Oxígeno medicinal Esteve Teijin 99.5% v/v gas for inhalation

Patient Information Leaflet

Introduction

Patient Information Leaflet

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

Oxygen

Read the entire leaflet carefully before you start using 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 for you only and must not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

• 1. What OXIGENO MEDICINAL is and what it is used for
• 2. What you need to know before using OXIGENO MEDICINAL
• 3. How to use OXIGENO MEDICINAL
• 4. Possible side effects
• 5. How to store OXIGENO MEDICINAL
• 6. Contents of the pack and other information

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

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

• Correction of oxygen deficiency of various origins requiring administration of oxygen at normal or increased pressure.
• Supplying anaesthetic and resuscitation ventilators.
• Administration via nebulizer of inhaled medications.

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

Do not use MEDICAL OXYGEN

With flammable materials, oxygen supports and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the pressure conditions under which the gas is used. However, the most significant fire hazards in the presence of oxygen are associated with combustible materials, especially those of a greasy nature (oils, lubricants) and organic substances (fabrics, wood, paper, plastic materials...) which may ignite upon contact with oxygen, either spontaneously or due to a spark, flame, or ignition source, or as a result of adiabatic compression.

Therefore, do not smoke or place the cylinder near sources of heat.

Warnings and precautions

Consult your doctor or pharmacist before starting to use MEDICAL 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 occur. (See section “Possible adverse effects”)
• High oxygen concentrations should be used for the shortest possible time and monitored by analysis of arterial blood gases, while simultaneously measuring the concentration of inhaled oxygen; in any case, it is advisable to use the lowest dose capable of maintaining arterial partial pressure of oxygen (PaO2) at 50–60 mm Hg (i.e., 5.67–8 kPa), and after 24 hours of exposure, to maintain, as far as possible, an oxygen concentration below 45%.

Precautions for use:

• In infants, due to the risk of developing retinal abnormalities (see section “Use in infants”).
• Hyperbaric oxygen therapy: to avoid risks of injury caused by high pressure in body cavities containing air and communicating with the outside, compression and decompression must be performed slowly.

Interaction of MEDICAL OXYGEN with other medicines

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Oxygen toxicity may be increased by: corticosteroids, certain 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 requiring an oxygen concentration above 30%, arterial partial pressure of oxygen (PaO2) must be regularly monitored to ensure it does not exceed 100 mm Hg (i.e., 13.33 kPa) due to the risk of developing retinal abnormalities (see section “Possible adverse 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 are no data regarding the effect of MEDICAL OXYGEN on driving and using machines.

3. How to use MEDICINAL OXYGEN

Follow exactly the instructions for the administration of MEDICINAL OXYGEN as indicated by your doctor. If you have any doubts, consult your doctor or pharmacist.

Your doctor will determine the correct dose of MEDICINAL OXYGEN and will administer it using a system appropriate to your needs, ensuring the delivery of the correct amount of oxygen.

If you feel that the effect of MEDICINAL OXYGEN is too strong or too weak, inform your doctor.

If you use more MEDICINAL OXYGEN than you should

The inhaled oxygen concentration should be reduced and symptomatic treatment is recommended.

In case of overdose, contact your doctor immediately or call the Toxicology Information Service at telephone number: 91 562 04 20.

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

4. Possible adverse effects

Like all medicines, MEDICAL OXYGEN may cause adverse effects, although not everybody experiences them.

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

Inhalation of high concentrations of oxygen may cause small collapses in the lung.

Administration of oxygen at high pressures may cause injuries to the inner ear (which may involve a risk of tympanic membrane rupture), sinuses, and lungs (which may involve a risk of pneumothorax).

Seizure episodes have been reported after administration of 100% oxygen for more than 6 hours, particularly when administered at high pressure.

Lung injuries may occur following administration of oxygen concentrations exceeding 80%.

In newborns, especially if premature, exposed to high oxygen concentrations (FiO2 > 40%; PaO2 above 80 mm Hg, i.e., 10.67 kPa) or for prolonged periods (more than 10 days at FiO2 > 30%), there is a risk of retinopathy, appearing between 3 and 6 weeks after treatment, which may either regress or lead to retinal detachment or even permanent blindness.

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

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform 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 expiry date stated on the container.

All regulations concerning the handling of pressurized containers must be followed.

The following considerations apply regarding storage and transport:

Storage of cylinders: Cylinders must be stored in a well-ventilated or ventilated area, protected from weather conditions, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and capable of being locked. Empty and full cylinders must be stored separately. Cylinders must be protected from impact or falling, as well as from sources of heat or ignition, temperatures equal to or above 50 °C, combustible materials, and adverse weather conditions. Cylinders with a capacity greater than 5 L must be kept in an upright position with valves closed.

Storage of cylinders at user facilities and in home settings: The cylinder must be installed in a location that protects it from impact or falling (e.g., using a stand with securing chains), sources of heat or ignition, temperatures equal to or above 50 °C, combustible materials, and adverse weather conditions.

Excessive storage must be avoided.

Transport of cylinders: Cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling. Special attention must be paid to securing the pressure regulator to prevent accidental breakage.

During transport in vehicles, cylinders must be securely grouped together. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

6. Contents of the container and other information

Composition of MEDICINAL OXYGEN

The active substance is Oxygen 99.5% v/v.

Appearance of the product and contents of the container

MEDICINAL OXYGEN is an inhalation gas packaged in cylinders at a pressure of 200 bar at 15°C. The cylinders may be made of steel, compact steel, aluminum, or compact aluminum, with the following capacities: 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 certain container sizes may be marketed.

Instructions for use/handling

Do not smoke.

Keep away from flames.

Do not grease.

In particular:

• Never introduce this gas into a device suspected of containing combustible materials, especially those of a greasy nature.
• Never clean devices containing this gas, or taps, seals, gaskets, closure devices, and valves with flammable products, especially those of a greasy nature.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (hairspray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

MEDICINAL OXYGEN cylinders are intended exclusively for therapeutic use.

1. To prevent any accidents, the following instructions must be strictly observed:
2. Check the equipment is in good condition before use.
3. Secure cylinders with a capacity greater than 5 L together using an appropriate method (chains, hooks, etc.) to keep them in an upright position and prevent unexpected falls; do not use cylinders if their pressure is below 10 bar.
4. Never force a cylinder into a holder that is too narrow.
5. Handle equipment with clean hands, free from grease.
6. Handle cylinders of 50 L or larger with clean handling gloves and safety shoes.
7. At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-proof seal.
8. Do not handle a cylinder whose tap is not protected by a cap, except for cylinders with a capacity below 5 L.
9. Never lift the cylinder by the tap.
10. Use connections or flexible connection components specifically designed for oxygen.
11. Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the maximum service pressure (200 bar) of the cylinder (unless a regulator is already integrated into the tap).
12. In the case of cylinder banks, use only pressure gauges calibrated to at least 315 bar.
13. Use flexible connection components on wall outlets equipped with nozzles specifically designed for oxygen.
14. Open the tap or valve gradually.
15. Never force the tap to open it, nor open it fully.
16. Purge the cylinder outlet connection before attaching the pressure regulator to remove any dust that may be present. Keep the connections between the cylinder and the pressure regulator clean.
17. Never subject the pressure regulator to repeated pressurizations.
18. Never stand directly in front of the tap outlet; always stand on the side opposite the pressure regulator, behind the cylinder and to the rear. Never expose patients to the gas flow.
19. Do not use intermediate connectors to connect two devices that are not compatible with each other.
20. Do not attempt to repair a defective tap.
21. Never tighten the pressure regulator-flowmeter with pliers, as this may damage the seal.
22. Check in advance the compatibility of materials in contact with oxygen, using in particular pressure regulator connection seals specifically designed for oxygen.
23. After use, close the cylinder tap, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, then close the flowmeter and loosen (except in the case of integrated pressure regulators) the pressure regulator adjustment screw.
24. In case of leakage, close the tap or circuit supply valve that has a leak. Never use a cylinder that leaks, and ensure the emergency device is activated.
25. Never completely empty a cylinder.
26. Store empty cylinders with the tap closed and empty frames with the valve closed (to prevent corrosion in the presence of moisture).
27. Do not transfer pressurized gas from one cylinder to another.
28. If possible, ventilate the area of use, especially in confined spaces (vehicles, homes).

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

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, Unipessoal, Lda

Rua do Progresso, 53

Perafita, 4451-801 Leca da Palmeira (Portugal)

Date of the most recent revision of this leaflet: February 2012