SODIUM CHLORIDE FOR IRRIGATION solution

Kraj: Stany Zjednoczone

Język: angielski

Źródło: NLM (National Library of Medicine)

Składnik aktywny:

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

Dostępny od:

B. Braun Medical Inc.

INN (International Nazwa):

SODIUM CHLORIDE

Skład:

SODIUM CHLORIDE 0.9 g in 100 mL

Droga podania:

IRRIGATION

Typ recepty:

PRESCRIPTION DRUG

Wskazania:

0.9% Sodium Chloride Irrigation USP is indicated for all general irrigation, washing, rinsing and dilution purposes which permit use of a sterile, nonpyrogenic electrolyte solution. 0.9% Sodium Chloride Irrigation USP is not for injection by usual parenteral routes. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

Podsumowanie produktu:

0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in single-dose 2000 mL and 3000 mL plastic containers packaged 4 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. Do not warm above 150°F (66°C).

Status autoryzacji:

New Drug Application

Charakterystyka produktu

SODIUM CHLORIDE FOR IRRIGATION- SODIUM CHLORIDE FOR IRRIGATION
SOLUTION
B. BRAUN MEDICAL INC.
----------
0.9% SODIUM CHLORIDE IRRIGATION USP
ISOTONIC SOLUTION FOR IRRIGATION.
FOR IRRIGATION ONLY.
NOT FOR INJECTION.
DESCRIPTION
Each 100 mL contains:
Sodium Chloride USP 0.9 g; Water for Injection USP qs
pH adjusted with Hydrochloric Acid NF
pH: 5.75 (4.50-7.00)
Calculated Osmolarity: 308 mOsmol/liter
Concentration of Electrolytes (mEq/liter): Sodium 154; Chloride 154
0.9% Sodium Chloride Irrigation USP is sterile, nonpyrogenic, isotonic
and contains no
bacteriostatic or antimicrobial agents.
The formula of the active ingredient is:
INGREDIENT
MOLECULAR FORMULA MOLECULAR WEIGHT
Sodium Chloride USP NaCl
58.44
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.
Not made with natural rubber latex, PVC or DEHP.
CLINICAL PHARMACOLOGY
0.9% Sodium Chloride Irrigation USP is utilized for a variety of
clinical indications such as
sterile irrigation of body cavities, tissues or wounds, indwelling
urethral catheters,
surgical drainage tubes, and for washing, rinsing or soaking surgical
dressings,
instruments and laboratory specimens. It also serves as a diluent or
vehicle for drugs
used for irrigation or other pharmaceutical preparations.
0.9% Sodium Chloride Irrigation USP provides an isotonic saline
irrigation identical in
composition with 0.9% Sodium Chloride Injection USP (normal saline).
Physiological irrigation solutions are considered generally compatible
with living tissues
and organs.
Sodium, the major cation of the extrac