Pulmoprodiff

PATIENT INFORMATION LEAFLET

Leaflet accompanying the packaging: information for the user

PulmoProDiff, 0.25% + 18%, medical gas, compressed
Carbonei monoxidum + Helium

You should carefully read the contents of this leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so you can read it again if you need to.
• If you have any doubts, you should consult a doctor or nurse.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor. See section 4.

Table of contents of the leaflet

• 1. What is PulmoProDiff and what is it used for
• 2. Important information before using PulmoProDiff
• 3. How to use PulmoProDiff
• 4. Possible side effects
• 5. How to store PulmoProDiff
• 6. Contents of the packaging and other information

1. What is PulmoProDiff and what is it used for

PulmoProDiff is a medical gas intended exclusively for diagnostic tests of lung function.
It is used exclusively during diagnostic tests of lung function: determination of diffusing capacity/coefficient of transfer and lung volume.
The medical gas PulmoProDiff may be used exclusively in patients who are able to perform the test, regardless of age.

2. Important information before using PulmoProDiff

This medical gas should not be used:

• unless a doctor has recommended that the patient undergo lung function tests.

Warnings and precautions

Before starting to use PulmoProDiff, you should discuss it with your doctor.
Patients with a history of coronary artery disease may be at risk of myocardial ischemia caused by the carbon monoxide contained in the mixture. This ischemia is indicated by changes in the ECG (ST segment depression).

Children

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

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult a doctor before using this medical gas.

Driving and operating machinery

Using this medical gas during lung function tests should not affect the ability to drive vehicles and operate machinery.

3. How to use PulmoProDiff

PulmoProDiff may be used exclusively for the purpose of conducting a lung function test by inhalation and exactly as recommended by a doctor or the medical staff caring for the patient. In case of doubts, you should consult a doctor or nurse.
The duration of the diagnostic lung test and the frequency of its repetition depend solely on the decision of the doctor or the medical staff caring for the patient.

Safety instructions

• Smoking and the presence of open flames are not allowed in the room where the medical gas is used.

In case of any further doubts related to the use of this medicine, you should consult a doctor or nurse.

4. Possible side effects

During inhalation of this medical gas as part of a lung function test, there is a very low probability of side effects in the form of dizziness, chest pain, and disorientation. If any symptoms of this type occur during the use of the medical gas, you should immediately stop inhaling the medical gas and apply pharmacological treatment.

Reporting side effects

If the patient experiences any side effects, including any side effects not listed in this leaflet, they should inform their doctor or nurse. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C
PL-02 222 Warsaw
Phone: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will allow for the collection of more information on the safety of the medicine.

5. How to store PulmoProDiff

Store the medical gas in a place out of sight and out of reach of children.
Do not use this medical gas after the expiration date stated on the gas cylinder after "Expiration date".
Do not dispose of the gas cylinder, but return it to the supplier.
This will help protect the environment.
Store at a temperature below 50°C.
Follow all regulations regarding the handling of pressure vessels.
Store in the original gas cylinder. Do not transfer the contents from the original gas cylinder to another.
Store gas cylinders in well-ventilated rooms inside buildings or outside in utility rooms with adequate ventilation, protecting them from rain and direct sunlight.
Protect the gas cylinders from shocks, falls, oxidizing materials, and flammable materials, moisture, heat sources, or fire.
Keep different types of medical gases separate. Full and empty gas cylinders should be stored separately.

6. Contents of the packaging and other information

What PulmoProDiff contains

• The active substances of the medicine are carbon monoxide and helium.
• The other ingredients are oxygen and nitrogen.

What PulmoProDiff looks like and what the packaging contains

PulmoProDiff is a colorless, odorless, and tasteless medical gas, compressed.
A 10-liter aluminum gas cylinder (marked with a light green edge and a white body) filled under pressure of 150 bar, equipped with a residual pressure valve made of brass with a special outlet connector.

Marketing authorization holder and manufacturer

Marketing authorization holder

Messer Polska Sp. z o.o.
ul. Maciejkowicka 30
41-503 Chorzów
Poland
e-mail: kontakt.pl@messergroup.com

Manufacturer

Messer Austria GmbH
Industriestraße 5
2352 Gumpoldskirchen
Austria

This medicinal product is authorized for sale in the Member States of the European Economic Area under the following names:

National authorization numbers and names:

Netherlands, Austria, Germany, Poland, Romania, and Spain: PulmoProDiff
Czech Republic: Zyplorin

Date of last update of the leaflet: