Medikarb 100% v/v liquefied medicinal gas

Patient Information Leaflet

Introduction

Patient Information Leaflet

Medikarb, 100% V/V medicinal liquefied gas

Carbon dioxide

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.

• If you have any questions, ask your doctor, pharmacist or nurse.

• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.

  • If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Medikarb is and what it is used for

2. What you need to know before using Medikarb

3. How to use Medikarb

4. Possible adverse effects

   1. Storage of Medikarb

5. Contents of the pack and other information

1. What Medikarb is and what it is used for

Medikarb is a liquefied medicinal gas supplied in high-pressure gas cylinders. This medicine is used in the following situations:

• to stimulate respiration after a period of respiratory arrest or controlled ventilation
• to prevent reduced carbon dioxide concentration in blood during hyperventilation
• to inflate body cavities during surgical procedures (such as laparoscopic surgery)
• during supplementary body examinations
• to create a foam for use in the treatment of varicose veins

If Medikarb is administered by inhalation, it will always be given together with medicinal oxygen.

2. What you need to know before starting to use Medikarb

Medikarb is administered exclusively in hospitals or medical centers under the supervision of medical, pharmacy, or nursing staff. Make sure your healthcare professional is aware of any medical conditions you have.

Do not use Medikarb

• if you have high acidity in the blood or tissues.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Medikarb.

Take special care with Medikarb

• if you have any condition causing difficulty in breathing
• if you have previously undergone surgery or suffered bodily trauma to prevent bubble formation in the body
• in case of hypovolemia

Other medicines and Medikarb

Medikarb may affect other medicines in the body, such as those used to treat hypertension, anticonvulsants, analgesics, and muscle relaxants.

Do not use this medicine together with epinephrine or similar medicines.

Medikarb must not be used with nitrous oxide or similar anesthetics.

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy and breastfeeding

The use of Medikarb during pregnancy is not recommended.

Breastfeeding should be avoided during treatment with Medikarb or if you are in close proximity to this medicine.

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may drive and operate machinery after using Medikarb, provided your healthcare professional considers you fit and able to do so.

3. How to use Medikarb

Your doctor, pharmacist, or nurse will ensure that your supply of Medikarb is appropriate for you and that the equipment has been correctly set up so that you receive the correct amount of gas.

Medikarb is administered by inhalation as a mixture with other medicinal gases using a breathing mask, mouthpiece, or endotracheal tube (inserted into the airways).

Special medical equipment will be used:

• to inflate parts of your body during laparoscopic surgery or gynecological procedures,
• to treat varicose veins.

If you use more Medikarb than you should

When this medicine is administered at concentrations above 5%, it may cause extreme difficulty in breathing, increased blood pressure, nausea, vomiting, and sometimes unconsciousness. In case of overdose, your doctor, pharmacist, or nurse will stop administration and provide appropriate care. Contact with the product may cause burns or frostbite.

If you have any doubts, consult your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

The possible adverse effects are:

• difficulty breathing, dry cough, increased blood pressure and heart rate, headache, tingling, taste disturbances, and nausea, if administered at a concentration below 5%;
• dizziness, sweating, vision and hearing disturbances, anxiety, and confusion, if administered at a concentration above 5%;
• seizures and loss of consciousness, if administered at a concentration above 10%.

Less frequent adverse effects include:

• cardiac arrest, meaning the heart temporarily stops beating. This may be fatal if cardiac arrest is not treated immediately;
• changes in heart rhythm, when high levels of carbon dioxide enter the bloodstream during laparoscopy;
• infarctions caused by gas bubbles in the bloodstream.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is an effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medikarb

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date stated on the label after EXP. The expiry date is the last day of the month indicated.

Gas cylinders must be stored:

• at a temperature between −20 °C and +65 °C;
• under cover and protected from adverse weather conditions;
• in a well-ventilated area used exclusively for the storage of medical gases;
• separated from gas cylinders containing other gases or gases with different compositions;
• protected from falls and other types of impact;
• away from sources of heat. The gas cylinder valves are equipped with a rupture disc to prevent the cylinder from bursting due to excessive pressure. The rupture disc may fail at excessively high temperatures, resulting in the release of the entire contents of the gas cylinder. In such a case, do not enter the storage area and ventilate the area thoroughly until a qualified expert certifies it is safe.

Empty gas cylinders must be stored separately. Return empty gas cylinders to the supplier.

6. Contents of the container and additional information

Composition of Medikarb

• The active substance is medicinal carbon dioxide, 100% V/V.
• It contains no excipients.

Appearance of Medikarb and contents of the container

Medikarb is a liquefied medicinal gas, transparent and odourless. This medicine is stored under pressure in gas cylinders made of steel or aluminium. The cylinder body is white and the cap is grey.

Gas cylinders with a capacity of x litres provide y (unit of volume) of gaseous carbon dioxide at 15°C and 1 bar (see table).

Not all container sizes may be marketed.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder:

S.E. de Carburos Metálicos, S.A., Av. De la Fama, 1, 08940 Cornellà de Llobregat, Spain

Manufacturers:

S.E. de Carburos Metálicos, S.A., Carretera de Toledo, 7, 28300 Aranjuez, Spain

Air Products S.A.S., 21 Rue de l'Epinoy, Zone Industrielle de l’Epinoy, 59175 Templemars, France

This medicinal product is authorized in the European Economic Area member states under the following names:

Spain: Medikarb 100 % V/V medicinal liquefied gas

Portugal: Medikarb, 100% V/V, medicinal liquefied gas

Date of the most recent review of this leaflet: 12/2022

Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/