MEDICAL AIR COMPRESSED GAS LINDE 200 BAR, COMPRESSED MEDICAL GAS

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

Warnings and precautions

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

Linde

• Before starting treatment with medicinal air, ensure that it is administered at atmospheric pressure (air pressure in the atmosphere), and the healthcare staff will adjust the manometer or indicate how to do so.

Administration of medicinal air under pressure can cause decompression sickness and oxygen toxicity. Decompression sickness can occur during the transition from excess pressure to normal pressure and can cause headache, dizziness, nausea, confusion, sometimes paralysis, and unconsciousness (even death).

Using Medicinal Air Compressed Gas Linde with other medicines

Tell your doctor or pharmacist if you are taking, have recently taken, or may need to start taking any other medicine.

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

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.

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

Driving and using machines

There is no data on the effect of Medicinal Air Compressed Gas Linde on driving and using machines.

3. How to use Medicinal Air Compressed Gas Linde

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

In case of doubt, consult your doctor again.

The doctor will determine the correct dose of Medicinal Air Compressed Gas Linde and administer it through a system suitable for your needs, ensuring the supply of the correct amount of Medicinal Air Compressed Gas Linde.

Medicinal Air Compressed Gas Linde can be used with Medicinal Oxygen whenever high oxygen concentrations are needed.

If you think the effect of Medicinal Air Compressed Gas Linde is too strong or too weak, tell your doctor.

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

Medicinal Air Compressed Gas Linde is purified ambient air, so it is a gas with an oxygen content equal to that of ambient air, eliminating any possible contamination by smoke or other irritating substances. Therefore, there is no risk of overdose associated with it.

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

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

4. Possible side effects

No side effects are known to be associated with the use of Medicinal Air Compressed Gas Linde.

Reporting side effects

If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medicines and Health Products Agency (AEMPS) website: www.notificaRAM.es

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

5. Storage of Medicinal Air Compressed Gas Linde

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

Do not use this medicine after the expiration date stated on the label after {CAD}. The expiration date is the last day of the month indicated.

All regulations regarding the handling of pressure vessels must be followed. With regard to storage and transportation, the following must be taken into account:

Storage of bottles:

Bottles must be stored in a well-ventilated or ventilated area, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked.

Empty and full bottles must be stored separately.

Bottles must be protected from the risk of impact or falls, as well as from heat sources or ignition, temperatures equal to or above 50°C, and combustible materials and weather conditions.

Bottles with a capacity greater than 5 liters must be kept in a vertical position, with the valves closed.

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 impact or falls. Special attention must be paid to securing the reducer to avoid accidental rupture risks.

During transportation in vehicles, bottles must be securely fastened, preferably in a vertical position. Smoking must be strictly prohibited.

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

The active principle is: atmospheric air

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

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

Medicinal Air Compressed Gas Linde is an odorless, colorless, and tasteless gas for inhalation that is packaged in bottles at 200 bar pressure at 15°C. The bottles are made of steel and have the following volumes:

Not all pack sizes are marketed.

Marketing authorization holder:

LINDE GAS ESPAÑA, S.A.U.

Camino de Liria, s/n,

46530 Puzol, Valencia, Spain.

Phone: 93.476.74.00

Manufacturer:

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 last revision of this leaflet: February 2009

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

-Instructions for use/manipulation

Do not smoke during use.

Do not approach an open flame.

Do not grease.

In particular:

• Never clean with combustible products, especially if they are greasy, the devices that contain this gas or the valves, gaskets, seals, or closing devices.
• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

To avoid any incidents, it is necessary to strictly follow the following instructions:

1. Check the good condition of the material before use.
2. Secure bottles with a capacity greater than 5 liters with a suitable means (chains, hooks, etc.) to keep them in a vertical position and avoid any unexpected falls.
3. Do not use bottles if their pressure is less than 10 bar.
4. Never force a bottle into a support that is too narrow for it.
5. Handle bottles of 50 liters or greater capacity with clean handling gloves and safety shoes.
6. Check at the time of delivery by the manufacturer that the bottle has an intact tamper-evident system.
7. Do not handle a bottle whose valve is not protected by a tulip, except for bottles with a capacity less than 5 liters.
8. Do not lift the bottle by holding the valve.
9. Use connections or flexible connection elements specifically designed for Medicinal Air
10. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (200 bar) of the bottle.
11. In the case of bottle blocks, use only manometers graduated to at least 315 bar.
12. Use flexible connection elements in wall outlets provided with specific nozzles for Medicinal Air.
13. Open the valve progressively.
14. Never force the valve to open, nor open it completely.
15. 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.
16. Never subject the manoreducer to several successive pressurizations.
17. Never position yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the bottle, and facing away. Never expose patients to the gas flow.
18. Do not use intermediate connections to allow the connection of two devices that do not fit together.
19. Do not attempt to repair a faulty valve.
20. Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.
21. Check beforehand the compatibility of the materials in contact with Medicinal Air, using in particular connection gaskets of the manoreducer special for Medicinal Air.
22. 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 adjustment screw.
23. In case of leakage, close the valve that has a leak and check that the emergency device is activated.
24. Never completely empty a bottle.
25. Keep bottles and blocks with the valve closed to avoid corrosion processes in the presence of internal humidity.
26. Do not transfer gas under pressure from one bottle to another.