Oxygen Medicinal Compressed Gas Messer 200 bar, compressed medicinal gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno medicinal gas Messer 200 bar, medicinal compressed gas

Read the entire leaflet carefully before you start using this medicine, 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 medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, since it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Oxígeno medicinal gas Messer is and what it is used for
2. What you need to know before using Oxígeno medicinal gas Messer
3. How to use Oxígeno medicinal gas Messer
4. Possible side effects
5. How to store Oxígeno medicinal gas Messer
6. Contents of the pack and other information

1. What Oxígeno medicinal gas Messer is and what it is used for

Oxígeno medicinal gas comprimido Messer is a compressed gas for inhalation, packaged in gas cylinders at a pressure of 200 bar at 15ºC.

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

• Correction of oxygen deficiency of various origins requiring administration of oxygen at normal or elevated pressure.
• Supplying anaesthesia and resuscitation ventilators.
• Administration via nebuliser of inhaled medications.

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

Do not use Compressed Medicinal Oxygen gas Messer

With flammable materials, oxygen supports and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the pressure conditions under which the gas is used. However, the most significant fire risks in the presence of oxygen are associated with combustible materials, especially those of a greasy nature (oils, lubricants), and organic materials (fabrics, wood, paper, plastic materials...) which may ignite upon contact with oxygen, either spontaneously or due to a spark, flame, or ignition point, or as a result of adiabatic compression.

Warnings and precautions

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

High oxygen concentrations should be used for the shortest possible duration and monitored by arterial blood gas analysis. While measuring the inhaled oxygen concentration, it is advisable to always use the lowest dose capable of maintaining arterial partial pressure of oxygen (PaO₂) at 50–60 mm Hg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, it is recommended to maintain, as far as possible, an oxygen concentration below 45%.

For infants requiring an oxygen concentration above 30%, arterial partial pressure of oxygen (PaO₂) should be monitored regularly to ensure it does not exceed 100 mm Hg (i.e., 13.3 kPa) due to the risk of retinal abnormalities.

Hyperbaric oxygen therapy: To avoid risks of injury caused by high pressure in body cavities containing air and communicating with the outside, compression and decompression must be performed slowly.

Use of Medicinal Oxygen gas Messer with other medicines

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

Pregnancy, breastfeeding and fertility

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

Driving and use of machines

There is no evidence that Compressed Medicinal Oxygen gas Messer, when used at recommended doses, causes impairment of attention, reaction ability, or driving skills.

3. How to use Medicinal Oxygen Gas Messer

Follow exactly the instructions for administration of this medicine as given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. The doctor will determine the correct dose of compressed Medicinal Oxygen Gas Messer and will administer it using a system appropriate to your needs.

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

This medicine is administered at atmospheric pressure (air pressure in the atmosphere). Healthcare personnel will adjust the pressure gauge or instruct you on how to do so.

If you need to use Medicinal Oxygen for a prolonged period, it is recommended that the Medicinal Oxygen be humidified (moistened); healthcare personnel will perform this or instruct you on how to do it.

Medicinal Oxygen is an inhalation gas administered via a special device (such as a nasal cannula or a face mask), a mask secured around the head, or a tube inserted into the trachea (tracheostomy). The device must be used according to the manufacturer's instructions. Excess oxygen leaves the body through exhalation and mixes with the surrounding air.

The route of administration is by inhalation.

If you use more Medicinal Compressed Oxygen Gas Messer than you should:

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

However, if a significant amount has been inhaled, seek medical attention immediately or go to the nearest hospital emergency department. Bring this leaflet with you.

If you forget to use Medicinal Compressed Oxygen Gas Messer

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

4. Possible adverse effects

Like all medicines, medicinal compressed oxygen gas Messer may have adverse effects, although not everyone experiences them.

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

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

Administration of oxygen at high pressures may cause injuries to the inner ear (potentially risking rupture of the tympanic membrane), sinuses, and lungs (potentially risking pneumothorax).

Seizure episodes have been reported after administration of 100% oxygen concentration for more than 6 hours, particularly when administered under high pressure.

Pulmonary injuries may occur following administration of oxygen concentrations exceeding 80%.

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

Patients undergoing high-pressure oxygen therapy in chambers may experience claustrophobia episodes.

Reporting of adverse effects

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

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Oxygen Gas Messer

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

Do not store above 50°C.

All regulations concerning the handling of pressurized containers must be followed.

The following considerations apply to storage and transport:

Storage of gas cylinders:

Gas cylinders must be stored in a well-ventilated or ventilated area, protected from adverse weather conditions, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and capable of being secured with a lock.

Empty and full gas cylinders must be stored separately.

Gas cylinders must be protected from impact or falling, as well as from sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse 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 user facilities and in home settings:

The gas cylinder must be installed in a location that protects it from impact or falling risks (such as a stand with securing chains), sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

Excessive storage must be avoided.

Transport of gas cylinders:

Gas cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling. Special attention must be paid to securing the pressure regulator to prevent accidental breakage.

During transport in vehicles, gas cylinders must be firmly secured, preferably in an upright position. Smoking must be strictly prohibited.

6. Contents of the pack and other information

Composition of Messer Medicinal Compressed Oxygen Gas

The active substance in Messer Medicinal Compressed Oxygen Gas is Oxygen.

No excipients.

Appearance of the product and contents of the container

Messer Medicinal Compressed Oxygen Gas is a gas for inhalation, packaged in gas cylinders at a pressure of 200 bar at 15°C. The gas cylinders may be made of steel, aluminum, or alloys, with the following capacities:

• 1 L gas cylinder providing 0.2 m³ of gas. 1,2,3

• 2 L gas cylinder providing 0.4 m³ of gas. 1,2,3

• 3 L gas cylinder providing 0.6 m³ of gas. 1,2,3

• 5 L gas cylinder providing 1.1 m³ of gas. 1,2,3

• 6.7 L gas cylinder providing 1.3 m³ of gas. 1,2

• 7 L gas cylinder providing 1.5 m³ of gas. 1,2

• 8 L gas cylinder providing 1.7 m³ of gas. 1,2

• 10 L gas cylinder providing 2.1 m³ of gas. 1,2

• 13.4 L gas cylinder providing 2.8 m³ of gas. 1,2

• 14 L gas cylinder providing 3.0 m³ of gas. 1,2

• 20 L gas cylinder providing 4.3 m³ of gas. 1,2

• 27 L gas cylinder providing 5.8 m³ of gas. 1,2

• 30 L gas cylinder providing 6.4 m³ of gas. 1,2

• 33.6 L gas cylinder providing 7.1 m³ of gas. 1,2

• 40 L gas cylinder providing 8.6 m³ of gas. 1,2

• 50 L gas cylinder providing 10.7 m³ of gas. 1,2

• Bank of 8 x 50 L gas cylinders providing 85.5 m³ of gas. 1

• Bank of 12 x 50 L gas cylinders providing 128.3 m³ of gas. 1

• Bank of 18 x 50 L gas cylinders providing 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 sizes and packaging 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 most recent revision of this leaflet: March 2022

“Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/”.

Messer Medicinal Oxygen Gas cylinders are intended exclusively for therapeutic use.

Do not smoke during use.

Do not bring near open flame.

Do not grease.

In particular:

• Never introduce this gas into a device suspected of containing combustible materials, especially those of a greasy nature.
• Never clean devices containing this gas, valves, seals, gaskets, or closure devices with flammable products, especially those of a greasy nature.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

To prevent any incidents, the following instructions must be strictly observed:

1. Check the equipment is in good condition before use.
2. Securely fasten gas cylinders with a capacity greater than 5 liters using appropriate means (chains, hooks, etc.) to keep them in an upright position and prevent unexpected falls.
3. Do not use gas cylinders if the pressure is below 10 bar.
4. Never force a gas cylinder into a holder that is too narrow.
5. Handle equipment with clean hands, free from grease.
6. Handle 50-liter or larger gas cylinders with clean handling gloves and safety shoes.
7. At the time of delivery by the manufacturer, verify that the gas cylinder is equipped with an intact tamper-proof seal.
8. Do not handle a gas cylinder whose valve is not protected by a cap, except for cylinders with a capacity below 5 liters.
9. Never lift the gas cylinder by the valve.
10. Use flexible connection hoses with wall outlets fitted with specific nozzles for Medicinal Oxygen.
11. Use a pressure-reducing regulator with a flowmeter capable of withstanding at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (unless the valve already has an integrated reducer).
12. For banks of gas cylinders, use only pressure gauges calibrated to at least 315 bar.
13. Open the tap or valve gradually.
14. Never force the tap to open it, nor open it fully.
15. Purge the gas cylinder outlet connection before attaching the pressure-reducing regulator to remove any dust. Keep connections between the gas cylinder and the pressure-reducing regulator clean.
16. Never subject the pressure-reducing regulator to repeated pressurizations.
17. Never stand directly in front of the valve outlet; always stand to the side opposite the regulator, behind the gas cylinder and facing backward. Never expose patients directly to the gas flow.
18. Do not use intermediate adapters to connect two devices that are not compatible.
19. Do not attempt to repair a defective valve.
20. Never tighten the pressure-reducing regulator-flowmeter with pliers, as this may damage the seal.
21. Before use, verify the compatibility of all materials in contact with Medicinal Oxygen, always using appropriate connecting seals for the pressure-reducing regulator.
22. After use, close the gas cylinder valve, allow the pressure in the pressure-reducing regulator to dissipate by leaving the flowmeter open, close the flowmeter, and then (except for integrated pressure-reducing regulators) loosen the pressure adjustment screw on the regulator.
23. In case of leakage, close the valve with the integrity defect. Never use a gas cylinder with a leakage defect, and ensure the emergency device is activated.
24. Never completely empty a gas cylinder.
25. Store empty gas cylinders and empty cylinder banks with the valve closed (to prevent corrosion in the presence of moisture).
26. Do not transfer pressurized gas from one gas cylinder to another.
27. Whenever possible, ventilate the area of use, especially in confined spaces (homes, vehicles).