Cardioplegic solution Galenica Senese

Package leaflet: Information for the user

Galenica Senese Cardioplegic Solution

Sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate, sodium bicarbonate
Generic medicine
Please read all of this leaflet carefully before you start using 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, inform your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What SOLUZIONE CARDIOPLEGICA GALENICA SENESE is and what it is used for

SOLUZIONE CARDIOPLEGICA GALENICA SENESE 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 heart function during open-heart surgery under extracorporeal circulation.

2. What you need to know before using SOLUZIONE CARDIOPLEGICA GALENICA SENESE

Do not use SOLUZIONE CARDIOPLEGICA GALENICA SENESE

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

Warnings and precautions
SOLUZIONE CARDIOPLEGICA GALENICA SENESE will be administered only by a physician or
specialized personnel and only during heart surgery procedures involving extracorporeal circulation.
This medicine must not be injected intravenously or intramuscularly (systemic administration).
During treatment with SOLUZIONE CARDIOPLEGICA GALENICA SENESE, 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 SOLUZIONE CARDIOPLEGICA GALENICA SENESE, during the postoperative
period, you will be given medications that support proper heart function (inotropic agents).
Other medicines and SOLUZIONE CARDIOPLEGICA GALENICA SENESE
Inform your doctor if you are using, have recently used, or might use 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 breastfeeding, your doctors will determine whether this medicine can be administered to you.

3. How to use SOLUZIONE CARDIOPLEGICA GALENICA SENESE

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The side effects that may occur are listed below:
Frequency not known (frequency cannot be estimated from the available data)

• death (necrosis) of heart tissue, due to reduced or blocked blood and oxygen supply caused by obstruction of one of the coronary arteries (myocardial infarction);
• changes in heart rhythm (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 can also report side effects directly through 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 SENESSE CARDIOPLEGIC SOLUTION GALENIC

Medical and nursing staff are aware of the storage methods for this medicinal product.
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.
The expiry date applies to the product kept in its original, undamaged packaging and properly stored.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What SOLUZIONE CARDIOPLEGICA GALENICA SENESE contains
Galenica Senese Cardioplegic Solution Solution A of St. Thomas II

• The active substances are sodium chloride, potassium chloride, calcium chloride dihydrate, magnesium chloride hexahydrate. 1000 ml of solution contain 6.43 g of sodium chloride, 1.19 g of potassium chloride, 0.18 g of calcium chloride dihydrate, 3.25 g of magnesium chloride hexahydrate.
• The other component is water for injections.

Galenica Senese Cardioplegic Solution Solution B of St. Thomas II

• The active substance is sodium bicarbonate. 10 ml of solution contain 0.84 g of sodium bicarbonate.
• The other components are water for injections, carbon dioxide.

Description of the appearance of SOLUZIONE CARDIOPLEGICA GALENICA SENESE and contents of the pack
Pack containing two solutions (solution A and solution B).
Solution A:
Glass vial of 500 ml.
Plastic bag of 500 ml and 1000 ml.
Solution B:
Glass ampoule of 10 ml. The ampoules of sodium bicarbonate are packaged in the same container as solution A.

Marketing Authorisation Holder and Manufacturer
Industria Farmaceutica Galenica Senese S.r.l.
Via Cassia Nord 351 – 53014 Monteroni d’Arbia (Siena)

The following information is intended exclusively for physicians or healthcare professionals

Dosage and administration
At the time of use, mix extemporaneously 990 ml of solution A + 10 ml of solution B, or 495 ml of solution A + 5 ml of solution B, adding 10 ml of 1 Molar (8.4%) sodium bicarbonate for each 1-liter bag containing 990 ml of solution A and 5 ml for each 500 ml bag containing 495 ml of solution A, using aseptic technique with a dedicated tubular device.
Ionic composition of the final solution:
120 mEq/litre Na, 16 mEq/litre K, 2.4 mEq/litre Ca, 32 mEq/litre Mg, 160.4 mEq/litre Cl, 10 mEq/litre HCO₃. Theoretical osmolarity (mOsm/litre): 324.
pH of the final solution: 7.6–8.0.
The resulting solution, cooled to 4°C, is administered by rapid infusion into the aortic root after clamping 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 electrical and mechanical cardiac 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.
Shake well during preparation of the final solution and before administration. Do not use the medicinal product if the solution is not completely clear and colourless or if it contains particles.
Adopt all standard precautions to maintain sterility before and during use of the solution.
Unused medicinal product and waste materials must be disposed of in accordance with local regulations.

Special warnings and precautions for use
During extracorporeal circulation, hypothermia must be maintained and monitored; cardiac electrical activity must be monitored. A defibrillator must be available for possible restoration of cardiac activity. Inotropic drugs should be used in the postoperative period.
The solution is intended exclusively for use 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 completely 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 reused.

Incompatibilities
Not known.

Shelf life
2 years from the date of manufacture.
The final solution may be used up to 24 hours after preparation.

Special precautions for storage
Vials: store in tightly closed containers. Do not freeze.
Bags: store at a temperature not exceeding 30°C. Do not freeze.
Ampoules: store at a temperature not exceeding 30°C. Keep in the original packaging and in a tightly closed container. Do not refrigerate or freeze.

For further information, consult the Summary of Product Characteristics.