Leaflet: information for the user

OXÍGENO MEDICINAL GAS ESTEVE TEIJIN 99.5% v/v gas for inhalation

Oxygen

Read this leaflet carefully before starting to use the medicine.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medicine has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

• 1.What is OXÍGENO MEDICINAL and for what it is used
• 2.Before using OXÍGENO MEDICINAL
• 3.How to use OXÍGENO MEDICINAL
• 4.Possible adverse effects
• 5.Storage of OXÍGENO MEDICINAL
• 6.Additional information

Medical oxygen belongs to a group of medications known as medicinal gases. Oxygen treatment is indicated in the following cases:

• Correction of oxygen deficiency from various sources requiring oxygen administration at normal or elevated pressure.
• Supplying oxygen to ventilators in anesthesia-reanimation.
• Administration via nebulizer of medications for inhalation.

No use OXYGEN MEDICAL

With flammable materials.

Oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the conditions of pressure of gas use. However, the risks of inflammation are more important in the presence of oxygen, highlighting those associated with combustible compounds, especially those of fatty nature (lubricants, oils) and to organic materials (plastic materials, wood, paper, textiles) that can ignite upon contact with oxygen, either spontaneously or under the effect of a spark, a flame or an ignition point, or under the effects of adiabatic compression.

Therefore, do not smoke or approach the container to heat sources.

Be especially careful with OXYGEN MEDICAL

• 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 greater than 70%, pulmonary or neurological toxicity may appear (see section “Possible adverse effects”).
• High concentrations must be used for the shortest possible time and controlled by analyzing the gases in 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 mm Hg (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:

• In infants, due to the risk of appearance of alterations in the retina (see section “Use in infants”).
• Oxygen therapy: in order to avoid risks of injuries caused by high pressure, in body cavities containing air and communicating with the outside, compression and decompression must be slow.
• Liquid oxygen is at very low temperature (around -183°C) and can cause frostbite burns if it comes into contact with the skin, in case of occurrence, abundantly rinse with water (see section “Instructions for use/manipulation”).

Use of other medicationsInform your doctor or pharmacist if you are using or have recently used other medications, even those purchased without a prescription.

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.

Use in infants

For infants who require a concentration above 30%, the partial pressure of arterial oxygen (PaO2) must be regularly controlled to prevent it from exceeding 100 mm Hg (i.e., 13.3 kPa) due to the risk of appearance of alterations in the retina (see section “Possible adverse effects”).

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication. It has been widely used without any notable effect.

Driving and use of machines

There are no data on the effect of OXYGEN MEDICAL on driving and the use of machines.

Follow exactly the administration instructions for MEDICAL OXYGEN as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will determine the correct dose of MEDICAL OXYGEN and administer it through an appropriate system tailored to your needs, ensuring the correct supply of oxygen. If you estimate that the action of MEDICAL OXYGEN is too strong or too weak, inform your doctor.

If you use more MEDICAL OXYGEN than you shouldReduce the inhaled oxygen concentration and symptomatic treatment is recommended.

If you interrupt treatment with MEDICAL OXYGENIf you have any other questions about the use of this product, ask your doctor or pharmacist.

Like all medications, MEDICAL OXYGEN may cause adverse effects, although not all people will experience them.

In particular, chronic respiratory insufficiency, possibility of appearance of apnea (temporary suspension of breathing).

Inhalation of high oxygen concentrations may cause small lung collapses.

Administration of oxygen at high pressures may cause inner ear injuries (potentially posing a risk of tympanic membrane rupture), sinuses, lungs (potentially posing a risk of pneumothorax).

Seizures have been registered after administration of oxygen with a concentration of 100% for more than 6 hours, particularly with high-pressure administration. Lung injuries may occur after administration of oxygen concentrations above 80%.

In newborns, particularly premature ones, exposed to strong oxygen concentrations (FiO2 >40%; PaO2 above 80 mm Hg, i.e., 10.64 kPa) or for a prolonged period (more than 10 days at a FiO2 concentration > 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, potentially experiencing regression or causing retinal detachment, or even permanent blindness.

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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor or pharmacist.

Keep out of reach and sight of children.

Do not use MEDICAL OXYGEN after the expiration date shown on the packaging.

All guidelines for handling pressurized containers must be followed.

The following must be taken into account in relation to storage and transportation:

Storage of containers:

Containers must be stored in a well-ventilated or air-conditioned area, protected from the elements, clean, free from flammable materials, reserved for the storage of medical gases, and capable of being locked. Empty and full containers must be stored separately. Containers must be protected from the risk of impact or falling, as well as from heat sources or ignition, temperatures equal to or greater than 50°C, and combustible materials and weather conditions. They must be maintained in an upright position with the valves closed.

Storage of containers in the user service and at home:

The container must be installed in a location that allows it to be protected from the risks of impact and falling (such as a support with fixing chains), heat sources or ignition, temperatures equal to or greater than 50°C, combustible materials, and weather conditions, as well as heat sources that cause gasification.

Excessive storage must be avoided.

Transportation of containers:

Do not park vehicles in the oxygen transfer area.

Containers must be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of impact or falling and to maintain them in an upright position.

During transportation in vehicles, containers must be solidly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Composition of MEDICAL OXYGEN

The active principle is Oxygen 99.5% v/v.

Aspect of the product and contents of the packaging

The containers are portable cryogenic steel containers of various capacities.

Home Cryogenic Container:

Stationary Unit 20 of around 20 liters of oxygen

Stationary Unit 21 of around 21 liters of oxygen

Stationary Unit 30 of around 30 liters of oxygen

Stationary Unit 31 of around 31 liters of oxygen

Stationary Unit 36 of around 36 liters of oxygen

Stationary Unit 37 of around 37 liters of oxygen

Stationary Unit 41 of around 41 liters of oxygen

Stationary Unit 45 of around 45 liters of oxygen

Stationary Unit 46 of around 46 liters of oxygen

Stationary Unit 60 of around 60 liters of oxygen

Instructions for use/manipulation

Do not smoke.

Do not approach a flame.

Do not grease.

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

• Oxygen is a gas heavier than air, which can accumulate in low points after vaporization of the liquid and make the atmosphere hazardous.
• Oxygen at atmospheric pressure is a very cold liquid (around -183°C) and can cause cold burns if it comes into contact with the skin in the event of splashes or handling of the liquid without the use of suitable protective equipment. In the event of a cold burn, abundantly rinse with water.
• One liter of liquid oxygen releases 850 liters of gas by vaporization and warming to ambient temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore the necessary precautions for overpressures in closed volumes (equipment and installations) and overoxygenation of materials and the atmosphere of rooms must be taken.

The oxygen medicinal containers are reserved exclusively for therapeutic use.

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

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are of a greasy nature.
• Never clean with combustible products, especially if they are of a greasy nature, nor the apparatuses that contain this gas nor the faucets, joints, gaskets, closure devices, and valves.
• Do not apply any greasy substance (vaseline, ointments, etc.) to the patients' faces.
• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.
• Avoid exposure to heat sources (kitchens, radiators, chimneys, etc.) or prolonged solar heating.
• Ventilate if possible the place of use, if it is a reduced location (vehicles, home).
• Verify the good state of the material before its use.
• Verify at the time of delivery by the manufacturer that the container is provided with an intact inviolability guarantee system.
• Manipulate the material with clean and grease-free hands.
• For the manipulation of cryogenic containers, the indicated protective equipment (glasses or visors, clean gloves intended for that use, adaptation of clothing, etc.) must be used and the described instructions and precautions for the operation must be followed.
• Group the containers and keep them in a vertical position.
• Use specific connections or flexible connection elements for oxygen.
• Use only equipment specifically approved for this product and for the pressure and temperature of use.
• Provide safety devices against overpressures in each zone of the circuit where liquid oxygen residues may be left between two valves.
• Never touch the cold or frozen parts of the apparatuses.
• Do not use intermediate connections to allow the connection of two devices that do not fit together.
• The small cryogenic containers (Stationary Units) or their auxiliary equipment (portable units or backpacks) may be equipped with accessory elements for use (humidifier, flowmeter, nasal mask or goggles, etc.). These equipment will be used according to the prescription conditions (flow rates, doses, etc.).
• Open the valves slowly and close them when the product is not in use.
• Never force any part of the cryogenic container or attempt to repair defective valves, in the event of problems, contact the supplier.
• Never use a container with leaks.
• If the clothing becomes saturated with oxygen, move away from the oxygen liquid source and from areas that present a risk of ignition. Remove the clothing as well.
• In the event of a cryogenic burn (cold), abundantly rinse with water.
• Do not allow the retrograde of substances into the container. Prevent the entry of water into the container.
• Do not keep the valve of the equipment open if it is not in use.

Holder of the marketing authorization:

ESTEVE TEIJIN HEALTHCARE, S.L.

Paseo del Ferrocarril, 369, Castelldefels,

08860 – Barcelona, Spain

Responsible for manufacturing:

ESTEVE TEIJIN HEALTHCARE, S.L.

Av. Diagonal, 579, 8th floor,

Barcelona, 08014. Spain

Or

MESSER IBERICA DE GASES, S.A.U.

Autovía Tarragona-Salou Km 3.8

Vilaseca (Tarragona) Spain

Or

S.E. DE CARBUROS METALICOS, S.A.

Barrio Chaco s/n, Arrigorriaga – Vizcaya, SPAIN

Or

S.E. DE CARBUROS METALICOS, S.A.

Pol. Ind. Ca N'Estella. Doctor Fleming, 29, San Esteve de Sesrovires,

Barcelona – SPAIN

This prospectus was approved in JANUARY 2011

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