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

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37), SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F) (PHOSPHATE ION - UNII:NK08V8K8HR, SODIUM CATION - UNII:LYR4M0NH37)

Disponível em:

Hospira, Inc.

DCI (Denominação Comum Internacional):

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE

Composição:

SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE 276 mg in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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.

Resumo do produto:

Sodium Phosphates Injection, USP, 3 mM P/mL is supplied as per below. Each container is partially filled to provide air space needed for complete vacuum withdrawal of the contents into the I.V. container. Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Hospira, Inc., Lake Forest, IL 60045 USA LAB-1044-3.0 01/2018

Status de autorização:

New Drug Application

Características técnicas

SODIUM PHOSPHATES- SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE AND SODIUM
PHOSPHATE,
DIBASIC, ANHYDROUS INJECTION, SOLUTION
HOSPIRA, INC.
----------
SODIUM PHOSPHATES
INJECTION, USP
45 MM P IN 15 ML
(3 MM P AND 4 MEQ NA /ML)
FOR ADDITIVE USE ONLY AFTER DILUTION IN I.V. FLUIDS
PLASTIC VIAL
R 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 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 a 15 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.
The semi-rigid container is fabricated from a specially formulated
polyolefin. It is a copolymer of
ethylene and propylene. The safety of the plastic has been confirmed
by tests in animals according to
USP biological standards for plastic containers. The container
requires no vapor barrier to maintain the