Prospect: information for the user

Medical Gas Carburos Metálicos, 99.5% v/v compressed medicinal gas

99.5% Oxygen v/v

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, 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 adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What it isand what it is used for

2. What you need to know before starting to useMedical Gas Carburos Metálicos

3. How to useMedical Gas Carburos Metálicos

4. Possible adverse effects

5. Storage ofMedical Gas Carburos Metálicos

6. Contents of the container and additional information

Medical Oxygen Gas Carburos Metálicos is a compressed medicinal gas thatbelongs to a group of medications known as medicinal gases. It is packaged in gas cylinders under pressure that contain only pure oxygen.

Oxygen is an essential element for the body and is administered to increase its levels in the blood and as a result achieve greater oxygen transport to all body tissues.

Oxygen treatment is indicated in the following cases:

• Correction of oxygen deficiency from various sources that require oxygen administration at normal or elevated pressure.
• Supplying ventilators in anesthesia-reanimation.
• Administration via nebulizer of inhalation medications.

No useOxygen Medical Gas Carbon Dioxide:

This medication cannot be used at high pressure in cases of untreated pulmonary collapse (untreated pneumothorax). A pulmonary collapse is an accumulation of gas in the thoracic cavity between the two lung membranes. If you have had a pulmonary collapse in the past, inform your doctor.

Warnings and precautions:

Consult your doctor or pharmacist before starting to useOxygen Medical Gas Carbon Dioxide

You must inform your doctor if you have a chronic lung disease such as bronchitis, emphysema, or asthma and in severe cases of oxygen deficiency.

- Do not apply any greasy substances (vaseline, ointments, etc.) to the face of patients due to the risk of inflammation (see Section 6).

- Because it can be toxic to the lungs or nervous system depending on the concentration and the time it is applied (see Section 3 and Section 6).

Precautions for use

- Oxygen should not be used in the presence of flammable materials: oils, lubricants, tissues, wood, paper, plastics, etc. (see Section 6).

- If oxygen is applied at high pressure (hyperbaric oxygen therapy) there may be injuries caused by the high pressure in the body cavities that contain air and are in communication with the outside. To avoid risks, compression and decompression should be slow (see Section 4).

- When using high-pressure oxygen therapy (hyperbaric oxygen therapy), you should inform your doctor in case of:

• Chronic obstructive pulmonary disease (COPD)
• A lung alteration caused by the loss of elasticity of the lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema)
• Upper respiratory tract infections
• Recent middle ear surgery
• Chest surgery at any time in the patient's life
• Uncontrolled high fever
• Severe epilepsy
• Severe claustrophobia
• If you have had a pulmonary collapse in the past: an accumulation of air or gas in the thoracic cavity between the two lung membranes (pneumothorax)

Use in children

In newborns, especially if they are premature, there may be eye damage (retrolental fibroplasia) with certain oxygen concentrations (see Section 4).

Use of Oxygen Medical Gas Carbon Dioxide with other medications

Inform your doctor or pharmacist if you are taking or have recently taken other medications, even those purchased without a prescription.

• The toxicity of oxygen may be increased if used at the same time as other medications that also affect the lungs: corticosteroids, some cancer medications (bleomycin), sympathomimetics. It may also occur in the treatment of paraquat poisoning, using X-rays, or in cases of hyperthyroidism or vitamin C and E deficiency or glutathione deficiency.
• There are reports of interaction with amiodarone. The recurrence of lung damage induced by bleomycin or actinomycin may be fatal.
• Oxygen can also worsen alcohol-induced respiratory depression
• Among the medications known to produce adverse effects are: adriamycin, menadione, promazine, chlorpromazine, thioridazine, and chloroquine. The effects will be particularly pronounced in tissues with high oxygen levels, especially the lungs.

Pregnancy and lactation

Consult your doctor or pharmacist before using any medication

During pregnancy, the use of oxygen at normal pressure (normobaric oxygen therapy) in low concentrations is permitted.

During rescue treatments, oxygen can also be used during pregnancy at high concentrations and high pressures.

There are no contraindications for using oxygen during lactation periods.

Consult your doctor or pharmacist if you need advice before taking any medication.

Driving and using machines

There is no information on the effect of oxygen on driving and using machines, so you can drive but with extreme caution.

Follow exactly the oxygen administration instructions indicated by your doctor.

Oxygen Medicinal Gas Carburos Metálicosis used by inhalation. The doctor will determine the correct dose of medicinal oxygen and administer it through an appropriate system to meet your needs, ensuring the supply of the correct amount of oxygen.

Dosage.The usual dose is:

• In patients who breathe spontaneously (spontaneous ventilation) and with acute respiratory failure, oxygen is administered at a flow rate of0.5 to15 liters/minute. This may vary according to the results of the analyses performed (blood gas analysis).
• In patients who breathe spontaneously (spontaneous ventilation) and with chronic respiratory failure, oxygen is administered at a flow rate of0.5 to2 liters/minute. This may vary according to the results of the analyses performed (blood gas analysis).
• In patients who require assistance with breathing (assisted ventilation), oxygen should be administered at a dose that allows a minimum oxygen concentration of 21%, which can reach up to 100%.

Administration form

- In patients without ventilation problems: oxygen can be administered by spontaneous ventilation with the help of nasal glasses, a nasopharyngeal tube, or a mask, which should be adapted to the oxygen flow.

- In patients with ventilation problems, or who are anesthetized, oxygen is administered through special devices such as endotracheal tube, laryngeal mask, through a tracheotomy that allows assisted ventilation, or others.

- Oxygen administration at high pressure (hyperbaric oxygen therapy) is performed in a hyperbaric chamber at a pressure of2 to3 atmospheres and the duration of the sessions is between 90 minutes and 2 hours. These sessions can be repeated between 2 and 4 times a day, depending on the indications and the clinical condition of the patient.

Treatment duration

As a general rule, high concentrations of oxygen should be used for the shortest time possible to achieve the desired result. The oxygen concentration administered should be reduced as soon as possible to the minimum necessary concentration.

• Oxygen concentrations up to 100% should not be given for more than 6 hours.
• Oxygen concentrations between 60-70% should not be given for more than 24 hours.
• Oxygen concentrations between 40-50% should not be given for the next 24 hours.
• Any oxygen concentration above 40% is potentially toxic after 2 days.

If you estimate that the action of Oxygen Medicinal Gas Carburos Metálicos is too strong or too weak, inform your doctor.

Read carefully the usage instructions (see Section 6).

If you use more Oxygen Medicinal Gas Carburos Metálicos than you should:

In some situations, too much oxygen can affect breathing and, exceptionally, produce anesthesia or unconsciousness due to carbon dioxide.

The toxic effects of oxygen vary according to the inhaled oxygen pressure and the duration of exposure.

At low pressure (from0.5 to2.0 bars), these effects are more likely to occur in the pulmonary region than in the central nervous system (brain and spinal cord). At high pressure (hyperbaric oxygen therapy), the opposite occurs.

The effects in the pulmonary region include labored breathing (hypoventilation), coughing, and chest pain. The effects in the central nervous system include nausea, dizziness, anxiety, and confusion, to muscle spasms, loss of consciousness, and epileptic seizures.

If symptoms appear, contact your doctor or hospital or call the Toxicology Information Service, phone: 91 562 04 20.

In case of overdose, the mode of action is to reduce the inhaled oxygen concentration and symptomatic treatment is recommended.

Like all medications, Medical Gas Carbonic Oxide may cause adverse effects, although not everyone will experience them.

When oxygen is administered through nasal glasses, it may cause dryness of the nasal and labial mucosa.

Adverse effects typically appear when high concentrations of oxygen (above 70%) are used and after prolonged treatment (at least 6-12 hours).

Theinfrequent adverse effects, which may affect between 1 and 10 of every 1,000 patients, are:

- Respiratory, thoracic, and mediastinal disorders: atelectasis (alveolar lung collapse), dry cough, and respiratory pain.

- With high-pressure oxygen (hyperbaric oxygen therapy): disorders of the ear and labyrinth, such as a sensation of pressure in the middle ear and rupture of the tympanic membrane.

Therare adverse effects, which may affect between 1 and 10 of every 10,000 patients, are:

- Ocular disorders: eye damage that may affect vision (retrolental fibroplasia) in premature newborns exposed to high concentrations of oxygen.

Thevery rare adverse effects, which may affect fewer than 1 of every 10,000 patients, are:

- Respiratory, thoracic, and mediastinal disorders: severe difficulty breathing due to acute pulmonary failure (Acute Respiratory Distress Syndrome).

- With high-pressure oxygen (hyperbaric oxygen therapy): nervous system disorders, such as anxiety, confusion, loss of consciousness, and epileptic seizures.

Otheradverse effects reported and of unknown frequencyare:

- Apnea (respiratory interruption): in patients with chronic respiratory insufficiency.

- Nasal sinus injuries, pneumothorax (presence of air in the thoracic cavity), nausea, dizziness, temporary loss of vision, pain, and muscle contraction with high-pressure oxygen (hyperbaric oxygen therapy).

- Panic attacks: in patients subjected to high oxygen pressures in hyperbaric chambers

- Anemia.

- Affection of different organs with high oxygen concentrations in long-term treatments: heart (it may also decrease heart rate when oxygen is administered at 100% for short periods), liver, kidneys, and lungs (pulmonary fibrosis).

- Pulmonary malformations (bronchopulmonary dysplasia), hemorrhages in different locations (subependymal and intraventricular), and intestinal damage with tissue destruction (necrotizing enterocolitis) in newborns and premature babies.

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

Maintain this medicationout of the sight and reach of children.

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

All guidelines related to the handling of pressure vessels must be followed. In relation to storage and transportation, the following must be taken into account:

Storage of gas cylinders:

Gas cylinders must be stored in a well-ventilated or ventilated 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 gas cylinders must be stored separately.

Gas 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.

Gas cylinders with a capacity greater than5 litersmust be kept in an upright position (except those with a round bottom), with the valves closed.

Storage of gas cylinders in the user service and at home:

The gas 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 gas cylinders:

Gas 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 be given to securing the reducer to avoid accidental ruptures.

During transportation in vehicles, gas cylinders must be securely fastened, preferably in an upright position. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Composition of Medical Oxygen Gas Carburos Metálicos:

- The active ingredient is Oxygen.

- No excipients.

Appearance of the product and contents of the container:

Oxygen Medical Gas Carburos Metálicos 99.5% V/V compressed gas comes in gas cylindersat 200 bar pressure at 15°C. The gas cylinders can be of different sizes and materials with a discharge valve where the gas is extracted. Some of the valves are protected by a tulip.

The gas cylinders of x liters capacity provide and (unit of volume) of gaseous oxygen at15°Cand 1 atm (see table). It may not be commercially available in all container sizes.

Fill pressure 200 bars

Holder of the marketing authorization:

SE of CARBUROS METÁLICOS, S.A.

Avenida De la Fama, 1

08940 Cornellà de Llobregat, Barcelona

SPAIN

Responsible for manufacturing:

SE CARBUROS METÁLICOS, S.A. – Alcalá de Guadaira

Seville-Málaga-Granada Highway, Km. 9.6 Industrial Park La Red 41500 – Alcalá de Guadaira - Seville (SPAIN)

SE of CARBUROS METÁLICOS, S.A. – Massalfassar

Ildefonso Carrascosa, Par. 20-21 Mediterranean Industrial Park 46560 – Massalfassar – Valencia (SPAIN)

SE of CARBUROS METÁLICOS, S.A. – Aranjuez

Toledo Road, 7 28300 – Aranjuez – Madrid (SPAIN)

SE of CARBUROS METÁLICOS, S.A. – Ca N’Estella

Dr. Fleming Street, 29 Ca N’Estella Industrial Park 08635 – Sant Esteve de Sesrovires – Barcelona (SPAIN)

SE of CARBUROS METÁLICOS, S.A. – Telde

Salinetas Industrial Urbanization 35219 – Telde – Gran Canaria (SPAIN)

SE of CARBUROS METÁLICOS, S.A. – Arrigorriaga

Chaco Neighborhood, s/n 48480 – Arrigorriaga – Vizcaya (SPAIN)

SE of CARBUROS METÁLICOS, S.A. – Marratxí

Celleters Street 142 Can Rubiol Industrial Park 07151 Marratxí – Balearic Islands (SPAIN)

GASIN II GASES INDUSTRIAIS UNIPESSOAL L.D.A. - Perafita

Rua Do Progresso 53, Perafita, 4455-533 (PORTUGAL)

Last review of this prospectus: October 2023

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.es

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This information is exclusively intended for healthcare professionals

Handling instructions:

Do not smoke.

Do not approach a flame.

Do not lubricate.

Particularly:

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy.
• Never clean with combustible products, especially if they are greasy, or the apparatus containing this gas or the valves, or the seals, or the gaskets, or the closure devices.
• Do not apply any greasy substance (vaseline, ointments, etc.) to the faces of patients inhaling the gas.
• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or nearby.

The gas cylinders of Oxygen Medical Gas Carburos Metálicos 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 gas cylinders of capacity greater than5 literswith an appropriate means (chains, hooks, etc.) to keep it in a vertical position and avoid any unexpected fall.
3. Do not use the gas cylinders if their pressure is less than 10 bar.
4. Do not force the gas cylinder into a support that is too narrow for it.
5. Handle the material with clean and grease-free hands.

1. Handle the gas cylinders of50 litersor more capacity with clean manipulation gloves and safety shoes.
2. Verify in the moment of delivery by the manufacturer that the gas cylinder is provided with an intact inviolability guarantee system.
3. Do not handle a gas cylinder whose valve is not protected by a tulip, except for gas cylinders of capacity less than5 liters.
4. Do not lift the gas cylinder by the valve.
5. Use specific connections or flexible connection elements for Oxygen.
6. Use a flow regulator with a flow meter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (except if there is already a built-in reducer on the valve).
7. Use graduated manometers with a minimum of 315 bar for the gas cylinder blocks.
8. Use flexible connection elements in the wall outlets provided with specific nozzles for Oxygen.
9. Open the valve gradually.
10. Do not force the valve to open it, nor open it completely.
11. Purge the outlet connection of the gas cylinder before incorporating the flow regulator to eliminate any dust that may have accumulated. Keep the connections between the gas cylinder and the flow regulator clean.
12. Do not subject the flow regulator to multiple successive pressurizations.
13. Do not position yourself in front of the valve outlet, but always on the opposite side of the flow regulator, behind the gas cylinder and towards the back. Do not expose patients to the gas flow.
14. Do not use intermediate connections to allow the connection of two devices that do not fit together.
15. Do not attempt to repair a defective valve.
16. Do not clamp the flow regulator-caudalímetro with pliers, under risk of causing defects in the joint.
17. Verify the compatibility of the materials in contact with Oxygen beforehand, using in particular special seals for Oxygen on the flow regulator.
18. CLOSE the valve of the gas cylinder after its use, allow the pressure of the flow regulator to decrease by leaving the flow meter open, close the flow meter and loosen the flow regulator adjustment screw (except in the case of integrated flow regulators).
19. In case of leakage, close the valve with a defect in tightness and check that the emergency device is activated.
20. Do not empty a gas cylinder completely.
21. Keep the gas cylinders and blocks with the valve closed to avoid corrosion processes in the presence of internal humidity.
22. Do not transfer gas under pressure from one gas cylinder to another.

Air out, if possible, the place of use, if it is a small space (vehicles, home).