Medicinal oxygen gas Solgroup 99.5% v/v gas for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Medicinal Oxygen Gas Solgroup 99.5 % v/v for inhalation

Oxygen

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

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

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

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

Leaflet contents

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

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

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

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

Medicinal Oxygen contains oxygen, which is a gas essential for life. Oxygen treatment can be administered under normal pressure or under elevated pressure.

Oxygen treatment under normal pressure (normobaric oxygen therapy).

Oxygen treatment under normal pressure may be used to treat:

• Low oxygen levels in the blood or in a specific organ, or to prevent them.
• Cluster headache (a specific type of headache causing short but very severe attacks on one side of the head).

Oxygen treatment under high pressure (hyperbaric oxygen therapy).

Oxygen treatment under elevated pressure must only be administered by qualified healthcare professionals to avoid the risk of injury due to rapid pressure changes. Oxygen treatment under elevated pressure may be used for:

• Treatment of severe carbon monoxide poisoning (e.g., when the patient is unconscious)
• Gas embolism caused by a sudden decrease in atmospheric pressure (decompression sickness)
• Treatment of obstruction in the heart or blood vessels caused by gas bubbles (arterial gas embolism)
• Supportive treatment in cases of bone loss following radiotherapy
• Supportive treatment in cases of tissue necrosis due to infections with gas-producing bacteria.

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

Do not use Medicinal Oxygen

Medicinal oxygen must not be used 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 pleural 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 (collapse of alveoli, lung inflammation), which would impair oxygen delivery to the blood.
• If you have chronic obstructive pulmonary disease (COPD) with resulting blood oxygenation deficiency, the oxygen flow rate will need to be lower. Your doctor will adjust the appropriate oxygen flow rate accordingly.
• Special caution is required when administering oxygen to newborns and premature infants, in order to minimize the risk of adverse events such as eye damage. The lowest effective oxygen concentration achieving adequate oxygenation should be used.
• Exercise special caution if your blood carbon dioxide levels are elevated, as this may counteract the effects of oxygen.
• If you have respiratory problems triggered by low blood oxygen levels or if you are taking strong analgesics, close medical supervision will be necessary.
• If you have ever had lung injuries, inform your doctor.

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

Hyperbaric oxygen therapy

Before starting oxygen treatment at high pressure, inform your doctor if you have:

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

Children

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

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

Use of Medicinal Oxygen with other medicines

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

If you are taking or have been prescribed bleomycin (used to treat cancer), amiodarone (used to treat heart conditions), or nitrofurantoin (used to treat infections), inform your doctor before using oxygen, as these may increase the risk of pulmonary toxicity.

Oxygen may worsen pre-existing lung damage caused by the pesticide paraquat. In cases of paraquat poisoning, administration of additional oxygen should be avoided as much as possible.

Use of Medicinal Oxygen with food, drinks, and alcohol

Do not consume alcohol while using this medicine. Alcohol may cause respiratory depression.

Pregnancy, breastfeeding, and fertility

• During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) may be used only if necessary.
• There are no contraindications to the use of oxygen during breastfeeding.

Treatment with oxygen at high pressure (hyperbaric oxygen therapy) should only be used during pregnancy or if you suspect you might be pregnant if strictly necessary. Inform the treating physician or specialist if this applies to you.

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

Driving and use of machines

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

After receiving oxygen treatment at high pressure (hyperbaric oxygen therapy), you may experience visual and auditory disturbances that could affect your ability to drive or operate machinery.

3. How to use Medicinal Oxygen

Follow exactly the instructions for administration of this medicine given by your doctor or pharmacist. If in doubt, consult your doctor or pharmacist again. Under no circumstances should you change by yourself the oxygen concentration being administered to you or your child.

Dosage

Oxygen therapy at normal pressure (normobaric oxygen therapy)

• If blood oxygen concentration or that of a specific organ is too low:

Your doctor will indicate how long and how many times per day you should administer 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 must never be less than 21% and may be increased up to 100%.

• To treat respiratory problems when blood oxygen levels are reduced (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 newborn infants should be kept below 40% and may only be increased to 100% in very exceptional cases. The lowest effective oxygen concentration that achieves adequate oxygenation should be used. Fluctuations in oxygen saturation should be avoided if possible.

• To treat cluster headache:

100% oxygen is administered at a flow rate of 7 liters per minute for a period of 15 minutes via a mask. Treatment should be started at the onset of symptoms.

How to use oxygen therapy at normal pressure

• Medicinal Oxygen is a gas for inhalation administered using special equipment such as a nasal cannula or a mask. Excess oxygen is exhaled from the body and mixes with ambient air (known as a "non-rebreathing" system).
• If you are unable to breathe on your own, artificial respiratory support will be provided. During anesthesia, special equipment with rebreathing or recycling systems is used so that exhaled air is inhaled again (known as a "rebreathing" system).
• Oxygen may also be administered directly into the bloodstream using a so-called "oxygenator," for example during cardiac surgery with cardiopulmonary bypass and other situations requiring extracorporeal circulation.

How to receive oxygen therapy at elevated pressure

• Hyperbaric oxygen therapy must only be administered by healthcare professionals to avoid the risk of injury due to significant pressure fluctuations.
• Depending on your condition, each session of hyperbaric oxygen therapy lasts between 45 and 300 minutes. The treatment may consist of one or two sessions, but long-term treatment may require up to 30 or more sessions, with several sessions per day if necessary.
• Hyperbaric oxygen therapy is administered in a special pressurization chamber.
• Hyperbaric oxygen therapy may also be delivered via a tightly fitted facial mask, a hood covering the head, or through a tube placed in the mouth.

If you use more Medicinal Oxygen than you should

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount inhaled.

The toxic effects of oxygen may vary depending on 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 effects) than in the brain and spinal cord (central nervous system). At elevated pressure, the opposite is true.

Effects on the lungs (pulmonary effects) include breathing difficulties, cough, and chest pain.

Effects on the brain and spinal cord (central nervous system) include tinnitus, hearing and visual disturbances, nausea, dizziness, anxiety and confusion, localized muscle spasms (around the eyes, mouth, and forehead), fainting, 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 oxygen as described in the dosage section of this leaflet. Do not use a double dose to make up for a missed dose, as Medicinal Oxygen could be harmful at high concentrations.

If you stop using Medicinal Oxygen

Do not stop treatment with this medicine on your own initiative. Consult your doctor or pharmacist.

Safety measures for the use of medicinal oxygen

Oxygen is an oxidizing agent and promotes combustion. There must be no smoking or open flames (e.g., pilot lights, stoves, ovens, gas fireplaces, sparks, candles, etc.) in rooms where medicinal oxygen is being used, as this increases the risk of fire.

Handle the cylinder with care. Ensure the gas cylinder does not fall or suffer impacts.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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 may lead to vision impairment.

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

Common (may affect up to 1 in 10 people)

With hyperbaric treatment: Seizures

Uncommon (may affect up to 1 in 100 people)

With normobaric treatment: Pulmonary collapse (atelectasis).

With hyperbaric treatment: Rupture of the eardrum

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

With hyperbaric treatment: Dyspnea, abnormally low blood sugar levels in diabetic patients.

Frequency not known (cannot be estimated from available data)

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

With hyperbaric treatment: Difficulty breathing, involuntary muscle contractions, dizziness, hearing disturbances, acute serous otitis, noise or ringing in the ears (tinnitus), nausea, abnormal behaviour, reduced peripheral vision, visual changes, lens opacity (cataracts).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Oxygen

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

Do not use Medicinal Oxygen after its expiry date, which is stated on the gas cylinder, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.

• Gas cylinders may be stored at temperatures between -20 °C and +65 °C.
• They must be stored in an upright position, except for those with a convex back; these must be stored horizontally or in a container.
• Gas cylinders must be protected from falling or mechanical impact, for example, by securing them or placing them in a container.
• They must be stored in a well-ventilated room used exclusively for storing medicinal gases. This storage room must not contain any flammable materials.
• Gas cylinders containing different types of gas or gases with different compositions must be stored separately.
• Full and empty gas cylinders must be stored separately.
• They must not be stored near sources of heat. In case of fire risk, they must be moved to a safe location.
• Store covered and protected from weather conditions.
• The valves on gas cylinders must be closed after use.
• Return the cylinder when empty to the supplier.
• Clearly visible warning signs indicating "No smoking" and "No open flames" must be posted in the storage area.
• Emergency services must be informed of the location where gas cylinders are stored.

6. Contents of the pack and other information

Composition of Medicinal Oxygen

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

Nature of the product and contents of the container

Solgroup Medicinal Oxygen Gas is a gas for inhalation.

It is supplied in gaseous form in a special container.

Oxygen is a colorless, tasteless, and odorless gas.

In liquid form, it is blue in color.

Solgroup Medicinal Oxygen Gas is stored in gas cylinders in gaseous form and under a pressure of 150, 200, or 300 bar (at 15 °C). The gas cylinders are made of steel or aluminum. The valves are made of brass, steel, or aluminum.

Container	Available sizes (l) *
Aluminum gas cylinder with pressure regulator valves	1, 2, 3, 5, 7, 8, 10, 11, 20, 30, 40, 47, 50
Steel gas cylinder with pressure regulator valves	1, 2, 3, 5, 7, 8, 10, 11, 20, 30, 40, 47, 50
Aluminum gas cylinder with traditional valves or step down valves	1, 2, 3, 5, 7, 8, 10, 11, 20, 30, 40, 47, 50
Steel gas cylinder with traditional valves or step down valves	1, 2, 3, 5, 7, 8, 10, 11, 20, 30, 40, 47, 50
Steel gas cylinder bundles with traditional valves or step down valves	4x50, 8x50, 12x50, 16x50, 20x50
Aluminum gas cylinder bundles with traditional valves or step down valves	4x50, 8x50, 12x50, 16x50, 20x50

*7l, 40l and 47l available for filling pressure 150 bar only.

Valve type	Outlet pressure	Remarks
Pressure regulating valves	4 bar (at the outlet)
Traditional valves	150, 200 or 300 bar (when the gas cylinder is full)	Use only with an appropriate reducing device
Step down valves	60–70 bar	For 300 bar cylinders only. Use only with an appropriate reducing device

Gas cylinders comply with the requirements of Directive 1999/36/EC.

Color markings comply with EN 1089-3 standard: white body and neck.

Valves comply with the requirements of EN ISO 10297.

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

Pressure regulating valves also comply with EN ISO 10524-3.

Gas cylinders with a capacity of (x) liters contain (y) kg of gas and deliver (z) m³ of oxygen at 15°C and 1 bar when filled to 150 bar.

Content in liters (x)	1	2	5	7	10	20	30	40	47	50
Content in kg (y)	0.217	0.434	1.086	1.52	2.17	4.34	6.51	8.69	10.21	10.86
Number of m³ of oxygen (z)	0.160	0.321	0.80	1.12	1.60	3.21	4.81	6.41	7.53	8.02
Content in liters (x)	4x50	8x50	12x50	16x50	20x50
Content in kg (y)	43.4	86.8	130	174	217
Number of m³ of oxygen (z)	32.1	64.1	96.2	128.2	160.3

Gas cylinders with a content of (x) liters contain (y) kg of gas and provide (z) m³ of oxygen at 15°C and 1 bar when filled up to 200 bar.

Content in liters (x)	1	2	3	5	8	10	11	20	30	40
Content in kg (y)	0.288	0.577	0.86	1.44	2.30	2.88	3.17	5.77	8.65	11.5
Number of m³ of oxygen (z)	0.212	0.425	0.637	1.125	1.70	2.12	2.33	4.33	6.37	8.49
Content in liters (x)	50	4x50		8x50		12x50		16x50	20x50
Content in kg (y)	14.4	57.7		115		173		231	288
Number of m³ of oxygen (z)	10.61	42.5		85.0		127.5		170.0	212.0

Gas cylinders 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 up to 300 bar.

Content in liters (x)	1	2	5	10	20	30
Content in kg (y)	0.413	0.826	2.06	4.13	8.26	12.4
Number of m³ of oxygen (z)	0.308	0.616	1.54	3.08	6.16	9.24
Content in liters (x)	50	4x50	8x50	12x50	16x50	20x50
Content in kg (y)	20.6	82.6	165	248	330	413
Number of m³ of oxygen (z)	15.4	61.6	123	185	246	308

Some pack sizes may not be marketed.

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)

Spain

Manufacturer

SOL B srl

Zoning Ouest, 15

7860 Lessines

Belgium

Vivisol Ibérica S.L.

Calle Yeso, 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 Zelezarjev 8,

4270 Jesenice

Slovenia

SOL Technische Gase GmbH

Marie-Curie Strasse 1

2700 Wiener Neustadt

Austria

SOL Bulgaria EAD

South industrial zone, complex Agropolichim 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

The Irish Company Oxygen Ltd.

Waterfall Road, Cork, T12 PP40, Ireland

SOL Hungary Kft.

Mechwart András 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 authorized in the European Economic Area member states under the following names:

Belgium: Oxygène Médicinal Gazeux SOL

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

Czech Republic: Kyslík medicinální plynný SOL, 100%, Medicinální plyn, stlačený

Greece: Φαρμακευτικό Οξυγόνο σε αέρια μορφή SOL

Hungary: Oxigén SOL

Luxembourg: Oxygène Médicinal Gazeux SOL

Portugal: Oxigénio medicinal gasoso SOL

Romania: Oxigen SOL

Slovakia: Medicinálny kyslík plynný SOL

Slovenia: Medicinski kisik SOL 100% medicinski plin, stisnjeni

Spain: Oxígeno medicinal gas Solgroup

United Kingdom: Medical Oxygen

Date of the most recent review of this leaflet: 03.2026

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This information is intended for healthcare professionals only:

Dosage

The concentration, flow rate, and duration of treatment must be determined by a physician according to the characteristics of each pathology.

Hypoxemia is a condition in which the partial arterial pressure of oxygen (PaO₂) is below 10 kPa (< 70 mmHg). An oxygen pressure level of 8 kPa (55–60 mmHg) leads to respiratory failure.

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

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

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

Oxygen therapy at normal pressure (normobaric oxygen therapy):

Oxygen administration must be performed with caution. The dose should be adjusted to the individual patient's needs, maintaining oxygen pressure above 8.0 kPa (or 60 mmHg), and hemoglobin oxygen saturation should be > 90%. Regular monitoring of arterial oxygen pressure (PaO₂) or pulse oximetry (arterial oxygen saturation [SpO₂]) and clinical signs is necessary. The aim is to provide each patient with the lowest effective oxygen concentration required to maintain a pressure of 8 kPa (60 mmHg) or saturation > 90%. Administration of high oxygen concentrations should be as brief as possible and under strict control of blood gas values.

Oxygen can be safely administered at the following concentrations and for the indicated durations:

• 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 at concentrations above 40% after two days.

Neonates are not included in these guidelines because retrolental fibroplasia can occur at much lower FiO₂ levels. For 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%. Typically, a minimum of 30% oxygen is administered to ensure therapeutic concentrations with a safety margin.

Short-term administration of high oxygen concentrations (> 60%) is indicated in cases of severe asthma attack, pulmonary thromboembolism, pneumonia, pulmonary fibrosis, etc.

Low oxygen concentration is indicated for treating patients with chronic respiratory failure caused by chronic obstructive airway disorder or other causes. The oxygen concentration should not exceed 28%, and for some patients, even 24% may be excessive.

Higher oxygen concentrations (in some cases up to 100%) may be administered, although achieving concentrations > 60% (or 80% in children) is very difficult with most delivery devices.

The dose should be adjusted to individual patient needs, with flow rates ranging from 1 to 10 liters of gas per minute.

• Patients with chronic respiratory failure:

Oxygen should be administered at flow rates between 0.5 and 2 liters/minute, and the flow rate should be adjusted according to blood gas values. The effective oxygen concentration should be maintained below 28%, and occasionally 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 should be adjusted according to blood gas values. The partial arterial pressure of oxygen (PaO₂) should be > 60 mmHg (7.96 kPa) and arterial blood oxygen saturation ≥ 90%.

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

• Patients with acute respiratory failure:

Oxygen should be administered at a rate between 0.5 and 15 liters/minute, and the flow rate should be adjusted according to blood gas values. In emergencies, patients with severe respiratory distress may require considerably higher doses (up to 60 liters/minute).

• Patients on mechanical ventilation:

If oxygen is mixed with other gases, the fraction of oxygen in the inspired gas mixture (FiO₂) must not fall below 21%. In practice, 30% tends to be the lower limit. If necessary, the inspired oxygen fraction can be increased up to 100%.

• Paediatric population: Newborns:

In exceptional cases, oxygen concentrations up to 100% may be administered to newborn infants, but treatment must be closely supervised. The lowest effective concentrations should be used to achieve adequate oxygenation. In general, oxygen concentrations above 40% in inspired air should be avoided due to the risk of ocular damage (retinopathy) or pulmonary collapse. Arterial blood oxygen pressure must be carefully monitored and maintained below 13.3 kPa (100 mmHg). Fluctuations in oxygen saturation should be avoided. Preventing significant fluctuations in oxygenation may reduce the risk of ocular damage. (See also section 4.4).

• Cluster headache:

In cluster headache, 100% oxygen is administered at a flow rate of 7 liters/minute for 15 minutes via a tightly fitted face mask. Treatment should begin at the onset of the attack.

Hyperbaric oxygen therapy:

Doses and pressure must 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), typically between 1.4 and 3.0 atmospheres (usually between 2 and 3 atmospheres). Hyperbaric oxygen is delivered in a specialized pressurized chamber. High-pressure oxygen therapy can also be administered via a tightly fitted face mask, a hood covering the head, or via a tracheal tube.

Each treatment session lasts from 45 to 300 minutes, depending on the indication.

Acute hyperbaric oxygen therapy may last only one or two sessions, while chronic treatment may require up to 30 sessions or more. If necessary, sessions may be repeated two or three times per day.

• Carbon monoxide poisoning:

In cases of carbon monoxide poisoning, oxygen should be administered as soon as possible at high concentrations (100%) until carboxyhemoglobin concentration drops below dangerous levels (approximately 5%). Hyperbaric oxygen (starting at 3 atmospheres) is indicated in patients with acute CO poisoning or those exposed for ≥24 hours. Additionally, pregnant women, patients who have lost consciousness, or those with higher carboxyhemoglobin levels justify hyperbaric oxygen treatment. Normobaric oxygen should not be used between hyperbaric oxygen treatments, as it may contribute to toxicity. Hyperbaric oxygen also appears to have potential for delayed treatment of CO poisoning using multiple low-dose oxygen treatments.

• Patients with decompression sickness:

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

• Patients with arterial gas embolism:

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

• Patients with osteoradionecrosis:

Hyperbaric oxygen treatment for radiation-induced lesions typically consists of daily 90- to 120-minute sessions at 2.0 to 2.5 atmospheres for approximately 40 days.

• Patients with clostridial myonecrosis:

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

Method of administration

Normobaric oxygen therapy

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

If the patient cannot breathe independently, artificial respiratory support can be provided. Alternatively, oxygen can be injected directly into the bloodstream using a device known as an oxygenator. The use 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 improved oxygen transfer, thereby maintaining blood gas levels within acceptable clinical ranges. After recovery of pulmonary function, extracorporeal blood flow and gas flow are gradually reduced and finally stopped. This occurs, for example, during cardiac surgery using a cardiopulmonary bypass system, as well as in other circumstances requiring extracorporeal circulation, including acute respiratory failure.

Hyperbaric Oxygen Therapy

Hyperbaric oxygen treatment is administered in a specially pressurized chamber where ambient pressure can be increased up to three times normal atmospheric pressure. Hyperbaric oxygen therapy can also be delivered via a tightly fitted facial mask, a hood covering the head, or through a tracheal tube.

Preparation before use

Follow the provider's instructions, particularly:

• Do not use if the gas cylinder is visibly damaged or suspected of being damaged, or if it has been exposed to extreme temperatures.
• Avoid any contact with oils, greases, or hydrocarbons.
• Remove the valve seal and protective cap before use.
• Only equipment specifically designed for a particular gas cylinder and that specific gas may be used.
• Check that the quick connector and regulator are clean and that connections are in good condition.
• Open the cylinder valve slowly, at least half a turn.
• When opening or closing a gas cylinder valve, do not use pliers or other tools to prevent the risk of damage.
• The container's shape must not be altered.
• Check for leaks. Follow the instructions provided on the regulator. Do not attempt to repair a leak in the valve or equipment yourself, except by replacing the sealing plug or O-ring.
• In case of leakage, close the valve and disconnect the regulator. If the gas cylinder continues to leak, empty the outer cylinder. Mark defective gas cylinders, place them in a designated area for returns, and return them to the supplier.
• For cylinders equipped with pressure-reducing valves, a separate pressure regulator is not required. The built-in pressure-reducing valve has a quick connector for connecting "on-demand" valves, as well as a separate outlet for continuous gas flow, where flow rate can be adjusted.

Use of the gas cylinder

• Transferring pressurized gas is strictly prohibited.
• Smoking and ignition of flames are strictly prohibited in rooms where medicinal oxygen treatment is administered.
• When in use, the cylinder must be secured in an appropriate support stand.
• Consider replacing gas cylinders when the pressure in the cylinder has dropped to the point where the valve indicator enters the yellow zone.
• Close the gas cylinder valve when only a small amount of gas remains in the cylinder.

It is important to maintain a small residual pressure in the gas cylinder to prevent the entry of contaminating substances.

• Close valves on empty gas cylinders.
• Close the gas cylinder valve manually after use. Depressurize the regulator or connection.

Detailed and up-to-date 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/