Sodium Chloride Irrigant label

Sodium Chloride Irrigant

Sodium Chloride Irrigant Recall

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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

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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: 5.0 (4.5–7.0) Calculated Osmolarity: 310 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 a copolymer of ethylene and propylene formulated and developed for parenteral drugs. The copolymer contains no plasticizers and exhibits virtually no leachability. The plastic container is also virtually impermeable to vapor transmission and, therefore, requires no overwrap to maintain the proper drug concentration. The safety of the plastic container has been confirmed by biological evaluation procedures. The material passes Class Vl testing as specified in the U.S. Pharmacopeia for Biological Tests — Plastic Containers. These tests have shown that the container is nontoxic and biologically inert.

The PIC™ Container is PVC-free and DEHP-free.

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Sodium Chloride Irrigant Recall

Side Effects & Adverse Reactions

FDA Safety Alerts

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Sodium Chloride Irrigant Manufacturers

Remedyrepack Inc.
No Recall
Sodium Chloride Irrigant | Remedyrepack 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.
B. Braun Medical Inc.
No Recall
Sodium Chloride Irrigant | 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.
Hospira, Inc.
No Recall
Sodium Chloride Irrigant | Hospira, Inc.
The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer’s recommendations should be followed.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.
Baxter Healthcare Corporation
No Recall
Sodium Chloride Irrigant | Baxter Healthcare Corporation
The volume of slushed solution required will vary with patient’s age, clinical condition, cooling effect desired and duration of cooling effect desired, according to physician’s instructions.
Hospira, Inc.
No Recall
Sodium Chloride Irrigant | Hospira, Inc.
The dose is dependent upon the capacity or surface area of the structure to be irrigated and the nature of the procedure. When used as a diluent or vehicle for other drugs, the manufacturer’s recommendations should be followed. For use in cell washing, the manufacturer’s recommendations for blood salvaging and red cell processing should be followed.

Drug Interactions

Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution container permits. See PRECAUTIONS.
Baxter Healthcare Corporation
No Recall
Sodium Chloride Irrigant | Baxter Healthcare Corporation
As directed by a physician.

Cautions: Warm in oven to not more than 50°C for a maximum of 60 days. Discard after 60 days of warming. Do not use unless solution is clear and seal is intact. Discard unused portion. Rx only.
Cardinal Health
No Recall
Sodium Chloride Irrigant | Cardinal Health
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.
Baxter Healthcare Corporation
No Recall
Sodium Chloride Irrigant | Baxter Healthcare Corporation
There is currently no dosage information available for this product. We apologize for any inconvenience.
Baxter Healthcare Corporation
No Recall
Sodium Chloride Irrigant | Biocomp Pharma, Inc.
Wash affected areas once or twice daily, or as directed by your physician. Wet skin and liberally apply to areas to be cleansed. Massage gently into skin for 10 to 20 seconds, working into a full lather, rinse thoroughly and pat dry. If skin dryness occurs, it may be controlled by rinsing product off sooner or using less frequently.