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SODIUM CHLORIDE irrigant
[Baxter Healthcare Corporation]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

in ARTHROMATIC Plastic Container

DESCRIPTION

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.

CLINICAL PHARMACOLOGY

0.9% Sodium Chloride Irrigation, USP is useful as an irrigating fluid for body joints because the solution is isotonic, and provides a transparent fluid medium with optical properties suitable for good visualization of the interior joint surface during endoscopic examination. During arthroscopic surgical procedures, the solution acts as a lavage for removing blood, tissue fragments, and bone fragments.

INDICATIONS AND 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.

CONTRAINDICATIONS

None known.

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.

PRECAUTIONS

Because some of the fluid used to irrigate joints may be absorbed, caution must be exercised in the volume of irrigating fluid used especially with solutions containing the sodium ion in patients receiving corticosteroids or corticotropin.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Do not administer unless the solution is clear and the seal is intact.

ADVERSE REACTIONS

None known.

DOSAGE AND 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.

HOW SUPPLIED

0.9% Sodium Chloride Irrigation, USP in ARTHROMATIC Plastic Container is available as follows:

2B74741000 mLNDC 0338-0047-24
2B74773000 mLNDC 0338-0047-27
2B74795000 mLNDC 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.

DIRECTIONS FOR USE

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing bag firmly. If leaks are found, discard solution as sterility may be impaired.

Use Aseptic Technique.

  1. Suspend container using hanger hole.
  2. Remove protector from outlet port.
  3. Attach irrigation set. Refer to complete directions accompanying set.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

07-19-44-646

Rev. August 2004

Baxter, ARTHROMATIC and PL 146 are trademarks of Baxter International Inc.

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 Carton Label

0.9% Sodium Chloride Irrigation USP Carton Label

0.9% SODIUM CHLORIDE IRRIGATION, USP

ARTHROMATIC CONT

2-5000ML

SECONDARY BAR CODE

(17) YYMM00 (10) XXXXX

PRIMARY BAR CODE

(01) 50303380047296

LOT XXXXX

EXP XXXXX

2B7479

SODIUM CHLORIDE 
sodium chloride irrigant
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0338-0047
Route of AdministrationIRRIGATIONDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE9 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
WATER 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0338-0047-241000 mL in 1 BAG
2NDC:0338-0047-273000 mL in 1 BAG
3NDC:0338-0047-295000 mL in 1 BAG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA01786705/30/1980
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
NameAddressID/FEIBusiness Operations
Baxter Healthcare Corporation059140764MANUFACTURE

Revised: 12/2009
 
Baxter Healthcare Corporation

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