Leaflet: information for the user

Oxygen Medical gas VIVISOL 99.5% v/v, compressed medical 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 alone, 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 Oxygen Medical gas VIVISOL and what it is used for

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

3. How to use Oxygen Medical gas VIVISOL

4. Possible side effects

5. Storage of Oxygen Medical gas VIVISOL

6. Contents of the container and additional information

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

Oxygen treatment at normal pressure(normobaric oxygen treatment)

Oxygen treatment at normal pressure may serve to treat:

• Low oxygen concentrations in 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 injuries from strong pressure fluctuations. Oxygen treatment at elevated pressure may serve 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

No use Oxígeno Medicinal gas VIVISOL

Do not use medicinal oxygen gas VIVISOL

Advertencias y precauciones

Consult your doctor or pharmacist before starting to use medicinal oxygen gas VIVISOL

• The oxygen may have harmful effects inhigh concentrations.This could cause lung damage (alveolar collapse, lung inflation) which would obstruct the 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 oxygen therapy flow accordingly.
• 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 if your blood carbon dioxide levels have increased,as this neutralizes the effect of oxygen.
• If you have respiratory problems triggered by low blood oxygen levels, or if you are taking potent analgesics, you will need close monitoring by your doctor.
• If you have ever had lung injuries, inform your doctor.

Oxigenoterapia hiperbáricaInform your doctor before starting high-pressure oxygen treatment 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 disorders
• If you have ever hadneumothorax, 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 disorders

Children

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

When using oxygen, always be aware of the increased risk of fire ignition.

Using Oxígeno Medicinal gas 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 (for cancer treatment), amiodarone(for heart disease), nitrofurantoin (for 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 Oxígeno Medicinal gas 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 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.

High-pressure oxygen treatment (hyperbaric oxygen therapy) should only be used during pregnancy if strictly necessary. Inform your treating doctor or specialist if this is the case.

Driving and using machinery

Medicinal oxygen at normal pressure (normobaric oxygen therapy) does not affect the ability to drive or use machinery.

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

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

Under no circumstances should you change the oxygen concentration that is administered to you or your child on your own.

Dosage

Treatment with normal pressure oxygen(normobaric oxygen treatment)

• If the oxygen concentration in the blood or 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 treatingrespiratory problemswhen oxygen levels in the blood are reduced (hypoxia) or as arespiratory stimulant(e.g., in pulmonary diseases such as COPD):

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

• For treatingmigraine clusters:

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. Excess oxygen is expelled from the body through exhalation and mixes with the ambient air (known as a "no-rebreathing" system).
• If you cannot breathe on your own, you will be provided with artificial respiratory assistance. During anesthesia, a special device with a recycling or rebreathing system is used, where the exhaled air is inhaled again (known as a "rebreathing" system).
• Oxygen can also be administered directly into the bloodstream through the oxygenator, in cases such as cardiac surgery with a cardiopulmonary machine and other situations requiring 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 the 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 multiple sessions per day if necessary.
• High-pressure oxygen treatment is administered in aspecial pressurization room.
• High-pressure oxygen treatment can also be administered with a mask perfectly fitted to the face and a hood covering the head or through a tube placed in the mouth.

If you use more Oxígeno Medicinal gas 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. Atlow 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). Athigh 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 ocular 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 gas 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 gas VIVISOL

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

Precautions for 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 fireplaces, sparks, candles, etc.) in the rooms where medicinal oxygen is used, as this 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

Rarely frequent(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 mucous membrane, local irritation and inflammation of 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/reservoir, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Medical Oxygen Gas:

-Gas cartridges can be stored at a temperature between -20 °C and +65 °C.

-They must be stored in an upright position, except for those with a convex rear part; these must be stored in a horizontal position or in a container.

-Gas cartridges must be protected from falls or mechanical impacts, for example, by securing them or placing them in a container.

-They must be stored in a well-ventilated room that is used exclusively for storing medical gases. This storage room must not contain any flammable materials.

-Gas cartridges containing a different type of gas or one with a different composition must be stored separately.

-Full and empty gas cartridges must be stored separately.

-They cannot be stored near heat sources.

-They must be stored covered and protected from meteorological effects.

-The valves of the gas cartridges must be closed after use.

-When the cartridge is empty, it must be returned to the supplier.

-Clear warnings will be posted in the storage area prohibiting smoking and fire.

-Emergency services must know the location of the gas cartridge storage.

Composition of Medical Oxygen Gas VIVISOL

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

?It does not contain any other active principles.

Aspect of the product and content of the packaging

Oxygen medicinal is an inhalation gas.

It is supplied in gaseous form in a special container.

Oxygen is a colorless, odorless, and tasteless gas.

The gaseous oxygen is stored in gas cylinders in a gaseous state and under a pressure of 200 bar (at 15 °C). The gas cylinders are made of steel or aluminum. The valves are made of brass, steel, or aluminum.

The gas cylinders containing (x) liters supply (y) m³ of oxygen at 15 °C and 1 bar.

The color code of the neck of the gas cylinder is white.

The body of the gas cylinder is white.

The gas cylinders, valves, and valve connections comply with the relevant EU standards.

Only some sizes of packaging may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

VIVISOL IBÉRICA, S.L.

C/ Yeso, 2

28500 Arganda del Rey (Madrid)

Spain

ManufacturerSpain

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

Last review date of the leaflet:

The following information is exclusively directed at 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 mmHg).

In all cases, the objective of oxygen treatment is to maintain a PaO2 of > 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 inspired 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 air inhaled by 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%. Administration of high concentrations must 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. From 60 to 70% for 24 hours.

From 40 to 50% during the second 24-hour period.

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

Newborns are not included in these guidelines because retrolental fibroplasia occurs with a FiO2 much 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 oxygen concentrations with a safety margin.

Treatment with a high oxygen concentration (> 60%) for short periods is indicated in cases of severe asthma crisis, pulmonary embolism, pneumonia, pulmonary fibrosis, etc.

A low oxygen concentration is indicated for the treatment of 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 very difficult to obtain concentrations > 60% (or 80% in the case of children) with the use of most oxygen 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 range from 0.5 to 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 below 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) must be > 60 mmHg (7.96 kPa), and the arterial blood oxygen saturation must 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 CO2 concentrations twice every 3 or 4 weeks or 3 times a month, as CO2 concentrations may increase during oxygen administration (hypercapnia).

• Patients with acute respiratory insufficiency:

Oxygen should be administered at a flow rate that ranges from 0.5 to 15 liters/minute, and the flow rate should be adjusted according to blood gas values. In emergency situations, 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. In general, oxygen concentrations above 40% in the inhalation 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). 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 using a well-fitting facial mask. Treatment should be started in the initial stage of the crisis.

Hyperbaric oxygen therapy:

Doses and pressure should always be adapted to the patient's clinical condition, 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 using a well-fitting facial 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 reach 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. Additionally, pregnant patients, patients with loss of consciousness, or those with higher 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.

• Patients with air embolism:

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

• Patients with osteoradionecrosis:

Treatment of radiation lesions with hyperbaric oxygen typically consists of daily sessions of 90 to 120 minutes at between 2.0 and 2.5 atmospheres for about 40 days.

• Patients with Clostridial myonecrosis:

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 using an appropriate device (e.g., a nasal catheter or a mask). Through this device, oxygen is administered with the inhaled air. Subsequently, the gas and oxygen excess leave 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 levels 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 failure.

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 using a well-fitting facial mask with a hood that covers the head or through a tracheal tube.

Preparation before use

Follow the supplier's instructions, particularly:

• Do not use if the cylinder is visibly damaged or suspected to be damaged, or if it has been exposed to extreme temperatures.
• Avoid any contact with oils, fats, or hydrocarbons.
• Remove the valve seal and the protective cap before using it.
• Only the appropriate equipment for a specific gas cylinder and that gas can be used.
• Check that the quick connector and regulator are clean and that the connections are in good condition.
• Slowly open the cylinder valve, at least half a turn.
• When opening and closing the cylinder valve, no tools, such as pliers, should be used to avoid the risk of damage.
• The packaging shape cannot be modified.
• Check for leaks. Follow the instructions found in the regulator. Do not attempt to repair the leak in the valve or equipment yourself, unless you replace the obturator or the O-ring.
• In case of a leak, close the valve and disconnect the regulator. If the cylinder continues to leak gas, empty the outer cylinder. Mark the defective cylinders, place them in a special area for claims, and return them to the supplier.
• In cylinders with pressure-regulating valves, a separate pressure regulator is not necessary. The built-in pressure-regulating valve has a quick connector for connecting "demand" valves, but also a separate outlet for constant gas flow, where the flow can be regulated.

Use of the gas cylinder

• It is strictly prohibited to transfer gas under pressure.
• It is strictly prohibited to smoke or start fires in rooms where oxygen therapy is being performed.
• When using the cylinder, it should be fixed to an appropriate support.
• Consider replacing the gas cylinders when the pressure in the cylinder has decreased to the point where the valve indicator is in the yellow field.
• Close the cylinder valve when there is a small amount of gas left in the cylinder. It is essential to leave a small amount of pressure in the cylinder to prevent the entry of contaminants.
• Close the valves of empty gas cylinders.
• Close the cylinder valve by hand after use. Depressurize the regulator or connection.

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/