Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/432
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BranchAmin (Injection, Solution)
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| dailymed-instance:dosage |
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Additives may be incompatible with the fluid withdrawn from this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.<br/>Directions for Use
of Viaflex' plastic Pharmacy
Bulk Package container:<br/>To Open: Tear overpouch down side at slit and remove solution
container. Some opacity of the plastic due to moisture
absorption during the sterilization process may be
observed. This is normal and does not affect the
solution quality or safety. The opacity will diminish
gradually. Check for minute leaks by squeezing inner bag
firmly. If leaks are found, discard solution as
sterility may be impaired. For
compounding only, not for direct infusion.<br/>Preparation
for Admixing:
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| dailymed-instance:descripti... |
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/77��F
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:<br/>Essential Amino
Acids:
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| dailymed-instance:clinicalP... |
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.
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| dailymed-instance:activeIng... | |
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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.
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| dailymed-instance:supply |
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 (25��C/77��F). Baxter Healthcare Corporation Clintec Nutrition
Division Deerfield, IL 60015
USA Printed in
USA
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| dailymed-instance:activeMoi... | |
| dailymed-instance:genericMe... |
leucine, isoleucine and valine
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| dailymed-instance:fullName |
BranchAmin (Injection, Solution)
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| dailymed-instance:adverseRe... |
None
known
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| dailymed-instance:warning |
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��g/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.
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| dailymed-instance:indicatio... |
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.<br/>Central Vein
Administration:: Central
venous infusion should be considered when amino acid solutions
are to be admixed with hypertonic dextrose to promote protein
synthesis such as for hypercatabolic or depleted patients or
those requiring long-term parenteral nutrition.<br/>Peripheral Vein
Administration:: For
patients in whom the central venous route is not indicated,
amino acid solutions mixed with low dextrose concentrations may
be infused by peripheral vein when supplemented with or without
fat emulsion. Enrichment
of the TPN solution with the branched chain amino acid additive
is recommended until the patient exhibits a marked reduction in
the clinical signs and symptoms of metabolic stress, usually 7
to 14 days.
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| dailymed-instance:name |
BranchAmin
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