LACTATED RINGERS- sodium chloride, soldium lactate, potassium chloride and calcium chloride irrigant

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (SODIUM CATION - UNII:LYR4M0NH37, LACTIC ACID - UNII:33X04XA5AT), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)

Disponible depuis:

Baxter Healthcare Corporation

DCI (Dénomination commune internationale):

SODIUM CHLORIDE

Composition:

SODIUM CHLORIDE 6 g in 1000 mL

Mode d'administration:

IRRIGATION

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

Lactated Ringer’s Irrigation is indicated for use as an arthroscopic irrigating fluid with endoscopic instruments during arthroscopic procedures requiring distension and irrigation of the knee, shoulder, elbow, or other bone joints. Lactated Ringer’s Irrigation is contraindicated in patients with a known hypersensitivity to Sodium Lactate.

Descriptif du produit:

Lactated Ringer’s Irrigation in ARTHROMATIC Plastic Container is available as follows: 2B7487 3000 mL NDC 0338-0137-27 2B7489 5000 mL NDC 0338-0137-29 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. It is recommended the product be stored at room temperature (25° C); brief exposure up to 40° C does not adversely affect the product.

Statut de autorisation:

New Drug Application

Résumé des caractéristiques du produit

LACTATED RINGERS- SODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE
AND CALCIUM
CHLORIDE IRRIGANT
BAXTER HEALTHCARE CORPORATION
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LACTATED RINGER’S IRRIGATION
IN ARTHROMATIC PLASTIC CONTAINER
DESCRIPTION
Lactated Ringer’s Irrigation is a sterile, nonpyrogenic, isotonic
solution in a single dose
ARTHROMATIC plastic container for use as an arthroscopic irrigating
solution. Each liter contains
6.0 g Sodium Chloride, USP, (NaCl), 3.1 g Sodium Lactate (C H NaO ),
300 mg Potassium Chloride,
USP, (KCl), and 200 mg Calcium Chloride, USP, (CaCl
•2H O). pH 6.5 (6.0 to 7.5). Milliequivalents
per liter: Sodium - 130, Potassium - 4, Calcium - 3, Chloride - 109,
Lactate - 28. Osmolarity 273
mOsmol/L (calc.). No antimicrobial agent has been added.
The ARTHROMATIC plastic container is fabricated from a specially
formulated polyvinyl chloride
(PL 146 Plastic). The amount of water that can permeate from inside
the container into the overwrap is
insufficient to affect the solution significantly. Solutions in
contact with the plastic container can leach
out certain of its chemical components in very small amounts within
the expiration period, e.g., di-2-
ethylhexylphthalate (DEHP), up to 5 parts per million. However, the
safety of the plastic has been
confirmed in tests in animals according to USP biological tests for
plastic containers as well as by
tissue culture toxicity studies.
CLINICAL PHARMACOLOGY
Lactated Ringer’s Irrigation is useful as an irrigating fluid for
body joints because it approximates the
electrolyte composition of synovial fluid, and provides a transparent
fluid medium with optical
properties suitable for good visualization of the interior joint
surface during endoscopic examination.
During arthroscopic surgical procedures, the solution acts as a lavage
for removing blood, tissue
fragments, and bone fragments.
INDICATIONS AND USAGE
Lactated Ringer’s Irrigation is indicated for use as an arthroscopic
irrigating fluid with endoscopic
instruments during arthroscopic procedures requiring disten