0.9% Sodium Chloride Processing Solution in Flexible Plastic Container Not for injection
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.
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.
| 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 |
CLINICAL PHARMACOLOGY
0.9% Sodium Chloride Processing Solution has value as a physiological blood cell processing aid.
INDICATIONS AND USAGE
0.9% Sodium Chloride Processing Solution is indicated in processing blood cells.
See directions accompanying blood cell processing device for complete instructions for use.
CONTRAINDICATIONS
None known
WARNINGS
This container should not be connected for direct intravenous administration.
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 processing solution.
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.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Do not administer unless solution is clear and seal is intact.
ADVERSE REACTIONS
None known
DOSAGE AND ADMINISTRATION
As directed by a physician. See directions accompanying blood cell processing device.
Processing Solutions should be inspected visually for particulate matter and discoloration prior to use.
HOW SUPPLIED
0.9% Sodium Chloride Processing Solution in Flexible 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 (25º C); brief exposure up to 40º C does not adversely affect the product.
| Code | Size (mL) | NDC |
| 2B7207 | 3000 | 0338-0050-47 |
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.
Preparation for Use
- 1.Suspend container from eyelet support.
- 2.Remove plastic protector from outlet port at bottom of container.
- 3.Attach to blood cell processing device. Refer to complete directions accompanying blood cell processing device.
SPL UNCLASSIFIED SECTION
Baxter Healthcare CorporationDeerfield, IL 60015 USA
Printed in USA
©Copyright 1983, 1990, 1995, Baxter Healthcare Corporation. All rights reserved.
07-19-73-065
Rev. May 2014
BAXTER, AND PL 146 ARE TRADEMARKS OF BAXTER INTERNATIONAL INC.