Oxygen sol: detailed information

Patient information leaflet

OXYGEN SOL 200 BAR COMPRESSED MEDICINAL GAS

Oxygen
Please read all of this leaflet carefully before you use this medicine because it contains
important information for you.

Keep this leaflet. 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. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What medicinal oxygen is and what it is used for
What you need to know before using medicinal oxygen
How to use medicinal oxygen
Possible side effects
How to store medicinal oxygen
Contents of the pack and other information

The full name of this medicine is Oxygen SOL 200 bar compressed medicinal gas. For
convenience, it will be referred to as "medicinal oxygen" throughout this leaflet.

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

Medicinal oxygen contains oxygen, a gas naturally present in the air we breathe.
Medicinal oxygen increases the delivery of oxygen to all tissues of the body.
Medicinal oxygen is indicated in patients of all ages for the treatment of respiratory disorders
(acute and chronic respiratory failure).

2. What you need to know before using medicinal oxygen

Under normal conditions, there are no contraindications.
Warnings and precautions
Before starting oxygen therapy, you should be aware of the following:

Oxygen may have harmful effects at high concentrations. It can cause lung damage (alveolar collapse, lung inflammation) that hinders blood oxygenation.
If you suffer from severe chronic obstructive pulmonary disease (COPD) resulting in poor blood oxygenation, the oxygen flow rate will be low. Your doctor will determine the most appropriate flow rate for your oxygen therapy.
Exercise particular caution when administering oxygen to full-term and preterm neonates to minimize the risk of adverse events such as eye damage. The lowest possible oxygen concentration that ensures adequate oxygenation should be used.
Exercise particular caution if you have elevated blood levels of carbon dioxide, which may counteract the effects of oxygen.
If you have respiratory problems caused by low blood oxygen levels or if you are taking strong painkillers, you must be closely monitored by your doctor.
If you have previously had a lung injury, inform your doctor.

Consult your doctor or pharmacist before using medicinal oxygen.
Advice regarding the risk of fire in the presence of oxygen:

Oxygen is an oxidizing agent and promotes combustion. In areas where medicinal oxygen is used, there must be no sources of heat, smoking, or open flames (e.g. pilot lights, stoves, ovens, gas heaters, sparks, candles), as this increases the risk of fire.
Do not smoke in the environment where oxygen therapy is being administered.
Do not use electrical devices during your oxygen treatment.
In oxygen-enriched environments, oxygen may saturate clothing.
Do not apply oily substances (e.g. oils, creams, lotions) to surfaces in contact with oxygen. Only water-based products should be used on hands, face, or inside the nose.
Do not use pliers or other tools to open or close the cylinder valve to prevent the risk of damage.
The pressure regulator must be opened slowly and carefully to avoid the risk of sudden ignition.
In case of leakage, immediately close the cylinder valve if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
Always keep the valves of empty cylinders closed.

Thermal burns related to accidental fire have occurred in the presence of oxygen.
Advice for caregivers:

Handle the cylinder carefully. Ensure that the gas cylinder is not dropped or exposed to impacts.
Damage to the equipment may cause blockage of the outlet and/or incorrect readings on the pressure gauge regarding residual oxygen content and flow, leading to insufficient or absent oxygen delivery.

Children
In preterm and full-term neonates, oxygen therapy may cause eye damage (retinopathy of prematurity), lung damage, and brain hemorrhages. The doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your child.
Other medicines and medicinal oxygen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking:

catecholamines (e.g. epinephrine, norepinephrine), medicines that affect multiple organs and are generally used in emergency treatment of sudden allergic reactions,
corticosteroids (e.g. dexamethasone, methylprednisolone), medicines used to treat inflammation,
hormones (e.g. testosterone, thyroxine),
amiodarone, a medicine used to treat heart rhythm disorders,
chemotherapeutic agents (e.g. bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors,
antimicrobial agents (e.g. nitrofurantoin),
antibiotics (e.g. bleomycin, actinomycin, nitrofurantoin), medicines used to treat infections,
vitamin K supplements (menadione),
medicines used to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine),
chloroquine, a medicine used to treat malaria.

In addition, inform your doctor if:

you have recently undergone an X-ray examination,
you have undergone treatment for paraquat poisoning (a herbicide). Pre-existing lung damage caused by the pesticide paraquat could be worsened by oxygen. In cases of paraquat poisoning, administration of supplemental oxygen should be avoided as much as possible.
you suffer from hyperthyroidism or deficiency in vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

Medicinal oxygen and alcohol
Do not consume alcohol during oxygen therapy. Alcohol may impair breathing.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) should be administered only if necessary.
There are no contraindications for the use of oxygen during breastfeeding.
Driving and using machines
The use of medicinal oxygen at normal pressure (normobaric oxygen therapy) does not impair or impairs negligibly the ability to drive or operate machinery.
Consult your doctor before driving or operating machinery.

3. How to use medicinal oxygen

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
If you do not have respiratory failure, medicinal oxygen will be inhaled through the nose and
mouth via a nasal cannula or a face mask.
If you suffer from respiratory failure or are undergoing anaesthesia, medicinal oxygen will be
administered via assisted ventilation.
The dosage will be determined by your doctor according to your health condition.
During treatment with medicinal oxygen, your doctor may perform measurements of blood gases (oxygen and carbon dioxide) in arterial blood and monitor levels of oxygen bound to haemoglobin, a protein that carries oxygen in the blood.
If you use more medicinal oxygen than you should
If you use more medicinal oxygen than prescribed, contact your doctor or go to hospital
immediately.
The toxic effects of oxygen vary depending on the pressure of inhaled oxygen and the duration
of exposure.
Effects on the lungs (pulmonary region) include shortness of breath, cough, chest pain,
interstitial oedema, pulmonary fibrosis.
Effects on the brain and spinal cord (central nervous system) include ringing in the ears, disturbances of vision and hearing, nausea, dizziness, anxiety, confusion and irritability, localized muscle cramps (around the eyes, mouth and forehead), loss of consciousness and
convulsions (epileptic seizures).
Ocular effects include blurred vision and reduced peripheral vision (“tunnel vision”).
In premature infants, eye problems (retinopathy) may occur.
In cases of oxygen poisoning due to hyperoxia, oxygen therapy should be reduced or, if
possible, discontinued, and symptomatic treatment should be initiated.
If you forget to use medicinal oxygen
Use oxygen as described in the section of the package leaflet relating to dosage. Do not use
a double dose to make up for a missed dose, as medicinal oxygen may be harmful at high concentrations.
If you stop using medicinal oxygen
Do not stop using this medicine on your own initiative. Consult your doctor or pharmacist.
Safety advice on the use of medicinal oxygen
Oxygen is an oxidizing agent and promotes combustion. Smoking or open flames (e.g. pilot flames, stoves, ovens, gas heaters, sparks, candles...) must not be present in areas where medicinal oxygen is used, as they increase the risk of fire.
Handle the cylinder with care. Ensure that the gas cylinder does not fall or suffer impacts.
If you have any questions about the use of this medicine, consult 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)
In newborns exposed to high oxygen concentrations: eye damage, which may lead to impaired vision.
Uncommon (may affect up to 1 in 100 people)
Pulmonary collapse (atelectasis).
Frequency not known (cannot be estimated from the available data)
Pulmonary toxicity, worsening of excess carbon dioxide in the blood (hypercapnia), dryness of mucous membranes, local irritation and inflammation of mucous membranes.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You may also report side effects directly through the national reporting system at the following website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store medicinal oxygen

Store cylinders at temperatures between -10°C and 50°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What medicinal oxygen contains

The active substance is oxygen.

Description of the appearance of medicinal oxygen and package contents
Compressed medicinal gas (200 bar)
OSSIGENO SOL compressed medicinal gas is supplied in cylinders in compressed gaseous form at 200 bar at 15°C. The cylinders are made of steel or aluminum alloy and equipped with valves compatible with pressure regulators or with integrated pressure-reducing valves.
Available in the following pack sizes:
Compressed medicinal gas (200 bar)
Steel cylinders with valve of 0.5, 1, 2, 3, 5, 7, 10, 14, 27, 30 litres; aluminum cylinders with valve of 2, 5, 14 litres.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
SOL S.p.A - Via Borgazzi, 27 - Monza (MI)

Manufacturer
Compressed medicinal gas (200 bar)
VIVISOL Srl – Via Manin, 153 – Sesto San Giovanni (MI)
I.C.O.A. Srl Industria Calabrese Ossigeno ed Acetilene – Zona Industriale (Loc. Porto Salvo) – Vibo Valentia
SOL SPA – 4^ Strada z.i. Macchiareddu – Assemini (CA)
SOL SPA – Via Enzo Ferrari – Catania
SOL SPA – Via Acquaviva, 4 – Cremona
SOL SPA – Via dei Ciclamini, 19 – Modugno (BA)
SOL SPA – Via Belgio, 16 – Padova
SOL SPA – Via Nugolaio, 4 – Pisa
SOL SPA – Via dei Mandarini, 6 – Pomezia (RM)
SOL SPA – Via Poli, 2/A – Zola Predosa (BO)
SOL SPA – Via Vanoni, 5 – Ancona
SOL SPA – Via Giovanni Francesco Maggiò snc – Marcianise (CE)
SOL SPA – Via de Francisco 148/8-9 Settimo Torinese (TO)

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Oxygen must be administered with caution, with adjustments according to the individual patient's needs. The lowest effective dose that maintains arterial oxygen pressure at 8 kPa (60 mmHg) should be administered. Higher concentrations should be given for the shortest possible duration, with frequent monitoring of blood gas analysis.

Oxygen can be safely administered at the following concentrations and for the following durations:
Up to 100% for less than 6 hours
60-70% for 24 hours
40-50% during the second 24-hour period.
Oxygen may become potentially toxic after two days at concentrations above 40%.

Low oxygen concentrations should be used in patients with respiratory insufficiency in whom the respiratory drive is stimulated by hypoxia. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂) and clinical assessment.

Administration of oxygen to patients with respiratory insufficiency caused by drugs (opioids, barbiturates) or chronic obstructive pulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia resulting from elevated carbon dioxide levels in the blood, which abolishes receptor-mediated respiratory drive.

High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also reduces nitrogen levels in tissues and lungs (alveoli). If oxygen is absorbed into the blood through the alveoli faster than it is supplied by ventilation, alveolar collapse (atelectasis) may occur. This can impair arterial blood oxygenation, as gas exchange does not occur despite adequate perfusion.

In patients with reduced sensitivity to arterial carbon dioxide pressure, high oxygen levels may cause carbon dioxide retention. In extreme cases, this may lead to carbon dioxide narcosis.

High oxygen concentrations should be administered for the shortest time necessary to achieve the desired therapeutic effect, with continuous monitoring including repeated measurements of arterial gas pressure (PaO₂) or peripheral hemoglobin oxygen saturation (SpO₂), along with clinical evaluations.

Patients at risk of hypercapnic respiratory failure
Particular precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide pressure or at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis, morbid obesity, chest wall deformities, neuromuscular disorders, respiratory depressant drug overdose) and in patients with drug-induced respiratory insufficiency (opioids, barbiturates), as oxygen administration may worsen respiratory failure due to hypercapnia caused by elevated blood carbon dioxide levels, which neutralize oxygen's effects on respiratory receptors.

Supplemental oxygen administration may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.

Special precautions in patients with bleomycin-induced lung injury
Pulmonary toxicity from high-dose oxygen therapy may exacerbate lung injury, even when administered several years after the initial lung damage caused by bleomycin. The target oxygen saturation in these patients may need to be lower than in others.

Paediatric population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective concentration should be used to achieve adequate oxygenation. In preterm and term newborns, increased PaO₂ may lead to retinopathy of prematurity, chronic lung disease, and intraventricular haemorrhage.

It is recommended to initiate resuscitation of term or near-term newborns with air rather than 100% oxygen. In preterm newborns, the optimal oxygen concentration and target oxygenation are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.

Fire hazard:

Any oxygen delivery system or container must be kept away from sources of heat due to oxygen's role as a combustion supporter. Appropriate precautions must therefore be taken both in hospital and domestic settings where medicinal oxygen is used.
Oxygen may cause sudden ignition of smouldering materials or embers; therefore, smoking and the use of open, unshielded flames near oxygen containers and delivery systems are strictly prohibited.
Do not smoke in any environment where oxygen therapy is administered.
Do not place cylinders or containers near sources of heat.
Electrical equipment capable of producing sparks must not be used near patients receiving oxygen.
It is absolutely forbidden to tamper in any way with container connectors, delivery equipment, or their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Any contact with oil, grease, or other hydrocarbons must be avoided.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
In oxygen-enriched environments, oxygen may saturate clothing.
Cylinders must not be used if they show visible damage or if damage or exposure to extreme temperatures is suspected.
Only oxygen-compatible equipment suitable for the specific container model may be used.
Pliers or other tools must not be used to open or close the cylinder valve to prevent the risk of damage.
In case of leakage, the cylinder valve must be closed immediately if this can be done safely. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
Valves of empty cylinders must remain closed.
Oxygen is a strong oxidizing agent and may react violently with organic substances. For this reason, special precautions are required for handling and storage of containers.
It is not permitted to administer pressurized gas directly.

Oxygen is an oxidizing product and promotes combustion. When using oxygen, the increased risk of fire ignition must be taken into account:

Domestic fire risk: Patients and caregivers must be informed about the fire risk in the presence of other ignition sources (smoking, flames, sparks, kitchen stoves, ovens, etc.) and/or highly flammable substances, particularly greasy substances (oils, fats, creams, ointments, lubricants, etc.). During oxygen use, only water-based products should be used on hands, face, and inside the nose.
Hospital fire risk: This risk is increased during procedures involving diathermy, defibrillation, and electrical cardioversion.
Fires may occur when opening the valve (due to friction-induced heating).

Thermal burns associated with accidental fires in the presence of oxygen have occurred.

Handling of cylinders:
Patients' caregivers and all individuals handling medicinal oxygen cylinders must be instructed to handle cylinders carefully to avoid damage, particularly to the valve. Damage to the device may cause obstruction of the outlet and/or incorrect readings on the pressure gauge regarding residual oxygen volume and flow rate, resulting in inadequate or interrupted oxygen delivery.

Dosage, method and duration of administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (such as a nasal cannula or face mask); the dosage is delivered independently of the medicinal gas packaging through dosing devices (flowmeters).

With these systems, oxygen is delivered through the inspired air, while exhaled gas and any excess oxygen leave the patient's inspiratory circuit, mixing with the surrounding air (open system or anti-rebreathing system).

In patients without respiratory insufficiency, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable masks.

In patients with respiratory insufficiency or under anaesthesia, oxygen must be administered via assisted ventilation.

Oxygen cylinders contain a pressure of approximately 200 bar. This pressure is regulated by a pressure reducer and displayed on the pressure gauge. Multiplying the gauge reading by the cylinder's volume in litres gives the amount of oxygen remaining in the cylinder.

(Example: Content calculation: a cylinder has a volume of 10 litres and the pressure gauge reads 200 bar, resulting in 2000 litres of oxygen available. At a consumption rate of 2 litres per minute, the cylinder will be empty after approximately 16 hours.)

Spontaneous ventilation
Patients with chronic respiratory insufficiency: administer oxygen at a flow rate of 0.5 to 2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory insufficiency: administer oxygen at a flow rate of 0.5 to 15 litres/minute, adjustable according to blood gas analysis.

Paediatric population
Newborns may receive 100% oxygen when necessary. However, careful monitoring during treatment is essential. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or pulmonary collapse. Arterial blood oxygen pressure (PaO₂) should be monitored; however, if levels are maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Additionally, the risk of ocular damage may be minimized by avoiding marked fluctuations in oxygenation (see also Precautions for use).

Instructions for use and handling
Medicinal oxygen cylinders, as well as cryogenic containers, are intended exclusively for containing/transporting oxygen for inhalation and therapeutic use.

Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from impact and falls.

Strictly follow these instructions:

Carefully read the container’s (package) instruction and user manual.
Ensure all equipment is in good condition.
Secure cylinders and base units in an upright position to prevent falls. Protect containers from impact and maintain them at temperatures below 50°C. Ensure adequate ventilation in rooms where the product is used. Cylinders must be fitted with a protective cap or valve cover.
Handle equipment only with clean hands, free from grease or oil.
Lift and move cylinders and base units only using the appropriate trolley; never lift a cylinder by the valve.
Use only oxygen-specific, compatible connectors, tubing, and couplings.
Particular attention must be paid to the secure attachment of pressure reducers to cylinders, especially when not integrated into the container closure system, to prevent accidental dislodgement.
It is absolutely forbidden to tamper in any way with delivery equipment and related accessories or components (OIL AND GREASE MAY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves or taps.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.

General Instructions for Use

Cylinders equipped with shut-off valve only

Remove the protective cap, if present
Ensure that the delivery valve is closed
Remove the tamper-evident seal
Connect the pressure regulator to the cylinder valve and the corresponding flowmeter
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve until fully open
Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped with integrated pressure-reducing valve

Ensure that the valve is closed
Remove the tamper-evident seal
Ensure that the flow indicator is set to zero
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve until fully open
Adjust the flowmeter to the required flow rate (litres/minute)

NOTE: FOR FURTHER DETAILS, PLEASE CONSULT THE INSTRUCTIONS FOR USE OF THE
CONTAINER
WARNING

Gradually open the container closure systems (valve or tap) to avoid pressure surges.
Do not force taps or valves when opening or closing.
Never stand directly in front of the gas outlet of the tap/valve; always stand to the side. Do not expose yourself or the patient to the direct gas flow.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder tap.
In case of gas leakage, close the tap immediately and contact the technical service of the supplier indicated in the Container's User Manual.
Use only containers suitable for the product and for the intended operating pressure and temperature.

During use:

Do not use oily creams or lipsticks.
Do not smoke.
Do not bring open flames near the cylinder.
Do not use any electrical equipment that may generate sparks near patients receiving oxygen.
Do not apply oils or greases to connectors, taps, valves, or any materials in contact with oxygen.
Never introduce oxygen into a device that might contain combustible materials, particularly greasy substances.

Disposal

Store empty cylinders with valves closed.
Do not discharge into sewers, basements, or excavations where accumulation could be hazardous.
Return empty or unused cylinders, even if only partially empty, to the supplier. Any residual medicinal product remaining in the pressurized cylinder will be safely removed, through appropriate procedures, in a well-ventilated area by the company responsible for refilling the container.
Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance with applicable local regulations.

Observe all relevant rules regarding the use and handling of pressurized cylinders.
Store cylinders at temperatures between -10°C and 50°C, in well-ventilated areas or in well-ventilated sheds, avoiding the formation of hyperoxic atmospheres (O₂ > 21% vol), in an upright position with valves closed, protected from rain and weather, direct sunlight, and kept away from heat or ignition sources and from combustible materials. Empty containers or those containing other types of gas must be stored separately.
Package leaflet: information for the patient

OXYGEN SOL 300 BAR MEDICINAL COMPRESSED GAS

Oxygen
Please read this leaflet carefully before using this medicine, as it contains
important information for you.

Keep this leaflet. 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. Do not give it to others, even if their symptoms are the same as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What medicinal oxygen is and what it is used for
What you need to know before using medicinal oxygen
How to use medicinal oxygen
Possible side effects
How to store medicinal oxygen
Contents of the pack and other information

The full name of this medicine is OSSIGENO SOL 300 bar medicinal compressed gas. For
convenience, it will be referred to as "medicinal oxygen" throughout this leaflet.

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

2. What you should know before using medicinal oxygen

Under normal conditions, there are no contraindications.
Warnings and precautions
Before starting oxygen therapy, you should be aware of the following:

Oxygen may have harmful effects at high concentrations. It can cause lung damage (alveolar collapse, lung inflammation) that impairs blood oxygenation.
If you suffer from severe chronic obstructive pulmonary disease (COPD) leading to poor blood oxygenation, the oxygen flow rate will be low. Your doctor will determine the most appropriate flow rate for your oxygen therapy.
Exercise particular caution when administering oxygen to full-term and preterm neonates to minimize the risk of adverse events such as eye damage. The lowest possible oxygen concentration that ensures adequate oxygenation should be used.
Exercise particular caution if you have elevated blood levels of carbon dioxide, which may counteract the effects of oxygen.
If you have respiratory problems caused by low blood oxygen levels or if you are taking strong painkillers, you must be closely monitored by your doctor.
If you have had a lung injury, inform your doctor.

Consult your doctor or pharmacist before using medicinal oxygen.
Advice regarding the risk of fire in the presence of oxygen:

Oxygen is an oxidizing agent and promotes combustion. In areas where medicinal oxygen is used, there must be no sources of heat, smoking, or open flames (e.g., pilot lights, stoves, ovens, gas heaters, sparks, candles), as this increases the risk of fire.
Do not smoke in any area where oxygen therapy is administered.
Do not use electrical devices during your oxygen treatment.
In oxygen-enriched environments, oxygen may saturate clothing.
Do not apply oily substances (e.g., oils, creams, lotions) to surfaces in contact with oxygen. Only water-based products should be used on the hands, face, or inside the nose.
Do not use pliers or other tools to open or close the cylinder valve, to prevent the risk of damage.
The pressure regulator must be opened slowly and carefully to avoid the risk of sudden ignition.
In case of a leak, immediately close the cylinder valve if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
Always keep valves of empty cylinders closed.

Thermal burns related to accidental fire have occurred in the presence of oxygen.
Advice for caregivers:

Handle the cylinder carefully. Ensure that the gas cylinder is not dropped or subjected to impacts.
Damage to equipment may cause blockage of the outlet and/or incorrect readings on the pressure gauge display regarding residual oxygen content and flow, leading to inadequate or interrupted oxygen delivery.

Children
In preterm and full-term neonates, oxygen therapy may cause eye damage (retinopathy of prematurity), lung damage, and brain hemorrhages. Your doctor will determine the appropriate oxygen concentration to administer in order to ensure optimal treatment for your child.
Other medicines and medicinal oxygen
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor or pharmacist if you are taking or have been prescribed:

catecholamines (e.g., epinephrine, norepinephrine), medicines that affect multiple organs and are generally used in emergency treatment of sudden allergic reactions,
corticosteroids (e.g., dexamethasone, methylprednisolone), medicines used to treat inflammation,
hormones (e.g., testosterone, thyroxine),
amiodarone, a medicine used to treat heart rhythm disorders,
chemotherapeutic agents (e.g., bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors,
antimicrobial agents (e.g., nitrofurantoin), antibiotics (e.g., bleomycin, actinomycin, nitrofurantoin), medicines used to treat infections,
vitamin K supplements (menadione),
medicines used to treat mental disorders (e.g., promazine, chlorpromazine, thioridazine),
chloroquine, a medicine used to treat malaria.

Additionally, inform your doctor if:

you have recently undergone an X-ray examination,
you have undergone treatment for paraquat poisoning (a herbicide). Pre-existing lung damage caused by the pesticide paraquat may be worsened by oxygen. In cases of paraquat poisoning, administration of supplemental oxygen should be avoided as much as possible.
you suffer from hyperthyroidism or from a deficiency in vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

Medicinal oxygen and alcohol
Do not consume alcohol during oxygen therapy. Alcohol may impair breathing.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before using this medicine.
During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) should be administered only if necessary.
There are no contraindications for the use of oxygen during breastfeeding.
Driving and using machines
The use of medicinal oxygen at normal pressure (normobaric oxygen therapy) does not affect or affects only negligibly the ability to drive or operate machinery.
Ask your doctor for advice before driving or operating machinery.

3. How to use medicinal oxygen

Use this medicine exactly as directed by your doctor or pharmacist. If you have
any doubts, consult your doctor or pharmacist.
If you do not have respiratory insufficiency, medicinal oxygen will be inhaled through the nose and
mouth via a nasal cannula or a face mask.
If you suffer from respiratory insufficiency or are undergoing anaesthesia, medicinal oxygen will be
administered via assisted ventilation.
The dose will be determined by your doctor based on your health status.
During treatment with medicinal oxygen, your doctor may perform measurements of blood gases
(oxygen and carbon dioxide) in arterial blood and monitor haemoglobin oxygen levels, a protein that
transports oxygen in the blood.

If you use more medicinal oxygen than you should
If you use more medicinal oxygen than prescribed, contact your doctor or go to hospital
immediately.
Oxygen toxicity effects vary depending on the pressure of inhaled oxygen and the duration of
exposure.
Effects on the lungs (pulmonary region) include shortness of breath, cough, chest pain, interstitial
oedema, and pulmonary fibrosis.
Effects on the brain and spinal cord (central nervous system) include tinnitus, visual and hearing
disturbances, nausea, dizziness, anxiety, confusion and irritability, localized muscle cramps (around
the eyes, mouth and forehead), loss of consciousness, and seizures (epileptic fits).
Ocular effects include blurred vision and reduced peripheral vision (“tunnel vision”).
In premature infants, eye problems (retinopathy) may occur.
In cases of oxygen poisoning due to hyperoxia, oxygen therapy should be reduced or, if possible,
discontinued, and symptomatic treatment should be initiated.

If you forget to use medicinal oxygen
Use oxygen as described in the dosage instructions section of this leaflet. Do not use a double dose
to make up for a missed dose, as medicinal oxygen can be harmful at high concentrations.

If you stop using medicinal oxygen
Do not stop using this medicine on your own initiative. Consult your doctor or pharmacist.

Safety advice on the use of medicinal oxygen
Oxygen is an oxidizing agent and promotes combustion. Smoking or open flames (e.g. pilot flames,
cookers, ovens, gas heaters, sparks, candles, etc.) must not be present in rooms where medicinal
oxygen is being used, as they increase the risk of fire.
Handle the cylinder with care. Ensure that the gas cylinder does not fall or suffer impacts.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people)
In newborns exposed to high oxygen concentrations: eye damage, which may lead to visual impairment.
Uncommon (may affect up to 1 in 100 people)
Lung collapse (atelectasis).
Not known (frequency cannot be estimated from the available data)
Pulmonary toxicity, worsening of excess carbon dioxide in the blood (hypercapnia), dryness of mucous membranes, local irritation and inflammation of the mucous membranes.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly through the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store medicinal oxygen

Store the cylinders at temperatures between -10°C and 50°C.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after EXP. The
expiry date refers to the last day of that month.
Do not dispose of any medicinal product in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Package Contents and Other Information

What medicinal oxygen contains
The active substance is oxygen.
Description of the appearance of medicinal oxygen and package contents
OSSIGENO SOL compressed medical gas is supplied in cylinders as compressed gas at 300 bar pressure at 15°C. The cylinders are made of steel or aluminum alloy, wrapped in carbon fiber, and equipped with integrated pressure-reducing valves.
Available pack sizes:
Steel cylinders with valves of 3, 5, and 10 liters; aluminum cylinders with valves of 3, 5, and 10 liters.
Not all pack sizes may be marketed.
Marketing Authorization Holder
SOL S.p.A - Via Borgazzi, 27 - Monza (MI)
Manufacturer
SOL SPA – Via Acquaviva, 4 – Cremona

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Oxygen must be administered cautiously, with adjustments based on individual patient needs. The lowest effective dose that maintains arterial oxygen pressure at 8 kPa (60 mmHg) should be used. Higher concentrations should be administered for the shortest possible duration, with frequent monitoring of blood gas analysis.
Oxygen can be safely administered at the following concentrations and for the following durations:
Up to 100% for less than 6 hours
60–70% for 24 hours
40–50% during the second 24-hour period.
Oxygen may become potentially toxic after two days when administered at concentrations above 40%.
Low oxygen concentrations should be used in patients with respiratory failure in whom hypoxia is the primary respiratory drive. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), pulse oximetry (arterial oxygen saturation – SpO₂), and clinical assessments.
Administering oxygen to patients with respiratory failure induced by drugs (opioids, barbiturates) or chronic obstructive pulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia caused by elevated carbon dioxide levels in the blood, which overrides receptor responses.
High oxygen concentrations in the inhaled air or gas reduce nitrogen concentration and partial pressure. This also decreases nitrogen levels in tissues and alveoli. If oxygen is absorbed into the blood through the alveoli faster than it is replenished by ventilation, alveolar collapse (atelectasis) may occur. This can impair arterial oxygenation, as gas exchange does not occur despite adequate perfusion.
In patients with reduced sensitivity to arterial carbon dioxide pressure, high oxygen levels may lead to carbon dioxide retention. In extreme cases, this may result in carbon dioxide narcosis.
High oxygen concentrations should be administered for the shortest time necessary to achieve the desired therapeutic effect, with continuous monitoring through repeated arterial blood gas measurements (PaO₂) or peripheral hemoglobin oxygen saturation (SpO₂), along with clinical evaluation.
Patients at risk of hypercapnic respiratory failure
Special precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide pressure or those at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis, morbid obesity, chest wall deformities, neuromuscular disorders, or respiratory depressant drug overdose), and in patients with drug-induced respiratory failure (opioids, barbiturates), as oxygen administration may worsen respiratory failure due to hypercapnia caused by elevated blood carbon dioxide levels, which neutralizes oxygen effects on receptors.
Supplemental oxygen administration may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.
Special precautions in patients with bleomycin-induced lung injury
High-dose oxygen therapy may potentiate pulmonary toxicity, even years after the initial lung injury caused by bleomycin. The target oxygen saturation in these patients may need to be lower than in others.
Pediatric population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective oxygen concentration should be administered to achieve adequate oxygenation.
In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity, chronic lung disease, and intraventricular hemorrhage.
It is recommended to initiate resuscitation of term or near-term newborns with room air rather than 100% oxygen. In preterm neonates, the optimal oxygen concentration and target oxygen levels are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.
Fire risk:

Any oxygen delivery system or container must be kept away from heat sources due to oxygen’s combustive properties; appropriate precautions must be taken both in hospital and home settings when handling medicinal oxygen.
Oxygen can cause spontaneous ignition of smoldering materials or embers; therefore, smoking or using open, unshielded flames near oxygen containers and delivery systems is strictly prohibited.
Do not smoke in areas where oxygen therapy is being administered.
Do not place cylinders or containers near heat sources.
Electrical equipment capable of producing sparks must not be used near patients receiving oxygen.
It is absolutely forbidden to tamper in any way with container connections, delivery equipment, or their accessories or components (OIL AND GREASE CAN SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Contact with oil, grease, or other hydrocarbons must be strictly avoided.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
In oxygen-enriched environments, oxygen may saturate clothing.
Cylinders must not be used if visible damage is present or if damage or exposure to extreme temperatures is suspected.
Only oxygen-compatible and appropriate equipment must be used for the specific container model.
Pliers or other tools must not be used to open or close cylinder valves to prevent damage.
In case of leakage, the cylinder valve must be closed immediately if safe to do so. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to vent freely.
Valves of empty cylinders must remain closed.
Oxygen is a strong oxidizing agent and may react violently with organic substances. Therefore, special precautions are required for handling and storage of containers.
Pressurized gas must not be administered directly.

Oxygen is an oxidizing product and promotes combustion. When using oxygen, the increased risk of fire ignition must be considered:

Fire risk in domestic settings: Patients and caregivers must be informed of the fire risk in the presence of ignition sources (smoking, flames, sparks, stoves, ovens, etc.) and/or highly flammable substances, particularly greasy materials (oils, grease, creams, ointments, lubricants, etc.). During oxygen use, only water-based products should be used on the hands, face, and inside the nose.
Fire risk in hospital settings: This risk is increased during procedures involving diathermy, defibrillation, or electrical cardioversion.
Fires may occur upon valve opening (due to friction heating).

Thermal burns associated with accidental fires in the presence of oxygen have occurred.
Cylinder handling:
Patients’ caregivers and all individuals handling medicinal oxygen cylinders must be instructed to handle cylinders carefully to prevent damage, especially to the valve. Damage to the device may obstruct gas flow and/or cause incorrect readings on the pressure gauge regarding residual oxygen volume and flow rate, resulting in inadequate or interrupted oxygen delivery.
Dosage, method, and duration of administration
Oxygen is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or face mask). Dosage is delivered independently of the gas container packaging using dosing devices (flowmeters).
With these systems, oxygen is delivered through the inhaled air, while exhaled gas and excess oxygen exit the patient’s inspiratory circuit and mix with ambient air (open system or anti-rebreathing system).
Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air—i.e., with an inspired oxygen fraction (FiO₂) greater than 21%—at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
In patients without respiratory failure, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable masks.
In patients with respiratory failure or under anesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders contain gas at approximately 300 bar internal pressure. This high pressure is regulated by a pressure reducer and displayed on the pressure gauge. Multiplying the gauge reading by the cylinder’s volume (in liters) gives the remaining oxygen volume available.
(Example: Content calculation: a cylinder has a volume of 10 liters and the pressure gauge reads 200 bar, resulting in 2000 liters of oxygen remaining: at a consumption rate of 2 liters per minute, the cylinder will be empty after approximately 16 hours.)
With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate of 0.5 to 2 liters/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 liters/minute, adjustable according to blood gas analysis.
Pediatric population
Neonates may receive 100% oxygen when necessary. However, careful monitoring during treatment is essential. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or pulmonary collapse. Arterial oxygen pressure (PaO₂) should be monitored; however, if levels are maintained below 13.3 kPa (100 mmHg) and significant oxygenation fluctuations are avoided, the risk of ocular damage is reduced. Additionally, the risk of ocular damage may be minimized by avoiding large oxygenation fluctuations (see also Precautions for use).
Instructions for use and handling
Medicinal oxygen cylinders, as well as cryogenic containers, are intended exclusively for containing/transporting oxygen for inhalation and therapeutic use.
Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from impact and falls.
Strictly follow these instructions:

Carefully read the instruction and user manual of the container (packaging).
Ensure all equipment is in good condition.
Secure cylinders and base units in an upright position to prevent falls. Protect containers from impact and keep them at temperatures below 50°C. Ensure adequate ventilation in rooms where the product is used. Cylinders must be fitted with a protective cap or tulip valve cover.
Handle equipment with clean hands, free from grease or oil.
Lift and move cylinders and base units only using a proper trolley; never lift a cylinder by its valve.
Use oxygen-specific and compatible connectors, tubing, or flexible hoses.
Special care must be taken when attaching pressure reducers to cylinders, especially if not integrated into the container closure system, to prevent accidental breakage.
It is absolutely forbidden to tamper in any way with delivery equipment and their accessories or components (OIL AND GREASE CAN IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves or taps.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.

General Instructions for Use

Cylinders equipped with shut-off valve only

Remove the protective cap, if present
Ensure that the delivery valve is closed
Remove the tamper-evident seal
Connect the pressure regulator to the cylinder valve and the corresponding flowmeter
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve fully
Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped with integrated pressure-reducing valve

Ensure that the valve is closed
Remove the tamper-evident seal
Ensure that the flow indicator is set to zero
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve fully
Adjust the flowmeter to the required flow rate (litres/minute)

NOTE: FOR FURTHER DETAILS, CONSULT THE INSTRUCTIONS FOR USE OF THE
CONTAINER
WARNING

Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps or valves during opening or closing.
Never position yourself in front of the gas outlet of the tap/valve; always stand on the opposite side. Do not expose yourself or the patient to direct gas flow.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder tap.
In case of gas leakage, close the tap immediately and notify the technical service of the supplier indicated in the Container's Instruction Manual.
Use only containers suitable for the product and for the intended operating pressure and temperature.
During use:
- Do not use greasy creams or lipsticks.
- Do not smoke.
- Keep open flames away from the container.
- Do not use any electrical equipment capable of producing sparks near patients receiving oxygen.
- Do not apply oils or greases to fittings, taps, valves, or any material in contact with oxygen.
- Never introduce oxygen into a device that might contain combustible materials, and in particular greasy substances.

Disposal

Store empty cylinders with valves closed.
Do not discharge into sewers, basements, or excavations where accumulation could be hazardous.
Return empty or unused containers, even if only partially empty, to the supplier. Any residual unused medicinal product remaining in the pressurized cylinder will be safely eliminated, through appropriate procedures, in a well-ventilated area by the company responsible for refilling the container.
Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance with applicable local regulations.

Observe all relevant rules concerning the use and handling of pressurized cylinders.
Store cylinders at temperatures between -10°C and 50°C, in well-ventilated areas or in well-ventilated sheds, avoiding the formation of hyperoxic atmospheres (O₂ > 21% vol), in an upright position with valves closed and protected from rain and adverse weather conditions, direct sunlight, and away from sources of heat or ignition and from combustible materials. Empty containers or those containing other types of gas must be stored separately.
Patient Information Leaflet

OXYGEN SOL 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read this leaflet carefully before this medicine is administered to you because
it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What medicinal oxygen is and what it is used for
What you need to know before you are administered medicinal oxygen
How medicinal oxygen will be administered to you
Possible side effects
How to store medicinal oxygen
Contents of the pack and other information

The full name of this medicine is Oxygen SOL 200 bar compressed medicinal gas and
Oxygen SOL cryogenic medicinal gas. For convenience, it will be referred to as "medicinal oxygen"
throughout this leaflet.

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

for the treatment of respiratory disorders (acute and chronic respiratory failure),
for use in anaesthesia,
in intensive care, a hospital unit where seriously ill patients are admitted,
in a hyperbaric chamber, a room where air pressure is higher than atmospheric pressure.

2. What you need to know before you are given medicinal oxygen

Normobaric oxygen therapy
Under normal conditions, there are no contraindications.

Hyperbaric oxygen therapy
You will not be given medicinal oxygen in a hyperbaric chamber if:

you suffer from a lung disease causing the formation of lung bubbles (bullous emphysema)
you suffer from asthma
you currently have or have previously had lung collapse (pneumothorax)
you have untreated lung collapse (pneumothorax), or treated only conservatively (without chest drainage)
you suffer from a disease causing airway obstruction, making it difficult to expel air from the lungs, resulting in shortness of breath (also known as dyspnea) (COPD)
you suffer from lung inflammation (Pneumocystis carinii pneumonia)
you suffer from a condition characterized by uncontrolled body movements (epilepsy)
you are afraid of enclosed spaces (claustrophobia)
you are in the first 3 months of pregnancy and do not have a serious illness
you have an upper respiratory tract infection
you have heat stroke (hyperthermia)
you suffer from a red blood cell disorder, a type of blood cell (hereditary spherocytosis)
you suffer from an optic nerve disease
you suffer from malignant tumors
you suffer from high levels of acid in the blood (acidosis)
you are taking medicines to treat tumors such as doxorubicin, adriamycin, daunorubicin, bleomycin, cis-platinum (see section Other medicines and medicinal oxygen)
you are taking medicines to treat inflammation such as corticosteroids (see section Other medicines and medicinal oxygen)
you are taking a medicine to treat alcohol dependence (disulfiram – see section Other medicines and medicinal oxygen)
you consume alcohol
you have recently been exposed to toxic substances (aromatic hydrocarbons)
you smoke or use nicotine-containing medicines to help people quit smoking
the newborn was born prematurely

Warnings and precautions
Before starting oxygen therapy, you should be aware of the following:

Oxygen may have harmful effects at high concentrations. It may cause lung damage (alveolar collapse, lung inflammation) that impairs blood oxygenation.
If you suffer from severe chronic obstructive pulmonary disease (COPD) resulting in poor blood oxygenation, the oxygen flow rate will be low. Your doctor will determine the most appropriate flow rate for oxygen therapy.
Exercise particular caution when administering oxygen to term and preterm newborns to minimize the risk of adverse events such as eye damage. The lowest possible oxygen concentration that allows adequate oxygenation should be used.
Exercise particular caution if you have elevated levels of carbon dioxide in the blood, which may counteract the effects of oxygen.
If you have respiratory problems caused by low oxygen levels in the blood or if you are taking strong painkillers, you must be closely monitored by your doctor.
If you have had a lung injury, inform your doctor.

Talk to your doctor or pharmacist before using medicinal oxygen.

Hyperbaric oxygen therapy (HBOT)
Your doctor will carefully evaluate whether to administer oxygen in a hyperbaric chamber if you have:

inflammation of the ears and/or nose (recurrent otitis and/or sinusitis, laryngocele, mastoid cavity, vestibular syndrome, hearing loss, or recent middle ear surgery)
a heart disease (ischemic and/or congestive cardiac conditions)
high blood pressure not treated with medication (pharmacologically untreated arterial hypertension)
lung diseases that prevent air passage (restrictive and/or severely restrictive lung diseases)
an eye disease characterized by high pressure of the fluid inside the eyes (glaucoma), retinal detachment, or an eye membrane condition, even if surgically treated (compensation maneuvers)
a history of uncontrolled body movements (seizures), sometimes with loss of consciousness (epileptic seizures)
uncontrolled high fever
severe anxiety, altered perception of reality (psychosis), or fear of confined or enclosed spaces (claustrophobia)
diabetes mellitus, as hyperbaric therapy may counteract the effect of insulin and increase your blood sugar levels (hyperglycemia)
respiratory disorders (e.g., uncontrolled asthma, pulmonary emphysema, chronic obstructive bronchopneumopathy – COPD) or recent thoracic surgery.

Advice regarding the risk of fire in the presence of oxygen:

Oxygen is an oxidizing agent and promotes combustion. In areas where medicinal oxygen is used, there must be no sources of heat, smoke, or open flames (e.g., pilot lights, stoves, ovens, gas heaters, sparks, candles), as this increases the risk of fire.
Do not smoke in the environment where oxygen therapy is administered.
Do not use electrical devices during your oxygen treatment.
In oxygen-enriched environments, oxygen may saturate clothing.
Do not apply greasy substances (e.g., oils, creams, lotions) to surfaces in contact with oxygen. Only water-based products should be used on the hands, face, or inside the nose.
Do not use pliers or other tools to open or close the cylinder valve, to prevent the risk of damage.
The pressure regulator must be opened slowly and carefully to avoid the risk of sudden flames.
In case of leakage, immediately close the cylinder valve if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer outdoor location to allow oxygen to escape freely.
Always keep valves of empty cylinders closed.

Thermal burns related to accidental fire have occurred in the presence of oxygen.

Advice for caregivers:

Handle the cylinder carefully. Ensure the gas cylinder is not dropped or subjected to impacts.
Damage to equipment may cause blockage of the opening and/or incorrect display readings on the pressure gauge regarding residual oxygen content and flow, leading to insufficient or absent oxygen delivery.
Oxygen becomes liquid at approximately -183°C. At such low temperatures, there is a risk of frostbite. Always wear protective gloves and eye protection when handling liquid medicinal oxygen. If liquid oxygen comes into contact with the skin or eyes, the affected areas must be washed thoroughly with cold water or cold compresses applied; if such injuries occur, immediate medical assistance must be sought.

Children
In premature and term newborns, oxygen therapy may cause eye damage (retinopathy of prematurity), lung damage, and brain hemorrhages. The doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your child.

Other medicines and medicinal oxygen
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicines.

In particular, inform your doctor, nurse, or pharmacist if you are taking or have been prescribed:

catecholamines (e.g., epinephrine, norepinephrine), medicines that affect multiple body organs and are generally used for emergency treatment of sudden allergic reactions
corticosteroids (e.g., dexamethasone, methylprednisolone), medicines used to treat inflammation
hormones (e.g., testosterone, thyroxine)
amiodarone, a medicine used to treat heart rhythm disorders
chemotherapeutic agents (e.g., bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors
antimicrobial agents (e.g., nitrofurantoin)
antibiotics (e.g., bleomycin, actinomycin, nitrofurantoin), medicines used to treat infections
vitamin K supplements (menadione)
medicines used to treat mental disorders (e.g., promazine, chlorpromazine, thioridazine)
chloroquine, a medicine used to treat malaria

Additionally, inform your doctor if:

you have recently undergone an X-ray
you have undergone treatment for paraquat poisoning (a herbicide). Pre-existing lung damage caused by the pesticide paraquat may be worsened by oxygen. In cases of paraquat poisoning, administration of supplemental oxygen should be avoided as much as possible.
you suffer from hyperthyroidism or deficiency in vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

Medicinal oxygen and alcohol
Do not consume alcohol during oxygen therapy.
Alcohol may impair breathing.

Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

Normobaric oxygen therapy
During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) should be administered only if necessary.

Hyperbaric oxygen therapy
The use of hyperbaric treatment is contraindicated during the first trimester of pregnancy for non-acute conditions.
If you are pregnant or could be pregnant, high-pressure oxygen therapy (hyperbaric oxygen therapy) should be used only if strictly necessary. Inform your primary care physician or specialist if you are in any of these conditions.

There are no contraindications for the use of oxygen during breastfeeding.

Driving and using machines
The use of medicinal oxygen at normal pressure (normobaric oxygen therapy) does not affect or affects negligibly the ability to drive or operate machinery.
Consult your doctor before driving or operating machinery.
After high-pressure oxygen therapy (hyperbaric oxygen therapy), you may experience visual and hearing disturbances that could impair your ability to drive or operate machinery.
Avoid driving and operating machinery until all negative effects on attention and alertness have completely disappeared.

3. How medicinal oxygen will be administered to you

This medicine will be administered to you through the inhaled air, always following exactly the instructions given by your doctor or nurse. If you have any doubts, consult your doctor.
If you do not have respiratory failure, medicinal oxygen will be inhaled through your nose and mouth using a nasal cannula or a face mask.
If you suffer from respiratory failure or if you are undergoing anaesthesia, medicinal oxygen will be administered via assisted ventilation.
The dose will be determined by your doctor based on your health condition.
During treatment with medicinal oxygen, your doctor may perform measurements of blood gases (oxygen and carbon dioxide) in arterial blood and monitor the levels of oxygen bound to haemoglobin, a protein that carries oxygen in the blood.

If you are given more medicinal oxygen than you should
It is very unlikely that you will receive more oxygen than required, as your doctor or nurse will monitor you during treatment.
Oxygen toxicity effects vary depending on the pressure of the inhaled oxygen and the duration of exposure.
Effects on the lungs (pulmonary effects) include shortness of breath, cough, chest pain, interstitial oedema, and pulmonary fibrosis.
Effects on the brain and spinal cord (central nervous system) include tinnitus, visual and hearing disturbances, nausea, dizziness, anxiety, confusion and irritability, localized muscle cramps (around the eyes, mouth and forehead), loss of consciousness, and convulsions (epileptic seizures).
Ocular effects include blurred vision and reduced peripheral vision ("tunnel vision").
In premature infants, eye problems (retinopathy) may occur.
In case of oxygen poisoning due to hyperoxia, oxygen therapy should be reduced or, if possible, discontinued, and symptomatic treatment should be initiated.

If you forget to use medicinal oxygen
Use oxygen as described in the section of the package leaflet relating to dosage. Do not use a double dose to make up for a forgotten dose, as medicinal oxygen may be harmful at high concentrations.

If you stop using medicinal oxygen
Do not stop using this medicine on your own initiative. Consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.

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

With normobaric treatment: in newborns exposed to high oxygen concentrations: eye damage, which may lead to visual impairment.
With hyperbaric treatment: ear pain, myopia, barotrauma (injury to tissues or organs of the body 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: lung collapse (atelectasis).
With hyperbaric treatment: rupture of the eardrum.

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

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

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

With normobaric treatment: pulmonary toxicity, worsening of excess carbon dioxide in the blood (hypercapnia), dryness of mucous membranes, local irritation and inflammation of mucous membranes.
With hyperbaric treatment: breathing difficulties, involuntary muscle contractions, dizziness, hearing impairment, acute serous otitis, noise or ringing in the ears (tinnitus), nausea, abnormal behaviour, reduced peripheral vision, visual disturbances, clouding of the lens (cataract).

Limited to the cryogenic formulation

Cold burns may occur following direct contact with liquid oxygen (see section Warnings and precautions).

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store medicinal oxygen

Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C.
Keep this medicinal product out of the sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicinal product via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What medicinal oxygen contains
The active substance is oxygen.
Description of the appearance of medicinal oxygen and contents of the pack
Compressed medicinal gas
OSSIGENO SOL compressed medicinal gas is supplied in cylinders and cylinder packs, in the form of compressed gas at 200 bar at 15°C. The cylinders are made of steel and equipped with valves suitable for connection to a pressure reducer or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO SOL cryogenic medicinal gas is supplied in fixed cryogenic containers.
Available pack sizes:
Compressed medicinal gas
Steel cylinders with valve: 33, 40, 50 litres; cylinder packs: 9, 12, 16, 20 cylinders of 50 litres each.
Cryogenic medicinal gas
Fixed cryogenic containers: 1000, 1500, 3000, 5000, 10,000, 15,000, 20,000, 30,000 litres.
Not all pack sizes may be marketed.
Marketing Authorization Holder
SOL S.p.A
Via Borgazzi, 27
Monza (MI)
Manufacturer
Compressed medicinal gas
VIVISOL Srl – Via Manin, 153 – Sesto San Giovanni (MI)
I.C.O.A. Srl Industria Calabrese Ossigeno ed Acetilene – Zona Industriale (Loc. Porto Salvo) – Vibo Valentia
SOL SpA – 4a Strada z.i. Macchiareddu – Assemini (CA)
SOL SpA – Via Enzo Ferrari – Catania
SOL SPA – Via Acquaviva, 4 – Cremona
SOL SpA – Via dei Ciclamini, 19 – Modugno (BA)
SOL SpA – Via Belgio, 16 – Padova
SOL SPA – Via Nugolaio, 4 – Pisa
SOL SpA – Via dei mandarini 6 – Pomezia (RM)
SOL SpA – Via Poli, 2/A – Zola Predosa (BO)
SOL SPA – Via Vanoni, 5 – Ancona
SOL SPA – Via Giovanni Francesco Maggiò snc – Marcianise (CE)
SOL SPA – Via de Francisco 148/8-9 – Settimo Torinese (TO)
Cryogenic medicinal gas (fixed containers)
Sol Gas Primari – Via Firmio Leonzio, 2 – 84100 – Salerno
Sol Gas Primari – Viale del Lavoro, 12 – 37036 – San Martino Buon Albergo (VR)
Sol Gas Primari – Via Taliercio, 14 – 46100 – Mantova
Sol Gas Primari - Contrada Marcellino, 96011 Augusta (SR)
Air Liquide Italia Produzione srl – S.S. 195, km 17,200 – 09018 – Sarroch (CA)
Air Liquide Italia Produzione srl – Via Industrie, 28 – 37014 – Castelnuovo del Garda (VR)
Air Liquide Italia Produzione srl – Via Dante s.n.c. – 20090 – Pioltello (MI)
Chemgas srl – Via E. Fermi – 72100 – Brindisi
Linde Gas Italia srl – Via Turati, 18/a – 40010 – Sala Bolognese (BO)
Linde Gas Italia srl – Via di Servola, 1 – 34100 – Trieste
Sapio Produzione Idrogeno Ossigeno srl – Via Senatore Simonetta, 27 – 20040 – Caponago
Sapio Produzione Idrogeno Ossigeno srl – Via Malcontenta, 49 (locality Porto Marghera) – 30175 – Venice
Rivoira Operations Srl – Via Glair, 30 – 11029 – Verrès (AO)
Rivoira Operations Srl – Via Baiona, 107/111 – 48100 – Ravenna
Societa' Italiana Acetilene & Derivati "S.I.A.D." SpA – S.S. del Brembo, 1 – 24040 – Osio Sopra (BG)
SPG – SOL Plin Gorenjska d.o.o., Cesta 1 Maja 42, 4270 Jesenice, Slovenia
Medicair Italia S.r.l. - Contrada S. Benedetto Zona ASI - 92026 Favara (AG)
Air Liquide Italia Produzione srl - Contrada Biggemi Ex S.S. 114 - Priolo Gargallo (SR)
SOL SpA – Via Vanoni, 5 – 60100 Ancona

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Oxygen must be administered with caution, adjusted according to the individual needs of each patient. The lowest effective dose should be administered to maintain arterial oxygen pressure at 8 kPa (60 mmHg). Higher concentrations should be administered for the shortest possible duration, with frequent monitoring of blood gas analysis.
Oxygen can be safely administered at the following concentrations and for the following durations:
Up to 100% for less than 6 hours
60–70% for 24 hours
40–50% during the second 24-hour period.
Oxygen may become potentially toxic after two days at concentrations above 40%.
Low oxygen concentrations should be used in patients with respiratory failure in whom the respiratory drive is stimulated by hypoxia. In such cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂) and clinical assessment.
Administering oxygen to patients with respiratory failure induced by drugs (opioids, barbiturates) or chronic obstructive pulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia caused by elevated blood carbon dioxide levels, which neutralizes the effects on receptors.
High oxygen concentrations in the air or in inhaled gas lead to a decrease in nitrogen concentration and pressure. This also reduces nitrogen levels in tissues and lungs (alveoli). If oxygen is absorbed into the blood through alveoli faster than it is supplied via ventilation, alveoli may collapse (atelectasis). This may impair arterial blood oxygenation, as gas exchange does not occur despite adequate perfusion.
In patients with reduced sensitivity to arterial carbon dioxide pressure, high oxygen levels may cause carbon dioxide retention. In extreme cases, this may lead to carbon dioxide narcosis.
High oxygen concentrations should be administered for the shortest time necessary to achieve the desired effect, with repeated monitoring of arterial blood gas pressure (PaO₂) or peripheral hemoglobin oxygen saturation (SpO₂) and clinical evaluations.
Patients at risk of hypercapnic respiratory failure
Particular precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide pressure or at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis, morbid obesity, thoracic wall deformities, neuromuscular disorders, respiratory depressant drug overdose) and in patients with drug-induced respiratory failure (opioids, barbiturates), as oxygen administration may worsen respiratory failure due to hypercapnia caused by high blood carbon dioxide levels, which neutralizes the effects of oxygen on receptors.
Supplemental oxygen administration may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.
Special precautions in patients with bleomycin-induced lung injury
Pulmonary toxicity from high-dose oxygen therapy may exacerbate lung injury, even when administered several years after the initial lung damage caused by bleomycin, and the target oxygen saturation may need to be lower than in other patients.
Paediatric population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective oxygen concentration should be administered to achieve adequate oxygenation in neonates.
In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity, chronic lung disease, and intraventricular haemorrhage.
It is recommended to initiate resuscitation of term or near-term newborns with air rather than 100% oxygen. In preterm neonates, the optimal oxygen concentration and target oxygen levels are not precisely defined. If necessary, supplemental oxygen should be carefully monitored and guided by pulse oximetry.
Fire hazard:

Any oxygen delivery system or container must be kept away from heat sources due to oxygen's combustive properties; appropriate precautions must therefore be taken both in hospital and domestic settings when handling medicinal oxygen.
Oxygen may cause spontaneous ignition of smouldering materials or embers; therefore, smoking or using open, unshielded flames near containers and delivery systems is strictly prohibited.
Do not smoke in areas where oxygen therapy is administered.
Do not place cylinders or containers near heat sources.
Electrical equipment capable of producing sparks must not be used near patients receiving oxygen.
It is absolutely forbidden to tamper in any way with container connections, delivery equipment, or their accessories or components ( OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN ).
Contact with oil, grease, or other hydrocarbons must be avoided.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
In oxygen-enriched environments, oxygen may saturate clothing.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).
Cylinders and mobile cryogenic containers must not be used if there are visible damages or if damage is suspected, or if they have been exposed to extreme temperatures.
Only oxygen-compatible and appropriate equipment must be used for the specific container model.
Pliers or other tools must not be used to open or close the cylinder valve to prevent damage.
In case of leakage, the cylinder valve must be closed immediately, if safe to do so. If the valve cannot be closed, the cylinder must be moved to a safer outdoor location to allow oxygen to escape freely.
Valves of empty cylinders must remain closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. This is why handling and storage of containers require special precautions.
Pressurized gas must not be administered directly.

Oxygen is an oxidizing product and promotes combustion. When using oxygen, the increased risk of fire ignition must be taken into account:

Fire hazard in domestic settings: patients and caregivers must be informed of the fire risk associated with other ignition sources (smoking, flames, sparks, cooking appliances, ovens, etc.) and/or highly flammable substances, particularly greasy ones (oils, grease, creams, ointments, lubricants, etc.). During oxygen use, only water-based products should be used on hands, face, and inside the nose.
Fire hazard in hospital settings: this risk is increased during procedures involving diathermy, defibrillation, and electrical cardioversion.
Fires may occur upon opening the valve (heating due to friction).

Thermal burns associated with accidental fires in the presence of oxygen have occurred.
Handling of cylinders:
All caregivers and individuals handling medicinal oxygen cylinders must be informed of the need to handle cylinders carefully to avoid damage to devices, particularly the valve. Damage to the device may cause obstruction of the outlet and/or incorrect readings on the pressure gauge regarding residual oxygen quantity and flow rate, resulting in insufficient or absent oxygen delivery.
For the cryogenic formulation
Cold burns from direct contact with liquid oxygen:
Oxygen becomes liquid at approximately -183°C. At such low temperatures, direct contact of liquid oxygen with skin or mucous membranes may cause cold burns. Special safety precautions must be taken when handling cryogenic containers: appropriate protective clothing (gloves, goggles, loose clothing, and trousers covering shoes) must be worn. If liquid oxygen contacts skin or eyes, the affected areas must be washed with abundant cold water or cold compresses applied; immediate medical assistance must be sought.
Dosage, method, and duration of administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or face mask); dosing is performed independently of the medicinal gas packaging via dosing devices (flowmeters).
With these systems, oxygen is delivered through the inhaled air, while exhaled gas and any excess oxygen leave the patient's inspiratory circuit, mixing with the surrounding air (open or anti-rebreathing system).
In anaesthesia, a special system is often used that allows rebreathing of previously exhaled gas (closed or rebreathing system).
Oxygen may also be administered directly into the blood via an oxygenator, using a cardiopulmonary bypass system in cardiac surgery and other cases requiring extracorporeal circulation.
Numerous devices are available for oxygen administration, and they are classified as:

Low-flow systems This is the simplest system for delivering an oxygen-air mixture; an example is a system where oxygen is delivered via a flowmeter connected to a nasal cannula or face mask.
High-flow systems Systems designed to provide the patient with a gas mixture ensuring total respiratory requirements. These systems deliver stable and constant oxygen concentrations that are not diluted by surrounding air; an example is Venturi masks, where, once the oxygen flow is set, the air inhaled by the patient is enriched with a constant oxygen concentration.
Demand valve systems Systems designed to deliver 100% oxygen without contact with ambient air. Intended for short-term use only, in emergencies.
Hyperbaric oxygen therapy Hyperbaric oxygen therapy is performed in a specially designed pressurized chamber where pressure can be maintained at three times atmospheric pressure. Hyperbaric oxygen therapy may also be administered via a tightly sealed mask, helmet, or endotracheal tube.

Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air, i.e., with an inspired oxygen fraction (FiO₂) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
In patients without respiratory failure, oxygen may be administered via spontaneous ventilation using nasal cannulae, nasopharyngeal catheters, or suitable masks.
In patients with respiratory failure or under anaesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders contain an internal pressure of approximately 200–300 bar. Pressure is regulated by a reducer and indicated on the pressure gauge. Multiplying the pressure gauge reading by the cylinder volume (in litres) gives the amount of oxygen remaining in the cylinder.
(Example: Approximate content calculation: a cylinder has a volume of 10 litres and the pressure gauge reads 200 bar, resulting in 2000 litres of oxygen. At a consumption rate of 2 litres per minute, the cylinder will be empty after approximately 16 hours.)
With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate of 0.5 to 2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 litres/minute, adjustable according to blood gas analysis.
With assisted ventilation
The minimum FiO₂ value is 21%, and it may rise up to 100%.
The therapeutic goal of oxygen therapy is to ensure that arterial oxygen partial pressure (PaO₂) is not below 8 kPa (60 mmHg) or that arterial haemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO₂).
Dosage must be adjusted according to individual patient needs.
The general recommendation is to use the lowest FiO₂ necessary to achieve the desired therapeutic effect, i.e., normal PaO₂ values. In cases of severe hypoxemia, FiO₂ values that may pose a potential risk of oxygen toxicity may be indicated.
Continuous monitoring of therapy and ongoing assessment of therapeutic effect are required, through measurement of PaO₂ levels or alternatively, arterial oxygen saturation (SpO₂).
In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should maintain PaO₂ > 8 kPa with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), while avoiding FiO₂ values > 0.6 (i.e., >60% oxygen in the inhaled gas mixture) whenever possible.
Short-term oxygen therapy must be monitored with repeated arterial blood gas measurements (PaO₂) or transcutaneous oximetry providing a numerical value of haemoglobin oxygen saturation (SpO₂). In any case, these indices are only indirect measurements of tissue oxygenation. Clinical evaluation of treatment is of utmost importance.
For long-term treatment, the need for supplemental oxygen must be determined from arterial blood gas measurements. To avoid excessive carbon dioxide accumulation, blood oxygen levels must be monitored to adjust oxygen therapy in patients with hypercapnia.
Low oxygen concentrations should be used in patients with respiratory failure in whom the respiratory drive is stimulated by hypoxia (e.g., due to COPD). The oxygen concentration in inhaled air should not exceed 28%; in some patients, even 24% may be excessive.
If oxygen is mixed with other gases, its concentration in the inhaled gas mixture must be maintained at least at 21%. In practice, levels below 30% are generally avoided. When necessary, the inspired oxygen fraction may be increased up to 100%.
Paediatric population
Neonates may receive 100% oxygen when necessary. However, careful monitoring during treatment is required. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or lung collapse. Arterial blood oxygen pressure (PaO₂) must be monitored; however, if maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Additionally, the risk of ocular damage may be reduced by avoiding significant fluctuations in oxygenation (see also Precautions for use).
Hyperbaric oxygen therapy
Hyperbaric oxygen therapy refers to treatment with 100% oxygen at pressures 1.4 times higher than atmospheric pressure at sea level (1 atm = 101.3 kPa = 760 mmHg). For safety reasons, pressure in hyperbaric oxygen therapy should not exceed 3 atm.
Oxygen must be administered in a hyperbaric chamber.
The duration of sessions in a hyperbaric chamber at a pressure of 2 to 3 atmospheres (i.e., between 2.026 and 3.039 bar) ranges from 60 minutes to 4–6 hours. These sessions may be repeated 2 to 4 times daily, depending on the patient's clinical condition.
Compression and decompression should be performed slowly according to standard procedures to avoid barotrauma risk to air-containing anatomical cavities communicating with the outside.
Hyperbaric oxygen therapy must be performed by qualified personnel trained in this treatment.
Instructions for use and handling
Medicinal oxygen cylinders, as well as fixed and mobile cryogenic containers, are intended exclusively for containing/transporting oxygen for inhalation, for therapeutic use.
Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from impact and falling risks.
Strictly follow these instructions:

Carefully read the instruction and user manual of the container packaging
Verify that all materials are in good condition.
Secure cylinders and base units to keep them in an upright position and prevent falls; protect containers from impact and maintain them at temperatures below 50°C, ensuring adequate ventilation/aeration of rooms where the product is used. Cylinders must be equipped with a protective cap/tulip over the valve.
Handle materials with clean hands, free from traces of grease or oil.
Lift and move cylinders and base units using the appropriate trolley only; never lift a cylinder by the valve.
Use connectors, connecting tubes, or hoses specifically designed and compatible with oxygen.
Particular attention must be paid to securing pressure reducers onto cylinders , especially when not integrated into the container closure system, to prevent accidental breakage risks.
It is absolutely forbidden to tamper in any way with container connections, delivery equipment, and their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair a defective valve.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).

General instructions for use
Cylinders with only a shut-off valve

Remove the protective cap if present
Ensure the delivery valve is closed
Remove the tamper-evident seal
Connect the pressure reducer to the cylinder valve and the corresponding flowmeter
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve fully
Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders with integrated pressure-reducing valve

Ensure the valve is closed
Remove the tamper-evident seal
Ensure the flow indicator is set to zero
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve fully
Adjust the flowmeter to the required flow rate (litres/minute)

Mobile cryogenic containers

Ensure the flow indicator is set to zero
Remove the tamper-evident seal
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Set the flow regulator to the required flow rate (litres/minute)

NOTE: FOR MORE DETAILS, CONSULT THE USER MANUAL OF THE CONTAINER
ATTENTION

Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps or valves during opening and closing.
Never stand directly in front of the gas outlet from the tap/valve; always stand to the side. Do not expose yourself or the patient to direct gas flow.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder valve.
In case of gas leakage, close the valve and contact the technical service of the supplier indicated in the container's user manual.
Use only containers suitable for the product, and for the intended pressure and temperature of use.

During use

Do not use greasy creams or lipsticks.
Do not smoke
Do not bring open flames near the container.
Do not use electrical equipment capable of emitting sparks near patients receiving oxygen.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen.
Never introduce oxygen into a device that may contain combustible materials, especially greasy substances.

Disposal

Store empty cylinders with valves closed.
Do not discharge into sewers, basements, or pits where accumulation may be hazardous.
Return empty or unused containers, even if only partially empty, to the supplier. Any residual unused medicinal product in the pressurized cylinder will be eliminated via appropriate procedures in a well-ventilated area by the company responsible for refilling the container.
Unused medicinal product and waste derived from this medicinal product must be disposed of in accordance with local regulations.

Observe all applicable rules for the use and handling of pressurized cylinders and containers containing cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated areas or well-ventilated sheds, avoiding the formation of oxygen-enriched atmospheres (O₂ > 21% vol), in an upright position with valves closed and protected from rain and weather, direct sunlight, and away from heat or ignition sources and combustible materials. Empty containers or those containing other types of gas must be stored separately.
Fixed cryogenic containers installed at healthcare facilities must be located outdoors.