Apulco HE 9% medicinal compressed gas
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Apulco He 9% medicinal compressed gas
Helium (He)
Read the entire leaflet carefully before you start using this medicinal gas, 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 or pharmacist.
- 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 may harm them.
- If you experience any adverse reactions, consult your doctor or pharmacist, even if they are adverse reactions not listed in this leaflet. See section 4.
Leaflet contents
- What Apulco He is and what it is used for
- What you need to know before using Apulco He
- How to use Apulco He
- Possible adverse effects
- How to store Apulco He
- Contents of the pack and other information
1. What Apulco He is and what it is used for
Apulco He is for diagnostic use only. It is used in various pulmonary function tests with helium and is employed to measure lung volume.
2. What you need to know before using Apulco He
Do not use Apulco He:
- Unless your doctor has requested that you undergo pulmonary function tests.
Warnings and precautions
Consult your doctor before starting to use Apulco He for pulmonary function testing.
Use of Apulco He with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Use of Apulco He with food, drinks and alcohol
When using Apulco He, you should not be in a condition that would prevent you from properly performing the pulmonary function test as instructed by your doctor or medical 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 He.
Driving and using machines
The use of Apulco He during pulmonary function tests should not affect your ability to drive or operate machinery.
3. How to use Apulco He
Inhale Apulco He only during diagnostic tests of lung function and exactly as directed by your doctor or healthcare provider. If in doubt, consult your doctor again.
Only your doctor or healthcare provider should decide the duration of the diagnostic lung function test and how often the test should be repeated.
4. Possible adverse effects
None have been documented.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. You may also report them directly through the 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 Apulco He
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 package and other information
Composition of Apulco He
The active substance is helium.
The other components are nitrogen and oxygen.
Appearance of Apulco He and contents of the package
Apulco He is an odorless, colorless gas supplied compressed in an aluminum gas cylinder.
The body of the gas cylinder is white and the upper part of the cylinder is light blue.
Package sizes in liters (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 | 918 | 0.918 |
10 | 200 | 1837 | 1.837 |
20 | 200 | 3673 | 3.673 |
40 | 200 | 7346 | 7.346 |
Marketing Authorization Holder
S.E. de Carburos Metálicos S.A.
Avda. de la Fama, 1
08940 Cornellà 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 He.
Germany: Apulco He.
Spain: Apulco He.
Portugal: Apulco He.
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.