Leaflet: information for the user

Linde 200 bar Medical Compressed Gas, medicinal compressed gas

Oxygen / Nitrogen

Read this 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 must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

1. What it isand what it is used for

2. What you need to know before you start takingusingAire Medicinal Comprimido Gas Linde

3. How to useAire Medicinal Comprimido Gas Linde

4. Possible side effects

5. Storage ofAire Medicinal Comprimido Gas Linde

6. Contents of the pack and additional information

Medical 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 therapeutic activity of Medical Air is due to oxygen, which is an essential element for the body. The treatment with Medical Air is indicated in the following cases:

?During respiratory therapy and/or anesthesia, as part of the inhaled gas flow to create adequate oxygenation (FiO2),

?As a carrier gas in nebulizer therapy,

?As clean air for patients with reduced immunity.

Warnings and precautions

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

Linde

• Before starting treatment with medical air, ensure it is administered at atmospheric pressure (air pressure in the atmosphere), the healthcare staff will adjust the manometer or instruct you on how to do it.

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

• If medical air is mixed with other gases for inhalation, the gas mixture must always have sufficient oxygen presence (at least 21% v/v). Consequently, medical air mixtures with other gases must always include additional oxygen from other sources.

Use of Medical Compressed Gas Linde with other medications

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

No interactions between Medical Compressed Gas Linde and other medications are known.

Pregnancy and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Medical Compressed Gas Linde may be used during pregnancy and breastfeeding.

Driving and operating machines

No data is available on the effect of Medical Compressed Gas Linde on driving and operating machines.

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

In case of doubt, consult your doctor again.

Your doctor will determine the correct dose of Medicinal Air Tablets Gas Linde and administer it through an appropriate system for your needs that will ensure the supply of the correct amount of Medicinal Air Tablets Gas Linde.

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

If you estimate that the action of Medicinal Air Tablets Gas Linde is too strong or too weak, inform your doctor.

If You Use More Medicinal Air Tablets Gas Linde Than You Should:

Medicinal Air Tablets 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 by smoke or other irritating substances. Consequently, there is no risk associated with overdose.

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

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

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

Reporting Adverse Effects

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

Reporting adverse effects can help provide more information

about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label after

{CAD}. The expiration date is the last day of the month indicated.

All guidelines related to the handling of pressure containers must be followed. In relation

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 elements, clean, without flammable materials, reserved for the storage of medical gases and

that can be locked.

Empty and full bottles must be stored separately.

Bottles must be protected from the risk of impacts or falls, as well as from 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 liters must be kept in an upright position, with the valves

closed.

Transportation of bottles:

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 impacts or falls. Special attention must be paid to securing the reducer to avoid accidental ruptures.

During transportation in vehicles, bottles must be securely fastened, preferably in an upright position. Smoking is strictly prohibited.

The active principle is: atmospheric air

- There are no other ingredients in Linde Medical Compressed Gas.

- Pharmaceutical form: inhalation gas.

Appearance of the product and packaging of Linde Medical Compressed Gas 200 bar, inhalation gas

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

All packaging sizes are not commercially available.

Holder: :

LINDE GAS ESPAÑA, S.A.U.

Camino de Liria, s/n,

46530 Puzol, Valencia, Spain.

Phone: 93.476.74.00

Responsible for manufacture:

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;

Last review date of this prospectus: February 2009

The detailed information of this medication is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS)

http://www.aemps.gob.es

-Instructions for Use/Handling

Do not smoke while using it.

Do not approach a flame.

Do not lubricate.

Especially:

- Do not clean with flammable products, especially if they are greasy, or the devices that contain this gas or the valves, or the joints, or the gaskets, or the closure devices.

- Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

To avoid any incident, it is necessary to respect the following instructions:

1. Verify the good condition of the material before its use.

2. Secure the bottles with a capacity greater than 5 liters with an appropriate means (chains, hooks, etc.) to keep it in a vertical position and avoid any unexpected fall.

3. Do not use the bottles if their pressure is less than 10 bar.

4. Do not force a bottle into a support that is too narrow for it.

5. Handle the 50-liter bottles or larger with clean handling gloves and safety shoes.

6. Verify at the time of delivery by the manufacturer that the bottle is provided with an intact inviolability guarantee 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 the valve.

9. Use specific connections or flexible connection elements for Medical Air.

10. Use a pressure reducer with a flowmeter that can admit 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 graduated pressure gauges of at least 315 bar.

12. Use flexible connection elements on wall outlets provided with specific nozzles for Medical Air.

13. Open the valve gradually.

14. Do not force the valve to open it, nor open it completely.

15. Purge the outlet connection of the bottle before incorporating the pressure reducer to eliminate the dust that may have accumulated. Keep the connections between the bottle and the pressure reducer clean.

16. Do not subject the pressure reducer to multiple successive pressurizations.

17. Do not position yourself in front of the valve outlet, but always on the opposite side of the pressure reducer, behind the bottle and to the rear. Do not 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 defective valve.

20. Do not tighten the pressure reducer-flowmeter with pliers, under the risk of causing defects in the joint.

21. Verify in advance the compatibility of the materials in contact with Medical Air, using in particular special connection joints for the pressure reducer.

22. Close the bottle valve after use, allow the pressure of the pressure reducer to decrease by leaving the flowmeter open, close the flowmeter and then loosen (except in the case of integrated pressure reducers) the adjustment screw of the pressure reducer.

23. In case of leakage, close the valve with a defect in tightness and check that the emergency device is activated.

24. Do not empty a bottle completely.

25. Keep the 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.