OXIGENO 100% V/V Pulmonary Inhalation

Contents of the leaflet

1. Introduction
2. What is Medicinal Oxygen Gas Messer and what is it used for
3. What you need to know before starting to use Medicinal Oxygen Gas Messer
4. How to use Medicinal Oxygen Gas Messer
5. Possible Side Effects
6. Storage of Medicinal Oxygen Gas Messer
7. Package Contents and Additional Information

Introduction

Package Leaflet: Information for the User

Medicinal Oxygen Gas Messer 200 bar, Compressed Medical Gas

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 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. See section 4.

Contents of the Package Leaflet

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

1. What is Medicinal Oxygen Gas Messer and what is it used for

Medicinal Oxygen Gas Compressed Messer is an inhalation gas that is packaged in gas cylinders at 200 bar pressure at 15°C.

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

• Correction of oxygen deficiency of various origins that require the administration of oxygen at normal or elevated pressure.
• Feeding of ventilators in anesthesia - resuscitation.
• Administration of inhalation medications via a nebulizer.

2. What you need to know before starting to use Medicinal Oxygen Gas Messer

Do not use Medicinal Oxygen Gas Compressed Messer

With flammable materials, oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the pressure conditions of use of the gas. However, the most significant risks of inflammation in the presence of oxygen are associated with combustible materials, especially those of a fatty nature (oils, lubricants) and organic materials (tissues, wood, paper, plastic materials...) that can ignite when in contact with oxygen, either spontaneously or under the effect of a spark, flame, or 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 an oxygen concentration of 100%, or after 24 hours of exposure to an oxygen concentration above 70%, pulmonary or neurological toxicity may occur.

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

For infants who require a concentration above 30%, the arterial partial oxygen pressure (PaO2) should be regularly controlled so that it does not exceed 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 high pressure, in body cavities that contain air and are in communication with the outside, compression and decompression should be slow.

Use of Medicinal Oxygen Gas Messer with other medications

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

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 Medicinal Oxygen Gas Compressed Messer, used at the recommended doses, produces alterations in attention, reaction capacity, or ability to drive.

3. How to use Medicinal Oxygen Gas Messer

Follow the administration instructions of this medication exactly, as indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. The doctor will determine the correct dose of Medicinal Oxygen Gas Compressed Messer and administer it through a system suitable for your needs.

The normal dose will vary depending on the circumstances for which the Medicinal Oxygen is used.

This medication is administered at atmospheric pressure (air pressure in the atmosphere). The healthcare personnel will adjust the manometer or indicate how to do it.

If you need to use Medicinal Oxygen for a prolonged period, it is recommended that the Medicinal Oxygen be humidified (with humidity). The healthcare personnel will do this or indicate how to do it.

Medicinal oxygen is an inhalation gas that is administered through special equipment (such as a nasal catheter or face 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. The excess oxygen leaves the body through exhalation and mixes with the ambient air.

The form of administration is by inhalation.

If you use more Medicinal Oxygen Gas Compressed 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 Medicinal Oxygen Gas Compressed Messer

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

4. Possible Side Effects

Like all medications, Medicinal Oxygen Gas Compressed Messer can have side effects, although not everyone will experience them.

In chronic respiratory failure, in particular, there is a possibility of apnea.

Inhalation of high concentrations of oxygen can cause small collapses in the lung.

Administration of oxygen at high pressures can cause injuries to the inner ear (which can pose a risk of rupture of the eardrum), sinuses, lungs (which can pose a risk of pneumothorax).

Convulsive crises have been reported after administration of oxygen with a concentration of 100% for more than 6 hours, particularly with administration at high pressure.

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

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

Patients undergoing high oxygen pressures in chambers may experience claustrophobia crises.

Reporting Side Effects

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

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

5. Storage of Medicinal Oxygen Gas Messer

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 regulations regarding the handling of pressure vessels must be followed.

Regarding storage and transportation, the following must be taken into account:

Storage of gas cylinders:

Gas cylinders 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 gas cylinders must be stored separately.

Gas cylinders 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, combustible materials, and weather conditions.

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

Excessive storage should be avoided.

Storage of gas cylinders in the user service and at home:

The gas cylinder should be installed in a location that allows it to be protected from the risk of shocks 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 should be avoided.

Transportation of gas cylinders:

Gas cylinders 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 shocks or falls. Special attention should be paid to securing the reducer to avoid accidental breakage risks.

During transportation in vehicles, gas cylinders must be properly secured, preferably in a vertical position. Smoking is strictly prohibited.

6. Package Contents and Additional Information

Composition of Medicinal Oxygen Gas Compressed Messer

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

Without excipients.

Appearance of the Product and Package Contents

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

50 L gas cylinder 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

1 Containers available with valve without integrated pressure regulator.

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

3 Containers available with pin index valve.

Not all package sizes and formats may be marketed.

Marketing Authorization Holder

Messer Ibérica de Gases S.A.U.

Autovía Tarragona – Salou Km 3.8

43480 Vilaseca (Tarragona)

[email protected]

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.

1. San Isidro (Alicante)

Date of the Last Revision of this Package Leaflet:March 2022

“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/”.

The Medicinal Oxygen Gas Messer cylinders are reserved exclusively for therapeutic use.

Do not smoke during use.

Do not approach a flame.

Do not grease.

In particular:

• Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are of a fatty nature.
• Never clean the devices that contain this gas, the valves, the gaskets, the seals, or the closing devices with combustible products, especially if they are of a fatty nature.
• Never apply any fatty material (vaseline, ointments...) to the face of patients.
• Never use aerosols (hair spray, 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. Check the good condition of the material before use.
2. Group gas cylinders 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 gas cylinders if their pressure is less than 10 bar.
4. Never force a gas cylinder into a support that is too narrow for it.
5. Handle the material with clean and grease-free hands.
6. Handle gas cylinders of 50 liters or more with clean handling gloves and safety shoes.
7. Check, when receiving the gas cylinder from the manufacturer, that it has an intact tamper-evident system.
8. Never handle a gas cylinder whose valve is not protected by a tulip, except for gas cylinders with a capacity less than 5 liters.
9. Never lift the gas cylinder by holding the valve.
10. Use flexible connection elements in wall outlets equipped with specific nozzles for Medicinal Oxygen.
11. 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 gas cylinder (unless there is already a reducer incorporated into the valve).
12. In the case of blocks of gas cylinders, use only manometers graduated to at least 315 bar.
13. Open the tap or valve progressively.
14. Never force the tap to open it, nor open it all the way.
15. Purge the gas cylinder outlet connection before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the gas cylinder 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 gas cylinder, and backwards. Never expose patients to the gas flow.
18. Never use intermediate connections to allow the connection of two devices that do not fit together.
19. Never 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 the compatibility of materials in contact with Medicinal Oxygen before use, always using suitable manoreducer connection gaskets.
22. Close the gas cylinder valve after use, allow the manoreducer pressure to decrease by leaving the flowmeter open, close the flowmeter, and then loosen the manoreducer adjustment screw (except in the case of integrated manoreducers).
23. In case of leakage, close the valve that has a leak. Never use a gas cylinder that has a leak and check that the emergency device is activated.
24. Never completely empty a gas cylinder.
25. Keep empty gas cylinders and blocks of gas cylinders with the valve closed (to avoid corrosion processes in the presence of humidity).
26. Never transfer gas under pressure from one gas cylinder to another.
27. Ventilate, if possible, the place of use, if it is a reduced location (home, vehicles...).

)