Apulco Heoxy 9% medicinal compressed gas
Spain
Table of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Apulco HeOxy 9% medicinal compressed gas
Helium (He)
Read all of 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, ask 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 could harm them.
- If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.
Contents of the leaflet
- What Apulco HeOxy is and what it is used for
- What you need to know before using Apulco HeOxy
- How to use Apulco HeOxy
- Possible adverse effects
- How to store Apulco HeOxy
- Contents of the pack and other information
1. What Apulco HeOxy is and what it is used for
Apulco HeOxy is for diagnostic use only. It is used in various pulmonary function tests involving helium and is utilized to measure lung volume.
2. What you need to know before starting to use Apulco HeOxy
Do not use Apulco HeOxy:
- Unless your doctor instructs you to undergo pulmonary function tests.
Warnings and precautions
Consult your doctor before starting to use Apulco HeOxy for pulmonary function tests.
Use of Apulco HeOxy with other medicines
Inform your doctor if you are taking, have recently taken, or might need to take any other medicines.
Use of Apulco HeOxy with food, beverages and alcohol
When using Apulco HeOxy, 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 might be pregnant, or plan to become pregnant, consult your doctor before inhaling Apulco HeOxy.
Driving and using machines
Using Apulco HeOxy during pulmonary function tests should not affect your ability to drive or operate machinery.
3. How to use Apulco HeOxy
Inhale Apulco HeOxy only during pulmonary function diagnostic tests and exactly as directed by your doctor or the medical personnel attending you. If in doubt, consult your doctor again.
Only your doctor or the medical personnel attending you should decide on the duration of the pulmonary function diagnostic test and how often the test should be repeated.
4. Possible adverse effects
Not documented.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or pharmacist, even if these effects are 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 HeOxy
Keep out of the 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. Return it to your supplier. This will help protect the environment.
6. Contents of the pack and other information
Composition of Apulco HeOxy
The active substance is helium.
The other components are nitrogen and oxygen.
Appearance of Apulco HeOxy and contents of the pack
Apulco HeOxy is an odorless and colorless gas, supplied compressed in an aluminum gas cylinder.
The body of the gas cylinder is white and the upper part of the gas cylinder is light blue.
Pack 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 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 (EEA) member states under the following names:
Netherlands: Apulco HeOxy.
Germany: Apulco HeOxy.
Spain: Apulco HeOxy.
Portugal: Apulco HeOxy.
Date of the most recent review of this Summary of Product Characteristics: 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.