LUNPLORO 0.3%/0.3%/0.3% COMPRESSED MEDICAL GAS

Introduction

Package Leaflet:information for the user

Lunploro 0.3 %/0.3%/0.3% compressed medical gas

carbon monoxide (CO)/ methane (CH4)/ acetylene (C2H2)

Read the entire package leaflet carefully before starting to use this medication, as it containsimportant information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.

• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
  • If you experience side effects, consult your doctor or nurse, even if they are side effects not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Lunploro and what is it used for
2. What you need to know before taking
3. How to use Lunploro
4. Possible side effects
5. Storage of Lunploro
6. Package contents and additional information

1. What is Lunploro and what is it used for

This medication is indicated for diagnostic use only.

It is used during pulmonary function tests and serves to determine, mainly, the lung's ability to absorb the inhaled gas into the bloodstream, and it can also be used to measure lung volume and pulmonary blood flow.

Lunploro can only be used in patients who are capable of performing the test, regardless of age.

2. What you need to know before taking Lunploro

Do not use Lunploro

• Unless your doctor has requested that you undergo pulmonary function tests.
• If you are allergic to carbon monoxide, methane, or acetylene, or to any of the other components of this medication (listed in section 6).
• If you show signs and symptoms of carbon monoxide poisoning.

Warnings and precautions

Consult your doctor before using Lunploro.

Your doctor will assess whether you have any contraindications for undergoing a pulmonary function test or any disease that may pose a risk to you or interfere with the test.

During the test, you must follow the instructions given by the operator.

If you have a history of coronary artery disease, you may be at risk of ST segment depression (an abnormal electrocardiogram reading) caused by carbon monoxide.

During the test, there may be a slight increase in blood carboxyhemoglobin levels.

Inhaling carbon monoxide can cause symptoms of decreased oxygen supply, such as dizziness, chest pain, and disorientation. If any such symptoms occur, use of this product should be stopped immediately, and medical treatment should be administered if necessary.

Children

This medication should be used with caution in children. Consult your doctor or nurse before using this medication.

Other medications and Lunploro

Tell your doctor if you are taking, have recently taken, or may need to take any other medication.

Lunploro with food, drinks, and alcohol

Consult your doctor or nurse before using this medication.

Pregnancy, breastfeeding, and fertility

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

Lunploro should only be used during pregnancy when absolutely necessary.

Lunploro can be used during breastfeeding.

Driving and using machines

Inhaling this medicinal gas during pulmonary function tests should not affect your ability to drive and use machines.

3. How to use Lunploro

Always inhale this medicinal gas exactly as your doctor or nurse has instructed you, and only during the pulmonary function test. Consult your doctor or nurse if you are unsure.

Only your doctor can decide the duration of the pulmonary function test and the frequency of test repetition.

If you take more Lunploro than you should

Your doctor or nurse will take the necessary measures.

While inhaling this medicinal gas during a pulmonary function test procedure, there are very unlikely symptoms related to the pulmonary function test itself, such as dizziness, chest pain, and disorientation. If any such symptoms occur during the test, inhalation of this medicinal gas should be stopped immediately, and medical treatment should be administered if necessary. Toxicology Information Service, phone: 91 562 04 20

If you have any questions about using this medication, consult your doctor or nurse.

4. Possible side effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

No known side effects have been associated with the use of Lunploro.

Reporting side effects

If you experience any side effects, consult your doctor or nurse, even if they are possible side effects not listed in this package leaflet. You can also report them directly through the national reporting system: Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Lunploro

Keep this medication out of the sight and reach of children.

Store the cylinders in a restricted access area with good ventilation, reserved for medicinal gases.

The cylinders should be stored indoors, protected from adverse environmental conditions.

Do not use this medicinal gas after the expiration date shown on the label.

Do not use this medication if you notice any signs of deterioration of the valve or cylinder.

Do not dispose of this medicinal gas; return it to the supplier. These measures will help protect the environment.

6. Package contents and additional information

Composition of Lunploro

The active ingredients are carbon monoxide, methane, and acetylene.

The other excipients are oxygen and nitrogen.

Appearance and package contents

It is a colorless and odorless gas, compressed in aluminum alloy cylinders.

The body of the cylinder is white, and the top part (nose) of the cylinder is green.

Only some package sizes may be 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 medication has been 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, Netherlands

Date of last revision of this package leaflet: June 2024.

“Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.es/”.

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This information is intended only for healthcare professionals:

Safety instructions

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