SODIUM PHOSPHATES- sodium phosphate, monobasic, monohydrate and sodium phosphate, dibasic, anhydrous injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Sodium Phosphate, Monobasic, Monohydrate (UNII: 593YOG76RN) (Phosphate ION - UNII:NK08V8K8HR), Sodium Phosphate, Dibasic, Anhydrous (UNII: 22ADO53M6F) (Sodium Cation - UNII:LYR4M0NH37)

Fáanlegur frá:

Fresenius Kabi USA, LLC

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

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

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

SODIUM PHOSPHATES- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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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