SYNTHETIC AIR MEDICINAL COMPRESSED GAS MESSER 200 BAR, GAS FOR INHALATION IN A CYLINDER

Introduction

Package Leaflet: Information for the User

Synthetic Air Medical Compressed Gas MESSER 200 BAR, Gas for Inhalation in Bottle

Oxygen

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication 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 listed in this package leaflet.

Contents of the Package Leaflet:

1. What Synthetic Air Medical Compressed Gas MESSER is and what it is used for.
2. What you need to know before starting to use Synthetic Air Medical Compressed Gas MESSER.
3. How to use Synthetic Air Medical Compressed Gas MESSER.
4. Possible side effects.
5. Storage of Synthetic Air Medical Compressed Gas MESSER.
6. Package Contents and Additional Information.

1. What Synthetic Air Medical Compressed Gas MESSER is and what it is used for

Synthetic Air Medical Compressed Gas MESSER belongs to a group of medications called medical gases.

Synthetic Air Medical Compressed Gas MESSER is indicated for:

- Feeding respirators in anesthesia-reanimation.

- Vector of medications for inhalation administered through a nebulizer (a device that transforms liquid medications into very fine particles that form a kind of mist or fine vapor).

2. What you need to know before starting to use Synthetic Air Medical Compressed Gas MESSER

Do not use Synthetic Air Medical Compressed Gas MESSER

No situations are known in which Synthetic Air Medical should not be used.

Warnings and Precautions

• Before starting treatment with synthetic air medical, ensure that it is administered at atmospheric pressure (air pressure in the atmosphere). Healthcare personnel will adjust the manometer or indicate how to do so.
• Administration of synthetic air medical 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).

If synthetic air medical is mixed with other gases for inhalation, the gas mixture should always contain sufficient oxygen (at least 22% v/v). Consequently, mixtures of synthetic air medical with other gases should always include additional oxygen from other sources.

If you administer synthetic air medical at high flow rates (high speed in flow), you may feel cold to the touch.

Interaction of Synthetic Air Medical Compressed Gas MESSER with other medications

Consult your doctor or pharmacist about any medications you are taking, have recently taken, or may need to take.

Pregnancy, Breastfeeding, and Fertility

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

Driving and Using Machines

No evidence has been shown that Synthetic Air Medical Compressed Gas MESSER, used at recommended doses, produces alterations in attention, reaction capacity, or ability to drive.

3. How to use Synthetic Air Medical Compressed Gas MESSER

Follow the administration instructions for this medication exactly as indicated by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The doctor will determine the correct dose of Synthetic Air Medical Compressed Gas MESSER and administer it through a system suitable for your needs.

The normal dose will vary depending on the circumstances for which the Medical Air is used.

This medication is administered at atmospheric pressure (air pressure in the atmosphere). Healthcare personnel will adjust the manometer or indicate how to do so. If you need to use Medical Air for an extended period, it is recommended that Medical Air be humidified (with humidity); healthcare personnel will do this or indicate how to do it.

Medical air is an inhalation gas administered through special equipment (such as a nasal catheter or facial mask), with a mask that fits around the head or with a tube in the trachea (tracheotomy). The device should be used as described by the manufacturer. Excess oxygen leaves the body through exhalation and mixes with the ambient air. During anesthesia, special equipment with re-inspiration or recycling systems is used so that exhaled air is inhaled again (a "re-inspiration" system). If you are unable to breathe autonomously, you may be administered medical air through a ventilation machine.

The method of administration is by inhalation.

If you use more Synthetic Air Medical Compressed Gas MESSER than you should:

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 0420.

However, if the inhaled amount is significant, go to the doctor without delay or to the emergency service of the nearest hospital. Bring this package leaflet with you.

If you forget to use Synthetic Air Medical Compressed Gas MESSER

Do not take a double dose to make up for forgotten doses.

4. Possible Side Effects

Like all medications, Synthetic Air Medical Compressed Gas MESSER can have side effects, although not everyone will experience them.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet.

5. Storage of Synthetic Air Medical Compressed Gas MESSER

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date shown on the packaging. The expiration date is the last day of the month indicated.

Do not store above 50°C.

All regulations regarding 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 area, 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, flammable materials, and weather conditions.

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

Excessive storage should be avoided.

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

During transportation in vehicles, bottles must be well secured, preferably in a vertical position. Smoking is strictly prohibited.

6. Package Contents and Additional Information

Composition of Synthetic Air Medical Compressed Gas MESSER

The active principle of Synthetic Air Medical Compressed Gas MESSER is Oxygen.

The other component is Nitrogen.

Appearance of the Product and Package Contents.

The contents of the different formats are as follows:

1L bottle containing 0.19 m3 of gas at a pressure of 1 bar at 15°C

2L bottle containing 0.39 m3 of gas at a pressure of 1 bar at 15°C

3L bottle containing 0.58 m3 of gas at a pressure of 1 bar at 15°C

5L bottle containing 0.96 m3 of gas at a pressure of 1 bar at 15°C

6.7L bottle containing 1.29 m3 of gas at a pressure of 1 bar at 15°C

7L bottle containing 1.35 m3 of gas at a pressure of 1 bar at 15°C

8L bottle containing 1.54 m3 of gas at a pressure of 1 bar at 15°C

10L bottle containing 1.93 m3 of gas at a pressure of 1 bar at 15°C

13.4L bottle containing 2.58 m3 of gas at a pressure of 1 bar at 15°C

14L bottle containing 2.70 m3 of gas at a pressure of 1 bar at 15°C

20L bottle containing 3.85 m3 of gas at a pressure of 1 bar at 15°C

27L bottle containing 5.20 m3 of gas at a pressure of 1 bar at 15°C

33.6L bottle containing 6.47 m3 of gas at a pressure of 1 bar at 15°C

40L bottle containing 7.70 m3 of gas at a pressure of 1 bar at 15°C

50L bottle containing 9.63 m3 of gas at a pressure of 1 bar at 15°C

Block of 8 bottles of 50L containing 77.04 m3 of gas at a pressure of 1 bar at 15°C

Block of 12 bottles of 50L containing 115.56 m3 of gas at a pressure of 1 bar at 15°C

Block of 18 bottles of 50L containing 173.34 m3 of gas at a pressure of 1 bar at 15°C

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Holder

MESSER IBÉRICA DE GASES S.A.U

Autovía Tarragona – Salou Km 3,8

43480 Vilaseca (Tarragona)

info.es@messergroup.com

Manufacturer

MESSER IBÉRICA DE GASES S.A.U

Autovía Tarragona – Salou Km 3,8

43480 Vilaseca (Tarragona)

MESSER IBÉRICA DE GASES S.A.U

Pol Industrial La Granadina III. C/ Francia esquina C/Grecia. Parcela 11.

03349.San Isidro (Alicante).

This package leaflet was approved in October 2019.

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

This information is intended only for healthcare professionals

Bottles of Synthetic Air Medical Compressed Gas MESSER are reserved exclusively for therapeutic use.

Do not smoke during use.

Do not bring near a flame

Do not grease

In particular:

• Never introduce this gas into a device that may contain flammable materials, especially if they are greasy.
• Never clean the devices that contain this gas, the valves, the gaskets, the seals, or the closing devices with flammable products, especially if they are greasy.
• Never apply any greasy material (vaseline, ointments...) to the face of patients.
• Never use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

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

1. Verify the good condition of the material before use.
2. Group bottles with a capacity greater than 5 liters with a suitable means (chains, hooks...) to keep them in a vertical position and avoid any unexpected falls.
3. Do not use bottles if the 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 liters 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 tamper-evident system.
8. Do not handle a bottle whose valve is not protected by a tulip, except for bottles with a capacity less than 5 liters.
9. Do not lift the bottle by holding the valve.
10. Use flexible connection elements in wall outlets equipped with specific nozzles for Synthetic Air Medical.
11. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (200 bars) of the bottle (unless a reducer is already incorporated into the valve).
12. In the case of bottle blocks, use only manometers graduated to at least 315 bars.
13. Open the tap or valve progressively.
14. Never force the tap to open it, nor open it all the way.
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 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.
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. Verify, before use, the compatibility of the materials in contact with Synthetic Air Medical, using always suitable connection gaskets for the manoreducer.
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 regulation screw.
23. In case of leakage, close the valve that has a leak. Never use a bottle that has a leak and verify that the emergency device is activated.
24. Never completely empty a bottle.
25. Keep empty bottles and bottle blocks with the valve closed (to avoid corrosion processes in the presence of humidity).
26. Do not transfer gas under pressure from one bottle to another.
27. Ventilate, if possible, the place of use, if it is a reduced location (home, vehicles).