Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1559
Predicate | Object |
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rdf:type | |
rdfs:label |
Clinisol (Injection)
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dailymed-instance:dosage |
Doses which achieve
nitrogen equilibrium or positive balance are the most desirable. The
dosage on the first day should be approximately half the anticipated
optimal dosage and should be increased gradually to minimize glycosuria;
similarly, withdrawal should be accomplished gradually to avoid rebound
hypoglycemia. Fat emulsion
coadministration should be considered when prolonged (more than 5 days)
parenteral nutrition is required in order to prevent essential fatty
acid deficiency (EFAD).<br/>Pediatric Use: Use of 15%
Clinisol - sulfite-free (Amino Acid) Injection 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 mOsmol/L). Parenteral
drug products should be inspected visually for particulate
matter and discoloration prior to administration. A slight
yellow color does not alter the quality and efficacy of this
product. Additives
may be incompatible. 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 15% Clinisol - sulfite-free (Amino Acid)
Injection Pharmacy Bulk Package.<br/>Central Vein
Infusion: In
unstressed adult patients with no unusual nitrogen losses, a minimum dosage of 0.1 gram nitrogen (4.2 mL of 15% Clinisol -
sulfite-free (Amino Acid) Injection Pharmacy Bulk Package) plus
4.4 grams (15 calories) of dextrose/fat emulsion per kilogram of
body weight per day is required to achieve nitrogen balance and
weight stability. For patients stressed by surgery, trauma or
sepsis, and those with unusual nitrogen losses, the dosage
required for maintenance may be as high as 0.3 to 0.4 grams of
nitrogen (13 to 17 mL 15% Clinisol - sulfite-free (Amino Acid)
Injection Pharmacy Bulk Package) per kilogram of body weight per
day, with proportionate increases in non-protein calories.
Periodic assessment of nitrogen balance of the individual
patient is the best indicator of proper dosage. Use of an
infusion pump is advisable to maintain a steady infusion rate
during central venous infusion.<br/>Peripheral Infusion: In patients
for whom central vein catheterization is not advisable,
admixtures with 15% Clinisol - sulfite-free (Amino Acid)
Injection Pharmacy Bulk Package can be administered by
peripheral vein. Dilution of 250 mL 15% Clinisol - sulfite-free
(Amino Acid) Injection Pharmacy Bulk Package in 750 mL of 10%
dextrose will reduce the osmolarity to a level (718 mOsmol/L)
which is more favorable to the maintenance of the integrity of
the walls of the veins. If infused simultaneously, fat emulsion
will provide a dilution effect upon the osmolarity, as well. In
pediatric patients, the final solution should not exceed twice
normal serum osmolarity (718 mOsmol/L).
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dailymed-instance:descripti... |
15% Clinisol -
sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is a sterile,
clear, nonpyrogenic, hypertonic solution of essential and nonessential
amino acids. 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 test for plastic containers
as well as by tissue culture toxicity studies. Each 100 mL of 15%
Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk Package
contains: (pH adjusted with
glacial acetic acid and may have been adjusted with sodium hydroxide)
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dailymed-instance:clinicalP... |
15% Clinisol -
sulfite-free (Amino Acid) Injection Pharmacy Bulk Package administered
parenterally will provide biologically utilizable source material for
protein synthesis when used with concentrated calorie sources,
electrolytes, vitamins and minerals.<br/>Central Infusion: 15%
Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk
Package is intended for use in a pharmacy admixture program and
as such is restricted to the preparation of admixtures for
intravenous use. 15% Clinisol - sulfite-free (Amino Acid)
Injection Pharmacy Bulk Package given by central venous infusion
in combination with energy sources, vitamins, trace elements and
electrolytes, will meet the requirements for weight maintenance
or weight gain. The energy component maybe derived solely from dextrose or may be provided by a combination of dextrose and
intravenous fat emulsion.<br/>Peripheral Infusion: 15%
Clinisol - sulfite-free (Amino Acid) Injection Pharmacy Bulk
Package, when diluted to an appropriate osmolarity level (718 mOsmol/L) can also be administered by a peripheral vein when use
of a central venous catheter is contraindicated.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Hypersensitivity to
one or more amino acids Severe liver
disease or hepatic coma Anuria Metabolic disorders
involving impaired nitrogen utilization
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dailymed-instance:supply |
15% Clinisol -
sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is available
in Viaflex plastic containers as follows. 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). Baxter Healthcare Corporation Clintec Nutrition
Division Deerfield, IL 60015
USA 07-19-17-318 Rev. September 2002
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
General: In order
for parenterally administered amino acids to be retained by the
body and utilized for protein synthesis adequate calories must
be administered concurrently. The
administration of 15% Clinisol - sulfite-free (Amino Acid)
Injection Pharmacy Bulk Package as part of total parenteral
nutrition (TPN) with large volumes of hyperosmotic fluids
requires periodic monitoring of the patient for signs of
hyperosmolarity, hyperglycemia, glycosuria and
hypertriglyceridemia. During
parenteral nutrition with concentrated dextrose and amino acid
solutions, essential fatty acid deficiency syndrome may develop
but may not be clinically apparent. Early demonstration of this
condition can only be accomplished by analysis of plasma lipids.
The syndrome may be prevented or corrected by appropriate treatment with intravenous fat emulsions. For
complete nutritional support, TPN regimens must also include
multiple vitamins and trace elements. Potentially incompatible
ions such as calcium and phosphate may be added to alternate
infusate containers to avoid precipitation. Initiation
and termination of infusions of TPN fluids must be gradual to
permit adjustment of endogenous insulin release. Caution
should be exercised against volume overload. Do not
administer unless solution is clear. TPN
delivered through a central or large peripheral vein is a
special technique requiring a team effort by physician, nurse
and pharmacist. The responsibility for administering this
therapy should be confined to those trained in the procedures
and alert to signs of complications. Complications known to
occur from the placement of central venous catheters include sepsis and vein irritation due to hypertonicity of the infused
solution. The risk of sepsis is present during intravenous
therapy, especially when using central venous catheters for prolonged periods. It is imperative that the preparation of
admixtures and the placement and care of the catheters be
accomplished under controlled aseptic conditions. It is essential that a carefully prepared
protocol, based on current medical practices be
followed. Drug
product contains no more than 25��g/L of aluminum.<br/>Laboratory Tests: Frequent clinical evaluations and
laboratory determinations are necessary for proper
monitoring during administration. Laboratory
tests should include blood glucose, serum electrolytes, liver
and renal function, serum osmolarity, blood ammonia, serum
protein, pH, hematocrit, and WBC. When 15% Clinisol -
sulfite-free (Amino Acid) injection Pharmacy Bulk Package is
combined with electrolytes, care should be used in administering
this solution to patients with congestive heart failure, renal
failure, edema, adrenal hyperactivity, acid base imbalance and
those receiving diuretics or antihypertensive therapy. Serum
electrolytes should be monitored daily.<br/>Carcinogenesis,
Mutagenesis, Impairment of Fertility: Long term
animal studies with 15% Clinisol - sulfite-free (Amino Acid)
Injection Pharmacy Bulk Package have not been performed to
evaluate the carcinogenic potential, mutagenic potential or
effects on fertility.<br/>Pregnancy:<br/>Teratogenic Effects:<br/>Nursing Mothers: Caution
should be exercised when 15% Clinisol - sulfite-free (Amino
Acid) Injection Pharmacy Bulk Package is administered to a
nursing woman.<br/>Pediatric Use: Safety and
effectiveness of 15% Clinisol - sulfite-free (Amino Acid)
Injection 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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dailymed-instance:genericMe... |
Lysine, Leucine, Phenylalanine, Valine, Histidine,
Isoleucine, Methionine, Threonine, Tryptophan, Alanine,
Arginine, Glycine, Proline, Glutamic Acid, Serine,
Aspartic Acid, Tyrosine
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dailymed-instance:fullName |
Clinisol (Injection)
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dailymed-instance:adverseRe... |
Local reactions
consisting of a warm sensation, erythema, phlebitis and thrombosis at
the infusion site have occurred with peripheral intravenous infusion of
amino acids. In such cases the infusion site should be changed promptly
to another vein. Generalized flushing, fever and nausea also have been
reported during peripheral infusions of amino acid solutions. The following
metabolic complications have been reported with administration of TPN:
metabolic acidosis and alkalosis, hypophosphatemia, hypocalcemia,
osteoporosis, glycosuria, hyperglycemia, hyperosmolar nonketotic states
and dehydration, rebound hypoglycemia, osmotic diuresis and dehydration,
elevated liver enzymes, hypo- and hypervitaminosis, electrolyte
imbalances, hyperammonemia, coma and death. Sepsis has been
reported following intravenous therapy, especially when using centralvenous catheters for prolonged periods, Complications known
to occur from the placement of central venous catheters are
pneumothorax, hemothorax, hydrothorax, artery puncture and transection
injury to the brachial plexus, malposition of the catheter, formation of
arteriovenous fistula, phlebitis, thrombosis and air and catheter
emboli.
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dailymed-instance:warning |
Additives may be
incompatible. Consult with pharmacist, if available. When introducing
additives, use aseptic techniques. Mix thoroughly. Do not store. Because
of the potential for life-threatening events, caution should be taken to
ensure that precipitates have not formed in any parenteral nutrient
admixture. This injection is for compounding only, not
for direct infusion. Once container
closure has been penetrated, withdrawal of contents should be completed
within 4 hours. After initial entry, maintain contents at room
temperature (25��C/77��F). Any admixture
storage should be under refrigeration and limited to a brief period of
time, preferably less than 24 hours. Administration of
amino acid solutions at excessive rates or to patients with hepatic
insufficiency may result in plasma amino acid imbalances,
hyperammonemia, prerenal azotemia, stupor and coma. Conservative doses
of amino acids should be given to these patients, dictated by the
nutritional status of the patient. Should symptoms of hyperammonemia
develop, amino acid administration should be discontinued and the
patient's clinical status reevaluated. 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.
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dailymed-instance:indicatio... |
15% Clinisol -
sulfite-free (Amino Acid) Injection Pharmacy Bulk Package is 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.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Clinisol
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