MEDICAL OXYGEN GAS CARBIDE METALS 99.5% V/V COMPRESSED GAS

Introduction

Leaflet: Information for the user

Medicinal Oxygen Gas Carburos Metálicos, 99.5% v/v compressed medicinal gas

Oxygen 99.5% v/v

Read the entire leaflet carefully before starting to use this medication, 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 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 or pharmacist, even if they are not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What is Medicinal Oxygen Gas Carburos Metálicos and what is it used for

Medicinal Oxygen Gas Carburos Metálicos is a compressed medicinal gas that belongs to a group of medications called medical gases. It is packaged in high-pressure gas cylinders 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 consequence, achieve greater oxygen transport to all body tissues.

Treatment with oxygen is indicated in the following cases:

• Correction of oxygen deficiency from various sources that require the administration of oxygen at normal or high pressure.
• Feeding respirators in anesthesia-reanimation.
• Administration of inhalation medications via nebulizer.

2. What you need to know before starting to use Medicinal Oxygen Gas Carburos Metálicos

Do not useMedicinal Oxygen Gas Carburos Metálicos:

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

Warnings and precautions:

Consult your doctor or pharmacist before starting to useMedicinal Oxygen Gas Carburos Metálicos

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.

• No greasy substances (vaseline, ointments, etc.) should be applied 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 duration of application (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, plastic materials, ... (see Section 6).

-If oxygen is applied at high pressure (hyperbaric oxygen therapy), there may be injuries caused by the high pressure in 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 hyperbaric oxygen therapy, you should inform your doctor in case of:

• Chronic obstructive pulmonary disease (COPD)
• A lung condition caused by the loss of elasticity of lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema)
• Infections of the upper respiratory tract
• Recent middle ear surgery
• Thoracic surgery, at any time in the patient's life
• Uncontrolled high fever
• Severe epilepsy
• Claustrophobia (fear of enclosed spaces)
• If you have had a lung 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 concentrations of oxygen (see Section 4).

Use of Medicinal Oxygen Gas Carburos Metálicos with other medications

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

• The toxicity of oxygen may be increased if used at the same time as other medications that also have an effect on the lungs: corticosteroids, some cancer medications (bleomycin), sympathomimetics. This may also occur in the treatment of paraquat poisoning, when using X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione.
• There are reports of interaction with amiodarone. The recurrence of bleomycin- or actinomycin-induced lung damage can be fatal.
• Oxygen can also worsen respiratory depressions induced by alcohol
• 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 breastfeeding

Consult your doctor or pharmacist before using any medication

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

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

There are no contraindications for using oxygen during breastfeeding periods.

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

Driving and using machines

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

3. How to use Medicinal Oxygen Gas Carburos Metálicos

Follow the oxygen administration instructions indicated by your doctor exactly.

Medicinal Oxygen Gas Carburos Metálicos is used by inhalation. The doctor will determine the correct dose of medicinal oxygen and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen.

Dosage.The usual dose is:

• In patients who breathe spontaneously (spontaneous ventilation) and have acute respiratory failure, oxygen is administered at a flow rate of 0.5 to 15 liters/minute. This may vary depending on the results of the analyses performed (gasometry).
• In patients who breathe spontaneously (spontaneous ventilation) and have chronic respiratory failure, oxygen is administered at a flow rate of 0.5 to 2 liters/minute. This may vary depending on the results of the analyses performed (gasometry).
• In patients who require help breathing (assisted ventilation), oxygen should be administered at a dose that allows achieving a minimum oxygen concentration of 21%, which can reach up to 100%.

Method of administration

• 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 an endotracheal tube, laryngeal mask, through a tracheotomy that allows connection to assisted ventilation, or others.
• The administration of oxygen at high pressure (hyperbaric oxygen therapy) is performed in a hyperbaric chamber at a pressure of 2 to 3 atmospheres, and the duration of the sessions is between 90 minutes and 2 hours. These sessions can be repeated 2 to 4 times a day, depending on the indications and the patient's clinical condition.

Duration of treatment

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

• 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 more than 24 hours.
• Any oxygen concentration above 40% is potentially toxic after 2 days.

If you think the effect of Medicinal Oxygen Gas Carburos Metálicos is too strong or too weak, inform your doctor.

Read the instructions for use carefully (see Section 6).

If you use more Medicinal Oxygen 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 depending on the pressure of the inhaled oxygen and the duration of exposure.

At low pressure (from 0.5 to 2.0 bars), these effects are more likely 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 shortness of breath (hypoventilation), coughing, and chest pain. The effects in the central nervous system include nausea, dizziness, anxiety, and confusion, up to muscle spasms, loss of consciousness, and epileptic seizures.

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

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

4. Possible side effects

Like all medications, Medicinal Oxygen Gas Carburos Metálicos can cause side effects, although not everyone will experience them.

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

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

Uncommon side effects, which may affect between 1 and 10 out of 1,000 patients, are:

-Respiratory, thoracic, and mediastinal disorders: atelectasis (lung collapse), dry cough, and pain associated with breathing.

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

Rare side effects, which may affect between 1 and 10 out of 10,000 patients, are:

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

Very rare side effects, which may affect less than 1 in 10,000 patients, are:

-Respiratory, thoracic, and mediastinal disorders: severe difficulty breathing due to acute lung 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.

Other side effects of unknown frequencyare:

• Apnea (interruption of breathing): in patients with chronic respiratory failure.
• Lesions in the nasal sinuses, 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).
• Claustrophobia crisis: in patients undergoing high oxygen pressure in hyperbaric chambers
• Anemia.
• Affecting various organs with high oxygen concentrations in long-term treatments: heart (it can also decrease heart rate when 100% oxygen is administered for short periods), liver, kidneys, and lungs (pulmonary fibrosis).
• Pulmonary malformations (bronchopulmonary dysplasia), hemorrhages in various locations (subependymal and intraventricular) and intestinal damage with tissue destruction (necrotizing enterocolitis) in newborns and premature babies.

If you experience side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

5. Storage of Medicinal Oxygen Gas Carburos Metálicos

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

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

All regulations regarding the handling of pressure vessels must be followed. Regarding 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 weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked.

Empty gas cylinders and full gas cylinders must be stored separately.

Gas 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.

Gas cylinders with a capacity greater than 5 liters must be kept in a vertical position (except for those with a rounded 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 protecting it from the risks of shocks and falls (such as a support with fixation chains), heat sources or ignition, temperatures equal to or above 50°C, combustible materials, and weather conditions.

Excessive storage should 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 shocks or falls. Special attention should be paid to fixing the reducer to avoid accidental rupture risks.

During transportation in vehicles, gas cylinders must be well secured, preferably in a vertical position. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

6. Container Content and Additional Information

Composition of Medical Oxygen Gas Carburos Metálicos:

• The active ingredient is Oxygen.
• Without excipients.

Appearance of the Product and Container Content:

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

The x-liter capacity gas cylinders provide y (unit of volume) of gaseous oxygen at 15°C and 1 atm (see table). Not all packaging sizes may be marketed.

Filling pressure 200 bar

Marketing Authorization Holder:

S.E. de CARBUROS METÁLICOS, S.A.

Av. De la Fama, 1

08940 Cornellà de Llobregat, Barcelona

SPAIN

Manufacturer:

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

Ctra. Sevilla-Málaga-Granada, Km. 9,6 Polígono Ind. La Red 41500 – Alcalá de Guadaira - Sevilla (SPAIN)

S.E. de CARBUROS METÁLICOS, S.A. – Massalfassar

Ildefonso Carrascosa, Par. 20-21 Pol.Ind. Mediterráneo 46560 – Massalfassar – Valencia (SPAIN)

S.E. de CARBUROS METÁLICOS, S.A. – Aranjuez

Ctra. De Toledo, 7 28300 – Aranjuez – Madrid (SPAIN)

S.E. de CARBUROS METÁLICOS, S.A. – Ca N’Estella

C/ Dr. Fleming, 29 Pol. Ind. Ca N’Estella 08635 – Sant Esteve de Sesrovires – Barcelona (SPAIN)

S.E. de CARBUROS METÁLICOS, S.A. – Telde

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

S.E. de CARBUROS METÁLICOS, S.A. – Arrigorriaga

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

S.E. de CARBUROS METÁLICOS, S.A. – Marratxí

C/Celleters 142 Polígono Industrial Can Rubiol 07151 Marratxí – Baleares (SPAIN)

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

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

Last revision of this prospectus: October 2023

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

--------------------------------------------------------------------------------------------------------------

This information is intended exclusively for healthcare professionals

Handling Instructions:

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, neither the devices that contain this gas nor the valves, nor the gaskets, nor the seals, nor the closing devices.
• Never apply any greasy substance (vaseline, ointments, etc.) to the face of patients who inhale the gas.
• Never use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

The Medical Oxygen Gas Carburos Metálicos gas cylinders are exclusively reserved for therapeutic use.

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

1. Verify the good condition of the material before its use.
2. Group the gas cylinders with a capacity greater than 5 liters with a suitable means (chains, hooks, etc.) to keep them 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. Never force a gas cylinder into a support that is too narrow for it.
5. Handle the material with clean and grease-free hands.

1. Handle gas cylinders with a capacity of 50 liters or more with clean handling gloves and safety shoes.
2. Verify at the time of delivery by the manufacturer that the gas cylinder is equipped with an intact tamper-evident system.
3. Do not handle a gas cylinder whose valve is not protected by a tulip, except for gas cylinders with a capacity less than 5 liters.
4. Do not lift the gas cylinder by holding the valve.
5. Use connections or flexible connection elements specifically designed for Oxygen.
6. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (unless a reducer is already incorporated into the valve).
7. In the case of gas cylinder blocks, use only manometers graduated to at least 315 bar.
8. Use flexible connection elements in wall outlets equipped with specific nozzles for Oxygen.
9. Open the valve progressively.
10. Never force the valve to open, nor open it completely.
11. Purge the outlet connection of the gas cylinder before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the gas cylinder and the manoreducer clean.
12. Never subject the manoreducer to several successive pressurizations.
13. Never position yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the gas cylinder and backwards. Never 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 faulty valve.
16. Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.
17. Verify beforehand the compatibility of the materials in contact with Oxygen, using in particular Oxygen-specific connection gaskets for the manoreducer.
18. Close the gas cylinder valve after use, allow the pressure of the manoreducer to decrease by leaving the flowmeter open, close the flowmeter and then loosen (except in the case of integrated manoreducers) the manoreducer adjustment screw.
19. In case of leakage, close the valve that has a leak and check that the emergency device is activated.
20. Never completely empty a gas cylinder.
21. Store 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.

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