Medicinal oxygen liquid Linde Gas medicinal cryogenic 99.5% V/V in mobile cryogenic containers

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

LINDE MEDICAL LIQUID OXYGEN,

cryogenic medicinal gas, 99.5% v/v, in mobile cryogenic containers

Medical Oxygen

Read all of this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only, 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 any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What OXÍGENO MEDICINAL LÍQUIDO LINDE is and what it is used for
2. What you need to know before using OXÍGENO MEDICINAL LÍQUIDO LINDE
3. How to use OXÍGENO MEDICINAL LÍQUIDO LINDE
4. Possible side effects
5. How to store OXÍGENO MEDICINAL LÍQUIDO LINDE
6. Contents of the pack and other information

1. What OXIGENO MEDICINAL LÍQUIDO LINDE is and what it is used for

OXÍGENO MEDICINAL LÍQUIDO LINDE is an inhalation gas belonging to a group of medicines called medicinal gases. It is stored in cryogenic containers containing only pure oxygen.

Oxygen is an essential element for the body and is administered to increase its levels in the blood, thereby enhancing oxygen delivery 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 anaesthesia and resuscitation ventilators.
• Administration via nebulizer of inhaled medications.

2. Before using OXÍGENO MEDICINAL LÍQUIDO LINDE

Do not use OXÍGENO MEDICINAL LÍQUIDO LINDE:

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.

Take special care with OXÍGENO MEDICINAL LÍQUIDO LINDE:

• If you suffer from a chronic lung disease such as bronchitis, emphysema, or asthma, or are in a severe state of oxygen deficiency. You must inform your doctor of this.
• Do not apply any greasy substances (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 Section 3 and Section 6).

Precautions for use

• Oxygen must not be used in the presence of flammable materials: oils, lubricants, fabrics, wood, paper, plastic materials, etc. (see Section 6).

• When oxygen is administered under high pressure (hyperbaric oxygen therapy), injuries may occur due to high 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)
  • or a pulmonary disorder caused by loss of elasticity of lung tissue accompanied by (severe) breathing difficulty (pulmonary emphysema)
  • or upper respiratory tract infections
  • or recent middle ear surgery
  • or thoracic surgery at any time in your life
  • or uncontrolled high fever
  • or severe epilepsy
  • or fear of enclosed spaces (claustrophobia)
  • or if you have previously experienced a lung collapse (an 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 contact with the skin may cause severe frostbite.

• In case of frostbite, rinse with room temperature water for 15 minutes. Apply a sterile dressing. Seek medical attention.

• In case of eye contact, immediately rinse eyes with room temperature water for at least 15 minutes. Seek medical attention.

Use in children

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

Use of other medicines and other forms of interaction

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

• The toxicity of oxygen may be increased when used concomitantly with other medicines that may also affect the lungs: corticosteroids, certain cancer medications (bleomycin), sympathomimetics. This may also occur during treatment for paraquat poisoning, when undergoing X-ray therapy, or in cases of hyperthyroidism or deficiency in vitamins C and E or glutathione.
• There are reports of interaction with amiodarone. Recurrence 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. 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 use at normal pressure (normobaric oxygen therapy) at low concentrations is permitted.

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 available on the effects of medicinal oxygen on driving and operating machinery; therefore, driving is permitted but with extreme caution.

3. How to use OXIGEN MEDICINAL LIQUIDO LINDE

Follow exactly the oxygen administration instructions provided by your doctor.

OXIGEN MEDICINAL LIQUIDO LINDE is used by inhalation. The doctor will determine the correct dose of medicinal oxygen and administer it through a system appropriate to your needs, ensuring the delivery 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 test results (blood gas analysis).
• 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 test results (blood gas analysis).
• In patients requiring breathing assistance (assisted ventilation), oxygen should be administered at a dose allowing attainment 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 using special devices such as an endotracheal tube, laryngeal mask, via a tracheostomy allowing connection to assisted ventilation, or others.
• Administration of oxygen at high pressure (hyperbaric oxygen therapy) is performed in 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 for 24 hours.
• Any oxygen concentration above 40% is potentially toxic after 2 days.

If you feel that the effect of OXIGEN MEDICINAL LIQUIDO LINDE is too strong or too weak, inform your doctor.

Carefully read the instructions for use (see Section 6).

If you use more OXIGEN MEDICINAL LIQUIDO LINDE than you should:

In some situations, too much oxygen may affect breathing and, exceptionally, cause anesthesia or unconsciousness due to carbon dioxide retention.

The toxic effects of oxygen 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), coughing, and chest pain. Effects on the central nervous system range from nausea, dizziness, anxiety, and confusion to spasms, loss of consciousness, and epileptic seizures.

If any of these symptoms occur, contact your doctor or hospital, or call the Toxicology Information Service at: 91 562 04 20.

In case of excessive oxygen use, the inhaled oxygen concentration should be reduced, and symptomatic treatment is recommended.

4. Possible adverse effects

Like all medicines, MEDICAL LIQUID OXYGEN LINDE 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 mucous membranes.

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 lung alveoli), 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 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 in 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.
• Nasal sinus injuries, pneumothorax (presence of air in the pleural cavity), nausea, dizziness, temporary loss of vision, muscle pain and cramps with high-pressure oxygen (hyperbaric oxygen therapy).
• Claustrophobia attacks: in patients undergoing high-pressure oxygen treatment in hyperbaric chambers.
• Anemia.
• Organ involvement 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.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor.

5. Storage of MEDICAL LIQUID OXYGEN LINDE

Keep MEDICAL LIQUID OXYGEN LINDE out of the reach and sight of children.

Storage of containers

o Containers must be stored in a well-ventilated area, protected from weather conditions, clean, free from flammable materials, reserved for the storage of medical gases, and capable of being locked.

o Empty and full containers must be stored separately.

o Keep containers always in an upright position.

o Containers must be protected from impact or falling.

o Store at temperatures between –20°C and +50°C.

o Ensure that highly flammable substances or fuels are not stored in the same area.

o Ensure that containers are stored away from sources of heat or ignition.

o Do not smoke near the container.

Storage of containers at user facilities and in home settings:

o The container must be installed in a location that protects it from risks of impact or falling, sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

o Keep containers always in an upright position.

o Excessive storage must be avoided.

Transport of containers:

o Do not park vehicles in oxygen transfer areas.

o Transport of containers must comply with international regulations for the transport of dangerous goods.

o 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.

o 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.

Expiry date

Do not use MEDICAL LIQUID OXYGEN LINDE after the expiry date stated on the container label.

6. ADDITIONAL INFORMATION

Composition of LINDE LIQUID MEDICINAL OXYGEN

• The active substance is Oxygen.
• No excipients.

Presentation of LINDE LIQUID MEDICINAL OXYGEN and contents of the container

LINDE LIQUID MEDICINAL OXYGEN is a cryogenic medicinal 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 made of stainless steel.

These are supplied under pressure in the form of a liquid at very low temperature (approximately -183°C) in specially designed thermally insulated tanks intended for the storage of cryogenic liquids. Keep away from flames. Do not grease. Instructions for use / handling: Do not smoke. The capacity of the tanks is 30 and 45 liters.

Marketing Authorization Holder

Linde Médica, S.L.U.

Camino de Liria, s/n, apartado de correos nº 25,

46530 Puzol, Valencia

Spain

Manufacturer

Abelló Linde, S.A. Polígono Industrial Can Pí de Vilaroch, Avda. Antonio Gaudí, 151, Rubí, 08191 Barcelona

S.E. DE CARBUROS METALICOS, S.A. Barrio Chaco s/n (Arrigorriaga (Biscay)) - 48480 - Spain

S.E. DE CARBUROS METALICOS, S.A. Crta. Sevilla a Granada, Km. 9,6. Pol. Ind. La Red (Alcalá de Guadaira (Seville)) - 41500 – Spain

S.E. DE CARBUROS METALICOS, S.A. Pol. Ind. Can Rubiol. Celleters, 142 (Marratxí (Balearic Islands)) - 07141 - Spain

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

Avda. Madrid, 82.

Laguna de Duero (Valladolid)

Abelló Linde, S.A.

Camino de Lliria, s/n

Puçol (Valencia), 46530 – Valencia.

Abelló Linde, S.A.

Pol. Ind. El Bierzo, C/Hamburgo, 16.

Ponferrada, 24400 León.

Instructions for use / handling

Do not smoke

Keep away from flames

Do not grease

In particular:

• Never introduce this gas into equipment suspected of containing combustible materials, especially those of a greasy nature.
• Never clean with combustible products, especially those of a greasy nature, either the equipment containing this gas or the valves, seals, gaskets, and closure devices.
• Do not apply any greasy substances (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.

Containers of MEDICINAL OXYGEN are reserved exclusively for therapeutic use.

For liquid oxygen specifically, additional product-specific 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 and render the atmosphere hazardous.
• Oxygen at atmospheric pressure is a liquid at very low temperature (around -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 expands to release 850 liters of gas when vaporized and warmed to ambient temperature. The expansion of liquid oxygen upon warming is 850 times its liquid volume; therefore, precautions against overpressure in closed volumes (equipment and installations) and against over-oxygenation of materials and the atmosphere in enclosed spaces must be taken.

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

1. Check that the equipment is in good condition before use.
2. At the time of delivery by the manufacturer, verify that the container is equipped with an intact tamper-proof seal.
3. Handle the equipment with clean hands, free from grease.
4. Use protective goggles and clean gloves designated for this purpose.
5. Do not touch cold or frosted parts.
6. In case of cryogenic burn, rinse thoroughly with abundant water.
7. If clothing becomes saturated with oxygen, move away from the source of liquid oxygen and from areas presenting fire hazards, and remove the clothing immediately.
8. Ventilate the area of use if possible, especially if in confined spaces (vehicles, homes).
9. Avoid exposure to heat sources or prolonged solar heating.
10. Open the valve gradually.
11. Close the container valve after use.
12. Never force any part of the container and do not attempt to repair a defective valve.
13. Never exceed the maximum allowable working pressure.
14. Provide safety devices against overpressure in liquid oxygen circuits where there is a risk of liquid accumulation between two valves.
15. Store containers grouped together and in an upright position.
16. Use connections or flexible connecting elements specifically designed for oxygen.
17. Do not use intermediate adapters to connect two devices that do not fit together.
18. In case of leakage, close the valve with the integrity defect and ensure the emergency device is activated. Do not use a leaking container.
19. Use only equipment specifically approved for this product and for the intended pressure and temperature conditions.
20. Prevent backflow of substances into the container. Prevent water from entering the container.

This leaflet was approved on:

This information is intended for healthcare professionals only:

Dosage depends on the patient's clinical condition. The oxygen dose must be adjusted according to the individual requirements of each patient, taking into account the risk of oxygen toxicity.

In any case, the goal of oxygen therapy is to maintain arterial partial pressure of oxygen (PaO₂) above 60 mm Hg (i.e., 7.96 kPa) or arterial blood oxygen saturation at or above 90%.

If oxygen is administered diluted in another gas, its minimum concentration in the inspired air must be 21%, i.e., the inspired fraction (FiO₂) must be 21%, and may reach up to 100% concentration.

Warnings and precautions for use

• In certain severe cases of hypoxia, the therapeutic dose approaches the threshold of toxicity. Pulmonary or neurological toxicity may occur after 6 hours of exposure to 100% oxygen concentration, or after 24 hours of exposure to oxygen concentrations above 70%.

• High concentrations should be used for the shortest possible time and monitored by arterial blood gas analysis, while simultaneously measuring the concentration of inhaled oxygen. In all cases, the lowest effective dose should be used to maintain arterial partial pressure of oxygen (PaO₂) at 50–60 mm Hg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, oxygen concentration should be maintained, as far as possible, below 45%.

• In neonates and premature infants, the lowest possible concentration that achieves the desired effect should be used to minimize the risk of ocular damage, retrolental fibroplasia, or other potential adverse effects. For infants requiring an oxygen concentration (FiO₂) above 30%, PaO₂ should be monitored regularly to ensure it does not exceed 100 mmHg (i.e., 13.3 kPa) due to the risk of retinal damage.

• Whenever oxygen is used, the increased risk of spontaneous ignition and fire must always be considered. This risk is increased when using diathermy procedures, defibrillation, and electroconversion therapies.