MEDICAL LIQUID OXYGEN CARBURIC METALS, 99.5% v/v, MEDICINAL CRYOGENIC GAS, IN FIXED CRYOGENIC CONTAINERS

Introduction

Package Leaflet: Information for the User

Medical Liquid Oxygen Carburos Metálicos Cryogenic Medical Gas 99.5% v/v in Fixed Cryogenic Containers

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 Medical Liquid Oxygen Carburos Metálicos and what is it used for
2. What you need to know before starting to use Medical Liquid Oxygen Carburos Metálicos
3. How to use Medical Liquid Oxygen Carburos Metálicos
4. Possible side effects
5. Storage of Medical Liquid Oxygen Carburos Metálicos
6. Package Contents and Additional Information

1. What is Medical Liquid Oxygen Carburos Metálicos and what is it used for

Medical Liquid Oxygen Carburos Metálicos is an inhalation gas that belongs to a group of medications called medical gases. It is packaged in cryogenic containers 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 of different origins that require the administration of oxygen at normal or elevated pressure.
• Feeding of respirators in anesthesia-reanimation.
• Administration of inhalation medications via nebulizer.

2. What you need to know before starting to use Medical Liquid Oxygen Carburos Metálicos

Do not use Medical Liquid Oxygen 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 use Medical Liquid Oxygen Carburos Metálicos.

• If you have a chronic lung disease such as bronchitis, emphysema, or asthma, and in severe cases of oxygen deficiency, you should inform your doctor.
• No fatty 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 sections 3 and 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 if you have: chronic obstructive pulmonary disease (COPD)

• a lung condition caused by the loss of elasticity of lung tissue accompanied by breathing difficulties (severe) (pulmonary emphysema)
• upper respiratory tract infections
• recent middle ear surgery
• thoracic surgery at any time in the patient's life
• uncontrolled high fever
• severe epilepsy
• claustrophobia (fear of enclosed spaces)
• • Medical oxygen conditioned in cryogenic containers is a liquid at cryogenic temperature (approx. -183°C), so it can cause severe frostbite when in contact with the skin.
  • In case of frostbite, spray with water at room temperature for 15 minutes. Apply a sterile bandage. Seek medical attention.
  • In case of eye contact, rinse the eyes immediately with water at room temperature for at least 15 minutes. Seek medical attention.

Children

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

Using Medical Liquid Oxygen Carburos Metálicos with other medications

Inform your doctor or pharmacist if you are taking, have recently taken, or may need to take any other medication.

• 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. It can 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 exacerbate 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 medical oxygen on driving and using machines, so you can drive but with extreme caution.

3. How to use Medical Liquid Oxygen Carburos Metálicos

Follow the administration instructions of this medication exactly as indicated by your doctor.

Medical Liquid Oxygen Carburos Metálicos is used by inhalation. The doctor will determine the correct dose of medical 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 between 2 and 4 times a day, depending on the indications and the patient's clinical condition.

Duration of Treatment

As a general rule, high concentrations of oxygen should be used for the shortest possible time to achieve 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 the following 24 hours.
• Any oxygen concentration above 40% is potentially toxic after 2 days.

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

If you use more Medical Liquid Oxygen 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), cough, and chest pain. The effects in the central nervous system include nausea, dizziness, anxiety, and confusion, up to spasms, loss of consciousness, and epileptic seizures.

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

4. Possible Side Effects

Like all medications, Medical Liquid Oxygen Carburos Metálicos can cause side effects, although not everyone experiences them.

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

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

The uncommon side effects, which can 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.

The rare side effects, which can affect between 1 and 10 out of 10,000 patients, are:

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

The very rare side effects, which can affect less than 1 out of 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 reported and 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 concentrations of oxygen in long-term treatments: heart (it can also decrease heart rate when 100% oxygen is administered in 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

Reporting Side Effects

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

You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medications: www.notificaRAM.es

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

5. Storage of Medical Liquid Oxygen Carburos Metálicos

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

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

• The tanks should be placed in a well-ventilated area, exclusively dedicated to medical gases. This storage area should not contain combustible materials.
• The tanks should not be placed near heat sources.
• Any contact with fats, oils, or other hydrocarbons is prohibited.

6. Container Content and Additional Information

Composition of Medical Liquid Oxygen Carburos Metálicos:

• The active ingredient is Oxygen.
• Without excipients.

Product Appearance and Container Content

Medical Liquid Oxygen Carburos Metálicos is a cryogenic medicinal gas. Oxygen is a colorless, odorless, and tasteless gas. When liquefied, it has a slightly blue color.

It is stored in fixed cryogenic tanks made of stainless steel.

The fixed cryogenic tanks are made with a double layer of stainless steel.

These are supplied under pressure in the form of a liquid at a very low temperature (approximately -183°C) in tanks with thermal insulation designed specifically for storing cryogenic liquids.

The capacity of the tanks is

Marketing Authorization Holder

S.E. CARBUROS METÁLICOS, S.A.

Av. de la Fama, 1

08940 Cornellà de Llobregat (Barcelona)

SPAIN

Manufacturer

S.E. DE CARBUROS METALICOS, S.A.

Ronda Valdecarrizo, 49 28760 Tres Cantos, Madrid - Spain

S.E. DE CARBUROS METÁLICOS, S.A.

Políg. Industrial El Morell Apartado 3 – 43760 El Morell, Tarragona - Spain

S.E. DE CARBUROS METÁLICOS, S.A.

Urbanización Ind. Salinetas – 35219 -Telde, Las Palmas - Spain

S.E. DE CARBUROS METÁLICOS, S.A.

C/. Dr. Fleming, 29 - Pol. Ind. Ca n' Estella – 08635 - Sant Esteve Sesrovires, Barcelona -Spain

S.E. DE CARBUROS METÁLICOS, S.A.

C/ Celleters. 142 polígono Industrial Can Rubiol – 07141 – Marratxí, Baleares – Spain

LINDE GAS ESPAÑA, S.A.U.

Polígono Industrial Can Pí de Vilaroch Avenida Antonio Gaudí, 151 – 08191 – Rubí, Barcelona - Spain–

LINDE GAS ESPAÑA, S.A.U.

Polígono Industrial Ciudad del Transporte Parcela 27-1/2/3/4 – 11407 - Jerez de la Frontera, Cádiz – Spain

OXÍGENO DE SAGUNTO, S.L.

C/Acería s/n – 46520 - Puerto de Sagunto, Valencia - Spain

ANDALUZA DE GASES, S.A. - AGSA

Carretera Sevilla - Málaga, Km 6,3 41500 - Alcalá de Guadaira,Sevilla - Spain

GASES OXINORTE AIE

Buen Pastor s/n – 48903 - Baracaldo, Vizcaya - Spain

SOCIEDADE PORTUGUESA DE OXIGÉNIO, LDA - SPO

Rua Profesor Antonio Marques, 99 - 4470-909 -Fogosa, Maia - Portugal

NIPPON GASES ESPAÑA, S.L.

C/ Gavilanes, 12 P. I. La Estación – 28320 - Pinto, Madrid - Spain

NIPPON GASES ESPAÑA, S.L.

C/ Metalurgia, 14 P. I. San Vicente – 08755 - Castellbisbal, Barcelona - Spain

Instructions for Use/Handling

Do not smoke.

Do not approach a flame.

Do not grease.

In particular:

• Never introduce this product into a device that may contain combustible materials, especially if they are greasy;
• Never clean with combustible products, especially if they are greasy, either the devices that contain this gas or the taps, joints, gaskets, closing devices, and valves;
• Never apply any greasy material (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 containers are reserved exclusively for therapeutic use.

For the specific case of liquid oxygen, additional particularities of the product must be considered as precautions for its use and handling:

• Oxygen is a gas heavier than air, which can accumulate in low points after the vaporization of the liquid and make the atmosphere dangerous.
• Atmospheric pressure oxygen is a liquid at a very low temperature (around -183°C) and can cause frostbite if it comes into contact with the skin due to splashes or handling of the liquid without adequate protective equipment.
• One liter of liquid oxygen releases 850 liters of gas by vaporization and heating to ambient temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore, precautions must be taken against overpressure in closed volumes (equipment and installations) and over-oxygenation of materials and the atmosphere of the premises.

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. Never force a container into a support that is too narrow for it.
3. Handle the material with clean and grease-free hands.
4. Handle containers of 50 l or more with clean handling gloves and safety shoes.
5. Never lift the container by holding the tap.
6. Use specific connections or flexible connection elements for oxygen.
7. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure of the container (unless a reducer is already incorporated into the tap).
8. Use flexible connection elements in wall outlets, equipped with specific nozzles for oxygen.
9. Open the tap or valve progressively.
10. Never force the tap to open it, nor open it all the way.
11. Purge the outlet connection of the container before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the container and the manoreducer clean.
12. Never subject the manoreducer to several successive pressurizations.
13. Never place yourself in front of the tap outlet, but always on the opposite side of the manoreducer, behind the container, and backwards. Never expose patients to the gas flow.
14. Never use intermediate connections to allow the connection of two devices that do not fit together.
15. Never attempt to repair a faulty tap.
16. Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.
17. Verify in advance the compatibility of materials in contact with oxygen, using in particular oxygen-specific connection gaskets for the manoreducer.
18. Close the container tap after its 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 regulation screw.
19. In case of leakage, close the tap or valve that supplies the circuit with a leak. Never use a container that has a leak, and check that the emergency device is activated.
20. Never completely empty a container.
21. Keep empty containers with the tap closed and empty frames with the valve closed (to avoid corrosion processes in the presence of humidity).
22. Never transfer the product from one container to another.
23. Ventilate the place of use if possible, if it is a reduced location (vehicle, home).

Date of the last revision of this prospectus:June 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.gob.es/