CONOXIA 99.5% (v/v) MEDICINAL CRYOGENIC GAS IN FIXED TANK

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

Cryogenic oxygen in fixed containers is a liquid at cryogenic temperature (approx. -183°C), so it can cause severe frostbite (see "Additional Information" section) when in contact with the skin.

In case of frostbite, spray with water at room temperature for 15 minutes. Apply a sterile bandage and seek medical attention. In case of eye contact, rinse eyes immediately with water at room temperature for at least 15 minutes and seek medical attention.

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

This medicine cannot be used at high pressure in cases of untreated lung collapses (untreated pneumothorax). A lung collapse is a collection of gas in the thoracic cavity between the two lung membranes.

Tell your doctor if you have had a lung collapse before.

Warnings and Precautions

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

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

No greasy substances (vaseline, ointments, etc.) should be applied to the face, due to the risk of inflammation of this medicine (see section 6).

In certain severe cases of oxygen deficiency, after 6 hours of exposure to an oxygen concentration of 100%, or after 24 hours of exposure to an oxygen concentration above 70%, pulmonary or neurological toxicity may appear (see sections 3 and 6). Therefore, high concentrations should be used for as short a time as possible and controlled by analyzing the gases in the arterial blood, while measuring the inhaled oxygen concentration.

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

Precautions for Use:

• This medicine should not be used in the presence of flammable materials: oils, lubricants, tissues, wood, paper, plastic materials (see section 6).
• If oxygen is applied at high pressure (hyperbaric oxygen therapy), there may be injuries caused by the high pressure in body cavities that contain air and are in communication with the outside, compression and decompression must be slow (see section 4).
• If you are going to receive high-pressure oxygen therapy (hyperbaric oxygen therapy), you should inform your doctor of any of the following situations:
• If you have COPD (chronic obstructive pulmonary disease).
• If you have a lung disorder caused by the loss of elasticity of lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema).
• If you have an infection in the upper respiratory tract (e.g., bronchitis).
• If you have chronic bronchitis.
• If you have recently undergone middle ear surgery.
• If you have undergone thoracic surgery at any point in your life.
• If you have high and uncontrolled fever.
• If you have severe epilepsy.
• If you have a fear of enclosed spaces (claustrophobia).
• If you have had a lung collapse before (accumulation of air or gas in the thoracic cavity between the two lung membranes (pneumothorax).

Children

In newborns, especially if they are premature, eye damage (retinal alterations) can occur with certain oxygen concentrations.

In infants who need a concentration above 30%, the arterial partial oxygen pressure (PaO2) should be regularly controlled so that it does not exceed 100 mmHg (i.e., 13.3 kPa).

Using Conoxia 99.5% (v/v) cryogenic medicinal gas in fixed tank with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or might use any other medicines.

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

Pregnancy and Breastfeeding

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

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

Driving and Using Machines

There is no data on the effect of Conoxia 99.5% (v/v) cryogenic medicinal gas in fixed tank on driving and using machines.

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

Follow exactly the administration instructions of this medicine indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will determine the correct dose of Conoxia 99.5% (v/v) cryogenic medicinal gas in fixed tank and will administer it through a system suitable for your needs that guarantees the supply of the correct amount of oxygen.

If you think the action of Conoxia 99.5% (v/v) cryogenic medicinal gas in fixed tank is too strong or too weak, tell your doctor.

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

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

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

4. Possible Side Effects

Like all medicines, Conoxia 99.5% (v/v) cryogenic medicinal gas in fixed tank can cause side effects, although not everybody gets them.

In chronic respiratory failure, in particular, there is a possibility of apnea. Inhalation of high oxygen concentrations can cause small lung collapses.

Administration of oxygen at high pressures can cause injuries to the inner ear (which can pose a risk of eardrum rupture), sinuses, and lungs (which can pose a risk of pneumothorax).

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

Lung injuries can occur after administration of oxygen concentrations above 80%.

In newborns, especially if they are premature, exposed to high oxygen concentrations (FiO2 > 40%; PaO2 > 80 mmHg, i.e., 10.64 kPa), or for a prolonged period (more than 10 days at a FiO2 > 30% concentration), there is a risk of retinopathy, which appears between 3 and 6 weeks after treatment, and can regress or cause retinal detachment, or even permanent blindness.

Patients undergoing high-pressure oxygen therapy in chambers may experience claustrophobia.

If you experience side effects, talk to your doctor, pharmacist, or nurse, even if they are not listed in this leaflet.

5. Storage of Conoxia 99.5% (v/v) cryogenic medicinal gas in fixed tank

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

All rules related to the handling of pressure vessels must be followed. Regarding storage and transportation, the following must be taken into account:

Storage of fixed cryogenic containers:

• Fixed cryogenic containers must be installed in clean, ventilated areas without flammable materials.
• Storage of gases for medical use must be separated from gases 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 risk of shocks, impacts, or falls.
• No parking should be done in the area where the fixed cryogenic containers are located.

6. Package Contents and Additional Information

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

• The active ingredient is: Oxygen (O2) in a concentration equal to or greater than 99.5% (v/v).
• It does not contain excipients.

Appearance of the Product and Package Contents

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

Cryogenic oxygen in 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 pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LINDE GAS ESPAÑA, S.A.U.

Camino de Liria, s/n,

46530 Puzol, Valencia, Spain. Phone: 93.476.74.00

Date of the Last Revision of this Leaflet:June 2009

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

This information is intended only for healthcare professionals:

Instructions for Use/Handling

Do not smoke.

Do not approach a flame.

Do not grease.

Handling of cryogenic containers:

In the specific case of liquid oxygen, additional particularities of the product must be considered, which must be taken into account as precautions for its use and handling:

• Oxygen is a gas heavier than air, which can accumulate in low points after liquid vaporization and make the atmosphere dangerous.
• The content of fixed cryogenic containers is oxygen in a liquid state at atmospheric pressure and very low temperature (around -183°C), which can cause frostbite if it comes into contact with the skin due to splashes or handling of the liquid without adequate protective equipment.
• One liter of liquid oxygen releases 850 liters of gas by vaporization and heating to room temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore, precautions typical of overpressure in closed volumes (equipment and facilities) and over-oxygenation of materials and room atmosphere must be taken.

To avoid any incident, it is necessary to strictly follow the following instructions:

1. Never introduce gas into a device that is suspected to contain combustible materials, especially if they are greasy in nature.
2. Never clean devices that contain this gas or valves, gaskets, seals, and closing devices with combustible products, especially if they are greasy in nature.
3. Do not apply any greasy substance (vaseline, ointments, etc.) to the face of patients.
4. Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.
5. Check the good condition of the material before use.
6. Handle the material with clean and grease-free hands.
7. For handling cryogenic containers, use the indicated protective equipment (glasses or visors, clean gloves intended for this use, adaptation of clothing, etc.) and follow the instructions and precautions described for the operation.

Do not touch cold or frosty parts.

In case of cryogenic burn, rinse with plenty of water.

If clothing becomes saturated with oxygen, move away from the liquid oxygen source and areas that pose a risk of inflammation, and remove the clothing.

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

Only use equipment specifically approved for Medicinal Oxygen and for the pressures and temperatures of use.

Never exceed the maximum service pressure.

Provide safety devices against overpressure in oxygen liquid circuits where there is a risk of liquid accumulation between two valves.

In case of leakage, close the valve that has a leak and check that the emergency device is activated.