Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1921
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Travasol (Injection)
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If a patient is
unable to take enteral nourishment for a prolonged period of time,
institution of total parenteral nutrition (TPN) with exogenous calories
should be considered. The total daily
dose of 5.5% and 8.5% Travasol (Amino Acid) Injections
depends on the patient's metabolic requirement and clinical response.
The determination of nitrogen balance and accurate daily body weights,
corrected for fluid balance, are probably the best means of assessing
individual nitrogen requirements. Recommended Dietary
Allowances* of protein range from approximately 0.75 g/kg of body weight
for adults to 1.68 g/kg for infants. It must be recognized, however,
that protein as well as caloric requirements in traumatized or
malnourished patients may be increased substantially. Daily amino acid
doses of approximately 1.0 to 1.5 g/kg of body weight for adults with
adequate calories are generally sufficient to satisfy protein needs and
promote positive nitrogen balance. For the initial
treatment of trauma or protein calorie malnutrition, higher doses of
protein with corresponding quantities of carbohydrate will be necessary
to promote adequate patient response to therapy. The severity of the
illness being treated is the primary consideration in determining proper
dose level. Such higher doses, especially in infants, must be
accompanied by more frequent laboratory evaluation. For protein-sparing
in well nourished patients not receiving significant additional
calories, amino acid dosages of 1.0 to 1.7 g/kg/day reduce nitrogen
losses and spare body protein. If daily increases in BUN in the range of
10 to 15 mg% for more than three days should occur, then protein-sparing therapy should be discontinued and a regimen with full nonprotein
calorie substrates should be adopted. 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. It may be necessary to add quantities of this
electrolyte to these injections, depending primarily on the amount of
carbohydrate administered to and metabolized by the patient. Patients receiving
these injections should be monitored (carefully) and their electrolyte
requirements individualized. Total daily fluid
requirements can be met beyond the volume of amino acids solution by
supplementing with noncarbohydrate or carbohydrate-containing
electrolyte solutions. Maintenance
vitamins, additional electrolytes and trace elements should be
administered as required. Fat emulsion
coadministration should be considered when prolonged parenteral
nutrition (more than 5 days) is required in order to prevent essential
fatty acid deficiency (EFAD). Serum lipids should be monitored for
evidence of EFAD in patients maintained on fat free total parenteral
nutrition.<br/>Pediatric Use:: Use of 5.5%
and 8.5% Travasol (Amino Acid) Injections 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 m0smol/L).<br/>Central Vein
Administration:: Hypertonic
mixtures of amino acids and dextrose may be administered safely
by continuous infusion through a central vein catheter with the
tip located in the vena cava. In addition to meeting nitrogen
needs, the administration rate is governed, especially during
the first few days of therapy, by the patient's tolerance to
dextrose. Daily intake of amino acids and dextrose should be
increased gradually to the maximum required dose as indicated by
frequent determinations of urine and blood sugar levels. In many
patients, provision of adequate calories in the form of
hypertonic dextrose may require the administration of exogenous
insulin to prevent hyperglycemia and glycosuria. Parenteral
nutrition may be started with infusates containing lower
concentrations of dextrose; dextrose content may be gradually
increased to estimated caloric needs as the patient's glucose
tolerance increases. Sudden
cessation in administration of a concentrated dextrose solution
may result in insulin reaction due to continued endogenous insulin production. Such solutions should be withdrawn
slowly.<br/>Peripheral Vein
Administration:: For
patients requiring parenteral nutrition in whom the central vein
route is not indicated, these injections can be mixed with low
concentration dextrose solutions and administered by peripheral
vein in conjunction with or without fat emulsions. In pediatric
patients, the final solution should not exceed twice normal
serum osmolarity (718 m0smol/L). Intravenous
fat emulsion provides approximately 1.1 kcal/mL (10%) or 2.0
kcal/mL (20%) and may be administered along with amino
acid-dextrose solutions by means of a short Y-connector near the
infusion site to supplement caloric intake. Fat, however, should
not be the sole caloric intake since studies have indicated that
glucose is more nitrogen sparing in the stressedpatient.<br/>Protein-Sparing:: For well
nourished patients who require short-term parenteral support,
these injections can be administered peripherally with or
without carbohydrate calories. Such infusates can be prepared by
dilution of these injections with Sterile Water for injection or
5% Dextrose Injection to prepare isotonic or slightly hypertonic
solutions which may be administered by peripheral vein. Depending
upon the clinical condition of the patient, approximately 3
liters of solution may be administered per 24 hour period. When
used postoperatively, the therapy should begin with 1000 mL the
first postoperative day. Thereafter, the dose may be increased
to 3000 mL per day. 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, A slight
yellow color does not alter the quality and efficacy of the
product. 5.5% and
8.5% Travasol (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 5.5% and 8.5% Travasol (Amino
Acid) Injection. 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.
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5.5% and 8.5%
Travasol (Amino Acid) Injections are sterile,
nonpyrogenic, hypertonic solutions of essential and nonessential amino
acids 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 confirmedin tests in animals
according to USP biological test for plastic containers as well as by
tissue culture toxicity studies. Each 100 mL of 5.5%
and 8.5% Travasol (Amino Acid) Injection contains: (pH adjusted with
glacial acetic acid and may have been adjusted with sodium hydroxide)
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5.5% and 8.5%
Travasol (Amino Acid) Injections administered via
central vein provide biologically utilizable source material for protein
synthesis when used with concentrated calorie sources (such as hypertonic dextrose or fat emulsion), electrolytes, vitamins and
minerals. Administered peripherally after appropriate dilution or with
minimal calorie supplementation (such as 5% dextrose), it enhances the
conservation of body protein.
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Hypersensitivity to
one or more amino acids. Severe liver
disease or hepatic coma. Anuria.
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5.5% and 8.5%
Travasol (Amino Acid) Injections are supplied in
Viaflex plastic Pharmacy Bulk Package containers in the
following sizes and concentrations: 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 (25��C/77��F). Protect from light until immediately prior
to use. Do not remove
container from overpouch until ready to use. Do not use if
overpouch has been previously opened or damaged. *Food and Nutrition
Board National Academy of Sciences - National Research Council (Revised
1989) Baxter Healthcare Corporation Clintec Nutrition
Division | Deerfield, IL 60015
USA 07-19-12-856 Rev. July 2002
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It is essential to
provide adequate calories concurrently if parenterally administered
amino acids are to be retained by the body and utilized for protein
synthesis. Concentrated dextrose solutions are an effective source of
such calories. With the
administration of 5.5% and 8.5% Travasol (Amino Acid)
Injections in combination with highly concentrated dextrose solutions,
hyperglycemia, glycosuria and hyperosmolar syndrome may result. Blood
and urine glucose should be monitored on a routine basis in patients
receiving this therapy. Sudden cessation in
administration of a concentrated dextrose solution may result in insulin
reaction due to continued endogenous insulin production. Parenteral
nutrition mixtures should be withdrawn slowly. Electrolytes may be
added to these injections as dictated by the patient's electrolyte
profile. The metabolizable
acetate anion and amino acid profiles in these injections were designed
to minimize or prevent occurrences of hyperchloremic metabolic acidosis
and hyperammonemia. However, the physician should be aware of
appropriate countermeasures if they become necessary. Strongly hypertonic
nutrient solutions should be administered through an indwelling
intravenous catheter with the tip located in the superior vena cava. 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. During
protein-sparing therapy 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. Protein-sparing
therapy is useful for periods up to 10 to 12 days. Patients requiring
nutritional support thereafter should be placed on oral or parenteral
regimens that employ adequate nonprotein calorie components. Drug product
contains no more than 25��g/L of aluminum.<br/>Laboratory Tests: Frequent clinical evaluation and laboratory
determinations are necessary for proper monitoring during
administration. Studies should include blood
sugar, serum proteins, kidney and liver function tests,
electrolytes, hemogram, carbon dioxide combining power or
content, serum osmolarities, blood cultures and blood ammonia
levels.<br/>Carcinogenesis and
Mutagenesis and Impairment of Fertility: Studies
with 5.5% and 8.5% Travasol (Amino Acid) Injections
have not been performed to evaluate carcinogenesis potential,
mutagenic potential, or effects on fertility.<br/>Pregnancy:<br/>Teratogenic
Effects:<br/>Nursing Mothers: Caution
should be exercised when 5.5% and 8.5% Travasol
(Amino Acid) Injections are administered to a nursing
woman.<br/>Pediatric Use: Safety and
effectiveness of 5.5% and 8.5% Travasol (Amino Acid)
Injections 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. SeeDOSAGE AND
ADMINISTRATION.
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See CONTRAINDICATIONS and WARNINGS.
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Leucine, Phenylalanine, Lysine hydrochloride,
Methionine, Isoleucine, Valine, Histidine, Threonine,
Tryptophan, Alanine, Glycine, Arginine, Proline,
Tyrosine
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dailymed-instance:fullName |
Travasol (Injection)
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See WARNINGS
and SPECIAL
PRECAUTIONS. Infusion of any
hypertonic solution can result in local inflammatory reactions. Policies
and procedures should be established for the recognition and management
of such reactions.
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dailymed-instance:warning |
These injections are for compounding only, not
for direct infusion. Caution should be
exercised when admixing 5.5% and 8.5% Travasol (Amino Acid)
Injections. Studies have shown that admixtures of Travasol
(Amino Acid) Injection, 10% and 20% Travamulsion Intravenous
Fat Emulsion Injection and high concentration dextrose injection (10 to
70%) from Baxter Healthcare Corporation, are stable over short periods
of time. These solutions should be used promptly after admixing. Any
storage shouldbe under refrigeration and limited to a brief period of
time, preferably less than 24 hours. Reference should be made to
Travamulsion Injection and high concentration dextrose
injection from Baxter Healthcare Corporation package inserts for
detailed information on each component. Proper
administration of these injections requires a knowledge of fluid and
electrolyte balance and nutrition as well as clinical expertise in
recognition and treatment of the complications which may occur. Administration of
amino acid solutions to a patient with hepatic insufficiency may result
in serum amino acid imbalances, hyperammonemia, stupor and coma. Hyperammonemia is
of special significance in infants.
This reaction appears to be related to a deficiency of the urea cycle
amino acids of genetic or product origin. It is essential that blood
ammonia be measured frequently in infants. Conservative doses
of these injections should be given to patients with known or suspected
hepatic dysfunction. Should symptoms of hyperammonemia develop,
administration should be discontinued and the patient's clinical status
reevaluated. Administration of
amino acid solutions in the presence of impaired renal function presents
special issues associated with retention of electrolytes. These injections
should not be administered simultaneously with blood through the same
infusion set because of the possibility of pseudoagglutination. 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. Administration by central venous catheter
should be used only by those familiar with this technique and its
complications.
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5.5% and 8.5%
Travasol (Amino Acid) Injections are indicated as an
adjunct in the offsetting of nitrogen loss or in the treatment of
negative nitrogen balance in patients where: (1) the alimentary tract
cannot or should not be used, (2) gastrointestinal absorption of protein
is impaired, or (3) metabolic requirements for protein are substantially
increased, as with extensive burns.<br/>Central Vein
Administration:: Central vein 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 vein route is not indicated, amino
acid solutions diluted with low dextrose concentrations may be
infused by peripheral vein when supplemented with or without
added fat emulsion.<br/>Protein-Sparing:: Dilute
amino acid solutions for peripheral
administration may be used in patients who exhibit
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. Protein-sparing can be
achieved by peripheral infusion of amino acid solutions with or
without dextrose.
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Travasol
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