ICOMIX 0.28%/9.3% MEDICINAL COMPRESSED GAS

Introduction

Package Leaflet: Information for the User

ICOMIX 0.28%/ 9.3% Compressed Medical Gas

Carbon Monoxide (CO), Helium (He)

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

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

Contents of the Package Leaflet

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

1. What is ICOMIX and what is it used for

This medicinal product is for diagnostic use of lung function only. ICOMIX should only be used in patients who are able to perform the test, regardless of age.

2. What you need to know before you start using ICOMIX

Children and Adolescents

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

Pregnancy and Breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before using ICOMIX.

ICOMIX should only be used during pregnancy when absolutely necessary.

ICOMIX can be used during breast-feeding.

3. How to use ICOMIX

ICOMIX is for use only during diagnostic tests of lung function. You should follow the instructions of the medical staff attending you exactly. If in doubt, consult your doctor or nursing staff again.

If the dose of ICOMIX is higher than prescribed

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, shortness of breath, weakness, or other vague symptoms.

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

Safety Information

• ICOMIX 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 medicinal product, ask your doctor or nurse.

4. Possible Side Effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.

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

Reporting of Side Effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this package leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es

By reporting side effects, you can help provide more information on the safety of this medicinal product.

5. Storage of ICOMIX

Keep this medicinal product out of the sight and reach of children.

Store the cylinders in restricted access areas, 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 with the protective cap in place.

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

6. Contents of the Pack and Further Information

What ICOMIX contains

The active substances are carbon monoxide (CO) and helium (He).

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

Appearance and Packaging

ICOMIX is a colorless, odorless, and tasteless gas.

Pharmaceutical form: medicinal gas, compressed

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

Packaging (including materials) and valves:

10-liter aluminum cylinder with closing valve.

20-liter aluminum cylinder with closing valve.

40-liter aluminum cylinder with closing valve.

50-liter aluminum cylinder with closing valve.

Marketing Authorization Holder and Manufacturer

Linde Sverige AB

Rättarvägen 3

169 68 Solna

Sweden.

Date of last revision of this package leaflet:December 2024

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/).

The following information is intended for healthcare professionals only:

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.
• ICOMIX 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.