Apulco Cohe 0.28%/9.5% medicinal compressed gas
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
Apulco CoHe 0.28%/9.5% medicinal compressed gas
Carbon monoxide (CO), helium (He)
Read this entire 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 should not give it to others, even if they have the same symptoms as you, because it could 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 CoHe is and what it is used for
- What you need to know before using Apulco CoHe
- How to use Apulco CoHe
- Possible side effects
- How to store Apulco CoHe
- Contents of the pack and other information
1. What Apulco CoHe is and what it is used for
Apulco CoHe is a medicinal gas used solely for diagnostic purposes. It is used during diagnostic tests of lung function: determination of diffusion capacity/transfer factor.
2. What you need to know before using Apulco CoHe
Do not use Apulco CoHe:
Unless your doctor has instructed 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 CoHe with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Use of Apulco CoHe with food, drinks and alcohol
When using Apulco CoHe, you should not be in a condition that would prevent you from properly performing the pulmonary function test as instructed by your doctor or healthcare personnel.
Pregnancy, breast-feeding and fertility
If you are pregnant or breast-feeding, think you may be pregnant or are planning to become pregnant, consult your doctor before inhaling Apulco CoHe.
Driving and using machines
Using Apulco CoHe during pulmonary function tests should not affect your ability to drive or operate machinery.
3. How to use Apulco CoHe
Inhale Apulco CoHe only during diagnostic tests of lung function and exactly as directed by your doctor or the medical staff attending you. If in doubt, consult your doctor again.
Only your doctor or the medical staff attending you should decide the duration of the diagnostic lung function test and how frequently the test should be repeated.
4. Possible adverse effects
During inhalation of Apulco CoHe 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 CoHe must be stopped immediately and medical treatment should be administered.
A venous blood sample may need to be drawn for blood gas analysis after inhalation of Apulco CoHe.
Reporting of 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 leaflet. You may also report them directly through 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 CoHe
Keep out of sight and reach of children.
Gas cartridges must be stored indoors 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 in the trash. Return it to your supplier. This will help protect the environment.
6. Contents of the pack and other information
What Apulco CoHe contains
The active substances are carbon monoxide and helium.
The other components are nitrogen and oxygen.
What Apulco CoHe looks like and contents of the pack
Apulco CoHe is an odourless, colourless compressed gas in aluminium gas cylinders.
The body of the gas cylinder is white and the top part of the gas cylinder is bright green.
Pack sizes in litres (200 bar): 5L, 10L, 20L and 40L.
Capacity in liters | Filling pressure (bar) | Gas liters | 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 Member States of the European Economic Area under the following names:
Netherlands: Apulco CoHe.
Germany: Apulco CoHe.
Spain: Apulco CoHe.
Portugal: Apulco CoHe.
Slovenia: Apulco CoHe.
Czech Republic: Apulco CoHe.
Date of the most recent review of this leaflet: March 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es.