OHECON 0.25 %/10 % MEDICINAL COMPRESSED GAS

Introduction

Package Leaflet: Information for the User

Ohecon 0.25%/ 10% Compressed Medical Gas

Carbon Monoxide (CO) / Helium (He)

Read this 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, consult your doctor, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

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

1. What Ohecon is and what it is used for

Ohecon is a medical gas for diagnostic use only for lung function. It is used during diagnostic tests of lung function: determination of diffusion capacity / transfer factor and lung volume.

The medicinal gas Ohecon can only be used in patients who are able to perform the test, regardless of their age.

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

Do not use this medicinal gas:

Unless your doctor has asked you to undergo respiratory function tests.

Warnings and Precautions

Consult your doctor before starting to use Ohecon.

If you have a history of coronary arteriopathy, you may be at risk of myocardial ischemia caused by carbon monoxide, as indicated by changes in the ECG (ST segment descent).

Children

This medicinal gas should be used with caution in children due to the lack of data on the systemic toxicity of this mixture.

Pregnancy and Breastfeeding

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

Driving and Using Machines

The use of this medicinal gas during respiratory function tests does not affect the ability to drive and use machines.

3. How to Administer Ohecon

Ohecon can only be used for respiratory function tests by inhalation and exactly as your doctor or the medical staff responsible has indicated. If you have any doubts, consult your doctor or the medical staff attending you.

Only the doctor or the medical staff responsible should decide the duration of the respiratory function test and the frequency of repetition of the test.

Safety Instructions

Smoking or lighting open flames is not allowed in the room where the medicinal gas is being used.

If you have any doubts about the use of this medicine, consult your doctor or the medical staff attending you.

4. Possible Side Effects

During inhalation of this medicinal gas during respiratory function tests, very unlikely side effects such as dizziness, chest pain, and disorientation may occur. If any symptoms of this nature occur during the use of the medicinal gas, inhalation should be suspended immediately and medical treatment should be administered.

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

5. Storage of Ohecon

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

Do not use this medicinal gas after the expiration date shown on the gas cylinder after CAD.

Do not dispose of the container of this medicinal gas; return it to the supplier.

These measures will help protect the environment.

Store below 50°C.

All regulations regarding the handling of pressure vessels must be followed.

Store in the original gas cylinder. Do not transfer the contents of the original gas cylinder to another gas cylinder.

Store gas cylinders indoors, in well-ventilated rooms or outdoors under cover and protected from adverse weather conditions.

Protect gas cylinders from impacts, falls, oxidizing and flammable materials, humidity, heat sources, or ignition.

Different types of medicinal gas should be separated from each other. Full and empty gas cylinders should be stored separately.

6. Package Contents and Additional Information

Composition of Ohecon

• The active ingredients are carbon monoxide and helium.
• The other components are nitrogen and oxygen.

Appearance of the Product and Package Contents

Ohecon is a colorless, odorless, and tasteless compressed medical gas.

10-liter aluminum gas cylinder (identified with a bright green tip and white body) filled to a pressure of 150 bar, equipped with a residual pressure valve made of copper with a specific outlet connection.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Messer Ibérica de Gases S.A.U.

Autovía Tarragona-Salou, km. 3.8

E-43480, Vilaseca (Tarragona)

Spain

Manufacturer

Messer Austria GmbH

Industriestraße 5

2352 Gumpoldskirchen

Austria

This medicine is authorized in the EEA member states under the following names:

PneumoXON: Netherlands, Austria, Germany, and Romania

Ohecon: Czech Republic, Poland, and Spain

Date of the Last Revision of this Package Leaflet:

May 2023

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