Ficha técnica de Apulco heoxy 9% gas comprimido medicinal – Espanha

Como usar Apulco heoxy 9% gas comprimido medicinal

Introduction

Leaflet: information for the user

Apulco HeOxy 9% medicinal compressed gas

Helium (He)

Read this leaflet carefully before starting to use this medicine, 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 only for you, 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

1. What Apulco HeOxy is and for what it is used

2. What you need to know before starting to use Apulco HeOxy

3. How to use Apulco HeOxy

4. Possible side effects

5. Storage of Apulco HeOxy

6. Contents of the container and additional information

1. What is Apulco HeOxy and what is it used for

Apulco HeOxy is for diagnostic use only. It is used in various respiratory function tests with helium and is used to measure lung volume.

2. What you need to know before starting to use Apulco HeOxy

Do not use Apulco HeOxy:

Unless your doctor tells 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 medications

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Use of Apulco HeOxy with food, drinks, and alcohol

When using Apulco HeOxy, you should not be in a state that would prevent you from performing the pulmonary function test correctly according to your doctor's or medical staff's instructions.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before inhaling Apulco HeOxy.

Driving and operating machinery

The use of Apulco HeOxy during pulmonary function tests should not affect your ability to drive and operate machinery.

3. How to Use Apulco HeOxy

Inhale Apulco HeOxy 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 the medical staff attending to you should decide the duration of the pulmonary function test and the frequency of repeating the test.

4. Possible Adverse Effects

None have been documented.

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 for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

5. Conservation of Apulco HeOxy

Keep out of sight and reach of children.

The 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 container and additional information

Composition of Apulco HeOxy

The active principle is helium.

The other components are nitrogen and oxygen.

Appearance of Apulco HeOxyand contents of the container

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 top of the gas cylinder is light blue.

Container 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	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

Responsible for manufacture

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 HeOxy.

Germany: Apulco HeOxy.

Spain: Apulco HeOxy.

Portugal: Apulco HeOxy.

Last review date of this leaflet: March 2021

The detailed information of this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.