Medicinsk Oxygen Aga
PACKAGE LEAFLET: INFORMATION FOR THE USER
Medicinsk Oxygen AGA 100%, Medicinal gas, cryogenic
Oxygen 100% (O2)
Cryogenic means deep cold.
Read all of this leaflet carefully because it contains important information for you.
This medicine is available without prescription. However, you still need to use Medicinsk Oxygen AGA carefully to get the best results from it.
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Keep this leaflet. You may need to read it again.
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Ask your pharmacist if you need more information or advice.
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You must contact a doctor if your symptoms worsen or do not improve.
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If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet:
1. What Medicinsk Oxygen AGA is and what it is used for
2. Before you use Medicinsk Oxygen AGA
3. How to use Medicinsk Oxygen AGA
4. Possible side effects
How to store Medicinsk Oxygen AGA
6. Further information
WHAT MEDICINSK OXYGEN AGA IS AND WHAT IT IS USED FOR
Medicinsk Oxygen AGA contains oxygen, which is used for inhalation. It is colourless, odourless and tasteless, and is supplied in cryogenic vessels that have a dosing device to regulate the flow. The vessel contains only pure liquefied oxygen (cooled to approx. –180°C).
Medicinsk Oxygen AGA increases the level of oxygen in the blood (increased oxygen saturation). Medicinsk Oxygen AGA results in more oxygen being transported to all the tissues in the body.
Medicinsk Oxygen AGA is used:
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To treat or prevent acute or chronic oxygen deficiency
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As part of the gas flow in anaesthesia, pain relief and intensive care
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As a propellant for inhalation of other medicinal products (nebuliser treatment)
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As first aid treatment with 100% oxygen in decompression accidents
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For treatment of an acute attack of cluster headache
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In pressurised chambers to reduce the risk of damage caused by decompression sickness (the bends), gas or air bubbles in blood vessels and in treatment of severe carbon monoxide poisoning and gangrene
BEFORE YOU USE MEDICINSK OXYGEN AGA
If you personally have been prescribed MedicinskOxygen AGA you should inform your doctor if you: - suffer from chronic lung diseasefor example asthma or COPD.
Take special care with Medicinsk Oxygen AGA:
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If your baby requires extra oxygen and is premature. Only give the amount of Medicinsk Oxygen AGA advised by your healthcare professional.
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If you are prescribed hyperbaric treatment, the risk associated to damage of the pleura (so called pneumothorax) should be acknowledged.
Using other medicines
If you are taking or have been prescribed bleomycine (to treat cancer), amiodarone (to treat heart disease) or furadantin or similar antibiotics (to treat infection), please advise your doctor prior to using medical oxygen, as there is a possibility of toxic effects to the lungs.
Pregnancy and breast-feeding
Medicinsk Oxygen AGA can be used during pregnancy.
Medicinsk Oxygen AGA can be used during the period of breast-feeding.
If you are prescribed hyperbaric treatment (treatment in pressurised chambers), you should inform your doctor if you are pregnant or suspect you might be pregnant.
Driving and using machines
You may drive after using Medicinsk Oxygen AGA providing that your doctor considers that you are both fit and capable.
HOW TO USE MEDICINSK OXYGEN AGA
If you personally have been prescribed Medicinsk Oxygen AGA, do not alter the dosage without first consulting your doctor.
Medicinsk Oxygen AGA is used by inhalation. The usual dose for adults to treat or prevent acute oxygen deficiencyis 3–4 litres per minute when using nasal prongs, or 5–15 litres per minute with a mask. For the dosage in other cases consult your doctor.
Medicinsk Oxygen AGA is usually breathed through nasal prongs or a mask. Either you breathe yourself – you “breathe spontaneously” – or you are helped to breathe by means of a respirator/ventilator.
Read the instructions for use/patient instructions for your breathing equipment carefully!
If you use more Medicinsk Oxygen AGAthan you should
In vulnerable situations, too much Medicinsk Oxygen AGA can affect respiratory function and in exceptional cases cause carbon dioxide anaesthesia/unconsciousness.
Prolonged use of too much Medicinsk Oxygen AGA can cause pain, a dry cough, and even breathlessness.
If these signs of overdose occur, always contact your doctor, hospital or the Poisons Information Centre (tel. 112).
Safety instructions
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Medicinsk Oxygen AGA is intended for medical use only.
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Oxygen must only be used in rooms with good ventilation.
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As medicinal liquid oxygen is a very cold liquid, there is a risk of frostbite injury whenever medicinal liquid oxygen is handled.
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Parts of the vessel/valve can become cold when in use. This will be evident by ice forming on the cold sections and care should be taken not to touch these areas.
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Keep the vessels upright. If the vessels fall over, liquefied Medicinsk Oxygen AGA may leak out and cause severe cold damage. With normal use the cold liquefied oxygen does not cause any damage. If it escapes from the vessel it is converted to oxygen in its usual gaseous form.
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The vessels must not be exposed to strong heat.
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There must be no smoking or open flames in rooms where Medicinsk Oxygen AGA is used, as it increases the risk of fire.
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Do not use toasters, hairdryers or similar electrical equipment during treatment with Medicinsk Oxygen AGA.
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Never place an oxygen mask or nasal prongs directly on textiles while treatment is being carried out – fabrics that become saturated with oxygen can be highly flammable/cause a risk of fire. If this should occur, thoroughly shake and air the textiles.
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Never use grease, oil or similar substances for lubricating screw threads that jam since there is a risk of self-combustion in contact with Medicinsk Oxygen AGA.
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Switch off the equipment when it is not in use.
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In the event of fire – switch off the equipment.
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Vessels must be carried to safety in the event of a danger of fire.
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Handle carefully. Ensure that the vessel is not being dropped or exposed to knocks.
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Keep the vessel clean and dry.
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Must be stored and transported with the valve closed
POSSIBLE SIDE EFFECTS
Like all medicines, Medicinsk Oxygen AGAcan cause side effects, although not everybody gets them.
If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
Treatment outside a hospital facility:
Medicinsk Oxygen AGA treatment through nasal prongs may cause dry mucous membranes in the nose and mouth on account of the gas being dry.
Also read the section “If you use more Medicinsk Oxygen AGA, than you should”
Treatment in a hospital facility:
Side effects are usually seen with high concentrations (over 70%) and after prolonged treatment (at least 6–12 hours):
Common (more than 1 out of 100 patients)
None
Uncommon(fewer than 1 out of 100 patients)
Breathing-related pain and dry cough and breathlessness
Hyperbaric treatment
Feeling pressure in the middle ear, rupture of the eardrum
Rare (fewer than 1 out of 1000 patients)
In newborns exposed to high oxygen concentrations: Damage to the eye, which can result in impaired vision.
Very rare (fewer than 1 out of 10 000 patients)
Severe difficulty breathing (respiratory distress syndrome)
Hyperbaric treatment
Anxiety or confusion and epileptic seizures.
HOW TO STORE MEDICINSK OXYGEN AGA
Keep out of the reach and sight of children.
Keep the vessels in a well-ventilated place where it is not exposed to strong heat.
Keep the vessel clean and dry.
Ensure that the vessel is not dropped or exposed to knocks.
Store away from combustible materials.
Do not use Medicinsk Oxygen AGAafter the expiry date which is stated on the label.
6. FURTHER INFORMATION
What Medicinsk Oxygen AGAcontains
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The active substance is 100% oxygen (chemical symbol: O2)
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There are no other components in Medicinsk Oxygen AGA
What Medicinsk Oxygen AGAlooks like and contents of the pack
Packs:
230-litre cryogenic vessel and 600 litre.
Cryogenic vessels fitted with a dosing device for regulation of the flow to the patient. Sizes: 10, 12, 15, 20, 21, 26, 30, 31, 32, 36, 37, 40, 41, 45, 46 and 55 litres.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
AGA AB
SE-181 81 Lidingö
Sweden
Information:Linde Healthcare (division within AGA AB) Tel: +46 (0)8 731 100
In Sweden to be nationally completed
Manufacturers
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AGA AS |
AGA A/S |
Oy AGA Ab Agantie 2 FI-11310 Riihimäki |
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ISAGA ehf Breidhöfda 11 ICE-110 Reykjavik Iceland |
AGA Gas AB Rotevägen 2 SE-192 78 Sollentuna Sweden |
AGA SIA Linde Healthcare Putnu iela 2 Ropazu region, Zakumuiza, LV-2133 Latvia |
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This leaflet was last approved on 22 November 2013
Detailed information on this medicine is available on the web site of Swedish MPA: www.lakemedelsverket.se
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