Apulco CoheMax 0.28%/14% medicinal compressed gas
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Apulco CoHeMax 0.28%/14% medicinal compressed gas
Carbon monoxide (CO), helium (He)
Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.
- Keep this leaflet, as you may need to read it again. If you have any questions, consult your doctor.
- 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 adverse effects, consult your doctor, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
- What Apulco CoHeMax is and what it is used for
- What you need to know before using Apulco CoHeMax
- How to use Apulco CoHeMax
- Possible adverse effects
- How to store Apulco CoHeMax
- Contents of the pack and other information
1. What Apulco CoHeMax is and what it is used for
Apulco CoHeMax is a medicinal gas used exclusively for diagnostic purposes. It is used during diagnostic tests of lung function: measurement of diffusion capacity/transfer factor.
2. What you need to know before using Apulco CoHeMax
Do not use Apulco CoHeMax:
- Unless your doctor has instructed you to undergo pulmonary function tests.
Warnings and precautions
Consult your doctor before starting to use Apulco CoHeMax for pulmonary function tests.
Use of Apulco CoHeMax with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Use of Apulco CoHeMax with food, beverages, and alcohol
When using Apulco CoHeMax, you should not be in a condition that would prevent you from properly performing the pulmonary function test as directed by your doctor or healthcare personnel.
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 inhaling Apulco CoHeMax.
Driving and use of machines
Using Apulco CoHeMax during pulmonary function testing should not affect your ability to drive or operate machinery.
3. How to use Apulco CoHeMax
Inhale Apulco CoHeMax only during pulmonary function diagnostic tests and exactly as directed by your doctor or healthcare provider. If in doubt, consult your doctor again.
Only your doctor or healthcare provider should determine the duration of the pulmonary function diagnostic test and how frequently the test should be repeated.
4. Possible adverse effects
During inhalation of Apulco CoHeMax in pulmonary function tests, adverse effects such as dizziness, chest pain, and a sensation of disorientation may occur, although these are very rare. If any of these symptoms appear while using the medicinal gas, inhalation of Apulco CoHeMax must be stopped immediately and medical treatment should be administered.
A venous blood sample may need to be taken for blood gas analysis after inhalation of Apulco CoHeMax.
Reporting of adverse effects
If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet. You may also report them directly via the 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 Apulco CoHeMax
Keep out of sight and reach of children.
Gas cartridges must be stored under cover and protected from adverse weather conditions.
Do not use this medicinal gas after the expiry date stated on the label.
Do not dispose of this medicinal gas. Return it to your supplier. This will help protect the environment.
6. Contents of the package and other information
What Apulco CoHeMax contains
The active substances are carbon monoxide and helium.
The other components are nitrogen and oxygen.
Appearance of Apulco CoHeMax and contents of the pack
Apulco CoHeMax is an odourless, colourless compressed gas in aluminium gas cylinders.
The cylinder body is white and the upper part of the cylinder is bright green.
Package sizes in litres (200 bar): 5L, 10L, 20L and 40L.
Capacity in liters | Filling pressure (bar) | Liters of gas | m3 of 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
S.E. de Carburos Metálicos S.A.
Avda. de la Fama, 1
08940 Cornella de Llobregat
Spain
Manufacturer Responsible for Batch Release
S.E. de Carburos Metálicos S.A.
Pol. Nord-Este C-35, km 59
08470 Sant Celoni
Spain
This medicinal product is authorized in the European Economic Area member states under the following names:
Netherlands: Apulco CoHeMax.
Germany: Apulco CoHeMax.
Spain: Apulco CoHeMax.
Portugal: Apulco CoHeMax.
Slovenia: Apulco CoHeMax.
Czech Republic: Apulco CoHeMax.
Date of latest revision of this leaflet: March 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es.