ICOMAS 0.3%/0.3%/0.3% MEDICINAL COMPRESSED GAS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

ICOMAS 0.3%/0.3%/0.3% medicinal compressed gas

Carbon monoxide (CO), methane (CH4) and acetylene (C2H2).

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

Leaflet contents

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

1. What ICOMAS is and what it is used for

This medicine is for diagnostic use only in pulmonary function tests. ICOMAS should only be used in patients capable of performing the test, regardless of age.

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

Children and adolescents

This product should be used with caution in children. Ask your doctor or nurse before taking this medicine.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or nurse before taking this medicine.

ICOMAS should only be used during pregnancy when absolutely necessary.

ICOMAS may be used during breastfeeding.

3. How to use ICOMAS

ICOMAS must only be used for diagnostic testing of lung function. You must strictly follow the instructions given by your doctor or nursing staff. If in doubt, please consult your doctor or nurse again.

If you have used more ICOMAS than you should

If you have inhaled too much product, you may experience symptoms of low blood oxygen levels, such as altered consciousness, headache, dizziness, nausea, vomiting, and blurred vision; chest pain, difficulty breathing, weakness, or other nonspecific symptoms.

If you experience any of these symptoms, inform the healthcare professional immediately and stop inhaling ICOMAS.

Safety information

• ICOMAS is intended exclusively for medical use.
• Smoking or lighting flames is not permitted in the room where this product is being used.

If you have any further questions about the use of this medicine, ask your doctor or nurse.

4. Possible adverse effects

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

No known adverse effects have been associated with the use of ICOMAS.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of ICOMAS

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

Store the cylinders in restricted-access areas designated for medical gases. Do not expose to high temperatures.

In case of fire, if possible, move the cylinders to a safe location. Handle with care. Return used cylinders to the supplier with a minimum residual pressure (5 bar overpressure).

Store and transport the cylinders with the valve closed and the protective cap in place.

Do not use ICOMAS after the expiry date stated on the cylinder label.

6. Contents of the packaging and other information

What ICOMAS contains

The active substances are carbon monoxide (CO), acetylene (C₂H₂), and methane (CH₄).

The other components are nitrogen (N₂) and oxygen (O₂).

Appearance of the product and contents of the packaging

ICOMAS is a colourless, odourless, and tasteless gas.

Pharmaceutical form: medicinal compressed gas.

The shoulder (dome) of the cylinders has light green markings (inert gas). The body of the gas cylinder is white (medicinal gas).

Packaging (including materials) and valves:

• 10-litre aluminium cylinder with shut-off valve.
• 20-litre aluminium cylinder with shut-off valve.
• 40-litre aluminium cylinder with shut-off valve.
• 50-litre aluminium cylinder with shut-off valve.

Marketing Authorisation Holder and Manufacturing Responsible Person

Linde Sverige AB
Rättarvägen 3
169 68 Solna
Sweden

Manufacturer

Linde Gas AB
Baltzar von Platens gata 4-6
749 47 Enköping
Sweden

Date of the last revision of this leaflet: December 2024

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu/ <, and on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)}>.

The following information is intended exclusively for healthcare professionals:

Safety instructions

• Connect only to medical-grade connections.

• Keep the cylinder clean, dry, and free from grease and oil.

• Turn off/Disconnect the equipment when not in use.

• In case of fire, turn off/disconnect the equipment.

• The pressure regulator must be opened slowly and carefully.

• ICOMAS must only be used in well-ventilated areas.

• When the cylinder is in use, it must be properly secured.

• This product must not be used at pressures below 5 bar. This residual pressure protects the cylinder from potential contamination.

After use, the cylinder valve should be closed using normal manual force. Depressurize the regulator or connector.