SODIUM CHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

Baxter Healthcare Corporation

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

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.

Dettagli prodotto:

The available sizes of each injection in VIAFLEX plastic containers are shown below: Code Size (mL) NDC Product Name 2B1313 500 0338-0043-03 0.45% Sodium Chloride Injection, USP 2B1314 1000 0338-0043-04 2B1300 25 Quad Pack 0338-0049-10 0.9% Sodium Chloride Injection, USP 50 2B1306 Single pack 0338-0049-41 2B1301 Quad pack 0338-0049-11 2B1308 Multi pack 0338-0049-31 100 2B1307 Single pack 0338-0049-48 2B1302 Quad pack 0338-0049-18 2B1309 Multi pack 0338-0049-38 2B1321 150 0338-0049-01 2B1322 250 0338-0049-02 2B1323 500 0338-0049-03 2B1324 1000 0338-0049-04 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25°C/77°F); brief exposure up to 40°C/104°F does not adversely affect the product.

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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SODIUM CHLORIDE INJECTION, USP
IN VIAFLEX PLASTIC CONTAINER
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 nominal pH is 5.0 (4.5 to 7.0). Composition, osmolarity,
and ionic concentration are shown
below:
0.45% SODIUM CHLORIDE INJECTION, USP contains 4.5 g/L Sodium Chloride,
USP (NaCl) and is
hypotonic with an osmolarity of 154 mOsmol/L (calc). It contains 77
mEq/L sodium and 77 mEq/L
chloride.
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 VIAFLEX 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-
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 Injection, USP is also indicated for use as a
priming solution in hemodialysis
procedures.
CONTRAINDICATIONS
None known.
WARNINGS
HYPERS ENS ITIVITY
Hypersensitivity and infusion reactions, including hypotension,
pyrexia, tremor, chills, urticaria, rash,