Drugplain

Travasol 2.07 g/100mL

Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine · INJECTION · Baxter Healthcare Corporation

10 Recalls on RecordCurrently in Shortage
Plain English

Travasol is a injection containing leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine, arginine, proline, tyrosine, serine at 2.07 g/100mL, taken intravenous. Manufactured by Baxter Healthcare Corporation.

Key Facts

Brand Name
Travasol
Generic Name
Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine
NDC Code (Product)
0338-0644
Manufacturer
Baxter Healthcare Corporation
Strength
2.07 g/100mL
Dosage Form
INJECTION
Route
INTRAVENOUS
Marketing Status
Application #
NDA018931
Drug Class
Amino Acid [EPC]
Marketing Start
08/23/1984

Recall History

10 Recalls on Record
Class II06/19/2019

RXQ Compounding LLC

Lack of Assurance of Sterility

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated
Class II11/12/2013

Baxter Healthcare Corp.

Lack of Assurance of Sterility; Drug product leaking from container therefore sterility cannot be assured

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated
Class II05/28/2015

Lincare, Inc.

Lack of Assurance of Sterility: Sterility of product is not assured.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

no adverse event9 reports
vomiting7 reports
death6 reports
incorrect dose administered6 reports
dyspnoea5 reports
pain5 reports
fatigue4 reports
nausea4 reports
transfusion4 reports
blood fibrinogen increased3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients. TRAVASOL is indicated as a source of amino acids for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. TRAVASOL may be used to treat negative nitrogen balance in patients. (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION • Pharmacy Bulk Package. Not for direct intravenous infusion. (2.1) • See full prescribing information for information on preparation, administration, instructions for use, dosing considerations, including the recommended dosage in adults and pediatrics, and dosage modifications in patients with renal impairment. ( 2.1 , 2.2 , 2.3 , 2.4 , 2.5 , 2.6 , 2.7 , 2.8 ) • Protect the admixed parenteral nutrition solution from light. ( 2.3 ) 2.1 Important Preparation Information TRAVASOL is supplied as a pharmacy bulk package for admixing only and is not for direct intravenous infusion . Prior to administration, TRAVASOL must be transferred to a separate parenteral nutrition container, diluted and used as an admixture with or without dextrose, electrolytes and/or lipid emulsion. • The key factor in preparation is careful aseptic technique to avoid inadvertent touch contamination during mixing of solutions and addition of other nutrients. • Do not remove container from overpouch until ready to use. • Tear protective overpouch across top at slit and remove solution container. Small amounts of moisture may be found on the solution container from water permeating fro

Contraindications

4 CONTRAINDICATIONS The use of TRAVASOL is contraindicated in: • Patients with known hypersensitivity to one or more amino acids [see Warnings and Precautions (5.2) ] . • Patients with inborn errors of amino acid metabolism due to risk of severe metabolic or neurologic complications. • Patients with pulmonary edema or acidosis due to low cardiac output. • Known hypersensitivity to one or more amino acids. (4) • Inborn errors of amino acid metabolism. (4) Patients with pulmonary edema or acidosis due to low cardiac output. (4)

Adverse Reactions

6 ADVERSE REACTIONS The following serious adverse reactions are discussed in greater detail in other sections of the prescribing information. • Pulmonary embolism due to pulmonary vascular precipitates [see Warnings and Precautions (5.1) ] • Hypersensitivity reactions [see Warnings and Precautions (5.2) ] • Risk of Infections [see Warnings and Precautions (5.3) ] • Refeeding syndrome [see Warnings and Precautions (5.4) ] • Hyperglycemia or hyperosmolar hyperglycemic state [see Warnings and Precautions (5.5) ] • Vein damage and thrombosis [see Warnings and Precautions (5.6) ] • Hepatobiliary disorders [see Warnings and Precautions (5.7) ] • Aluminum toxicity [see Warnings and Precautions (5.8) ] • Parenteral Nutrition Associated Liver Disease [see Warnings and Precautions (5.9) ] • Electrolyte imbalance and fluid overload [see Warnings and Precautions (5.10) ] The following adverse reactions from voluntary reports or clinical studies have been reported with TRAVASOL. Because many of these reactions were 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. • Metabo

Frequently Asked Questions

What is Travasol used for?

Travasol contains Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine. It is a injection taken intravenous. Consult your doctor for specific uses.

Is Travasol a controlled substance?

Travasol is not classified as a controlled substance by the DEA.

What is the generic name for Travasol?

The generic name for Travasol is Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine. There are no other listed brand versions of Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Serine.

What is the NDC code for Travasol 2.07 g/100mL?

The NDC (National Drug Code) for Travasol 2.07 g/100mL is 0338-0644, listed by Baxter Healthcare Corporation.

Product NDC

0338-0644

Package NDC

0338-0644-03

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)