Prospect: Information for the user

Liquid Medical Oxygen Solgroup 99, 5 % v/v, gas for inhalation

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 only to you, and you should 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 not listed in this prospect. See section 4.

1.What is Medical Oxygen and how it is used.

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

3.How to use Medical Oxygen.

4.Possible adverse effects.

5.Storage of Medical Oxygen.

6.Contents of the package and additional information.

The full name of this medication is Liquid Medical Oxygen Solgroup 99,5 % v/v gas for inhalation.

To facilitate your consultation, it will be referred to as Medical Oxygen throughout this prospect.

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 can 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 strong crises on one side of the head).

Oxygen treatment at high 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 can be used for:

•Treatment ofsevere carbon monoxide poisoning(e.g., when the patient is unconscious)

•Gas embolism caused by a sudden decrease in atmospheric pressure (decompression sickness)

•Treatment ofobstructionin the heart or blood vessels caused by gas bubbles (aeroembolism)

•Treatment of support in cases ofbone lossafter radiation therapy

•Por thesupportive treatment in cases of tissue necrosisdue to infected wounds with gas-producing bacteria.

Do not use Medical Oxygen

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

Before starting treatment with oxygen, you should know the following information:

•Oxygen may have harmful effects inhigh concentrations. This could cause lung damage (alveolar collapse, lung inflammation) 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 flow rate.

•Pay special attention when administering oxygen tonewborns 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, you will need close monitoring by your doctor.

•If you have ever had lung injuries, inform your doctor.

Consult your doctor or pharmacist before starting to use medical oxygen.

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 therapy sessions
• 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

Newborns

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 Medical Oxygen with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take 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 can 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 Medical Oxygen with Food, Drinks, andAlcohol

Do not consumealcoholwhile using this medication. Alcohol can cause respiratory depression.

Pregnancy, Breastfeeding, and Fertility

•During pregnancy, it is permissible to use oxygen at normal pressure (normobaric oxygen therapy) only if necessary.

•There are no contraindications for using oxygen during breastfeeding.

Hyperbaric oxygen therapy should only be used if strictly necessary during pregnancy. Inform your treating doctor or specialist if this is the case.

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

Driving and Operating Machines

Medical oxygen at normal pressure (normobaric oxygen therapy) does not affect the ability to drive or operate machines.

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

Follow exactly the administration instructions of this medication 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 administered to yourself or your child on your own.

Dosage

Treatment with normal pressure oxygen(normobaric oxygen 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%.

•To treat respiratory problems when there are 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 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. It is recommended to use the lowest effective oxygen concentration to achieve adequate oxygenation. It is advisable to avoid fluctuations in oxygen saturation.

•To treat 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 equipment, such as a nasal catheter or a mask. The excess oxygen leaves the body through exhalation and mixes with the ambient air (known as the “no re-breathing” system).

•If you cannot breathe on your own, you will be provided with artificial respiratory assistance. During anesthesia, a special equipment with re-breathing or recycling systems is used, so that the exhaled air is inhaled again (known as the “re-breathing” 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 injuries due to strong fluctuations in pressure.

•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 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 to the face and a hood that covers the head or through a tube placed in the mouth.

If you use more medicinal oxygen 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 pressure of the oxygen 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, cough, 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, localized muscle cramps (around eyes, mouth, and forehead), fainting, and seizures (epileptic crises).

The effects on the eyes 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 forget to use medicinal oxygen

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

If you interrupt medicinal oxygen treatment

Do not interrupt treatment with this medication on your own initiative. 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 chimneys, sparks, candles, etc.) in the rooms where medicinal oxygen is used, as it increases the risk of fire.

Handle the cylinder with caution. 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 will 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 impairment.

With hyperbaric treatment:Ear pain, myopia, barotrauma (injuries caused in the body's 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, exacerbation of carbon dioxide excess in the 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 Medicinal Products for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use the Medical Oxygen after its expiration date, which appears on the container/cylinder, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Keep the container/cylinder 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. If there is a risk of fire, it must be taken to a safe place.

Do not smoke near the container/cylinder.

Transportation must be conducted in accordance with international regulations for transporting hazardous materials.

Avoid any contact with oils, fats, or hydrocarbons.

Medical Oxygen Compositionmedical

•The active principle is oxygen, in a concentration greater than 99.5% v/v.

•No contains excipients.

Appearance of the product and contents of thecontainer

The Medical Oxygen Liquid Solgroup is a gas for inhalation.

It is supplied in liquid form in a special container.

Oxygen is an odorless, tasteless, and colorless gas.

In liquid state, it is blue.

The Medical Oxygen Liquid Solgroup is packaged in mobile cryogenic tanks and fixed cryogenic containers.

The mobile cryogenic tanks are made of an outer and inner stainless steel enclosure. The valves are made of brass, stainless steel, and bronze and are specially designed for low temperatures.

These tanks contain liquid oxygen at very low temperatures.

The contents of the tanks vary from 9,000 to 26,000 liters.

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

Only some tank sizes may be commercially available.

The fixed cryogenic containers are special steel tanks with a double wall separated by a high vacuum. The valves are made of brass, stainless steel, and bronze and are specially designed for low temperatures.

These containers contain liquid oxygen at very low temperatures.

The contents of the containers can reach up to 50,000 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.

Marketing Authorization Holder

SOL S.p.A.

Via Borgazzi 27

20900Monza

Italy

Local Representative:

Sol France Sucursal en España

Calle Yeso, número 2

28500 Arganda del Rey (Madrid)

Responsible for Manufacturing

SOL spa

Zoning –Industriel de Feluy –

Zone B, 7180 Seneffe

Belgium

SPG - SOL Plin Gorenjska d.o.o.

Cesta železarjev 8,

SI-4270 Jesenice

Slovenia

SOL Bulgaria JSC

12 Vladaiska Reka Str., Poduiane area

1510 Sofia

Bulgaria

SOL Bulgaria JSC

South Industrial Zone, Complex Agropolychim AD,

9160 Devnya

Bulgaria.

Sol France, sucursal España (SOLFSE),

Calle Telégraf, s/n, Nt.17-19,

Polígono Industrial Sota el Molí,

08160 Montmeló, (Barcelona),

Spain

SOL Hellas S.A

ElladosSindos, Industrial

zone Sindos 12th km

Thessaloniki-Edessa

Thessaloniki, GR-570 08,

Greece

SOL Hellas S.A.

Sximatari,

59th km Athens-Lamia National Road, Viotia,

32009, Greece

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Belgium: Oxygène Médicinal Liquide SOL

Bulgaria: ?????????? ????????, ????? SOL

Czech Republic: Kyslík medicinální kapalný SOL, 100%, Medicinální plyn, kryogenní

Greece: Φαρμακευτικ? Οξυγ?νο σε υγρ? μορφ? SOL

Hungary: Oxigén SOL

Luxembourg: Oxygène Médicinal Liquide SOL

Portugal: Oxygénio medicinal liquid SOL

Romania: Oxigen SOL

Slovakia: Medicinálny kyslík kvapalný SOL

Slovenia: Medicinski kisik SOL 100% medicinski plin, kriogenski

Spain: Oxígeno medicinal líquido Solgroup

Netherlands: Zuurstof Medicinaal Vloeibaar SOL

United Kingdom: Liquid Medical Oxygen

Last review date of this leaflet:

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

In all 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:

The administration of oxygen 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 control 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%. High-concentration administration 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.

Between 60 and 70% for 24 hours.

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

Oxygen is potentially toxic in concentrations greater than 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 oxygen concentrations with a safety margin.

High-concentration oxygen treatment 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 must 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 must be adapted to the individual needs of the patient, at flows that vary between 1 and 10 liters of gas per minute.

•Patients with chronic respiratory insufficiency:

Oxygen must be administered at flows that vary between 0.5 and 2 liters/minute and the flow rate must 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 oxygen pressure (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 CO2concentrations twice every 3 or 4 weeks or 3 times a month, as CO2concentrations may increase during oxygen administration (hypercapnia).

•Patients with acute respiratory insufficiency:

Oxygen must be administered at a flow rate that varies between 0.5 and 15 liters/minute and the flow rate must 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) must 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 must be closely monitored. The lowest effective concentrations should be used to achieve adequate oxygenation. Generally, 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 must 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:

The doses and pressure always have to be adapted to the clinical condition of the patient and the 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 special 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 treatment. 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 blood gas values. The target values are: PaO2> 8 kPa or 60 mmHg, hemoglobin saturation > 90%.

•Osteoradionecrosis:

Hyperbaric oxygen therapy of radiation lesions typically 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 excess leave the patient with the exhaled air and are mixed 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 (rebreathing system).

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 clinically acceptable 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 special 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 facial mask with a hood that covers the head or through a tracheal tube.

Only the gas supplier can handle these containers.

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