RINGERS IRRIGATION- sodium chloride, potassium chloride, and calcium chloride irrigant injection, solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Bahan aktif:

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)

Tersedia dari:

ICU Medical Inc.

Rute administrasi :

IRRIGATION

Jenis Resep:

PRESCRIPTION DRUG

Indikasi Terapi:

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.

Ringkasan produk:

Ringer’s Irrigation, USP is supplied in a single-dose 1000 mL semi-rigid irrigation container (NDC No. 0409–6140–09; NDC No. 0990-6140-09). ICU Medical is transitioning NDC codes from the "0409" to a "0990" labeler code. Both NDC codes are expected to be in the market for a period of time. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Revised: July, 2020 EN-5962 Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045, USA

Status otorisasi:

New Drug Application

Karakteristik produk

RINGERS IRRIGATION- SODIUM CHLORIDE, POTASSIUM CHLORIDE, AND CALCIUM
CHLORIDE IRRIGANT INJECTION, SOLUTION
ICU MEDICAL 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 moi