Prospect: information for the user

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

Medical Oxygen

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 questions, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, 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 any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospect. See section 4.

1. What isLinde Medical Oxygenand how it is used

2. What you need to know before starting to useLinde Medical Oxygen

3. How to useLinde Medical Oxygen

4. Possible adverse effects

5. Storage ofLinde Medical Oxygen

6. Contents of the package and additional information

MEDICAL LIQUID OXYGEN LINDEis an inhalation 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 the administration of oxygen at normal or elevated pressure.

• Feeding of respirators in anesthesia - resuscitation.

• Administration via nebulizer of medications for inhalation.

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Do not use LIQUEFIED MEDICAL OXYGEN LINDE:

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 pulmonary membranes. If you have had a pulmonary collapse in the past, inform your doctor.

Be especially careful with LIQUEFIED MEDICAL OXYGEN LINDE:

• 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 of this.

• Do not apply any greasy substances (vaseline, ointments, etc.) to the faces 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 Section 3 and Section 6).

Precautions for use

• Oxygen should not be used in the presence of flammable materials: oils, lubricants, fabrics, 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 must be slow (see Section 4).

• When using high-pressure oxygen therapy (hyperbaric oxygen therapy), you must inform your doctor in the following cases:

• Chronic obstructive pulmonary disease (COPD)
• or a pulmonary alteration caused by the loss of elasticity of the lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema)
• or upper respiratory tract infections
• or recent middle ear surgery
• or thoracic surgery, at any time in the patient's life
• or uncontrolled high fever
• or severe epilepsy
• or claustrophobia
• or if you have had a pulmonary collapse in the past (an accumulation of air or gas in the thoracic cavity between the two pulmonary membranes (pneumothorax))

• The oxygen conditioned 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.

Use in children

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

Use of other medications and other forms of interaction

Inform your doctor or pharmacist if you are taking or have recently taken other medications, even those purchased without a prescription.

• 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, when using X-rays, or in cases of hyperthyroidism or vitamin C and E deficiency or glutathione deficiency.

• There have been 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 lactation

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 permitted.

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 periods.

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 oxygen administration instructions indicated by your doctor.

LIQUID MEDICAL OXYGEN LINDE is used by inhalation. The doctor will determine the correct dose of medical oxygen and administer it through an appropriate system that will ensure 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 achieving a minimum oxygen concentration of 21%, which can reach up to 100%.

Administration form

• In patients who do not have 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 who have ventilation problems, or are anesthetized, oxygen is administered through special devices such as endotracheal tube, laryngeal mask, through a tracheotomy that allows connecting 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 between 2 and 4 times a day, depending on the indications and the clinical condition of the patient.

Treatment duration

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

• Concentrations of oxygen up to 100% should not be given for more than 6 hours.

• Concentrations of oxygen between 60-70% should not be given for more than 24 hours.

• Concentrations of oxygen 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 LIQUID MEDICAL OXYGEN LINDE is too strong or too weak, inform your doctor.

Read carefully the usage instructions (see Section 6).

If you use more LIQUID MEDICAL OXYGEN LINDE 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 spasms, loss of consciousness, and epileptic seizures.

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

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

Like all medications, MEDICAL LIQUID OXYGEN LINDE can cause adverse effects, although not everyone will experience them.

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

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

Rare 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 pain.

• With high-pressure oxygen (hyperbaric oxygen therapy): disorders of the ear and labyrinth, such as a sensation of pressure in the middle ear and rupture of the tympanic membrane.

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

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

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 (respiratory 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 subjected to high oxygen pressures in hyperbaric chambers

• Anemia.

• Affection of different organs with high oxygen concentrations in long-term treatments: heart (it can 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

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor.

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

Storage of containers

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

or Empty and full containers must be stored separately.

or Keep containers always in an upright position.

or Containers must be protected from impact or falls.

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

or Ensure that highly flammable or combustible products are not stored in the same area.

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

or Do not smoke near the container.

Storage of containers in the user service and at home :

The container must be installed in a location that allows it to be protected from the risks of impact and falls, from heat sources or ignition sources, from temperatures equal to or greater than 50°C, from combustible materials, and from the elements.

or Keep containers always in an upright position.

or Excessive storage should be avoided.

Transportation of containers:

or Do not park vehicles in the oxygen transfer area.

The transportation of containers must be carried out in accordance with international regulations for the transportation of hazardous goods.

or Containers must be transported with suitable equipment (such as a chain-equipped hand truck, barriers, or rings) to protect them from the risk of impact or falls.

or During transportation in vehicles, containers must be securely fastened, preferably in an upright position. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Expiration Date

Do not use MEDICAL LIQUID LINDE OXYGEN after the expiration date indicated on the label of the packaging.

Composition of MEDICAL LIQUEFIED OXYGEN LINDE

- The active principle is Oxygen.

- Without excipients.

Presentation of MEDICAL LIQUEFIED OXYGEN LINDE and packaging content

MEDICAL LIQUEFIED OXYGEN LINDE is a cryogenic medicinal gas. Oxygen is a colourless, odourless and tasteless gas. When it is liquefied, it has a slightly blue colour.

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. Do not approach a flame. Do not lubricate. Instructions for use / handling Do not smoke. The container capacity is 30 and 45 litres.

Marketing authorization holder

Linde Médica, S.L.U.

Camino de Liria, s/n, post office box nº 25,

46530 Puzol, Valencia

Spain

Responsible for manufacturing

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 (Vizcaya)) - 48480 - Spain S.E. DE CARBUROS METALICOS, S.A. Crta. Sevilla a Granada, Km. 9,6. Pol. Ind. La Red (Alcalá de Guadaira (Sevilla)) - 41500 – Spain

S.E. DE CARBUROS METALICOS, S.A. Pol. Ind. Can Rubiol. Celleters, 142 (Marratxí (Islas Baleares)) - 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

Do not approach a flame

Do not lubricate

Especially:

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy.

• Never clean with combustible products, especially if they are greasy, or the apparatus containing this gas or the valves, joints, seals and closure devices.

• Never apply greasy substances (vaseline, ointments, etc.) to the patient's face.

• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or nearby.

The OXÍGENO MEDICINAL 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 handling:

• Oxygen is a heavier gas than air, which can accumulate in low points after the liquid vaporization and make the atmosphere dangerous.

• 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 handling of the liquid without the appropriate protective equipment.

• One litre of liquid oxygen releases 850 litres of gas by vaporization and warming to ambient temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore, the necessary precautions for overpressures in closed volumes (equipment and installations) and overoxygenation of materials and the atmosphere of the premises must be taken.

To avoid any incident, the following instructions must be strictly respected:

1. Verify the good condition of the material before its use.

2. Verify at the time of delivery by the manufacturer that the bottle is provided with an intact inviolability guarantee system.

3. Handle the material with clean and grease-free hands.

4. Use protective glasses and clean gloves intended for this use.

5. Do not touch the cold or frosty parts.

6. In the event of cryogenic burns, rinse with plenty of water.

7. If the clothing becomes saturated with oxygen, move away from the oxygen liquid source and from areas that present a risk of ignition, and remove this clothing.

8. Ventilate, if possible, the use area, if it is a reduced location (vehicles, home).

9. Avoid exposure to heat sources or prolonged solar heating.

10. Open the valve gradually.

11. Close the valve of the container after its use.

12. Never force any part of the container and do not attempt to repair a faulty valve.

13. Never exceed the maximum service pressure.

14. Provide safety devices against overpressures in oxygen liquid circuits where there is a risk of liquid accumulation between two valves.

15. Group the containers and keep them in an upright position.

16. Use specific connections or flexible connection elements for oxygen.

17. Do not use intermediate connections to allow the connection of two devices that do not fit together.

18. In the event of a leak, close the valve with a defect in tightness and check that the emergency device is activated. Do not use a container with leaks.

19. Use only equipment specifically approved for this product and for the pressure and temperature of use.

20. Do not allow the return of substances to the inside of the container. Prevent water from entering the container.

This prospectus has been authorized in:

This information is intended only for healthcare professionals:

The dosage depends on the clinical condition of the patient. The oxygen dose must be adjusted according to the individual needs of each patient and taking into account the risk of oxygen intoxication.

Oxygen therapy aims to maintain a partial arterial oxygen pressure (PaO2) above 60 mm Hg (i.e. 7.96 kPa) or an arterial blood oxygen saturation above or equal to 90%,

If oxygen is administered diluted in another gas, its minimum concentration in the inspired air must be 21%, i.e. the inspired fraction (Fi O2) must be 21%, which can reach a concentration of 100%.

Warnings and precautions for use

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

• Important concentrations should be used for the shortest possible time and controlled by analysing the arterial blood gases, at the same time as measuring the inhaled oxygen concentration; it is advisable to use the lowest dose capable of maintaining the partial arterial oxygen pressure (Pa O2) at 50-60 mm Hg (i.e. 5.65-7.96 kPa) and, after 24 hours of exposure, try to maintain, as far as possible, an oxygen concentration below 45%.

• In neonates and premature babies, it is necessary to use the lowest possible concentration that has the desired effect to minimize the risk of eye damage, retrolental fibroplasia or other possible undesirable effects. For infants who need an oxygen concentration (Fi O2) above 30%, the Pa O2 concentration must be regularly controlled to avoid exceeding 100 mmHg (i.e. 13.3 kPa) due to the risk of retinal alterations.

• Whenever oxygen is used, the increased risk of spontaneous ignition and fire must be taken into account. This risk increases when working with diathermy processes, and cardioversion and defibrillation therapies.