Leaflet: Information for the user

Oxygen medicinal gas Solgroup 99.5% v/v gas for inhalation

Oxygen

Read this leaflet carefully before starting to use this medicine, as 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 or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

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

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

3.How to use Oxygen medicinal.

4.Possible side effects.

5.Storage of Oxygen medicinal.

6.Contents of the package and additional information.

The full name of this medicine is Oxygen medicinal Gas Solgroup 99.5% v/v gas for inhalation.

To make it easier to consult, it will be referred to as Oxygen medicinal throughout this leaflet.

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 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 injury 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 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.

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

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 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 (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 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 permitted to use oxygen at normal pressure (normobaric oxygen therapy) only if necessary.

•There are no contraindications for using oxygen during lactation.

Oxygen therapy at high pressure (hyperbaric oxygen therapy) should only be used if strictly necessary when pregnant or if you suspect you may be pregnant. Inform your treating doctor or specialist in this case.

If you are pregnant or breastfeeding, suspect 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 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 administered to yourself or your child on your own.

Dosage

Treatment with normal pressure oxygen(normobaric oxygen treatment)

•If the blood or organ oxygen concentration 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 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 the “no re-breathing” system).

•If you cannot breathe on your own, you will be provided with artificial respiratory assistance. During anesthesia, a special device 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 injury from 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 multiple 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 mask perfectly fitted 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 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, localized muscle cramps (around the 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. 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 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 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, worsening 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 gas bottle, after the abbreviation CAD. The expiration date is the last day of the month indicated.

-Gas bottles 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; these must be stored in a horizontal position or in a container.

-Gas bottles 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 will not contain any flammable materials.

-Gas bottles containing different types of gas or a gas with a different composition must be stored separately.

-Full and empty gas bottles must be stored separately.

-They must not be stored near heat sources. If there is a risk of fire, they must be taken to a safe location.

-Store them covered and protected from meteorological effects.

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

-Return the bottle when it is empty to the supplier.

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

-The emergency services must know where the gas bottle storage is located.

Medical Oxygen Composition

•The active ingredient is oxygen, in a concentration of more than 99.5% v/v.

•No contains excipients.

Appearance of the product and packaging contents

Medical Oxygen gas Solgroup is a gas for inhalation.

It is supplied in gaseous form in a special container.

Oxygen is a colorless, odorless, and tasteless gas.

In liquid form, it is blue.

Medical Oxygen gas Solgroup is stored in gas bottles in gaseous state and under a pressure of 150, 200 or 300 bars (at 15 ° C). The gas bottles are made of steel or aluminum. The valves are made of brass, steel or aluminum.

*7l,40ly47lavailable forthe filling pressure150 baronly.

The gas bottles meet the requirements of Dir. 1999/36/EC.

The color marks comply with the EN 1089-3: white body and neck.

The valves comply with the requirements of the EN ISO 10297 standard.

The traditional valves and step-down valves comply with the NEN 3268 (NL), DIN 477 (DE), BS 341-3 (UK), NBN 226 (BE), EN ISO 407, ISO 5145 standards.

The pressure regulator valves also comply with the EN ISO 10524-3 standard.

The gas bottles with a content of (x) liters contain (y) kg of gas and supply (z) m³ of oxygen at 15°C and 1 bar when filled to 150 bar.

The gas bottles with a content of (x) liters contain (y) kg of gas and supply (z) m³ of oxygen at 15°C and 1 bar when filled to 200 bar.

The gas bottles with a content of (x) liters contain (y) kg of gas and supply (z) m³ of oxygen at 15°C and 1 bar when filled to 300 bar.

Only some sizes of packaging may be commercially available.

Marketing Authorization Holder

SOL S.p.A.

Via Borgazzi 27

20900 Monza

Italy

Local Representative:

Sol France Sucursal en España

Calle Yeso, número 2

28500 Arganda del Rey (Madrid)

Responsible for manufacture

SOL B srl

Zoning Ouest, 15

7860 Lessines

Bélgica

Vivisol Ibérica S.L.

Calle Yeso, Polígono Velasco

Arganda del Rey

28500 Madrid

España

SOL S.p.A.

(Via Acquaviva 4

26100 Cremona

Italia.

SOL Bulgaria JSC.

12 Vladaiska Reka Str.

1510 Sofia

Bulgaria

SPG - SOL Plin Gorenjskad.o.o.

Cesta Zelezarjev 8,

4270 Jesenice

Eslovenia

SOL Technische Gase GmbH

Marie-Curie Strasse 1

2700 Wiener Neustadt

Austria

Dolby Medical Home Respiratory Care Limited

Unit 18, Arkwright Road Industrial Estate

Arkwright Road

Bedford

MK42 0LQ

Reino Unido

Dolby Medical Home Respiratory Care Limited

Unit 2,

Broadleys Road

Springkerse Industrial Estate

Stirling

FK7 7ST

Reino Unido

SOL Bulgaria EAD

South industrial zone, complex Agropolichim AD

9160 Devnja

Bulgaria

Sol France, sucursal España (SOLFSE)

Calle Telégraf, s/n, Nt.17-19,

Polígono Industrial Sota el Molí,

08160 Montmeló, (Barcelona)

España

The Irish Company Oxygen ltd.

Waterfall Road, Cork, T12 PP40, Irlanda

SOL Hungary Kft.

Mechwart Andràs utca 6.

Dunaharaszti, 2330, Hungría

SOL Hellas S.A.

Sindos, Industrial zone Sindos

12th km Thessaloniki-Edessa,

Thessaloniki, GR-570 08,

Grecia

SOL Hellas S.A.

Thesi Stefani,ASPROPYRGOS ATTIKI,

GR-193 00,

Grecia

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

Bélgica: Oxygène Médicinal Gazeux SOL

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

Republica Checa: Kyslík medicinální plynný SOL, 100%, Medicinální plyn, stlacený

Grecia: Φαρμακευτικ? Οξυγ?νο σε α?ρια μορφ? SOL

Hungria: Oxigén SOL

Luxemburgo: Oxygène Médicinal Gazeux SOL

Portugal: Oxygéniomedicinal gasoso SOL

Rumania: Oxigen SOL

Eslovaquia: Medicinálny kyslík plynný SOL

Eslovenia: Medicinski kisik SOL 100% medicinski plin, stisnjeni

España: Oxígeno medicinal gas Solgroup

Reino Unido: Medical Oxygen

Date of the last review 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 inhaled air 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 goal 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 should be done with caution. The dose should be adapted to the individual needs of the patient, the oxygen pressure should be maintained above 8.0 kPa (60 mmHg) and the arterial blood oxygen saturation should 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 oxygen administration should be as short 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.

Treatment with high oxygen concentrations (> 60%) for short periods is indicated in cases of severe asthma crisis, pulmonary embolism, pneumonia, 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 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 range from 0.5 to 2 liters per 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) 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 per 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 should be administered at a flow rate that ranges from 0.5 to 15 liters per 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 per 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 up to 100%.

•Pediatric population: Newborns:

In exceptional cases, oxygen concentrations 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). 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 per minute for 15 minutes through a well-fitting facial mask. Treatment should be started in the initial phase 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 special pressurized room. 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.

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. Additionally, pregnant patients, patients with loss of consciousness or 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:

It is recommended to administer rapid treatment at 2.8 atmospheres, with repetition 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, arterial blood oxygen saturation > 90%.

•Patients with 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.

•Patients with clostridial myonecrosis:

It is recommended to administer a 90-minute treatment at 3.0 atmospheres for the first 24 hours, followed by twice-d