CARDIOPLEGIC SOLUTION- potassium chloride, sodium chloride, calcium chloride, and magnesium chloride injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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)

Pieejams no:

Fresenius Kabi, USA, LLC

Ievadīšanas:

INTRA-ARTERIAL

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery. Cardioplegic Solution must not be administered without the addition of 8.4% Sodium Bicarbonate Injection, USP. NOT FOR INTRAVENOUS INJECTION. This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate. Flexible Plastic Container (free flex ® bag) Do not remove solution container from its overwrap until immediately before use. The intact port cap provides visual tamper evidence. Do not use if port cap is prematurely removed. Maintain strict aseptic technique during handling. To Open - Always inspect the solution container before and after removal from the overwrap. - Place the solution container on a clean, flat surface. Remove the solution container from the overwrap. - Check the solution container for leaks by squeezing firmly. If leaks are found, discard. To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, and i

Produktu pārskats:

Cardioplegic Solution is supplied (without sodium bicarbonate) in a single-dose 1000 mL free flex ® plastic container as follows: WARNING: Do not use flexible container in series connections. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. The container closure is not made with natural rubber latex. Non-PVC, Non-DEHP, Sterile. Manufactured for: Lake Zurich, Illinois 60047 Made in Germany 451744 www.fresenius-kabi.com/us Issued: April 2022

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

CARDIOPLEGIC SOLUTION- POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM
CHLORIDE, AND MAGNESIUM CHLORIDE INJECTION, SOLUTION
FRESENIUS KABI, USA, LLC
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CARDIOPLEGIC SOLUTION FOR CARDIAC PERFUSION
NOT FOR INTRAVENOUS INJECTION
FLEXIBLE PLASTIC CONTAINER
RX ONLY
DESCRIPTION
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 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 electrolytes (per