Ficha técnica de Pulmoprodiff 0,25 %/18 % gas compriido medicinal – Espanha

Como usar Pulmoprodiff 0,25 %/18 % gas compriido medicinal

Introduction

Prospect: information for the user

PulmoProDiff 0.25%/ 18% medicinal compressed gas

carbon monoxide (CO)/helium (He)

Read this prospect carefully before starting to use this medication, because it contains important information for you.

Keep this prospect, as you may need to read it again.
If you have any doubts, consult your doctor or nurse.

-If you experience adverse effects, consult your doctor, even if they are not listed in this prospect. See section 4.

1.What PulmoProDiff is and what it is used for

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

3.How to administer PulmoProDiff

4.Possible adverse effects

5.Storage of PulmoProDiff

6.Contents of the package and additional information

1. What is PulmoProDriff and what is it used for

PulmoProDriff is a medicinal gas for exclusive use in the diagnosis of lung function. It is used during diagnostic tests of lung function: determination of diffusion capacity/transference factor and lung volume.

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

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

Do not use this medicinal gas:

Unless your doctor asks you to undergo pulmonary 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 a lack of data on systemic toxicity of this mixture.

Pregnancy and breastfeeding

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

Driving and operating machinery

The use of this medicinal gas during pulmonary function tests does not affect your ability to drive and operate machinery.

3. How PulmoProDiff is Administered

PulmoProDiff can only be used for functional respiratory tests by inhalation and exactly as your doctor or the responsible medical staff has instructed you. If you have any doubts, consult your doctor or the medical staff that attends to you.

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

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 medication, consult your doctor orthe medical staff that attends to you.

4. Possible Adverse Effects

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse,even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of PulmoProDiff

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

Do not use this medicinal gas after the expiration date that appears on the gas cartridge after CAD.

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

These measures will help to protect the environment.

Store below 50°C.

All regulations regarding the handling of pressurized containers must be followed.

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

Store gas cartridges indoors, in well-ventilated rooms orin outdoor areas under cover and protected from adverse weather conditions.

Protect gas cartridges from blows, falls, oxidizing and flammable materials, moisture, heat sources, or ignition sources.

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

6. Contents of the packaging and additional information

Composition of PulmoProDiff

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

Appearance of the product and contents of the packaging

PulmoProDiff is an incolored, odorless, and tasteless medicinal compressed gas.

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

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

Messer Ibérica de Gases S.A.U.

Autovía Tarragona-Salou, km. 3.8

E-43480, Vilaseca (Tarragona)

Spain

Responsible for manufacturing

Messer Austria GmbH

Industriestraße 5

2352 Gumpoldskirchen

Austria

This medicinal product is authorized in the EEA member states with the following names:

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

Zyplorin: Czech Republic

Last review date of this leaflet:

May 2023

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