Drug Facts
Composition & Profile
Identifiers & Packaging
HOW SUPPLIED 0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container is available as follows: 2B7477 3000 mL NDC 0338-0047-27 2B7479 5000 mL NDC 0338-0047-29 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25º C); brief exposure up to 40º C does not adversely affect the product.; PACKAGE LABEL.PRINCIPLE DISPLAY PANEL 0.9% Sodium Chloride Irrigation USP Container Label 0.9% Sodium Chloride Irrigation USP Container Label NOT FOR INJECTION 5000 mL 2B7479 NDC 0338-0047-29 0.9% SODIUM CHLORIDE Irrigation USP EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.5 (4.5 to 7.0) mEq/L SODIUM 154 CHLORIDE 154 OSMOLARITY 308 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT 0.9% Sodium Chloride NaCl Irrigation USP ARTHROMATIC CONTAINER PL 146 PLASTIC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA BAXTER ARTHROMATIC AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 0.9% Sodium Chloride Irrigation USP Container Label
- HOW SUPPLIED 0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container is available as follows: 2B7477 3000 mL NDC 0338-0047-27 2B7479 5000 mL NDC 0338-0047-29 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25º C); brief exposure up to 40º C does not adversely affect the product.
- PACKAGE LABEL.PRINCIPLE DISPLAY PANEL 0.9% Sodium Chloride Irrigation USP Container Label 0.9% Sodium Chloride Irrigation USP Container Label NOT FOR INJECTION 5000 mL 2B7479 NDC 0338-0047-29 0.9% SODIUM CHLORIDE Irrigation USP EACH 100 mL CONTAINS 900 mg SODIUM CHLORIDE USP NO ANTIMICROBIAL AGENT HAS BEEN ADDED pH 5.5 (4.5 to 7.0) mEq/L SODIUM 154 CHLORIDE 154 OSMOLARITY 308 mOsmol/L (CALC) STERILE NONPYROGENIC SINGLE DOSE CONTAINER DO NOT USE UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND RX ONLY STORE UNIT IN MOISTURE BARRIER OVERWRAP AT ROOM TEMPERATURE (25°C) UNTIL READY TO USE AVOID EXCESSIVE HEAT SEE INSERT 0.9% Sodium Chloride NaCl Irrigation USP ARTHROMATIC CONTAINER PL 146 PLASTIC BAXTER HEALTHCARE CORPORATION DEERFIELD IL 60015 USA MADE IN USA BAXTER ARTHROMATIC AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC FOR PRODUCT INFORMATION 1-800-933-0303 0.9% Sodium Chloride Irrigation USP Container Label
Overview
0.9% Sodium Chloride Irrigation, USP is a sterile nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 9 g Sodium Chloride, USP (NaCl) in Water for Injection. pH 5.5 (4.5 to 7.0). Milliequivalents per liter: Sodium - 154, Chloride - 154. Osmolarity 308 mOsmol/L (calc.). No antimicrobial agent has been added. The ARTHROMATIC plastic container is fabricated from a specially formulated polyvinyl chloride (PL 146 Plastic). The amount of water that can permeate from inside the container into the overwrap is insufficient to affect the solution significantly. Solutions in contact with the plastic container can leach out certain of its chemical components in very small amounts within the expiration period, e.g., di-2-ethylhexylphthalate (DEHP), up to 5 parts per million. However, the safety of the plastic has been confirmed in tests in animals according to USP biological tests for plastic containers as well as by tissue culture toxicity studies.
Indications & Usage
0.9% Sodium Chloride Irrigation, USP is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints.
Dosage & Administration
The volume of solution needed will vary with the nature and duration of the arthroscopic procedure. If desired, warm in overpouch to near body temperature in a water bath or oven heated to not more than 45º C. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Warnings & Precautions
WARNINGS Not for injection. Because fluids used to irrigate joints may be absorbed into the general circulation, solutions containing sodium ion should be used with great care in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention. The contents of an opened container should be used promptly to minimize the possibility of bacterial growth or pyrogen formation. Discard the unused portion of irrigating solution since no antimicrobial agent has been added.
Contraindications
None known.
Adverse Reactions
None known.
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