DESCRIPTION

4% BranchAmin® (Branched Chain Amino Acid) Injection is a sterile, nonpyrogenic solution of the essential amino acids isoleucine, leucine, and valine provided in a Pharmacy Bulk Package. A Pharmacy Bulk Package is a container of a sterile preparation for parenteral use that contains many single doses. The contents are intended for use in a pharmacy admixture program and are restricted to the preparation of admixtures for intravenous infusion.

The Viaflex® plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146® Plastic). Exposure to temperatures above 25°C/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 can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexyl phthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.

Each 100 mL of 4% BranchAmin® (Branched Chain Amino Acid) Injection contains:

Amino Acids	4g
Total Nitrogen	443 mg
pH	6.0 (5.0 to 7.0)
Osmolarity (calc.)	316 mOsmol/L

CLINICAL PHARMACOLOGY

4% BranchAmin® (Branched Chain Amino Acid) Injection, when appropriately admixed with a complete amino acid injection, such as Travasol® (Amino Acid) Injection, with or without a concentrated calorie source, provides total parenteral nutrition for the severely compromised patient. A common effect of severe stress conditions is depletion of branched chain amino acids. Enriching the standard amino acid solution in TPN with additional branched chain amino acid results in their repletion.

See package insert of the complete amino acid solution for additional information such as Contraindications, Warnings and Precautions pertinent to that drug and general total parenteral nutrition therapy.

INDICATIONS AND USAGE

4% BranchAmin® (Branched Chain Amino Acid) Injection, when appropriately admixed with a complete amino acid injection such as Travasol® Injection, is indicated as an adjunct in offsetting of nitrogen loss or in the treatment of negative nitrogen balance in patients where (1) the alimentary tract cannot or should not he used; (2) gastrointestinal absorption of protein is impaired; or (3) nitrogen homeostasis is substantially impaired as with severe trauma or sepsis. Dosage, route of administration and concomitant infusion of nonprotein calories are dependent on various factors such as nutritional and metabolic status of the patient, anticipated duration of parenteral nutritional support and vein tolerance. See Dosage and Administration for additional information.

CONTRAINDICATIONS

4% BranchAmin® (Branched Chain Amino Acid) Injection should not be administered to patients with inborn errors of metabolism, especially those involving branched chain amino acids such as maple syrup urine disease, isovaleric acidemia, etc.

WARNINGS

This injection is for compounding only, not for direct infusion.

Supplementation of branched chain amino acids should occur only with concomitant administration of solutions having complete amino acid profiles and energy substrates designed to meet minimal protein and calorie requirements.

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.

Hyperammonemia has been reported to occur in infants receiving various amino acid supplementation regimens. Blood ammonia monitoring may be prudent in 4% BranchAmin® infusions.

PRECAUTIONS

ADVERSE REACTIONS

None known

DOSAGE AND ADMINISTRATION

Clinical studies have shown that stressed patients can safely utilize up to 1.4 g/kg/day of a 50% branched chain amino acid supplemented solution. However, the total daily dose of the branched chain amino acid supplemented solutions depends upon the judgement of the physician based upon the patient's metabolic requirement, branched chain amino acid deficits and clinical response.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Use of a final filter is recommended during administration of all parenteral solutions where possible.

Do not administer unless solution is clear and seal is intact.

For dosage and administration of concomitantly administered solutions, reference should be made to the specific product information pertinent to that drug.

Care should be exercised to insure the maintenance of proper levels of serum potassium. Quantities of 60 to 180 mEq of potassium per day have been used with adequate clinical effect. All serum electrolytes should be monitored frequently and electrolyte requirements individualized.

Usual administration of 4% BranchAmin® (Branched Chain Amino Acid) Injection is as a supplement to parenteral nutrition solutions to achieve an amino acid solution which is approximately 50% w/w branched chain amino acid. (One method for achieving this ratio is the admixture of two volumes of 4% BranchAmin® (Branched Chain Amino Acid) Injection at 4 g/100 mL concentration with one volume of an amino acid solution of 8 to 10 g/100 mL concentration.) The supplemental amino acid mixture is administered in combination with energy substrates to provide at least 35 kcal/kg ideal body weight as nonprotein calories.

The treatment regimen should be discontinued when the patient exhibits a marked reduction in the clinical manifestations of metabolic stress, usually 7 to 14 days.

4% BranchAmin® (Branched Chain Amino Acid) Injection in the Pharmacy Bulk Package is intended for use in the preparation of sterile, intravenous admixtures. Additives may be incompatible with the fluid withdrawn from this container. Complete information is not available. Those additives known to be incompatible should not be used. Consult with pharmacist, if available. When compounding admixtures, use aseptic technique. Mix thoroughly. Do not store any unused portion of 4% BranchAmin® (Branched Chain Amino Acid) Injection.

HOW SUPPLIED

4% BranchAmin® (Branched Chain Amino Acid) Injection is available in a Viaflex® plastic Pharmacy Bulk Package container as shown below.

2B6153 500 mL NDC 0338-0477-03

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from excessive cold or freezing. It is recommended the product be stored at room temperature (25ºC/77ºF).

Baxter Healthcare Corporation

Clintec Nutrition Division

Deerfield, IL 60015 USA

Printed in USA

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

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EXP

2B6153
NDC 0338-0477-03

500 mL

4% BranchAmin®
(Branched Chain Amino Acid)
Pharmacy Bulk Package
Not for Direct Infusion

Rx Only

EACH 100 mL CONTAINS ISOLEUCINE 1.38 g LEUCINE 1.38 g VALINE 1.24 g
pH 6.0 (5.0 TO 7.0)
OSMOLARITY 316 mOsmol/L (CALC)

STERILE NONPYROGENIC

CONTAINS NO MORE THAN 25 μg/L OF ALUMINUM

ADDITIVES MAY BE INCOMPATIBLE WITH THE FLUID
WITHDRAWN FROM THIS CONTAINER CONSULT WITH
PHARMACIST IF AVAILABLE WHEN COMPOUNDING
ADMIXTURES USE ASEPTIC TECHNIQUE
MIX THOROUGHLY DO NOT STORE

DOSAGE ADMIX FOR INTRAVENOUS ADMINISTRATION
AS DIRECTED BY A PHYSICIAN SEE ACCOMPANYING
DIRECTIONS FOR USE ONCE CONTAINER CLOSURE HAS
BEEN PENETRATED WITHDRAWAL OF CONTENTS SHOULD
BE COMPLETED WITHOUT DELAY AFFIX ACCOMPANYING LABEL FOR DATE AND TIME OF ENTRY DISPENSE CONTENTS WITHIN 4 HOURS AFTER INITIAL ENTRY

IF EXPOSED TO COLD CRYSTALS MAY FORM REDISSOLVE BY WARMING TO 50ºC

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE UNLESS SOLUTION IS CLEAR AND SEAL IS INTACT

STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25ºC/77ºF) UNTIL READY TO USE AVOID EXCESSIVE HEAT PROTECT FROM EXCESSIVE COLD AND FREEZING SEE INSERT

Viaflex® CONTAINER

PL 146 ® PLASTIC

Baxter Logo
BAXTER HEALTHCARE CORPORATION
CLINTEC NUTRITION DIVISION
DEERFIELD IL 60015 USA MADE IN USA

18 - 500 ML

2B6153
VIAFLEX ® CONTAINER

4% BRANCHAMIN® (BRANCHED CHAIN
AMINO ACID) INJECTION

PROTECT FROM
EXCESSIVE COLD AND FREEZING

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
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PRIMARY BAR CODE
(01) 50303380477031