MEDICAL OXYGEN LIQUID SOLGROUP 99.5% V/V GAS FOR INHALATION

Introduction

Package Leaflet: Information for the User

Liquid Medical Oxygen Solgroup 99.5% v/v, Gas for Inhalation

Oxygen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.

If you have any further questions, ask your doctor or pharmacist.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Oxygen medicinal is and what it is used for.
2. What you need to know before you use Oxygen medicinal.
3. How to use Oxygen medicinal.
4. Possible side effects.
5. Storage of Oxygen medicinal.
6. Contents of the pack and other information.

The full name of this medicine is Liquid Medical Oxygen Solgroup 99.5% v/v Gas for Inhalation.

For ease of reference, this medicine will be referred to as Oxygen medicinal throughout this leaflet.

1. What Oxygen medicinal is and what it is used for

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

Treatment with oxygen at normal pressure(normobaric oxygen treatment).

Treatment with oxygen at normal pressure can be used to treat:

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

Treatment with oxygen at high pressure(hyperbaric oxygen treatment).

Treatment with oxygen at high pressure should only be administered by qualified healthcare professionals to avoid the risk of injury from strong pressure fluctuations. Treatment with oxygen at high pressure can be used for:

• Treatment of severe carbon monoxide poisoning (e.g., when the patient is unconscious)
• Gas embolism caused by a sudden drop in atmospheric pressure (decompression sickness)
• Treatment of blockage in the heart or blood vessels caused by gas bubbles (air embolism)
• Supportive treatment in cases of bone loss after radiation therapy
• For supportive treatment in cases of tissue necrosis due to infected injuries with gas-producing bacteria.

2. What you need to know before you use Oxygen medicinal

Do not use Oxygen medicinal

Oxygen at pressures above atmospheric pressure (hyperbaric oxygen therapy) should not be used 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 oxygen treatment, you should be aware of the following information:

• Oxygen may have harmful effects at high concentrations. This could cause lung damage (alveolar collapse, lung inflammation) which would obstruct the supply of oxygen to the blood.
• If you have chronic obstructive pulmonary disease (COPD) with resulting deficiency in blood oxygenation, the oxygen flow will be lower. Your doctor will adjust the oxygen flow accordingly.
• Pay special attention when administering oxygen to newborns and premature babies. The reason is to minimize the risk of adverse events, such as eye damage. The lowest concentration of oxygen possible that is effective 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 that have been triggered by low oxygen levels in the blood or if you are taking potent painkillers, close monitoring by your doctor will be necessary.
• If you have ever had lung injuries, inform your doctor.

Consult your doctor or pharmacist before starting to use Oxygen medicinal.

Hyperbaric oxygen therapy

Before starting hyperbaric oxygen treatment, inform your doctor if you have:

• Psychiatric problems(anxiety, psychosis)
• Claustrophobia(fear of enclosed spaces)
• Diabetes(high blood sugar levels); due to the risk of hypoglycemia, blood sugar levels should be measured between hyperbaric therapy sessions
• Respiratory disorders
• If you have ever had pneumothorax, which is an accumulation of air in the thoracic cavity between the two lung membranes
• Heart problems
• High blood pressure
• Eye problems
• Ear, nose, and throat disorders

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 that your baby receives the correct treatment.

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

Using Oxygen medicinal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

If you are taking or have been prescribed bleomycin (to treat cancer), amiodarone (to treat heart disease), or nitrofurantoin (to treat infections), inform your doctor before using oxygen, as there is a possibility that it may cause toxic effects on the lungs.

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

Using Oxygen medicinal with food, drinks, and alcohol

Do not consumealcoholwhile using this medicine. Alcohol may cause respiratory depression.

Pregnancy, breastfeeding, and fertility

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

Hyperbaric oxygen treatment (hyperbaric oxygen therapy) should only be used during pregnancy or if you think you may be pregnant, if it is strictly necessary. Inform the treating doctor or specialist if this is the case.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.

Driving and using machines

Normobaric oxygen therapy does not affect the ability to drive or use machines.

After receiving hyperbaric oxygen treatment, you may experience visual and auditory disturbances that may affect your ability to drive or use machines.

3. How to use Oxygen medicinal

Follow exactly the administration instructions of this medicine as indicated by your doctor or pharmacist. If you are unsure, consult your doctor or pharmacist again. Never change the oxygen concentration that is administered to you or your child on your own.

Dosage

Treatment with oxygen at normal pressure(normobaric oxygen treatment)

• If the oxygen concentration in the blood or in a specific organ is too low:

Your doctor will indicate the duration and how many times a day you should administer Oxygen medicinal, as the dose may vary depending on each patient. The goal is always to use the lowest concentration of oxygen possible that is effective. 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 oxygen levels are reduced in the blood (hypoxia) or as a respiratory stimulant (e.g., in lung diseases such as COPD):

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

• To treat cluster headache:

100% oxygen is administered at a flow rate of 7 liters per minute, for a period of 15 minutes, through a mask. Treatment should be started when the first symptoms occur.

How to use normobaric oxygen treatment

• Oxygen medicinal is a gas for inhalation that is administered with 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 a "non-rebreathing" system).
• If you are unable to breathe on your own, you will be provided with artificial respiratory assistance. During anesthesia, special equipment with rebreathing or recycling systems 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 an "oxygenator", in cases such as cardiac surgery with a heart-lung machine and other situations that require extracorporeal circulation.

How to receive hyperbaric oxygen treatment

• Hyperbaric oxygen treatment should only be administered by healthcare professionals to avoid the risk of injury from strong pressure fluctuations.
• Depending on your situation, hyperbaric 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.
• Oxygen treatment is administered in a special pressure chamber.
• Hyperbaric oxygen treatment can also be provided with a tightly fitting mask and hood that covers the head or through a tube placed in the mouth.

If you use more Oxygen medicinal than you should

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone 91 562 04 20, indicating the medicine 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(from 0.5 to 2.0 bars), it is more likely that toxic effects will occur in the lungs (pulmonary area) than in the brain and spinal cord (central nervous system). At high pressure, the opposite occurs.

The effects on the lungs (pulmonary area) 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 spasms (around the eyes, mouth, and forehead), fainting, and convulsions (epileptic seizures).

The ocular effects include blurred vision and reduced peripheral vision ("tunnel vision").

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

If you forget to use Oxygen medicinal

Use the oxygen as described in the dosage section of the leaflet. Do not use a double dose to make up for the forgotten dose; Oxygen medicinal could be harmful at high concentrations.

If you stop using Oxygen medicinal

Do not stop using this medicine on your own. Consult your doctor or pharmacist.

Safety precautions for the use of Oxygen medicinal

Oxygen is an oxidizing product and promotes combustion. There should be no smoking or open flames (e.g., pilot lights, stoves, ovens, gas chimneys, sparks, candles, etc.) in the rooms where Oxygen medicinal 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 shocks.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

Common(may affect up to 1 in 10 people)

With hyperbaric treatment: Convulsions

Uncommon(may affect up to 1 in 100 people)

With normobaric treatment: lung collapse (atelectasis).

With hyperbaric treatment: eardrum rupture

Rare(may affect up to 1 in 1,000 people)

With hyperbaric treatment: shortness of breath, abnormally low blood sugar levels in diabetic patients.

Frequency not known(cannot be estimated from the available data)

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

With hyperbaric treatment: difficulty breathing, involuntary muscle contractions, dizziness, hearing impairment, acute serous otitis, ringing or buzzing in the ears (tinnitus), nausea, abnormal behavior, reduced peripheral vision, visual changes, cataracts.

Reporting of side effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxygen medicinal

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

Do not use Oxygen medicinal after the expiry date, which is stated on the container/cylinder after the abbreviation EXP. The expiry date is the last day of the month indicated.

Store 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 should be taken to a safe place.

Do not smoke near the container/cylinder.

Transportation should be carried out in accordance with international regulations for the transport of hazardous materials.

Avoid any contact with oils, fats, or hydrocarbons.

6. Container Content and Additional Information

Oxygen Compositionmedicina

• The active ingredient is oxygen, in a concentration greater than 99.5% v/v.
• It does not contain excipients.

Appearance of theproductand container content

Medical Liquid Oxygen Solgroup is an inhalation gas.

It is supplied in liquid form in a special container.

Oxygen is a colorless, tasteless, and odorless gas.

In liquid form, it is blue in color.

Medical Liquid Oxygen 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 content of the tanks varies 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 marketed.

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 content 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 marketed.

Marketing Authorization Holder

SOL S.p.A.

Via Borgazzi 27

20900 Monza

Italy

Local Representative:

Sol France Branch in Spain

Calle Yeso, number 2

28500 Arganda del Rey (Madrid)

Manufacturer

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, branch in Spain (SOLFSE),

Calle Telégraf, s/n, Nt.17-19,

Polígono Industrial Sota el Molí,

08160 Montmeló, (Barcelona),

Spain

SOL Hellas S.A

Ellados Sindos, 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 under 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

Date of the last revision of this leaflet:

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This information is intended only for healthcare professionals:

Posology

The concentration, flow, and duration of treatment should be determined by a doctor, according to the characteristics of each pathology.

Hypoxemia is a disorder in which the partial arterial pressure of oxygen (PaO2) is less than 10 kPa (<70 mmhg). an oxygen pressure level of 8 kpa (55 60 mmhg) leads to respiratory failure.< p>

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

In all cases, the goal of oxygen therapy is to maintain a PaO2 > 60 mmHg (7.96 kPa) or an arterial oxygen saturation of ≥ 90%.

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

Normal pressure oxygen therapy (normobaric oxygen therapy):

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

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

Up to 100% for less than 6 hours.

60-70% for 24 hours.

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

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

Neonates are not included in these guidelines because retrolental fibroplasia occurs with much lower FiO2. To achieve adequate and appropriate oxygenation in neonates, 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.

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

Low oxygen concentration is indicated for the treatment of patients with chronic respiratory failure caused by chronic obstructive 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 achieve concentrations > 60% (or 80% in the case of children) with the use of most administration devices.

The dose should be adapted to the individual patient's needs, with flows ranging from 1 to 10 liters of gas per minute.

• Patients with chronic respiratory failure:

Oxygen should be administered in flows ranging from 0.5 to 2 liters/minute and it is necessary to adjust the flow rate based on blood gas values. The effective oxygen concentration will be maintained below 28% and sometimes even below 24% in patients with respiratory disorders who depend on hypoxia as a respiratory stimulus.

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

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

The most frequent administration 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 three times a month, as CO2 concentrations may increase during oxygen administration (hypercapnia).

• Patients with acute respiratory failure:

Oxygen should be administered at a rate ranging from 0.5 to 15 liters/minute and it is necessary to adjust the flow rate based on blood gas values. In emergency situations, patients with severe respiratory distress require considerably higher doses (up to 60 liters/minute).

• Patients with mechanical ventilation:

If oxygen is mixed with other gases, the fraction of oxygen in the inhaled gas mixture (FiO2) should not fall below 21%. In practice, 30% tends to be the lower limit. If necessary, the fraction of inhaled oxygen can be increased up 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. As a general rule, oxygen concentrations above 40% in the inhaled air should be avoided, taking into account the risk of eye damage (retinopathy) or lung 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 substantial 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 facial mask. Treatment should be started in the initial stage of the crisis.

Hyperbaric oxygen therapy:

The doses and pressure should always be adapted to the patient's clinical picture and treatment should only be administered after medical consultation. However, the following are some recommendations based on current knowledge:

Hyperbaric oxygen therapy is administered at pressures above 1 atmosphere (1,013 bar), between 1.4 and 3.0 atmospheres (normally between 2 and 3 atmospheres). Hyperbaric oxygen is administered in a special pressurized room. Hyperbaric oxygen treatment can also be administered through 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.

Sometimes, acute hyperbaric oxygen therapy lasts only one or two sessions, while chronic treatment 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 falls below hazardous levels (around 5%). Hyperbaric oxygen (from 3 atmospheres) is indicated in patients with acute CO poisoning or who have been exposed to 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 multiple hyperbaric oxygen treatments as it may contribute to toxicity. Hyperbaric oxygen also appears to have potential for deferred treatment of CO poisoning using multiple low-dose oxygen treatments.

• Patients with decompression sickness:

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

• Patients with air embolism:

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

• Patients with osteoradionecrosis:

Hyperbaric oxygen treatment of radiation lesions typically consists of daily sessions of 90 to 120 minutes at 2.0 to 2.5 atmospheres for about 40 days.

• Patients with clostridial myonecrosis:

Treatment with 90 minutes at 3.0 atmospheres is recommended during the first 24 hours, followed by twice-daily treatments for 4 or 5 days, until clinical improvement is observed.

Method of Administration

Normobaric Oxygen Therapy

Oxygen is administered through the inhaled air, preferably with equipment designed for this purpose (e.g., a nasal catheter or mask). Through this equipment, oxygen is administered with the inhaled air. Subsequently, the gas and excess oxygen exit the patient with the exhaled air and mix with the ambient air (non-rebreathing system). In many cases, during anesthesia, special systems with a rebreathing or recycling system are used so that the exhaled air is inhaled again (rebreathing system).

If the patient is unable to 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 ranges. After recovery of lung function, the extracorporeal blood and gas flow are reduced and finally stopped. This occurs, for example, during cardiac surgery using 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 treatment 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 Health Products (AEMPS) http://www.aemps.gob.es/