PLEGISOL Dosage and Administration

(cardioplegic solution for cardiac perfusion)

DOSAGE AND ADMINISTRATION

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. 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 used within 24 hours. The solution should be cooled to 4°C prior to use.

Following institution of cardiopulmonary bypass at perfusate temperatures of 28° to 30°C, and after cross-clamping of the ascending aorta, the buffered solution is administered by rapid infusion into the aortic root. The initial rate of infusion may be 300 mL/m2/minute (about 540 mL/min in a 5'8", 70 kg adult with 1.8 square meters of surface area) given for a period of two to four minutes. Concurrent external cooling (regional hypothermia of the pericardium) may be accomplished by instilling a refrigerated (4°C) physiologic solution such as Normosol-R (balanced electrolyte replacement solution) or Ringer's Injection, USP into the chest cavity.

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 PRECAUTIONS).

INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch and remove solution container. 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, Hospira List 4900, and other supplemental medication, follow directions below before preparing for administration.

To Add Medication

  1. Prepare additive port.

  2. 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. The additive port may be protected by covering with an additive cap.

  4. Mix container contents thoroughly.

Preparation for Administration

(Use aseptic technique)

  1. Close flow control clamp of administration set.

  2. Remove cover from outlet port at bottom of container.

  3. 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. Suspend container from hanger.

  5. Squeeze and release drip chamber to establish proper fluid level in chamber.

  6. Attach aortic infusion device to set.

  7. Open flow control clamp to expel air from set and aortic infusion device. Close clamp.

  8. Position aortic infusion device to introduce solution into aortic root.

  9. Regulate rate of administration with flow control clamp.

Find PLEGISOL medical information:

Find PLEGISOL medical information:

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

PLEGISOL Quick Finder

Prescribing Information
Download Prescribing Information

Health Professional Information

Dosage and Administration

DOSAGE AND ADMINISTRATION

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. 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 used within 24 hours. The solution should be cooled to 4°C prior to use.

Following institution of cardiopulmonary bypass at perfusate temperatures of 28° to 30°C, and after cross-clamping of the ascending aorta, the buffered solution is administered by rapid infusion into the aortic root. The initial rate of infusion may be 300 mL/m2/minute (about 540 mL/min in a 5'8", 70 kg adult with 1.8 square meters of surface area) given for a period of two to four minutes. Concurrent external cooling (regional hypothermia of the pericardium) may be accomplished by instilling a refrigerated (4°C) physiologic solution such as Normosol-R (balanced electrolyte replacement solution) or Ringer's Injection, USP into the chest cavity.

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 PRECAUTIONS).

INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch and remove solution container. 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, Hospira List 4900, and other supplemental medication, follow directions below before preparing for administration.

To Add Medication

  1. Prepare additive port.

  2. 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. The additive port may be protected by covering with an additive cap.

  4. Mix container contents thoroughly.

Preparation for Administration

(Use aseptic technique)

  1. Close flow control clamp of administration set.

  2. Remove cover from outlet port at bottom of container.

  3. 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. Suspend container from hanger.

  5. Squeeze and release drip chamber to establish proper fluid level in chamber.

  6. Attach aortic infusion device to set.

  7. Open flow control clamp to expel air from set and aortic infusion device. Close clamp.

  8. Position aortic infusion device to introduce solution into aortic root.

  9. Regulate rate of administration with flow control clamp.

Resources

Didn’t find what you were looking for? Contact us.

MI Digital Assistant

Chat online with Pfizer Medical Information regarding your inquiry on a Pfizer medicine.

Call 800-438-1985*

*Contact Medical Information. 8AM-9PM ET Monday to Friday; excluding holidays.

Medical Inquiry

Submit a medical question for Pfizer prescription products.

Report Adverse Event

Pfizer Safety

To report an adverse event related to the Pfizer-BioNTech COVID-19 Vaccine, and you are not part of a clinical trial* for this product, click the link below to submit your information:

Pfizer Safety Reporting Site

*If you are involved in a clinical trial for this product, adverse events should be reported to your coordinating study site.

If you cannot use the above website, or would like to report an adverse event related to a different Pfizer product, please call Pfizer Safety at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatch or call (800) 822-7967.