OXIGENO 99.5% v/v Pulmonary Inhalation

Contents of the leaflet

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

Introduction

Package Leaflet: Information for the User

Medicinal Oxygen Gas Oxigen Salud 99.5% v/v Compressed Medical Gas 300 bar

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, pharmacist, or nurse.
• 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, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What is Medicinal Oxygen Gas Oxigen Salud and what is it used for
2. What you need to know before starting to use Medicinal Oxygen Gas Oxigen Salud
3. How to use Medicinal Oxygen Gas Oxigen Salud
4. Possible side effects

5 Conservation of Medicinal Oxygen Gas Oxigen Salud

1. Package Contents and Additional Information

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

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 high pressure.
• Feeding of respirators in anesthesia - resuscitation.
• Administration of medications for inhalation via a nebulizer.

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

Do not use Medicinal Oxygen Gas Oxigen Salud:

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 compounds, especially those of a fatty nature (lubricants, oils), and organic materials (plastic materials, wood, paper, fabrics) that can ignite when in contact with oxygen, either spontaneously or under the effect of a spark, flame, or point of ignition, or under the effects of adiabatic compression.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Medicinal Oxygen Gas Oxigen Salud:

• 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 above 70%, pulmonary or neurological toxicity may appear.
• High concentrations should be used for the shortest possible time and controlled by analyzing the gases in the arterial blood, while measuring the concentration of inhaled oxygen; it is convenient to use, in any case, the lowest dose capable of maintaining the partial arterial pressure of oxygen (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, a concentration below 45%.

• For infants who need a concentration above 30%, the partial arterial pressure of oxygen (PaO2) should be regularly controlled so that it does not exceed 100 mmHg (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 Oxigen Salud with other medications

Tell your doctor or pharmacist if you are using, have recently used, or 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 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.

It has been widely used without any notable effects.

Driving and Using Machines

There is no data on the effect of Medicinal Oxygen Gas Oxigen Salud on driving and using machines.

3. How to Use Medicinal Oxygen Gas Oxigen Salud

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

Your doctor will determine the correct dose of Medicinal Oxygen Gas Oxigen Salud and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen.

If you think the effect of Medicinal Oxygen Gas Oxigen Salud is too strong or too weak, tell your doctor.

The form of administration is by inhalation.

If you use more Medicinal Oxygen Gas Oxigen Salud than you should

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

In case of overdose, the concentration of inhaled oxygen should be reduced, and symptomatic treatment is recommended.

If you forget to use Medicinal Oxygen Gas Oxigen Salud

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

If you interrupt treatment with Medicinal Oxygen Gas Oxigen Salud

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

In particular, in chronic respiratory failure, there is a possibility of apnea (suspension of breathing while sleeping).

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 lead to a risk of rupture of the eardrum), sinuses, lungs (which can lead to a risk of pneumothorax).

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

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

In newborns, especially if premature, exposed to high concentrations of oxygen (FiO2 > 40%; PaO2 above 80 mmHg, 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 can regress 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, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es

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

5. Conservation of Medicinal Oxygen Gas Oxigen Salud

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

Do not use this medication after the expiration date shown on the packaging after CAD. The expiration date is the last day of the month indicated.

All regulations regarding the handling of pressure vessels and the instructions of your particular equipment must be followed.

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

Storage of cylinders:

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 cylinders must be stored separately.

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, and combustible materials and weather conditions. Cylinders with a capacity above 5 L must be kept in a vertical position, with the valves closed.

Storage of cylinders in user services and at home:

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

Excessive storage should be avoided.

Transportation of cylinders:

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 must also be paid to securing the reducer to avoid accidental rupture risks.

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

Medications should not be thrown away through the sewers or in the trash. Deposit the packaging and medications you no longer need in the SIGRE Point of the pharmacy. If in doubt, ask your pharmacist how to dispose of the packaging and medications you no longer need. This way, you will help protect the environment.

6. Package Contents and Additional Information

Composition of Medicinal Oxygen Gas Oxigen Salud

• The active ingredient is Oxygen 99.5% v/v

Appearance of the Product and Package Contents

Medicinal Oxygen Gas Oxigen Salud is an inhalation gas packaged in 300-bar pressure cylinders at 15°C. The cylinders can be made of steel, compact steel, aluminum, or compact aluminum in the following volumes:

• 1 L cylinder that provides 0.306 m3 of gas, equivalent to 414 g of packaged product
• 2 L cylinder that provides 0.611 m3 of gas, equivalent to 827 g of packaged product
• 2.7 L cylinder that provides 0.825 m3 of gas, equivalent to 1118 g of packaged product
• 3 L cylinder that provides 0.917 m3 of gas, equivalent to 1240 g of packaged product
• 4.7 L cylinder that provides 1.438 m3 of gas, equivalent to 1945 g of packaged product
• 5 L cylinder that provides 1.53 m3 of gas, equivalent to 2070 g of packaged product
• 7 L cylinder that provides 2.14 m3 of gas, equivalent to 2890 g of packaged product
• 10 L cylinder that provides 3.06 m3 of gas, equivalent to 4140 g of packaged product
• 13 L cylinder that provides 3.97 m3 of gas, equivalent to 5380 g of packaged product
• 15 L cylinder that provides 4.58 m3 of gas, equivalent to 6200 g of packaged product
• 16 L cylinder that provides 4.89 m3 of gas, equivalent to 6620 g of packaged product
• 20 L cylinder that provides 6.11 m3 of gas, equivalent to 8270 g of packaged product
• 30 L cylinder that provides 9.17 m3 of gas, equivalent to 12410 g of packaged product
• 40 L cylinder that provides 12.22 m3 of gas, equivalent to 16540 g of packaged product
• 50 L cylinder that provides 15.28 m3 of gas, equivalent to 20680 g of packaged product
• Block of 12 cylinders of 50 L that provide 183.3 m3 of gas, equivalent to 248100 g of packaged product
• Block of 16 cylinders of 50 L that provide 244.5 m3 of gas, equivalent to 330900 g of packaged product

Not all package sizes may be marketed.

Marketing Authorization Holder

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallés (Barcelona)

Manufacturer

OXIGEN SALUD, S.A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos)

Or

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallés (Barcelona)

Date of the Last Revision of this Package Leaflet:November 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.es/

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This information is intended only for healthcare professionals

Instructions for Use/Handling

Do not smoke.

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 or the valves, gaskets, seals, closing devices, and valves with combustible products, especially if they are of a fatty nature;

• Never apply any fatty material (vaseline, pomades...) to the face of patients;

• Never use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

Medicinal oxygen cylinders are exclusively reserved for therapeutic use.

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

1. Verify the good condition of the material before use.
2. Group cylinders with a capacity above 5 L with a suitable means (chains, hooks...) to keep them in a vertical position and avoid any accidental fall; do not use cylinders if their pressure is below 10 bar.
3. Never force a cylinder into a support that is too narrow for it.
4. Handle the material with clean and grease-free hands.
5. Handle cylinders of 50 L or more with clean handling gloves and safety shoes.
6. Verify at the time of delivery by the manufacturer that the cylinder is equipped with an intact inviolability guarantee system.
7. Never handle a cylinder whose valve is not protected by a tulip, except in cylinders with a capacity below 5L.
8. Never lift the cylinder by holding the valve.
9. Use connections or flexible connection elements specifically designed for oxygen.
10. Use homologated manoreductors that comply with current regulations
11. Use a manoreductor with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (300 bar) of the cylinder (unless there is already a reducer incorporated into the valve).
12. In the case of blocks of cylinders, use only manometers graduated to at least 315 bar.
13. Use connectors or flexible connection elements in wall outlets equipped with oxygen-specific nozzles and terminated with oxygen-specific terminations.
14. In case of leakage, close the valve or feed circuit.
15. Never use a container that has a leak.
16. Open the valve or valve progressively.
17. Never force the valve to open, nor open it all the way.
18. Purge the cylinder outlet connection before incorporating the manoreductor to eliminate any dust that may be present. Keep the connections between the cylinder and the manoreductor clean.
19. Never subject the manoreductor to several successive pressurizations.
20. Never position yourself in front of the valve outlet, but always on the opposite side of the manoreductor, behind the cylinder, and backwards. Never expose patients to the gas flow.
21. Never use intermediate connections to allow the connection of two devices that do not fit together.
22. Never attempt to repair a faulty valve.
23. Never tighten the manoreductor - flowmeter with pliers, under the risk of causing damage to the gasket.
24. Verify in advance the compatibility of materials in contact with oxygen, using in particular oxygen-specific connection gaskets for the manoreductor.
25. Close the cylinder valve after use, allow the pressure of the manoreductor to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated manoreductors) the manoreductor regulation screw.
26. In case of leakage, close the valve or feed circuit that has a leak. Never use a cylinder that has a leak, and check that the emergency device is activated.
27. Never completely empty a cylinder.
28. Keep empty cylinders with the valve closed and empty frames with the valve closed (to avoid corrosion processes in the presence of humidity).
29. Never transfer gas under pressure from one cylinder to another.

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