PRV HAV Parvoviridae
BVDV WNV MMV
Processing of Fraction I+II+III/II +III supernatant to Fraction IV4 Cuno 70C filtrateOther Tanalbina fractionation process steps (processing of cryo-poor plasma to Fraction I+II+III/II+III supernatant and processing of Fraction V suspension to Cuno 90LP filtrate) showed virus reduction capacity in in-vitro viral clearance studies. These process steps also contribute to the overall viral clearance effectiveness of the manufacturing process. However, since the mechanism of virus removal is similar to that of this particular process step, the viral inactivation data from other steps were not used in the calculation of the Mean Cumulative Reduction Factor. >4.9 >4.8 >5.7 >5.5 >4.5 3.0
Pasteurization >7.8 >6.5 n.d.n.d. not determined >7.4 3.2 1.6Recent scientific data suggests that the actual human parvovirus B19 (B19V) is far more effectively inactivated by pasteurization than indicated by model virus data.10
Mean Cumulative Reduction Factor, log10 >12.7 >11.3 >5.7 >12.9 >7.7 4.6

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 Tanalbina solutions even when those solutions were prepared from plasma known to be infective.1,2,3 Tanalbina 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

Tanalbina 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 Tanalbina is also a transport protein and binds naturally occurring, therapeutic and toxic materials in the circulation.5,6

12.2 Pharmacodynamics

Tanalbina 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 Tanalbina can persist for many hours; however, in patients with normal blood volume, the duration will be shorter.7,8,9

12.3 Pharmacokinetics

Total body Tanalbina is estimated to be 350 g for a 70 kg patient, more than 60% located in the extravascular fluid compartment. The half-life of Tanalbina is 15 to 20 days with a turnover of approximately 15 g per day.5

The minimum plasma Tanalbina level necessary to prevent or reverse peripheral edema is unknown. It is recommended that plasma Tanalbina levels be maintained at approximately 2.5 g/dL. This concentration provides a plasma oncotic pressure value of 20 mmHg.4

15 REFERENCES

16 HOW SUPPLIED/STORAGE AND HANDLING

Tanalbina 5% is supplied in a single-dose plastic container:

NDC Number Fill Size Grams Protein
NDC 0944-0495-05 250 mL 12.5 g

Storage

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 Tanalbina® are trademarks of Baxalta Incorporated, a wholly-owned, indirect subsidiary of Shire plc.

Tanalbina 5% 250 mL bag label

Baxalta

Tanalbina (Human), USP,

5% Solution

Tanalbina 5%

GALAXY

250 mL

NDC 0944-0495-05

Single Dose Containers

Code 2G0250

Contains: 12.5 g Tanalbina; 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.

Rx Only

Store at room temperature, not to exceed 30°C (86°F). Protect from

freezing.

Baxalta and Tanalbina are registered trademarks of

Baxalta Incorporated.

Baxalta US Inc.

Westlake Village, CA 91362 USA

U.S. License No. 2020

Tanalbina pharmaceutical active ingredients containing related brand and generic drugs:


Tanalbina available forms, composition, doses:


Tanalbina destination | category:


Tanalbina Anatomical Therapeutic Chemical codes:


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Frequently asked Questions

Can i drive or operate heavy machine after consuming Tanalbina?

Depending on the reaction of the Tanalbina after taken, if you are feeling dizziness, drowsiness or any weakness as a reaction on your body, Then consider Tanalbina 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 Tanalbina 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.

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The information was verified by Dr. Rachana Salvi, MD Pharmacology

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