Cardioplegic - Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride solution
(Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride)Cardioplegic - Calcium Chloride, Magnesium Chloride, Potassium Chloride And Sodium Chloride solution Prescribing Information
Baxter Cardioplegic Solution when suitably buffered in combination with ischemia and hypothermia is used to induce cardiac arrest during open heart surgery.
The following information is suggested as a guide and is subject to variation according to the preference and experience of the surgeon. 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.
Should myocardial electromechanical activity persist or recur, the solution may be reinfused at a rate of 300 mL/m2/min for a period of two minutes. Reinfusion of the solution may be repeated every 20 to 30 minutes or sooner if myocardial temperature rises above 15° to 20°C or returning cardiac activity is observed. The regional hypothermia solution around the heart also may be replenished continuously or periodically in order to maintain adequate hypothermia. Suction may be used to remove warmed infusates. An implanted thermistor probe may be used to monitor myocardial temperature.
The volumes of solution instilled into the aortic root may vary depending on the duration or type of open heart surgical procedure.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit (See
Myocardial temperature should be monitored during surgery to maintain hypothermia.
Continuous electrocardiogram monitoring is essential to detect changes in myocardial activity during the procedure.
Appropriate equipment to defibrillate the heart following cardioplegia should be readily available.
Inotropic support drugs should be available during postoperative recovery.
Do not administer unless solution is clear and container is undamaged.
Discard unused portion.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store (See INSTRUCTIONS FOR USE).
Safety and effectiveness in pediatric patients have not been established. Because of differences in structure, function, and metabolism, clinical myocardial protection strategies and Cardioplegia solutions that are effective in adult hearts may be less effective in the immature heart.
Clinical studies of cardioplegic solution did not include sufficient numbers of subjects aged 65 and over to determine whether they responded differently from younger subjects. Other reported clinical experience has not identified differences in responses between older and younger patients.
In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosage range reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease.
This product is unique in that there is no hepatic or renal excretion and specific adjustments for dosing in the elderly are not known.
This solution is only for instillation into cardiac vasculature after buffering with sodium bicarbonate.
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.
Additives may be incompatible. Consult with pharmacist, if available. When introducing additives, use aseptic technique, mix thoroughly and do not store (See
Tear outer wrap at notch and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, Hospira1List 4900, and other supplemental medication, follow directions below before preparing for administration.
1.000000000000000e+00 Prepare additive port.2.000000000000000e+00 Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.3.000000000000000e+00 The additive port may be protected by covering with an additive cap.4.000000000000000e+00 Mix container contents thoroughly.
1.000000000000000e+00 Close flow control clamp of administration set.2.000000000000000e+00 Remove cover from outlet port at bottom of container.3.000000000000000e+00 Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.NOTE:See full directions on administration set carton.4.000000000000000e+00 Suspend container from hanger.5.000000000000000e+00 Squeeze and release drip chamber to establish proper fluid level in chamber.6.000000000000000e+00 Attach aortic infusion device to set.7.000000000000000e+00 Open flow control clamp to expel air from set and aortic infusion device. Close clamp.8.000000000000000e+00 Position aortic infusion device to introduce solution into aortic root.9.000000000000000e+00 Regulate rate of administration with flow control clamp.
Baxter Cardioplegic Solution is a sterile, nonpyrogenic, essentially isotonic, formulation of electrolytes in Water for Injection, USP. It is a “core solution” intended for use
Tear outer wrap at notch and remove solution container. Visually inspect the container. If the outlet port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. If supplemental medication is desired, follow directions below before preparing for administration. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. To add 10 mL of 8.4% Sodium Bicarbonate Injection, USP, Hospira1List 4900, and other supplemental medication, follow directions below before preparing for administration.
1.000000000000000e+00 Prepare additive port.2.000000000000000e+00 Using aseptic technique and an additive delivery needle of appropriate length, puncture resealable additive port at target area, inner diaphragm and inject. Withdraw needle after injecting medication.3.000000000000000e+00 The additive port may be protected by covering with an additive cap.4.000000000000000e+00 Mix container contents thoroughly.
1.000000000000000e+00 Close flow control clamp of administration set.2.000000000000000e+00 Remove cover from outlet port at bottom of container.3.000000000000000e+00 Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated.NOTE:See full directions on administration set carton.4.000000000000000e+00 Suspend container from hanger.5.000000000000000e+00 Squeeze and release drip chamber to establish proper fluid level in chamber.6.000000000000000e+00 Attach aortic infusion device to set.7.000000000000000e+00 Open flow control clamp to expel air from set and aortic infusion device. Close clamp.8.000000000000000e+00 Position aortic infusion device to introduce solution into aortic root.9.000000000000000e+00 Regulate rate of administration with flow control clamp.
Each 100 mL of solution contains Calcium Chloride Dihydrate USP 17.6 mg, Magnesium Chloride, Hexahydrate USP 325.3 mg, Potassium Chloride USP 119.3 mg and Sodium Chloride USP 643 mg in Water for Injection, USP. May contain HCl and/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.
Calcium Chloride, USP is chemically designated calcium chloride, dihydrate (CaCl2 • 2 H2O), white fragments or granules freely soluble in water.
Magnesium Chloride, USP is chemically designated magnesium chloride, hexahydrate (MgCl2 • 6 H2O), deliquescent flakes or crystals very soluble in water.
Potassium Chloride, USP is chemically designated KCl, a white granular powder freely soluble in water.
Sodium Chloride, USP is chemically designated NaCl, a white crystalline powder freely soluble in water.
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated polyvinyl chloride. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.