Medication Information for the User

Messer 200 bar Medical Oxygen Gas, Compressed Medical Gas

Read this entire leaflet carefully before starting to use this medication, as 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 or pharmacist.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. See section 4

1. What is Messer 200 bar Medical Oxygen Gas and how is it used

2. What you need to know before starting to use Messer 200 bar Medical Oxygen Gas

3. How to use Messer 200 bar Medical Oxygen Gas

4. Possible adverse effects

5. Storage of Messer 200 bar Medical Oxygen Gas

6. Contents of the container and additional information

Messer Medical Oxygen Gas is a compressed gas for inhalation that is packaged in gas cylinders at 200 bars of pressure at 15°C.

Oxygen is an essential element for the body. Oxygen treatment is indicated in the following cases:

• Correction of oxygen deficiency from various sources requiring oxygen administration at normal or elevated pressure.
• Supplying respirators in anesthesia-reanimation.
• Administration of inhalation medications via nebulizer.

No use Messer Medical Oxygen Compressed Gas

With flammable materials, oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the conditions of pressure of use of the gas. However, the most important risks of inflammation in the presence of oxygen are associated with combustible materials, especially those of fatty nature (oils, lubricants) and organic materials (tissues, wood, paper, plastic materials...) that can ignite upon contact with oxygen, either spontaneously or under the effect of a spark, a flame or an ignition point, or under the effects of adiabatic compression.

Warnings and Precautions

In certain severe cases of oxygen deficiency. After 6 hours of exposure to a concentration of oxygen of 100%, or after 24 hours of exposure to an oxygen concentration above 70%, pulmonary or neurological toxicity may appear.

Important concentrations should be used for the shortest possible time and controlled by analysis of blood gases, at the same time as the oxygen concentration inhaled is measured. It is advisable to use in any case the smallest dose capable of maintaining the partial pressure of arterial oxygen (PaO2) at 50-60 mm Hg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, to try to maintain, as far as possible, an oxygen concentration below 45%.

For infants who require a concentration above 30%, the partial pressure of arterial oxygen (PaO2) should be regularly controlled to prevent it from exceeding 100 mm Hg (i.e., 13.3 kPa) due to the risk of retinal alterations.

Hyperbaric oxygen therapy: in order to avoid risks of injuries caused by the high pressure, in the body cavities that contain air and are in communication with the outside, compression and decompression should be slow.

Use of Messer Medical Oxygen Gas with Other Medications

The toxicity of oxygen may be increased by: corticosteroids, some cancer medications, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or vitamin C and E deficiency or glutathione deficiency.

Pregnancy, Lactation, and Fertility

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.

Driving and Operating Machines

No evidence has been shown that Messer Medical Oxygen 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 Oxygen Gas and administer it to you through an appropriate system for your needs.

The normal dose will vary depending on the circumstances for which you are using Messer Medical Oxygen.

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 it.

If you need to use Messer Medical Oxygen for an extended period, it is recommended that the Messer Medical Oxygen be humidified (with moisture), and healthcare personnel will do this or instruct you on how to do it.

Messer Medical Oxygen 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 your head or with a tube in your 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.

The administration method is by inhalation.

If you use more Messer Medical Oxygen 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 amount inhaled is significant, go to your doctor without delay or to the emergency service of the nearest hospital. Bring this leaflet with you.

If you forgot to use Messer Medical Oxygen Gas

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

Like all medications, Messer Medical Oxygen Compressed Gas may have adverse effects, although not everyone will experience them.

Particularly in chronic respiratory insufficiency, there is a possibility of apnea.

The inhalation of high oxygen concentrations may cause small lung collapses.

The administration of oxygen at high pressures may cause inner ear injuries (which may pose a risk of tympanic membrane rupture), sinuses, lungs (which may pose a risk of pneumothorax).

Seizures have been registered after administration of oxygen with a concentration of 100% for more than 6 hours, particularly with high-pressure administration.

Pulmonary injuries may occur after administration of oxygen concentrations above 80%.

In newborns, particularly if premature, exposed to strong oxygen concentrations (FiO2 > 40%; PaO2 above 80 mm Hg, i.e., 10.64 kPa) or for a prolonged period (more than 10 days at a FiO2 concentration > 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, and may experience regression or cause retinal detachment, or even permanent blindness.

Patients subjected to high oxygen pressures in chambers may experience claustrophobia crises.

Reporting Adverse Effects

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

By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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 in relation to storage and transportation:

Storage of gas cylinders:

Gas cylinders must be stored in a well-ventilated or ventilated area, protected from the elements, clean, free from flammable materials, reserved for the storage of medical gases and capable of being locked.

Empty and full gas cylinders must be stored separately.

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

Gas cylinders with a capacity greater than 5 liters must be kept in an upright position, with valves closed.

Excessive storage must be avoided.

Storage of gas cylinders at the user's service and at home:

The gas cylinder must be installed in a location that allows it to be protected from the risks of impacts and falls (such as a support with fixing chains), heat sources or ignition, temperatures equal to or above 50°C, combustible materials, and weather conditions.

Excessive storage must be avoided.

Transportation of gas cylinders:

Gas cylinders 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 given to securing the reducer to avoid accidental ruptures.

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

Messer Medical Oxygen Compressed Gas Composition

The active ingredient of Messer Medical Oxygen Compressed Gas is Oxygen.

No excipients.

Appearance of the product and contents of the container.

Messer Medical Oxygen Compressed Gas is an inhalation gas that is packaged in gas cylinders at 200 bars of pressure at 15°C. The gas cylinders can be made of steel, aluminum or alloys of the following volumes:

Gas cylinder of 1 L that provides 0.2 m3 of gas.1,2,3

Gas cylinder of 2 L that provides 0.4 m3 of gas.1,2,3

Gas cylinder of 3 L that provides 0.6 m3 of gas.1,2,3

Gas cylinder of 5 L that provides 1.1 m3 of gas.1,2,3

Gas cylinder of 6.7 L that provides 1.3 m3 of gas.1,2

Gas cylinder of 7 L that provides 1.5 m3 of gas.1,2

Gas cylinder of 8 L that provides 1.7 m3 of gas.1,2

Gas cylinder of 10 L that provides 2.1 m3 of gas.1,2

Gas cylinder of 13.4 L that provides 2.8 m3 of gas.1,2

Gas cylinder of 14 L that provides 3.0 m3 of gas.1,2

Gas cylinder of 20 L that provides 4.3 m3 of gas.1,2

Gas cylinder of 27 L that provides 5.8 m3 of gas.1,2

Gas cylinder of 30 L that provides 6.4 m3 of gas.1,2

Gas cylinder of 33.6 L that provides 7.1 m3 of gas.1,2

Gas cylinder of 40 L that provides 8.6 m3 of gas.1,2

Gas cylinder of 50 L that provides 10.7 m3 of gas.1,2

Block of 8 gas cylinders of 50 L that provides 85.5 m3 of gas.1

Block of 12 gas cylinders of 50 L that provides 128.3 m3 of gas.1

Block of 18 gas cylinders of 50 L that provides 192.4 m3 of gas.1

1Containers available with valve without integrated pressure regulator.

2Containers available with valve with integrated digital or analog pressure regulator.

3Containers available with pin index valve.

Not all sizes and formats of packaging may be commercially available.

Marketing Authorization 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)

Last review date of this leaflet:March 2022

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

Messer Medical Oxygen gas cylinders are reserved exclusively for therapeutic use.

Do not smoke during use.

Do not approach a flame

Do not lubricate

Especially:

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy.
• Never clean with combustible products, especially if they are greasy, nor the apparatus that contains this gas nor the valves, nor the joints, nor the gaskets nor 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 nearby.

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

1. Verify the good condition of the material before its use.
2. Group the gas cylinders with a capacity greater than 5 liters with a suitable medium (chains, hooks...) to keep them in a vertical position and avoid any unexpected fall.
3. Do not use the gas cylinders if their pressure is less than 10 bars.
4. Do not force the gas cylinder into a too narrow support.
5. Manipulate the material with clean and grease-free hands.
6. Manipulate the 50-liter gas cylinders or more with clean manipulation gloves and safety shoes.
7. Verify at the time of delivery by the manufacturer that the gas cylinder is provided with an intact inviolability guarantee system.
8. Do not manipulate a gas cylinder whose valve is not protected by a tulip, except for gas cylinders with a capacity less than 5 liters.
9. Do not lift the gas cylinder by the valve.
10. Use flexible connection elements in the wall outlets provided with specific nozzles for Medical Oxygen.
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 gas cylinder (except if there is already a reducer incorporated into the valve).
12. In the case of gas cylinder blocks, use only graduated manometers of at least 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 gas cylinder before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the gas cylinder 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 gas cylinder 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 the compatibility of the materials in contact with Medical Oxygen before use, using suitable connection joints for the pressure reducer.
22. Closing the valve of the gas cylinder after its use, allowing the pressure of the pressure reducer to decrease, leaving the flowmeter open, closing the flowmeter and loosening the pressure reducer regulation screw (except in the case of integrated pressure reducers).
23. In case of leakage, close the valve with a defect in tightness. Do not use a gas cylinder with a defect in tightness and check that the emergency device is activated.
24. Do not empty a gas cylinder completely.
25. Store empty gas cylinders and gas cylinder blocks with the valve closed (to avoid corrosion processes in the presence of humidity).
26. Do not transfer gas under pressure from one gas cylinder to another.
27. Air the place of use, if possible, in reduced locations (home, vehicles...

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