{"adverse_reactions":["ADVERSE REACTIONS See WARNINGS and PRECAUTIONS Additionally, infusion of hypertonic solutions can result in local inflammatory reactions."],"carcinogenesis_and_mutagenesis_and_impairment_of_fertility":["Carcinogenesis and Mutagenesis and Impairment of Fertility: Studies with 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility."],"clinical_pharmacology":["CLINICAL PHARMACOLOGY 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes is intended for protein-sparing therapy to diminish net protein losses."],"contraindications":["CONTRAINDICATIONS Hypersensitivity to one or more amino acids Severe liver disease or hepatic coma Anuria or renal failure"],"description":["DESCRIPTION 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes is a sterile, nonpyrogenic, hypertonic solution of essential and nonessential amino acids and electrolytes in single dose containers for intravenous administration. The Viaflex ® Plastic Container is fabricated from a specially formulated polyvinyl chloride (PL 146 ® Plastic). Exposure to temperatures above 25ºC/77ºF during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Each 100 mL of 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes contains: Amino Acids 3.5 g Total nitrogen 0.591 g pH 6.0 (5.0 to 7.0) (pH adjusted with glacial acetic acid and may have been adjusted with sodium hydroxide.) Essential Amino Acids Leucine - (CH 3 ) 2 CHCH 2 C H (NH 2 ) COOH 217 mg Phenylalanine - (C 6 H 5 ) CH 2 CH (NH 2 ) COOH 217 mg Lysine (added as the hydrochloride salt) – H 2 N (CH 2 ) 4 CH (NH 2 ) COOH 203 mg Methionine – CH 3 S (CH 2 ) 2 CH (NH 2 ) COOH 203 mg Isoleucine – CH 3 CH 2 CH (CH 3 ) CH (NH 2 ) COOH 168 mg Valine - (CH 3 ) 2 CHCH (NH 2 ) COOH 161 mg Histidine - (C 3 H 3 N 2 ) CH 2 CH (NH 2 ) COOH 154 mg Threonine – CH 3 CH (OH) CH (NH 2 ) COOH 147 mg Tryptophan - (C 8 H 6 N) CH 2 CH (NH 2 ) COOH 63 mg Nonessential Amino Acids Alanine – CH 3 CH (NH 2 ) COOH 728 mg Glycine – H 2 NCH 2 COOH 728 mg Arginine – H 2 NC (NH) NH (CH 2 ) 3 CH (NH 2 ) COOH 364 mg Proline - [(CH 2 ) 3 NHCH] COOH 147 mg Tyrosine - [C 6 H 4 (OH)] CH 2 CH (NH 2 ) COOH 14 mg Electrolytes Sodium Acetate Trihydrate, USP – C 2 H 3 NaO 2 • 3H 2 O 218 mg Dibasic Potassium Phosphate, USP – K 2 HPO 4 131 mg Magnesium Chloride, USP – MgCl 2 • 6H 2 O 51 mg Sodium Chloride, USP – NaCl 35 mg Electrolyte profile per liter Balanced by ions from amino acids. Sodium 22 mEq Potassium 15 mEq Magnesium 5 mEq Acetate Acetate is added as sodium acetate and as glacial acetic acid used for pH adjustment. 49 mEq Chloride 25 mEq Phosphate (as HP0 4 = ) 15 mEq (7.5 mmol/L) Osmolarity (calc.) 444 mOsmol/L"],"description_table":["
Amino Acids 3.5 g
Total nitrogen 0.591 g
pH 6.0 (5.0 to 7.0)
","
Leucine - (CH3)2 CHCH2 CH (NH2) COOH 217 mg
Phenylalanine - (C6H5 ) CH2CH (NH2) COOH 217 mg
Lysine (added as the hydrochloride salt) – H2N (CH2)4 CH (NH2) COOH 203 mg
Methionine – CH3S (CH2)2CH (NH2) COOH 203 mg
Isoleucine – CH3CH2CH (CH3) CH (NH2) COOH 168 mg
Valine - (CH3)2CHCH (NH2) COOH 161 mg
Histidine - (C3H3N2 ) CH2CH (NH2) COOH 154 mg
Threonine – CH3CH (OH) CH (NH2) COOH 147 mg
Tryptophan - (C8H6N) CH2CH (NH2) COOH 63 mg
","
Alanine – CH3CH (NH2) COOH 728 mg
Glycine – H2NCH2COOH 728 mg
Arginine – H2NC (NH) NH (CH2)3CH (NH2) COOH 364 mg
Proline - [(CH2)3NHCH] COOH 147 mg
Tyrosine - [C6H4(OH)] CH2CH (NH2) COOH 14 mg
","
Sodium Acetate Trihydrate, USP – C2H3NaO2 • 3H2O 218 mg
Dibasic Potassium Phosphate, USP – K2HPO4 131 mg
Magnesium Chloride, USP – MgCl2• 6H2O 51 mg
Sodium Chloride, USP – NaCl 35 mg
","
Sodium 22 mEq
Potassium 15 mEq
Magnesium 5 mEq
AcetateAcetate is added as sodium acetate and as glacial acetic acid used for pH adjustment. 49 mEq
Chloride 25 mEq
Phosphate (as HP04 =) 15 mEq (7.5 mmol/L)
","
Osmolarity (calc.) 444 mOsmol/L
"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION This injection is not recommended for central venous administration . Protein-sparing therapy is implemented by administering 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes and any desired supporting electrolytes. The tonicity of this injection allows administration into a peripheral vein. The total daily dose of 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes depends on the patient's metabolic requirement and clinical response. Maintenance vitamins, additional electrolytes and trace elements should be administered as required. Pediatric Use: Use of 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes in pediatric patients is governed by the same considerations that affect the use of any amino acid solution in pediatrics. The amount administered is dosed on the basis of grams of amino acids/kg of body weight/day. Two to three g/kg of body weight for infants with adequate calories are generally sufficient to satisfy protein needs and promote positive nitrogen balance. Solutions administered by peripheral vein should not exceed twice normal serum osmolarity (718 mOsmol/L). Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Use of a final filter is recommended during administration. A slight yellow color does not alter the quality and efficacy of this product. Do not use unless solution is clear and seal is intact. Additives may be incompatible. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. If additives are indicated, use aseptic technique. Mix thoroughly if additives have been introduced. Solutions should be used promptly after mixing. Any storage should be under refrigeration and limited to a brief period of time, preferably less than 24 hours. Directions for Use of Viaflex ® plastic container Do not remove container from overpouch until ready to use. Do not use if overpouch has been previously opened or damaged. To Open Tear overpouch at notch and remove solution container. Some opacity of the plastic may be observed and will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard,"],"effective_time":"20001101","how_supplied":["HOW SUPPLIED 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes is supplied in single dose Viaflex ® plastic containers as follows: 2B6553 500 mL NDC 0338-0628-03 2B6554 1000 mL NDC 0338-0628-04 Exposure of pharmaceutical products to heat should be minimized, Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25ºC/77ºF). Protect from light until immediately prior to use, Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA Printed in USA ©Copyright1998, 1999, 2000, Baxter Healthcare Corporation. All rights reserved. 07-19-09-749 Rev, November 2000 *Bar Code Position Only 071909749"],"how_supplied_table":["
2B6553 500 mL NDC 0338-0628-03
2B6554 1000 mL NDC 0338-0628-04
"],"id":"40671360-be9e-415a-9fd6-50cc3058fb0b","indications_and_usage":["INDICATIONS AND USAGE 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes is designed for peripheral administration for use in patients who, before administration of the solution, have exemplified no clinically significant protein malnutrition. The purpose of the solution is to replace protein losses which occur in relation to an intercurrent phenomenon which is known or suspected to be productive of a protein loss condition for a short or moderate period of time, This injection is indicated as a source of nitrogen for patients with adequate stores of body fat, in whom oral nutrition cannot be tolerated, is undesirable, or is inadequate."],"nursing_mothers":["Nursing Mothers: Caution should be exercised when 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes is administered to a nursing woman"],"openfda":{},"package_label_principal_display_panel":["PACKAGE LABEL - PRINCIPAL DISPLAY PANEL Container Label LOT EXP 2B6553 500mL NDC 0338-0628-03 3.5% Travasol® - sulfite-free (Amino Acid) 3.5% Injection with Electrolytes Rx only EACH 100mL CONTAINS ESSENTIAL AMINO ACIDS LEUCINE 217 mg PHENYLALANINE 217 mg LYSINE(ADDED AS THE HYDROCHLORIDE SALT) 203 mg METHONINE 203 mg ISOLEUCINE 168 mg VALINE 161 mg HISTIDINE 154 mg THREONINE 147 mg TRYPTOPHAN 63 mg NONESSENTIAL AMINO ACIDS ALANINE 728 mg GLYCINE 728 mg ARGININE 364 mg PROLINE 147 mg TYROSINE 14 mg ELECTROLYTES SODIUM ACETATE TRIHYDRATE USP 35 mg pH ADJUSTED WITH GLACIAL ACETIC ACID AND MAY HAVE BEEN ADJUSTED WITH SODIUM HYDROXIDE pH 6.0 (5.0 TO 7.0) mEq/L* SODIUM 22 POTASSIUM 15 MAGNESIUM 5 ACETATE 49 CHLORIDE 25 PHOSPHATE (AS HPO 4 =) 15 (7.5 mmol/L) *BALANCED BY IONS FROM AMINO ACIDS HYPERTONIC OSMOLARITY 444 mOsmo/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER ADDITIVES MAY BE INCOMPATIBLE CONSULT WITH PHARMACIST IF AVAILABLE WHEN INTRODUCING ADDITIVES ASEPTIC TECHNIQUE MIX THOROUGHLY DO NOT STORE DOSAGE AS DIRECTED BY A PHYSICIAN ADMINISTER INTRAVENOUSLY USING STERILE EQUIPMENT SEE ACCOMPANYING DIRECTIONS FOR USE STORE AT ROOM TEMPERATURE (25°C/77°F) PROTECT FROM LIGHT IMMEDIATELY PRIOR TO USE CAUTION DO NOT USE UNLESS SOLUTION IS CLEAR AND SEAL IS INTACT Viaflex® CONTAINER PL 146® PLASTIC Baxter Logo BAXTER HEALTHCARE CORPORATION CLINTEC NUTRITION DIVISION DEERFIELD IL 60015 USA MADE IN THE USA 1 2 3 4 Carton Label 2B6553P 24-500 ML VIAFLEX® CONTAINER 3.5% TRAVASOL® - SULFITE-FREE (AMINO ACID) INJ W/ELECTROLYTES EXP XXXXX SECONDARY BAR CODE (17) YYMM00 (10) XXXXX LOT XXXXX PRIMARY BAR CODE (01) 50303380628037 Representative Container Label NDC 0338-0628-03 Representative Carton Label NDC 0338-0628-03"],"pediatric_use":["Pediatric Use: Safety and effectiveness of 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See DOSAGE AND ADMINISTRATION ."],"precautions":["PRECAUTIONS The electrolyte profile of 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes favors the intracellular ions and has been planned for protein-sparing therapy. Losses greater than normal should be monitored and replaced in the usual fashion. Because of its antianabolic activity, concurrent administration of tetracycline may reduce the protein-sparing effect of infused amino acids. Care should be taken to avoid excess fluid accumulation, particularly in patients with renal disease, pulmonary insufficiency and heart disease. In the absence of supporting carbohydrate metabolism, an accumulation of ketone bodies in the blood often occurs. Correction of ketonemia usually can be accomplished by administering some carbohydrates. Though not anticipated, if daily increases in BUN in the range of 10 to 15 mg% for more than 3 days should occur, then protein-sparing therapy should be discontinued and a regimen with full nonprotein calorie substrate should be adopted. Drug product contains no more than 25 µg/L of aluminum. Frequent clinical evaluation and laboratory determinations are necessary for proper monitoring during administration. This solution should not be given simultaneously with blood through the same infusion set because of the possibility of pseudoagglutination. Carcinogenesis and Mutagenesis and Impairment of Fertility: Studies with 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes have not been performed to evaluate carcinogenic potential, mutagenic potential, or effects on fertility. Pregnancy: Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes. It is also not known whether 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes should be given to a pregnant woman only if clearly needed. Nursing Mothers: Caution should be exercised when 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes is administered to a nursing woman Pediatric Use: Safety and effectiveness of 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes in pediatric patients have not been established by adequate and well-controlled studies. However, the use of amino acid injections in pediatric patients as an adjunct in the offsetting of nitrogen loss or in the treatment of negative nitrogen balance is referenced in the medical literature. See DOSAGE AND ADMINISTRATION ."],"pregnancy":["Pregnancy: Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes. It is also not known whether 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes should be given to a pregnant woman only if clearly needed."],"set_id":"40671360-be9e-415a-9fd6-50cc3058fb0b","spl_product_data_elements":["Travasol Leucine, Phenylalanine, Lysine hydrochloride, Methionine, Isoleucine, Valine, Histidine, Threonine, Tryptophan, Alanine, Glycine, Arginine, Proline, Tyrosine, Sodium Acetate Trihydrate, Dibasic Potassium Phosphate, Magnesium Chloride, Sodium Chloride LEUCINE LEUCINE ISOLEUCINE ISOLEUCINE LYSINE LYSINE METHIONINE METHIONINE VALINE VALINE HISTIDINE HISTIDINE THREONINE THREONINE TRYPTOPHAN TRYPTOPHAN ALANINE ALANINE GLYCINE GLYCINE ARGININE ARGININE PROLINE PROLINE TYROSINE TYROSINE SODIUM ACETATE ACETATE ION SODIUM CATION SODIUM ACETATE ANHYDROUS POTASSIUM PHOSPHATE, DIBASIC PHOSPHATE ION POTASSIUM CATION MAGNESIUM CHLORIDE MAGNESIUM CATION CHLORIDE ION SODIUM CHLORIDE CHLORIDE ION SODIUM CATION ACETIC ACID NITROGEN WATER"],"teratogenic_effects":["Teratogenic Effects Pregnancy Category C. Animal reproduction studies have not been conducted with 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes. It is also not known whether 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes should be given to a pregnant woman only if clearly needed."],"version":"1","warnings":["WARNINGS Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store. Because of the potential for life-threatening events, caution should be taken to ensure that precipitates have not formed in any parenteral nutrient admixture. Proper administration of 3.5% Travasol ® - sulfite-free (Amino Acid) Injection with Electrolytes requires a knowledge of fluid and electrolyte balance and nutrition and the role of protein-sparing therapy in relation to other forms of nutritional support. Administration of amino acid solutions to a patient with hepatic insufficiency may result in serum amino acid imbalances, hyperammonemia, stupor and coma. The use of this injection in such patients should be considered very carefully and the benefits of protein-sparing therapy should outweigh the risk of adverse results. WARNING: This product contains aluminum that may be toxic. Aluminum may reach toxic levels with prolonged parenteral administration if kidney function is impaired. Premature neonates are particularly at risk because their kidneys are immature, and they require large amounts of calcium and phosphate solutions, which contain aluminum. Research indicates that patients with impaired kidney function, including premature neonates, who receive parenteral levels of aluminum at greater than 4 to 5 µg/kg/day accumulate aluminum at levels associated with central nervous system and bone toxicity. Tissue loading may occur at even lower rates of administration."]}