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• Medicinsk oxygen Yara Praxair medicinal gas, cryogenic PL
• Medicinsk oxygen Yara Praxair medicinal gas, cryogenic ENG PL

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PACKAGE LEAFLET: INFORMATION FOR THE USER

Medicinal oxygen Yara Praxair 100%, medicinal gas, cryogenic

Oxygen 100% (O₂)

Read all of this leaflet carefully before you start using this medicine.

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

• If you have any further questions, ask your doctor or nurse.

• This medicinal product has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

• 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 nurse.

In this leaflet:

1. What Medicinal oxygen Yara Praxair is and what it is used for

2. Before you use Medicinal oxygen Yara Praxair

3. How to use Medicinal oxygen Yara Praxair

4. Possible side effects

6. Further information

Medicinal oxygen Yara Praxair contains oxygen for inhalation. It is colourless, odourless and tasteless and is kept in vessels fitted with a dosing device for regulation of the flow. The vessel contains pure liquified oxygen (cooled to approximately -180°C) (cryogenic gas).

Medicinal oxygen Yara Praxair increases the oxygen content of the blood (increased oxygen saturation). Medicinal oxygen causes the transportation of more oxygen to all tissues in the body.

Medicinal oxygen Yara Praxair is used

• to treat or to prevent acute or chronic oxygen deficit.

• as propellant for the inhalation of other medicines (nebuliser treatment).

• as part of the fresh gas flow in anaesthesia, pain relief and intensive care.

• in hyperbaric chamber to reduce the risk of injury caused by decompression sickness, gas- or air bubbles in the circulation and severe carbon monoxide poisoning, and in gangrene.

• for treatment of acute attack of Cluster headache.

If Medicinal oxygen Yara Praxair is prescribed to you personally, you should inform your doctor if:

Using other medicines

If you are using other medicines causing possible side effects in the lungs, such as bleomycin (used in cancer), oxygen treatment at the same time may worsen the side effects of these medicines.

Pregnancy and breast-feeding

Medicinal oxygen Yara Praxair can be used during pregnancy.

Medicinal oxygen Yara Praxair can be used during breast-feeding.

If Medicinal oxygen Yara Praxair is prescribed to you personally, you should not change the dose without first consulting your doctor.

Medicinal oxygen Yara Praxair is to be used by inhalation. Normal dose for treating or preventing acute oxygen deficit in adults is 3 – 4 litres per minute using a nasal canula, or 5 – 15 litres per minute using a mask. For dosage in other conditions consult your doctor.

Medicinal oxygen Yara Praxair is usually inspired trough a nasal canula or a mask. You breathe yourself – “spontaneous inhalation”, or you get help to breathe from a respirator/ventilator.

Carefully read the directions for use/the patient instruction for the oxygen delivery system you use!

If you use more Medicinal oxygen Yara Praxair than you should

In vulnerable situations excess medicinal oxygen can adversely affect the respiratory function and in exceptional cases give rise to carbon dioxide narcosis/unconsciousness.

Long term use of an excess of medicinal oxygen can cause pain, dry cough and even breathlessness.

If these indications of overdosing medicinal oxygen occur always contact a doctor, hospital or the National Poisonning center (phone [to be completed nationally]).

Safety precautions

• Medicinal oxygen Yara Praxair is for medical use only.

• If the batch label is missing or is illegible, please do not use the cylinder but return it to Yara Praxair AS.

• Medicinal oxygen Yara Praxair shall be used in well ventilated rooms only.

• Keep the vessel upright. If the vessel tip over cryogenic medicinal oxygen can leak and cause serious frost injuries. During normal use this cold, liquid oxygen makes no harm. When it is released from the vessel it is transformed to oxygen in its usual gaseous form.

• The vessel shall not be exposed to strong heat.

• Smoking and open fire must not occur in rooms where Medicinal oxygen is used, since this will increase the risk of fire.

• Do not use a toaster, hair dryer or similar electrical apparatus during therapy with Medicinal oxygen Yara Praxair.

• Do not put an oxygen mask or nasal canula directly on textiles during treatment – textiles being oxygen saturated can be very liable to catch fire/inflammable. If this yet should happen shake and air such textiles properly.

• Never use grease, oil etc. for lubricating screw threads that jam. These might cause a risk for spontaneous ignition with Medicinal oxygen Yara Praxair.

• Close the equipment when it is not in use.

• In case of fire – close the equipment.

• The vessels shall be moved to a safe place if at risk of fire.

• Handle with care. Ensure that the vessel is not dropped or exposed to knocks.

• Keep the vessel clean and dry.

• Store and transport upright with valves closed.

• Contact with cryogenic oxygen may cause sever burns or frostbite. When handling cryogenic oxygen systems do not allow oxygen or frosted systems to come in contact with the skin or non-protective clothing.

4. POSSIBLE SIDE EFFECTS

Like all medicines, Medicinal oxygen Yara Praxair can 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 hospital care

Medicinal oxygen therapy with nasal canula might, because the gas is dry, give rise to dry mucous membranes in the nose and mouth.

Also read the section “If you use more Medicinal oxygen than you should”

Treatment in hospital care

Adverse effects are usually seen with high concentrations (more than 70 %) and after long term therapy (at least 6 – 12 hours).

• Collapsed pulmonary alveoli

• Respiration related pain and dry cough, acute respiratory distress syndrome (ARDS)

Very rarely the following side effects might occur

In the newborn

Side effects from treatment in hyperbaric chamber (hyperbaric oxygen therapy)

5. HOW TO STORE MEDICINAL OXYGEN YARA PRAXAIR

Keep out of the reach and sight of children.

Do not store above 45^oC.

Keep the vessel 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 separately from combustible material.

Do not use Medicinal oxygen Yara Praxair after the expiry date which is stated on the label attached to the vessel.

6. FURTHER INFORMATION

What Medicinal oxygen Yara Praxair contains

• The active substance is oxygen 100% cryogenic gas (chemical term: O₂)

• Medicinal oxygen does not contain other ingredients.

What Medicinal oxygen Yara Praxair looks like and contents of the pack

Cryogenic vessels for homecare use by patients, sizes:

• (Filled by the patient or health care professionals): 0.3, 0.33, 0.38, 0.5, 0.6, 0.85, 1.2, 1,23

• (Filled by MAH): 10.7, 12, 15, 21, 21.6, 30, 31, 31.2, 36, 38.3, 40, 41, 46, 46.6, 60 and 196 litres.

The vessels are fitted with a dosing device for selection of the prescribed flow to the patient.

Not all vessel sizes may be marketed.

Marketing Authorisation Holder

Praxair Scandinavia Holding AS

P.O. Box 23, Haugenstua

N-0915 Oslo

Norway

Manufacturers

YARA Praxair AS P.O. Box 23, Haugenstua N-0915 Oslo Norway

YARA Praxair AS Røde Banke 120 DK-7000 Fredericia Denmark

This leaflet was last approved in2016-08-19

Detailed information on this medicine is available on the web site of [to be completed nationally].