Package leaflet: Information for the user

PulmoProDiff, 0.25% + 18%, medicinal gas, compressed
Carbon monoxide + Helium
Please read all of this leaflet carefully before the medicine is administered, because it contains
important information for the patient.

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 side effects, including any not listed in this leaflet, tell your doctor. See section 4.

Leaflet contents

What PulmoProDiff is and what it is used for
Important information before using PulmoProDiff
How to use PulmoProDiff
Possible side effects
How to store PulmoProDiff
Contents of the pack and other information

1. What PulmoProDiff is and what it is used for

PulmoProDiff is a medicinal gas intended solely for diagnostic testing of lung function.
It is used exclusively during diagnostic lung function tests: determination of diffusing capacity/transfer coefficient and lung volume.
The medicinal gas PulmoProDiff may be used only in patients capable of performing the test, regardless of age.

2. Important information before using PulmoProDiff

Do not use this medicinal gas:

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

Warnings and precautions
Before starting treatment with PulmoProDiff, discuss this with your doctor.
Patients with a history of coronary artery disease may be at risk of myocardial ischemia induced by carbon monoxide contained in the mixture.
Electrocardiographic signs (ECG) of ischemia include ST-segment depression.
Children
This medicinal gas should be used in children with caution due to the lack of data on systemic toxic effects of this mixture.
Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to become pregnant, she should consult her doctor before using this medicinal gas.
Driving and operating machinery
The use of this medicinal gas during lung function testing should not affect the ability to drive or operate machinery.

3. How to use PulmoProDiff

PulmoProDiff may only be used for conducting pulmonary function testing via inhalation and strictly according to the instructions of the physician or healthcare provider. If in doubt, consult your doctor or nurse.
The duration and frequency of the diagnostic lung testing are determined solely by the decision of the physician or healthcare provider.
Safety instructions

Smoking and open flames are not permitted in the room where medical gas is being used.

If you have any further doubts regarding the use of this medicine, consult your doctor or nurse.

4. Possible adverse reactions

When inhaling this medicinal gas as part of a lung function test, there is a very low probability of adverse reactions occurring, such as dizziness, chest pain, or a feeling of disorientation. If any such symptoms occur during administration of the medicinal gas, inhalation should be stopped immediately and appropriate pharmacological treatment initiated.

Reporting of adverse reactions
If any adverse symptoms occur in the patient, including any adverse reactions not listed in this leaflet, inform a physician or nurse immediately. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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

Adverse reactions may also be reported to the marketing authorization holder.
Reporting adverse reactions enables continuous monitoring of the drug’s safety and helps to provide more information on the safe use of the medicinal product.

5. How to store PulmoProDiff

Store the medical gas in a place out of sight and reach of children.
Do not use this medical gas after the expiry date stated on the gas cylinder after "Expiry date".
Do not dispose of the gas cylinder in household waste, but return it to the supplier.
This will help protect the environment.
Store at a temperature below 50°C.
Observe all regulations concerning the handling of pressure vessels.
Store in the original gas cylinder. Do not transfer the contents from the original gas cylinder to another container.
Store gas cylinders in well-ventilated indoor areas or outdoors in utility rooms with adequate ventilation, protecting them from rain and direct sunlight.
Protect gas cylinders from shocks, falls, oxidizing materials, flammable materials, moisture, and sources of heat or fire.
Keep different types of medical gases separated. Store full and empty gas cylinders separately.

6. Contents of the packaging and other information

What PulmoProDiff contains

The active substances in this medicinal product are carbon monoxide and helium.
The other components are oxygen and nitrogen.

What PulmoProDiff looks like and contents of the pack
PulmoProDiff is a colourless, odourless and tasteless compressed medical gas.
A 10-litre aluminium gas cylinder (clearly marked with a light green shoulder and white body), pressurized to 150 bar, equipped with a residual pressure valve made of brass and featuring a special outlet connector.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Messer Polska Sp. z o.o.
ul. Maciejkowicka 30
41-503 Chorzów
Poland
e-mail: [email protected]
Manufacturer
Messer Austria GmbH
Industriestraße 5
2352 Gumpoldskirchen
Austria
This medicinal product is authorised for sale in the Member States of the European Economic Area under the following names:
Netherlands, Austria, Germany, Poland, Romania and Spain: PulmoProDiff
Czech Republic: Zyplorin