Leaflet: information for the user

Oxygen Medical Gas Oxigen Salud 99.5 % v/v compressed medicinal gas 300 bar

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

1.What is Oxygen Medical Gas Oxigen Salud and how is it used

2.What you need to know before starting to use Oxygen Medical Gas Oxigen Salud

3.How to use Oxygen Medical Gas Oxigen Salud

4.Possible side effects

5.Storage of Oxygen Medical Gas Oxigen Salud

6.Contents of the container and additional information

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 ventilators in anesthesia – resuscitation.
• Administration via nebulizer of medications for inhalation.

No use Oxygen Medical Gas Oxygen Health:

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 compounds, especially those of fatty nature (lubricants, oils) and to organic materials (plastic materials, wood, paper, textiles) 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

Consult your doctor, pharmacist or nurse before starting to useOxygen Medical Gas Oxygen Health:

• 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 a concentration of oxygen greater than 70%, pulmonary or neurological toxicity may appear.
• High concentrations should be used for the shortest possible time and controlled by analysis of arterial blood gases, at the same time as the concentration of inhaled oxygen 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., at 5.65-7.96 kPa) and, after 24 hours of exposure, to try to maintain, as far as possible, a concentration below 45%.

• For infants who require a concentration greater than 30%, the partial pressure of arterial oxygen (PaO2) should be regularly controlled to prevent it from exceeding 100 mmHg (i.e., 13.3 kPa) due to the risk of appearance 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 ofOxygen Medical Gas Oxygen Healthwithother medications

Inform your doctor or pharmacist if you are using, have used recentlyor may need to use any other medication.

The toxicity of oxygen can 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

If you are pregnant or breastfeeding, believe you may be pregnant or intend to become pregnant, consultyour doctor or pharmacist before using this medication.

It has been widely used without any notable effect.

Driving and use of machines

There are no data on the effect of Oxygen Medical Gas Oxygen Health on driving and the use of machines.

Follow exactly the administration instructions of this medication as indicated by your doctor.This medicationin case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of Medical Oxygen Gas Oxygen Health and will administer it through an appropriate system for your needs that will ensure the supply of the correct amount of oxygen.

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

The administration form is by inhalation.

If you use more Medical Oxygen Gas Oxygen Health than you should

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 inhaled.

In case of overdose, you must reduce the concentration of oxygen inhaled and symptomatic treatment is recommended.

If you forgot to use Medical Oxygen Gas Oxygen Health

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

If you interrupt the treatment with Medical Oxygen Gas Oxygen Health

If you have any other doubt about the use of thismedication, ask your doctor,pharmacist or nurse.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Particularly in chronic respiratory failure, there is a possibility of apnea (suspension of breathing while the person is sleeping).

Inhalation of high oxygen concentrations may cause small lung collapses.

Administration of oxygen at high pressures may 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 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 premature ones, exposed to strong oxygen concentrations (FiO2>40%; PaO2 above 80 mmHg, that is, 10.64 kPa) or for a prolonged period (more than 10 days at a FiO2>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.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is about possible adverse effects that do not appear in this prospectus. You can also report them directly through the Spanish System of Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es

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

Keepthis medicationout of the sight and reach of children.

Do not usethis medicationafter the expiration date that appears onthecontainerafter CAD. The expiration date is the last day of the month indicated.

All guidelines related to the handling of pressure vessels and the instructions of your specific equipment must be followed.

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

Storage of the cylinders:

The cylinders must be stored in a well-ventilated or air-conditioned 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 cylinders must be stored separately.

The cylinders 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, and combustible materials and weather conditions. Cylinders with a capacity greater than 5 L must be kept in an upright position, with the valves closed.

Storage of cylinders in the user service and at home:

The 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 greater than 50°C, combustible materials, and weather conditions.

Excessive storage must be avoided.

Transportation of cylinders:

The 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 also be given to securing the reducer to avoid accidental ruptures.

During transportation in vehicles, the cylinders must be solidly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Medicines must not be thrown down the drains or in the trash. Dispose of the containers and medicines that you no longer need at the SIGRE point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the containers and medicines that you no longer need. In this way, you will help protect the environment.

Composition of Medical Oxygen Gas Oxygen Health

• The active ingredient is Oxygen 99.5% v/v

Aspect of the product and content of the packaging

Medical Oxygen Gas Oxygen Health is an inhalation gas that is packaged in gas cylinders at 300 bars of pressure at 15°C. The cylinders can be made of steel, compact steel, aluminum, or compact aluminum of the following volumes

-Cylinder of 1 L that provides 0.306 m3of gas, equivalent to 414 g of packaged product

-Cylinder of 2 L that provides 0.611 m3of gas, equivalent to 827 g of packaged product

-Cylinder of 2.7 L that provides 0.825 m3of gas, equivalent to 1118 g of packaged product

-Cylinder of 3 L that provides 0.917 m3of gas, equivalent to 1240 g of packaged product

-Cylinder of 4.7 L that provides 1.438 m3of gas, equivalent to 1945 g of packaged product

-Cylinder of 5 L that provides 1.53 m3of gas, equivalent to 2070 g of packaged product

-Cylinder of 7 L that provides 2.14 m3of gas, equivalent to 2890 g of packaged product

-Cylinder of 10 L that provides 3.06 m3of gas, equivalent to 4140 g of packaged product

-Cylinder of 13 L that provides 3.97 m3of gas, equivalent to 5380 g of packaged product

-Cylinder of 15 L that provides 4.58 m3of gas, equivalent to 6200 g of packaged product

-Cylinder of 16 L that provides 4.89 m3of gas, equivalent to 6620 g of packaged product

-Cylinder of 20 L that provides 6.11 m3of gas, equivalent to 8270 g of packaged product

-Cylinder of 30 L that provides 9.17 m3of gas, equivalent to 12410 g of packaged product

-Cylinder of 40 L that provides 12.22 m3of gas, equivalent to 16540 g of packaged product

-Cylinder of 50 L that provides 15.28 m3of gas, equivalent to 20680 g of packaged product

-Block of 12 cylinders of 50 L that provide 183.3 m3of gas, equivalent to 248100 g of packaged product

-Block of 16 cylinders of 50 L that provide 244.5 m3of gas, equivalent to 330900 g of packaged product

Some sizes of packaging may only be commercially available.

Holder of the marketing authorization

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallés (Barcelona)

Responsible for manufacturing

OXIGEN SALUD, S. A.

Polígono Industrial, Callea A, Parcela 63.

09320 Madrigal del Monte (Burgos)

Ó

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallés (Barcelona)

Date of the last review of this prospectus:November 2022

The 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.es/

<----------------------------------------------------------------------------------------------------------------?

This information is intended solely for healthcare professionals

Instructions for use/manipulation

Do not smoke.

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, the apparatus that contains this gas or the valves, joints, seals, devices, and valves;

• 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.

The oxygen medical cylinders are reserved exclusively for therapeutic use.

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 cylinders with a capacity greater than 5 L with a suitable medium (chains, hooks…) to keep them in a vertical position and avoid any unexpected fall; do not use the cylinders if their pressure is less than 10 bar.
3. Do not force the cylinder into a too narrow support.
4. Manipulate the material with clean and grease-free hands.
5. Manipulate the 50 L or more cylinders with clean manipulation gloves and safety shoes.
6. Verify at the time of delivery by the manufacturer that the cylinder is provided with an intact inviolability guarantee system.
7. Do not manipulate a cylinder whose valve is not protected by a tulip, except for cylinders with a capacity less than 5 L.
8. Do not lift the cylinder by the valve.
9. Use specific connections or flexible connection elements for oxygen.
10. Use homologated manorreductors and that comply with the current regulations
11. Use a manorreductor with a flowmeter that can admit a pressure of at least 1.5 times the maximum service pressure (300 bar) of the cylinder (except if there is already a built-in reductor).
12. In the case of cylinder blocks, use only manometers graduated at least to 315 bar.
13. Use connectors or flexible connection elements in wall outlets provided with specific nozzles for oxygen and that are provided with specific terminations for oxygen.
14. In case of leak, close the valve or the feeding valve of the circuit.
15. Do not use a container that presents a leak of tightness, and check that the emergency device is activated.
16. Do not empty a cylinder completely.
17. Keep the empty cylinders with the valve closed and the empty containers with the valve closed (to avoid corrosion processes in the presence of humidity).
18. Do not transfer gas under pressure from one cylinder to another.

Ventilate if possible the place of use, if it is a reduced location (vehicles, homes).