Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/2527
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Sodium Chloride (Injection, Solution)
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dailymed-instance:dosage |
The dose is dependent upon the age, weight and clinical condition
of the patient. 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... |
Sodium Chloride Injection, USP solutions are sterile and
nonpyrogenic. They are parenteral solutions containing various concentrations
of sodium chloride in water for injection intended for intravenous administration
after admixing with an ADD-Vantage vial. Each 100
mL of 0.45% Sodium Chloride Injection, USP contains 450 mg sodium chloride
in water for injection. Electrolytes per 1000 mL: sodium 77 mEq; chloride
77 mEq. The osmolarity is 154 mOsmol/L (calc.), which is hypotonic. Each 100 mL of 0.9% Sodium Chloride Injection, USP contains 900 mg sodium
chloride in water for injection. Electrolytes per 1000 mL: sodium 154 mEq;
chloride 154 mEq. The osmolarity is 308 mOsmol/L (calc.), which is isotonic. The pH for both concentrations is 5.6 (4.5 to 7.0). The solutions contain no bacteriostat, antimicrobial agent or added buffer
and each is intended only as a single-dose injection. When smaller doses are
required the unused portion should be discarded. The
solutions are parenteral fluid and electrolyte replenishers. Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder
freely soluble in water. Water for Injection, USP
is chemically designated HO. The flexible
plastic container is fabricated from a specially formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not in
amounts sufficient to affect the solution significantly. Solutions in contact
with the plastic container may leach out certain chemical components from
the plastic in very small amounts; however, biological testing was supportive
of the safety of the plastic container materials. 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.
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dailymed-instance:clinicalP... |
When administered intravenously, these solutions provide
a source of water and electrolytes. Solutions which
provide an isotonic concentration of sodium chloride are suitable for parenteral
maintenance or replacement of water and electrolyte requirements. Isotonic concentrations of sodium chloride are suitable for parenteral replacement
of chloride losses that exceed or equal the sodium loss. Sodium chloride in
water dissociates to provide sodium (Na) and chloride (Cl���)
ions. Sodium (Na) is the principal cation of the extracellular
fluid and plays a large part in the therapy of fluid and electrolyte disturbances.
Chloride (Cl���) has an integral role in buffering action when oxygen
and carbon dioxide exchange occurs in the red blood cells. 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. Water is an essential constituent of all body
tissues and accounts for approximately 70% of total body weight. Average normal
adult daily requirements range 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... | |
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None known.
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dailymed-instance:supply |
Exposure of pharmaceutical products to heat should be
minimized. Avoid excessive heat. Protect from freezing. It is recommended
that the product be stored at room temperature (25��C). INSTRUCTIONS FOR USE These instructions for use should be made available to the
individuals who perform the reconstitution steps. To Open: Peel overwrap at
corner 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. To Assemble Vial
and Flexible Diluent Container: (Use
Aseptic Technique) To Reconstitute the Drug: Preparation for Administration: (Use Aseptic Technique) WARNING: Do not use flexible container
in series connections. U.S. patent 4,757,911 June, 2004 HOSPIRA, INC., LAKE FOREST,
IL 60045 USA
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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. Caution must be exercised in the administration of parenteral fluids, especially
those containing sodium ions to patients receiving corticosteroids or corticotropin. Do not administer unless solution is clear and container is undamaged. Discard
unused portion.<br/>Carcinogenesis, Mutagenesis, Impairment of Fertility:: Studies with Sodium Chloride Injection, USP have not been
performed to evaluate carcinogenic potential, mutagenic potential or effects
on fertility.<br/>Pregnancy:: Teratogenic effects Pregnancy Category C. Animal reproduction studies
have not been conducted with Sodium Chloride Injection, USP. It is not known
whether sodium chloride injection can cause fetal harm when administered to
a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection,
USP should be given to a pregnant woman only if clearly needed.<br/>Nursing Mothers:: Caution should be exercised when Sodium Chloride Injection,
USP is administered to a nursing woman.<br/>Pediatric Use:: Safety and effectiveness in children have not been established. Only additives in the ADD-Vantage vial should be delivered via this solution.
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dailymed-instance:overdosag... |
In the event of overhydration or solute overload, re-evaluate
the patient and institute appropriate corrective measures. See WARNINGS, PRECAUTIONS,
and ADVERSE REACTIONS.
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dailymed-instance:genericMe... |
Sodium Chloride
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dailymed-instance:fullName |
Sodium Chloride (Injection, Solution)
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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 |
Solutions containing sodium ions 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. Excessive administration of potassium-free solutions may result in significant
hypokalemia. In patients with diminished renal function,
administration of solutions containing sodium ions may result in sodium retention. The intravenous administration of these solutions 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 administered
parenteral solutions. The risk of solute overload causing congested states
with peripheral and pulmonary edema is directly proportional to the electrolyte
concentrations of such solutions.
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dailymed-instance:indicatio... |
Intravenous solutions containing sodium chloride are indicated
for parenteral replenishment of fluid and sodium chloride as required by the
clinical condition of the patient. In this dosage
form, Sodium Chloride Injection, USP is intended to be used as a diluent for
the contents of an ADD-Vantage vial.
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dailymed-instance:represent... | |
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dailymed-instance:name |
Sodium Chloride
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