Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 0.9% Sodium Chloride Irrigation, USP is supplied sterile and nonpyrogenic in single-dose flexible plastic containers. Product Code Unit of Sale Each 1727180007 NDC 17271-800-07 Package of 6 bags NDC 17271-800-07 1000 mL fill in a 1500 mL bag 1727180008 NDC 17271-800-08 Package of 5 bags NDC 17271-800-08 2000 mL fill in a 2000 mL bag 1727180009 NDC 17271-800-09 Package of 4 bags NDC 17271-800-09 3000 mL fill in a 3000 mL bag Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the product. Do not warm container above 140°F (60°C).; PACKAGE LABEL - PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 1000 mL Bag Label solu flex ® NDC 17271- 800 -07 1000 mL 0.9% SODIUM CHLORIDE IRRIGATION, USP ISOTONIC SOLUTION FOR IRRIGATION nacl-label-01.jpg; PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 1000 mL Case Label NDC 17271-800-07 1727180007 0.9% Sodium Chloride Irrigation, USP 1,000 mL x 6 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. nacl-label-02.jpg; PACKAGE LABEL - PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 2000 mL Bag Label solu flex ® NDC 17271-800-08 2000 mL 0.9% SODIUM CHLORIDE IRRIGATION, USP ISOTONIC SOLUTION FOR IRRIGATION nacl-label-03.jpg; PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 2000 mL Case Label NDC 17271-800-08 1727180008 0.9% Sodium Chloride Irrigation, USP 2,000 mL x 5 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. nacl-label-04.jpg; PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 3000 mL Bag Label solu flex ® NDC 17271- 800 -09 3000 mL 0.9% SODIUM CHLORIDE IRRIGATION, USP ISOTONIC SOLUTION FOR IRRIGATION nacl-label-05.jpg; PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 3000 mL Case Label NDC 17271-800-09 1727180009 0.9% Sodium Chloride Irrigation, USP 3,000 mL x 4 STORE AT: 20 ° to 25 ° C (68 ° to 77 ° F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. nacl-label-06.jpg
- HOW SUPPLIED 0.9% Sodium Chloride Irrigation, USP is supplied sterile and nonpyrogenic in single-dose flexible plastic containers. Product Code Unit of Sale Each 1727180007 NDC 17271-800-07 Package of 6 bags NDC 17271-800-07 1000 mL fill in a 1500 mL bag 1727180008 NDC 17271-800-08 Package of 5 bags NDC 17271-800-08 2000 mL fill in a 2000 mL bag 1727180009 NDC 17271-800-09 Package of 4 bags NDC 17271-800-09 3000 mL fill in a 3000 mL bag Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the product. Do not warm container above 140°F (60°C).
- PACKAGE LABEL - PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 1000 mL Bag Label solu flex ® NDC 17271- 800 -07 1000 mL 0.9% SODIUM CHLORIDE IRRIGATION, USP ISOTONIC SOLUTION FOR IRRIGATION nacl-label-01.jpg
- PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 1000 mL Case Label NDC 17271-800-07 1727180007 0.9% Sodium Chloride Irrigation, USP 1,000 mL x 6 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. nacl-label-02.jpg
- PACKAGE LABEL - PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 2000 mL Bag Label solu flex ® NDC 17271-800-08 2000 mL 0.9% SODIUM CHLORIDE IRRIGATION, USP ISOTONIC SOLUTION FOR IRRIGATION nacl-label-03.jpg
- PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 2000 mL Case Label NDC 17271-800-08 1727180008 0.9% Sodium Chloride Irrigation, USP 2,000 mL x 5 STORE AT : 20 ° to 25 ° C ( 68 ° to 77 ° F ) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. nacl-label-04.jpg
- PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 3000 mL Bag Label solu flex ® NDC 17271- 800 -09 3000 mL 0.9% SODIUM CHLORIDE IRRIGATION, USP ISOTONIC SOLUTION FOR IRRIGATION nacl-label-05.jpg
- PACKAGE LABEL – PRINCIPAL DISPLAY – 0.9% Sodium Chloride Irrigation, USP 3000 mL Case Label NDC 17271-800-09 1727180009 0.9% Sodium Chloride Irrigation, USP 3,000 mL x 4 STORE AT: 20 ° to 25 ° C (68 ° to 77 ° F) [see USP Controlled Room Temperature] Avoid excessive heat. Protect from freezing. nacl-label-06.jpg
Overview
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 flexible plastic container is made from a multilayered film specifically developed for parenteral drugs. It contains no plasticizers. The solution contact layer is a 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. Not made with natural rubber latex, PVC or DEHP.
Indications & Usage
0.9% Sodium Chloride Irrigation is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution.
Dosage & Administration
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.
Warnings & Precautions
WARNINGS 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 container above 140°F (60°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.
Contraindications
0.9% Sodium Chloride Irrigation is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.
Adverse Reactions
Possible adverse effects arising from the irrigation of body cavities, tissues, or indwelling catheters and tubes can be minimized when proper procedures are followed. Displaced catheters or drainage tubes can lead to irrigation or infiltration of unintended structures or cavities. Excessive volume or pressure during irrigation of closed cavities may cause undue distension or disruption of tissues. Accidental contamination from careless technique may transmit infection. If an adverse reaction does occur, discontinue administration of the irrigant, evaluate the patient, institute appropriate therapeutic countermeasures, and save the remainder of the fluid for examination if deemed necessary.
Drug Interactions
Some additives may be incompatible. Consult with pharmacist. When introducing additives, use aseptic technique. Mix thoroughly. Do not store.
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