1. What isApulco CoHeMaxand what it is used for
2. What you need to know before starting to useApulco CoHeMax
3. How to useApulco CoHeMax
4. Possible side effects
5. Storage ofApulco CoHeMax
6. Contents of the pack and additional information
Apulco CoHeMax isa medicinal gas that is only used for diagnostic purposes. It is used during diagnostic tests of lung function: determination of diffusion capacity/transference factor.
Do not use Apulco CoHeMax:
Warnings and precautions
Consult your doctor before starting to use Apulco CoHeMax for pulmonary function tests.
Using Apulco CoHeMax with other medications
Inform your doctor if you are using, have used recently, or may need to use any other medication.
Using Apulco CoHeMax with food, drinks, and alcohol
When using Apulco CoHeMax, you should not be in a state that would prevent you from performing the pulmonary function test correctly according to your doctor's or medical staff's instructions.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor before inhaling Apulco CoHeMax.
Driving and operating machinery
The use of Apulco CoHeMax during pulmonary function tests should not affect your ability to drive and operate machinery.
Inhale Apulco CoHeMax only during pulmonary function tests and exactly as your doctor or the medical staff attending to you have instructed. If in doubt, consult your doctor again.
Only your doctor or themedicalstaff attending to you should decide the duration of the pulmonary function test and the frequency of repeating the test.
During inhalation of Apulco CoHeMax in pulmonary function tests, possible adverse effects may include dizziness, chest pain, and a feeling of disorientation, although this is very rare. If any of these symptoms appear while using the medicinal gas, Apulco CoHeMax inhalation should be stopped immediately and medical treatment should be administered.
You may need to have a blood sample taken for blood gas analysis after inhaling Apulco CoHeMax.
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is an adverse effect not listed in this prospectus. You can also report them directly through the 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 out of sight and reach of children.
Gas cartridges should be stored under cover and protected from adverse weather conditions.
Do not use this medicinal gas after the expiration date shown on the label.
Do not dispose of this medicinal gas. Return it to the supplier. This will help protect the environment.
What Apulco CoHeMax contains
The active principles are carbon monoxide and helium.
The other components are nitrogen and oxygen.
Appearance of Apulco CoHeMax and contents of the packaging
Apulco CoHeMax is a colorless and odorless compressed gas in aluminum gas cartridges.
The body of the gas cartridge is white and the top of the gas cartridge is bright green.
Container sizes in liters (200 bar): 5L, 10L, 20L, and 40L.
Capacity in liters | Filling pressure (bar) | Volume of gas | m3of gas at 1 bar and 15°C |
5 | 200 | 904 | 0.904 |
10 | 200 | 1808 | 1.808 |
20 | 200 | 3615 | 3.615 |
40 | 200 | 7231 | 7.231 |
Marketing authorization holder
SE of Carburos Metálicos S.A.
Avenida de la Fama, 1
08940 Cornella de Llobregat
Spain
Responsible manufacturer
SE of Carburos Metálicos S.A.
Nord-East Industrial Estate C-35, km59
08470 Sant Celoni
Spain
This medicinal product is authorized in the Member States of the European Economic Area with the following names:
Netherlands: Apulco CoHeMax.
Germany: Apulco CoHeMax.
Spain: Apulco CoHeMax.
Portugal: Apulco CoHeMax.
Slovenia: Apulco CoHeMax.
Czech Republic: Apulco CoHeMax.
Last review date of this leaflet: March 2021
Further information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.
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