Prospect: information for the user
ICOMAS 0.3%/ 0.3%/ 0.3% medicinal compressed gas
Carbon monoxide (CO), methane (CH4) and acetylene (C2H2).
Read this prospect carefully before starting to use this medication, as it contains important information for you.
1. What isICOMASand how it is used
2. What you need to know before starting to useICOMAS
3. How to useICOMAS
4. Possible adverse effects
5. Storage ofICOMAS
6. Contents of the package and additional information
This medicationis solely for diagnostic use in lung function tests. ICOMAS should be used only in patients capable of performing the test, regardless of age.
Children and adolescents
This product should be used with caution in children. Ask your doctor or nurse before taking this medication.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or nurse before taking this medication.
ICOMAS should be used during pregnancy only when absolutely necessary.
ICOMAS can be used during breastfeeding, but should not be used at the same time as breastfeeding.
ICOMASshould be used only for diagnostic tests of lung function. You must follow exactly the instructions given by your doctor or the nursing staff attending to you. In case of doubt, consult your doctor or nurse again.
If you take more ICOMAS than you should
If you have taken too much of the product, you may experience symptoms of low oxygen in the blood, such as altered consciousness, headache, dizziness, nausea, vomiting, and blurred vision; chest pain, difficulty breathing, weakness, or other vague symptoms.
If you experience any of these symptoms, report them immediately to the healthcare professional and discontinue ICOMAS inhalation.
Safety Information
If you have any other questions about the use of this medication, ask your doctor or nurse.
Like all medications, this medication may produce adverse effects, although not all people will experience them.
No known adverse effect has been associated with the use ofICOMAS.
Reporting Adverse Effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is possible adverse effects that do not appear 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 this medication out of the sight and reach of children.
Store the cartridges in areas with restricted access, reserved for medical gases. Do not expose to high temperatures.
In case of fire, if possible, move the cartridges to a safe place. Handle with caution. Return used cartridges to the supplier with a minimum residual pressure (5 bar overpressure).
Store and transport the cartridges with the valve closed and the protective cap in place.
Do not use ICOMAS after the expiration date appearing on the cartridge label.
What ICOMAS contains
The active principles are carbon monoxide (CO), acetylene (C2H2) and methane (CH4).
The other components are nitrogen (N2) and oxygen (O2).
Appearance of the product and contents of the container
ICOMASis an colourless, odourless and tasteless gas.
Pharmaceutical form: medicinal gas, compressed.
The top (crown) of the gas cylinders have light green marks (inert gas). The body of the gas cylinder is white (medicinal gas).
Containers (including materials) and valves:
10-liter aluminum cylinder with a closing valve.
20-liter aluminum cylinder with a closing valve.
40-liter aluminum cylinder with a closing valve.
50-liter aluminum cylinder with a closing valve.
Holder of the marketing authorization and responsible manufacturer
Linde Sverige AB
Rättarvägen 3
169 68 Solna
Sweden.
Manufacturer
Linde Gas AB
Baltzar von Platens gata 4-6
749 47Enköping
Sweden
. Linde GmbH Seitnerstr.70, 82049 Pullach Germany Manufactured at: Linde GmbH, Leuna site Spergauer Straße 1a 06237 Leuna Germany Linde Gas Therapeutics Benelux B.V This medicinal product is authorized in the member states of the European Union with the following names:
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Last review date of this leaflet:September 2020
Detailed information on this medicinal product is available on the website of the European Medicines Agency:http://www.ema.europa.eu/<, and on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)}.
The following information is directed exclusively to healthcare professionals:
Safety instructions
After use, the valve of the cylinder should be closed using a normal manual pressure. Depressurize the regulator or connector.
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