OHECON 0.25%/10% MEDICINAL COMPRESSED GAS

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Ohecon 0.25% / 10% medicinal compressed gas

carbon monoxide (CO)/helium (He)

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, consult your doctor or nurse.

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

Leaflet contents

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

1. What Ohecon is and what it is used for

Ohecon is a medicinal gas for diagnostic use exclusively in pulmonary function testing. 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 capable of performing 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 requested that you undergo respiratory function tests.

Warnings and precautions

Consult your doctor before starting to use Ohecon.

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

Children

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

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or are planning 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 or operate machinery.

3. How Ohecon is administered

Ohecon may only be used for respiratory function testing by inhalation and exactly as directed by your doctor or the medical personnel in charge. If you have any doubts, consult your doctor or attending medical staff.

Only the doctor or responsible medical personnel should determine the duration of the respiratory function test and how frequently the test is repeated.

Safety instructions

Smoking and open flames are prohibited in the room where the medicinal gas is being used.

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

4. Possible adverse effects

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, 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 Ohecon

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

Do not use this medicinal gas after the expiry date stated on the gas cylinder after EXP.

Do not dispose of the container for 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 pressurized containers 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 under cover in outdoor areas, protected from adverse weather conditions.

Protect gas cylinders from impact, dropping, oxidizing and flammable materials, moisture, and sources of heat or ignition.

Different types of medicinal gases must be stored separately. Full and empty gas cylinders must be stored separately.

6. Contents of the package and other information

Composition of Ohecon

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

Appearance of the product and contents of the container

Ohecon is a colourless, odourless and tasteless medicinal compressed gas.

Aluminium gas cylinder of 10 litres (identified with a bright green shoulder 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 Authorisation Holder and Manufacturer

Marketing Authorisation 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 medicinal product is authorised in the EEA Member States under the following names:

PneumoXON: Netherlands, Austria, Germany, and Romania

Ohecon: Czech Republic, Poland and Spain

Date of the most recent review of this leaflet:

May 2023

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