Liquid Medical Oxygen 100% Medicinal Gas Cryogenic – patient leaflet, side effects, dosage

1. WHAT MEDICINAL OXYGEN IS AND WHAT IT IS USED FOR

Medicinal oxygen contains oxygen, a gas that is essential for life. Treatment with oxygen can take place under normal pressure and under high pressure.

Oxygen therapy at normal pressure (normobaric oxygen therapy)

Oxygen therapy at normal pressure can be used to treat:

• Low oxygen concentration of the blood or of a specific organ, or to prevent this from happening
• Cluster headaches (a specific headache with short and very severe attacks on one side of the head)

Oxygen therapy at high pressure (hyperbaric oxygen therapy)

Oxygen therapy at high pressure should only be administered by qualified healthcare professionals in order to avoid the risk of injury due to strong fluctuations in pressure. Oxygen therapy at high pressure can be used:

monoxide poisoning (e.g., when the patient is unconscious)

tissue as a result of an injury infected with gas-producing bacteria

2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEDICINAL OXYGEN

Do not use medicinal oxygen

Oxygen at a pressure greater than atmospheric pressure (Hyperbaric Oxygen Therapy) must not be used in cases of untreated/undrained pneumothorax. A pneumothorax is due to the accumulation of air in the thoracic cavity between the two pulmonary membranes. If you have ever had a pneumothorax, please let your doctor know.

Warnings and precautions

Before you start oxygen therapy you should know the following:

• Oxygen may have harmful effects at high concentrations. This may cause pulmonary damages (collapse of the alveoli, inflammation of the lungs) which will obstruct the oxygen supply to the blood.
• If you have a severe chronic obstructive pulmonary disease (COPD) with subsequent deficiency in blood oxygenation, the flow rate of oxygen will be low. The doctor will adapt the appropriate flow rate of oxygen therapy.
• Be extra careful with administering oxygen to new-born infants and pre-term new-born infants. This is to minimise the risk of adverse events such as eye damage. The lowest possible oxygen concentration that is still effective should be used in order to achieve an adequate oxygenation.
• Be extra careful if you have raised carbon dioxide levels in your blood which neutralises the effects of oxygen.
• If you have breathing problems triggered by a reduced oxygen level in the blood or if you are taking strong pain killers, you need to be closely monitored by your doctor.
• If you have ever had a lung injury please let your doctor know.

Talk to your doctor or pharmacist before using medicinal oxygen.

Hyperbaric Oxygen therapy

Before using oxygen therapy at high pressure tell your doctor if you have:

• Psychiatric problems (anxiety, psychosis)
• Fear of confined spaces (claustrophobia)
• Diabetes (high glucose levels in your blood); due to the risk of hypoglycaemia, blood sugar should be measured between two hyperbaric therapies
• Respiratory disorders
• If you have ever had a pneumothorax which is an accumulation of air or gas in the thoracic cavity between the two pulmonary membranes
• Heart problems
• High blood pressure
• Eye problems
• Ear, nose and throat disorders

Children

In pre-term and new-born infants, oxygen therapy may lead to eye damage (retinopathy of prematurity). The doctor will determine the appropriate oxygen concentration to be administered to insure the optimal treatment for your baby.

as there is a possibility of toxic effects to the lungs. Previous pulmonary damage caused by the pesticide Paraquat may be exacerbated by oxygen. In case of Paraquat intoxication, oxygen supplementation should be avoided as far as possible.

Medicinal oxygen with food and drink Do not drink any alcohol during oxygen therapy. Alcohol can suppress breathing.

Pregnancy, breast-feeding and fertility

• During pregnancy, oxygen under normal pressure (normobaric oxygen therapy) may be administered only if necessary.
• There are no objections to the use of oxygen while breast-feeding.

Oxygen therapy at high pressure (hyperbaric oxygen therapy) should only be used if strictly necessary if you are pregnant or can be pregnant. Please inform your treating physician or specialist in case these conditions apply to you.

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

Driving and using machines

Using medicinal oxygen at normal pressure (normobaric oxygen therapy) does not affect your ability to drive or operate machines. After oxygen therapy at high pressure (hyperbaric oxygen therapy) you may experience sight and hearing disorders which can influence the ability to drive and using machines.

3. HOW TO USE MEDICINAL OXYGEN

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Under no circumstances should you yourself change the oxygen concentration administered to you or your child.

Dosage

Oxygen therapy at normal pressure (normobaric oxygen therapy)

• If the oxygen concentration of the blood or of a specific organ is too low.

  Your doctor will tell you for how long and how many times a day you should administer medicinal oxygen because the dosage can differ from person to person. The aim is always to use the lowest possible oxygen

  concentration that is still effective. However, the actual oxygen concentration for inhalation should never be less than 21%, and may be increased up to 100%.

• to treat breathing problems because of reduced oxygen levels in the blood (hypoxia) or as a breathing stimulus (e.g. in pulmonary diseases as COPD):

  The oxygen concentration will be kept below 28% and sometimes even lower than 24%. In the case of new-born infants, oxygen concentrations for inhalation should be kept below 40% and only in very exceptional cases raised to 100%.

  The lowest possible oxygen concentration that is still effective should be used in order to achieve an adequate oxygenation. Fluctuations in oxygen saturation should be avoided.

  100% oxygen is administered at a flow rate of 7 litres a minute, for a period of 15 minutes using a facial mask. Treatment should begin when the first symptoms occur.

UK_OX_P_GO_2024-10

• Medicinal oxygen is a gas for inhalation that is administered using special equipment, such as a nose catheter or a facial mask. Any excess oxygen leaves your body through exhalation and mixes with the ambient air (this is called a “non-rebreathing” system).
• If you cannot breathe independently, you will be put on artificial breathing. During anaesthesia, special equipment with rebreathing or recycling systems is used so that the exhaled air is inhaled once again (this is called a “rebreathing” system).
• Oxygen can also be supplied through a so-called ‘oxygenator’ directly to the blood in cases of, among other things, cardiac surgery with a heart–lung machine, and in other conditions that require extracorporeal circulation

How to receive oxygen therapy at high

• Oxygen therapy at high pressure should only be administered by healthcare professionals in order to avoid the risk of injury due to strong fluctuations in pressure.
• Depending on your condition, oxygen therapy under high pressure lasts 45 to 300 minutes per treatment session. The therapy sometimes includes one or two sessions, but long-term therapy can take up to 30 sessions or more, and multiple sessions a day if necessary.
• Oxygen therapy is given in a special pressure room.
• Oxygen therapy at high pressure can also be provided using a close-fitting facial mask with a hood covering the head or through a tube in your mouth.

If you use more medicinal oxygen than you should

If you have used more oxygen than you should, you should contact your doctor or pharmacist immediately.

The toxic effects of oxygen vary according to the pressure of the inhaled oxygen and the duration of exposure.

At low pressure (0.5 to 2.0 bar) toxic effects are more likely to occur in the lungs (pulmonary region) than in the brain and spinal cord (central nervous system). At higher pressure, the opposite applies. The effects in the lungs (pulmonary region) include shortness of breath, coughing and chest pain.

The effects in the brain and spinal cord (central nervous system) include ringing in ears, hearing and sight disorders, nausea, dizziness, anxiety and confusion, localised muscle cramps(around eyes, mouth and forehead), loss of consciousness, and seizures (epileptic fits).

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 symptomatic treatment initiated.

If you forget to use medicinal oxygen

Use the oxygen as described in the dosage section of the leaflet. Do not use a double dose to make up for a forgotten dose. This is

Do not stop using this medicinal product at your own initiative. Ask your doctor or pharmacist.

Hypoxemia refers to a condition where the arterial partial pressure of oxygen (PaO₂) is lower than 10 kPa (<70 mmHg). An oxygen pressure level of 8 kPa (55 / 60 mmHg) will result in respiratory insufficiency.

Hypoxemia is treated by enriching the patient’s inhalation air with extra oxygen.

The decision to introduce oxygen therapy depends on the degree of hypoxemia and the patient’s individual tolerance level.

In all cases, the objective of the oxygen therapy is to maintain a PaO₂ > 60 mm Hg (7,96 kPa) or oxygen saturation in the arterial blood ≥ 90%. If oxygen is administered diluted in another gas, the oxygen concentration in the inspired air (FiO₂) must be at least 21%.

Oxygen therapy at normal pressure

(Normobaric oxygen therapy):

Administration of oxygen should be performed cautiously. The dose should be adapted to the individual needs of the patient, oxygen tension should remain higher than 8.0 kPa (or 60 mmHg) and oxygen saturation of haemoglobin should be > 90%. Regular monitoring of arterial oxygen tension (PaO₂) or pulsoxymetry (arterial oxygen saturation (SpO₂)) and clinical signs is necessary. The aim is always to use the lowest possible effective oxygen concentration in the inhaled air for the individual patient, which is the lowest dose to maintain a pressure of 8 kPa (60 mmHg)/saturation > 90%. Higher concentrations should be administered as short as possible accompanied by close monitoring of blood gas values.

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

Up to 100% less than 6 hours

60-70% 24 hours

40-50% during the second 24-hour

period Oxygen is potentially toxic after two days in concentrations in excess of 40%.

Neonates are excluded from these guidelines because retrolental fibroplasia occurs with a much lower FiO₂. The lowest effective concentrations should be sought in order to achieve an adequate oxygenation appropriate for neonates.

• Spontaneously breathing patients: The effective oxygen concentration is at least 24%. Normally, a minimum of 30% oxygen is administrated to ensure therapeutic concentrations with a safety margin. The therapy with high oxygen concentration (> 60%) is indicated for short periods in case of serious asthmatic crisis, pulmonary thromboembolism, pneumonia and alveolitic fibrosis, etc.

  A low oxygen concentration is indicated for the treatment of patients with chronic respiratory insufficiency due to a chronic obstructive upheaval of the airways or other causes. The oxygen concentration must not be more than 28%, for some patients even 24% can be excessive.

  concentrations (in some cases up to 100%) is possible, although when using most

  obtain concentrations > 60% (80% in the case of children).

  The dose should be adapted to the individual needs of the patient, at flow rates ranging from 1 to 10 litres of gas per minute.

  should be adjusted on the basis of blood gas values. The effective oxygen concentration will be kept below 28% and sometimes even lower than 24% in patients suffering from breathing disorders who depend on hypoxia as a breathing stimulus.

  • Chronic respiratory insufficiency resulting from Chronic Obstructive Pulmonary Disease (C.O.P.D.) or other conditions: The treatment is adjusted on the basis of blood gas values. Arterial partial oxygen pressure (PaO₂) should be > 60 mm Hg (7,96 kPa) and oxygen saturation in the arterial blood ≥ 90%.

    The most common administration rate is 1 to 3 liters/minute for 15 to 24 hours/day, also covering paradoxical sleep (the most hypoxemia-sensitive period within a day). During a stable disease period, CO₂ concentrations should monitored twice every 3-4 weeks or 3 times per month as CO₂ concentrations can increase during oxygen administration (hypercapnia).

  • Patients with acute respiratory insufficiency: Oxygen must be administered at a rate ranging from 0.5 to 15 liters/minute, flow rates should be adjusted on the basis of blood gas values. In case of emergency, considerably higher doses (up to 60 liters/ minute) are required in patients with severe respiratory difficulties.
  • Mechanically ventilated patients: If oxygen is mixed with other gases, the oxygen fraction in the inhaled gas mixture (FiO₂) may not fall under 21%. In practice, 30% tends to be used as the lower limit. If necessary, the inhaled oxygen fraction can be raised to 100%.
  • Paediatric population: New-born infant: In new-born infant, concentrations of up to 100% can be administered in exceptional cases; however, the treatment must be closely monitored. The lowest effective concentrations should be sought in order to achieve an adequate oxygenation. As a rule, oxygen concentrations in excess of 40% in inhalation air must be avoided, considering the risk of eye damage (retinopathy) or pulmonary collapse. Oxygen pressure in the arterial blood must be closely monitored and kept 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. (Also see 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 close-fitting facial mask. The treatment should begin in the earliest stage of a crisis. Hyperbaric oxygen therapy:

Dosage and pressure should always be adapted to the patient’s clinical condition and therapy should only be given after doctor’s advice. However, some

recommendations based on current knowledge are given below.

Safety advice on the use of medicinal oxygen

combustion. There must be no smoking or open flames(e.g. pilot lights, cookers, oven, gas fire, sparkles, candles …) in rooms where medicinal oxygen is used, as it increases the risk of fire.

Handle carefully the cylinder. Ensure that the gas cylinder is not dropped or exposed to knocks.

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 oxygen concentrations: Damage to the eye, which can result in impaired vision.

With hyperbaric treatment: ear pain, myopia, barotrauma (injury caused to 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: Rupture of the eardrum

Rare (may affect up to 1 in 1000 people) With hyperbaric treatment: breathlessness, abnormally low blood sugar level in diabetic patients.

Not known (frequency cannot be estimated from the available data)

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

With hyperbaric treatment: breathing difficulty, involuntary muscular contraction, vertigo, audition impairment, acute serous otitis, noise or ringing in the ears (tinnitus), sickness, abnormal behaviour, decrease in peripheral vision, visual changes, clouding of the lens (cataract).

Reporting of side effects

If you get 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 via the Yellow Card Scheme

(Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

5. HOW TO STORE MEDICINAL OXYGEN

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

Do not use this medicine after the expiry date which is stated on the gas cylinder after EXP. The expiry date refers to the last day of that month.

• The gas cylinders should be stored between -20°C and +65°C.
• The gas cylinders should be stored vertically, except gas cylinders with a convex bottom; these should be stored horizontally, or in a crate.
• The gas cylinders should be protected from falling over or from mechanical shocks, for example, by fixing the gas cylinders or placing them in a crate.

hood covering the head, or through a tracheal tube.

whereas chronic therapy may take up to 30 or more sessions. If necessary, the sessions can be repeated two to three times a day.

• Carbon monoxide poisoning:

  Oxygen should be given in high

  concentrations (100%) as soon as possible following carbon monoxide poisoning until the carboxyhaemoglobin concentration has fallen below dangerous levels (around 5%). Hyperbaric oxygen (starting at

  3 atmospheres) is indicated for patients with acute CO poisoning or have exposure intervals ≥24 hours. In addition, pregnant patients, patients with loss of consciousness or higher carboxyhemoglobin levels warrant hyperbaric oxygen therapy. Normobaric oxygen should not be used between multiple hyperbaric oxygen treatments as this can contribute to toxicity. Hyperbaric oxygen seems to also have potential in the delayed treatment of CO poisoning using multiple treatments of low dose of oxygen.

• Patients with decompression sickness: Rapid treatment at 2.8 atmosphere is recommended, repeated up to ten times if symptoms persist.

• Patients with air embolism:

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

• Patients with osteoradionecrosis: Hyperbaric oxygen therapy in radiation injury usually consist of daily 90-120 min sessions at 2.0-2.5 atmosphere for about 40 days.
• Patients with clostridial myonecrosis: It is recommended that a 90-min treatment should be given at 3.0 atmosphere in the first 24h, followed by twice-daily treatments for 4-5 days, until clinical improvement is seen.

Method of administration

Normobaric oxygen therapy

Oxygen is administered through inhaled air, preferably using dedicated equipment (e.g., a nose catheter or facial mask) via this equipment, oxygen is administered with inhaled air. The gas plus any excess oxygen subsequently leaves the patient in the exhaled air, and mixes with the ambient air (“non-rebreathing” system). In many cases, during anaesthesia special systems with a rebreathing system or recycling system are used so that the exhaled air is inhaled once again (“rebreathing” system).

If the patient cannot breathe independently, artificial breathing support can be provided. In addition, oxygen can be injected into the bloodstream directly using a so-called oxygenator. The application of extracorporeal gas exchange devices facilitate oxygenation and decarboxylation without the harm associated with aggressive mechanical ventilation strategies. The oxygenator, which acts as an artificial lung, provides improved oxygen transfer and therefore, blood gas levels are kept within clinical acceptable ranges. After recovery of lung function extracorporeal blood and gas flow is reduced and eventually,

Hyperbaric oxygen therapy is administered in a specially constructed pressure room where the ambient pressure can be increased to up to three times the atmospheric pressure. Hyperbaric oxygen therapy can also be provided through a close-fitting facial mask with a hood covering the head, or through a tracheal tube. Preparation prior to use

Follow the instructions of your supplier, particularly:

• If the gas cylinder is visibly damaged, or if there is a suspicion of damage or exposure to extreme temperatures has occurred, the gas cylinder may not be used
• All contact with oil, grease or hydrocarbons must be avoided
• Remove the seal from the valve and the protective cap before use
• Only equipment suitable for use with a specific gas cylinder and that specific gas may be used
• Check that the quick connector and regulator are clean and that the connections are in good condition
• Open the cylinder valve slowly - at least half a turn
• When opening and closing the valve of a gas cylinder, no pliers or other tools must be used so as to avoid the risk of damage
• No modifications to the form of packaging must be made
• Check for leakage in accordance with the instructions accompanying the regulator. Do not try to deal with leakage from the valve or equipment yourself, other than by changing the gasket or O-ring
• In the event of leakage, close the valve and uncouple the regulator. If the cylinder continues to leak, empty the cylinder outdoor. Label defective cylinders, place them in an area intended for claims and return them to the supplier.
• For cylinders with an inbuilt pressure regulator valve, it is not necessary to use a separate pressure regulator. The inbuilt pressure regulator valve has a quick connector for connecting ‘on demand’ valves, but also a separate outlet for constant flow of gas, where the flow can be regulated.

Using the gas cylinder

• The transferring of gas under pressure is prohibited.
• Smoking and open flames are strictly forbidden in rooms where treatment with medicinal oxygen takes place.
• When the cylinder is in use it must be fixed in a suitable support.
• One should consider replacing the gas cylinder when the pressure in the bottle has dropped to a point where the indicator on the valve is within the yellow field.
• When a small quantity of gas is left in the gas cylinder, the cylinder valve must be closed. It is important that a small amount of pressure is left in the cylinder to avoid the entrance of contaminants.
• Valves of empty gas cylinders must be closed.

• After use the cylinder valve must be closed hand-tight. Depressurise the regulator or connection.

  • The gas cylinders should be stored in a well-ventilated room that is exclusively used for the storage of medicinal gases. This storage room must not contain any inflammable materials.
  • Gas cylinders containing a different kind of gas, or a gas that has a different composition, should be stored separately.
  • Full and empty gas cylinders should be stored separately.
  • The gas cylinders must not be stored near sources of heat. If at risk of fire - move to a safe place.
  • Gas cylinders must be stored covered and protected against the effects of the weather.
  • Close the valves of the cylinders after use.
  • Return cylinder to the supplier when empty.
  • Warning notices prohibiting smoking and naked lights must be posted clearly in the storage area.
  • Emergency services should be advised of the location of the cylinder storage.

6. CONTENTS OF THE PACK AND OTHER INFORMATION

What medicinal oxygen contains

• The active substance is oxygen, 100% v/v.
• There are no other ingredients.

What medicinal oxygen looks like and contents of the pack

Medicinal oxygen is an inhalation gas. It is supplied as a liquid or gas in a special container. Oxygen is a colourless, tasteless and odourless gas. In liquid state it has a blue colour. Gaseous medicinal oxygen is stored in gas cylinders in a gaseous state and under a pressure of 150, 200 or 300 bars (at 15°C). The cylinders are made of steel or aluminium. The valves are made of brass, steel or aluminium.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

SOL S.p.A.

via Borgazzi 27 - 20900 Monza, Italy

Manufacturer

Sol B Srl

Zoning Ouest 15, 7860 Lessines, Belgium Vivisol Ibérica, S.L.

C/ Yeso 2, Polígono Velasco

Arganda del Rey, 28500 Madrid, Spain SOL S.p.A.

Via Acquaviva 4, 26100 Cremona, Italy SOL Bulgaria JSC

12 Vladaiska Reka Str., 1510 Sofia, Bulgaria SPG - SOL Plin Gorenjska d.o.o.

Cesta železarjev 8, 4270 Jesenice, Slovenia 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, United Kingdom

Dolby Medical Home Respiratory Care Limited Unit 2, Broadleys Road

Springkerse Industrial Estate, Stirling FK7 7ST, United Kingdom

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), Spain The Irish Company Oxygen ltd.

Waterfall Road, Cork, T12 PP40, Ireland

SOL Hungary Kft.

Mechwart Andràs utca 6

Dunaharaszti, 2330, Hungary

SOL Hellas S.A.

Sindos, Industrial zone Sindos

12th km Thessaloniki-Edessa,

Thessaloniki, GR-570 08, Greece

SOL Hellas S.A.

Thesi Stefani, Aspropyrgos Attiki,

GR-193 00, Greece

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: Oxygène Médicinal Gazeux SOL Bulgaria: Медицински кислород, газообразен SOL

Czech Repubic : Kyslík medicinální plynný SOL 100% Medicinální plyn, stlačený Greece: Φαρμακευτικό Οξυγόνο σε αέρια μορφή SOL

Hungary: Oxigén SOL

Luxemburg: Oxygène Médicinal Gazeux SOL Portugal: Oxygénio medicinal gasoso SOL Romania: Oxigen SOL

Slovakia: Medicinálny kyslík plynný SOL Slovenia: Medicinski kisik SOL 100% medicinski plin, stisnjeni

Spain: Oxígeno medicinal gas Solgroup UK: Medical Oxygen

This leaflet was last revised in 10/2024

100% oxygen is administered at a flow rate of 7 litres a minute, for a period of 15 minutes using a facial mask. Treatment should begin when the first symptoms occur.

• Medicinal oxygen is a gas for inhalation that is administered using special equipment, such as a nose catheter or a facial mask. Any excess oxygen leaves your body through exhalation and mixes with the ambient air (this is called a “non-rebreathing” system).
• If you cannot breathe independently, you will be put on artificial breathing. During anaesthesia, special equipment with rebreathing or recycling systems is used so that the exhaled air is inhaled once again (this is called a “rebreathing” system).
• Oxygen can also be supplied through a so-called ‘oxygenator’ directly to the blood in cases of, among other things, cardiac surgery with a heart–lung machine, and in other conditions that require extracorporeal circulation.

How to receive oxygen therapy at high

• Oxygen therapy at high pressure should only be administered by healthcare professionals in order to avoid the risk of injury due to strong fluctuations in pressure.
• Depending on your condition, oxygen therapy under high pressure lasts 45 to 300 minutes per treatment session. The therapy sometimes includes one or two sessions, but long-term therapy can take up to 30 sessions or more, and multiple sessions a day if necessary.
• Oxygen therapy is given in a special pressure room.
• Oxygen therapy at high pressure can also be provided using a close-fitting facial mask with a hood covering the head or through a tube in your mouth.

If you use more medicinal oxygen than you should

If you have used more oxygen than you should, you should contact your doctor or pharmacist immediately.

The toxic effects of oxygen vary according to the pressure of the inhaled oxygen and the duration of exposure.

At low pressure (0.5 to 2.0 bar) toxic effects are more likely to occur in the lungs (pulmonary region) than in the brain and spinal cord (central nervous system).

At higher pressure, the opposite applies. The effects in the lungs (pulmonary region) include shortness of breath, coughing and chest pain.

The effects in the brain and spinal cord (central nervous system) include ringing in ears, hearing and sight disorders, nausea, dizziness, anxiety and confusion, localised muscle cramps (around eyes, mouth and forehead), loss of consciousness, and seizures (epileptic fits).

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 symptomatic treatment initiated.

If you forget to use medicinal oxygen

Use the oxygen as described in the dosage section of the leaflet. Do not use a double dose to make up for a forgotten dose. This is

Hypoxemia refers to a condition where the arterial partial pressure of oxygen (PaO₂) is lower than 10 kPa (<70 mmHg). An oxygen pressure level of 8 kPa (55 / 60 mmHg) will result in respiratory insufficiency.

Hypoxemia is treated by enriching the patient’s inhalation air with extra oxygen.

The decision to introduce oxygen therapy depends on the degree of hypoxemia and the patient’s individual tolerance level.

In all cases, the objective of the oxygen therapy is to maintain a PaO₂ > 60 mm Hg (7,96 kPa) or oxygen saturation in the arterial blood ≥ 90%. If oxygen is administered diluted in another gas, the oxygen concentration in the inspired air (FiO₂) must be at least 21%.

Oxygen therapy at normal pressure (Normobaric oxygen therapy):

Administration of oxygen should be performed cautiously. The dose should be adapted to the individual needs of the patient, oxygen tension should remain higher than 8.0 kPa

(or 60 mmHg) and oxygen saturation of haemoglobin should be > 90%.

Regular monitoring of arterial oxygen tension (PaO₂) or pulsoxymetry (arterial oxygen saturation (SpO₂)) and clinical signs is necessary. The aim is always to use the lowest possible effective oxygen concentration in the inhaled air for the individual patient, which is the lowest dose to maintain a pressure of 8 kPa (60 mmHg)/saturation > 90%. Higher concentrations should be administered as short as possible accompanied by close monitoring of blood gas values.

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

Up to 100% less than 6 hours

60-70% 24 hours

40-50% during the second 24-hour period

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

Neonates are excluded from these guidelines because retrolental fibroplasia occurs with a much lower FiO₂. The lowest effective concentrations should be sought in order to achieve an adequate oxygenation appropriate for neonates.

• Spontaneously breathing patients: The effective oxygen concentration is at least 24%. Normally, a minimum of 30% oxygen is administrated to ensure therapeutic concentrations with a safety margin. The therapy with high oxygen concentration (> 60%) is indicated for short periods in case of serious asthmatic crisis, pulmonary thromboembolism, pneumonia and alveolitic fibrosis, etc.

  A low oxygen concentration is indicated for the treatment of patients with chronic respiratory insufficiency due to a chronic obstructive upheaval of the airways or other causes. The oxygen concentration must not be more than 28%, for some patients even 24% can be excessive.

  concentrations (in some cases up to 100%) is possible, although when using most

  obtain concentrations > 60% (80% in the case of children).

  The dose should be adapted to the individual needs of the patient, at flow rates ranging from 1 to 10 litres of gas per minute.

  should be adjusted on the basis of blood gas values.

  The effective oxygen concentration will be kept below 28% and sometimes even lower than 24% in patients suffering from breathing disorders who depend on hypoxia as a breathing stimulus.

  • Chronic respiratory insufficiency resulting from Chronic Obstructive Pulmonary Disease (C.O.P.D.) or other conditions: The treatment is adjusted on the basis of blood gas values. Arterial partial oxygen pressure (PaO₂) should be > 60 mm Hg (7,96 kPa) and oxygen saturation in the arterial blood ≥ 90%.

    The most common administration rate is 1 to 3 liters/minute for 15 to 24 hours/day, also covering paradoxical sleep

    (the most hypoxemia-sensitive period within a day). During a stable disease period, CO₂ concentrations should monitored twice every 3-4 weeks or 3 times per month as CO₂ concentrations can increase during oxygen administration (hypercapnia).

  • Patients with acute respiratory insufficiency: Oxygen must be administered at a rate ranging from 0.5 to 15 liters/minute, flow rates should be adjusted on the basis of blood gas values. In case of emergency, considerably higher doses

    (up to 60 liters/minute) are required in patients with severe respiratory difficulties.

  • Mechanically ventilated patients: If oxygen is mixed with other gases, the oxygen fraction in the inhaled gas mixture (FiO₂) may not fall under 21%. In practice, 30% tends to be used as the lower limit. If necessary, the inhaled oxygen fraction can be raised to 100%.
  • Paediatric population: New-born infant: In new-born infant, concentrations of up to 100% can be administered in exceptional cases; however, the treatment must be closely monitored. The lowest effective concentrations should be sought in order to achieve an adequate oxygenation. As a rule, oxygen concentrations in excess of 40% in inhalation air must be avoided, considering the risk of eye damage (retinopathy) or pulmonary collapse. Oxygen pressure in the arterial blood must be closely monitored and kept 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. (Also see 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 close-fitting facial mask. The treatment should begin in the earliest stage of a crisis. Hyperbaric oxygen therapy:

Dosage and pressure should always be adapted to the patient’s clinical condition and therapy should only be given after doctor’s advice. However, some

recommendations based on current knowledge are given below.

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

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you.

• Keep this leaflet. You may need to read it again.
• Ask your pharmacist if you need more information or advice.
• 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.
• You must talk to a doctor if you do not feel better or if you feel worse.

What is in this leaflet

The full name of this medicine is Liquid Medical Oxygen 100% Medicinal gas, cryogenic, and Liquid Medical Oxygen 100% medicinal gas, cryogenic.

For ease of reference it will be referred to as medicinal oxygen throughout the leaflet.

1. 1. WHAT MEDICINAL OXYGEN IS AND WHAT IT IS USED FOR

Medicinal oxygen contains oxygen, a gas that is essential for life. Treatment with oxygen can take place under normal pressure and under high pressure.

Oxygen therapy at normal pressure (normobaric oxygen therapy)

Oxygen therapy at normal pressure can be used to treat:

• Low oxygen concentration of the blood or of a specific organ, or to prevent this from happening
• Cluster headaches (a specific headache with short and very severe attacks on one side of the head)

Oxygen therapy at high pressure (hyperbaric oxygen therapy)

Oxygen therapy at high pressure should only be administered by qualified healthcare professionals in order to avoid the risk of injury due to strong fluctuations in pressure. Oxygen therapy at high pressure can be used:

monoxide poisoning (e.g., when the patient is unconscious)

tissue as a result of an injury infected with gas-producing bacteria

1. 2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEDICINAL OXYGEN

Do not use medicinal oxygen

Oxygen at a pressure greater than atmospheric pressure (Hyperbaric Oxygen Therapy) must not be used in cases of untreated/undrained pneumothorax. A pneumothorax is due to the accumulation of air in the thoracic cavity between the two pulmonary membranes. If you have ever had a pneumothorax, please let your doctor know.

Warnings and precautions

Before you start oxygen therapy you should know the following:

• Oxygen may have harmful effects at high concentrations. This may cause pulmonary damages (collapse of the alveoli, inflammation of the lungs) which will obstruct the oxygen supply to the blood.
• If you have a severe chronic obstructive pulmonary disease (COPD) with subsequent deficiency in blood oxygenation, the flow rate of oxygen will be low. The doctor will adapt the appropriate flow rate of oxygen therapy.
• Be extra careful with administering oxygen to new-born infants and pre-term new-born infants. This is to minimise the risk of adverse events such as eye damage. The lowest possible oxygen concentration that is still effective should be used in order to achieve an adequate oxygenation.
• Be extra careful if you have raised carbon dioxide levels in your blood which neutralises the effects of oxygen.
• If you have breathing problems triggered by a reduced oxygen level in the blood or if you are taking strong pain killers, you need to be closely monitored by your doctor.
• If you have ever had a lung injury please let your doctor know.

Talk to your doctor or pharmacist before using medicinal oxygen.

Hyperbaric Oxygen therapy

Before using oxygen therapy at high pressure tell your doctor if you have:

• Psychiatric problems (anxiety, psychosis)
• Fear of confined spaces (claustrophobia)
• Diabetes (high glucose levels in your blood); due to the risk of hypoglycaemia, blood sugar should be measured between two hyperbaric therapies
• Respiratory disorders
• If you have ever had a pneumothorax which is an accumulation of air or gas in the thoracic cavity between the two pulmonary membranes
• Heart problems
• High blood pressure
• Eye problems
• Ear, nose and throat disorders

Children

In pre-term and new-born infants, oxygen therapy may lead to eye damage (retinopathy of prematurity). The doctor will determine the appropriate oxygen concentration to be administered to insure the optimal treatment for your baby.

as there is a possibility of toxic effects to the lungs.

Previous pulmonary damage caused by the pesticide Paraquat may be exacerbated by oxygen. In case of Paraquat intoxication, oxygen supplementation should be avoided as far as possible.

Medicinal oxygen with food and drink Do not drink any alcohol during oxygen therapy. Alcohol can suppress breathing.

Pregnancy, breast-feeding and fertility

• During pregnancy, oxygen under normal pressure (normobaric oxygen therapy) may be administered only if necessary.
• There are no objections to the use of oxygen while breast-feeding.

Oxygen therapy at high pressure (hyperbaric oxygen therapy) should only be used if strictly necessary if you are pregnant or can be pregnant. Please inform your treating physician or specialist in case these conditions apply to you.

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

Driving and using machines

Using medicinal oxygen at normal pressure (normobaric oxygen therapy) does not affect your ability to drive or operate machines. After oxygen therapy at high pressure (hyperbaric oxygen therapy) you may experience sight and hearing disorders which can influence the ability to drive and using machines.

1. 3. HOW TO USE MEDICINAL OXYGEN

Always use this medicine exactly as described in this leaflet or as your doctor or pharmacist has told you. Check with your doctor or pharmacist if you are not sure. Under no circumstances should you yourself change the oxygen concentration administered to you or your child.

Dosage

Oxygen therapy at normal pressure (normobaric oxygen therapy)

• If the oxygen concentration of the blood or of a specific organ is too low.

  Your doctor will tell you for how long and how many times a day you should administer medicinal oxygen because the dosage can differ from person to person. The aim is always to use the lowest possible oxygen concentration that is still effective. However, the actual oxygen concentration for inhalation should never be less than 21%, and may be increased up to 100%.

• to treat breathing problems because of reduced oxygen levels in the blood (hypoxia) or as a breathing stimulus (e.g. in pulmonary diseases as COPD):

  The oxygen concentration will be kept below 28% and sometimes even lower than 24%. In the case of new-born infants, oxygen concentrations for inhalation should be kept below 40% and only in very exceptional cases raised to 100%. The lowest possible oxygen concentration that is still effective should be used in order to achieve an adequate oxygenation. Fluctuations in oxygen saturation should be avoided.

Liquid Medical Oxygen

100% medicinal gas, cryogenic

Oxygen

UK_OX_P_LO_2024-10

Do not stop using this medicinal product at your own initiative. Ask your doctor or pharmacist.

Safety advice on the use of medicinal oxygen

combustion. There must be no smoking or open flames (e.g. pilot lights, cookers, oven, gas fire, sparkles, candles …) in rooms where medicinal oxygen is used, as it increases the risk of fire. Handle carefully the cylinder. Ensure that the gas cylinder is not dropped or exposed to knocks.

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

1. 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 oxygen concentrations: Damage to the eye, which can result in impaired vision.

With hyperbaric treatment: ear pain, myopia, barotrauma (injury caused to 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: Rupture of the eardrum

Rare (may affect up to 1 in 1000 people) With hyperbaric treatment: breathlessness, abnormally low blood sugar level in diabetic patients.

Not known (frequency cannot be estimated from the available data)

With normobaric treatment: Pulmonary toxicity, aggravation of the excess carbon dioxide in the blood (hypercapnia), mucosal dryness, local irritation and inflammation of the mucosa. With hyperbaric treatment: breathing difficulty, involuntary muscular contraction, vertigo, audition impairment, acute serous otitis, noise or ringing in the ears (tinnitus), sickness, abnormal behaviour, decrease in peripheral vision, visual changes, clouding of the lens (cataract).

Reporting of side effects

If you get 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 via the Yellow Card Scheme

(Website: www.mhra.gov.uk/yellowcard). By reporting side effects you can help provide more information on the safety of this medicine.

1. 5. HOW TO STORE MEDICINAL OXYGEN

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

Do not use this medicine after the expiry date which is stated on the vessel/cistern after EXP. The expiry date refers to the last day of that month.

Keep the vessel/cistern in a well-ventilated area within a temperature range of -20°C and +50°C. Keep away from inflammable and combustible materials and sources of heat or open fire. If at risk of fire – move to a safe place. Do not smoke near the vessel/cistern. The transport must be conducted in accordance with international regulations for transporting dangerous materials.

Avoid any contact with oil, grease or hydrocarbons.

hood covering the head, or through a tracheal tube.

whereas chronic therapy may take up to 30 or more sessions. If necessary, the sessions can be repeated two to three times a day.

• Carbon monoxide poisoning:

  Oxygen should be given in high

  concentrations (100%) as soon as possible following carbon monoxide poisoning until the carboxyhaemoglobin concentration has fallen below dangerous levels (around 5%). Hyperbaric oxygen (starting at 3

  atmospheres) is indicated for patients with acute CO poisoning or have exposure intervals ≥24 hours. In addition, pregnant patients, patients with loss of consciousness or higher carboxyhemoglobin levels warrant hyperbaric oxygen therapy. Normobaric oxygen should not be used between multiple hyperbaric oxygen treatments as this can contribute to toxicity. Hyperbaric oxygen seems to also have potential in the delayed treatment of CO poisoning using multiple treatments of low dose of oxygen.

• Patients with decompression sickness: Rapid treatment at 2.8 atmosphere is recommended, repeated up to ten times if symptoms persist.

• Patients with air embolism:

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

• Patients with osteoradionecrosis: Hyperbaric oxygen therapy in radiation injury usually consist of daily 90-120 min sessions at 2.0-2.5 atmosphere for about 40 days.
• Patients with clostridial myonecrosis: It is recommended that a 90-min treatment should be given at 3.0 atmosphere in the first 24h, followed by twice-daily treatments for 4-5 days, until clinical improvement is seen.

Method of administration

Normobaric oxygen therapy

Oxygen is administered through inhaled air, preferably using dedicated equipment (e.g., a nose catheter or facial mask) via this equipment, oxygen is administered with inhaled air. The gas plus any excess oxygen subsequently leaves the patient in the exhaled air, and mixes with the ambient air (“non-rebreathing” system). In many cases, during anaesthesia special systems with a rebreathing system or recycling system are used so that the exhaled air is inhaled once again (“rebreathing” system).

If the patient cannot breathe independently, artificial breathing support can be provided. In addition, oxygen can be injected into the bloodstream directly using a so-called oxygenator. The application of extracorporeal gas exchange devices facilitate oxygenation and decarboxylation without the harm associated with aggressive mechanical ventilation strategies. The oxygenator, which acts as an artificial lung, provides improved oxygen transfer and therefore, blood gas levels are kept within clinical acceptable ranges. After recovery of lung function extracorporeal blood and gas flow is reduced and eventually,

Hyperbaric oxygen therapy is administered in a specially constructed pressure room where the ambient pressure can be increased to up to three times the atmospheric pressure. Hyperbaric oxygen therapy can also be provided through a close-fitting facial mask with a hood covering the head, or through a tracheal tube.

Mobile cryogenic vessel

General

Medicinal gases must only be used for medicinal purposes.

Different gas types and gas qualities must be separated from each other.

Full and empty containers must be stored separately.

Never use grease, oil or similar substances for lubricating screw threads that jam or are difficult to connect.

Handle valves and devices to match with clean and grease-free (hand cream, etc.) hands.

Use only standard equipment that is intended for medicinal oxygen.

Preparation for use

Use only dosing devices that are intended for medicinal oxygen.

Check that the automatic coupling or dosing device is clean, and that the gaskets are in working order.

Never use tools on pressure-/flow regulators that are intended for manual connection, as this may damage the coupling.

Open the valve slowly – at least one half turn. Check for leakage in accordance with the instructions supplied with the regulator. In case of leakage, the valve must be closed and the regulator disconnected. Label defective vessels, store them separately and return them to the supplier.

Use

Smoking and open flames are strictly forbidden in rooms where oxygen therapy is being carried out.

Close down the apparatus in the event of fire or if it is not being used.

Carry to safety in the event of fire. Larger vessels must be transported by means of vehicles meant for this purpose. Pay special attention to connected devices which should not be accidentally loosened. When the vessel is empty, the gas flow is dropping. Close the exit valve and remove any couplings after the pressure has been released.

Mobile cryogenic cistern and fixed cryogenic vessels.

Only the gas supplier may handle these vessels.

1. 6. CONTENTS OF THE PACK AND OTHER INFORMATION

What medicinal oxygen contains

• The active substance is oxygen, 100% v/v.
• There are no other ingredients.

What medicinal oxygen looks like and contents of the pack

Medicinal oxygen is an inhalation gas. It is supplied as a liquid or gas in a special container.

Oxygen is a colourless, tasteless and odourless gas.

In liquid state it has a blue colour.

Liquid medicinal oxygen is packed in mobile cryogenic vessels.

Mobile cryogenic vessels are made of an outer and an inner vessel of stainless steel with a vacuum insulation layer in between and fitted with dedicated filling port and withdrawal hose connection.

The valves are made of brass, stainless steel and/or bronze and are specially designed for low temperatures.

These vessels contain oxygen in the liquid state at very low temperature.

The content of the vessels varies from 10 to 1100 litres.

Each litre of liquid oxygen delivers 853 litres of oxygen gas at 15°C and 1 bar.

Liquid medicinal oxygen is packed in mobile cryogenic cisterns and fixed cryogenic vessels.

Mobile cryogenic cisterns are made of an outer and an inner enclosure of stainless steel. The valves are made of brass, stainless steel and/or bronze and are specially designed for low temperatures.

These cisterns contain oxygen in the liquid state at very low temperature.

The content of the cisterns varies from 9000 to 26000 litres.

Each litre of liquid oxygen delivers 853 litres of oxygen gas at 15°C and 1 bar.

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

These vessels contain oxygen in the liquid state at very low temperature.

The content of the vessels ranges up to 50,000 litres.

Each litre of liquid oxygen delivers 853 litres of oxygen gas at 15°C and 1 bar.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

SOL S.p.A.

via Borgazzi 27

20900 Monza, Italy

Manufacturer

Liquid Medical Oxygen

(mobile cryogenic vessels)

SOL B Srl

Zoning Ouest 15, 7860 Lessines, Belgium Vivisol Ibérica, S.L.

C/ Yeso 2, Polígono Velasco

Arganda del Rey, 28500 Madrid, Spain SOL Bulgaria JSC

12 Vladaiska Reka Str., 1510 Sofia, Bulgaria SPG - SOL Plin Gorenjska d.o.o. Cesta železarjev 8, 4270 Jesenice , Slovenia Dolby Medical Home Respiratory Care Limited Unit 18, Arkwright Road Industrial Estate Arkwright Road, Bedford

MK42 0LQ, United Kingdom

Dolby Medical Home Respiratory Care Limited Unit 2, Broadleys Road

Springkerse Industrial Estate

Stirling, FK7 7ST, United Kingdom 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), Spain The Irish Company Oxygen ltd.

Waterfall Road, Cork, T12 PP40, Ireland SOL Hellas S.A.

Sindos, Industrial zone Sindos

12th km Thessaloniki-Edessa,

Thessaloniki, GR-570 08, Greece SOL Hellas S.A.

Thesi Stefani, Aspropyrgos Attiki, GR-193 00, Greece

Liquid Medical Oxygen (mobile cryogenic cisterns and fixed cryogenic vessels) SOL S.p.A.

Zoning Industriel de Feluy, Zone B 7180 Seneffe, Belgium

SPG - SOL Plin Gorenjska d.o.o. Cesta železarjev 8 , 4270 Jesenice, Slovenia SOL Bulgaria JSC

12 Vladaiska Reka Str., 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.

Sindos, Industrial zone Sindos

12th km Thessaloniki-Edessa,

Thessaloniki, GR-570 08, Greece

SOL Hellas S.A.

59th km Athens-Lamia National Road, Sximatari, Viotia, 32009, Greece

SOL Gas Primari S.r.l.

Via Del Lavoro 12

S. Martino Buon Albergo

37036 Verona (Italy)

This medicinal product is authorised in the Member States of the EEA under the following names:

Belgium: Oxygène Médicinal Liquide SOL - Oxygène Médicinal Liquide SOL Bulgaria: Медицински кислород, течен SOL Czech Repubic: Kyslík medicinální kapalný SOL 100% Medicinální plyn, kryogenní Greece: Φαρμακευτικό Οξυγόνο σε υγρή μορφή SOL

Hungary: Oxigén SOL - Oxigén BTG Luxemburg: Oxygène Médicinal Liquide SOL

• 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 Solspa - Oxígeno medicinal líquido Solgroup The Netherlands: Zuurstof Medicinaal Vloeibaar SOL

UK: Liquid Medical Oxygen

This leaflet was last revised in 10/2024