Prospectus: information for the user

Medical Liquid Oxygen, 99.5% v/v medicinal cryogenic gas in mobile cryogenic containers

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

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

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

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

3. How to use Medical Liquid Oxygen

4. Possible adverse effects

5. Storage of Medical Liquid Oxygen

6. Contents of the container and additional information

Liquid Medical Oxygen and Metal Carbonyls is a cryogenic medicinal gas that belongs to a group of medications known as medicinal 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 result achieve greater oxygen transport to all body tissues.

The oxygen treatment is indicated in the following cases:

• Correction of oxygen deficiency of different origins that require oxygen administration at normal or elevated pressure.
• Supply of respirators in anesthesia - resuscitation.
• Administration via nebulizer of medications for inhalation.

No use Liquid Medical Oxygen Carbonic Metals

This medication cannot be used at high pressure in cases of untreated pulmonary collapses (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 use Liquid Medical Oxygen Carbonic Metals.

• If you have a chronic lung disease such as bronchitis, emphysema, or asthma and in severe cases of oxygen deficiency. You must inform your doctor.
• Do not apply any fatty substance (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 the nervous system depending on the concentration and the time it is applied (see sections 3 and 6).

Precautions for use

• A pulmonary 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
• Thoracic 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))
• • Liquid Oxygen in cryogenic containers is a cryogenic liquid (approx. -183°C), so in contact with the skin it can cause severe frostbite.
  • In case of frostbite, rinse with water at room temperature for 15 minutes. Apply a sterile dressing. Obtain medical assistance.
  • In case of contact with the eyes, rinse immediately with water at room temperature for at least 15 minutes. Obtain medical assistance.

Children

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

Use of Liquid Medical Oxygen Carbonic Metals with other medications

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

Pregnancy and breastfeeding

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 allowed.

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.

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

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

Medical Liquid Oxygen Carbonic Metals is used by inhalation. The doctor will determine the correct dose of medical oxygen and administer it through an appropriate system for your needs that will ensure the supply of the correct amount of oxygen.

Dosage.

The usual dose is:

Administration form

Treatment duration

As a general rule, high oxygen concentrations 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.

If you estimate that the action of Medical Liquid Oxygen Carbonic Metals is too strong or too weak, inform your doctor.

If you use more Medical Liquid Oxygen Carbonic Metals 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 (0.5 to 2.0 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 seizures, loss of consciousness, and epileptic crises.

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

Like all medications, Liquid Medical Metallic Carbon Dioxide Oxygen 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:

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

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

Otheradverse effects reported and of unknown frequencyare:

Reporting adverse effects

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

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

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

Keep this medication out 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 containers must be followed. In relation to storage and transportation, the following must be taken into account:

Storage of cylinders:

• Cylinders must be stored in a well-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 cylinders must be stored separately.
• Keep cylinders always in an upright position.
• Cylinders must be protected from impact or falls.
• Store at temperatures between – 20°C and + 50°C.
• Ensure that highly flammable or combustible products are not stored in the same area.
• Ensure that cylinders are stored away from heat sources or ignition sources.
• Do not smoke near the cylinder.

Storage of cylinders at the user's service and at home:

• The cylinder must be installed in a location that protects it from the risks of impact and falls, heat sources or ignition sources, temperatures equal to or greater than 50°C, combustible materials, and weather conditions.
• Keep cylinders always in an upright position.
• Excessive storage must be avoided.

Transportation of cylinders:

• Do not park vehicles in the oxygen transfer area.
• The transportation of cylinders must be carried out in accordance with international regulations for the transportation of hazardous goods.
• Cylinders must be transported with suitable material (such as a chain-equipped dolly, barriers, or rings) to protect them from the risk of impact or falls.
• During transportation in vehicles, 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 Liquid Oxygen Carburos Metálicos:

- The active principle is Oxygen.

- Without excipients.

Aspect of the product and contents of the packaging

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

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

The mobile cryogenic containers are made of a double layer of stainless steel.

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

The capacity of the containers is indicated below:

Holder of the marketing authorization

S.E. CARBUROS METÁLICOS, S.A.

Av. De la Fama, 1

08940 Cornellà de Llobregat, Barcelona

SPAIN

Responsible for manufacturing

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, Sevilla - 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, Vizcaya – Spain

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

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

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not grease.

Specifically:

The oxygen containers are reserved exclusively for therapeutic use.

For the specific case of liquid oxygen, the following additional particularities of the product must be taken into account as precautions for its use and manipulation:

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

1. Verify the good condition of the material before its use.
2. Do not force the container into a support that is too narrow for it.
3. Manipulate the material with clean and grease-free hands.
4. Manipulate containers of 50 liters or more with clean manipulation gloves and safety shoes.
5. Do not lift the container by the faucet.
6. Use specific oxygen connections or flexible connection elements.
7. Use a reducer with a flowmeter that can admit a pressure of at least 1.5 times the maximum service pressure of the container (unless there is already a built-in reducer on the faucet).
8. Use flexible connection elements in wall outlets, provided with specific nozzles for oxygen.
9. Open the faucet or valve gradually.
10. Do not force the faucet to open it, nor open it completely
11. Purge the outlet connection of the container before incorporating the reducer to eliminate any dust that may have accumulated. Keep the connections between the container and the reducer clean.
12. Do not subject the reducer to multiple successive pressurizations.
13. Do not position yourself in front of the outlet faucet, but always on the opposite side of the reducer, behind the container, and to the rear. 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 faulty faucet.
16. Do not clamp the reducer-flowmeter with pliers, under the risk of causing defects in the joint.
17. Verify in advance the compatibility of the materials in contact with oxygen, using in particular special connection joints for the reducer.
18. Close the faucet of the container after its use, allow the pressure of the reducer to decrease by leaving the flowmeter open, close the flowmeter, and then loosen the adjustment screw of the reducer (except in the case of integrated reducers).
19. In the event of a leak, close the faucet or valve of the circuit with a defect in tightness. Do not use a container that has a defect in tightness, and check that the emergency device is activated.
20. Do not empty a container completely.
21. Keep empty containers with the faucet closed and empty bases with the valve closed (to avoid corrosion processes in the presence of humidity).
22. Do not transfer the product from one container to another.
23. Ventilate the place of use, if possible, in reduced locations (vehicles, home).

Last review date of this prospectus: February2022

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.gob.es/