


Ask a doctor about a prescription for APULCO HEOXY 9% COMPRESSED MEDICAL GAS
Package Leaflet: Information for the User
Apulco HeOxy 9% Compressed Medical Gas
Helium (He)
Read this package leaflet carefully before you start using this medicine because it contains important information for you.
Contents of the Package Leaflet
Apulco HeOxy is for diagnostic use only. It is used in various respiratory function tests with helium and is used to measure lung volume.
Do not use Apulco HeOxy:
Warnings and Precautions
Consult your doctor before using Apulco HeOxy for lung function tests.
Using Apulco HeOxy with other medicines
Tell your doctor if you are using, have recently used, or might use any other medicines.
Using Apulco HeOxy with food, drinks, and alcohol
When using Apulco HeOxy, you should not be in a state that would prevent you from correctly performing the lung function test according to your doctor's or medical staff's instructions.
Pregnancy, Breast-feeding, and Fertility
If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before inhaling Apulco HeOxy.
Driving and Using Machines
Using Apulco HeOxy during lung function tests should not affect your ability to drive and use machines.
Inhale Apulco HeOxy only during diagnostic lung function tests and exactly as your doctor or the medical staff has told you. If in doubt, consult your doctor again.
Only your doctor or the medical staff should decide the duration of the diagnostic lung function test and how often the test should be repeated.
None have been documented.
Reporting of Side Effects
If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this package leaflet. You can also report side effects directly via the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.
Keep out of the sight and reach of children.
The gas cylinders should 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 throw away this medicinal gas. Return it to the supplier. This will help protect the environment.
Composition of Apulco HeOxy
The active substance is helium.
The other ingredients are nitrogen and oxygen.
Appearance of Apulco HeOxy and Contents of the Pack
Apulco HeOxy is a colorless and odorless gas, supplied compressed in aluminum gas cylinders.
The body of the gas cylinder is white and the top of the gas cylinder is light blue.
Package sizes in liters (200 bar): 5L, 10L, 20L, and 40L.
Capacity in liters | Filling Pressure (bar) | Liters of Gas | m3of 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
S.E. de Carburos Metálicos S.A.
Pol. Nord-Este C-35, km 59
08470 Sant Celoni
Spain
This medicine is authorized in the Member States of the European Economic Area under the following names:
Netherlands: Apulco HeOxy.
Germany: Apulco HeOxy.
Spain: Apulco HeOxy.
Portugal: Apulco HeOxy.
Date of the Last Revision of this Package Leaflet: March 2021
Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.
Discuss dosage, side effects, interactions, contraindications, and prescription renewal for APULCO HEOXY 9% COMPRESSED MEDICAL GAS – subject to medical assessment and local rules.