Label: SODIUM CHLORIDE solution
- NDC Code(s): 0338-0050-47
- Packager: Baxter Healthcare Corporation
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated July 25, 2014
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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 0.9% Sodium Chloride Processing Solution
Size
(mL)Composition (g/L)
Osmolarity (mOsmol/L) (calc)
pH
Ionic Concentration
(mEq/L)Sodium
Chloride, USP (NaCl)Sodium
Chloride
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.
- CLINICAL PHARMACOLOGY
- INDICATIONS AND USAGE
- CONTRAINDICATIONS
- WARNINGS
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PRECAUTIONS
Careful review and understanding of the use of this solution in conjunction with blood cell processing equipment is essential.
Pregnancy
Teratogenic Effects
Pregnancy Category C.
Animal reproduction studies have not been conducted with 0.9% Sodium Chloride Processing Solution. It is also not known whether 0.9% Sodium Chloride Processing Solution can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. 0.9% Sodium Chloride Processing Solution should be given to a pregnant woman only if clearly needed.
- ADVERSE REACTIONS
- DOSAGE AND ADMINISTRATION
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HOW SUPPLIED
0.9% Sodium Chloride Processing Solution in Flexible Plastic Container is available as follows:
Code
Size (mL)
NDC
2B7207
3000
0338-0050-47
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.
To Open
Tear overwrap down side at slit and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. 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 inner bag firmly. If leaks are found, discard solution as sterility may be impaired.
- SPL UNCLASSIFIED SECTION
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PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
3000 mL
2B7207
NDC 0338-0050-47NOT FOR INJECTION
0.9%
SODIUM CHLORIDE
Processing SolutionEACH 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
CONTAINERDOSAGE AS DIRECTED BY A PHYSICIAN SEE DIRECTIONS
ACCOMPANYING BLOOD CELL PROCESSING DEVICE FOR USE THIS
CONTAINER SHOULD NOT BE CONNECTED FOR DIRECT INTRAVENOUS
ADMINISTRATIONCAUTIONS 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 INSERT0.9%
Sodium Chloride
NaCl
Processing SolutionVIAFLEX CONTAINER
PL146 PLASTIC
FOR PRODUCT INFORMATION1-800-933-0303
Baxter Logo
Baxter Healthcare Corporation
Deerfield, IL 60015 USAMade in USA
Baxter VIAFLEX and
PL 146 are trademarks of
Baxter International Inc -
INGREDIENTS AND APPEARANCE
SODIUM CHLORIDE
sodium chloride solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0338-0050 Route of Administration EXTRACORPOREAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698) SODIUM CHLORIDE 900 mg in 100 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0338-0050-47 4 in 1 CARTON 05/30/1980 1 3000 mL in 1 BAG; Type 0: Not a Combination Product 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 Business 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 Business Operations Baxter Healthcare Corporation 194684502 ANALYSIS(0338-0050)
