Šalis: Jungtinės Valstijos
kalba: anglų
Šaltinis: NLM (National Library of Medicine)
Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (Phosphate ION - UNII:NK08V8K8HR), Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) (Sodium Cation - UNII:LYR4M0NH37)
Fresenius Kabi USA, LLC
INTRAVENOUS
PRESCRIPTION DRUG
Sodium Phosphates Injection, USP, 3 mM P/mL is indicated as a source of phosphorus, for addition to large volume intravenous fluids, to prevent or correct hypophosphatemia in patients with restricted or no oral intake. It is also useful as an additive for preparing specific parenteral fluid formulas when the needs of the patient cannot be met by standard electrolyte or nutrient solutions. The concomitant amount of sodium (Na+ 4 mEq/mL) must be calculated into total electrolyte dose of such prepared solutions. Sodium phosphate is contraindicated in diseases where high phosphorus or low calcium levels may be encountered, and in patients with hypernatremia.
Sodium Phosphates Injection, USP, 3 mM P/mL in single dose vials, is supplied as follows: *The container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the IV container. STORE AT: 20 ° to 25 °C (68 ° to 7 7°F) [see USP Controlled Room Temperature]. Discard unused portion. The container closure is not made with natural rubber latex. Lake Zurich, IL 60047 www.fresenius-kabi.com/us 451540A Revised: November 2021
Abbreviated New Drug Application
SODIUM PHOSPHATES- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INJECTION, SOLUTION FRESENIUS KABI USA, LLC ---------- SODIUM PHOSPHATES INJECTION, USP 451540A /Revised: November 2021 3 mM P and 4 mEq Na /mL FOR ADDITIVE USE ONLY AFTER DILUTION IN INTRAVENOUS FLUIDS. Rx only DESCRIPTION: Sodium Phosphates Injection, USP, 3 mM P/mL (millimoles/mL), is a sterile, nonpyrogenic, concentrated solution containing a mixture of monobasic sodium phosphate and dibasic sodium phosphate in water for injection. The solution is administered after dilution by the intravenous route as an electrolyte replenisher. _It must not be administered undiluted._ Each mL contains 276 mg of monobasic sodium phosphate, monohydrate and 142 mg of dibasic sodium phosphate, anhydrous (equivalent to 268 mg of dibasic sodium phosphate, heptahydrate). One mM of phosphorus weighs 31 mg, and the product provides 93 mg (approximately 3 mM) of phosphorus/mL plus 92 mg (4 mEq) of sodium/mL. Note: 1 mM P = 1 mM PO . It contains no bacteriostat, antimicrobial agent (preservative free) or added buffer. The pH is 5.5 (5.0 to 6.0). The osmolar concentration is 7 mOsmol/mL (calc). The solution is intended as an alternative to potassium phosphate to provide phosphorus for addition to large volume infusion fluids for intravenous use. It is provided as 5 mL, 15 mL and 50 mL partial fill single-dose vial; when lesser amounts are required, the unused portion should be discarded with the entire unit. Monobasic Sodium Phosphate, USP (monohydrate) is chemically designated NaH PO • H O, white, odorless crystals or granules freely soluble in water. Dibasic Sodium Phosphate, USP (anhydrous) is chemically designated Na HPO , colorless or white granular salt freely soluble in water. CLINICAL PHARMACOLOGY: Phosphorus in the form of organic and inorganic phosphate has a variety of important biochemical functions in the body and is involved in many significant metabolic and enzyme reactions in almost all organs and tissues. It exerts a Perskaitykite visą dokumentą