Oxygen Medicinal Liquid Carburos Metalicos, 99.5% v/v, cryogenic medicinal gas in mobile cryogenic containers

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno Medicinal Líquido Carburos Metálicos, 99.5% v/v medicinal cryogenic gas in mobile cryogenic containers

Read the entire leaflet carefully before you start using 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 for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Oxígeno Medicinal Líquido Carburos Metálicos is and what it is used for
2. What you need to know before using Oxígeno Medicinal Líquido Carburos Metálicos
3. How to use Oxígeno Medicinal Líquido Carburos Metálicos
4. Possible adverse effects
5. Storage of Oxígeno Medicinal Líquido Carburos Metálicos
6. Contents of the pack and other information

1. What Oxígeno Medicinal Líquido Carburos Metálicos is and what it is used for

Oxígeno Medicinal Líquido Carburos Metálicos is a medicinal cryogenic gas belonging to a group of medicines known as medicinal gases. It is packaged in cryogenic containers containing pure oxygen only.

Oxygen is an essential element for the body and is administered to increase its levels in the blood, thereby achieving improved oxygen transport to all body tissues.

Oxygen therapy is indicated in the following cases:

• Correction of oxygen deficiency of various origins requiring administration of oxygen at normal or increased pressure.
• Supplying anaesthetic and resuscitation breathing apparatus.
• Administration via nebuliser of inhaled medications.

2. What you need to know before using Oxígeno Medicinal Líquido Carburos Metálicos

Do not use Oxígeno Medicinal Líquido Carburos Metálicos

This medicine must not be used under high pressure in cases of untreated lung collapse (untreated pneumothorax). A lung collapse is an accumulation of gas in the pleural cavity between the two lung membranes. If you have previously experienced a lung collapse, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Oxígeno Medicinal Líquido Carburos Metálicos.

• If you have chronic lung disease such as bronchitis, emphysema, or asthma, or are in a serious condition with oxygen deficiency. You must inform your doctor of this.
• Do not apply any greasy substances (e.g. vaseline, ointments, etc.) to the patient's face due to the risk of ignition (see Section 6).
• Because it may be toxic to the lungs or nervous system depending on the concentration and duration of administration (see sections 3 and 6).

Precautions for use

• Oxygen must not be used in the presence of flammable materials: oils, lubricants, fabrics, wood, paper, plastics, etc. (see Section 6).
• When oxygen is administered under high pressure (hyperbaric oxygen therapy), injuries may occur due to increased pressure in body cavities containing air that communicate with the outside. To avoid risks, compression and decompression must be performed slowly (see Section 4).
• When undergoing hyperbaric oxygen therapy, inform your doctor if you have:
  • Chronic obstructive pulmonary disease (COPD)
  • A lung disorder caused by loss of elasticity of lung tissue accompanied by (severe) respiratory difficulty (pulmonary emphysema)
  • Upper respiratory tract infections
  • Recent middle ear surgery
  • Thoracic surgery at any time in your life
  • Uncontrolled high fever
  • Severe epilepsy
  • Fear of enclosed spaces (claustrophobia)
  • A previous history of lung collapse (accumulation of air or gas in the pleural cavity between the two lung membranes (pneumothorax))
  • Oxygen stored in cryogenic containers is a liquid at cryogenic temperature (approx. -183°C) and may cause severe frostbite upon contact with the skin.
  • In case of frostbite, irrigate with room-temperature water for 15 minutes. Apply a sterile dressing. Seek medical assistance.
  • In case of eye contact, immediately flush eyes with room-temperature water for at least 15 minutes. Seek medical assistance.

Children

In newborns, especially premature infants, eye damage (retrolental fibroplasia) may occur with certain oxygen concentrations (see Section 4).

Use of Oxígeno Medicinal Líquido Carburos Metálicos with other medicines

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

• Oxygen toxicity may be increased when used concomitantly with other medicines that may also affect the lungs: corticosteroids, certain anticancer drugs (bleomycin), sympathomimetics. This may also occur during treatment for paraquat poisoning, when using X-rays, or in cases of hyperthyroidism or deficiency in vitamins C and E or glutathione deficiency.
• There are reports of interaction with amiodarone. Relapse of pulmonary damage induced by bleomycin or actinomycin may be fatal.
• Oxygen may also worsen respiratory depression caused by alcohol.
• Medicines known to cause adverse effects include: adriamycin, menadione, promazine, chlorpromazine, thioridazine, and chloroquine. These 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 medicine.

During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) may be used at low concentrations.

During life-saving treatments, oxygen may also be used during pregnancy at high concentrations and high pressures.

There are no contraindications for using oxygen during breastfeeding.

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

Driving and use of machines

There are no data on the effects of medicinal oxygen on driving and operating machinery; therefore, driving is possible but with extreme caution.

3. How to use Medicinal Liquid Oxygen Carburos Metálicos

Follow exactly the administration instructions for this medicine as given by your doctor.

Medicinal Liquid Oxygen Carburos Metálicos is used by inhalation. The appropriate dose of medicinal oxygen will be determined by your doctor and administered via a suitable system tailored to your needs, ensuring delivery 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 of 0.5 to 15 liters/minute. This may vary according to test results (blood gas analysis).
• In patients who breathe spontaneously (spontaneous ventilation) and with chronic respiratory failure, oxygen is administered at a flow rate of 0.5 to 2 liters/minute. This may vary according to test results (blood gas analysis).
• In patients requiring breathing assistance (assisted ventilation), oxygen should be administered at a dose allowing achievement of a minimum oxygen concentration of 21%, up to 100%.

Method of administration

• In patients without ventilation problems: oxygen may be administered via spontaneous ventilation using nasal glasses, a nasopharyngeal catheter, or a mask, which should be adapted to the oxygen flow rate.
• In patients with ventilation problems or who are anesthetized, oxygen is administered via special devices such as an endotracheal tube, laryngeal mask, through a tracheostomy allowing connection to assisted ventilation, or others.
• Administration of oxygen at high pressure (hyperbaric oxygen therapy) is performed inside a hyperbaric chamber at a pressure of 2 to 3 atmospheres, with session durations ranging from 90 minutes to 2 hours. These sessions may be repeated 2 to 4 times daily depending on clinical indications and the patient's condition.

Duration of treatment

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

• Oxygen concentrations up to 100% should not be administered for longer than 6 hours.
• Oxygen concentrations between 60–70% should not be administered for longer than 24 hours.
• Oxygen concentrations between 40–50% should not be administered continuously over the following 24 hours.
• Any oxygen concentration above 40% is potentially toxic after 2 days.

If you feel that the effect of Medicinal Liquid Oxygen Carburos Metálicos is too strong or too weak, inform your doctor.

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

In certain situations, excessive oxygen may affect breathing and, exceptionally, cause anesthesia or unconsciousness due to carbon dioxide retention.

Oxygen toxicity effects vary depending on the pressure of inhaled oxygen and the duration of exposure.

At low pressure (0.5 to 2.0 bar), 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.

Effects in the pulmonary region include interrupted breathing (hypoventilation), cough, and chest pain. Effects on the central nervous system range from nausea, dizziness, anxiety, and confusion to muscle spasms, loss of consciousness, and epileptic seizures.

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20.

4. Possible adverse effects

Like all medicines, Medicinal Liquid Oxygen from Carburos Metálicos may cause adverse effects, although not everyone experiences them.

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

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

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

• Respiratory, thoracic and mediastinal disorders: atelectasis (collapse of pulmonary alveoli), dry cough, and pain associated with breathing.
• With high-pressure oxygen (hyperbaric oxygen therapy): Ear and labyrinth disorders such as sensation of pressure in the middle ear and rupture of the tympanic membrane.

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

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

Very rare adverse effects, which may affect fewer 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 reported adverse effects with unknown frequency are:

• Apnea (cessation of breathing): in patients with chronic respiratory insufficiency.

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

• Claustrophobia attacks: in patients undergoing high-pressure oxygen treatment in hyperbaric chambers.

• Anaemia.

• Organ damage with high oxygen concentrations during long-term treatment: heart (bradycardia may also occur 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 infants.

Reporting of adverse effects

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

You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es

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

5. Storage of Medicinal Liquid Oxygen Metal Carbides

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated.

All regulations concerning the handling of pressure vessels must be followed. With regard to storage and transport, the following points must be observed:

Storage of containers:

• Containers must be stored in a well-ventilated area, protected from weather conditions, clean, free from flammable materials, designated exclusively for the storage of medical gases, and capable of being locked.
• Empty and full containers must be stored separately.
• Containers must always be kept in an upright position.
• Containers must be protected from impact or falling.
• Store at temperatures between –20°C and +50°C.
• Ensure that highly flammable or combustible materials are not stored in the same area.
• Ensure that containers are stored away from sources of heat or ignition.
• No smoking near the container.

Storage of containers at user facilities and in domestic settings:

• The container must be installed in a location that protects it from impact or falling risks, sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.
• Containers must always be kept in an upright position.
• Excessive storage must be avoided.

Transport of containers:

• Do not park vehicles in areas where oxygen transfer operations take place.
• Transport of containers must comply with international regulations for the transport of dangerous goods.
• Containers must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling risks.
• During transport in vehicles, containers must be securely fastened, preferably in an upright position. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

6. Contents of the container and other information

Composition of Carburos Metálicos Medicinal Liquid Oxygen:

• The active substance is Oxygen.
• No excipients.

Appearance of the product and contents of the container

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

It is stored in mobile cryogenic containers made of stainless steel.

The mobile cryogenic containers consist of a double wall of stainless steel.

These are supplied under pressure in liquid form at a very low temperature (approximately -183°C) in specially designed, thermally insulated tanks intended for the storage of cryogenic liquids.

The capacity of the containers is indicated below:

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 METÁLICOS, S.A. – Alcalá de Guadaira

Ctra. Sevilla-Málaga-Granada, Km 9.6 Polígono Ind. La Red – 41500 – Alcalá de Guadaira, Seville - Spain

S.E. DE CARBUROS METÁLICOS, S.A. - Massalfassar

Ildefonso Carrascosa, Par. 20-21, Polígono 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. - Telde

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

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

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

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

Barrio Chaco, s/n – 48480 – Arrigorriaga, Biscay – Spain

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

C/ Celleters, 142 Polígono Ind. Can Rubiol – 07141 – Marratxí, Balearic Islands – Spain

Instructions for Use/Handling

Do not smoke.

Do not bring near a flame.

Do not grease.

In particular:

• Never introduce this product into a device suspected of containing combustible materials, especially those of a greasy nature;
• Never clean with flammable products, especially those of a greasy nature, either the devices containing this gas or the taps, seals, gaskets, closure devices, and valves;
• Do not apply any greasy substance (vaseline, ointments, etc.) to the patient's face;
• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

Medical oxygen containers are reserved exclusively for therapeutic use.

For liquid oxygen specifically, additional product characteristics must also be considered as precautions for its use and handling:

• Oxygen is a gas heavier than air, which may accumulate in low-lying areas after vaporization of the liquid, creating a hazardous atmosphere.
• At atmospheric pressure, oxygen is a liquid at a very low temperature (approximately -183°C), and may cause frostbite if it comes into contact with the skin due to splashing or handling the liquid without appropriate protective equipment.
• One liter of liquid oxygen releases 850 liters of gas upon vaporization and warming to room temperature. The expansion of liquid oxygen upon warming is 850 times its liquid volume; therefore, precautions must be taken against overpressure in closed volumes (equipment and installations) and against over-oxygenation of materials and the atmosphere in enclosed spaces.

To prevent any incident, the following instructions must be strictly observed:

1. Check the equipment is in good condition before use.
2. Never force a container into a support that is too narrow.
3. Handle the equipment with clean hands, free from grease.
4. Handle containers of 50 L or larger using clean handling gloves and safety shoes.
5. Never lift the container by the tap.
6. Use connections or flexible connecting elements specifically designed for oxygen.
7. Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the container's maximum service pressure (unless a regulator is already integrated into the tap).
8. Use flexible connecting elements on wall outlets, equipped with nozzles specifically designed for oxygen.
9. Open the tap or valve gradually.
10. Never force the tap to open it, nor open it fully.
11. Purge the container's outlet connection before attaching the pressure regulator to remove any dust that may be present. Keep the connections between the container and the pressure regulator clean.
12. Never subject the pressure regulator to multiple successive pressurizations.
13. Never stand directly in front of the tap outlet; always stand on the side opposite the pressure regulator, behind the container and to the rear. Never expose patients to the gas flow.
14. Do not use intermediate connectors to connect two devices that do not fit together.
15. Do not attempt to repair a defective tap.
16. Never tighten the pressure regulator-flowmeter assembly with pliers, as this may damage the seal.
17. Verify in advance the compatibility of materials in contact with oxygen, using in particular pressure regulator connection seals specifically designed for oxygen.
18. Close the container tap after use, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure regulators) the pressure regulator adjustment screw.
19. In case of leakage, close the tap or valve supplying the circuit with a leak. Never use a container that has a leak, and ensure the emergency device is activated.
20. Never completely empty a container.
21. Store empty containers with the tap closed and empty frames with the valve closed (to prevent corrosion in the presence of moisture).
22. Never transfer the product from one container to another.
23. Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).

Date of the most recent review of this leaflet: February 2022

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/