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Sodium Chloride For Irrigation Solution Recall
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Questions & Answers
Side Effects & Adverse Reactions
FOR IRRIGATION ONLY. NOT FOR INJECTION.
Irrigating fluids have been demonstrated to enter the systemic circulation in relatively large volumes; thus, irrigation solutions must be regarded as systemic drugs. Absorption of large amounts can cause fluid and/or solute overload 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 administered parenteral solutions. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration.
Do not warm above 150°F (66°C).
After opening container, its contents should be used promptly to minimize the possibility of bacterial growth or pyrogen formation.
Discard unused portion of irrigating solution since it contains no preservatives.
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
0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
History
There is currently no drug history available for this drug.
Other Information
Each 100 mL contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.75 (4.50-7.00)
Calculated Osmolarity: 308 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154
0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic and contains no bacteriostatic or antimicrobial agents.
The formula of the active ingredient is:
Ingredient | Molecular Formula | Molecular Weight |
Sodium Chloride USP | NaCl | 58.44 |
The plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers and exhibits virtually no leachables. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary.
Not made with natural rubber latex, PVC or DEHP.
Sources
Sodium Chloride For Irrigation Solution Manufacturers
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B. Braun Medical Inc.
Sodium Chloride For Irrigation Solution | B. Braun Medical Inc.
As required for irrigation.
When used as a diluent, or vehicle for other drugs, the drug manufacturer's recommendations should be followed.
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic techniques. Mix thoroughly. Do not store.
Solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permits.
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