1. What isApulco Acomethand for what it is used
2. What you need to know before starting to useApulco Acometh
3. How to useApulco Acometh
4. Possible adverse effects
5. Storage ofApulco Acometh
6. Contents of the package and additional information
Apulco Acometh isa medicinal gas that is only used for diagnostic purposes. It is administered during lung function tests and is primarily used to measure the lungs' ability to absorb the inhaled gas into the bloodstream, and it can also be used to measure lung volume and pulmonary blood flow.
Do not use Apulco Acometh:
Warnings and precautions
Consult your doctor before starting to use Apulco Acometh for pulmonary function tests.
Use of Apulco Acomethwith other medications
Inform your doctor if you are using, have used recently, or may need to use any other medication.
Use of Apulco Acometh with food, drinks, and alcohol
When using Apulco Acometh, 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 Acometh.
Driving and operating machinery
The use of Apulco Acometh during pulmonary function tests should not affect your ability to drive and operate machinery.
Inhale Apulco Acometh 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 themedicalstaff attending to you should decide the duration of the pulmonary function test and the frequency of repeating the test.
During inhalation of Apulco Acometh in lung function tests, possible adverse effects may appear, such as dizziness, chest pain, and a feeling of disorientation, although this is very rare. If any of these symptoms appear while using the medicinal gas, inhalation of Apulco Acometh should be stopped immediately and medical treatment should be administered.
You may need to have a blood sample taken for blood gas analysis after inhaling Apulco Acometh.
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 Medicinal Products for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.
Keep out of sight and reach of children.
Gas cartridges must 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.
What Apulco Acometh contains
The active principles are carbon monoxide and helium.
The other components are nitrogen and oxygen.
Appearance of Apulco Acometh and contents of the packaging
Apulco Acometh is a colourless and odourless compressed gas in aluminium gas cylinders.
The body of the gas cylinder is white and the top of the gas cylinder is bright green.
Packaging sizes in litres (200 bar): 5L, 10L, 20L and 40L.
Capacity in litres | Filling pressure (bar) | Volume of gas | m3of 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 authorisation holder
SE of Carburos Metálicos S.A.
Avda. de la Fama, 1
08940 Cornella de Llobregat
Spain
Manufacturer
SE of Carburos Metálicos S.A.
Pol. Nord-Este C-35, km59
08470 Sant Celoni
Spain
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Netherlands: Apulco Acometh.
Germany: Apulco Acometh.
Spain: Apulco Acometh.
Portugal: Apulco Acometh.
Last date of revision of this leaflet: March 2021
Detailed information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.
Have questions about this medication or your symptoms? Connect with a licensed doctor for guidance and personalized care.