Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2262
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PLASMA-LYTE 56 (Injection)
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| dailymed-instance:dosage |
As directed by a
physician. Dosage is dependent upon the age, weight and clinical
condition of the patient as well as laboratory determinations. Parenteral drug
products should be inspected visually for particulate matter and
discoloration prior to administration whenever solution and container
permit. All injections in
VIAFLEX plastic containers are intended for intravenous administration
using sterile equipment. Additives may be
incompatible. Complete information is not available. Those additives
known to be incompatible should not be used. Consult with pharmacist, if
available. If, in the informed judgment of the physician, it is deemed
advisable to introduce additives, use aseptic technique. Mix thoroughly
when additives have been introduced. Do not store solutions containing
additives.
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| dailymed-instance:descripti... |
PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) is a sterile,
nonpyrogenic, hypotonic solution in a single dose container for
intravenous administration. Each 100 mL contains 234 mg of Sodium
Chloride, USP (NaCl); 128 mg of Potassium Acetate, USP
(CHKO); and 32 mg of Magnesium
Acetate Tetrahydrate
(Mg(CHO)���4HO).
It contains no antimicrobial agents. The pH is adjusted with
hydrochloric acid. The pH is 5.5 (4.0 to 8.0). PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) administered
intravenously has value as a source of water and electrolytes. One liter
has an ionic concentration of 40 mEq sodium, 13 mEq potassium, 3 mEq
magnesium, 40 mEq chloride, and 16 mEq acetate. The osmolarity is 111
mOsmol/L (calc). Normal physiologic osmolarity range isapproximately
280 to 310 mOsmol/L. Administration of substantially hypertonic
solutions may cause vein damage. The VIAFLEX plastic container is fabricated from a specially formulated polyvinyl chloride
(PL 146 Plastic). 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 chemicalcomponents 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.
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| dailymed-instance:clinicalP... |
PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) has value as a
source of water and electrolytes. It is capable of inducing diuresis
depending on the clinical condition of the patient. PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) produces a
metabolic alkalinizing effect. Acetate ions are metabolized ultimately
to carbon dioxide and water, which requires the consumption of hydrogen
cations.
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| dailymed-instance:activeIng... | |
| dailymed-instance:contraind... |
None
known
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| dailymed-instance:supply |
PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) in VIAFLEX
plastic containers is available as shown below: Exposure of
pharmaceutical products to heat should be minimized. Avoid excessive
heat. It is recommended the product be stored at room temperature
(25��C); brief exposure up to 40��C does not adversely affect the
product.
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| dailymed-instance:inactiveI... | |
| dailymed-instance:precautio... |
Clinical evaluation
and periodic laboratory determinations are necessary to monitor changes
in fluid balance, electrolyte concentrations and acid base balance
during prolonged parenteral therapy or whenever the condition of the
patient warrants such evaluation. PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) should be used
with caution. Excess administration may result in metabolic alkalosis. Caution must be
exercised in the administration of PLASMA-LYTE 56 Injection (Multiple
Electrolytes Injection, Type 1, USP) to patients receiving
corticosteroids or corticotropin.<br/>Pregnancy:<br/>Teratogenic
Effects:<br/>Pediatric Use: Safety and
effectiveness of PLASMA-LYTE 56 Injection (Multiple Electrolytes
Injection, Type 1, USP) in pediatric patients have not been
established by adequate and well controlled trials, however, the
use of electrolyte solutions in the pediatric population is
referenced in the medical literature. The warnings, precautions
and adverse reactions identified in the label copy should be
observed in the pediatric population.<br/>Geriatric Use: Clinical
studies of PLASMA-LYTE 56 Injection (Multiple Electrolytes
Injection, Type 1, USP) did not include sufficient numbers of
subjects aged 65 and over to determine whether they respond
differently from younger subjects. Other reported clinical
experience has not identified differences in responses between
the elderly and younger patients. In general, dose selection for
an elderly patient should be cautious, usually starting at the
low end of the dosing range, reflecting the greater frequency of
decreased hepatic, renal, or cardiac function, and of
concomitant disease or drug therapy. Do not
administer unless solution is clear and seal is
intact.
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| dailymed-instance:genericMe... |
Sodium Chloride, Potassium Acetate, Magnesium Acetate Tetrahydrate
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| dailymed-instance:fullName |
PLASMA-LYTE 56 (Injection)
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| dailymed-instance:adverseRe... |
Reactions which may
occur because of the solution or the technique of administration include
febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation and
hypervolemia. If an adverse
reaction does occur, discontinue the infusion, evaluate the patient,
institute appropriate therapeutic countermeasures and save the remainder
of the fluid for examination if deemed necessary.
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| dailymed-instance:warning |
PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) should be used
with great care, if at all, in patients with congestive heart failure,
severe renal insufficiency and in clinical states in which there exists
edema with sodium retention. PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) should be used
with great care, if at all, in patients with hyperkalemia, severe renal
failure and in conditions in which potassium retention is present. PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) should be used
with great care in patients with metabolic or respiratory alkalosis. The
administration of acetate ions should be done with great care in those
conditions in which there is an increased level or an impaired
utilization of these ions, such as severe hepatic insufficiency. PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) should not be
administered simultaneously with blood through the same administration
set because of the possibility of hemolysis. The intravenous
administration of PLASMA-LYTE 56 Injection (Multiple Electrolytes
Injection, Type 1, USP) can cause fluid and/or solute overloading
resulting in dilution of serum electrolyte concentrations,
overhydration, congested states or pulmonary edema. The risk of
dilutional states is inversely proportional to the electrolyte
concentrations of the injection. The risk of solute overload causing
congested states with peripheral and pulmonary edema is directly
proportional to the electrolyte concentrations of the injection. In patients with
diminished renal function, administration of PLASMA-LYTE 56 Injection
(Multiple Electrolytes Injection, Type 1, USP) may result in sodium or
potassium retention.
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| dailymed-instance:indicatio... |
PLASMA-LYTE 56
Injection (Multiple Electrolytes Injection, Type 1, USP) is indicated as
a source of water and electrolytes or as an alkalinizing
agent.
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| dailymed-instance:represent... | |
| dailymed-instance:routeOfAd... | |
| dailymed-instance:name |
PLASMA-LYTE 56
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