Cardioplegic Solution
Generic: POTASSIUM CHLORIDE, SODIUM CHLORIDE, CALCIUM CHLORIDE, AND MAGNESIUM CHLORIDE
Basic Information
Manufacturer
Fresenius Kabi, USA, LLC
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
INTRA-ARTERIAL
FDA Set ID
eb360dc4-88d6-4b28-9b61-bc359e16bd22
Indications & Usage
INDICATIONS AND USAGE Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
Warnings
WARNINGS This solution should be used only by those trained to perform open heart surgery.
This solution is intended only for use during cardiopulmonary bypass when the coronary circulation is isolated from the systemic circulation (See INDICATIONS AND USAGE ).
Do not instill the solution into the coronary vasculature unless sodium bicarbonate has been added.
If large volumes of cardioplegic solution are infused and allowed to return to the heart lung machine without any venting from the right heart, then plasma magnesium and potassium levels may rise.
Development of severe hypotension and metabolic acidosis while on bypass has been reported when large volumes (8 to 10 liters) of solution are instilled and allowed to enter the pump and then the systemic circulation.
Right heart venting is therefore recommended.
The buffered solution with added sodium bicarbonate should be cooled to 4°C prior to administration and used within 24 hours of mixing.
This solution is intended only for use during cardiopulmonary bypass when the coronary circulation is isolated from the systemic circulation (See INDICATIONS AND USAGE ).
Do not instill the solution into the coronary vasculature unless sodium bicarbonate has been added.
If large volumes of cardioplegic solution are infused and allowed to return to the heart lung machine without any venting from the right heart, then plasma magnesium and potassium levels may rise.
Development of severe hypotension and metabolic acidosis while on bypass has been reported when large volumes (8 to 10 liters) of solution are instilled and allowed to enter the pump and then the systemic circulation.
Right heart venting is therefore recommended.
The buffered solution with added sodium bicarbonate should be cooled to 4°C prior to administration and used within 24 hours of mixing.
Adverse Reactions
ADVERSE REACTIONS Intraoperative and perioperative potential hazards of open heart surgery include myocardial infarction, electrocardiographic abnormalities, and arrhythmias, including ventricular fibrillation.
Spontaneous recovery after cardioplegic cardiac arrest may be delayed or absent when circulation is restored.
Defibrillation by electric shock may be required to restore normal cardiac function.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Spontaneous recovery after cardioplegic cardiac arrest may be delayed or absent when circulation is restored.
Defibrillation by electric shock may be required to restore normal cardiac function.
To report SUSPECTED ADVERSE REACTIONS, contact Fresenius Kabi USA, LLC at 1-800-551-7176 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.