Aire Medicinal Comprimido Gas Linde 200 bar, compressed medicinal gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aire Medicinal Comprimido Gas Linde 200 bar, medicinal compressed gas

Oxygen / Nitrogen

Read the entire leaflet carefully before you start using this medicine, because 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these effects are not listed in this leaflet.

Leaflet contents

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

1. What Aire Medicinal Comprimido Gas Linde is and what it is used for

Aire Medicinal Comprimido Gas Linde is an odorless, colorless, and tasteless inhalation gas
packaged in cylinders at a pressure of 200 bar at 15°C.

The therapeutic activity of Aire Medicinal is due to oxygen, which is an essential element for the body. Treatment with Aire Medicinal is indicated in the following cases:
• During respiratory therapy and/or anesthesia, as part of the inhaled gas flow to achieve adequate oxygenation (FiO₂),
• As a carrier gas in nebulizer therapy,
• As clean air for patients with reduced immunity.

2. What you need to know before starting to use Compressed Medicinal Air Gas Linde

Warnings and precautions

Consult your doctor or pharmacist before starting to use Compressed Medicinal Air Gas Linde

• Before starting treatment with medicinal air, ensure that it is administered at atmospheric pressure (the air pressure in the atmosphere). Healthcare personnel will adjust the pressure gauge for you or instruct you on how to do it.
• Administration of medicinal air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness may occur during the transition from high pressure to normal pressure and may cause headache, dizziness, nausea, confusion, and sometimes paralysis, unconsciousness (and even death).
• If medicinal air is mixed with other gases for inhalation, the gas mixture must always contain sufficient oxygen (at least 21% v/v). Therefore, mixtures of medicinal air with other gases must always include additional oxygen from other sources.

Use of Compressed Medicinal Air Gas Linde with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

No interactions between Compressed Medicinal Air Gas Linde and other medicines are known.

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.

Compressed Medicinal Air Gas Linde may be used during pregnancy and breastfeeding.

Driving and use of machines

There are no data regarding the effect of Compressed Medicinal Air Gas Linde on driving and the use of machines.

3. How to use Medicinal Air Compressed Tablets Gas Linde

Follow exactly the administration instructions for this medicine as indicated by your doctor.

If in doubt, consult your doctor again.

Your doctor will determine the correct dose of Medicinal Air Compressed Gas Linde and will administer it using a system appropriate to your needs, which will ensure the delivery of the correct amount of Medicinal Air Compressed Gas Linde.

Medicinal Air Compressed Gas Linde may be used together with Medicinal Oxygen whenever high oxygen concentrations are required.

If you feel that the effect of Medicinal Air Compressed Gas Linde is too strong or too weak, inform your doctor.

If you use more Medicinal Air Compressed Gas Linde than you should:

Medicinal Air Compressed Gas Linde is purified ambient air; therefore, it is a gas with an oxygen content equal to that of ambient air, eliminating any possible contamination from fumes or other irritating substances. For this reason, there is no risk associated with overdose.

In case of overdose or accidental ingestion, consult your doctor immediately.

Contact the Toxicology Information Service (Telephone 91 562 04 20), indicating the product and the amount inhaled.

4. Possible adverse effects

No adverse effects associated with the use of Compressed Medicinal Air Gas Linde are known.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if these are adverse effects not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Compressed Medicinal Air Gas Linde

Keep Compressed Medicinal Air Gas Linde out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the label after
{EXP}. The expiry date refers to the last day of the month indicated.

All regulations concerning the handling of pressurized containers must be observed. With regard to
storage and transport, the following points should be taken into account:

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 secured with a lock.

Empty and full cylinders must be stored separately.

Cylinders must be protected against impact or falling, as well as against 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 liters must be kept in an upright position, with valves closed.

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 care must be taken when attaching
the pressure regulator to prevent accidental breakage.

During transport in vehicles, cylinders must be securely fastened, preferably in an upright position.
Smoking must be strictly prohibited.

6. Composition of Medicinal Compressed Air Gas Linde 200 bar, inhalation gas

The active substance is: atmospheric air

• There are no other ingredients in Medicinal Compressed Air Gas Linde.
• Pharmaceutical form: Inhalation gas.

Appearance of the product and contents of the container for Medicinal Compressed Air Gas Linde 200 bar, inhalation gas

Medicinal Compressed Air Gas Linde is an odourless, colourless and tasteless inhalation gas, supplied in cylinders at a pressure of 200 bar at 15°C. The cylinders are made of steel and are available in the following volumes:

Not all pack sizes are marketed.

Marketing Authorisation Holder:

LINDE GAS ESPAÑA, S.A.U.
Camino de Liria, s/n,
46530 Puzol, Valencia, Spain.
Telephone: 93.476.74.00

Manufacturer Responsible:

LINDE GAS ESPAÑA, S.A.U.
P.I. Can Pí de Vilaroch, Avd. Antonio Gaudí, 151;
Rubí, 08191 Barcelona, Spain.

LINDE PORTUGAL Lda,
Alenquer Ic Km38 4 Chaganças,
Alenquer, 2580381, Portugal;

Date of most recent review of this leaflet: February 2009

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

-Instructions for Use/Handling

Do not smoke during use.
Do not bring near a flame.
Do not grease.

In particular:

• Never clean with flammable products, especially those of a greasy nature, either the equipment containing this gas or the valves, seals, gaskets, or closure devices.
• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

To prevent any incident, the following instructions must be strictly observed:

1. Check the equipment is in good condition before use.
2. Secure cylinders with a capacity greater than 5 litres in an upright position using suitable means (chains, hooks, etc.) to prevent unexpected falls.
3. Do not use cylinders if their pressure is below 10 bar.
4. Never force a cylinder into a support that is too narrow.
5. Handle cylinders of 50 litres or greater capacity using clean handling gloves and safety shoes.
6. At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-proof seal.
7. Do not handle a cylinder whose valve is not protected by a cap, except for cylinders with a capacity below 5 litres.
8. Never lift the cylinder by the valve.
9. Use connections or flexible connecting components specifically designed for Medicinal Air.
10. Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the cylinder's maximum service pressure (200 bar).
11. In the case of cylinder banks, use only pressure gauges calibrated to at least 315 bar.
12. Use flexible connecting components on wall outlets equipped with nozzles specifically designed for Medicinal Air.
13. Open the valve gradually.
14. Never force the valve to open it, nor open it fully.
15. Purge the cylinder outlet connection before attaching the pressure regulator to remove any dust that may be present. Keep connections between the cylinder and pressure regulator clean.
16. Never subject the pressure regulator to repeated pressurizations.
17. Never stand in front of the valve outlet; always stand on the side opposite the pressure regulator, behind the cylinder and to the rear. Never expose patients to the gas stream.
18. Do not use intermediate connectors to connect two devices that are not compatible with each other.
19. Do not attempt to repair a defective valve.
20. Never tighten the pressure regulator-flowmeter with pliers, as this may damage the seal.
21. Check beforehand the compatibility of materials in contact with Medicinal Air, particularly by using pressure regulator connecting seals specifically designed for Medicinal Air.
22. After use, close the cylinder valve, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, close the flowmeter, and then (except in the case of integrated pressure regulators) loosen the pressure regulator adjusting screw.
23. In case of leakage, close the valve with the sealing defect and check that the emergency device is activated.
24. Never completely empty a cylinder.
25. Store cylinders and cylinder banks with the valve closed to prevent corrosion processes due to internal moisture.
26. Never transfer pressurized gas from one cylinder to another.