Veoplore 0.28%/14% medicinal compressed gas
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Veoplore 0.28 %/9.5 % medicinal compressed gas
Veoplore 0.28 %/14 % medicinal compressed gas
Carbon monoxide (CO)/ Helium (He)
Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.
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Keep this leaflet, as you may need to read it again.
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If you have any questions, ask your doctor or nurse.
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This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
- If you experience any kind of adverse reaction, consult your doctor or nurse, even if it is an adverse reaction not listed in this leaflet. See section 4.
Leaflet contents:
- What Veoplore is and what it is used for
- What you need to know before using Veoplore
- How to use Veoplore
- Possible side effects
- How to store Veoplore
- Contents of the pack and other information
1. What Veoplore is and what it is used for
This medicine is indicated for diagnostic use only.
It is used during pulmonary function tests and serves primarily to determine the lung's capacity to absorb inhaled gas into the bloodstream, and may additionally be used to determine lung volume.
Veoplore can only be used in patients capable of performing the test, regardless of age.
2. What you need to know before using Veoplore
Do not use Veoplore
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Unless your doctor has requested that you undergo pulmonary function testing.
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If you are allergic to helium or carbon monoxide, or to any of the other components of this medicine (listed in section 6).
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If you have signs and symptoms of carbon monoxide poisoning.
Warnings and precautions
Talk to your doctor before using Veoplore.
Your doctor will assess whether you have any contraindications to undergoing a pulmonary function test or any medical condition that might 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.
A small increase in blood carboxyhemoglobin concentration may occur during the test.
Inhalation of carbon monoxide may cause symptoms of reduced oxygen delivery, such as dizziness, chest pain, and disorientation. If any such symptoms occur, use of this product must be stopped immediately and medical treatment administered if necessary.
Children
This medicine should be used with caution in children. Consult your doctor or nurse before using this medicine.
Other medicines and Veoplore
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Veoplore with food, drinks and alcohol
Consult your doctor or nurse before using this medicine.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before using this medicinal gas.
Veoplore should only be used during pregnancy when absolutely necessary.
Veoplore may be used during breastfeeding.
Driving and using machines
Inhalation of this medicinal gas during pulmonary function testing should not affect your ability to drive or operate machinery.
3. How to use Veoplore
Always 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 how often the test should be repeated.
If you inhale more Veoplore than you should
Your doctor or nurse will take appropriate measures.
While inhaling this medicinal gas during a lung function test procedure, very unlikely symptoms related to the lung function test itself may occur, such as dizziness, chest pain, and disorientation. If any such symptoms occur during the test, inhalation of this medicinal gas must be stopped immediately and, if necessary, medical treatment administered. Toxicology Information Service, telephone: 91 562 04 20.
If you have any doubts about how to use this medicine, consult your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
No known adverse effects have been associated with the use of Veoplore.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is an effect not listed in this leaflet. You may also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Veoplore
Keep this medicine out of the sight and reach of children.
Store the cylinders in a restricted-access, well-ventilated area designated for medicinal gases.
The cylinders must be stored under cover, protected from adverse environmental conditions.
Do not use this medicinal gas after the expiry date stated on the label.
Do not use this medicine 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. Contents of the container and additional information
Composition of Veoplore
The active substances are carbon monoxide and helium.
The other excipients are oxygen and nitrogen.
Appearance of the product and contents of the container
It is an odourless, colourless, compressed gas in aluminium alloy cylinders.
The cylinder body is white and the top (shoulder) of the cylinder is green.
Veoplore 0.28 %/9.5 % medicinal compressed gas
Capacity in liters | Filling pressure (bar) | Gas volume in m3 (at 1 bar and 15 °C) |
10 | 200 | 1.97 |
11 | 200 | 2.17 |
20 | 200 | 3.94 |
50 | 200 | 9.84 |
Veoplore 0.28%/14% medicinal compressed gas
Capacity in liters | Filling pressure (bar) | Gas volume in m3 (at 1 bar and 15 °C) |
10 | 200 | 1.97 |
11 | 200 | 2.17 |
20 | 200 | 3.95 |
50 | 200 | 9.86 |
Some package sizes may not 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 medicinal product has been authorized in the Member States of the European Economic Area under the following names:
Veoplore: Austria, Denmark, Netherlands, Norway, Portugal, Spain, Sweden, Belgium, Luxembourg, Germany, Italy, France
Date of the most recent review of this leaflet: June 2024
"Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.es/"
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This information is intended for healthcare professionals only:
Safety instructions
- Connect the cylinder only to a connection intended for medical use.
- Keep the cylinder clean, dry, and free from oil or grease.
- Turn off the equipment when not in use.
- In case of fire, switch off the equipment.
- The pressure regulator must be opened slowly and carefully.
- Cylinders must only be used in well-ventilated areas.
- When in use, the cylinder must be properly secured.
- Cylinders should be returned with a minimum residual pressure, as this protects the cylinder from potential contamination.
- After use, close the cylinder valve using normal hand pressure. Depressurize the regulator or connector.