Apulco cohe 0,28%/9,5% gas comprimido medicinal
Introduction
Leaflet: information for the user
Apulco CoHe 0.28%/9.5% medicinal compressed gas
Carbon monoxide (CO), helium (He)
Read this leaflet carefully before you start using this medicine, because 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 must not give it to others even if they have the same symptoms as you, as it may harm them.
- If you experience any side effects, consult your doctor, even if they are not listed in this leaflet. See section 4.
1. What isApulco CoHeand what it is used for
2. What you need to know before starting to useApulco CoHe
3. How to useApulco CoHe
4. Possible side effects
5. Storage ofApulco CoHe
6. Contents of the pack and additional information
1. What is Apulco CoHe and what is it used for
Apulco CoHe 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.
2. What you need to know before starting to use Apulco CoHe
Do not use Apulco CoHe:
Unless your doctor asks you to undergo pulmonary function tests.
Warnings and precautions
Consult your doctor before starting to use Apulco CoHe for pulmonary function tests.
Use of Apulco CoHewith other medications
Inform your doctor if you are using, have used recently, or may need to use any other medication.
Use of Apulco CoHewith food, drinks, and alcohol
When using Apulco CoHe, you should not be in a state that would prevent you from performing the pulmonary function test correctly according to your doctor's or healthcare 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 CoHe.
Driving and operating machinery
The use of Apulco CoHe during pulmonary function tests should not affect your ability to drive and operate machinery.
3. How to Use Apulco CoHe
Inhale Apulco CoHe 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.
4. Possible Adverse Effects
During inhalation of Apulco CoHe 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, inhalation of Apulco CoHe 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 CoHe.
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 of Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.
5. Conservation of Apulco CoHe
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.
6. Contents of the packaging and additional information
What Apulco CoHe contains
The active principles are carbon monoxide and helium.
The other components are nitrogen and oxygen.
Appearance of Apulco CoHe and contents of the packaging
Apulco CoHe is an odorless and colorless compressed gas in aluminum gas capsules.
The body of the gas capsule is white and the top of the gas capsule is bright green.
Packaging 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
S.E. de Carburos Metálicos S.A.
Avda. de la Fama, 1
08940 Cornella de Llobregat
Spain
Responsible for Manufacturing
S.E. de Carburos Metálicos S.A.
Pol. Nord-Este 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 CoHe.
Germany: Apulco CoHe.
Spain: Apulco CoHe.
Portugal: Apulco CoHe.
Slovenia: Apulco CoHe.
Czech Republic: Apulco CoHe.
Last review date of this leaflet: March 2021
Detailed 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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