OXIGENO 99.5% v/v PULMONARY INHALATION

Contents of the leaflet

1. Introduction
2. What is MEDICINAL OXYGEN and what is it used for
3. What you need to know before starting to use MEDICINAL OXYGEN
4. How to use MEDICINAL OXYGEN
5. Possible side effects
6. Storage of MEDICINAL OXYGEN
7. Contents of the package and additional information

Introduction

Leaflet: Information for the user

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

Oxygen

Read the entire 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 doubts, consult your doctor or pharmacist.
• This medicine has been prescribed to you only, and you should not give it to others, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience side effects, consult your doctor or pharmacist, even if they are not mentioned in this leaflet.

Contents of the leaflet:

• 1. What is MEDICINAL OXYGEN and what is it used for
• 2. What you need to know before starting to use MEDICINAL OXYGEN
• 3. How to use MEDICINAL OXYGEN
• 4. Possible side effects
• 5. Storage of MEDICINAL OXYGEN
• 6. Contents of the package and additional information

1. What is MEDICINAL OXYGEN and what is it used for

Oxygen belongs to a group of medicines called medicinal gases. Treatment with oxygen is indicated in the following cases:

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

2. What you need to know before starting to use MEDICINAL OXYGEN

Do not use MEDICINAL OXYGEN

With flammable materials, oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the conditions of pressure use of the gas. However, the most significant risks of inflammation in the presence of oxygen are associated with combustible materials, especially those of a fatty nature (oils, lubricants) and organic materials (tissues, wood, paper, plastic materials...) that can ignite when in 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 bring the bottle near heat sources.

Warnings and precautions

Consult your doctor or pharmacist before starting to use MEDICINAL OXYGEN

• 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 section "Possible side effects")
• High concentrations should be used for the shortest possible time and controlled by analyzing the gases in the arterial blood, while measuring the concentration of inhaled oxygen; it is advisable to use, in any case, the smallest dose capable of maintaining the arterial partial oxygen pressure (PaO2) at 50-60 mm Hg (i.e., 5.67-8 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").
• Hyperbaric oxygen therapy: in order to avoid risks of injuries produced by the high pressure, in the body cavities that contain air and are in communication with the exterior, compression and decompression must be slow.

Interaction of MEDICINAL OXYGEN with other medicines

Tell your doctor or pharmacist if you are using or have recently used other medicines, including those purchased without a prescription.

The toxicity of oxygen can 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 deficiency.

Use in infants

For infants who need a concentration above 30%, the arterial partial oxygen pressure (PaO2) should be regularly controlled so that it does not exceed 100 mm Hg (i.e., 13.33 kPa) due to the risk of appearance of alterations in the retina (see section "Possible side effects").

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

It has been widely used without any notable effect.

Driving and using machines

There is no data on the action of MEDICINAL OXYGEN on driving and using machines.

3. How to use MEDICINAL OXYGEN

Follow exactly the administration instructions of MEDICINAL OXYGEN indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The doctor will determine the correct dose of MEDICINAL OXYGEN and administer it through a system suitable for your needs that guarantees the supply of the correct amount of oxygen.

If you think that the action of MEDICINAL OXYGEN is too strong or weak, tell your doctor.

If you use more MEDICINAL OXYGEN than you should

The concentration of inhaled oxygen should be decreased, and symptomatic treatment is recommended.

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

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

4. Possible side effects

Like all medicines, MEDICINAL OXYGEN can cause side effects, although not everyone may experience them.

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

Inhaling high concentrations of oxygen can cause small collapses in the lung.

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

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

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

In newborns, especially if they are premature, exposed to high concentrations of oxygen FiO2 > 40%; PaO2 above 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 retinopathy, which appears between 3 and 6 weeks after treatment, may experience regression or cause retinal detachment, or even permanent blindness.

Patients undergoing high oxygen pressures in chambers may experience claustrophobia crises.

If you think that any of the side effects you are experiencing is serious or if you notice any side effect not mentioned in this leaflet, tell your doctor or pharmacist.

5. Storage of MEDICINAL OXYGEN

Keep out of the reach and sight of children.

Do not use MEDICINAL OXYGEN after the expiration date that appears on the packaging.

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 bottles: Bottles must be stored in a well-ventilated or ventilated room, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked. Empty bottles and full bottles must be stored separately. Bottles must be protected from the risk of shocks or falls, as well as from heat sources or ignition, temperatures equal to or above 50 °C, and also from combustible materials and weather conditions. Bottles with a capacity greater than 5 L must be kept in a vertical position, with the valves closed.

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

Excessive storage should be avoided.

Transportation of bottles: Bottles must be transported with the help of suitable material (such as a cart with chains, barriers, or rings) to protect them from the risk of shocks or falls. Special attention must be paid to fixing the reducer to avoid accidental breakage risks.

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

6. Contents of the package and additional information

Composition of MEDICINAL OXYGEN

The active principle is Oxygen 99.5% v/v.

Appearance of the product and contents of the package

MEDICINAL OXYGEN is an inhalation gas that is packaged in bottles at 200 bars of pressure at 15°C. Bottles can be made of steel, compact steel, aluminum, or compact aluminum with 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).

Not all package sizes may be marketed.

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not grease.

In particular:

• Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are of a fatty nature.
• Never clean the devices that contain this gas or the valves, joints, gaskets, closing devices, and valves with combustible products, especially if they are of a fatty nature.
• Never apply any greasy material (vaseline, ointments...) to the face of patients.
• Never use aerosols (hair spray, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

The bottles of MEDICINAL OXYGEN are exclusively reserved for therapeutic use.

1. To avoid any incident, it is necessary to respect the following instructions obligatorily:
2. Verify the good condition of the material before its use.
3. Group bottles with a capacity greater than 5 L with a suitable means (chains, hooks...) to keep them in a vertical position and avoid any unexpected fall; do not use bottles if their pressure is less than 10 bars.
4. Never force a bottle into a support that is too narrow for it.
5. Handle the material with clean and grease-free hands.
6. Handle bottles of 50 L or more with clean handling gloves and safety shoes.
7. Verify at the time of delivery by the manufacturer that the bottle is equipped with an intact inviolability guarantee system.
8. Do not handle a bottle whose valve is not protected by a tulip, except in bottles with a capacity less than 5 L.
9. Do not lift the bottle by holding the valve.
10. Use connections or flexible connection elements specific to oxygen.
11. Use a manoreducer with a flowmeter that admits a pressure of at least 1.5 times the maximum service pressure (200 bars) of the bottle (unless there is already a reducer incorporated into the valve).
12. In the case of bottle racks, use only manometers graduated to at least 315 bars.
13. Use flexible connection elements in wall outlets equipped with specific nozzles for oxygen.
14. Open the valve or valve progressively.
15. Never force the valve to open, nor open it completely.
16. Purge the outlet connection of the bottle before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the bottle and the manoreducer clean.
17. Never subject the manoreducer to successive pressurizations.
18. Never place yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the bottle, and backwards. 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 valve.
21. Never tighten the manoreducer - flowmeter with pliers, under the risk of causing damage to the gasket.
22. Verify in advance the compatibility of materials in contact with oxygen, using in particular connection gaskets of the manoreducer special for oxygen.
23. Close the bottle valve after use, allow the pressure of the manoreducer to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated manoreducers) the manoreducer regulation screw.
24. In case of leakage, close the valve or feeding circuit valve that has a leak. Never use a bottle that has a leak, and verify that the emergency device is activated.
25. Never completely empty a bottle.
26. Keep empty bottles with the valve closed and empty racks with the valve closed (to avoid corrosion processes in the presence of humidity).
27. Do not transfer gas under pressure from one bottle to another.
28. Ventilate the place of use if possible, if it is reduced locations (vehicles, home).

Marketing authorization holder:

ESTEVE TEIJIN HEALTHCARE, S.L.

Paseo del Ferrocarril, 369, Castelldefels,

08860 – Barcelona, Spain

Manufacturer:

MESSER IBERICA DE GASES, S.A.U.

Autovía Tarragona-Salou Km 3.8

43480 Vilaseca (Tarragona), Spain

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ESTEVE TEIJIN HEALTHCARE, S.L.

Av. Diagonal, 579, Planta 8,

Barcelona, 08014. Spain

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

(Ctra. De Toledo 7, Aranjuez,

Madrid - Spain).

O

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

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

Massalfassar, Valencia - Spain).

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

(Barrio Chaco s/n, Arrigorriaga,

Vizcaya - Spain).

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GASIN II Gases Industriais, Uniperssonal, Lda

Rua do Progresso, 53

Perafita, 4451-801 Leca da Palmeira (Portugal)

Date of the last revision of this leaflet: February 2012