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

Introduction

Package Leaflet: Information for the User

ICOMAS 0.3%/ 0.3%/ 0.3% Compressed Medical Gas

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

Read the entire package leaflet carefully before starting to use this medicine, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience side effects, ask your doctor or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What ICOMAS is and what it is used for
2. What you need to know before starting to use ICOMAS
3. How to use ICOMAS
4. Possible side effects
5. Storage of ICOMAS
6. Package Contents and Additional Information

1. What ICOMAS is and what it is used for

This medicinal product is for diagnostic use only in pulmonary function tests. ICOMAS should only be used in patients who are able to perform 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 may be pregnant, or plan to become pregnant, ask your doctor or nurse before taking this medicine.

ICOMAS should only be used during pregnancy when absolutely necessary.

ICOMAS can be used during breastfeeding.

3. How to use ICOMAS

ICOMAS should only be used for diagnostic tests of pulmonary function. You should follow the instructions given by your doctor or the nurse attending you exactly. If in doubt, ask your doctor or nurse again.

If you take more ICOMAS than you should

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

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

Safety Information

• ICOMAS is for medicinal use only.
• Smoking or igniting flames is not allowed in the room where this product is being used.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.

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

Reporting Side Effects

If you experience any side effects, ask your doctor or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/ or the European Medicines Agency website: http://www.ema.europa.eu/.

By reporting side 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 areas with restricted access, reserved for medical gases. Do not expose to high temperatures.

In case of fire, if possible, move the cylinders to a safe place. 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 expiration date stated on the cylinder label.

6. Package Contents and Additional 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 and Package Contents

ICOMAS is a colorless, odorless, and tasteless gas.

Pharmaceutical form: compressed medical gas.

The top (nose) of the cylinders has light green marks (inert gas). The body of the gas cylinder is white (medical gas).

Packages (including materials) and valves:

10-liter aluminum cylinder with a closing valve.

20-liter aluminum cylinder with a closing valve.

40-liter aluminum cylinder with a closing valve.

50-liter aluminum cylinder with a closing valve.

Marketing Authorization Holder and Manufacturer

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 Package Leaflet:December 2024

Detailed information on this medicine is available on the European Medicines Agency website: http://www.ema.europa.eu/ and on the Spanish Medicines and Healthcare Products Agency (AEMPS) website: http://www.aemps.gob.es/.

The following information is intended exclusively for healthcare professionals:

Safety Instructions

• Connect only to medical 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 should be opened slowly and with care.
• ICOMAS should only be used in well-ventilated areas.

• When the cylinder is in use, it should be properly secured.
• This product should not be used with a pressure lower than 5 bar. This residual pressure protects the cylinder from possible contamination.

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