SODIUM CHLORIDE irrigant

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (CHLORIDE ION - UNII:Q32ZN48698)

זמין מ:

REMEDYREPACK INC.

INN (שם בינלאומי):

SODIUM CHLORIDE

הרכב:

SODIUM CHLORIDE 0.9 g in 100 mL

מסלול נתינה (של תרופות):

IRRIGATION

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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.  

leaflet_short:

0.9% Sodium Chloride Irrigation USP is supplied sterile and nonpyrogenic in PIC™ (Plastic Irrigation Container). The 1000 mL and 500 mL containers are packaged 16 per case, the 2000 mL containers are packaged 8 per case, and the 4000 mL containers are 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).  

מצב אישור:

New Drug Application

מאפייני מוצר

SODIUM CHLORIDE - SODIUM CHLORIDE IRRIGANT
REMEDYREPACK INC.
----------
0.9% SODIUM CHLORIDEIRRIGATION USP
SPL UNCLASSIFIED
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: 5.0 (4.5–7.0) Calculated Osmolarity: 310 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 a copolymer of ethylene and propylene
formulated and developed for parenteral
drugs. The copolymer contains no plasticizers and exhibits virtually
no leachability. The plastic
container is also virtually impermeable to vapor transmission and,
therefore, requires no overwrap to
maintain the proper drug concentration. The safety of the plastic
container has been confirmed by
biological evaluation procedures. The material passes Class Vl testing
as specified in the U.S.
Pharmacopeia for Biological Tests — Plastic Containers. These tests
have shown that the container is
nontoxic and biologically inert.
The PIC™ Container is PVC-free and DEHP-free.
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 t