Document: Medicinsk Oxygen Air Liquide 100% medicinal gas, compressed ENG PL change

• Medicinsk Oxygen Air Liquide 100% medicinal gas, compressed PL
• Medicinsk Oxygen Air Liquide 100% medicinal gas, compressed ENG PL

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Package leaflet: Information for the user

Medicinal Oxygen Air Liquide 100%, Medicinal gas, compressed

Oxygen 100% (O₂)

Read all of this leaflet carefully before you start using this medicine because it contains important information for you

Always use this medicine exactly as described in this leaflet or as your doctor, pharmacist or nurse have told you.

• Keep this leaflet. You may need to read it again.

• Ask your pharmacist if you need more information or advice.If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet:

1. What MedicinalOxygen Air Liquide is and what it is used for

2. What you need to know before you use Medicinal Oxygen Air Liquide

3. How to use MedicinalOxygen Air Liquide

4. Possible side effects

6. Contents of the pack and otherinformation

Medicinal Oxygen Air Liquide contains oxygen, which is used for inhalation. It is colourless, odourless and tasteless, and is supplied in gas cylinders, which have a pressure regulator to reduce the pressure of the gas. The gas cylinder contains only pure oxygen.

Medicinal Oxygen Air Liquide increases the level of oxygen in the blood (increased oxygen saturation). Medicinal Oxygen Air Liquide results in more oxygen being transported to all the tissues in the body.

Medicinal Oxygen Air Liquide is used:

• To treat or prevent acute or chronic oxygen deficiency

• As a propellant for inhalation of other medicinal products (nebuliser treatment)

• As part of the gas flow in anaesthesia, pain relief and intensive care

• In pressurised chambers to reduce the risk of damage caused by decompression sickness, gas or air bubbles in blood vessels and in treatment of severe carbon monoxide poisoning and gangrene

• For treatment of an acute attack of cluster headache

If you personally have been prescribed MedicinalOxygen Air Liquide you should inform your doctor if you:

Take special care with Medicinal Oxygen Air Liquide:

• If your baby requires extra oxygen and is premature. Only give the amount of Medicinal Oxygen Air Liquide advised by your healthcare professional.

• If you are prescribed hyperbaric treatment, the risk associated to damage of the lung sack (so called pneumothorax) should be acknowledged.

Other medicines and Medicinal Oxygen Air Liquide

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

Medicinal Oxygen Air Liquide can be used during pregnancy.

Medicinal Oxygen Air Liquide can be used during the period of breast-feeding.

If you are prescribed treatment in pressurised chambers (hyperbaric treatment), you should inform your doctor if you are pregnant or suspect you might be pregnant.

Driving and using machines

You may drive and use machines when using Medicinal Oxygen Air Liquide providing that your doctor considers that you are both fit and capable.

If you personally have been prescribed Medicinal Oxygen Air Liquide, do not alter the dosage without first consulting your doctor.

Medicinal Oxygen Air Liquide is used by inhalation. The usual dose for adults to treat or prevent acute oxygen deficiency is 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.

Medicinal Oxygen Air Liquide 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 Medicinal Oxygen Air Liquide than you should

In vulnerable situations, too much Medicinal Oxygen Air Liquide can affect respiratory function and in exceptional cases cause carbon dioxide anaesthesia/unconsciousness.

Prolonged use of too much Medicinal Oxygen Air Liquide can cause pain, a dry cough, and even breathlessness. If these signs of overdose occur, always contact your doctor or the nearest hospital.

Safety instructions

• Medicinal Oxygen Air Liquide is intended for medical use only.

• Only connect the cylinder to a connection intended for medicinal oxygen.

• Oxygen (container and cylinder) must only be used in rooms with good ventilation.

• The gas cylinders must not be exposed to strong heat.

• There must be no smoking or open flames in rooms where Medicinal Oxygen Air Liquide is used, as it increases the risk of fire.

• Do not use toasters, hairdryers or similar electrical equipment during treatment with Medicinal Oxygen Air Liquide.

• 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.

• Switch off the equipment when it is not in use.

• In the event of fire – switch off the equipment.

• Gas cylinders must be carried to safety in the event of a danger of fire.

• Never use grease, oil or similar substances for lubricating screw threads that jam. There is a risk of self-combustion in contact with Medicinal Oxygen Air Liquide under high pressure.

• The pressure regulator must be opened slowly and cautiously.

• Handle carefully. Ensure that the gas cylinder is not dropped or exposed to knocks.

• Keep the cylinder clean and dry.

• Must be stored and transported with the valve closed and, where used, with the protective cap and cover in place.

4. Possible side effects

Like all medicines, Medicinal Oxygen Air Liquide can cause side effects, although not everybody gets them.

Treatment outside a hospital facility:

Medicinal Oxygen Air Liquide 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 Medicinal Oxygen Air Liquide, 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.

Reporting of side effects

If you get any side effects, talk to your doctor or pharmacist 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 Medicinal Oxygen Air Liquide

Keep out of the reach and sight of children.

Do not use Medicinal Oxygen Air Liquideafter the expiry date which is stated on the label.

Keep the cylinder in a well-ventilated place where it is not exposed to strong heat.

Keep the cylinder clean and dry.

Ensure that the gas cylinder is not dropped or exposed to knocks.

Store away from combustible materials.

6. Contents of the pack and other information

What Medicinal Oxygen Air Liquidecontains

• The active substance is 100% oxygen (chemical symbol: O₂)

• There are no other components in Medicinal Oxygen Air Liquide

What Medicinal Oxygen Air Liquidelooks like and contents of the pack

The shoulder of the gas cylinder is marked with white paint (oxygen). The body of the gas cylinder is white

(medicinal gas).

Cylinder size in litres

1

2

2.5

3

4

5

10

15

20

40

50

Bundle size in litres

12x40

10x50

15x40

12x50

20x40

20x50

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

AIR LIQUIDE Santé INTERNATIONAL

75 Quai d’ Orsay

75007 Paris

France

Manufacturers

Air Liquide Gas AB

Fabriksgatan 2

S-565 22 Mullsjö

Sweden

Air Liquide Danmark A/S

Frejasvej 2

DK-8722 Hedensted

Denmark

Representative:

Air Liquide Gas AB

Lundavägen 151

S-212 24 Malmö

Sweden

This leaflet was last approved in .17 January 2015