Leaflet: information for the user

Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank

Oxygen

Read this leaflet carefully before you start takingusingthis medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
  If you have any questions, consult yourdoctor, pharmacistor nurse.
• This medicine has been prescribed for you only, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor,pharmacistor nurse, even if they are not listed in this leaflet.

1. What isConoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tankand for what it is used

2. What you need to know before starting touseConoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank

3. How to useConoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank

4. Possible side effects

5. Storage ofConoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank

6. Contents of the container and additional information

Conoxia 99.5% (v/v) medical cryogenic gas in fixed tank is an inhalation gas that is supplied

in liquid state conditioned in cryogenic fixed containers and at cryogenic temperature (approx. -183°C).

It contains oxygen, in a concentration equal to or greater than 99.5% v/v.

It does not contain excipients.

Oxygen is an essential element for the body. Oxygen treatment is indicated in the following cases:

• Correction of oxygen deficiency of different origins that require oxygen administration at normal or elevated pressure.
• Feeding of respirators in anesthesia - resuscitation.
• Administration via nebulizer of inhalation medications.

Supercritical Oxygen in cryogenic containers is a liquid at cryogenic temperature (approximately -183°C), so in contact with the skin it can cause severe frostbites (see Additional Information section).

In case of frostbite, spray with room temperature water for 15 minutes. Apply a sterile dressing and seek medical assistance. In case of contact with the eyes, immediately wash the eyes with room temperature water for at least 15 minutes and seek medical assistance.

Do not use Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank:

This medication cannot be used at high pressure in cases of untreated pulmonary collapse (untreated pneumothorax). A pulmonary collapse is an accumulation of gas in the thoracic cavity between the two pulmonary membranes.

Inform your doctor if you have had a pulmonary collapse in the past.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Conoxia 99.5% (v/v) medicinal cryogenic gas.

You must inform your doctor if you have a chronic lung disease such as bronchitis, emphysema, or asthma and in severe cases of oxygen deficiency.

Do not apply any fatty substance (vaseline, ointments, etc.) to the face, due to the risk of inflammation of this medication (see section 6).

In severe cases of oxygen deficiency. After 6 hours of exposure to a concentration of oxygen of 100%, or after 24 hours of exposure to a concentration of oxygen greater than 70%, pulmonary or neurological toxicity may appear (see sections 3 and 6). Therefore, important concentrations should be used for the shortest possible time and controlled by analyzing the gases in the arterial blood, at the same time as measuring the inhaled oxygen concentration.

It is advisable to use in any case the smallest dose capable of maintaining the partial pressure of arterial oxygen (PaO2) at 50-60 mmHg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, to try to maintain, as far as possible, an oxygen concentration less than 45%.

Precautions for use:

- This medication should not be used in the presence of flammable materials: oils, lubricants, tissues, wood, paper, plastics (see section 6).

- If oxygen is applied at high pressure (hyperbaric oxygen therapy) there may be injuries caused by the high pressure, in the body cavities that contain air and are in communication with the outside, the compression and decompression must be slow. (see section 4).

- If you are going to receive high-pressure oxygen therapy (hyperbaric oxygen therapy), you must inform your doctor of any of the following situations:

- If you have Chronic Obstructive Pulmonary Disease (COPD).

- If you have a pulmonary alteration caused by the loss of elasticity of the pulmonary tissue accompanied by severe respiratory difficulty (pulmonary emphysema).

- If you have any upper respiratory tract infection (e.g. bronchitis).

- If you have chronic bronchitis.

- If you have recently undergone middle ear surgery.

- If you have had thoracic surgery at any time in your life.

- If you have high and uncontrolled fever.

- If you have severe epilepsy.

- If you have claustrophobia.

- If you have had a pulmonary collapse in the past (accumulation of air or gas in the thoracic cavity between the two pulmonary membranes (pneumothorax).

Children

In newborns, especially if they are premature, eye damage (alterations in the retina) may occur with certain oxygen concentrations.

In infants who need a concentration greater than 30%, the partial pressure of arterial oxygen (PaO2) must be regularly controlled to ensure it does not exceed 100 mmHg (i.e., 13.3 kPa).

Use of Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

The toxicity of oxygen may be increased by: corticosteroids, some cancer medications, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or vitamin C and E deficiency or glutathione deficiency.

Pregnancy and lactation

If you are pregnant or breastfeeding, or think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank has been widely used without any notable effect.

Driving and use of machines

There is no information on the effect of Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank on driving and the use of machines

Follow exactly the administration instructions for this medication as indicated by your doctor. Incase of doubt, consult your doctor again.

Your doctor will determine the correct dose of Conoxia 99.5% (v/v) medical cryogenic gas in a fixed tank andwill administer it through an appropriate system for your needs that will ensure the supply of the correct amount of Oxygen.

If you estimate that the action of Conoxia 99.5% (v/v) medical cryogenic gas in a fixed tank is toostrong or weak, inform your doctor.

If you use more Conoxia 99.5% (v/v) medical cryogenic gas in a fixed tank than you should:

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, telephone 91 562 04 20, indicating the medication and the amount inhaled.

In case of overdose, the oxygen concentration inhaled should be reduced and symptomatic treatment is recommended.

Like all medications, Conoxia 99.5% (v/v) cryogenic gas in a fixed tank may produceadverse effects, although not all people will experience them.

In particular, chronic respiratory insufficiency may lead to the possibility of apnea. Inhalation ofhigh oxygen concentrations may cause small lung collapses.

Administration of oxygen at high pressures may cause inner ear injuries (which may pose a risk oftympanic membrane rupture), nasal sinuses, and lungs (which may pose a risk of pneumothorax).

Seizures have been reported after administration of oxygen with a concentration of 100%for more than 6 hours, particularly with high-pressure administration.

Pulmonary injuries may occur after administration of oxygen concentrations above 80%.

In newborns, particularly premature infants, exposed to strong oxygen concentrations (FiO2 > 40%PaO2 > 80 mmHg (i.e., 10.64 kPa)), or for an extended period (more than 10 days at a FiO2 > 30%),there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, and mayexperience regression or cause retinal detachment, or even permanent blindness.

Patients subjected to high oxygen pressures in chambers may experience claustrophobia crises.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not

appear in this prospectus

Keep this medication out of the sight and reach of children.

All guidelines for handling pressure containers must be followed. In relation to storage and transportation, the following must be taken into account:

Conservation of fixed cryogenic containers:

- Fixed cryogenic containers must be installed in clean, well-ventilated areas free from flammable materials.

- Storage of medicinal gases must be separate from gases intended for other uses.

- Fixed cryogenic containers must be protected from ignition sources, heat, combustible materials, and even static discharges.

- Fixed cryogenic containers must be protected from the risks of shocks, impacts, or falls.

- No parking should be allowed in the area where the fixed cryogenic containers are located.

Composition of Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank

- The active principle is: Oxygen (O2) in a concentration of 99.5% (v/v) or greater.

- It does not contain excipients

Appearance of the product and contents of the packaging

Conoxia 99.5% (v/v) medicinal cryogenic gas is an inhalation gas.

The Oxygen conditioned in cryogenic fixed containers is a liquid at cryogenic temperature (approx. -183°C). The table shows the geometric capacity in liters and its correspondence in m3 of gas at 1 bar and 15°C. One liter of liquid Oxygen provides approximately 850 liters of Oxygen gas under conditions of 1 bar and 15°C.

Not all packaging sizes may be commercially available.

Marketing authorization holder and responsible manufacturer

LINDE GAS ESPAÑA, S.A.U.

Camino de Liria, s/n,

46530 Puzol, Valencia, Spain. Phone: 93.476.74.00

Last review date of this prospectus:June 2009

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

This information is intended solely for healthcare professionals:

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not grease.

Manipulation of cryogenic containers:

For the specific case of liquid Oxygen, additional product-specific precautions must be considered for its use and handling:

- Oxygen is a heavier gas than air, which can accumulate in low points after vaporization of the liquid and make the atmosphere hazardous.

- The contents of cryogenic fixed containers are Oxygen in liquid state at atmospheric pressure and very low temperature (around -183°C) and can cause cryogenic burns if they come into contact with the skin in the event of splashes or handling of the liquid without the appropriate protective equipment.

- One liter of liquid Oxygen releases 850 liters of gas by vaporization and warming to ambient temperature. The expansion of liquid Oxygen by warming is 850 times its liquid volume and therefore precautions should be taken for overpressures in closed volumes (equipment and installations) and overoxygenation of materials and the atmosphere of the premises.

To avoid any incidents, the following instructions must be strictly respected:

1. Never introduce the gas into an apparatus that is suspected to contain combustible materials, especially if they are of a greasy nature.

2. Never clean with combustible products, especially if they are of a greasy nature, nor the apparatus containing this gas nor the valves, seals, gaskets and closing devices.

3. Do not apply any greasy substance (vaseline, ointments, etc.) to the patients' faces.

4. Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or nearby.

5. Verify the good condition of the material before its use.

6. Handle the material with clean and grease-free hands.

7. For the manipulation of cryogenic containers, the indicated protective equipment (glasses or visors, clean gloves intended for that use, adaptation of clothing, etc.) and the described instructions and precautions for the operation must be followed.

8. Do not touch the cold or frosty parts.

9. In the event of cryogenic burns, rinse with plenty of water.

10. If the clothing becomes saturated with Oxygen, move away from the Oxygen liquid source and from areas that pose a risk of ignition, and remove this clothing.

11. Ventilate, if possible, the area of use, if it is a reduced location (vehicles, home).

12. Use only equipment specifically approved for Medical Oxygen and for the pressures and temperatures of use.

13. Never exceed the maximum service pressure.

14. Provide safety devices against overpressures in Oxygen liquid circuits where there is a risk of liquid accumulation between two valves.

15. In the event of a leak, close the valve with a leak and check that the emergency device is activated

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