0.9% SODIUM CHLORIDE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

HF Acquisition Co LLC, DBA HealthFirst

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride Injection, USP is also indicated for use as a priming solution in hemodialysis procedures. None known.

Product summary:

NDC 51662-1609-1 0.9% SODIUM CHLORIDE INJECTION, USP 500 mL BAG HF Acquisition Co LLC, DBA HealthFirst 11629 49th Pl W. Mukilteo, WA 98275 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at 20° to 25°C (68° to 77°F); excursions are permitted between 15° to 30°C (59° to 86°F). [see USP Controlled Room Temperature.]Store unit in moisture barrier overwrap. Brief exposure up to 40°C (104°F) does not adversely affect the product.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

0.9% SODIUM CHLORIDE- 0.9% SODIUM CHLORIDE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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0.9% SODIUM CHLORIDE INJECTION, USP 500 ML BAG
DESCRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for
fluid and electrolyte
replenishment in single dose containers for intravenous
administration. It contains no
antimicrobial agents. The pH ranges from 4.5 to 7.0. Composition,
osmolarity, and ionic
concentration are shown below:
0.9% Sodium Chloride Injection, USP contains 9 g/L Sodium Chloride,
USP (NaCl) with an
osmolarity of 308 mOsmol/L (calc). It contains 154 mEq/L sodium and
154 mEq/L
chloride.
The FLEBOFLEX and FLEBOFLEX LUER plastic containers are fabricated
from latex-free
polyolefins or polypropylene plastic materials. The solution contact
materials do not
contain PVC, DEHP, or other plasticizers. The amount of water that can
permeate from
inside the container into the overwrap is insufficient to affect the
solution significantly.
The suitability of the container materials has been established
through biological
evaluations, which have shown the containers pass Class VI U.S.
Pharmacopeia (USP)
testing for plastic containers. These tests confirm the biological
safety of the container
systems.
CLINICAL PHARMACOLOGY
Sodium Chloride Injection, USP has value as a source of water and
electrolytes. It is
capable of inducing diuresis depending on the clinical condition of
the patient.
INDICATIONS & USAGE
Sodium Chloride Injection, USP is indicated as a source of water and
electrolytes.
0.9% Sodium Chloride Injection, USP is also indicated for use as a
priming solution in
hemodialysis procedures.
CONTRAINDICATIONS
None known.
WARNINGS
Hypersensitivity
Hypersensitivity and infusion reactions, including hypotension,
pyrexia, tremor, chills,
urticaria, rash, and pruritus have been reported with 0.9% Sodium
Chloride Injection,
USP.
Stop the infusion immediately if signs or symptoms of a
hypersensitivity reaction
develop, such as tachycardia, chest pain, dyspnea and flushing.
App