Երկիր: Ամերիկայի Միացյալ Նահանգներ
Լեզու: անգլերեն
Աղբյուրը: NLM (National Library of Medicine)
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)
Baxter Healthcare Corporation
SODIUM CHLORIDE
SODIUM CHLORIDE 6 g in 1000 mL
IRRIGATION
PRESCRIPTION DRUG
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.
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.
New Drug Application
LACTATED RINGERS- SODIUM CHLORIDE, SOLDIUM LACTATE, POTASSIUM CHLORIDE AND CALCIUM CHLORIDE IRRIGANT BAXTER HEALTHCARE CORPORATION ---------- 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 Կարդացեք ամբողջական փաստաթուղթը