Icomix 0,28 %/9,3 % gas comprimido medicinal
Introduction
Leaflet: information for the user
ICOMIX 0.28%/ 9.3% medicinal compressed gas
Carbon monoxide (CO), helium (He)
Read this leaflet carefully before you start using this medicine, because 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 nurse.
- If you experience any side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.
1. What is ICOMIX and what it is used for
2. What you need to know before starting to use ICOMIX
3. How to use ICOMIX
4. Possible side effects
5. Storage of ICOMIX
6. Contents of the pack and additional information
1. What is ICOMIX and what is it used for
This medication is solely for diagnostic use of lung function. ICOMIX should be used only in patients capable of performing the test, regardless of age.
2. What you need to know before starting to use ICOMIX
Children and adolescents
This medication should be used with caution in children. Ask your doctor or nurse before using this medication.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor before inhaling ICOMIX.
ICOMIX should be used during pregnancy only when absolutely necessary.
ICOMIX can be used during breastfeeding, but should not be used at the same time as breastfeeding.
3. How to use ICOMIX
ICOMIX is for use only during pulmonary function diagnostic tests. You must follow exactly the instructions of the medical staff attending you. In case of doubt, consult your doctor or nursing staff again.
If the ICOMIX dose is greater than the prescribed dose
If you have taken too much of the product, you may experience symptoms of low blood oxygen, such as altered consciousness, headache, dizziness, nausea, vomiting, and blurred vision; chest pain, shortness of breath, weakness, or other vague symptoms.
If you experience any of these symptoms, inform the healthcare staff immediately and discontinue ICOMIX inhalation.
Safety Information
- ICOMIX is for exclusive medicinal use.
- It is not permitted to smoke or ignite flames in the room where this product is being used.
If you have any other questions about the use of this medication, ask your doctor or nurse.
4. Possible Adverse Effects
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 of ICOMIX.
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.
5. Conservation of ICOMIX
Keep this medication out of the sight and reach of children.
Store the cartridges in restricted access areas, 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 ICOMIX after the expiration date appearing on the cartridge label.
6. Contents of the packaging and additional information
What ICOMIX contains
The active principles are carbon monoxide (CO) and helium (He).
The other components are nitrogen (N2) and oxygen (O2).
Appearance of the product and contents of the container
ICOMIX is 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 for manufacturing
Linde Sverige AB
Rättarvägen 3
169 68 Solna
Sweden.
Manufacturer Linde Gas AB Baltzar von Platens gata 4-6 749 47 Enköping Sweden. Linde GmbH Seitnerstr.70, 82049 Pullach
This medicinal product is authorized in the Member States of the European Union with the following names: Austria: iCOmix Belgium: Carbon monoxide 0.28%, Helium 9.3% Linde Denmark: Lung test gas CO/He Linde Finland: Lung test gas CO/He Linde Germany: iCOmix Iceland: Lung test gas CO/He Linde Luxembourg: ICOMIX Netherlands: ICOMIX Portugal: Icomix Spain: ICOMIX Sweden: Lung test gas CO/He Linde |
Last review date of this leaflet:September 2020
The detailed information of this medicinal product is available on the webpage of the {Spanish Agency of Medicines and Medical Devices (AEMPS)} (http://www.aemps.gob.es/)}.
The following information is exclusively directed to healthcare professionals:
Safety instructions
- Connect only to medicinal use connections.
- Keep the cylinder clean and dry and free of grease and oil.
- Turn off/disconnect the equipment when not in use.
- In case of fire - turn off/disconnect the equipment.
- The pressure regulator must be opened slowly and carefully.
- ICOMIX should only be used in well-ventilated areas.
- When the cylinder is in use, it must be properly secured.
- This product should not be used with a pressure below 5 bars. This residual pressure protects the cylinder from possible contamination.
After use, the cylinder valve should be closed using normal manual pressure. Depressurize the regulator or connector.
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