Oxygen Air Liquide Sanità: detailed information

PATIENT INFORMATION LEAFLET

Patient information leaflet: information for the patient

OXYGEN AIR LIQUIDE SANITÀ 200 BAR MEDICINAL COMPRESSED GAS

OXYGEN AIR LIQUIDE SANITÀ CRYOGENIC MEDICINAL GAS
Oxygen
Please read this leaflet carefully before this medicine is administered to you, 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, 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 Oxygene Air Liquide Sanità is and what it is used for
What you need to know before you are administered Oxygene Air Liquide Sanità
How Oxygene Air Liquide Sanità will be administered to you
Possible side effects
How to store Oxygene Air Liquide Sanità
Package contents and other information

1. What Ossigeno Air Liquide Sanità is and what it is used for

Ossigeno Air Liquide Sanità contains oxygen, a gas naturally present in the air we breathe.
Medical oxygen increases the amount of oxygen in the blood and its distribution to all body tissues.
Ossigeno Air Liquide Sanità is indicated in patients of all ages:

for the treatment of acute and chronic respiratory failure,
for use in anaesthesia,
in intensive care,
in hyperbaric chambers, which are rooms where air pressure is higher than atmospheric pressure.

2. What you should know before being administered Ossigeno Air Liquide Sanità

Normobaric oxygen therapy
There are no absolute contraindications.
Hyperbaric oxygen therapy (oxygen at a pressure higher than atmospheric pressure)
You will not be administered Ossigeno Air Liquide Sanità in a hyperbaric chamber if you:

suffer from a lung disease causing formation of air bubbles in the lungs (bullous emphysema)
have asthma
have or have previously had pneumothorax
suffer from a lung disease making it difficult to expel air from the lungs, shortness of breath (also known as dyspnea), or a feeling of fatigue (chronic obstructive bronchopulmonary disease - COPD)
suffer from lung inflammation (Pneumocystis carinii pneumonia)
are experiencing status epilepticus
have fear of enclosed spaces (claustrophobia)
are in the first 3 months of pregnancy unless in a life-threatening condition
have an upper respiratory tract infection
have heat stroke (hyperthermia)
suffer from a red blood cell disorder (hereditary spherocytosis)
suffer from an optic nerve disease
suffer from malignant tumors
suffer from high levels of acid in the blood (acidosis)
are taking medications such as doxorubicin, adriamycin, bleomycin, daunorubicin, cisplatin, steroids, disulfiram (used to treat alcohol dependence)
are consuming alcohol
are receiving aromatic hydrocarbons (toxic substances) or nicotine
are a premature newborn.

Warnings and precautions
Talk to your doctor or pharmacist before using Ossigeno Air Liquide Sanità.
Before starting oxygen therapy, you should be aware of the following:

Oxygen may have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), which may impair oxygen delivery into the blood.
If you have severe chronic obstructive lung disease (COPD) resulting in blood oxygen deficiency, cystic fibrosis, pathological obesity, chest wall deformity, neuromuscular disorders, or respiratory depression due to drug overdose, supplemental oxygen administration may cause respiratory problems. In these cases, the oxygen concentration and flow rate will be low. Your doctor will adjust the oxygen flow rate accordingly.
If you have pulmonary lesions due to bleomycin, high-dose oxygen therapy toxicity—even if administered several years later—may worsen existing lung injury.
Adverse events may occur in newborns and preterm infants, such as eye damage. If your baby requires extra oxygen, the doctor will determine the appropriate oxygen concentration to administer.

Your doctor will carefully evaluate whether to administer oxygen in a hyperbaric chamber if you:

suffer from recurrent ear and/or nasal inflammation (recurrent otitis and/or sinusitis)
suffer from heart disease (ischemic and/or congestive cardiac conditions)
have untreated high blood pressure (pharmacologically untreated arterial hypertension)
suffer from severe lung diseases that restrict airflow (severe restrictive and/or obstructive lung diseases)
suffer from high eye pressure (glaucoma) or retinal detachment
suffer from seizures or epileptic attacks
have uncontrolled high fever
suffer from diabetes mellitus, as hyperbaric therapy may counteract insulin effects and increase blood sugar levels (hyperglycemia).

Advice regarding fire risk in the presence of oxygen:

Oxygen is an oxidizing agent and promotes combustion. In areas where Ossigeno Air Liquide Sanità 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 areas 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 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 cautiously 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 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 outlet and/or incorrect 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 gloves and protective goggles when handling liquid medical oxygen. If liquid oxygen comes into contact with skin or eyes, the affected areas must be washed thoroughly with cold water or cold compresses applied; immediate medical assistance must be sought if such injuries occur.

Children
In newborns and preterm infants, oxygen therapy may lead to eye damage (retinopathy of prematurity). The doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your baby.
Other medicines and Ossigeno Air Liquide Sanità
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines.
In particular, inform your doctor if you are taking:

catecholamines (e.g., adrenaline, noradrenaline), 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), medicines used to treat bacterial infections
antineoplastic antibiotics (e.g., actinomycin, adriamycin)
menadione-based supplements
medicines used to treat mental disorders (e.g., promazine, chlorpromazine, thioridazine)
chloroquine, a medicine used to treat malaria. Also inform your doctor if:
you have recently undergone an X-ray
you have undergone treatment for paraquat poisoning (a herbicide)
you suffer from hyperthyroidism or deficiency in vitamin C, vitamin E, or glutathione (an antioxidant), as these may increase oxygen toxicity.

Ossigeno Air Liquide Sanità and alcohol
Oxygen may worsen respiratory depression induced by alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Normobaric oxygen therapy:
Ossigeno Air Liquide Sanità may be used during pregnancy, but only when necessary. Inform your doctor if you are pregnant or suspect pregnancy.
Hyperbaric oxygen therapy:
Ossigeno Air Liquide Sanità should not be used during the first three months of pregnancy unless you are in a life-threatening condition.
Ossigeno Air Liquide Sanità may be used during breastfeeding.
Driving and use of machinery
Normobaric oxygen therapy:
Ossigeno Air Liquide Sanità does not alter or alters negligibly the ability to drive vehicles or operate machinery. Consult your doctor before driving or operating machinery.
Hyperbaric oxygen therapy:
Visual and hearing disturbances have been reported after hyperbaric oxygen therapy, which may affect the ability to drive vehicles and operate machinery.

3. How Oxygen Air Liquide Sanità will be administered to you

This medicine will be administered to you through inhaled air, always following exactly the instructions given by your doctor or nurse. If you have any doubts, consult your doctor.
Oxygen Air Liquide Sanità is usually inhaled through the nose and mouth via a nasal cannula or a face mask.
The dosage will be determined by your doctor based on your health condition.
During treatment with Oxygen Air Liquide Sanità, your doctor may perform measurements of arterial blood gases and monitor haemoglobin oxygen levels, a protein that carries oxygen in the blood.
If you are given more Oxygen Air Liquide Sanità than you should receive
If you are administered an excessive dose of Oxygen Air Liquide Sanità, it may affect respiratory function (substernal pain, dry cough, interstitial oedema, pulmonary fibrosis, shortness of breath) and, in rare cases, cause neurological adverse effects that could lead to loss of consciousness in extreme situations. If these signs of overdose occur, always contact your doctor or the nearest hospital.
In premature children, eye problems (retinopathy) may occur.

4. Possible side effects

Like all medicines, Ossigeno Air Liquide Sanità can cause side effects, although not everyone experiences them.
After approximately 4 hours of exposure to 95% oxygen at ambient atmospheric pressure, tracheobronchitis, substernal pain, and dry cough may occur. Exposure to 100% oxygen may lead to a reduction in the total volume of air exhaled after 8–12 hours of exposure; however, serious lesions require much longer exposure times.
Inhalation of high concentrations of oxygen may cause lung collapse (atelectasis) due to decreased nitrogen in the alveoli, thereby compromising oxygen delivery to the blood.
Administration of excessively high oxygen concentrations may cause respiratory depression in cases of severe chronic obstructive pulmonary disease (COPD) or when taking medications that depress respiration (opioids, barbiturates).
Due to the relatively small size of some hyperbaric chambers, anxiety from confinement (claustrophobia) may develop, which is not due to a direct effect of oxygen.

Below are the side effects reported for Ossigeno Air Liquide Sanità:
Very common (may affect more than 1 in 10 people):
Retinopathy in premature infants. With hyperbaric treatment: ear pain, progressive myopia, barotrauma (tissue or organ injury caused by pressure changes).
Common (may affect up to 1 in 10 people):
With hyperbaric treatment: seizures.
Uncommon (may affect up to 1 in 100 people):
With hyperbaric treatment: rupture of the eardrum.
Rare (may affect up to 1 in 1,000 people):
With hyperbaric treatment: shortness of breath, low blood sugar levels in diabetic patients.
Frequency not known (frequency cannot be estimated from the available data):

Pain related to breathing and dry cough, interstitial edema, pulmonary fibrosis
Worsening of hypercapnia (excess carbon dioxide in body fluids, particularly in the blood) with hypoventilation, respiratory acidosis, respiratory arrest
Dryness of the mucosa; local irritation and inflammation of the mucosa

With hyperbaric treatment: difficulty breathing, involuntary muscle contractions, dizziness, decreased hearing, tinnitus, acute serous otitis, nausea, abnormal behavior, reduced peripheral vision, visual disturbances, cataract.

Oxygen administration may cause a slight reduction in heart rate and cardiac output.
Contact with liquid oxygen causes cold burns.

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 may also report side effects directly via the website http://aifa.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ossigeno Air Liquide Sanità

Store 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 into wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Ossigeno Air Liquide Sanità Contains

The active substance is oxygen.

Description of the Appearance of Ossigeno Air Liquide Sanità and Contents of the Package
Compressed medicinal gas
Ossigeno Air Liquide Sanità 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 compatible with a pressure regulator.
Cryogenic medicinal gas
Ossigeno Air Liquide Sanità cryogenic medicinal gas is supplied in fixed cryogenic containers.
Available pack sizes are as follows:
Compressed medicinal gas
Steel cylinders with valve, 40 and 50 litres.
Cylinder packs containing 12 cylinders of 40 and 50 litres.
Cryogenic medicinal gas
Fixed cryogenic containers of 800, 1300, 1500, 1800, 3000, 4000, 5000, 6000, 10000, 14000, 21000, 30000, 35000, 41000 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
AIR LIQUIDE ITALIA GAS e SERVIZI S.r.l.
Via Bisceglie, 66
20152 Milano

Manufacturer
Compressed medicinal gas
Air Liquide Sanità Service S.p.A. – Via Lussemburgo, 17 – 37135 Verona
Air Liquide Sanità Service S.p.A. – Via Campobello, 7 – 00071 Pomezia (RM)
SOL SpA – 4 Strada Z.I. Macchiareddu – 09032 Assemini (CA)
SOL SpA – Via Acquaviva, 4 - 26100 Cremona
SOL SpA – Via XVI Strada S.N.Z.I. – 95100 Catania
SOL SpA – Via Laurentina km 26,6 – 00071 Pomezia (RM)
SOL SpA – Via Belgio, 16 – 35100 Padova
SOL SpA – Zona Interconsortile Asi – 81025 Marcianise (CE)
Cryogenic medicinal gas (fixed containers)
Air Liquide Italia Produzione S.r.l. – Via Industrie, 28 – 37014 Castelnuovo del Garda (VR)
Air Liquide Italia Produzione S.r.l. – Via Vigonovese, 79 – 35100 Padova
Air Liquide Italia Produzione S.r.l. – Via Dante s.n.c. – 20090 Pioltello (MI)
Air Liquide Italia Produzione S.r.l. – Strada Provinciale, 28 – 27032 Ferrera Erbognone (PV)
Air Liquide Italia Produzione S.r.l.– Contrada Biggemi ex S.S. 114 – 96010 Priolo Gargallo (SR)
Air Liquide Italia Produzione S.r.l.– S.S. 195, km 17,200 – 09018 Sarroch (CA)
Chemgas S.r.l. – Via E. Fermi – 72100 Brindisi
Linde Gas Italia S.r.l. – Via Turati, 18/a – 40010 Sala Bolognese (BO)
Linde Gas Italia S.r.l. – Via di Servola, 1 – 34100 Trieste
Rivoira Operations S.r.l. – Via Baiona, 107/111 – 48100 Ravenna
Rivoira Operations S.r.l. – Via Glair, 30 – 11029 Verres (AO)
Società Italiana Acetilene & Derivati "S.I.A.D." S.p.A.–S.S. del Brembo, 1 –24040 Osio Sopra (BG)
Sol Gas Primari S.r.l. – Viale Unità d'Italia, 49 – 57025 Piombino
Sol Gas Primari S.r.l. – Via Firmio Leonzio, 2 – 84100 Salerno
Sol Gas Primari S.r.l. – Via Taliercio, 14 – 46100 Mantova
Sapio Produzione Idrogeno Ossigeno S.r.l. – Via Senatore Simonetta, 27 – 20040 Caponago (MI)
Sapio Produzione Idrogeno Ossigeno S.r.l. – Via Malcontenta, 49 (località Porto Marghera) – 30175 Venezia
Sapio Produzione Idrogeno Ossigeno S.r.l. - Località Caldare, snc – 01028 Orte (VT)
Linde Gas Italia S.r.l. – Viale Brin, 218 – 05100 Terni
SICO Società Italiana Carburo Ossigeno S.p.A. – Via Marconato s.n.c. – 20031 Cesano Maderno (MI)
IGAT SpA – SS Appia Km. 192,500 – 81052, Pignataro Maggiore (CE)
SOL GAS PRIMARI SRL – Contrada Marcellino C.P. 119 Snc – 96011, Augusta (SR)

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for Use
Oxygen must be administered with caution, adjusting dosage according to the individual patient's 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 toxic after two days at concentrations exceeding 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 via pulse oximetry (arterial oxygen saturation – SpO₂), along with clinical assessment.
High oxygen concentrations in inspired air or gas mixtures 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 replenished by ventilation, alveolar collapse (atelectasis) may occur. This can impair arterial blood oxygenation, as gas exchange does not occur despite 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.

Children
In newborns and premature infants, oxygen therapy may cause eye damage (retrolental fibroplasia). The risk of such ocular damage can be reduced by appropriate selection of oxygen concentration by the physician.

Dosage, Method and Duration of Administration
With these systems, oxygen is delivered via the inspired air, while exhaled gas and any excess oxygen leave the patient's inspiratory circuit, mixing with ambient air (open or anti-rebreathing system).
In anesthesia, a special system is often used that allows rebreathing of previously exhaled gas (closed or rebreathing system).
Oxygen can also be administered directly into the blood via an oxygenator, using a cardiopulmonary bypass system in cardiac surgery and in other cases requiring extracorporeal circulation.
Several devices are available for oxygen delivery, classified as follows:

Low-flow systems: The simplest method for delivering an oxygen-enriched mixture in inspired air. An example is oxygen delivery via a flowmeter connected to a nasal catheter or face mask.
High-flow systems: Designed to meet the patient’s total respiratory gas requirements. These systems deliver a constant, predetermined oxygen concentration that is not diluted by ambient air. An example is Venturi masks, which provide a constant oxygen concentration in the air inspired by the patient, once the oxygen flow rate is set.
Demand valve systems: Designed to deliver 100% oxygen without contact with ambient air. Intended for short-term use only, in emergency situations.
Hyperbaric oxygen therapy: Performed in a specially designed pressurized chamber capable of maintaining pressures up to 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 can 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 a maximum internal pressure of approximately 200 bar. Pressure is regulated by a pressure reducer and displayed on the manometer. Multiplying the manometer reading by the cylinder’s volume in litres gives the amount of oxygen remaining in the cylinder.

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 is 21%, and it may be increased 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 hemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO₂).
Dosage must be individualized according to each patient’s 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, higher FiO₂ values, which may carry a potential risk of oxygen toxicity, may be indicated.
Continuous monitoring of therapy and ongoing assessment of therapeutic effect are essential, through measurement of PaO₂ or, alternatively, arterial oxygen saturation (SpO₂).
In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should be sufficient to 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.
For long-term treatment, the need for supplemental oxygen should be determined based on arterial blood gas measurements. To prevent excessive carbon dioxide accumulation, blood oxygen levels must be monitored to allow appropriate adjustment of oxygen therapy in patients with hypercapnia.
Low oxygen concentrations should be used in patients with respiratory failure whose respiratory drive depends on 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%.
Newborns may receive 100% oxygen when clinically indicated. However, careful monitoring during treatment is essential. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or lung collapse. Arterial oxygen pressure (PaO₂) should be monitored; however, if PaO₂ is maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Furthermore, the risk of eye damage can be minimized by avoiding marked fluctuations in oxygenation (see also Precautions for Use).

Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy refers to treatment with 100% oxygen at pressures exceeding 1.4 times atmospheric pressure at sea level (1 atm = 101.3 kPa = 760 mmHg). For safety reasons, pressures in hyperbaric oxygen therapy should not exceed 3 atm.
Oxygen must be administered in a hyperbaric chamber.
Treatment sessions in a hyperbaric chamber at pressures between 2 and 3 atmospheres (i.e., between 2.026 and 3.039 bar) last 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, in accordance with standard procedures, to avoid barotrauma to air-containing anatomical cavities communicating with the external environment.
Hyperbaric oxygen therapy must be administered by personnel qualified in this treatment.

Instructions for Use and Handling
Medicinal oxygen cylinders and fixed cryogenic containers are intended exclusively for the storage and transport of oxygen for inhalation, for therapeutic use.
Cylinders 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) for further details.
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.
Lift and move cylinders and base units only using the appropriate trolley. Never lift a cylinder by its valve.
Use only oxygen-compatible, specific connectors, connecting tubes, or flexible hoses.
Pay particular attention to the secure attachment of pressure regulators to cylinders, especially when not integrated into the container closure system, to prevent accidental dislodgement.
Do not lubricate or attempt to repair a defective valve. Oxygen liquefies at approximately -183°C. There is a risk of cold burns at such low temperatures. Always wear gloves and protective goggles when handling medicinal liquid oxygen.

General Instructions for Use
Cylinders equipped with a single 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 attach the flowmeter.
Connect the humidifier/bubbler.
Connect the nasal cannula with mask or goggles to the humidifier.
Slowly open the main valve fully.
Adjust the flowmeter to the required flow rate (litres/minute).

ATTENTION

Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps or valves during 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 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 compatible with the intended pressure and temperature conditions.

Disposal

Store empty cylinders with valves closed.
Do not discharge gas into sewers, basements, or pits where accumulation could be hazardous.
Return empty or unused containers, even if only partially empty, to the supplier. Any residual medicinal product remaining in the pressurized cylinder will be safely eliminated, via appropriate procedures, in a well-ventilated area by the company responsible for subsequent refilling of the container.

Observe all applicable rules for the use and handling of pressurized cylinders and containers holding cryogenic liquids.
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). Store them upright with valves closed, protected from rain and weather, direct sunlight, and away from heat or ignition sources and combustible materials. Empty containers or those containing other gases must be stored separately. It is strictly forbidden to touch frozen parts (for cryogenic containers). Cylinders must not be used if they show visible damage, if damage is suspected, or if they have been exposed to extreme temperatures.
Only equipment suitable and compatible with oxygen must be used for the specific container model. Fixed cryogenic containers installed in healthcare facilities must be placed outdoors.

Patient information leaflet

OXYGEN AIR LIQUIDE SANTE 200 BAR COMPRESSED MEDICINAL GAS

OXYGEN AIR LIQUIDE SANTE 300 BAR COMPRESSED MEDICINAL GAS
OXYGEN AIR LIQUIDE SANTE CRYOGENIC MEDICINAL GAS
Oxygen
Please read this leaflet carefully before using this medicinal product, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, consult your doctor or pharmacist.
This medicinal product has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OXYGEN AIR LIQUIDE SANTE is and what it is used for
What you need to know before using OXYGEN AIR LIQUIDE SANTE
How to use OXYGEN AIR LIQUIDE SANTE
Possible adverse reactions
How to store OXYGEN AIR LIQUIDE SANTE
Contents of the pack and other information

1. What OSSIGENO AIR LIQUIDE SANITÀ is and what it is used for

OSSIGENO AIR LIQUIDE SANITÀ contains oxygen, a gas naturally present in the air we breathe. Medical oxygen increases the amount of oxygen in the blood and its distribution to all body tissues.
OSSIGENO AIR LIQUIDE SANITÀ is indicated in patients of all ages:

for the treatment of acute and chronic respiratory failure.

2. What you should know before using OSSIGENO AIR LIQUIDE SANITÀ

There are no absolute contraindications.
Warnings and precautions
Consult your doctor or pharmacist before using OSSIGENO AIR LIQUIDE SANITÀ.
Before starting oxygen therapy, you should be aware of the following:

Oxygen may have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), which will hinder oxygen delivery into the blood.
If you have severe chronic obstructive pulmonary disease (COPD) resulting in impaired blood oxygenation, cystic fibrosis, pathological obesity, a deformity of the chest wall, a neuromuscular disorder, or a drug overdose that depresses respiration, supplemental oxygen administration may cause respiratory problems. In these cases, the oxygen concentration and oxygen flow rate will be low. Your doctor will adjust the oxygen flow rate of the oxygen therapy accordingly.
If you have pulmonary lesions due to bleomycin, the pulmonary toxicity of high-dose oxygen therapy—even if administered several years later—may exacerbate existing lung damage.
Adverse events may occur in newborns and preterm infants, such as eye damage. If your baby requires additional oxygen, your doctor will determine the appropriate oxygen concentration to administer.

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

Oxygen is an oxidizing agent and promotes combustion. In areas where OSSIGENO AIR LIQUIDE SANITÀ 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 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 leakage, immediately close the cylinder valve 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.
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 equipment may cause blockage of the outlet and/or incorrect readings on the pressure gauge display 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 medical oxygen. If liquid oxygen comes into contact with the skin or eyes, the affected areas must be washed thoroughly with large amounts of cold water or cold compresses applied; if such injuries occur, immediate medical assistance must be sought.

Children
In newborns and preterm infants, oxygen therapy may lead to eye damage (retinopathy of prematurity). Your doctor will determine the appropriate oxygen concentration to administer in order to ensure optimal treatment for your baby.
Other medicines and OSSIGENO AIR LIQUIDE SANITÀ
Inform your doctor or pharmacist if you are taking or have recently taken any other medicines. In particular, inform your doctor if you are taking:

catecholamines (e.g. adrenaline, noradrenaline), 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 cancer,
antimicrobial agents (e.g. nitrofurantoin), medicines used to treat bacterial infections,
antineoplastic antibiotics (e.g. actinomycin, adriamycin),
menadione-containing supplements,
medicines used to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine),
chloroquine, a medicine used to treat malaria. Also inform your doctor if:
you have recently undergone an X-ray examination,
you have been treated for paraquat poisoning (a herbicide),
you suffer from hyperthyroidism or deficiencies in vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

OSSIGENO AIR LIQUIDE SANITÀ and alcohol
Oxygen may worsen respiratory depression caused by alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
OSSIGENO AIR LIQUIDE SANITÀ may be used during pregnancy, but only when necessary. Inform your doctor if you are pregnant or suspect you may be pregnant.
OSSIGENO AIR LIQUIDE SANITÀ may be used during breastfeeding.
Driving and using machines
OSSIGENO AIR LIQUIDE SANITÀ does not affect or affects negligibly the ability to drive vehicles and operate machinery. Consult your doctor before driving vehicles or operating machinery.

3. How to use OSSIGENO AIR LIQUIDE SANITÀ

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor.
OSSIGENO AIR LIQUIDE SANITÀ is usually inhaled through the nose and mouth via a
nasal cannula or a face mask.
Your doctor will determine the dose based on your health condition.
During treatment with OSSIGENO AIR LIQUIDE SANITÀ, your doctor may perform
measurements of arterial blood gases and monitor oxygen levels bound to haemoglobin, a protein that carries oxygen in the blood.
If you use more OSSIGENO AIR LIQUIDE SANITÀ than you should
If you use more OSSIGENO AIR LIQUIDE SANITÀ than you should, contact your doctor or go to
hospital immediately.
An excessive dose of OSSIGENO AIR LIQUIDE SANITÀ may affect respiratory function (substernal pain, dry cough, interstitial edema, pulmonary fibrosis, shortness of breath) and, in rare cases, cause neurological adverse effects that could lead to loss of consciousness in extreme situations. If these signs of overdose occur, always contact your doctor or the nearest hospital.
In premature infants, eye problems (retinopathy) may occur.

4. Possible side effects

Like all medicines, OXYGEN AIR LIQUIDE SANITÀ can cause side effects,
although not everyone experiences them.
After approximately 4 hours of exposure to 95% oxygen at ambient atmospheric pressure, tracheobronchitis, substernal pain, and dry cough may occur. Exposure to 100%
oxygen may lead to a reduced total volume of expired air after 8–12 hours of exposure, but severe lesions require much longer exposure times.
Inhalation of high concentrations of oxygen may cause lung collapse (atelectasis) due to decreased nitrogen in the alveoli, compromising oxygen delivery to the blood.
Administration of excessively high oxygen concentrations may cause respiratory depression in cases of severe chronic obstructive pulmonary disease (COPD) or when taking medications that depress respiration (opioids, barbiturates).
The following are the side effects of Ossigeno Air Liquide Sanità:
Very common (may affect more than 1 in 10 people):
Retinopathy in premature infants
Frequency not known (frequency cannot be estimated from the available data):

pain related to breathing and dry cough, interstitial edema, pulmonary fibrosis
worsening of hypercapnia (excess carbon dioxide in body fluids, particularly in the blood) with hypoventilation, respiratory acidosis, respiratory arrest
dryness of the mucosa; local irritation and inflammation of the mucosa

Oxygen administration may cause a slight reduction in heart rate and cardiac output.
Contact with liquid oxygen causes cold burns.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You may 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 OSSIGENO AIR LIQUIDE SANITÀ

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 which is stated on the label after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicinal product into wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer used. This will help protect the environment.

6. Package contents and other information

What OSSIGENO AIR LIQUIDE SANITÀ contains

The active substance is oxygen.

Description of the appearance of OSSIGENO AIR LIQUIDE SANITÀ and package contents
Compressed medicinal gas (200 bar)
OSSIGENO AIR LIQUIDE SANITÀ compressed medicinal gas packaged in cylinders in the form of
compressed gas at 200 bar at 15°C. The cylinders are made of steel or aluminium alloy, equipped with
valves compatible with a pressure reducer or with integrated pressure-reducing valves.
Compressed medicinal gas (300 bar)
OSSIGENO AIR LIQUIDE SANITÀ compressed medicinal gas packaged in cylinders in the form of
compressed gas at 300 bar at 15°C.
The cylinders are composite and equipped with an integrated pressure-reducing valve.
Cryogenic medicinal gas
OSSIGENO AIR LIQUIDE SANITÀ cryogenic medicinal gas is packaged in mobile cryogenic
containers (base units).
Available pack sizes:
Compressed medicinal gas (200 bar)
Steel cylinders of 0.5, 1, 2, 3, 4, 5, 7, 10, 12, 14, 20, 27, 30 litres
Steel cylinders with integrated pressure-reducing valve of 1, 2, 3, 5, 7, 10, 11, 14, 20 litres
Aluminium cylinders of 2, 5, 7, 11, 14 litres
Aluminium cylinders with integrated pressure-reducing valve of 1, 2, 3, 5, 7, 10, 11, 14 litres
Aluminium cylinders with integrated TAKEO pressure-reducing valve of 2, 5, 11 litres
Aluminium cylinders with integrated XO-OYAN pressure-reducing valve with low-pressure outlet
connection NF of 2, 3, 5, 7, 10, 11, 14 litres
Aluminium cylinders with integrated XO-OYAN pressure-reducing valve with low-pressure outlet
connection UNI of 2, 3, 5, 7, 10, 11, 14 litres
Aluminium cylinders with integrated OYAN SMART pressure-reducing valve with low-pressure outlet
connection NF of 2, 5, 11 litres
Aluminium cylinders with integrated OYAN SMART pressure-reducing valve with low-pressure outlet
connection UNI of 2, 5, 11 litres
Compressed medicinal gas (300 bar)
Composite cylinders with integrated OYAN LIGHT pressure-reducing valve with low-pressure outlet
connection UNI of 2 litres
Composite cylinders with integrated OYAN LIGHT pressure-reducing valve with low-pressure outlet
connection NF of 2 litres
Cryogenic medicinal gas
Mobile cryogenic container of 20, 31, 32, 36, 44, 500, 700 litres
Not all pack sizes may be marketed.
Marketing Authorization Holder
AIR LIQUIDE ITALIA GAS e SERVIZI S.r.l.
Via Bisceglie, 66
20152 Milano
Manufacturer
Compressed medicinal gas 200 bar
Air Liquide Sanità Service SpA - Via Lussemburgo 17 – 37135 Verona
Air Liquide Sanità Service SpA - Via Campobello, 7 - 00071 Pomezia (RM)
SOL SpA – 4 Strada Z.I. Macchiareddu – 09032 Assemini (CA)
SOL SpA – Via Acquaviva, 4 - 26100 Cremona
SOL SpA – Via XVI Strada S.N.Z.I. – 95100 Catania
SOL SpA – Via Laurentina km 26,6 – 00071 Pomezia (RM)
SOL SpA – Via Belgio, 16 – 35100 Padova
SOL SpA – Zona Interconsortile Asi – 81025 Marcianise (CE)
Compressed medicinal gas 300 bar
Air Liquide Medical – Tolhuisstraat 46 – 2627 Schelle (Belgium)
Cryogenic medicinal gas (mobile containers)
Air Liquide Sanità Service SpA - Via Lussemburgo 17 – 37135 Verona
Vitalaire Italia S.p.A. – Via della Stazione, 2 – 81030 Gricignano d'Aversa (CE)
Vitalaire Italia S.p.A.– Viale F. de Blasio, 27 – 70100 Bari
Vitalaire Italia S.p.A. – Stradale Giovanni Agnelli, 10 – 95121 Catania
Vitalaire Italia S.p.A.– Via Masetti, 16 – 40069 Zola Predosa (BO)
Vitalaire Italia S.p.A.– Via Sernagiotto 1 Z.I. Casic – 09034 Elmas (CA)
Vitalaire Italia S.p.A.– Strada Statale 54, 53 – 33047 Remanzacco (UD)
Vitalaire Italia S.p.A.– Via Edison, 50 – 20090 Trezzano sul Naviglio (MI)
Vitalaire Italia S.p.A. – Via Postiglione, 12 – 10024 Moncalieri (TO)
Vitalaire Italia S.p.A. – Via Nino Savarese, 27 – 90100 Palermo
SOL SpA – 4 Strada Z.I. Macchiareddu – 09032 Assemini (CA)
SOL SpA – Via Acquaviva, 4 - 26100 Cremona
SOL SpA – Via XVI Strada S.N.Z.I. – 95100 Catania
SOL SpA – Via Laurentina km 26,6 – 00071 Pomezia (RM)
SOL SpA – Via Belgio, 16 – 35100 Padova
VIVISOL S.r.l. – Via Manin, 153 – 20099 Sesto San Giovanni (MI)

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 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 toxic after two days at concentrations exceeding 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 via pulse oximetry (arterial oxygen saturation – SpO₂), along with clinical assessment.
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, alveoli may collapse (atelectasis). This may impair arterial blood oxygenation, as gas exchange cannot occur despite 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.
Children
In newborns and premature infants, oxygen therapy may cause eye damage (retrolental fibroplasia). The risk of such eye damage can be reduced by appropriate selection of oxygen concentration by the physician.
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 using 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).
Numerous oxygen delivery devices exist, and they are classified as:

Low-flow systems: The simplest method for delivering an oxygen-enriched air mixture; for example, systems where oxygen is delivered via a flowmeter connected to a nasal cannula or face mask.
High-flow systems: Systems designed to meet the patient's total respiratory gas requirements. These systems deliver a constant, predetermined oxygen concentration that is not diluted by ambient air; an example is Venturi masks, where, once the oxygen flow is set, the air inspired 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 emergency situations.

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 can 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 an internal pressure of approximately 300 bar. This high pressure is regulated by a pressure reducer and is displayed on the pressure gauge. Multiplying the pressure gauge reading by the cylinder volume in litres gives the amount of oxygen still available in the cylinder.
With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate between 0.5 and 2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate between 0.5 and 15 litres/minute, adjustable according to blood gas analysis.
With assisted ventilation
The minimum FiO₂ is 21%, and it can 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 hemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO₂). The dose must be tailored to the individual patient's 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 pose a potential risk of oxygen toxicity may be indicated. Continuous monitoring of therapy and ongoing assessment of therapeutic effect are required, through repeated measurement of PaO₂ or, alternatively, arterial oxygen saturation (SpO₂).
In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should be sufficient to 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 by repeated arterial blood gas measurements (PaO₂) or transcutaneous oximetry, which provides a numerical value of hemoglobin oxygen saturation (SpO₂). In any case, these indices are only indirect measurements of tissue oxygenation. Clinical evaluation of treatment is of paramount importance. For long-term therapy, the need for supplemental oxygen must be determined from arterial blood gas measurements. To prevent 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 whose respiratory drive depends on 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%.
Instructions for use and handling
Medicinal oxygen cylinders, as well as 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 the instructions below:

Carefully read the instruction and user manual of the container (packaging) for further details.
Verify that all equipment is 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 fitted with a protective cap or shroud over the valve.
Lift and handle cylinders and base units using the appropriate trolley only; never lift a cylinder by the valve.
Use connectors, connecting tubes, or flexible hoses specifically designed and compatible with oxygen.
Particular attention must be paid to securing pressure reducers to cylinders, if not already integrated into the container closure system, to avoid accidental breakage.
Do not lubricate or attempt to repair defective valves/taps. Oxygen becomes liquid at approximately -183°C. There is a risk of cold burns at such low temperatures. Always wear gloves and protective goggles when handling medicinal liquid oxygen.

General instructions for use
Cylinders equipped only with 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 until fully open
Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped 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 until fully open
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)

WARNING

Open container closure systems (valve or tap) gradually 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 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 and contact the technical support 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.

Disposal

Store empty cylinders with valves closed.
Do not discharge into sewers, basements, or pits where accumulation could be hazardous.
Return empty or unused containers, even if only partially empty, to the supplier. Any residual medicinal product remaining in the pressurized cylinder will be safely eliminated through specific procedures in a well-ventilated area by the company responsible for refilling the container. Observe all applicable rules for the use and handling of pressurized cylinders and containers holding cryogenic liquids. Store cylinders and mobile cryogenic containers 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 weather, direct sunlight, and away from heat sources or ignition sources and combustible materials. Empty containers or those containing other types of gas must be stored separately. It is absolutely forbidden to touch frozen parts (for cryocontainers). 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 equipment suitable and compatible with oxygen for the specific container model may be used.