Icomix 0.28%/9.3% medicinal compressed gas
SpainTable of Contents
Patient Information Leaflet
Introduction
Patient Information Leaflet
ICOMIX 0.28%/9.3% medicinal compressed gas
Carbon monoxide (CO), helium (He)
Read this entire leaflet carefully before you start using 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 nurse.
- If you experience any adverse reactions, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.
Contents of this leaflet
- What ICOMIX is and what it is used for
- What you need to know before using ICOMIX
- How to use ICOMIX
- Possible side effects
- How to store ICOMIX
- Contents of the pack and other information
1. What ICOMIX is and what it is used for
This medicinal product is for diagnostic use only in pulmonary function testing. ICOMIX should only be used 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 medicine should be used with caution in children. Ask your doctor or nurse before using this medicine.
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor before inhaling ICOMIX.
ICOMIX should only be used during pregnancy if absolutely necessary.
ICOMIX may be used during breastfeeding.
3. How to use ICOMIX
ICOMIX is intended solely for use during diagnostic testing of lung function. You must follow exactly the instructions provided by the medical staff attending you. If in doubt, consult your doctor or nursing staff again.
If the dose of ICOMIX is higher than prescribed
If you have inhaled too much product, you may experience symptoms of low blood oxygen levels, such as altered consciousness, headache, dizziness, nausea, vomiting, and blurred vision; chest pain, shortness of breath, weakness, or other nonspecific symptoms.
If you experience any of these symptoms, inform the healthcare personnel immediately and stop inhaling ICOMIX.
Safety information
- ICOMIX is for medical use only.
- Smoking or lighting flames is not permitted in the room where this product is being used.
If you have any further questions about the use of this medicine, ask your doctor or nurse.
4. Possible adverse effects
Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.
No known adverse effects have been associated with the use of ICOMIX.
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es
By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of ICOMIX
Keep this medicine out of the sight and reach of children.
Store cylinders in restricted-access areas designated for medical gases. Do not expose to high temperatures.
In case of fire, if possible, move cylinders to a safe location. Handle with care. Return used cylinders to the supplier with a minimum residual pressure (5 bar overpressure).
Store and transport cylinders with the valve closed and the protective cap in place.
Do not use ICOMIX after the expiry date stated on the cylinder label.
6. Contents of the package and other information
What ICOMIX contains
The active substances are carbon monoxide (CO) and helium (He).
The other components are nitrogen (N2) and oxygen (O2).
Nature of the product and contents of the container
ICOMIX is a colourless, odourless and tasteless gas.
Pharmaceutical form: medicinal gas, compressed.
The upper part (dome) of the cylinders has light green markings (inert gas). The body of the gas cylinder is white (medicinal gas).
Containers (including materials) and valves:
Aluminium cylinder of 10 litres with shut-off valve.
Aluminium cylinder of 20 litres with shut-off valve.
Aluminium cylinder of 40 litres with shut-off valve.
Aluminium cylinder of 50 litres with shut-off valve.
Marketing Authorisation Holder and Manufacturer
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 under 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 |
Date of most recent review of this leaflet: December 2024
Detailed information on this medicinal product is available on the website of the {Spanish Agency for Medicines and Health Products (AEMPS)} (http://www.aemps.gob.es/)}>.
The following information is intended exclusively for healthcare professionals:
Safety instructions
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Connect only to medical gas outlets.
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Keep the cylinder clean, dry, and free from grease and oil.
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Turn off/Disconnect the equipment when not in use.
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In case of fire—turn off/disconnect the equipment.
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The pressure regulator must be opened slowly and carefully.
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ICOMIX must only be used in well-ventilated areas.
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When in use, the cylinder must be properly secured.
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This product must not be used at pressures below 5 bar. This residual pressure protects the cylinder from potential contamination.
After use, the cylinder valve should be closed using normal manual force. Depressurize the regulator or connector.