Consumer medicine information

What is in this leaflet?

What Cardioplegia "A" Solution is used for?

Before Cardioplegia "A" Solution is used on you

Using Cardioplegia "A" Solution

When is Cardioplegia "A" Solution used?

Amount of Cardioplegia "A" Solution used

Inadequate Dosage

Overdosage

Side Effects

What Cardioplegia "A" Solution looks like

Ingredients

Manufacturer

This leaflet does not contain all of the available information about Cardioplegia "A" Solution. It does not take the place of talking to your Doctor.

What Cardioplegia "A" Solution is used for

Cardioplegia "A" Solution is used in Open-Heart Surgery to stop the heart and to protect the heart muscle during your operation.

Before Cardioplegia "A" Solution is used on you

1. Ask your Doctor about the risks and benefits of using Cardioplegia "A" Solution while you are pregnant.
2. Inform your Doctor if you are breast feeding.

It is not recommended to use Cardioplegia "A" Solution if you are breast feeding. Your baby can absorb Cardioplegia "A" Solution from breast milk if you are breastfeeding.

Using Cardioplegia "A" Solution

When is Cardioplegia "A" Solution used?

Cardioplegia "A" Solution is used, by your surgeon, during Open-Heart surgery by pouring the solution through your heart.

Amount of Cardioplegia "A" Solution used

The volume of Cardioplegia "A" Solution used is dependent on your weight, height and body surface area. It is also dependent on the duration of the surgery and type of Open-Heart surgery. Cardioplegia "A" Solution may be re-introduced every 20-30 minutes or sooner depending on the temperature of your body (which must be between 15-20 °Celsius) and whether your heart starts to beat again during surgery.

Inadequate Dosage

Inadequate dosage of Cardioplegia "A" Solution may result in uneven cooling of your heart and may not stop your heart completely during surgery, leading to injury caused by lack of blood flow.

Overdosage

Overuse of Cardioplegia "A" Solution may result in swelling and eventually fluid build up in the heart.

Side Effects

Some people may get side effects following the use of Cardioplegia "A" Solution during Open-Heart surgery. Tell your Doctor if you experience anything making you feel unwell. Your Doctor will be able to explain to you any potential side-effects.

What Cardioplegia "A" Solution looks like

Cardioplegia "A" Solution is a clear, colourless solution supplied in a 1000mL Viaflex® plastic container. It is labelled Cardioplegia "A" Solution for Cardiac Perfusion.

Ingredients

One litre of this solution contains:

Sodium Chloride: 6.43 grams

Potassium Chloride: 1.19 grams

Magnesium Chloride Hexahydrate: 3.25 grams

Calcium Chloride Dihydrate: 176 milligrams

Water for Injections: Made up to 1 Litre Volume

Prior to use the surgeon adds 10mL of Sodium Bicarbonate 8.4% w/v.

Manufacturer

Cardioplegia "A" Solution is made in Australia by:

BAXTER HEALTHCARE PTY. LTD.,
1 Baxter Drive,
Old Toongabbie,
N.S.W., 2146, Australia.

This leaflet was revised in March, 2004

Australian Registration Number

AUST R 56336

88-19-01-046A

Published by MIMS December 2006

1 Name of Medicine

Sodium chloride, potassium chloride, calcium chloride dihydrate and magnesium chloride hexahydrate.

2 Qualitative and Quantitative Composition

Baxter Cardioplegia Solution A is a sterile, non-pyrogenic solution in a Viaflex bag. It is used to induce cardiac stasis and to protect the myocardium during open-heart surgery.
Baxter Cardioplegia Solution A is an isotonic crystalloid solution based on extracellular fluid ionic concentrations. Approximate osmolality is 275 mOsm/kg and approximate pH is 3.7.
See Table 1.
For the full list of excipients, see Section 6.1 List of Excipients.
Baxter Cardioplegia Solution A requires the aseptic addition of 10 mL of Sodium Bicarbonate 8.4% w/v Injection prior to use to adjust the pH to 7.4 - 7.8. Following pH adjustment the total sodium ionic concentration is 120 mmol/L.

3 Pharmaceutical Form

Sterile aqueous solution (for cardiac perfusion).

4 Clinical Particulars

4.1 Therapeutic Indications

Following pH adjustment with 10 mL of Sodium Bicarbonate 8.4% w/v Injection, Baxter Cardioplegia Solution A is used in combination with ischaemia and hypothermia to induce cardiac arrest during open heart surgery and to preserve the myocardium during asystole.

4.2 Dose and Method of Administration

It is important that an appropriate dose of Baxter Cardioplegia Solution A is used to ensure that all areas of the myocardium are cooled evenly, especially those areas distal to arterial obstruction in patients with coronary-artery disease. Inadequate dosage may result in uneven cooling, incomplete arrest and ischaemic injury.
Dosage may vary depending upon the perfusion technique in use, and the preferences and experience of the surgeon. The volume of solution instilled into the aortic root may vary depending upon the duration or type of open heart surgical procedure. The following information is provided for guidance.
The pH must be adjusted with 10 mL of Sodium Bicarbonate 8.4% w/v Injection and the solution cooled to 4°C before use. Following institution of cardiopulmonary bypass at perfusate temperature of 28°C to 30°C, and after cross-clamping of the ascending aorta, the pH adjusted solution is administered by rapid infusion into the aortic root. The initial rate of infusion may be 300 mL/m²/minute (approximately 540 mL/min for 173 cm, 70 kg adult with a body surface area of 1.8 m²) given over a period of two to four minutes.
Concurrent external cooling (regional hypothermia of the pericardium) may be accomplished by instilling a refrigerated physiological solution such as Plasma-Lyte 148 (approx. pH 7.4), Compound Sodium Lactate IV Infusion (Hartmann's Solution), or a physiological ice slush into the chest cavity.
Should myocardial activity persist or recur, Baxter Cardioplegia Solution A may be reinfused at a rate of 300 mL/m²/minute for a period of two minutes. Reinfusion of the solution may be repeated every 20 to 30 minutes or sooner if the myocardial temperature rises above 15°C to 20°C or returning cardiac activity is observed. The regional hypothermia solution around the heart may also be replenished continuously or periodically in order to maintain adequate hypothermia. Suction may be used to remove warmed infusates.

4.3 Contraindications

Baxter Cardioplegia Solution A must not be administered without the prior addition of sodium bicarbonate.

4.4 Special Warnings and Precautions for Use

Baxter Cardioplegia Solution A is intended only for cardiac perfusion when the coronary circulation is isolated from the systemic circulation. It must not be injected intravenously.
It should be used only by those trained in cardiac perfusion techniques and open heart surgery and in the presence of inotropic support drugs and the appropriate defibrillation equipment.
The pH of the solution must be adjusted by the aseptic addition of Sodium Bicarbonate Injection. The Baxter Cardioplegia Solution A container should then be rapidly inverted five times to ensure complete mixing. It should be cooled to 4°C before use. Once mixed, the solution should be used within 24 hours. It should not be used in serial connections with other containers. The remainder of any partly-used solutions should be discarded.
If large volumes of Baxter Cardioplegia Solution A are perfused and permitted to return to the extracorporeal circuit without any venting from the right heart, serum magnesium and potassium levels may rise. It is recommended that the right heart be vented.
It is important that the appropriate dosage of Baxter Cardioplegia Solution A be used (see Section 4.2 Dose and Method of Administration) to ensure that all areas of the myocardium are cooled evenly, especially those areas distal to arterial obstruction in patients with coronaryartery disease. Inadequate dosage may result in uneven cooling, incomplete arrest and ischaemic injury.
Numerous clinical parameters require close monitoring in patients receiving Baxter Cardioplegia Solution A. Maintenance of hypothermia is critical and myocardial temperature should be monitored throughout the procedure. Continuous monitoring of myocardial activity is essential.

Use in the elderly.

Paediatric use.

Effects on laboratory tests.

4.5 Interactions with Other Medicines and Other Forms of Interactions

No data available.

4.6 Fertility, Pregnancy and Lactation

Effects on fertility.

4.7 Effects on Ability to Drive and Use Machines

The effects of this medicine on a person's ability to drive and use machines were not assessed as part of its registration.

4.8 Adverse Effects (Undesirable Effects)

The use of cardioplegia solutions during open-heart surgery has been associated with a number of intraoperative and perioperative risks, including myocardial infarction, ECG abnormalities and arrhythmias (including ventricular fibrillation). Spontaneous recovery after cardioplegiainduced cardiac arrest may be delayed or absent at reperfusion; shock defibrillation may be required to restore normal cardiac function. In addition, cardioplegia solutions may cause potential electrolyte and acid-base abnormalities.

Reporting suspected adverse effects.

4.9 Overdose

Overuse of the solution may result in unnecessary dilatation of the myocardial vasculature and leakage into the perivascular myocardium, possibly causing tissue oedema (see Section 4.4 Special Warnings and Precautions for Use; Section 4.8 Adverse Effects (Undesirable Effects)).
For information on the management of overdose, contact the Poisons Information Centre on 13 11 26 (Australia).

5 Pharmacological Properties

5.1 Pharmacodynamic Properties

Mechanism of action.

Sodium and chloride.

Potassium.

Magnesium.

Calcium.

Bicarbonate.

Clinical trials.

5.2 Pharmacokinetic Properties

No data available.

5.3 Preclinical Safety Data

Genotoxicity.

Carcinogenicity.

6 Pharmaceutical Particulars

6.1 List of Excipients

Water for injections.

6.2 Incompatibilities

No data available.

6.3 Shelf Life

In Australia, information on the shelf life can be found on the public summary of the Australian Register of Therapeutic Goods (ARTG). The expiry date can be found on the packaging.

6.4 Special Precautions for Storage

The product should be stored below 30°C.

6.5 Nature and Contents of Container

Baxter Cardioplegia Solution A is supplied in 1000 mL Viaflex plastic containers for single use only.
The pH of the solution must be adjusted to between 7.4 and 7.8 with 10 mL Sodium Bicarbonate 8.4% w/v Injection (not supplied) before use.

6.6 Special Precautions for Disposal

Any unused product or waste material should be disposed of in accordance with local requirements.

6.7 Physicochemical Properties

Chemical structure.

Sodium chloride.

Potassium chloride.

Calcium chloride dihydrate.

Magnesium chloride hexahydrate.

CAS number.

Sodium chloride.

Potassium chloride.

Calcium chloride dihydrate.

Magnesium chloride hexahydrate.

7 Medicine Schedule (Poisons Standard)

Not scheduled.

Summary Table of Changes