FDA records indicate that there are no current recalls for this drug.
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A2857-20 Portex Single Shot Epidural 20g Tuohy Recall
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Questions & Answers
Side Effects & Adverse Reactions
WARNING
Sodium Chloride must be used with caution in the presence of congestive heart failure, circulatory insufficiency, kidney dysfunction or hypoproteinemia.
Excessive amounts of sodium chloride by any route may cause hypokalemia and acidosis. Excessive amounts by parental routes may precipitate congestive heart failure and acute pulmonary edema, especially seen in patients with preexisting cardiovascular disease and those receiving coricos-teroids, corticotrophin or other drugs that may give rise to sodium retention. For use in newborns, when a Sodium Chloride solution is required for preparation or diluting medications, or in flushing intravenous catheters, only preservative-free Sodium Chloride Injection, USP, 0.9% should be used.
Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
INDICATIONS AND USAGE
Sodium Chloride Injection is used to flush intravascular catheters or as a sterile, isontonic single dose vehicle, solvent, or diluent for substances to administered intravenously,k intramuscularly or sub-cutaneously and for other extemporaneously prepared single dose sterile solutions according to instructions of the manufacture of the drug to be administered.
History
There is currently no drug history available for this drug.
Other Information
Spectra Medical Devices, Inc.
SODIUM CHLORIDE
INJECTION, USP, 0.9%
DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic, isotonic solution of sodium chloride 0.9% (9mg/mL) in Water for Injection containing no antimicrobial agent or other added substance. The pH is between 4.5 and 7.0. Its chloride and sodium ion concentrates are approximately 0.154 mEq of each per milliliter and its calculated osmolality is 0.308 milliosmols per mL.
Sodium chloride occurs as colorless cubic crystals or white crystalline powder and has a saline taste. Sodium Chloride is freely soluble in water. It is soluble in glycerin and slightly soluble in alcohol. The empirical formula for sodium chloride is NaCl, and the molecular weight is 58.44.
Sources
A2857-20 Portex Single Shot Epidural 20g Tuohy Manufacturers
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Smiths Medical Asd, Inc.
A2857-20 Portex Single Shot Epidural 20g Tuohy | Smiths Medical Asd, Inc.
DOSAGE AND ADMINISTRATION
Before Sodium Chloride Injection, USP, 0.9% is used as a vehicle for the administration of a drug;specific references should be checked for any possible incompatibility with sodium chloride. 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 manufacture.Sodium Chloride Injection, USP, 0.9% is also indicated for use in flushing intravenous catheters. Prior to and after administration of the medication, the intravenous catheter should be flushed in its entirety with Sodium Chloride Injection, USP, 0.9%. Use in accord with any warnings or precautions appropriate to the medication being administered as recommended by the manufacture. Parental drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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