Lunploro 0.3%/0.3%/0.3% medicinal compressed gas
Spain
Table of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Lunploro 0.3%/0.3%/0.3% medicinal compressed gas
carbon monoxide (CO)/ methane (CH4)/ acetylene (C2H2)
Read the entire leaflet carefully before you start using this medicine, as 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, consult 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, as it may harm them.
- If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents:
- What Lunploro is and what it is used for
- What you need to know before using Lunploro
- How to use 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
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. It may also be used to measure lung volume and pulmonary blood circulation.
Lunploro can only be used in patients capable of performing the test, regardless of age.
2. What you need to know before using Lunploro
Do not use Lunploro
- Unless your doctor has requested that you undergo pulmonary function testing.
- If you are allergic to carbon monoxide, methane, or acetylene, or to any of the other components of this medicine (listed in section 6).
- If you are experiencing 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 to undergoing a pulmonary function test, or any medical condition that could pose a risk to you or interfere with the test.
During the test, you must follow all 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) induced 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 supply, 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
Lunploro should be used with caution in children. Consult your doctor or nurse before using this medicine.
Other medicines and Lunploro
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Lunploro 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.
Lunploro should only be used during pregnancy if absolutely necessary.
Lunploro may be used during breastfeeding.
Driving and using machines
Inhalation of this medicinal gas during pulmonary function tests should not affect your ability to drive or operate machinery.
3. How to use Lunploro
Always inhale this medicinal gas exactly as directed by your doctor or nurse 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 frequently the test should be repeated.
If you inhale more Lunploro than you should
Your doctor or nurse will take appropriate measures.
While inhaling this medicinal gas during a lung function test procedure, symptoms related to the lung function test itself are very unlikely, 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 medical treatment administered if necessary. 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 Lunploro.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly through the national reporting system: Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Lunploro
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 in the environment; return it to the supplier. These measures will help protect the environment.
6. Contents of the pack and other information
Composition of Lunploro
The active substances 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 odourless, colourless gas, compressed in aluminium alloy cylinders.
The cylinder body is white and the top (shoulder) of the cylinder is green.
Capacity in liters | 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 |
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 European Economic Area Member States under the following names:
Lunploro: Austria, Belgium, Luxembourg, France, Spain, Portugal, Italy, Norway, Denmark, Sweden, Germany, Netherlands
Date of the most recent review of this summary: 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 and 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.
- Cylinders must only be used 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 against potential contamination.
- After use, close the cylinder valve using normal manual pressure. Depressurize the regulator or connector.