RINGERS- sodium chloride, potassium chloride, and calcium chloride irrigant

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

זמין מ:

Hospira, Inc.

INN (שם בינלאומי):

SODIUM CHLORIDE

הרכב:

SODIUM CHLORIDE 860 mg in 100 mL

מסלול נתינה (של תרופות):

IRRIGATION

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

Ringer’s Irrigation, USP is indicated for all general irrigation, washing and rinsing purposes which permit use of a sterile, nonpyrogenic electrolyte solution. NOT FOR INJECTION BY USUAL PARENTERAL ROUTES. An electrolyte solution should not be used for irrigation during electrosurgical procedures.

leaflet_short:

Ringer’s Irrigation, USP is supplied in a single-dose 1000 mL semi-rigid irrigation container (NDC No. 0409–6140–09). Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: June, 2010 Printed in USA                            EN-2517 Hospira, Inc., Lake Forest, IL 60045 USA

מצב אישור:

New Drug Application

מאפייני מוצר

RINGERS- SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE
IRRIGANT
HOSPIRA, INC.
----------
RINGER'S IRRIGATION, USP
_FOR ALL GENERAL IRRIGATION, WASHING AND RINSING PURPOSES_
NOT FOR INJECTION BY USUAL PARENTERAL ROUTES
SEMI-RIGID IRRIGATION CONTAINER
Rx only
DESCRIPTION
These products are sterile, nonpyrogenic solutions of electrolytes in
water for injection intended only
for sterile irrigation, washing and rinsing purposes.
Each 100 mL of Ringer’s Irrigation, USP contains: Sodium chloride
860 mg; potassium chloride 30 mg;
calcium chloride dihydrate 33 mg. The pH is 5.7 (5.0 — 7.5). The
solution is isotonic (309
mOsmol/liter, calc.) and has the following electrolyte content
(mEq/liter): Na 147.5; K 4; Ca
4.5;
Cl
156.
The solution contains no bacteriostat, antimicrobial agent or added
buffer and is intended only for use as
single-dose or short procedure irrigation. When smaller volumes are
required the unused portion
should be discarded. Ringer’s Irrigation, USP may be classified as a
sterile irrigant, wash, rinse and
pharmaceutical vehicle.
Calcium Chloride, USP is chemically designated calcium chloride
dihydrate (CaCl
• 2H O), white
fragments or granules freely soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular
powder freely soluble in
water.
Sodium Chloride, USP is chemically designated NaCl, a white
crystalline powder freely soluble in
water.
Water for Injection, USP is chemically designated H O.
The semi-rigid container is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The container requires no vapor barrier to
maintain the proper drug
concentration.
Solutions in contact with the plastic container may leach out certain
chemical components from the
plastic in very small amounts; however, biological testing was
supportive of the safety of the plastic
container materials.
Exposure to temperatures above 25°C/77°F during transport and
storage will lead to minor losses in
moisture content. Higher temperatures