Leaflet: information for the user

MESSEER MEDICAL LIQUID OXYGEN

Medical oxygen 99.5% v/v

Oxygen

Read this leaflet carefully before you start using the 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 should not be given to other people, even if they have the same symptoms of illness as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What is Messer medical liquid oxygen and how is it used

2. What you need to know before starting to use Messer medical liquid oxygen

3. How to use Messer medical liquid oxygen

4. Possible side effects

5. Storage of Messer medical liquid oxygen

6. Contents of the container and additional information

Messer Medical Liquid Oxygen is an inhalation gas that is packaged in containers that are cryogenic tanks

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

• Correction of oxygen deficiency of different origins that require oxygen administration at normal or elevated pressure.
• Supply of respirators in anesthesia - resuscitation.
• Administration via nebulizer of inhalation medications.

Do not use Messer Medical Liquid Oxygen

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, flame, or ignition point, or under the effects of adiabatic compression.

Warnings and precautions

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

Significant concentrations must be used for the shortest possible time and controlled through analysis of arterial blood gases, at the same time as measuring the concentration of inhaled oxygen. 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 greater than 30%, the partial pressure of arterial oxygen (PaO2) must 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 high pressure, in body cavities containing air and in communication with the outside, compression and decompression must be slow.

Interaction of Messer Medical Liquid Oxygen 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, breastfeeding, and fertility

It has been widely used without any notable effect.

Driving and operating machines

There are no data on the effect of Messer Medical Liquid Oxygen on driving and operating machines.

The doctor will determine the correct dose of Medical Oxygen and administer it through an appropriate system that will ensure the supply of the correct amount of oxygen.

If you estimate that the action of Medical Oxygen is too strong or too weak, inform your doctor.

If you use more Messer Medical Liquid Oxygen than you should:

Reduce the concentration of inhaled oxygen and symptomatic treatment is recommended.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medications,MEDICAL LIQUID OXYGEN MESSERcan cause adverse effects, although not everyone will experience them.

In particular, chronic respiratory insufficiency, possibility of apnea occurrence.

The inhalation of high oxygen concentrations can be a cause of small lung collapses.

The administration of oxygen at high pressures can cause inner ear injuries (possibly posing a risk of tympanic membrane rupture), sinuses, lungs (possibly posing a risk of pneumothorax).

Seizures have been registered after oxygen administration 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 premature ones, 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, possibly experiencing regression or causing retinal detachment, or even permanent blindness.

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

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

Keep out of the sight and reach of children

The containers must be installed in clean and well-ventilated areas, away from flammable and combustible materials, protected from heat and ignition sources.

The containers must be protected from shocks, especially from filling, emptying, and safety elements.

The storage of gases intended for medical use must be separated from gases intended for other uses.

No parking should be done in the area of the fixed container filling zone.

Do not use Messer Medical Liquid Oxygen after the expiration date appearing on the packaging. The expiration date is the last day of the month indicated.

MEDICAL LIQUID OXYGEN MESSER COMPOSITION

-The active ingredient is Oxygen.

-Without excipients

Aspect of the product and contents of the package

MEDICAL LIQUID OXYGEN MESSER is an inhalation gas that is packaged in cryogenic containers of the following volumes:

Cryogenic mobile container of the following capacities (in liters): 0.4, 0.8, 1.2, 21, 30, 31, 37, 41, 45, 50, 60, 120, 180, 196, 240, 448, 659, 897, and 996.

Cryogenic fixed container of the following capacities (in liters): 1900, 1975, 2650, 3200, 3300, 3370, 4700, 4820, 5520, 6000, 7000, 7900, 9540, 10530, 11000, 11700, 14250, 21600, 25580, 29450, 29900, 34850, 40500, 40900, 52600, 52840, 59040, and 62300.

Holder of the marketing authorization and responsible for manufacturing

Holder

Messer Ibérica de gases S.A.

Autovía Tarragona- Salou, Km 3,8

43480 Vilaseca (Tarragona)

Responsible for manufacturing:

Messer Ibérica de gases S.A.

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)

Linde Gas España SAU

Pol. Industrial Can Pí de Vilaroch. Avinguda Antoní Gaudí, 151

08191 Rubí (Barcelona)

Linde Gas España SAU

Calle Del Pico Ocejon 40

19190 Torija (Guadalajara)

This information is intended solely for healthcare professionals

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not lubricate.

Specifically:

1. Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are of a greasy nature.
2. Never clean with combustible products, especially if they are of a greasy nature, nor the apparatuses that contain this gas nor the faucets, joints, gaskets, closure devices, and valves.
3. Do not apply any greasy substance (vaseline, ointments...) to the patients' faces.
4. Do not use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

The MESSER medical liquid oxygen tanks are reserved exclusively for therapeutic use.

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

1. Verify the correct state of all materials before use.
2. Handle the containers with protective glasses and clean gloves intended for this use.
3. Do not touch the cold or frosty parts of the material without proper protection.
4. In case of cryogenic burn, rinse with abundant water.
5. Use specific oxygen regulators.
6. If clothing becomes saturated with oxygen, move away from the oxygen liquid source and areas that pose a risk of inflammation and remove the clothing.
7. Do not use intermediate regulators that allow connecting two devices that do not fit.
8. Do not smoke near the installation.
9. Keep the tanks away from flames.
10. Open the consumption valve gradually.
11. Never force a valve to open, nor open it fully.
12. Do not attempt to repair a defective valve.
13. Use flexible connection elements in wall outlets provided with specific nozzles for oxygen.
14. In case of leakage, close the feeding valve of the defective circuit and check the emergency system operation.

Date of the last review of this prospectus:April 2025

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