DESCRIPTION

Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic solution in a single dose ARTHROMATIC plastic container for use as an arthroscopic irrigating solution. Each liter contains 6.0 g Sodium Chloride, USP, (NaCl), 3.1 g Sodium Lactate (C3H5NaO3), 300 mg Potassium Chloride, USP, (KCl), and 200 mg Calcium Chloride, USP, (CaCl2•2H2O). pH 6.5 (6.0 to 7.5). Milliequivalents per liter: Sodium - 130, Potassium - 4, Calcium - 3, Chloride - 109, Lactate - 28. Osmolarity 273 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

Lactated Ringer’s Irrigation is useful as an irrigating fluid for body joints because it approximates the electrolyte composition of synovial fluid, 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

Lactated Ringer’s Irrigation 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.

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 overwrap to near body temperature in a water bath or oven heated to not more than 45° C.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.

HOW SUPPLIED

Lactated Ringer’s Irrigation in ARTHROMATIC Plastic Container is available as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25° C); brief exposure up to 40° 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

07-19-44-612
Rev. Aug. 2004

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

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL

Container Label

NOT FOR INJECTION

5000 mL

 2B7489

NDC 0338-0137-29

Lactated Ringers

IRRIGATION

EACH 100 mL CONTAINS 600 mg SODIUM CHLORIDE USP
310 mg SODIUM LACTATE 30 mg POTASSIUM CHLORIDE
USP 20 mg CALCIUM CHLORIDE USP NO ANTIMICROBIAL
AGENT HAS BEEN ADDED pH 6.5 (6.0 to 7.5)
mEq/L SODIUM 130 POTASSIUM 4 CALCIUM 3
CHLORIDE 109 LACTATE 28 OSMOLARITY 273 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

Lactated Ringers

IRRIGATION

ARTHROMATIC CONTAINER

PL 146 PLASTIC

Baxter
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

Carton Label

LACTATED RINGER’S IRRIGATION

ARTHROMATIC CONT
2-5000ML

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

PRIMARY BAR CODE
(01) 50303380137294

LOT XXXXX
EXP XXXXX

2B7489