Plegisol (Cardioplegic Solution) when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.

Cardioplegia Solution; Cardiovascular Agent, Miscellaneous

None known

Plegisol must not be administered without the addition of 8.4% Sodium Bicarbonate Injection. It is not for IV Injection.

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The potential risks during and after cardiac surgery include myocardial infarction, abnormal electrocardiogram (ECG) readings, and arrhythmias, including ventricular fibrillation. When circulation is restored, the automatic recovery of heart rhythm after cardiac arrest may be delayed or may not occur, so electrical defibrillation may be necessary to restore normal heart function.【文字內容由仿單翻譯而來】。

Hospira List 4900, 8.4% Sodium Bicarbonate Injection, USP (10 mEq each of sodium and bicarbonate per 10 mL, 840 mg) should be aseptically added to Plegisol 1000 mL and mixed thoroughly to adjust the pH to 7.8 (at room temperature). Due to the instability of sodium bicarbonate with other components, it should only be added just before use. The resulting buffered solution should be used within 24 hours and must be cooled to 4°C prior to use.After cardiopulmonary bypass (心肺繞道術, CPB), the infusion temperature should be maintained between 28°C to 30°C. Following cross-clamping of the ascending aorta, the solution should be rapidly infused into the base of the artery. The initial infusion rate can be 300 mL/m2/min (approximately 540 mL/min for an adult with a height of 172.72 cm, weight of 70 kg, and a body surface area of 1.8 m2), sustained for 2 to 4 minutes. Concurrent external cooling (regional hypothermic pericardium) may be applied with infused cooled (4°C) physiological solutions such as Normosol-R (a balanced electrolyte replacement solution) or Ringer's Injection entering the thoracic cavity. If the electrocardiac activity persists or recurs, additional infusions of Plegisol should be administered at a rate of 300 mL/m2/min for 2 minutes. If the myocardial temperature rises above 15°C to 20°C or heart activity is observed, subsequent infusions should be repeated every 20 to 30 minutes or more frequently.【文字內容由仿單翻譯而來】。

Store at 20-25°C.Before use, the solution containing the added sodium bicarbonate buffer should be cooled to 4°C and used within 24 hours after mixing. 【文字內容由仿單翻譯而來】。