Prospecto:Information for the User

Veoplore0.28 %/9.5 % Medical Compressed Gas

Veoplore0.28 %/14Medical Compressed Gas

Carbon Monoxide (CO)/ Helium (He)

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 others, even if they have the same symptoms as you, as it may harm them.

• If you experience any type of adverse effect, consult your doctor or nurse,even if it is an adverse effect that does not appear in this prospectus. See section 4.

1.What is Veoplore and what it is used for

2.What you need to know before starting to use

3.How to use Veoplore

4.Possible adverse effects

5.Storage of Veoplore

6.Contents of the package and additional information

This medicationis 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 determine lung volume.

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

Do not use Veoplore

• Unless your doctor requests that you undergo pulmonary function tests.

• If you are allergic to helium or carbon monoxide, 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 Veoplore.

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 Veoplore

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

Veoplore 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 intend to become pregnant, consult your doctor before using this medicinal gas.

Veoplore should only be used during pregnancy when absolutely necessary.

Veoplore 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 Veoplore 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 feeling disoriented. If any of these symptoms occur during the test, the inhalation of this gas should be stopped immediately and, if necessary, medical treatment should be administered.Toxicological 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 Veoplore.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or nurse,even if it is an adverse effect thatdoes 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 an area with restricted access and good ventilation, designated for medicinal gases.

The cartridges must 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.

Veoplore Composition

The active principles are carbon monoxide and helium.

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.

Veoplore 0.28%/9.5% medicinal compressed gas

Veoplore 0.28%/14% medicinal compressed gas

Only some sizes of packaging 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:

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

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:

Safety instructions

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

• Keep the ball clean, dry and 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.