Cardioplegic solution Monico

PACKAGE LEAFLET: INFORMATION FOR THE USER

MONICO CARDIOPLEGIC SOLUTION

St. Thomas II Solution A and B
Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium bicarbonate
Equivalent medicine
Please read this leaflet carefully before you use this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

1. What MONICO CARDIOPLEGIC SOLUTION is and what it is used for
2. What you need to know before using MONICO CARDIOPLEGIC SOLUTION
3. How to use MONICO CARDIOPLEGIC SOLUTION
4. Possible side effects
5. How to store MONICO CARDIOPLEGIC SOLUTION
6. Contents of the pack and other information

1. What SOLUZIONE CARDIOPLEGICA MONICO is and what it is used for

SOLUZIONE CARDIOPLEGICA MONICO contains the active substances sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, and sodium bicarbonate. The cardioplegic solution allows the heart to be stopped without suffering irreversible damage.
This medicinal product is indicated for inducing temporary arrest of cardiac function during open-heart surgery with extracorporeal circulation, enabling the heart to be restarted at the end of the surgical procedure.

2. What you need to know before using MONICO CARDIOPLEGIC SOLUTION

Do not use MONICO CARDIOPLEGIC SOLUTION

• if you are allergic to the active substances or to any of the other components of this medicine.

Warnings and precautions
MONICO CARDIOPLEGIC SOLUTION will be administered to you only by a physician or specialized personnel and only during heart surgery with extracorporeal circulation.
This medicine must not be injected intravenously or intramuscularly (systemic route).
During treatment with MONICO CARDIOPLEGIC SOLUTION, the physician must monitor:

• maintenance of low heart temperature (hypothermia);
• the heart's electrical activity;
• the availability of a defibrillator, which may be needed to restart the heart.

After treatment with MONICO CARDIOPLEGIC SOLUTION, during the postoperative period, you will be given medicines that help support proper heart function (inotropic agents).
Other medicines and MONICO CARDIOPLEGIC SOLUTION
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicines are known.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, your doctors will decide whether this medicine should be administered to you.

3. How to use SOLUZIONE CARDIOPLEGICA MONICO

This medicinal product will be administered to you only by a doctor or trained medical staff during heart surgery procedures.
If you are given more SOLUZIONE CARDIOPLEGICA MONICO than you should
This medicinal product will be administered by a doctor or trained medical staff, so it is unlikely that you will receive an excessive dose.
If you have any doubts about the use of this medicinal product, consult your doctor or nurse.

4. Possible side effects

Like all medicines, SOLUZIONE CARDIOPLEGICA MONICO can cause side effects,
although not everybody will experience them.
The possible side effects are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• death (necrosis) of heart tissue, due to reduced or absent blood and oxygen supply caused by obstruction of one of the coronary arteries (myocardial infarction);
• irregular heartbeat (arrhythmias);
• changes in heart activity (electrocardiographic alterations);
• prolonged effect of this medicine on the heart;
• interruption of the heart's rhythmic beating.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist.
You may also report side effects directly via the national reporting system at http://www.aifa.gov.it/content/-segnalazioni-reazioni-avverse. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store MONICO CARDIOPLEGIC SOLUTION

Medical and nursing staff are aware of the storage conditions for this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the packaging after “EXP.”. The expiry date refers to the last day of that month and to the product in its original, undamaged packaging, stored correctly.
Special precautions for storage
Store in tightly closed containers. Do not freeze.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What SOLUZIONE CARDIOPLEGICA MONICO contains
MONICO Cardioplegic Solution – St. Thomas II Solution A

• The active substances are sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate. 480 ml of solution contain 3.22 g of sodium chloride, 0.60 g of potassium chloride, 0.09 g of calcium chloride dihydrate, and 1.63 g of magnesium chloride hexahydrate.
• The other component is water for injections.

MONICO Cardioplegic Solution – St. Thomas II Solution B

• The active substance is sodium bicarbonate. 20 ml of solution contain 0.42 g of sodium bicarbonate.
• The other component is water for injections.

Description of the appearance of SOLUZIONE CARDIOPLEGICA MONICO and contents of the pack
Solution A:
Glass bottle of 500 ml (containing 480 ml of solution) or plastic bag of 500 ml (containing 480 ml of solution).
Solution B:
Glass vial of 20 ml.

Marketing Authorization Holder and Manufacturer
MONICO SPA – Via Ponte di Pietra 7, 30173 – VENEZIA/MESTRE – Italy

The following information is intended exclusively for physicians or healthcare professionals

Dosage and administration
Immediately before use, mix extemporaneously 480 ml of solution A with 20 ml of solution B, using aseptic technique and a dedicated tubular device.
The resulting solution, cooled to 4°C, is administered by rapid infusion into the aortic root after clamping of the ascending aorta. The infusion rate is 300 ml/m² of body surface area per minute over 5–8 minutes. Administration may be repeated if cardiac electromechanical activity persists or recurs.
Infusion may be repeated every 20–30 minutes if body temperature rises above 15–20°C or if cardiac activity resumes.
Final solution for use
480 ml of solution A + 20 ml of solution B
The addition must be performed immediately before use, using aseptic technique and mixing via a dedicated tubular system.
Ionic composition of the final solution
mmol/litre
Na+ 120
K+ 16
Ca++ 1.2
Mg++ 32
Cl- 160.4
HCO3- 10
Theoretical osmolarity (mOsm/litre) 324
pH 7.6 ÷ 8.0
Shake well during preparation of the final solution and before administration. Do not use the medicinal product if the solution is not perfectly clear and colourless or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use of the solution.
Any unused medicinal product and waste materials derived from it must be disposed of in accordance with local regulations.
Special warnings and precautions for use
The solution is intended for use exclusively during extracorporeal circulation. Do not inject systemically.
Do not use solution A alone without adding solution B.
Solutions A and B must be used immediately after opening the containers.
The final solution must be perfectly clear, colourless and free from visible particles, and may be used up to 24 hours after preparation. The reconstituted solution must be cooled to 4°C before use. It is intended for a single, uninterrupted administration; any remaining solution must not be used.
For further information, consult the Summary of Product Characteristics.