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 0.9% Sodium Chloride Injection, USP in VIAFLO dripless access containers (DAC) and non-DAC plastic containers are shown below. VIAFLO DAC will not drip once the spike is removed. VIAFLO non-DAC will drip once the spike is removed from the administration port: Code Size (mL) Product NDC UE1322 250 Non-DAC 0338-9543-01 UE1322D 250 DAC 0338-9543-02 UE1323 500 Non-DAC 0338-9543-03 UE1323D 500 DAC 0338-9543-04 UE1324 1000 Non-DAC 0338-9543-05 UE1324D 1000 DAC 0338-9543-06 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 VIAFLO 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:
0.9% 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.
VIAFLO is a flexible plastic container fabricated from a multilayer
sheeting (PL-2442) composed of
Polypropylene (PP), Polyamide (PA) and Polyethylene (PE). The amount
of water that can permeate from
inside the container into the overwrap is insufficient to affect the
solution significantly. Two different
administration connectors are available with VIAFLO containers. The
VIAFLO dripless access
container (DAC) will not drip once the spike is removed. The non-DAC
VIAFLO will drip once the
spike is removed from the administration port.
VIAFLO is not made with natural rubber latex, DEHP, or PVC.
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,
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. Appropriate th