PULMOPRODIFF 0.25%/18% MEDICINAL COMPRESSED GAS

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

PulmoProDiff 0.25%/18% 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, ask your doctor or nurse.

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

Leaflet contents

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

1. What PulmoProDriff is and what it is used for

PulmoProDriff is a medicinal gas for exclusive use in diagnosing lung function. It is used during pulmonary function tests: measurement of diffusion capacity/transfer factor and lung volume.

The medicinal gas PulmoProDiff may only be used in patients capable of performing the test, regardless of their age.

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

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 PulmoProDiff.

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 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 or operate machinery.

3. How PulmoProDiff is administered

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

Only your doctor or the responsible medical staff should decide the duration of the respiratory function test and how often the test should be repeated.

Safety instructions

Smoking and open flames are strictly 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 the medical personnel attending you.

4. Possible adverse effects

During inhalation of this medicinal gas in respiratory function tests, very unlikely side effects such as dizziness, chest pain, and disorientation may occur. If any symptom of this nature occurs 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 PulmoProDiff

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 in covered 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 pack and other information

Composition of PulmoProDiff

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

Appearance of the product and contents of the container

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

Aluminium gas cylinder of 10 litres (identified by a bright green shoulder and white body), filled to a pressure of 150 bar, equipped with a residual pressure valve made of copper and featuring 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 EEA Member States under the following names:

PulmoProDiff: Netherlands, Austria, Germany, Poland, Romania and Spain

Zyplorin: Czech Republic

Date of the most recent revision 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/)