SODIUM CHLORIDE injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

Sodium Chloride (UNII: 451W47IQ8X) (Chloride Ion - UNII:Q32ZN48698, Sodium Cation - UNII:LYR4M0NH37)

Dostopno od:

LABORATORIOS GRIFOLS SA

INN (mednarodno ime):

Sodium Chloride

Sestava:

Sodium Chloride 9 g in 1000 mL

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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.

Povzetek izdelek:

The available sizes of 0.9% Sodium Chloride Injection, USP are shown below: 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.

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
LABORATORIOS GRIFOLS SA
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0.9% SODIUM CHLORIDE INJECTION, USP
IN FLEBOFLEX AND FLEBOFLEX LUER 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 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 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
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 a