Veoplore

Package leaflet: Information for the user

VEOPLORE 9.5%/0.28% medicinal gas, compressed, 14%/0.28% medicinal gas, compressed

helium, carbon monoxide
Please read all of this leaflet carefully before taking this medicine because it contains
important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not give it to other people, even if they have the same symptoms as yours, because it may be harmful.
• If you experience any adverse reaction, contact your doctor or nurse. Such adverse reactions include those not listed in this leaflet. See section 4.

Contents of this leaflet

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

1. What VEOPLORE is and what it is used for

VEOPLORE is indicated for diagnostic use only.
It is used during pulmonary function testing and primarily measures the lung's ability to absorb inhaled gas into the bloodstream, and may also be used to measure lung volume.
VEOPLORE may only be used in patients capable of performing the test, regardless of age.

2. What you need to know before taking VEOPLORE

Do not take VEOPLORE
Unless your doctor has specifically requested that you undergo a pulmonary function test.

• If you are allergic to helium and carbon monoxide or to any of the other components of this medicine (listed in section 6).
• If you have signs and symptoms of carbon monoxide poisoning.

Warnings and precautions
Talk to your doctor before taking VEOPLORE.
Your doctor will assess whether you have any contraindications to undergoing a pulmonary function test or any medical conditions that might put you at risk or interfere with the test.
During the test, you must follow the instructions given by the operator.
Patients with a history of coronary artery disease may be at risk of ST-segment depression (an abnormal electrocardiogram reading) induced by carbon monoxide.
A slight increase in blood carboxyhemoglobin concentration may occur during the test.
Inhalation of carbon monoxide may cause symptoms related to reduced oxygen supply, such as mild confusion, chest pain, and dizziness. If any such symptoms occur, use of this product must be immediately discontinued and, if necessary, appropriate medical treatment should be administered.

Children
This product should be used with caution in children. Please consult your doctor or nurse before taking this medicine.

Other medicines and VEOPLORE
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.

VEOPLORE with food, beverages and alcohol
Please consult your doctor or nurse before taking this medicine.

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or are breastfeeding, consult your doctor before using this medicinal gas.
VEOPLORE should be used during pregnancy only if absolutely necessary.
VEOPLORE may be used during breastfeeding.

Driving and using machines
Inhalation of this medicinal gas during pulmonary function tests should not affect the ability to drive or operate machinery.

3. How to take VEOPLORE

Always inhale this medicinal gas exactly as directed by your doctor or nurse and only during the lung function test. If you have any doubts, consult your doctor or nurse.
The duration of the lung function test and how often it should be repeated must be determined solely by the doctor.
If you take more VEOPLORE than you should
Your doctor or nurse will take appropriate measures.
During inhalation of this medicinal gas as part of a lung function test, symptoms may occur that are very unlikely related to the procedure itself, such as mild confusion, chest pain, and dizziness. If any of these symptoms occur during the test, inhalation of this medicinal gas must be immediately stopped and, if necessary, appropriate medical treatment must be administered.
If you have further questions about the use of this medicinal product, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone gets them.
VEOPLORE is not known to have side effects.
Reporting of side effects
If you experience any side effect, talk to your doctor or nurse. These side effects also include those not listed in this leaflet. You can also report side effects directly via the
. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store VEOPLORE

Keep this medicinal product out of the sight and reach of children.
Cylinders must be stored in a closed, well-ventilated area reserved for medicinal gases.
Cylinders must be stored indoors, protected from adverse weather conditions.
Do not use this medicinal gas after the expiry date stated on the label.
Do not use this medicinal product if you notice any signs of deterioration of the valve or cylinder.
Do not dispose of this medicinal gas; instead, return it to your supplier. This will help protect the environment.

6. Package contents and other information

What VEOPLORE contains
The active substances are helium and carbon monoxide.
The other excipients are oxygen and nitrogen.
What VEOPLORE looks like and contents of the pack
It is an odourless, colourless gas, compressed in aluminium cylinders.
The cylinder body is white and the cylinder shoulder is green.
VEOPLORE 9.5%/0.28% medicinal gas, compressed:

Elio / Carbon monoxide Air Liquide 14%/0.28% medicinal gas, compressed:

It is possible that not all pack sizes are marketed.
Marketing Authorization Holder
AIR LIQUIDE SANTE INTERNATIONAL
75 Quai d'Orsay
75007 Paris
FRANCE
Manufacturer
AIR LIQUIDE MEDICAL
Tolhuisstraat 46
2627 Schelle
BELGIUM
This medicinal product is authorized in the Member States of the European Economic Area under the following
names:
Pulmixal: Austria, Denmark, Netherlands, Norway, Portugal, Spain, Sweden
Hélium / Monoxyde de carbone Air Liquide Santé International: Belgium, Luxembourg
Helium / Kohlenmonoxid Air Liquide: Germany
VEOPLORE: Italy
Hélium / Monoxyde de carbone Air Liquide France
This leaflet was last updated {MM/YYYY}.
[To be completed at national level]
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The following information is intended exclusively for healthcare professionals:
Safety instructions

• Connect only to a supply intended for medical use.
• Keep the cylinder clean, dry, and free from oil and grease.
• Turn off the equipment when not in use.
• In case of fire, turn off the equipment.
• The pressure regulator must be opened slowly and carefully.
• Cylinders must be used only in well-ventilated areas.
• When in use, the cylinder must be properly secured.
• Cylinders must be returned with a minimum residual pressure, as this protects the cylinder from contamination.
• After use, close the cylinder valve with normal manual force. Depressurize the regulator or connector.