SODIUM CHLORIDE solution

Land: Verenigde Staten

Taal: Engels

Bron: NLM (National Library of Medicine)

Werkstoffen:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698)

Beschikbaar vanaf:

Baxter Healthcare Corporation

INN (Algemene Internationale Benaming):

SODIUM CHLORIDE

Samenstelling:

SODIUM CHLORIDE 900 mg in 100 mL

Toedieningsweg:

EXTRACORPOREAL

Prescription-type:

PRESCRIPTION DRUG

therapeutische indicaties:

0.9% Sodium Chloride Processing Solution is indicated in processing blood cells. See directions accompanying blood cell processing device for complete instructions for use. None known

Product samenvatting:

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. 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.

Autorisatie-status:

New Drug Application

Productkenmerken

SODIUM CHLORIDE- SODIUM CHLORIDE SOLUTION
BAXTER HEALTHCARE CORPORATION
----------
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.
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.
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
Terat