CLINIMIX E- leucine, phenylalanine, lysine, methionine, isoleucine, valine, histidine, threonine, tryptophan, alanine, glycine,

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

LEUCINE (UNII: GMW67QNF9C) (LEUCINE - UNII:GMW67QNF9C), PHENYLALANINE (UNII: 47E5O17Y3R) (PHENYLALANINE - UNII:47E5O17Y3R), LYSINE (UNII: K3Z4F929H6) (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 (UNII: 8DUH1N11BX

Available from:

Baxter Healthcare Corporation

INN (International Name):

LEUCINE

Composition:

LEUCINE 201 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

CLINIMIX E is indicated as a source of calories, protein, and electrolytes for patients requiring parenteral nutrition when oral or enteral nutrition is not possible, insufficient, or contraindicated. CLINIMIX E may be used to treat negative nitrogen balance in patients. There are no adequate or well-controlled studies in pregnant women with CLINIMIX E. Additionally, animal reproduction studies have not been conducted with amino acids and electrolytes and dextrose. It is not known whether CLINIMIX E can cause fetal harm when administered to a pregnant woman. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. However, the estimated background risk in the U.S. general population of major birth defects is 2 to 4% and of miscarriage is 15 to 20% of clinically recognized pregnancies. Disease-Associated Maternal and/or Embryo-Fetal Risk Based on clinical practice guidelines, parenteral nutrition should be considered in cases of severe maternal malnutriti

Product summary:

CLINIMIX E (amino acids with electrolytes in dextrose with calcium) injection (sulfite-free) is available in 1000 mL and 2000 mL volumes (See Table 9 ). Minimize exposure of CLINIMIX E to heat and avoid excessive heat. Protect from freezing. Store CLINIMIX E at room temperature (25°C/77°F) (may briefly store at up to 40°C/104°F). Refrigerated storage is limited to 9 days once the protective overwrap has been opened. Do not use if the protective overwrap has been previously opened or damaged. For storage of admixed solutions see Dosage and Administration (2.3, 2.4) .

Authorization status:

New Drug Application

Summary of Product characteristics

CLINIMIX E- LEUCINE, PHENYLALANINE, LYSINE, METHIONINE, ISOLEUCINE,
VALINE,
HISTIDINE, THREONINE, TRYPTOPHAN, ALANINE, GLYCINE, ARGININE, PROLINE,
SERINE,
TYROSINE, SODIUM ACETATE, DIBASIC POTASSIUM PHOSPHATE, MAGNESIUM
CHLORIDE,
SODIUM CHLORIDE, CALCIUM CHLORIDE, DEXTROSE INJECTION
BAXTER HEALTHCARE CORPORATION
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
CLINIMIX E SAFELY AND
EFFECTIVELY. SEE FULL PRESCRIBING INFORMATION FOR CLINIMIX E.
CLINIMIX E (AMINO ACIDS WITH ELECTROLYTES IN DEXTROSE WITH CALCIUM)
INJECTION, FOR
INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1997
RECENT MAJOR CHANGES
INDICATIONS AND USAGE
CLINIMIX E is indicated as a source of calories, protein, and
electrolytes for patients requiring parenteral
nutrition when oral or enteral nutrition is not possible,
insufficient, or contraindicated. CLINIMIX E may be
used to treat negative nitrogen balance in patients. (1)
DOSAGE AND ADMINISTRATION
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 kidney disease. (2.1, 2.2, 2.3, 2.4, 2.5, 2.6, 2.7, 2.8)
DOSAGE FORMS AND STRENGTHS
CLINIMIX E injection is available in multiple strengths. See full
prescribing information for detailed
description of each formulation. (3, 11)
CONTRAINDICATIONS
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WARNINGS AND PRECAUTIONS
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ADVERSE REACTIONS
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
USE IN SPECIFIC POPULATIONS
SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 4/2021
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
2.1 Preparation Prior to Administration
2.2 Important Administration Instructions
2.3 Instructions for Use
2.4 Preparation and Addition of Lipid Emulsion
2.5 Dosing Consid