PLEGISOL- potassium chloride, sodium chloride, calcium chloride, and magnesium chloride injection, solution

Land: USA

Sprog: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv bestanddel:

POTASSIUM CHLORIDE (UNII: 660YQ98I10) (POTASSIUM CATION - UNII:295O53K152, CHLORIDE ION - UNII:Q32ZN48698), SODIUM CHLORIDE (UNII: 451W47IQ8X) (SODIUM CATION - UNII:LYR4M0NH37, CHLORIDE ION - UNII:Q32ZN48698), CALCIUM CHLORIDE (UNII: M4I0D6VV5M) (CALCIUM CATION - UNII:2M83C4R6ZB, CHLORIDE ION - UNII:Q32ZN48698), MAGNESIUM CHLORIDE (UNII: 02F3473H9O) (MAGNESIUM CATION - UNII:T6V3LHY838, CHLORIDE ION - UNII:Q32ZN48698)

Tilgængelig fra:

Hospira, Inc.

INN (International Name):

POTASSIUM CHLORIDE

Sammensætning:

POTASSIUM CHLORIDE 119.3 mg in 100 mL

Indgivelsesvej:

INTRA-ARTERIAL

Recept type:

PRESCRIPTION DRUG

Terapeutiske indikationer:

Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery. Plegisol must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP, Hospira List 4900. NOT FOR INTRAVENOUS INJECTION. This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.

Produkt oversigt:

Plegisol® (Cardioplegic Solution) is supplied (without sodium bicarbonate) as follows: NDC 0409-7969-05 Case of 12 single-dose 1000 mL flexible plastic containers WARNING: Do not use flexible container in series connections. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1244-3.0 Revised: 01/2021

Autorisation status:

New Drug Application

Produktets egenskaber

PLEGISOL- POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND
MAGNESIUM CHLORIDE INJECTION, SOLUTION
HOSPIRA, INC.
----------
PLEGISOL
_CARDIOPLEGIC SOLUTION FOR CARDIAC PERFUSION_
NOT FOR INTRAVENOUS INJECTION
FLEXIBLE PLASTIC CONTAINER
R ONLY
DESCRIPTION
Plegisol (Cardioplegic Solution) is a sterile, nonpyrogenic,
essentially isotonic, formulation
of electrolytes in water for injection. It is a "core solution"
intended for use _ONLY AFTER_
_ADDITION OF SODIUM BICARBONATE_ to adjust pH prior to administration.
After buffering
with sodium bicarbonate it is suitable for cardiac instillation
(usually with hypothermia) to
induce arrest during open heart surgery. Other agents may be added to
the solution
prior to instillation (See INSTRUCTIONS FOR USE).
Each 100 mL of solution contains calcium chloride, dihydrate 17.6 mg,
magnesium
chloride, hexahydrate 325.3 mg, potassium chloride 119.3 mg and sodium
chloride 643
mg in water for injection. May contain HCl or NaOH for pH adjustment.
Electrolyte
content per liter (not including ions for pH adjustment): Calcium (Ca
) 2.4 mEq;
magnesium (Mg
) 32 mEq; potassium (K ) 16 mEq; sodium (Na ) 110 mEq; chloride
(Cl‾) 160 mEq. Osmolar concentration, 304 mOsmol/liter (calc.); pH
3.8 (3.5 to 3.9) prior
to sodium bicarbonate addition.
It is required that 10 mL (840 mg) of 8.4% Sodium Bicarbonate
Injection, USP (10 mEq
each of sodium and bicarbonate) be added aseptically and thoroughly
mixed with each
1000 mL of cardioplegic solution to adjust pH. USE 10 ML OF HOSPIRA
LIST 4900,
8.4% SODIUM BICARBONATE INJECTION, USP, TO ACHIEVE THE APPROXIMATE PH
OF
7.8 WHEN MEASURED AT ROOM TEMPERATURE. USE OF ANY OTHER SODIUM
BICARBONATE INJECTION MAY NOT ACHIEVE THIS PH DUE TO THE VARYING PH'S
OF
SODIUM BICARBONATE INJECTIONS. Due to its inherent instability with
other components,
sodium bicarbonate must be added just prior to administration. After
this addition, the
solution must be stored under refrigeration and be used within 24
hours.
The buffered admixture contains the following el