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 this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medicine has been prescribed only for you and should not be given to others, even if they present the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

• 1. What is OXÍGENO MEDICINAL and how is it used
• 2. What you need to know before starting to use OXÍGENO MEDICINAL
• 3. How to use OXÍGENO MEDICINAL
• 4. Possible side effects
• 5. Storage of OXÍGENO MEDICINAL
• 6. Contents of the container and 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 respirators during anesthesia-reanimation.
• Administration via nebulizer of medications for inhalation.

No use OXYGEN THERAPEUTIC

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

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use OXYGEN THERAPEUTIC.

• In certain cases of severe 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")
• Significant concentrations should be used for the shortest possible time and controlled by analyzing arterial blood gases at the same time as measuring the inhaled oxygen concentration; it is advisable to use the smallest dose capable of maintaining the partial pressure of arterial oxygen (PaO2) at 50-60 mm Hg (i.e., 5.67-8 kPa) and, after 24 hours of exposure, try to maintain an oxygen concentration below 45% as much as possible.

Precautions for use:

• In infants, due to the risk of appearance of alterations in the retina (see section "Use in infants").
• Hyperbaric 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 should be slow.

Interaction of OXYGEN THERAPEUTIC with other medications

Inform 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) should be regularly controlled to prevent it from exceeding 100 mm Hg (i.e., 13.33 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 THERAPEUTIC on driving and machine use.

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 supply of the correct amount 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 should

Reduce the concentration of inhaled oxygen and recommend symptomatic treatment.

In case of overdose, consult your doctor immediately or call the Toxicological Information Service, phone: 91 562 04 20.

If you have any doubts about the use of this product, ask your doctor or pharmacist.

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

In particular, chronic respiratory failure, there is a possibility of the appearance of apnea (temporary suspension of breathing).

The inhalation of high oxygen concentrations can cause small lung collapses.

The administration of oxygen at high pressures can cause inner ear injuries (which may pose a risk of tympanic membrane rupture), sinuses, and lungs (which may pose 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.

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

In newborns, particularly if premature, exposed to strong oxygen concentrations FiO2 > 40%; PaO2 greater than 80 mm Hg (i.e., 10.67 kPa) or for a prolonged period (more than 10 days at a concentration FiO2 > 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, which may experience regression or cause 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 regarding storage and transportation:

Storage of bottles: Bottles 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 bottles must be stored separately. Bottles must be protected from the risk of impact or falls, as well as heat sources or ignition, temperatures equal to or greater than 50 °C, and combustible materials and weather conditions. Bottles with a capacity greater than 5 L must be kept in an upright position, with the valves closed.

Storage of bottles at the user's site and at home: The bottle must be installed in a location that allows it to be protected from the risks of impact and falls (such as a support with chain fixation), heat sources or ignition, temperatures equal to or greater than 50 °C, combustible materials, and weather conditions.

Excessive storage must be avoided.

Transportation of bottles:The bottles 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 falls. Special attention must be paid to securing the reducer to prevent accidental ruptures.

During transportation in vehicles, the bottles 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.

Appearance of the product and contents of the container

MEDICAL OXYGEN is an inhalation gas that is packaged in bottles at 200 bars of pressure at 15°C. The bottles can be made of steel, compact steel, aluminum, or compact aluminum of the following volumes: 0.8 L; 1 L; 1.2 L; 1.34 L; 1.5 L; 1.8 L; 2 L; 2.7 L; 3 L; 3.5 L; 4 L; 4.75 L; 5 L; 6.7 L; 7 L; 7.5 L; 8 L; 10 L; 12 L; 13.4 L; 15 L; 18 L; 20 L; 25 L; 26.8 L; 30 L; 35 L; 40 L; 45 L, and 50 L (expressed in liters).

Only some sizes of containers may be commercially available.

Instructions for use/manipulation

Do not smoke.

Do not approach a flame.

Do not lubricate.

Particularly:

• 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, or the apparatus containing this gas, or the faucets, joints, gaskets, closure devices, and valves.
• Do not apply any greasy substance (vaseline, ointments...) to the patients' faces.
• Do not use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or nearby.

The MEDICAL OXYGEN bottles are reserved exclusively for therapeutic use.

1. To avoid any incidents, it is necessary to respect the following instructions:
2. Verify the good condition of the material before its use.
3. Group the bottles with a capacity greater than 5 L with a suitable medium (chains, hooks...) to keep them in a vertical position and prevent any unexpected fall; do not use the bottles if their pressure is less than 10 bars.
4. Never force a bottle into a support that is too narrow for it.
5. Manipulate the material with clean and grease-free hands.
6. Manipulate the 50 L or more bottles with clean handling gloves and safety shoes.
7. Verify in advance, upon delivery by the manufacturer, that the bottle is equipped with an intact inviolability guarantee system.
8. Do not manipulate a bottle whose faucet is not protected by a tulip, except for bottles with a capacity less than 5 L.
9. Do not lift the bottle by the faucet.
10. Use specific oxygen connections or flexible connection elements.
11. Use a pressure reducer with a flowmeter that can accept a pressure of at least 1.5 times the maximum service pressure (200 bars) of the bottle (except if there is already a built-in reducer on the faucet).
12. In the case of bottle holders, use only pressure gauges graduated at least to 315 bars.
13. Use flexible connection elements on wall-mounted outlets equipped with specific oxygen nozzles.
14. Open the faucet or valve progressively.
15. Never force the faucet to open it, nor open it completely.
16. Purge the outlet connection of the bottle before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the bottle and the pressure reducer clean.
17. Never subject the pressure reducer to successive pressurizations.
18. Never position yourself in front of the faucet outlet, but always on the opposite side of the pressure reducer, behind the bottle, and to the rear. Never expose patients to the gas flow.
19. Do not use intermediate connections to allow the connection of two devices that do not fit together.
20. Do not attempt to repair a defective faucet.
21. Never clamp the pressure reducer-flowmeter with pliers, under the risk of causing damage to the seal.
22. Verify in advance the compatibility of the materials in contact with oxygen, using in particular special connection seals for oxygen on the pressure reducer.
23. Close the bottle faucet after use, allow the pressure in the pressure reducer to decrease while keeping the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure reducers) the adjustment screw of the pressure reducer.
24. In case of leakage, close the faucet or the feeding valve of the defective circuit. Never use a bottle that presents a leakage defect, and check that the emergency device is activated.
25. Never empty a bottle completely.
26. Store empty bottles with the faucet closed and empty holders with the valve closed (to prevent corrosion in the presence of humidity).
27. Do not transfer gas under pressure from one bottle to another.
28. Ventilate if possible the place of use, if it is a reduced location (vehicles, home).

Holder of the marketing authorization:

ESTEVE TEIJIN HEALTHCARE, S.L.

Paseo del Ferrocarril, 369, Castelldefels,

08860 – Barcelona, Spain

Responsible for manufacturing:

MESSER IBERICA DE GASES, S.A.U.

Autovía Tarragona-Salou Km 3.8

43480 Vilaseca (Tarragona), Spain

Or

ESTEVE TEIJIN HEALTHCARE, S.L.

Av. Diagonal, 579, 8th floor,

Barcelona, 08014. Spain

Or

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

(Ctra. De Toledo 7, Aranjuez,

Madrid - Spain).

Or

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

(Ildefonso Carrascosa, parcel 20-21. Pol. Ind. Mediterráneo,

Massalfassar, Valencia - Spain).

Or

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

(Barrio Chaco s/n, Arrigorriaga,

Vizcaya - Spain).

Or

GASIN II Gases Industriais, Uniperssonal, Lda

Rua do Progresso, 53

Perafita, 4451-801 Leca da Palmeira (Portugal)

Date of the last review of this prospectus:February 2012