SODIUM CHLORIDE irrigant

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Baxter Healthcare Corporation

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 900 mg in 100 mL

Administration route:

IRRIGATION

Prescription type:

PRESCRIPTION DRUG

Authorization status:

New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE- SODIUM CHLORIDE IRRIGANT
BAXTER HEALTHCARE CORPORATION
----------
DIRECTIONS FOR USE OF FLEXIBLE PLASTIC IRRIGATION CONTAINERS
If desired, warm in overwrap to near body temperature in a water bath
or oven heated to not more than
45°C.
Parenteral drug products should be inspected visually for particulate
matter and discoloration prior to
administration whenever solution and container permit.
DIRECTIONS FOR USE
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 bag firmly. If
leaks are found, discard solution
as sterility may be impaired.
Use Aseptic Technique.
1.
2.
3.
Exposure of pharmaceutical products to heat should be minimized. Avoid
excessive heat. It is
recommended the product be stored at room temperature (25°C): brief
exposure up to 40°C does not
adversely affect the product.
BAXTER HEALTHCARE CORPORATION
Deerfield, IL 60015 USA
Printed in Mexico
©Copyright 1980, 1984, 1989, Baxter Healthcare Corporation.
All rights reserved.
Rev. May 2017
88-80-31-833
PRINCIPAL DISPLAY PANEL - PACKAGING LABELING
Suspend container using hanger hole.
Remove plastic protector from outlet port at bottom of container.
Attach irrigation set. Refer to complete directions accompanying set.
3000 mL
2B77127
NDC 0338-0047-47
NOT FOR INJECTION
0.9%
SODIUM CHLORIDE
_Irrigation USP_
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
Do not use unless solution is clear Discard
unused portion
Cautions Squeeze and inspect inner bag
which maintains pro