Sodium Chloride Mini-Bag

Dosage Form: injection

0.9% Sodium Chloride Injection, USP
in Mini-Bag™ Plus Container
Viaflex® Plastic Container

Sodium Chloride Mini-Bag Description

0.9% Sodium Chloride Injection, USP in the Mini-Bag Plus Container is a sterile, nonpyrogenic solution for intravenous administration after admixture with a single dose powdered drug. It contains no antimicrobial agents. Each 100 mL contains 900 mg of Sodium Chloride, USP (NaCl). The osmolarity is 308 mOsmol/L (calculated). The pH is 5.0 (4.5 to 7.0). It contains 154 mEq/L of sodium and 154 mEq/L of chloride.

The Mini-Bag Plus Container is a standard diluent container with an integral drug vial adaptor. It allows for drug admixture after connection to a single dose powdered drug vial having a 20 mm closure. A breakaway seal in the tube between the vial adaptor and the container is broken to allow transfer of the diluent into the vial and reconstitution of the drug. The reconstituted drug is then transferred from the vial into the container diluent and mixed to result in an admixture for delivery to the patient.

The Viaflex® plastic container is fabricated from polyvinyl chloride (PL 146® Plastic). Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period. 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 may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials.

Sodium Chloride Mini-Bag - Clinical Pharmacology

Sodium Chloride Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient.

Indications and Usage for Sodium Chloride Mini-Bag

0.9% Sodium Chloride Injection, USP is indicated as a source of water and electrolytes and may also be used as diluent for reconstitution of a powdered drug product packaged in a vial with a 20 mm closure.

Contraindications

None known.

Warnings

Sodium Chloride Injection, USP should be used with great care, if at all, in patients with congestive heart failure, severe renal insufficiency, and in clinical states in which there exists edema with sodium retention.

In patients with diminished renal function, administration of Sodium Chloride Injection, USP may result in sodium retention.

For use only with a single dose powdered drug vial with a 20 mm closure.

Do not administer unless drug is completely dissolved and drug vial is empty.

Additives may be incompatible.

Do not remove drug vial at any time prior to or during administration.

Precautions

General

Do not administer unless solution is clear and all seals are intact

Laboratory Tests

Clinical evaluation and periodic laboratory determinations are necessary to monitor changes in fluid balance, electrolyte concentrations, and acid base balance during prolonged parenteral therapy or whenever the condition of the patient warrants such evaluation.

Drug Interactions

Caution must be exercised in the administration of Sodium Chloride Injection, USP to patients receiving corticosteroids or corticotropin.

Carcinogenesis and Mutagenesis and Impairment of Fertility

Studies with 0.9% Sodium Chloride Injection, USP have not been performed to evaluate carcinogenic potential, mutagenic potential or effects on fertility.

Pregnancy

Pregnancy Category C

Animal reproduction studies have not been conducted with Sodium Chloride Injection, USP. It is also not known whether Sodium Chloride Injection, USP can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Sodium Chloride Injection, USP should be given to a pregnant woman only if clearly needed.

Nursing Mothers

Caution should be exercised when 0.9% Sodium Chloride Injection, USP is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in the pediatric population are based on the similarity of the clinical conditions of the pediatric and adult populations. In neonates and very small infants, the volume of fluid may affect fluid and electrolyte balance.

Adverse Reactions

Reactions which may occur because of the solution or the technique of administration include febrile response, infection at the site of injection, venous thrombosis or phlebitis extending from the site of injection, extravasation, and hypervolemia.

If an adverse reaction does occur, discontinue the infusion, evaluate the patient, institute appropriate therapeutic countermeasures and save the remainder of the fluid for examination if deemed necessary.

Sodium Chloride Mini-Bag Dosage and Administration

As directed by a physician. Dosage is dependent upon the age, weight and clinical condition of the patient as well as laboratory determinations.

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

All injections in Mini-Bag Plus containers are intended for intravenous administration using sterile equipment.

Do not remove unit from overwrap until ready for use. The overwrap is a moisture barrier.

To Open

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 should diminish gradually.

Prior to use, check that the vial adaptor cover is intact. Check the solution container for minute leaks by squeezing inner bag firmly. If leaks are found or if the vial adaptor cover is not intact, discard product as sterility may be impaired.

To Assemble and Reconstitute

See other side for detailed instructions.

Additives may be incompatible.

How is Sodium Chloride Mini-Bag Supplied

0.9% Sodium Chloride Injection, USP in Mini-Bag Plus Container is available as follows:

Code Size (mL) NDC
2B0042 50 0338-0553-11
2B0043 100 0338-0553-18

Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F).

7. Remove port protector. Attach administration set per its directions.

8. Hang container on I.V. pole and prime set per directions. Ensure that vial is empty of drug and solution. Repeat step 6 if drug and solution remain in vial.

Warning: Do not use in series connections.

9. Administer medication per directions. Use within specified time for drug stability. Refer to drug package insert.

Baxter Healthcare Corporation

Deerfield, IL 60015 USA

Printed in USA

©Copyright 1990, 1991, 1992, 1995, Baxter Healthcare Corporation. All rights reserved.

7-19-4-589 Rev. June 1999

PACKAGE LABEL.PRINCIPLE DISPLAY PANEL

0.9% Sodium Chloride Injection USP Container Label

LOT EXP

0.9% Sodium

Chloride Injection USP

MINI-BAG Plus Container

2B0042

NDC 0338-0553-11

50mL

EACH 50 mL CONTAINS 450 mg SODIUM CHLORIDE

USP pH 5.0 (4.5 TO 7.0) mEq/50 mL SODIUM 8

CHLORIDE 8 OSMOLARITY 308 mOsmol/L (CALC) STERILE

NONPYROGENIC READ PACKAGE INSERT FOR FULL INFORMATION

ADDITIVES MAY BE INCOMPATIBLE DOSAGE INTRAVENOUSLY AS

DIRECTED BY A PHYSICIAN CAUTIONS MUST NOT BE USED IN SERIES

CONNECTIONS DO NOT USE UNLESS SOLUTION IS CLEAR RX ONLY

US PAT NOS 4 340 049 4 607 671 5 304 163

Baxter

BAXTER HEALTHCARE CORPORATION

DEERFIELD IL 60015 USA

MADE IN USA

VIAFLEX SINGLE DOSE CONTAINER

PL 146 PLASTIC

BAXTER VIAFLEX MINI-BAG

AND PL 146 ARE TRADEMARKS OF

BAXTER INTERNATIONAL INC

BREAK SEAL AND MIX BEFORE USE

0.9% Sodium Chloride Injection USP Carton Label

Lot:PXX Exp: XX XX

QTY: 80-50 mL 2B0042

NDC: 0338-0553-11

0.9% SODIUM CHLORIDE INJECTION, USP

IN MINI-BAG PLUS CONTAINER

(17) XXXX00 (10) PXX

(01) 50303380553117

SODIUM CHLORIDE 
sodium chloride injection
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0553
Route of Administration INTRAVENOUS DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION) SODIUM CHLORIDE 900 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0338-0553-11 50 mL in 1 BAG
2 NDC:0338-0553-18 100 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA020178 12/07/1992
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
BAXTER HEALTHCARE SA, dba Baxter Healthcare of Puerto Rico 189326168 MANUFACTURE
Revised: 12/2009
 
Baxter Healthcare Corporation
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