البلد: الولايات المتحدة
اللغة: الإنجليزية
المصدر: 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)
Fresenius Kabi USA, LLC
INTRAVENOUS
PRESCRIPTION DRUG
Lactated Ringer's Injection is indicated as a source of water and electrolytes or as an alkalinizing agent. As for other calcium-containing infusion solutions, concomitant administration of ceftriaxone and Lactated Ringer's Injection is contraindicated in newborns (≤ 28 days of age), even if separate infusion lines are used (risk of fatal ceftriaxone-calcium salt precipitation in the neonate's bloodstream). In patients older than 28 days (including adults), ceftriaxone must not be administered simultaneously with intravenous calcium-containing solutions, including Lactated Ringer's Injection, through the same infusion line (e.g., via Y-connector). If the same infusion line is used for sequential administration, the line must be thoroughly flushed between infusions with a compatible fluid. Lactated Ringer's Injection is contraindicated in patients with a known hypersensitivity to sodium lactate. Check flexible container solution composition, lot number, and expiry date. Do not remove solution container from i
Lactated Ringer's Injection, USP in a single dose flexible plastic container, is available as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. STORE AT: 20 ° to 25 °C (68 ° to 77 °F) [see USP Controlled Room Temperature]; brief exposure up to 40°C does not adversely affect the product. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile.
Abbreviated New Drug Application
LACTATED RINGERS- SODIUM CHLORIDE, SODIUM LACTATE, POTASSIUM CHLORIDE, CALCIUM CHLORIDE INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- LACTATED RINGER'S INJECTION, USP in FREE-_flex_ Bag 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 Size (mL) Composition (g/L) Ionic Composition (mEq/L) Caloric Content (kcal/L) Sodium Chloride, USP (NaCl) Sodium Lactate, USP (C H NaO ) Potassium Chloride, USP (KCl) Calcium Chloride, USP (CaCl •2H O) Osmolarity (mOsmol/L) (calc) pH SodiumPotassiumCalciumChlorideLactate Lactated Ringer's Injection, USP 250 6 3.1 0.3 0.2 273 6.5 (6.0 to 7.5) 130 4 2.7 109 28 9 500 1,000 The flexible container is fabricated from a specially formulated non-plasticized, film containing polypropylene and thermoplastic elastomers (FREE_flex_ bag). 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 flexible container can leach out certain of the container's chemical components in very small amounts within the expiration period. The suitability of the container material has been confirmed by tests in animals according to USP biological tests for plastic containers. CLINICAL PHARMACOLOGY: Lactated Ringer's Injection 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 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 is indicated as a source of water and electrolytes or as an alkalinizing agent. CONTRAINDICATIONS: As for other calcium-containing infus اقرأ الوثيقة كاملة