Package leaflet: Information for the user

Lunploro 0.3%/0.3%/0.3% medicinal gas, compressed

carbon monoxide, methane, acetylene
Please read 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 their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reactions, contact your doctor or nurse. Such adverse reactions include those not listed in this leaflet. See section 4.

Contents of this leaflet

What Lunploro is and what it is used for
What you need to know before taking Lunploro
How to take Lunploro
Possible side effects
How to store Lunploro
Contents of the pack and other information

1. What Lunploro is and what it is used for

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

2. What you need to know before taking Lunploro

Do not take Lunploro

Unless your doctor has specifically requested that you undergo a lung function test.
If you are allergic to carbon monoxide, methane, and acetylene or to any of the other ingredients 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 Lunploro.
Your doctor will assess whether you have any contraindications to undergoing a lung 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.
During the test, a slight increase in blood carboxyhemoglobin concentration may occur.
Inhalation of carbon monoxide may cause symptoms of 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 medical treatment administered if necessary.

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

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

Lunploro with food, drinks 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 breastfeeding, consult your doctor before using this medicinal gas.
Lunploro should be used during pregnancy only if absolutely necessary.
Lunploro may be used during breastfeeding.

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

3. How to take Lunploro

Always inhale this medicinal gas exactly as instructed 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 is repeated must be determined solely by the doctor.
If you take more Lunploro 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 medicine, please consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everybody gets them.
Lunploro is not known to have side effects.

Reporting of side effects
If you experience any side effect, contact your doctor or nurse. These side effects also include those not listed in this leaflet. You may also report side effects directly through the national reporting system at the following address:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Lunploro

Keep this medicinal product out of the sight and reach of children.
Cylinders must be stored in a closed, well-ventilated area designated 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; return it to your supplier. This will help protect the environment.

6. Contents of the pack and other information

What Lunploro contains
The active substances are carbon monoxide, methane and acetylene.
The other excipients are oxygen and nitrogen.
What Lunploro 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.

Capacity in litres	Filling pressure (bar)	Gas volume in m3 (at 1 bar and 15°C)
10	150	1.49
11	150	1.64
20	150	2.99
50	150	7.47

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:
Lunploro: Austria, Belgium, Luxembourg, France, Spain, Portugal, Italy, Norway, Denmark, Sweden, Germany
Koolstofmonoxide / Methaan / Acetyleen Air Liquide: Netherlands
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 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 hand pressure. Depressurize the regulator or connector.