Nazione: Stati Uniti
Lingua: inglese
Fonte: 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 600 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
Lactated Ringer’s Injection, USP is indicated as a source of water and electrolytes or as an alkalinizing agent. Lactated Ringer’s Injection, USP is contraindicated in:
Lactated Ringer’s Injection, USP in VIAFLEX plastic container is available as follows: Code Size (mL) NDC 2B2322 250 0338-0117-02 2B2323 500 0338-0117-03 2B2324 1000 0338-0117-04 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, POTASSIUM CHLORIDE, SODIUM LACTATE AND CALCIUM CHLORIDE INJECTION, SOLUTION BAXTER HEALTHCARE CORPORATION ---------- LACTATED RINGER’S INJECTION, USP IN VIAFLEX PLASTIC CONTAINER DESCRIPTION Lactated Ringer’s Injection, USP is a sterile, nonpyrogenic solution for fluid and electrolyte replenishment in single dose containers for intravenous administration. It contains no antimicrobial agents. Composition, osmolarity, pH, ionic concentration and caloric content are shown in Table 1. TABLE 1 Composition (g/L) Ionic Concentration (mEq/L) Size (mL) Sodium Chloride, USP, (NaCl) Sodium Lactate, (C H NaO ) Potassium Chloride, USP, (KCl) Calcium Chloride, USP (CaCl ·2H O) Osmolarity (mOsmol/L) (calc) pH SodiumPOTAS S IUM CalciumChloride Lactate Caloric Content (kcal/L) Lactated Ringer’s Injection, USP 250 500 1000 6 3.1 0.3 0.2 273 6.5 (6.0 to 7.5) 130 4 2.7 109 28 9 The VIAFLEX 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- ethylhexyl phthalate (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 Injection, USP has value as a source of water and electrolytes. It is capable of inducing diuresis depending on the clinical condition of the patient. Lactated Ringer’s Injection, USP produces a metabolic alkalinizing effect. Lactate ions are metabolized ultimately to carbon dioxide and water, which requires the consumption of hydrogen cations. INDICATIONS AND USAGE Lactated Ringer’s Injection, USP is indicated as a source of water and electroly Leggi il documento completo