TRAVASOL- leucine, phenylalanine, lysine hydrochloride, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanin

Krajina: Spojené štáty

Jazyk: angličtina

Zdroj: NLM (National Library of Medicine)

Aktívna zložka:

LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), LYSINE HYDROCHLORIDE (UNII: JNJ23Q2COM) (LYSINE - UNII:K3Z4F929H6), METHIONINE (UNII: AE28F7PNPL) (METHIONINE - UNII:AE28F7PNPL), ISOLEUCINE (UNII: 04Y7590D77) (ISOLEUCINE - UNII:04Y7590D77), VALINE (UNII: HG18B9YRS7) (VALINE - UNII:HG18B9YRS7), HISTIDINE (UNII: 4QD397987E) (HISTIDINE - UNII:4QD397987E), THREONINE (UNII: 2ZD004190S) (THREONINE - UNII:2ZD004190S), TRYPTOPHAN (UN

Dostupné z:

Baxter Healthcare Corporation

INN (Medzinárodný Name):

LEUCINE

Zloženie:

LEUCINE 730 mg in 100 mL

Spôsob podávania:

INTRAVENOUS

Typ predpisu:

PRESCRIPTION DRUG

Terapeutické indikácie:

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. The use of TRAVASOL is contraindicated in: Risk Summary Limited published data with injectable amino acids solutions, including TRAVASOL in pregnant women are not sufficient to inform a drug associated risk for adverse developmental outcomes. However, malnutrition in pregnant women is associated with adverse maternal and fetal outcomes [see Clinical Considerations]. Animal reproduction studies have not been conducted with injectable amino acids solutions, including TRAVASOL. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. However, the background risk in the U.S. general population of major birth defects is 2 to 4% and of miscar

Prehľad produktov:

TRAVASOL 10% (amino acids) injection is available in plastic Pharmacy Bulk Package flexible containers in the following sizes as shown in Table 5 below. Code NDC Number 1B6623 NDC 0338-0644-03 1B6624 1000 mL NDC 0338-0644-04 1B6626P 2000 mL NDC 0338-0644-06 Minimize exposure of TRAVASOL to heat and avoid excessive heat. Protect from freezing. Store TRAVASOL at room temperature (25ºC/77ºF). Do not use if protective overpouch has been previously opened or damaged. For storage of admixed solutions [see Dosage and Administration (2.3)] .

Stav Autorizácia:

New Drug Application

Súhrn charakteristických

TRAVASOL- LEUCINE, PHENYLALANINE, LYSINE HYDROCHLORIDE, METHIONINE,
ISOLEUCINE, VALINE,
HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE,
TYROSINE, SERINE INJECTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
TRAVASOL SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING INFORMATION FOR TRAVASOL.
TRAVASOL (AMINO ACIDS) INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1984
RECENT MAJOR CHANGES
Dosage and Administration, Preparation Instructions for
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. (1)
DOSAGE AND ADMINISTRATION
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DOSAGE FORMS AND STRENGTHS
Injection: 10% (0.1 grams/mL), 10 grams of amino acid solution per 100
mL in 500 mL, 1000 mL, and 2000 mL flexible
containers. (3)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
Adverse reactions include pulmonary vascular emboli, hypersensitivity
reactions infection, refeeding syndrome,
hyperglycemia and hyperosmolar hyperglycemic state, vein thrombosis,
elevated liver function tests, hyperammonemia,
electrolyte imbalances, and hypervolemia. (6)
TO REPORT SUSPECTED ADVERSE REACTIONS, CONTACT BAXTER HEALTHCARE
CORPORATION AT 1-866-888-2472 OR
FDA AT 1-800-FDA-1088 OR WWW.FDA.GOV/MEDWATCH.
Admixing Using a Parenteral Nutrition Container (2.3) 09/2020
_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)
Known hyp