Leaflet: information for the user

Liquid Medical Oxygen VIVISOL 99.5% v/v, medicinal cryogenic gas

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

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

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

3. How to use Liquid Medical Oxygen VIVISOL

4. Possible side effects

5. Storage of Liquid Medical Oxygen VIVISOL

6. Contents of the pack and additional information

Liquid medical oxygen contains oxygen, which is an essential gas for life. Oxygen treatment can be performed under normal pressure and elevated pressure.

Oxygen treatment at normal pressure(normobaric oxygen treatment)

Oxygen treatment at normal pressure may be used to treat:

• Low oxygen concentrations in the blood or in a specific organor to prevent them
• Cluster headache(a specific headache that causes short but very intense crises on one side of the head)

Oxygen treatment at elevated pressure(hyperbaric oxygen treatment)

Oxygen treatment at elevated pressure should only be administered by qualified healthcare professionals to avoid the risk of injury from strong pressure fluctuations. Oxygen treatment at elevated pressure may be used to:

• Treatment of severe carbon monoxide poisoning(e.g., when the patient is unconscious)
• Gas embolism produced by a sudden decrease in atmospheric pressure (decompression sickness)
• Treatment of obstruction in the heart or blood vessels caused by gas bubbles (aeroembolism)
• Treatment of support in cases ofbone lossafter radiation therapy

For thesupport treatment in cases of tissue necrosisdue to infected wounds with gas-producing bacteria

Do not use Liquid Medical Oxygen VIVISOL

Do not use oxygen at pressures higher than atmospheric pressure (hyperbaric oxygen therapy) in cases of untreated or undrained pneumothorax. Pneumothorax occurs due to the accumulation of air in the thoracic cavity between the two lung membranes. If you have ever had pneumothorax, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Liquid Medical Oxygen VIVISOL:

• Oxygen may be harmful inhigh concentrations.This could cause lung damage (alveolar collapse (inflammation of the lungs) which would obstruct oxygen supply to the blood.
• If you have chronic obstructive pulmonary disease (COPD) with resulting blood oxygen deficiency, the oxygen flow will be less. Your doctor will adjust the appropriate oxygen therapy flow.
• Pay special attention when administering oxygen tonewborn babies and premature babies.The reason is to minimize the risk of adverse events, such as eye damage. The lowest effective oxygen concentration should be used to achieve adequate oxygenation.
• Pay special attention ifyour blood carbon dioxide levels have increased, as this would neutralize the effect of oxygen.
• If you have respiratory problems triggered by low blood oxygen levels, or if you are taking potent analgesics, close monitoring by your doctor will be necessary.
• If you have ever had lung injuries, inform your doctor.

Hyperbaric oxygen therapy

Before starting treatment with high-pressure oxygen, inform your doctor if you have:

• Mental health problems(anxiety, psychosis)
• Claustrophobia (fear of enclosed spaces)
• Diabetes(high blood glucose levels); due to the risk of hypoglycemia, blood sugar levels should be measured between two hyperbaric oxygen therapies
• Respiratory problems
• If you have ever hadpneumothorax, which is an accumulation of air in the thoracic cavity between the two lung membranes
• Cardiac problems
• High blood pressure
• Eye problems
• Ear, nose, and throat problems

Children

In premature babies and newborns, oxygen therapy can cause eye damage (retinopathy of prematurity). Your doctor will determine the appropriate oxygen concentration to be administered to ensure your baby receives the correct treatment.

Whenever oxygen is used, the increased risk of fire ignition should be taken into account.

Using Liquid Medical Oxygen VIVISOL with other medications

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you are takingor have been prescribed bleomycin (to treat cancer), amiodarone(to treat heart conditions), nitrofurantoin (to treat infections), inform your doctor before using oxygen, as there is a possibility of causing lung toxicity.

Oxygen may exacerbate pre-existing lung damage caused by the pesticide Paraquat. In cases of Paraquat poisoning, additional oxygen administration should be avoided as much as possible.

Using Liquid Medical Oxygen VIVISOL with food, drinks, and alcohol

Do not consume alcoholwhile using this medication. Alcohol can cause respiratory depression.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, or if you think you may be pregnant, consult your doctor or pharmacist before using any medication.

• During pregnancy, it is permitted to use oxygen at normal pressure (normobaric oxygen therapy) only if necessary.
• There are no contraindications for using oxygen during breastfeeding.

Oxygen therapy at high pressure (hyperbaric oxygen therapy) should only be used if strictly necessary during pregnancy. Inform the responsible doctor or specialist if this is the case.

Driving and using machines

Liquid Medical Oxygen VIVISOL at normal pressure (normobaric oxygen therapy) does not affect the ability to drive or use machines.

After receiving treatment with high-pressure oxygen, you may experience visual and auditory disturbances that may affect your ability to drive and use machines.

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Under no circumstances can you change the concentration of oxygen administration for yourself or your child.

Dosage

Treatment with normal pressure oxygen(normal baric treatment)

• If the blood oxygen concentration or that of a specific organ is too low: Your doctor will indicate the time period and how many times a day you should administer the medicinal oxygen, as the dose may vary depending on each patient. The goal is always to use the lowest effective oxygen concentration possible. However, the actual oxygen concentration for inhalation should never be less than 21% and may be increased up to 100%.
• For treating respiratory problems when you have reduced oxygen levels in the blood (hypoxia) or as a respiratory stimulant (e.g., in pulmonary diseases such as COPD):

The oxygen concentration will be kept below 28% and sometimes below 24%. Oxygen concentrations for inhalation in the case of newborn babies should be kept below 40% and can only be increased up to 100% in very exceptional cases. It is recommended to avoid fluctuations in oxygen saturation.

• For treating cluster headaches:

100% oxygen is administered at a flow rate of 7 liters per minute for 15 minutes via a mask. Treatment should begin when the first symptoms occur.

How to use normal pressure oxygen treatment

• Medicinal oxygen is a gas for inhalation that is administered with a special device, such as a nasal catheter or a mask. The excess oxygen leaves the body through exhalation and mixes with the ambient air (known as a “non-rebreathing” system).
• If you cannot breathe on your own, you will be provided with artificial respiratory assistance. During anesthesia, a special device with a rebreathing or recycling system is used, so that the exhaled air is inhaled again (known as a “rebreathing” system).
• Oxygen can also be administered directly into the bloodstream through the so-called “oxygenator”, in cases such as, for example, cardiac surgery with a cardiopulmonary machine and other situations that require extracorporeal circulation.

How to receive high-pressure oxygen treatment

• High-pressure oxygen treatment should only be administered by healthcare professionals to avoid the risk of injury from strong pressure fluctuations.
• Depending on your situation, high-pressure oxygen treatment lasts between 45 and 300 minutes per session. Treatment may consist of one or two sessions, but long-term treatment can last up to 30 sessions or more and, with several sessions per day if necessary.
• High-pressure oxygen treatment is administered in a special pressurization room.
• High-pressure oxygen treatment can also be supplied with a perfectly fitted mask and hood that covers the head or through a tube placed in the mouth.

If you use more Oxígeno Medicinal líquido VIVISOL than you should

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

The toxic effects of oxygen can vary depending on the oxygen pressure inhaled and the duration of exposure. At low pressure (0.5 to 2.0 bars), it is more likely that toxic effects will occur in the lungs (pulmonary zone) than in the brain and spinal cord (central nervous system). At high pressure, the opposite occurs.

The effects on the lungs (pulmonary zone) include respiratory difficulties, coughing, and chest pain.

The effects on the brain and spinal cord (central nervous system) include tinnitus, auditory and visual disturbances, nausea, dizziness, anxiety, and confusion, muscle cramps, localized (around eyes, mouth, and forehead), fainting, and seizures (epileptic crises).

The eye effects include blurred vision and reduced peripheral vision (“tunnel vision”).

In case of oxygen intoxication due to hyperoxia, oxygen therapy should be reduced or, if possible, interrupted and treatment of symptoms initiated.

If you forgot to use Oxígeno Medicinal líquido VIVISOL

Use the oxygen as described in the dosage section of the prospectus. Do not use a double dose to compensate for the missed dose. This is because medicinal oxygen could be harmful at high concentrations.

If you interrupt treatment with Oxígeno Medicinal líquido VIVISOL

Do not interrupt treatment with this medication on your own. Consult your doctor or pharmacist.

Measures of safety on the use of medicinal oxygen

Oxygen is an oxidizing agent and promotes combustion. There should be no smoke or flames (e.g., pilot lights, stoves, gas chimneys, sparks, candles, etc.) in the rooms where medicinal oxygen is used, as it increases the risk of fire.

Handle the cylinder with care. Ensure that the gas cylinder does not suffer falls or is exposed to blows.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

Very Frequent(may affect more than 1 in 10people)

With normobaric treatment:In newborns exposed to high concentrations of oxygen: eye damage, which may cause vision alteration.

With hyperbaric treatment:Ear pain, myopia, barotrauma (injuries caused in the body tissues or organs by a change in pressure).

Frequent(may affect up to 1 in 10people)

With hyperbaric treatment:Seizures

Infrequent(may affect up to 1 in 100people)

With normobaric treatment:Pulmonary collapse (atelectasis).

With hyperbaric treatment:Tympanic membrane rupture

Rare(may affect up to 1 in 1000people)

With hyperbaric treatment:Dyspnea, abnormally low blood sugar levels in diabetic patients.

Unknown frequency(cannot be estimated from available data)

With normobaric treatment:Pulmonary toxicity, worsening of carbon dioxide excess in blood (hypercapnia), dryness of the mucous membrane, local irritation, and inflammation of the mucosa.

With hyperbaric treatment:Difficulty breathing, involuntary muscle contractions, vertigo, auditory alteration, acute serous otitis, ringing or buzzing in the ears (tinnitus), nausea, abnormal behavior, reduced peripheral vision, visual changes, opacity of the crystalline lens (cataracts).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus.

You can also report them directly through the Spanish System for Pharmacovigilance of Medicines 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 the medical oxygen after the expiration date that appears on the gas cartridge/container/vessel, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Liquid Medical Oxygen

Keep the container/vessel in a well-ventilated area with a temperature range of -20 °C and +50 °C.

Keep it away from flammable and combustible materials, heat sources, or fires.

Do not smoke near the container/vessel.

Transportation must be conducted according to international regulations for transporting hazardous materials.

Avoid any contact with oils, fats, or hydrocarbons.

Composition of Medical Oxygen Liquid VIVISOL

?The active ingredient is oxygen, 100% v/v.

?It does not contain more active principles.

Aspect of the product and contents of the container

Medical oxygen is a gas for inhalation.

It is supplied in liquid form in aspecial container.

Medical oxygen is a colorless, odorless, and tasteless gas.

Liquid oxygen is blue in color.

Medical Oxygen Liquid:

Medical oxygen liquid is packaged in mobile cryogenic containers. The mobile cryogenic containers are made of an outer and inner stainless steel container, with vacuum insulation between them and equipped with a filling port and a tube retraction connection.

These containers contain oxygen in liquid state at very low temperatures.

The contents of the containers vary from 10 to 1000 liters.

Each liter of liquid oxygen supplies 853 liters of gaseous oxygen at 15°C and 1 bar.

Only some container sizes may be commercially available.

Holder of the marketing authorization and responsible for the manufacture

Holder of the marketing authorization

VIVISOL IBÉRICA, S.L.

C/ Yeso, 2

28500 Arganda del Rey (Madrid)

Spain

Manufacturer

Sol B S.R.L.

Zoning Ouest 15

7860 Lessines, Belgium

O

VIVISOL IBÉRICA, S.L.

C/ Yeso, 2

28500 Arganda del Rey (Madrid)

Spain

O

MESSER IBERICA DE GASES, S.A.

Autovia Tarragona-Salou, Km 3,800,

Vilaseca, 43480 Tarragona

Spain

O

MESSER IBERICA DE GASES, S.A.

Pol. Industrial La Granadina III. C/Francia esquina C/Grecia Parcela 11.

San Isidro 03349 Alicante

Spain

O

SOL FRANCE, SUCURSAL EN ESPAÑA

C/ del Telègraf 17-19, PI SOTA EL MOLI,

Montmeló, 08160 Barcelona

Revision date of the prospectus:September 2020.

This information is intended solely for healthcare professionals:

Dosage

The concentration, flow rate, and duration of treatment must be determined by a doctor, in accordance with the characteristics of each pathology.

Hypoxemia is a disorder in which the arterial partial pressure of oxygen (PaO2) is less than 10 kPa (<70>

Hypoxemia is treated by enriching the inhaled air of the patient with additional oxygen. The decision to introduce oxygen treatment depends on the degree of hypoxemia and the individual tolerance level of the patient.

In both cases, the objective of oxygen treatment is to maintain a PaO2> 60 mmHg (7.96 kPa) or an arterial blood oxygen saturation of ≥ 90%.

If oxygen is administered diluted in another gas, the oxygen concentration in the inhaled air (FiO2) must be at least 21%.

Normobaric oxygen therapy:

Oxygen administration must be done with caution. The dose must be adapted to the individual needs of the patient, the oxygen pressure must be maintained above 8.0 kPa (or 60 mmHg) and the oxygen saturation of hemoglobin must be > 90%. Regularly monitor the arterial oxygen pressure (PaO2) or pulse oximetry (arterial oxygen saturation [SpO2]) and clinical signs. The goal is to have the inhaled air of each patient always have the minimum effective oxygen concentration possible, which is the minimum dose to maintain a pressure of 8 kPa (60 mmHg)/saturation > 90%. High-concentration administration should be as brief as possible, under strict control of blood gas values.

Oxygen can be administered safely in the following concentrations and for the indicated periods:

Up to 100% for less than 6 hours.

Between 60 and 70% for 24 hours.

Between 40 and 50% for the second 24-hour period.

Oxygen is potentially toxic in concentrations above 40% after two days.

Newborns are not included in these guidelines because retrolental fibroplasia occurs with a FiO2much lower. To achieve adequate and appropriate oxygenation in newborns, the lowest effective concentrations should be selected.

•Patients with spontaneous breathing:

The effective oxygen concentration is at least 24%. Normally, a minimum of 30% oxygen is administered to ensure therapeutic concentrations with a safety margin.

High-oxygen treatment in short periods is indicated in cases of severe asthma crisis, pulmonary embolism, pneumonia, pulmonary fibrosis, etc.

Low-oxygen treatment is indicated for patients with chronic respiratory insufficiency caused by obstructive chronic respiratory disease or other causes. The oxygen concentration should not exceed 28% and for some patients, even 24% may be excessive.

It is possible to administer higher oxygen concentrations (in some cases up to 100%) although it is difficult to obtain concentrations > 60% (or 80% in the case of children) with the use of most administration devices.

The dose should be adapted to the individual needs of the patient, at flows that range from 1 to 10 liters of gas per minute.

•Patients with chronic respiratory insufficiency:

Oxygen should be administered at flows that vary between 0.5 and 2 liters/minute and the flow rate should be adjusted according to blood gas values. The effective oxygen concentration will be maintained below 28% and in some cases even 24% in patients with respiratory disorders who depend on hypoxia as a respiratory stimulus.

•Chronic respiratory insufficiency caused by chronic obstructive pulmonary disease (COPD) or other diseases.

Treatment is adjusted according to blood gas values. The arterial partial pressure of oxygen (PaO2) should be > 60 mmHg (7.96 kPa) and the arterial blood oxygen saturation should be ≥ 90%.

The most frequent flow rate is 1 to 3 liters/minute for 15 to 24 hours/day, which also includes paradoxical sleep (the most sensitive period to hypoxemia during the day). During a stable period of the disease, it is recommended to control CO2concentrations twice every 3 or 4 weeks or 3 times a month, as CO2concentrations can increase during oxygen administration (hypercapnia).

•Acute respiratory insufficiency:

Oxygen should be administered at a flow rate that varies between 0.5 and 15 liters/minute and the flow rate should be adjusted according to blood gas values. In emergency cases, patients with severe respiratory difficulties require significantly higher doses (up to 60 liters/minute).

•Patients with mechanical ventilation:

If oxygen is mixed with other gases, the oxygen fraction in the inhaled gas mixture (FiO2) should not fall below 21%. In practice, 30% tends to be the lower limit. If necessary, the inhaled oxygen fraction can be increased to 100%.

•Pediatric population: Newborns:

In exceptional cases, concentrations of up to 100% can be administered to newborns, however, treatment should be closely monitored. The lowest effective concentrations should be used to achieve adequate oxygenation. Generally, oxygen concentrations above 40% in the inhaled air should be avoided, taking into account the risk of eye damage (retinopathy) or pulmonary collapse. Arterial oxygen pressure should be closely monitored and maintained below 13.3 kPa (100 mmHg). Significant fluctuations in oxygen saturation should be avoided. By preventing significant fluctuations in oxygenation, the risk of eye damage can be reduced. (See also section 4.4).

•Cluster headache:

In the case of cluster headache, 100% oxygen is administered at a flow rate of 7 liters/minute for 15 minutes through a well-fitting face mask. Treatment should be started in the initial stage of the crisis.

Hyperbaric oxygen therapy:

Doses and pressure should always be adapted to the clinical condition of the patient and treatment can only be administered after medical consultation. However, the following recommendations are based on current knowledge:

Hyperbaric oxygen therapy is administered at pressures above 1 atmosphere (1.013 bar), between 1.4 and 3.0 atmospheres (usually between 2 and 3 atmospheres). Hyperbaric oxygen is administered in a specially pressurized room. Hyperbaric oxygen therapy can also be administered through a well-fitting face mask with a hood that covers the head or through a tracheal tube.

Each treatment session lasts from 45 to 300 minutes, depending on the indication.

In some cases, acute hyperbaric oxygen therapy lasts only one or two sessions, while chronic therapy can last up to 30 sessions or more. If necessary, sessions can be repeated two or three times a day.

•Carbon monoxide poisoning:

If carbon monoxide poisoning occurs, oxygen should be administered as soon as possible in high concentrations (100%), until the carboxyhemoglobin concentration decreases below dangerous levels (around 5%). Hyperbaric oxygen (from 3 atmospheres) is indicated in patients with acute CO poisoning or who have been exposed at intervals of ≥24 hours. Pregnant patients, patients with loss of consciousness, or those with high carboxyhemoglobin levels justify hyperbaric oxygen therapy. Normobaric oxygen should not be used between hyperbaric oxygen treatments as it may contribute to toxicity. Hyperbaric oxygen also appears to have potential for delayed treatment of CO poisoning that uses multiple low-dose oxygen treatments.

•Patients with decompression sickness:

Rapid treatment at 2.8 atmospheres is recommended, with repetition of up to 10 times if symptoms persist.

•Air embolism:

In this case, doses are adapted to the clinical condition of the patient and to blood gas values. The target values are: PaO2> 8 kPa or 60 mmHg, hemoglobin saturation > 90%.

•Osteoradionecrosis:

Hyperbaric oxygen therapy of radiation lesions usually consists of daily sessions of 90 to 120 minutes at between 2.0 and 2.5 atmospheres for about 40 days.

•Gas gangrene:

It is recommended to administer a 90-minute treatment at 3.0 atmospheres during the first 24 hours, followed by twice-daily treatments for 4 or 5 days, until clinical improvement is observed.

Administration form

Normobaric oxygen therapy

Oxygen is administered through the inhaled air, preferably with an equipment designed for this purpose (e.g. a nasal catheter or a mask). Through this equipment, oxygen is administered with the inhaled air. Subsequently, the gas and oxygen surplus exit the patient with the exhaled air and mix with the ambient air (system "without rebreathing"). In many cases, during anesthesia, special systems are used with a rebreathing or recycling system so that the exhaled air is inhaled again (system "rebreathing").

If the patient cannot breathe on their own, they can be provided with artificial respiratory assistance. On the other hand, oxygen can be injected directly into the bloodstream through the so-called oxygenator. The application of extracorporeal gas exchange devices facilitates oxygenation and decarboxylation without the damage associated with aggressive mechanical ventilation strategies. The oxygenator, which acts as an artificial lung, provides better oxygen transfer and, therefore, blood gas values are maintained within acceptable clinical intervals. After recovery of pulmonary function, extracorporeal blood and gas flow are reduced and finally stopped. This occurs, for example, during cardiac surgery that uses a cardiopulmonary bypass system, as well as in other circumstances that require extracorporeal circulation, including acute respiratory insufficiency.

Hyperbaric oxygen therapy

Hyperbaric oxygen therapy is administered in a specially pressurized room where the ambient pressure can be multiplied up to three times the atmospheric pressure. Hyperbaric oxygen therapy can also be administered through a well-fitting face mask with a hood that covers the head or through a tracheal tube.

General

Medicinal gases should only be used for medical purposes.

Different types of gases and gas qualities should be separated from each other.

Full and empty containers should be stored separately.

Never use grease, oil, or similar substances to lubricate stuck or difficult-to-connect threaded parts.

Manipulate valves and devices with clean hands and no grease (hand cream, etc.).

Only use standard equipment designed for medical oxygen.

Preparation for use

Only use dose administration devices designed for medical oxygen.

Check that the automatic coupling and device are clean and that the joints function properly. Never use pressure tools/flow regulators designed for manual connection, as this can damage the coupling.

Slowly open the valve: at least half a turn.

Check for leaks according to the instructions provided with the regulator.

In case of a leak, close the valve and disconnect the regulator. Mark the defective containers, store them separately, and return them to the supplier.

Use

It is strictly forbidden to smoke and start fires in rooms where hyperbaric oxygen therapy is performed.

If not used or in case of fire, the device should be closed.

Take it to a safe place in case of fire.

Larger containers should be transported by vehicles specifically designed for this purpose.

Pay special attention to connected devices so that they do not accidentally disconnect.

When the container is empty, the gas flow will drop. Close the outlet valve and remove the connections after releasing the pressure.

More detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/