País: Estats Units
Idioma: anglès
Font: NLM (National Library of Medicine)
SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), SODIUM LACTATE (UNII: TU7HW0W0QT) (LACTIC ACID - UNII:33X04XA5AT, SODIUM CATION - UNII:LYR4M0NH37), POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698)
B. Braun Medical Inc.
INTRAVENOUS
PRESCRIPTION DRUG
This solution is indicated for use in adults and pediatric patients as a source of electrolytes and water for hydration. The use of Lactated Ringer’s Injection USP is contraindicated in neonates (28 days of age or younger) receiving concomitant treatment with ceftriaxone, even if separate infusion lines are used, due to the risk of fatal ceftriaxone-calcium salt precipitation in the neonate’s bloodstream [see Warnings, Drug Interactions, Pediatric Use ]. This solution is contraindicated where the administration of sodium, potassium, calcium, lactate, or chloride could be clinically detrimental. Lactate administration is contraindicated in severe metabolic acidosis or alkalosis, and in severe liver disease or anoxic states which affect lactate metabolism.
Lactated Ringer's Injection USP is supplied sterile and nonpyrogenic in EXCEL® Plus Containers. The 1000 mL containers are packaged 12 per case, and 500 mL containers are packaged 24 per case. Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat. Protect from freezing.
New Drug Application
LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, AND CALCIUM CHLORIDE INJECTION, SOLUTION B. BRAUN MEDICAL INC. ---------- LACTATED RINGER'S INJECTION USP DESCRIPTION RX ONLY Each 100 mL of Lactated Ringer's Injection USP contains: Sodium Chloride USP 0.6 g; Sodium Lactate 0.31 g Potassium Chloride USP 0.03 g; Calcium Chloride Dihydrate USP 0.02 g Water for Injection USP qs pH may be adjusted with Hydrochloric Acid NF or Sodium Hydroxide NF pH: 6.2 (6.0–7.5) Calculated Osmolarity: 274 mOsmol/liter Concentration of Electrolytes (mEq/liter): Sodium 130; Potassium 4; Calcium 3; Chloride 109; Lactate (CH CH(OH)COO ) 28 Lactated Ringer's Injection USP is sterile, nonpyrogenic and contains no bacteriostatic or antimicrobial agents. This product is intended for intravenous administration in a single dose container. The formulas of the active ingredients are: INGREDIENTS MOLECULAR FORMULAMOLECULAR WEIGHT Sodium Chloride USP NaCl 58.44 Sodium Lactate CH CH(OH)COONa 112.06 Potassium Chloride USP KCl 74.55 Calcium Chloride Dihydrate USP CaCl •2H O 147.02 Not made with natural rubber latex, PVC or DEHP. The plastic container is made from a multilayered film specifically developed for parenteral drugs. The solution contact layer is a rubberized copolymer of ethylene and propylene. The container is nontoxic and biologically inert. The container-solution unit is a closed system and is not dependent upon entry of external air during administration. The container is overwrapped to provide protection from the physical environment and to provide an additional moisture barrier when necessary. Addition of medication should be accomplished using complete aseptic technique. The closure system has two ports; the one for the administration set has a tamper evident foil cover and the other is a medication addition site. Refer to the Directions for Use of the container. CLINICAL PHARMACOLOGY 3 − 3 2 2 Lactated Ringer's Injection USP provides electrolytes and is a source of water for hydration. It is capable of i Llegiu el document complet