Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/831
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rdf:type | |
rdfs:label |
Sodium Chloride (Injection)
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dailymed-instance:dosage |
The volume of the preparation
to be used for diluting or dissolving any drug for injection, is dependent
on the vehicle concentration, dose and route of administration as
recommended by the manufacturer. Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to administration, whenever solution
and container permit. See PRECAUTIONS.
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dailymed-instance:descripti... |
This preparation is designed
for parenteral use only after addition of drugs that require dilution
or must be dissolved in an aqueous vehicle prior to injection. Bacteriostatic 0.9% Sodium Chloride
Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium
chloride in water for injection. Each milliliter (mL) contains sodium
chloride 9 mg and 0.9% (9 mg/mL) benzyl alcohol added as a bacteriostatic
preservative. May contain hydrochloric acid for pH adjustment. It
is supplied in a multiple-dose container from which repeated withdrawals
may be made to dilute or dissolve drugs for medication. The pH is
5.0 (4.5 to 7.0). Sodium
Chloride, USP is chemically designated NaCl, a white crystalline powder
freely soluble in water. The semi-rigid vial is fabricated from a specially formulated polyolefin.
It is a copolymer of ethylene and propylene. The safety of the plastic
has been confirmed by tests in animals according to USP biological
standards for plastic containers. The container requires no vapor
barrier to maintain the proper drug concentration.
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dailymed-instance:clinicalP... |
Sodium chloride in water
dissociates to provide sodium (Na) and chloride (Cl) ions. These ions are normal constituents of the body
fluids (principally extracellular) and are essential for maintaining
electrolyte balance. The distribution and excretion of sodium (Na) and chloride
(Cl) are largely under the control of the kidney
which maintains a balance between intake and output. The small volume of fluid and amount of sodium chloride provided
by Bacteriostatic 0.9% Sodium Chloride Injection, USP, when used only
as a vehicle for parenteral injection of drugs, is unlikely to exert
a significant effect on fluid and electrolyte balance except possibly
in neonates and very small infants. Water is an essential constituent of all body tissues and accounts
for approximately 70% of total body weight. Average normal adult daily
requirement ranges from two to three liters (1.0 to 1.5 liters
each for insensible water loss by perspiration and urine production). Water balance is maintained by
various regulatory mechanisms. Water distribution depends primarily
on the concentration of electrolytes in the body compartments and
sodium (Na) plays a major role in maintaining physiologic
equilibrium.
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dailymed-instance:activeIng... | |
dailymed-instance:contraind... |
Due to the potential toxicity
of benzyl alcohol in neonates, solutions containing benzyl alcohol
must not be used in this patient population. Parenteral preparations with benzyl alcohol should not be used for
fluid or sodium chloride replacement. Parenteral preparations containing benzyl alcohol should not be used
in epidural or spinal anesthetic procedures.
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dailymed-instance:supply |
Bacteriostatic 0.9% Sodium
Chloride Injection, USP is supplied in multiple-dose 10, 20 and 30
mL plastic fliptop vials (List No. 1966) or in multiple-dose 10 and
30 mL plastic LifeShield fliptop vials*. (List No.
1966). *Intended for
use with the LifeShield Blunt Cannula. Store at 20 to 25��C (68
to 77��F). [See USP Controlled Room Temperature.] Rev: April, 2005 HOSPIRA, INC., LAKE FOREST, IL 60045 USA
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dailymed-instance:boxedWarn... |
WARNING: NOT FOR USE IN NEONATES.
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dailymed-instance:activeMoi... | |
dailymed-instance:inactiveI... | |
dailymed-instance:precautio... |
Consult the manufacturer's
instructions for choice of vehicle, appropriate dilution or volume
for dissolving the drugs to be injected, including the route and rate
of injection. Inspect
reconstituted (diluted or dissolved) drugs for clarity (if soluble)
and freedom from unexpected precipitation or discoloration prior to
administration.<br/>Pregnancy Category C.: Animal reproduction
studies have not been conducted with Bacteriostatic 0.9% Sodium Chloride
Injection, USP. It is also not known whether Bacteriostatic 0.9% Sodium
Chloride Injection containing additives can cause fetal harm when
administered to a pregnant woman or can affect reproduction capacity.
Bacteriostatic 0.9% Sodium Chloride Injection containing additives
should be given to a pregnant woman only if clearly needed.<br/>Pediatric Use: The safety and effectiveness
in the pediatric population are based on the similarity of the clinical
conditions of the pediatric and adult populations. However, due to
potential toxicity of benzyl alcohol in neonates, solutions containing
benzyl alcohol are contraindicated in this patient population.<br/>Drug Interactions: Some drugs for injection
may be incompatible in a given vehicle, or when combined in the same
vehicle or in a vehicle containing benzyl alcohol. Consult with pharmacist,
if available. Use aseptic technique for single or multiple entry and withdrawal
from all containers. When diluting or dissolving drugs, mix thoroughly and use promptly. Do not store reconstituted
solutions of drugs for injection unless otherwise directed by the
manufacturer of the solute. Do not use unless the solution is clear and seal intact.
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dailymed-instance:overdosag... |
Use only as a diluent or
solvent. This parenteral preparation is unlikely to pose a threat
of sodium chloride or fluid overload except possibly in neonates and
very small infants. In the event these should occur, re-evaluate the
patient and institute appropriate corrective measures. See PRECAUTIONS
and ADVERSE REACTIONS.
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dailymed-instance:genericMe... |
Sodium Chloride
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dailymed-instance:fullName |
Sodium Chloride (Injection)
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dailymed-instance:adverseRe... |
Reactions which may occur
because of this solution, added drugs or the technique of reconstitution
or administration include febrile response, local tenderness, abscess,
tissue necrosis or infection at the site of injection, venous thrombosis
or phlebitis extending from the site of injection and extravasation. If an adverse reaction does occur,
discontinue the infusion, evaluate the patient, institute appropriate
countermeasures, and if possible, retrieve and save the remainder
of the unused vehicle for examination. Although adverse reactions to intravenous, intramuscular or subcutaneous
injection of 0.9% benzyl alcohol are not known to occur in man, experimental
studies of small volume parenteral preparations containing 0.9% benzyl
alcohol in several species of animals have indicated that an estimated
intravenous dose up to 30 mL may be safely given to an adult without
toxic effects. Administration of an estimated 9 mL to a 6 kg neonate
or infant is potentially capable of producing blood pressure changes.
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dailymed-instance:warning |
Benzyl alcohol, a preservative
in Bacteriostatic Sodium Chloride Injection, USP has been associated
with toxicity in neonates. Data are unavailable on the toxicity of
other preservatives in this age group. Preservative-free Sodium Chloride
Injection should be used for flushing intravascular catheters. Where
a sodium chloride solution is required for preparing or diluting medications
for use in neonates, only preservative-free Sodium Chloride Injection
should be used.
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dailymed-instance:indicatio... |
This parenteral preparation
is indicated only for diluting or dissolving drugs for intravenous,
intramuscular or subcutaneous injection, according to instructions
of the manufacturer of the drug to be administered.
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dailymed-instance:represent... | |
dailymed-instance:routeOfAd... | |
dailymed-instance:name |
Sodium Chloride
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