SODIUM CHLORIDE injection, solution

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

B. Braun Medical Inc.

Vía de administración:

INTRAVENOUS

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

These intravenous solutions are indicated for use in adults and pediatric patients as sources of electrolytes and water for hydration. 0.9% Sodium Chloride Injection USP is indicated for extracellular fluid replacement, treatment of metabolic alkalosis in the presence of fluid loss and mild sodium depletion. 0.9% Sodium Chloride Injection USP is also indicated for use as a priming solution in hemodialysis procedures and may be used to initiate and terminate blood transfusions without hemolyzing red blood cells. 0.45% Sodium Chloride Injection USP is primarily a hydrating solution and may be used to assess the status of the kidneys, since more water is provided than is required for excretion of salt. It may also be used in the treatment of hyperosmolar diabetes where the use of dextrose is inadvisable and there is a need for large amounts of fluid without an excess of sodium ions. Sodium Chloride Injections USP are also indicated as pharmaceutic aids and diluents for the infusion of compatible drug additives.

Resumen del producto:

Sodium Chloride Injections USP are supplied sterile and nonpyrogenic in EXCEL® Containers. The 1000 mL containers are packaged 12 per case; the 500 mL and 250 mL containers are packaged 24 per case. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature (25°C); however, brief exposure up to 40°C does not adversely affect the product.

Estado de Autorización:

New Drug Application

Ficha técnica

SODIUM CHLORIDE- SODIUM CHLORIDE INJECTION, SOLUTION
B. BRAUN MEDICAL INC.
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SODIUM CHLORIDE INJECTIONS USP
DESCRIPTION
Each 100 mL of 0.9% SODIUM CHLORIDE INJECTION USP contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH: 5.6 (4.5–7.0) Calculated Osmolarity: 310 mOsmol/liter
pH adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 154 Chloride 154
Each 100 mL of 0.45% SODIUM CHLORIDE INJECTION USP contains:
Sodium Chloride USP 0.45 g; Water for Injection USP qs
pH: 5.6 (4.5–7.0) Calculated Osmolarity: 155 mOsmol/liter, hypotonic
pH adjusted with Hydrochloric Acid NF
Concentration of Electrolytes (mEq/liter): Sodium 77 Chloride 77
Sodium Chloride Injections USP are sterile, nonpyrogenic, isotonic and
contain no
bacteriostatic or antimicrobial agents.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULAMOLECULAR WEIGHT
Sodium Chloride USP
NaCl
58.44
Not made with natural rubber latex, PVC or DEHP.
The plastic container is made from a multilayered film specifically
developed for
parenteral drugs. It contains no plasticizers and exhibits virtually
no leachables. The
solution contact layer is a rubberized copolymer of ethylene and
propylene. The
container is nontoxic and biologically inert. The container-solution
unit is a closed system
and is not dependent upon entry of external air during administration.
The container is overwrapped to provide protection from the physical
environment and
to provide an additional moisture barrier when necessary.
Addition of medication should be accomplished using complete aseptic
technique.
The closure system has two ports; the one for the administration set
has a tamper
evident plastic protector and the other is a medication addition site.
Refer to the
Directions for Use of the container.
CLINICAL PHARMACOLOGY
Sodium Chloride Injections USP provide electrolytes and are a source
of water for
hydration. They are capable of inducing diuresis depending on the
clinical condition of
the patient.
Sodium, the major