Sodium Chloride Extracorporeal Solution

Name: Sodium Chloride Extracorporeal Solution

Sodium Chloride Extracorporeal Solution Description

Sodium Chloride Processing Solution is a sterile, nonpyrogenic solution in single dose container for use in blood cell processing devices. It contains no antimicrobial agents. Composition, osmolarity, pH, and ionic concentration are shown in Table 1.

Table 1

Size
(mL)

Composition (g/L)


Osmolarity (mOsmol/L) (calc)


pH

Ionic Concentration (mEq/L)

Sodium
Chloride, USP (NaCl)

Sodium

Chloride

0.9% Sodium Chloride Processing Solution

3000

9

308

5.5
(4.5 to 7.0)

154

154

The 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.

Sodium Chloride Extracorporeal Solution - Clinical Pharmacology

0.9% Sodium Chloride Processing Solution has value as a physiological blood cell processing aid.

Contraindications

None known

Adverse Reactions

None known

Package/label principal display panel

3000 mL

2B7207
NDC 0338-0050-47

NOT FOR INJECTION

0.9%
SODIUM CHLORIDE
Processing Solution

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

DOSAGE AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS
ACCOMPANYING BLOOD CELL PROCESSING DEVICE FOR USE THIS
CONTAINER SHOULD NOT BE CONNECTED FOR DIRECT INTRAVENOUS
ADMINISTRATION

CAUTIONS SQUEEZE AND INSPECT INNER BAG WHICH MAINTAINS
PRODUCT STERILITY DISCARD IF LEAKS ARE FOUND DO NOT USE
UNLESS SOLUTION IS CLEAR DISCARD UNUSED PORTION 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
Processing Solution

VIAFLEX CONTAINER

PL146 PLASTIC
FOR PRODUCT INFORMATION

1-800-933-0303

Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Made in USA

Baxter VIAFLEX and
PL 146 are trademarks of
Baxter International Inc

2B7207

4-3000 ML
PLASTIC CONTAINER

0.9% SODIUM CHLORIDE PROCESSING SOLUTION

EXP
XXXXX

SECONDARY BAR CODE
(17) YYMM00 (10) XXXXX

LOT
XXXXX

PRIMARY BAR CODE
(01) 50303380050470

SODIUM CHLORIDE 
sodium chloride solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0338-0050
Route of Administration EXTRACORPOREAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM CHLORIDE (SODIUM CATION and CHLORIDE ION) SODIUM CHLORIDE 900 mg  in 100 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
Packaging
# Item Code Package Description
1 NDC:0338-0050-47 4 BAG in 1 CARTON
1 3000 mL in 1 BAG
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA017867 05/30/1980
Labeler - Baxter Healthcare Corporation (005083209)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 059140764 MANUFACTURE(0338-0050), STERILIZE(0338-0050), PACK(0338-0050), LABEL(0338-0050), ANALYSIS(0338-0050)
Establishment
Name Address ID/FEI Operations
Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0050)
Revised: 07/2014   Baxter Healthcare Corporation
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