Prospect: information for the user

MEDICAL SYNTHETIC GAS COMPRESSED MESSER 200 BAR, gas for inhalation in a bottle

Oxygen

Read this prospect thoroughly before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people, even if they present the same symptoms of disease as you, as it may harm them.
• If you experience adverse effects, consult your doctor or pharmacist, even if they do not appear in this prospect.

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

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

3. How to use Medical Synthetic Gas Compressed MESSER.

4. Possible adverse effects.

5. Storage of Medical Synthetic Gas Compressed MESSER.

6. Contents of the package and additional information.

MESSER medicinal compressed synthetic air gas belongs to a group of medications called medicinal gases.

MESSER medicinal compressed synthetic air gas is indicated for:

-Supply of respirators in anesthesia-reanimation.

-Carrier of medications for inhalation administered via nebulizer (device that transforms liquid medications into extremely fine particles forming a kind of mist or fine vapor).

Do not use MESSER Medical Synthetic Air Compressed Gas

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

Warnings and precautions

• Before starting treatment with synthetic air, ensure that 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 synthetic air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness may 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 synthetic air is mixed with other gases for inhalation, there must always be sufficient presence of oxygen (at least 22% v/v) in the gas mixture. Therefore, synthetic air mixtures with other gases must always include additional oxygen from other sources.

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

Interaction of MESSER Medical Synthetic Air Compressed Gas with other medications

Consult your doctor or pharmacist about any other medication 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 operating machinery

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

Follow exactly the administration instructions for this medication, as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Your doctor will determine the correct dose of Messer Medical Synthetic Air Compressed Gas and administer it through an appropriate system 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 instruct you on how to do so. If you need to use medical air for an extended period, it is recommended that medical air be humidified (with moisture), and healthcare personnel will do so or instruct you on how to do it.

Medical air is an inhalation gas that is administered through a special device (such as a nasal catheter or a facial mask), with a mask that fits around the head or with a tube in the trachea (tracheotomy). The device must be used as described by the manufacturer. Excess oxygen is eliminated from the body through exhalation and mixes with the surrounding air. During anesthesia, a special device with a recycling system is used, so that the exhaled air is inhaled again (a "recycling" system). If you cannot breathe independently, you may be administered medical air through a ventilation machine.

The administration method is by inhalation.

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

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

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

If you forgot to use Messer Medical Synthetic Air Compressed Gas

Do not take a double dose to compensate for the missed doses.

Like all medications, Messer's Medical Synthetic Air Compressed Gas may have adverse effects, although not everyone will experience them.

If you experience adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus.

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

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

Do not store at a temperature above 50°C.

All guidelines for handling pressure containers must be followed. The following must be taken into account for storage and transportation:

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, combustible 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 must be avoided.

Transportation of bottles:

Bottles must be transported with suitable material (such as a cart with chains, barriers, or rings) to protect them from the risk of impacts or falls. Special attention must be given to securing the reducer to avoid accidental ruptures.

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

Composition of Messer Synthetic Air Medical Compressed Gas

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

The other component is nitrogen.

Appearance of the product and contents of the packaging.

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

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

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

Not all packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder

MESSER IBÉRICA DE GASES S.A.U

Autovía Tarragona – Salou Km 3.8

43480 Vilaseca (Tarragona)

[email protected]

Responsible for manufacturing

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 prospectus was approved in October 2019.

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

This information is intended solely for healthcare professionals

The Messer Synthetic Air Medical Compressed Gas bottles are reserved exclusively for therapeutic use.

Do not smoke during use.

Do not approach a flame

Do not lubricate

Specifically:

• Do not introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy.
• Do not clean with combustible products, especially if they are greasy, or the apparatus containing this gas, or the valves, or the seals, or the gaskets, or the closure devices.
• Do not apply greasy substances (vaseline, ointments...) to the patients' faces.
• Do not use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

To avoid any incidents, the following instructions must be strictly respected:

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

2.Group the bottles with a capacity greater than 5 liters with a suitable means (chains, hooks...) to keep them in a vertical position and prevent any unexpected fall.

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

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

5.Manipulate the material with clean and grease-free hands.

6.Manipulate the 50-liter bottles or more with clean and sterile handling gloves and safety shoes.

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

8.Do not manipulate 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 the valve.

10.Use flexible connection elements in the wall outlets provided with specific nozzles for Synthetic Medical Air.

11.Use a pressure reducer with a flowmeter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bars) of the bottle (except if there is already a built-in reducer on the valve).

12.In the case of bottle blocks, use only pressure gauges graduated at least to 315 bars.

13.Open the tap or valve gradually.

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

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

16.Do not subject the pressure reducer to several 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 backwards. 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 risk of causing defects in the joint.

21.Verify prior to use the compatibility of the materials in contact with Synthetic Medical Air, using always suitable connection joints for the pressure reducer.

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

23.In case of leakage, close the valve with a leak defect. Do not use a bottle with a leak defect and check that the emergency device is activated.

24.Do not empty a bottle completely.

25.Store empty bottles and bottle blocks with the valve closed (to prevent 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 small location (home, vehicles)