Ohecon 0,25 %/10 % gas comprimido medicinal
Introduction
Label: information for the user
Ohecon 0.25%/ 10% medicinal compressed gas
carbon monoxide (CO)/helium (He)
Read this label carefully before starting to use this medication, because it contains important information for you.
- Keep this label, as you may need to read it again.
- If you have any questions, consult your doctor or nurse.
-If you experience any adverse effects, consult your doctor, even if they are not listed in this label. See section 4.
1.What is Ohecon and what it is used for
2.What you need to know before starting to use Ohecon
3.How to administer
4.Possible adverse effects
5.Storage ofOhecon
6.Contents of the package and additional information
1. What is Ohecon and what is it used for
Ohecon is a medicinal gas for exclusive diagnostic use in pulmonary function. It is used during diagnostic tests of pulmonary function: determination of diffusion capacity/transference factor and lung volume.
The medicinal gas Ohecon can only be used in patients capable of performing the test, regardless of age.
2. What you need to know before starting to use Ohecon
Do not use this medicinal gas:
Unless your doctor asks you to undergo pulmonary function tests.
Warnings and precautions
Consult your doctor before starting to use Ohecon.
If you have a history of coronary artery disease, you may be at risk of myocardial ischemia caused by carbon monoxide as indicated by changes in the ECG (ST segment depression).
Children
This medicinal gas should be used with caution in children due to a lack of data on the systemic toxicity of this mixture.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, or think you may be pregnant or plan to become pregnant, consult your doctor before using this medicinal gas.
Driving and operating machinery
The use of this medicinal gas during pulmonary function tests does not affect your ability to drive and operate machinery.
3. How Ohecon is administered
Only the doctor or the responsible medical staff should decide the duration of the functional respiratory test and the frequency of repeating the test.
Safety Instructions
Smoking or lighting open flames is not allowed in the room where the medicinal gas is being used.
If you have any doubts about the use of this medication, consult your doctor or the medical staff that attends to you.
4. Possible Adverse Effects
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse,even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of 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.
5. Conservation of Ohecon
Keep this medicinal gas out of sight and reach of children.
Do not use this medicinal gas after the expiration date that appears on the gas cartridge after CAD.
Do not dispose of the container of this medicinal gas; return it to the supplier.
These measures will help to protect the environment.
Store below 50°C.
All regulations regarding the handling of pressurized containers must be followed.
Store in the original gas cartridge. Do not transfer the contents of the original gas cartridge to another gas cartridge.
Store gas cartridges indoors, in well-ventilated rooms or in outdoor areas under a roof and protected from adverse weather conditions.
Protect gas cartridges from impacts, falls, oxidizing and flammable materials, moisture, heat sources, or ignition sources.
Different types of medicinal gas must be separated from each other. Full and empty gas cartridges must be stored separately.
6. Contents of the packaging and additional information
- The active principles are carbon monoxide and helium.
- The other components are nitrogen and oxygen.
Appearance of the product and contents of the packaging
Ohecon is an incolored, odorless, and tasteless medicinal compressed gas.
10-liter aluminum gas cartridge (identified with a bright green tip and a white body) filled at a pressure of 150 bars, equipped with a copper-made pressure residual valve with a specific outlet connection.
Holder of the marketing authorization and responsible for manufacturing
Holder of the marketing authorization
Messer Ibérica de Gases S.A.U.
Autovía Tarragona-Salou, km. 3.8
E-43480, Vilaseca (Tarragona)
Spain
Responsible for manufacturing
Messer Austria GmbH
Industriestraße 5
2352 Gumpoldskirchen
Austria
This medication is authorized in the EEA member states with the following names:
PneumoXON: Netherlands, Austria, Germany, and Romania
Ohecon: Czech Republic, Poland, and Spain
Last review date of this prospectus:
May 2023
The detailed information of this medication is available on the website of the {Spanish Agency of Medicines and Medical Devices (AEMPS) ( http://www.aemps.gob.es/
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