DESCRIPTION

Lactated Ringer’s Irrigation in the Baxter Sterile Container System is a sterile, nonpyrogenic, isotonic solution for the preparation of slushed solution. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1.

The Baxter Sterile Container System is designed to provide a slush container with a sterile exterior surface for use within the surgical field. Within the overwrap, the unit is packaged in a dispensing bag which maintains the sterility of this surface.

The flexible plastic slush 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-ethylhexyl phthalate (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 culture toxicity studies.

CLINICAL PHARMACOLOGY

Slushed solution is used to induce regional hypothermia in conditions such as certain open heart and kidney surgical procedures by direct application of slushed solution. The objective of regional hypothermia is to reduce cellular metabolic activity so that body tissues can tolerate a period of total or relative ischemia thereby inhibiting the formation and buildup of destructive autolytic enzymes and anaerobic by-products usually produced and accumulated in ischemic tissues.

INDICATIONS AND USAGE

Slushed solution is used to create regional hypothermia in order to reduce and minimize manifestations of warm-temperature ischemia. Temperature probes may be used to determine requirements for replacement or addition of slushed solution.

CONTRAINDICATIONS

None known

WARNINGS

Not for injection. For use in slush preparation for regional hypothermia.

PRECAUTIONS

Avoid prolonged direct contact between ice crystals and body tissues.

Experience in use of slushed solutions in pediatrics is limited.

ADVERSE REACTIONS

No serious adverse reactions are known.

DOSAGE AND ADMINISTRATION

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.

HOW SUPPLIED

Lactated Ringer’s Irrigation in the Baxter Sterile Container System is supplied as follows:

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Avoid freezing except during controlled slushing procedure. It is recommended that this product be stored at room temperature (25ºC); brief exposure up to 40ºC does not adversely affect this product.

DIRECTIONS FOR USE OF THE BAXTER STERILE CONTAINER SYSTEM

To Open: Use Aseptic Technique

A. To prepare unit outside the surgical field.

1.

Tear overwrap down side at slit and remove dispensing bag which contains the slush container.

2.

Allow unit to stand at room temperature for approximately 10 minutes to allow container material to regain flexibility.

3.

Check that all the seals of the dispensing bag are intact including the tamper evident button. If any broken seals or holes are detected, discard unit as sterility may be impaired.

4.

Grasp tab of dispensing bag and peel open (Figure 1). Remove wrapped inner slush container.

5.

Grasp point of sterile transfer wrap (Figure 2), and pull forward then back to expose sterile slush container (Figure 3). Caution should be exercised to avoid touch contamination.

B. To transfer sterile slush container to the surgical field.

1.

Using sterile gloved hands, remove slush container from the sterile transfer wrap (Figure 4). Place on surgical field or use immediately.

2.

Grasp tab at top of slush container and peel directly across the width of the container with a steady motion (Figure 5).

3.

Slush is ready for dispensing.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

Distributed in Canada by
Baxter Corporation
Toronto, Ontario, Canada

©Copyright 1984, 1988, 1995, Baxter Healthcare Corporation.
All rights reserved.

07-19-04-502
Rev. October 2003

BAXTER and PL 146 are trademarks of Baxter International Inc.

PRINCIPAL DISPLAY PANEL - PACKAGING LABELING

Container Label

1000 mL
2B7233

NOT FOR INJECTION
NDC 0338-0188-44

LACTATED RINGER'S
INJECTION

Baxter Sterile Container System

EACH 100 mL CONTAINS 600 mg SODIUM CHLORIDE
USP 310 mg SODIUM LACTATE 30 mg POTASSIUM
CHLORIDE USP 20 mg CALCIUM CHLORIDE USP 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

FOR USE ONLY IN SLUSH PREPARATION
FOR REGIONAL HYPOTHERMIA

SEE ACCOMPANYING DIRECTIONS FOR USE
DOSAGE AS DIRECTED BY A PHYSICIAN

CAUTION RX ONLY

BAXTER LOGO
BAXTER HEALTHCARE CORPORATION
DEERFIELD IL 60015 USA

MADE IN USA

PL 146 PLASTIC

BAXTER AND PL 146
ARE TRADEMARKS OF
BAXTER INTERNATIONAL INC

Carton Label

2B7233

6-1000 ML
BAXTER'S STERILE CONTAINER SYSTEM

LACTATED RINGER'S IRRIGATION

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380118446