Prospecto:information for the user

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

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

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or nurse.

-This medication has been prescribed only to you, and you should not give it to other people even if they have the same symptoms as you, as it may harm them.

• If you experience any adverse effects, consult your doctor or nurse,even if they are not listed in this prospectus. See section 4.

1.What is Lunploro and what is it used for

2.What you need to know before starting to use

3.How to use Lunploro

4.Possible adverse effects

5.Storage of Lunploro

6.Contents of the package and additional information

This medication is indicated only for diagnostic use.

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

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

Do not use Lunploro

• Unless your doctor requests 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 present signs and symptoms of carbon monoxide poisoning.

Warnings and precautions

Consult your doctor before using Lunploro.

Your doctor will evaluate if you have any contraindications for performing a pulmonary function test or any disease that may pose a risk to you or interfere with the test.

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

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

During the test, a small increase in carboxyhemoglobin blood concentration may occur.

Inhalation of carbon monoxide may cause symptoms of reduced oxygen supply, such as dizziness, chest pain, and disorientation. If any of these symptoms occur, immediately stop using this product and, if necessary, administer medical treatment.

Children

Use this medication with caution in children. Consult your doctor or nurse before using this medication.

Other medications and Lunploro

Inform your doctor if you are taking, have taken recently, 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 operating machines

Inhalation of this medicinal gas during pulmonary function tests should not affect your ability to drive and operate machines.

Inhale this medicinal gas exactly as your doctor or nurse has instructed you and only during the lung function test. Consult your doctor or nurse if you are unsure.

Only your doctor can decide the duration of the lung function test and the frequency of repeating the test.

If you take more Lunploro than you should

Your doctor or nurse will take the necessary measures.

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

If you have any doubts about the use of this medication, consult your doctor or nurse.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

No known adverse effect has been associated with the use of Lunploro.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse,even if it is about possible adverse effects that do not appear in this prospectus.You can also report them directly through the national notification system: Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

Store the cartridges in a restricted access area with good ventilation, designated for medicinal gases.

Cartridges should be stored under cover, 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 observe any sign of valve or cartridge deterioration.

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

Composition of Lunploro

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

The other excipients are oxygen and nitrogen.

Appearance of the product and contents of the container

It is an odorless and colorless gas, compressed in aluminum alloy balls.

The body of the ball is white and the top (nose) of the ball is green.

Only some sizes of containers may be commercially available.

Marketing Authorization Holder

AIR LIQUIDE SANTE INTERNATIONAL

75 Quai d’Orsay

75007 Paris

FRANCE

Responsible for manufacturing

AIR LIQUIDE MEDICAL

Tolhuisstraat 46

2627 Schelle

BELGIUM

This medicinal product has been authorized in the Member States of the European Economic Area with the following names:

Lunploro: Austria, Belgium, Luxembourg, France, Spain, Portugal, Italy, Norway, Denmark, Sweden, Germany, Netherlands

Last review date of this leaflet: June 2024.

“Detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.es/”.

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This information is intended solely for healthcare professionals:

Security instructions

• Connect the ball only to a connection intended for medical use.

• Keep the ball clean,dryand free of oil or 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.

• Only use the balls in well-ventilated areas.

• When using the ball,,it must be properly secured.

• The balls with a minimum residual pressure will be returned, as it protects the ball from possible contaminations.

• After use, the valve of the ball must be closed using normal manual pressure. Depressurize the regulator or connector.