MEDICAL OXYGEN GAS OXIGEN SALUD 99.5% V/V 200 bar COMPRESSED MEDICAL GAS

Introduction

Leaflet: information for the user

Medicinal Oxygen Gas Oxigen Salud 99.5% v/v 200 bar compressed medicinal gas

Read this leaflet carefully before starting to use 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, pharmacist, or nurse.
• This medicine 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 side effects not listed in this leaflet. If you consider any of the side effects you are suffering from to be serious, or if you notice any side effect not mentioned in this leaflet, inform your doctor or pharmacist. See section 4.

Contents of the leaflet

1. What is Oxigen Salud and what is it used for
2. What you need to know before starting to use Oxigen Salud
3. How to use Oxigen Salud
4. Possible side effects
5. Storage of Oxigen Salud
6. Package contents and additional information

1. What is 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 Oxigen Salud

Do not use 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 those 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 or pharmacist before starting to use 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 advisable to use, in any case, the smallest dose capable of maintaining the partial arterial pressure of oxygen (PaO2) at 50-60 mmHg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, try to maintain, as far as possible, a concentration of oxygen below 45%.

Precautions for use

• 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 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 and lactation

Consult your doctor or pharmacist before using any medication.

It has been widely used without any notable effects.

Driving and using machines

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

3. How to use Oxigen Salud

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

Your doctor will determine the correct dose of 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 action of Oxigen Salud is too strong or too weak, tell your doctor.

If you use more 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 interrupt the treatment with Oxigen Salud

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

4. Possible side effects

Like all medications, Oxigen Salud can cause side effects, although not everyone gets them.

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

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

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

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

Lung damage 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, may experience regression, or may cause retinal detachment, or even permanent blindness.

Patients undergoing high oxygen pressures in chambers may experience claustrophobia.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they are side effects not listed in this 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. Storage of Oxigen Salud

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

Do not use Oxigen Salud after the expiration date stated on the packaging.

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

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

Storage of cylinders:

Cylinders should 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 should be stored separately.

Cylinders should 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 also from combustible materials and weather conditions. Cylinders with a capacity greater than 5 liters should be kept in a vertical position, with the valves closed.

Storage of cylinders in the user service and at home:

The cylinder should 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 should 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 also be paid to securing the reducer to avoid accidental breakage risks.

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

6. Container Content and Additional Information

Composition of Oxígeno Medicinal Gas Oxigen Salud

• The active ingredient is Oxygen 99.5% v/v

Appearance of the Product and Container Content

Oxígeno Medicinal Gas Oxigen Salud is an inhalation gas packaged in cylinders at 200 bars of pressure at 15°C. The cylinders can be made of steel, compact steel, aluminum, or compact aluminum in the following volumes

Cylinders of 0.75 L that provide 0.15 m3 at 15°C and a pressure of 1 bar.

Cylinders of 1 L; that provide 0.2 m3 at 15°C and a pressure of 1 bar.

Cylinders of 1.4 L; that provide 0.28 m3 at 15°C and a pressure of 1 bar.

Cylinders of 1.6 L; that provide 0.32 m3 at 15°C and a pressure of 1 bar.

Cylinders of 2 L; that provide 0.4 m3 at 15°C and a pressure of 1 bar.

Cylinders of 2.5 L; that provide 0.5 m3 at 15°C and a pressure of 1 bar.

Cylinders of 2.75 L; that provide 0.55 m3 at 15°C and a pressure of 1 bar.

Cylinders of 3 L; that provide 0.6 m3 at 15°C and a pressure of 1 bar.

Cylinders of 3.5 L; that provide 0.7 m3 at 15°C and a pressure of 1 bar.

Cylinders of 4 L; that provide 0.8 m3 at 15°C and a pressure of 1 bar.

Cylinders of 4.55 L; that provide 0.91 m3 at 15°C and a pressure of 1 bar.

Cylinders of 4.7 L; that provide 0.94 m3 at 15°C and a pressure of 1 bar.

Cylinders of 5 L; that provide 1 m3 at 15°C and a pressure of 1 bar.

Cylinders of 6.7 L; that provide 1.34 m3 at 15°C and a pressure of 1 bar.

Cylinders of 7 L; that provide 1.4 m3 at 15°C and a pressure of 1 bar.

Cylinders of 10 L; that provide 2 m3 at 15°C and a pressure of 1 bar.

Cylinders of 10.7 L; that provide 2.14 m3 at 15°C and a pressure of 1 bar.

Cylinders of 13 L; that provide 2.6 m3 at 15°C and a pressure of 1 bar.

Cylinders of 13.4 L; that provide 2.68 m3 at 15°C and a pressure of 1 bar.

Cylinders of 15 L; that provide 3 m3 at 15°C and a pressure of 1 bar.

Cylinders of 20 L; that provide 4 m3 at 15°C and a pressure of 1 bar.

Cylinders of 28 L; that provide 5.54 m3 at 15°C and a pressure of 1 bar.

Cylinders of 30 L; that provide 6 m3 at 15°C and a pressure of 1 bar.

Cylinders of 40 L; that provide 8 m3 at 15°C and a pressure of 1 bar.

Cylinders of 50 L; that provide 10 m3 at 15°C and a pressure of 1 bar.

Blocks 12x50 600 L; that provide 120 m3 at 15°C and a pressure of 1 bar.

Blocks 16x50 800 L; that provide 160 m3 at 15°C and a pressure of 1 bar.

Not all packaging sizes may be marketed.

Marketing Authorization Holder and Manufacturer

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

Manufacturer

OXIGEN SALUD, S.A.

Carretera Rubí 141-143

08174 San Cugat del Valles (Barcelona)

Or

OXIGEN SALUD, S.A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos)

Date of the Last Revision of the Prospectus:

November 2022.

Detailed and updated information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/

This information is intended solely for healthcare professionals

Instructions for Use/Handling

Do not smoke.

Do not approach an open 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 greasy nature;

• Never clean with combustible products, especially if they are of a greasy nature, either the devices that contain this gas or the taps, joints, gaskets, closing devices, and valves;

• Never apply any greasy substance (vaseline, ointments...) to the face of patients;

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

Medical oxygen cylinders are reserved exclusively for therapeutic use.

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

1. Verify the good condition of the material before its use.
2. Group cylinders with a capacity greater than 5 L with a suitable means (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 bars.

1. Never force a cylinder into a support that is too narrow for it.

1. Handle the material with clean and grease-free hands.

1. Handle cylinders of 50 L or more with clean handling gloves and safety shoes.

1. Verify at the time of delivery by the manufacturer that the cylinder is equipped with an intact tamper-evident system.

1. Do not handle a cylinder whose tap is not protected by a tulip, except in cylinders with a capacity less than 5 L.

1. Do not lift the cylinder by holding it by the tap.

1. Use connections or specific flexible connection elements for oxygen.

1. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (200 bars) of the cylinder (unless there is already a built-in reducer on the tap).

1. In the case of cylinder frames, use only manometers graduated to at least 315 bars.

1. Use flexible connection elements in wall outlets, equipped with specific nozzles for oxygen.

1. Open the tap or valve progressively.

1. Never force the tap to open it, nor open it completely.

1. Purge the cylinder outlet connection before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the cylinder and the manoreducer clean.

1. Never subject the manoreducer to several successive pressurizations.

1. Never position yourself in front of the tap outlet, but always on the opposite side of the manoreducer, behind the cylinder, and backwards. Never expose patients to the gas flow.

1. Do not use intermediate connections to allow the connection of two devices that do not fit together.

1. Do not attempt to repair a faulty tap.

1. Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.

1. Verify in advance the compatibility of materials in contact with oxygen, using in particular oxygen-specific connection gaskets for the manoreducer.

1. Close the cylinder tap after use, allow the manoreducer pressure to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated manoreducers) the manoreducer adjustment screw.

1. In case of leakage, close the tap or valve that supplies the circuit with the leak. Never use a cylinder that has a leak, and verify that the emergency device is activated.

1. Never completely empty a cylinder.

1. Keep empty cylinders with the tap closed and empty frames with the valve closed (to avoid corrosion processes in the presence of humidity).

1. Never transfer gas under pressure from one cylinder to another.

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