SODIUM CHLORIDE injection, solution

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:

Fresenius Kabi USA, LLC

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 9 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Intravenous solutions containing sodium chloride are indicated for parenteral replenishment of fluid and sodium chloride as required by the clinical condition of the patient. None known. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open - Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloudy or a precipitate is present. To Add Medication - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. - Hold base of WHITE Additive Port horizontally. - Insert needle horizont

Product summary:

0.9% Sodium Chloride Injection, USP is supplied in single-dose flexible plastic containers as follows: Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Manufactured for: Lake Zurich, IL 60047 www.fresenius-kabi.com/us Revised: January 2021

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

SODIUM CHLORIDE - SODIUM CHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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0.9% SODIUM CHLORIDE INJECTION, USP
Rx only
DESCRIPTION
0.9% Sodium Chloride Injection, USP solution is sterile and
nonpyrogenic. It is a
parenteral solution containing sodium chloride in water for injection
intended for
intravenous administration.
For 0.9% Sodium Chloride Injection, USP, each 100 mL contains 900 mg
sodium chloride
in water for injection.
Electrolytes per 1,000 mL: sodium 154 mEq; chloride 154 mEq. The
osmolarity is 308
mOsmol/L (calc.).
The pH in the 100 mL and smaller containers is 6.0; for the 250 mL and
larger
containers, the pH is 5.6. The pH range is 4.5 to 7.0 for all
containers.
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is
intended only as a single-dose injection. When smaller doses are
required the unused
portion should be discarded.
The solution is a parenteral fluid and electrolyte replenisher.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely
soluble in water.
Water for injection, USP is chemically designated H O.
The flexible container is fabricated from a specially formulated
non-plasticized, film
containing polypropylene and thermoplastic elastomers (FREE_flex_
bag). The amount of
water that can permeate from the container into the overwrap is
insufficient to affect
the solution significantly. Solutions in contact with the flexible
container can leach out
certain of the container's chemical components in very small amounts
within the
expiration period. The suitability of the container material has been
confirmed by tests in
animals according to USP biological tests for plastic containers.
CLINICAL PHARMACOLOGY
When administered intravenously, the solution provides a source of
water and
electrolytes.
Solutions which provide combinations of hypotonic or isotonic
concentrations of sodium
chloride are suitable for parenteral maintenance or replacement of
water and electrolyte
requirements.
Isotonic concentrations of sodium chl