Lung Test Gas Co (He) Aga
Package leaflet: Information for the user
Lung test gas CO/He AGA 0.28%, 9.3%
medicinal gas, compressed
Carbon monoxide (CO), helium (He)
Read all of this leaflet carefully before you start using this medicine because it contains important information for you..
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Keep this leaflet. You may need to read it again.
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If you have any further questions, ask your doctor or nurse.
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If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet:
1. What Lung test gas CO/He AGA is and what it is used for
2. What you need to know before you use Lung test gas CO/He AGA
3. How to use Lung test gas CO/He AGA
4. Possible side effects
5. How to store Lung test gas CO/He AGA
6. Contents of the pack and other information
1. What Lung test gas CO/He AGA is and what it is used for.
This medicine is for lung function diagnostic use only. Lung test gas, CO/He AGA may be used in patients capable of following the instructions needed to perform the test, irrespective of age.
2. What you need to know before you use Lung test gas CO/He AGA
Pregnancy and breast-feeding
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Data regarding the treatment of pregnant women is not available. Lung test gas CO/He AGA should only be used during pregnancy when it is absolutely necessary.
Lung test gas CO/He AGA may be used during the breast-feeding period, but should not be used during breast-feeding itself.
3. How to use Lung test gasCO/He AGA
Lung test gas CO/He AGA is only for use for performing lung function tests. You should follow the instructions the personnel performing the test give you.
Always use this medicine exactly as your doctor or nurse have told you. Check with your doctor or nurse if you are not sure.
If you take more Lung test gas CO/He AGA than you should
If you find that you have taken too much of the product and are affected by shortness of breath (too little oxygen in the blood) tell the personnel and interrupt the supply of Lung test gas CO/He AGA. If you feel pain in your chest (angina) or feel affected in any other way, tell the healthcare personnel about this.
Likewise, if you experience signs of changed perception or impairment in moving, inform your doctor immediately.
Safety instructions
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Lung test gas CO/He AGA is intended for medicinal use only.
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Smoking and naked flames are not permitted in the room where the product is in use.
If you have any further questions on the use of this medicine, ask your doctor or nurse.
4. Possible side effects
Like all medicines, this medicine may cause side effects, although not everybody gets them.
No known side effects are associated with the use of Lung test gas CO/He AGA.
Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
5. How to store Lung test gasCO/He AGA
Keep this medicine out of the sight and reach of children.
Store the cylinder in a locked area, reserved for medicinal gases. Do not expose to high temperatures.
Move to a safe place in case of fire. Handle with care. Return with 5 bars over-pressure.
Gas cylinders must be stored and transported with the valve closed and a protective cap in place.
Do not use Lung test gas CO/He AGA after the expiry date which is stated on the cylinder label.
6. Contents of the pack and other information
What Lung test gas CO/He AGA contains
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The active substances are carbon monoxide (CO) and helium (He).
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Other ingredients are oxygen (O2) and nitrogen (N2).
What Lung test gas CO/He AGA looks like and contents of the pack
Lung test gas CO/He AGA is a colourless, odourless, tasteless gas.
Pharmaceutical form:medicinal gas, compressed
The shoulder of the gas cylinder is marked with a light green colour (inert gas). The body of the gas cylinder is white (medicinal gas).
The packs (including material) and valves:
10 litre aluminium cylinder with shut-off valve
20 litre aluminium cylinder with shut-off valve
Marketing Authorisation Holder
AGA AB
SE-181 81 Lidingö
Sweden
Manufacturer
AGA Gas AB
Rotevägen 2
SE-192 78 Sollentuna (Rotebro site), Sweden
Information provided by
[To be completed
nationally]
This leaflet was last revised on 2014-12-19
Detailed information on this medicine is available on the web site of the Swedish Medical Products Agency website:www.lakemedelsverket.se
The following information is intended for healthcare professionals only:
Safety instructions
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Only connect to a connection intended for medicinal use
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Keep the cylinder clean and dry and free from oil and grease.
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Switch off the equipment when not in use.
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In case of fire- switch off the equipment.
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The pressure regulator must be opened slowly and carefully.
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Lung test gas CO/He AGA may only be used in well ventilated areas.
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When the cylinder is in use it must be secured in a suitable manner.
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The product must not be used at a pressure of less than 5 bars. This residual pressure protects the cylinder from contaminations.
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After use, the cylinder valve should be closed using normal hand pressure. Depressurise the regulator or connector.
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