HAEMONETICS 0.9 % SODIUM CHLORIDE- sodium chloride solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37)

Available from:

Haemonetics Corporation

INN (International Name):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 900 mg in 100 mL

Administration route:

EXTRACORPOREAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Sodium Chloride Injection, USP is indicated as a source of water and electrolytes. 0.9% Sodium Chloride in hemodialysis procedures. None Known Safety and effectiveness of Sodium Chloride Injection, USP in pediatric patients have not been established by adequate and well controlled trials; however, the use of sodium chloride solutions in the pediatric populations is referenced in the medical literature. The warnings, precautions and adverse reactions identified in the label copy should be observed in the pediatric population.  Do not administer unless solution is clear and seal is intact.

Product summary:

500mL of 0.9% Sodium Chloride Injection, USP are contained in a flexible plastic bag and individually overwrapped. The Product Code is 441A and the NDC is 057826 441.  Exposure of pharmaceutical products to beat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25 degree C): brief exposure up to 40 C does not adversely affect the product.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

HAEMONETICS 0.9 % SODIUM CHLORIDE- SODIUM CHLORIDE SOLUTION
HAEMONETICS CORPORATION
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HAEMONETICS 0.9 % SODIUM CHLORIDE
DES CRIPTION
Sodium Chloride Injection, USP is a sterile, nonpyrogenic solution for
fluid and electrolyte
replenishment in a single dose container for intravenous
administration. It contains no antimicrobial
agents. The pH is 4.5 to 7.0. Composition, osrnolarity, 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 (cale). It contains 154 mEq/L sodium and 154 mEQ/L
chloride. The amount of water that
can permeate from inside the container into the overlap in
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-ethylhexyl phthalate (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
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 AND USAGE
Sodium Chloride Injection, USP is indicated as a source of water and
electrolytes. 0.9% Sodium
Chloride in hemodialysis procedures.
CONTRAINDICATIONS
None Known
WARNINGS
Sodium Chloride Injection, USP should be used with great care, if at
all, in patients with congestive
heart failure, servere renal insufficiency, and in clinical states in
which there exist ederna with sodium
retention. In patients with diminshed renal function administration of
Sodium Chloride Injection, USP
may result in sodium retention.
PRECAUTIONS
Clinical evaluation and periodic laboratory determinations are
necessary to monitor changes in fluid
balance, electrolyte concentrations, and acid base balance during
prolong