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)
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 its overwrap until immediately before use. Use sterile equipment and aseptic technique. To Open - Turn solution container over so that the text is face down. Using the pre-cut corner tabs, peel open the overwrap and remove solution container. - Check the solution container for leaks by squeezing firmly. If leaks are found, or if the seal is not intact, discard the solution. - Do not use if the solution is cloudy or a precipitate is present. Preparation for Administration - Immediately before inserting the infusion set, break off BLUE Infusion Port Cap with the arrow pointing away from container. - Use a non-vented infusion set or close the air-inlet on a vented set. - Close the roller clamp of the infusion set. - Hold the base of BLUE Infusion Port. - Insert spike through BLUE Infusion Port by rotating wrist slightly until the spike is inserted. NOTE: See full directions accompanying administration set. To Add Medication Prior to Solution Administration - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, break off WHITE Additive Port Cap with the arrow pointing toward container. - Hold base of WHITE Additive Port horizontally. - Prepare medication site. - Insert an 18 to 23 gauge needle horizontally through the center of WHITE Additive Port's septum and inject additives. - Mix container contents thoroughly. For high density medication such as potassium chloride, squeeze ports while ports are upright and mix thoroughly. To Add Medication During Solution Administration - Close the clamp on the set. - Identify WHITE Additive Port with arrow pointing toward container. - Immediately before injecting additives, if the Cap has not been broken off, break off WHITE Additive Port Cap with the arrow pointing toward container. - Hold base of WHITE Additive Port horizontally. - Prepare medication site. - Using a syringe with an 18 to 23 gauge needle, horizontally insert through the center of WHITE Additive Port's septum and inject additives. - Remove container from IV pole and/or turn to an upright position. - Mix container contents thoroughly. - Using aseptic technique, repeat steps 4-7 as necessary. - Return container to in use position and continue administration. WARNING: Do not use flexible container in series connections. Manufactured for: Lake Zurich, IL 60047 Made in Norway www.fresenius-kabi.com/us 451533 Issued: November 2018
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 inf Leggi il documento completo