SODIUM CHLORIDE irrigant

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

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

Disponibil de la:

B. Braun Medical Inc.

INN (nume internaţional):

SODIUM CHLORIDE

Compoziție:

SODIUM CATION 0.9 g in 100 mL

Calea de administrare:

IRRIGATION

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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.

Rezumat produs:

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. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] However, brief exposure up to 40°C does not adversely affect the product. Do not warm above 150°F (66°C).

Statutul autorizaţiei:

New Drug Application

Caracteristicilor produsului

SODIUM CHLORIDE- SODIUM CHLORIDE IRRIGANT
B. BRAUN MEDICAL INC.
----------
0.9% SODIUM CHLORIDE IRRIGATION USP
Package Insert
PIC™ (PLASTIC IRRIGATION CONTAINER)
0.9% SODIUM CHLORIDE IRRIGATION USP
ISOTONIC SOLUTION FOR IRRIGATION.
FOR IRRIGATION ONLY.
NOT FOR INJECTION.
RX ONLY
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 FORMULAMOLECULAR 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.
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).