Oxigeno medicinal liquido carburos metalicos, 99,5% v/v, gas criogenico medicinal, en recipientes criogenicos fijos.
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Introduction
Prospect: information for the user
Medical Liquid Oxygen Carbon Dioxide Metallic Gas Cryogenic Medicinal 99.5% v/v in fixed cryogenic containers
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, pharmacist, or nurse.
- 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 adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this prospect. See section 4.
1. What is Medical Liquid Oxygen Carbon Dioxide Metallic and for what it is used
2. What you need to know before starting to use Medical Liquid Oxygen Carbon Dioxide Metallic
3. How to use Medical Liquid Oxygen Carbon Dioxide Metallic
4. Possible adverse effects
5. Storage of Medical Liquid Oxygen Carbon Dioxide Metallic
6. Contents of the package and additional information
1. What is Liquid Medical Oxygen and Carbon Dioxide and for what it is used
Liquid Medical Oxygen and Carbon Dioxide 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 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 inhalation medications.
2. What you need to know before starting to use Liquid Medical Oxygen Carbon Dioxide Metals
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 may be toxic to the lungs or nervous system depending on the concentration and the time it is applied (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, 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), inform your doctor if you have: or chronic obstructive pulmonary disease (COPD)
- 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 liquid at cryogenic temperature (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, wash the eyes 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.
- 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 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.
3. How to Use Liquid Medical Oxygen Carbon Dioxide
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 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 have acute respiratory failure, oxygen is administered at a flow rate of 0.5 to 15 liters/minute. This may vary according to the results of the analyses performed (blood 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 according to the results of the analyses performed (blood gasometry).
- 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 under anesthesia, 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 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 clinical condition of the patient.
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.
- 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 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.
4. Possible Adverse Effects
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:
- Respiratory, thoracic, and mediastinal disorders: atelectasis (alveolar lung collapse), dry cough, and respiratory-related pain.
- With high-pressure oxygen (hyperbaric oxygen therapy): Ear and labyrinth disorders such as middle ear pressure sensation and tympanic membrane rupture.
Therare adverse effects, which may affect between 1 and 10 of every 10,000 patients, are:
- Eye disorders: eye damage that may affect vision (retrolental fibroplasia) in premature newborns exposed to high oxygen concentrations.
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 (breathing interruption): in patients with chronic respiratory insufficiency.
- Nasal sinus lesions, 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 undergoing high oxygen pressures in hyperbaric chambers
- Anemia.
- Organ damage in different organs with high oxygen concentrations in long-term treatments: heart (it may also decrease heart rate when administering 100% oxygen 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
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.
5. Conservation of Liquid Medical Oxygen, Metallic Cylinders
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.
- Cylinders must be placed in a well-ventilated area, exclusively dedicated to medical gases. This storage area must not contain combustible materials.
- Cylinders must not be placed near heat sources.
- Contact with fats, oils, or other hydrocarbons is strictly prohibited.
6. Contents of the packaging and additional information
Composition of Medical Liquid Oxygen Carburos Metálicos:
- The active principle is Oxygen.
- No excipients.
Aspect of the product and packaging content
Medical Liquid Oxygen Carburos Metálicos is a cryogenic medicinal gas. Oxygen is a colorless, odorless, and tasteless gas. When it is liquefied, it has a slightly blue color.
It is stored in fixed cryogenic containers made of stainless steel.
The fixed 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
Tanks O2 | |
Product | Average capacities (liters) |
Medical liquid oxygen | 1,000 |
2,000 | |
3,000 | |
6,000 | |
10,000 | |
20,000 | |
30,000 |
Marketing Authorization Holder
CARBURS METÁLICOS, S.A.
Av. de la Fama, 1
08940 Cornellà de Llobregat (Barcelona)
SPAIN
Responsible for manufacturing
CARBURS METÁLICOS, S.A.
Ronda Valdecarrizo, 49 28760 Tres Cantos, Madrid - Spain
CARBURS METÁLICOS, S.A.
Políg. Industrial El Morell Apartado 3 – 43760 El Morell, Tarragona - Spain
CARBURS METÁLICOS, S.A.
Urbanización Ind. Salinetas – 35219 - Telde, Las Palmas - Spain
CARBURS METÁLICOS, S.A.
C/. Dr. Fleming, 29 - Pol. Ind. Ca n' Estella – 08635 - Sant Esteve Sesrovires, Barcelona - Spain
CARBURS METÁLICOS, S.A.
C/ Celleters. 142 polígono Industrial Can Rubiol – 07141 – Marratxí, Balearic Islands – 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, Seville - 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/manipulation
Do not smoke.
Do not approach a flame.
Do not lubricate.
Especially:
- Do not introduce this product into an apparatus that is suspected to contain combustible materials, especially if they are greasy;
- Do not clean with combustible products, especially if they are greasy, nor the apparatus that contains this gas nor the faucets, joints, seals, devices, and valves;
- Do not apply any greasy substance (vaseline, ointments...) to the patients' faces;
- Do not use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.
The oxygen containers are reserved exclusively for therapeutic use.
For the specific case of liquid oxygen, some additional particularities of the product must be taken into account as precautions for its use and manipulation:
- Oxygen is a gas heavier than air, which can accumulate in low points after vaporization of the liquid and make the atmosphere hazardous.
- Oxygen at atmospheric pressure is a very low-temperature liquid (around -183°C) that can cause frostbite if it comes into contact with the skin in the event of splashes or manipulation of the liquid without the appropriate protective equipment.
- One liter of liquid oxygen releases 850 liters of gas by vaporization and warming to ambient temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore, precautions must be taken for overpressures in closed volumes (equipment and installations) and overoxygenation of materials and the atmosphere of the rooms.
To avoid any incident, it is necessary to respect the following instructions:
- Verify the good condition of the material before its use.
- Do not force the container into a support that is too narrow for it.
- Manipulate the material with clean and grease-free hands.
- Manipulate containers of 50 liters or more with clean manipulation gloves and safety shoes.
- Do not lift the container by the faucet.
- Use specific connections or flexible connection elements for oxygen.
- Use a flow regulator 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).
- Use flexible connection elements in wall outlets, provided with specific nozzles for oxygen.
- Open the faucet or valve gradually.
- Do not force the faucet to open it, nor open it completely
- Purge the outlet connection of the container before incorporating the flow regulator to eliminate any dust that may have accumulated. Keep the connections between the container and the flow regulator clean.
- Do not subject the flow regulator to multiple successive pressurizations.
- Do not position yourself in front of the outlet faucet, but always on the opposite side of the flow regulator, behind the container, and to the rear. Do not expose patients to the gas flow.
- Do not use intermediate connections to allow the connection of two devices that do not fit together.
- Do not attempt to repair a faulty faucet.
- Do not clamp the flow regulator - flowmeter with pliers, under the risk of causing defects in the joint.
- Verify in advance the compatibility of the materials in contact with oxygen, using in particular special connection joints for the flow regulator.
- Close the container faucet after use, allow the pressure in the flow regulator to decrease by leaving the flowmeter open, close the flowmeter, and then loosen the flow regulator adjustment screw (unless it is a built-in reducer).
- In the event of a leak, close the faucet or valve of the defective circuit. Do not use a container that has a leak, and check that the emergency device is activated.
- Do not empty a container completely.
- Store empty containers with the faucet closed and empty holders with the valve closed (to prevent corrosion in the presence of moisture).
- Do not transfer the product from one container to another.
- Ventilate the area of use, if possible, in reduced locations (vehicles, home).
Last review date of this prospectus:June 2023
The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/
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