Oxygen Medigas Italia: detailed information

Package leaflet: Information for the user

OXYGEN MEDIGAS ITALIA 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read all of this leaflet carefully before you start using 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 they have the same symptoms as you, because it could be harmful.
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

1. What Ossigeno MEDIGAS ITALIA is and what it is used for

Ossigeno MEDIGAS ITALIA contains oxygen, a gas naturally present in the air we breathe.
Medical oxygen increases the amount of oxygen reaching the lungs and consequently the tissues.
Ossigeno MEDIGAS ITALIA is indicated in patients of all ages:

for the treatment of a respiratory disease (acute and chronic respiratory failure).

2. What you need to know before using OXYGEN MEDIGAS ITALIA

Normobaric oxygen therapy (administration of oxygen at atmospheric pressure levels) has no contraindications.
Warnings and precautions
Talk to your doctor or pharmacist before using OXYGEN MEDIGAS ITALIA.
Oxygen will be administered cautiously, adjusted according to your needs and at the lowest effective dose. If a higher dose is required, it will be given for the shortest possible duration and you will be monitored frequently.
Inform your doctor:

if you have respiratory insufficiency (a disease impairing gas exchange between air and blood);
if you are taking medicines for epilepsy (barbiturates) and/or pain (opioids) and have difficulty breathing;
if you have chronic obstructive pulmonary disease (COPD: a chronic lung disease with inflammation and narrowing of the bronchi);
if you have cystic fibrosis (a hereditary disease);
if you have severe obesity;
if you have a chest wall deformity;
if you have neuromuscular disorders (diseases affecting motor function);
if you have reduced respiratory capacity due to excessive intake of certain medications;
if you are being treated with bleomycin or have previously had lung problems caused by bleomycin;
if you suffer from thyroid problems (hyperthyroidism);
if you consume alcohol;
if you have recently undergone X-ray imaging;
if you have a deficiency in vitamin C, E, or glutathione (an antioxidant);
if the patient to be treated is a newborn.

Safety precautions
During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring the cylinder near open flames and/or heat sources.
Do not use any electrical equipment that may produce sparks near patients receiving oxygen.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen, and avoid contact of oils/fats with the cylinder.
Never introduce oxygen into any device that might contain materials capable of catching fire, especially greasy substances.

Children
In full-term and preterm newborns, oxygen therapy may cause eye damage (retinopathy of prematurity). The doctor will determine the appropriate oxygen concentration to ensure optimal treatment for your child.
Oxygen becomes liquid at approximately -183°C. At such low temperatures, 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 comes into contact with skin or eyes, the affected areas must be washed with large amounts of cold water or cold compresses applied; immediate medical assistance must be sought.
Other medicines and OXYGEN MEDIGAS ITALIA
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor if you are taking:

catecholamines (e.g. adrenaline, noradrenaline), medicines used in emergencies to treat severe 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,
antibiotics (e.g. actinomycin, nitrofurantoin), medicines used to treat bacterial infections,
menadione-based supplements (vitamin K),
medicines for mental disorders (e.g. promazine, chlorpromazine, thioridazine),
chloroquine, a medicine used to treat malaria,
nitric oxide (a medicinal gas used for pulmonary hypertension). Additionally, inform your doctor if you have been treated for paraquat poisoning (a herbicide).

OXYGEN MEDIGAS ITALIA and alcohol
Do not consume alcohol during treatment with OXYGEN MEDIGAS ITALIA, as oxygen may worsen respiratory depression (breathing difficulties) caused by alcohol.
Pregnancy, breastfeeding and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
OXYGEN MEDIGAS ITALIA may be used during pregnancy, but only when necessary.
Your doctor will prescribe OXYGEN MEDIGAS ITALIA only if clearly needed.
Breastfeeding
OXYGEN MEDIGAS ITALIA may be used during breastfeeding.
In all cases, you must inform your doctor if you are pregnant or suspect you may be pregnant.
Fertility
There are no known effects on male or female fertility following oxygen administration.
Driving and using machines
OXYGEN MEDIGAS ITALIA does not affect or affects negligibly the ability to drive vehicles and operate machinery.

3. How to use Ossigeno MEDIGAS ITALIA

Use this medicine exactly as instructed by your doctor or nurse. If you have any doubts, consult your doctor.
Ossigeno MEDIGAS ITALIA is administered through the inhaled air, via a nasal cannula or a facial mask.
The dose will be determined by your doctor based on your health condition.
During treatment with Ossigeno MEDIGAS ITALIA, your doctor may perform measurements of arterial blood gases and monitor levels of oxygen bound to haemoglobin, a protein that carries oxygen in the blood.

If you use more Ossigeno MEDIGAS ITALIA than you should
The toxic effects of oxygen vary depending on the pressure of the inhaled oxygen and the duration of exposure.
Symptoms of oxygen overdose (oxygen toxicity) include:

dry cough and chest pain,
sore throat,
breathing difficulties (dyspnoea, hypoventilation) and bluish skin discoloration (cyanosis),
damage to the bronchi and lungs,
interstitial oedema (fluid in the lungs),
pulmonary fibrosis (a respiratory disease characterized by the formation of scar tissue replacing normal lung tissue),
tracheobronchitis (inflammation of the trachea and bronchi),
uncoordinated movements,
tingling in the limbs,
visual and hearing disturbances,
nausea, dizziness,
anxiety and confusion, irritability,
muscle cramps and spasms, loss of consciousness,
uncontrolled body movements (convulsions), sometimes with loss of consciousness (epileptic seizures),
eye damage (retinopathy of prematurity) in premature infants,
respiratory depression and increased blood acidity in patients at risk of high carbon dioxide levels in the blood (hypercapnic respiratory failure).

In case of oxygen toxicity, oxygen therapy will be reduced and, if possible, discontinued, and symptomatic treatment will be initiated (treatment aimed at relieving symptoms will be started).

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
Very common (may affect more than 1 in 10 people):
Impairment of vision in newborns born prematurely (retinopathy of prematurity).
Frequency not known (frequency cannot be estimated from the available data):

Pulmonary toxicity characterized by:

✓ chest pain and dry cough (tracheobronchitis),
✓ presence of fluid in the lungs (interstitial edema),
✓ respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis)

Increase in carbon dioxide in the blood (hypercapnia), leading to:
✓ increase in acid levels in the blood (respiratory acidosis),
✓ reduced ventilation (hypoventilation),
✓ respiratory arrest
Dryness and irritation of mucous membranes (sinus congestion or obstruction with pain and bleeding)
Local irritation and inflammation of the mucosa

Other reported side effects:
✓ slight reduction in heart rate and strength of heartbeat
✓ small areas of the lung not properly ventilated (atelectasis)
✓ lung injuries
✓ dryness and irritation of the eyes
✓ slowed clearance of nasal secretions
✓ increase in antioxidant enzymes or endogenous antioxidant compounds.

Contact with liquid oxygen (contained in OSSIGENO MEDIGAS ITALIA GAS MEDICINALE CRIOGENICO) causes cold burns.

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:
http://www.agenziafarmaco.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 OXYGEN MEDIGAS ITALIA

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

6. Package contents and other information

What Ossigeno MEDIGAS ITALIA contains

The active substance is oxygen.

Description of the appearance of Ossigeno MEDIGAS ITALIA and package contents
Compressed medicinal gas (200 bar)
OSSIGENO MEDIGAS ITALIA compressed medicinal gas is supplied in cylinders in a compressed
gaseous state at 200 bar at 15°C. The cylinders are made of aluminum and/or steel, equipped with
valves suitable for connection to a pressure regulator or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO MEDIGAS ITALIA cryogenic medicinal gas is supplied in mobile cryogenic containers
(base units).

Available pack sizes:
Compressed medicinal gas (200 bar)
Aluminum cylinders with valve: 5, 15 litres.
Steel cylinders with valve: 5, 7, 14 litres.
Cryogenic medicinal gas
Cryogenic containers: 10.1, 10.7, 31, 41 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
MEDIGAS ITALIA S.R.L.
Via Edison, 6
Assago (MI)

Manufacturer*
Compressed medicinal gas 200 bar
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada Settimo, 342 – San Mauro Torinese (TO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via dei Lavoratori, 117 – Cinisello Balsamo (MI)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – S.S. 525 del Brembo, 1 – Osio Sopra (BG)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Rose, 13 – Brescia
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada al Monte d’Oro, 1 – Trieste
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via della Libertà, 17 – Ozzano nell’Emilia (BO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via G. Bruzzo, 4/M – Genova
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Viale D. Zaccagna, 37 – Avenza (MS)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Zona Industr. Loc. Tossillo – Macomer (NU)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Vitorchiano, 99 – Roma
NIPPON GASES INDUSTRIAL Srl – Via Pacinotti, 8 – Messina
NIPPON GASES PHARMA SUD srl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate case rosse – Zona ASI - Salerno
NIPPON GASES INDUSTRIAL Srl – Via Strada regionale Casilina 6, n.114 – Anagni (FR)
NIPPON GASES PHARMA Srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA Srl – Via Martino della Torre,16 – Novara

Cryogenic medicinal gas (mobile containers)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via della Libertà, 17 – Ozzano nell’Emilia (BO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada Settimo, 342 – San Mauro Torinese (TO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via dei Lavoratori, 117 – Cinisello Balsamo (MI)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – S.S. 525 del Brembo, 1 – Osio Sopra (BG)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Rose, 13 – Brescia
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Andorra, 13/15 Loc. Camin – Padova
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada al Monte d’Oro, 1 – Trieste
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via G. Bruzzo, 4/M – Genova
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Viale D. Zaccagna, 37 – Avenza (MS)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Zona Industr. Loc. Tossillo – Macomer (NU)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Vitorchiano, 99 – Roma
NIPPON GASES INDUSTRIAL Srl – Via Pacinotti, 8 – Messina
NIPPON GASES PHARMA SUD srl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate case rosse – Zona ASI – Salerno
NIPPON GASES INDUSTRIAL Srl – Via Strada regionale Casilina 6, n.114 – Anagni (FR)
NIPPON GASES PHARMA Srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA Srl – Via Martino della Torre,16 – Novara
T.S.A. S.A.S di Piani Alessandro Jr. e C. – Via Ezio Vanoni Snc 23037 – Tirano (SO)

*In the FI mock-up implemented in production, the list of sites actually shown will be limited to only those manufacturers active during the reference period.

The following information is intended exclusively for healthcare professionals:

Dosage, method, and duration of administration
Oxygen (compressed or cryogenic) is administered via the inhaled air, preferably using dedicated devices (such as, for example, a nasal cannula or a facial mask). The dosage delivered to the patient is regulated independently of the medicinal gas packaging, using metering devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while the expired gas and any excess oxygen leave the patient’s inspiratory circuit, mixing with the surrounding air (open system or anti-rebreathing system).
In anesthesia, a special system is often used that allows the patient to re-inhale previously exhaled gases (closed system or rebreathing system).
Oxygen may also be administered directly into the blood through an oxygenator, using a cardiopulmonary bypass system in cardiac surgery and in other cases requiring extracorporeal circulation.
There are numerous devices available for oxygen delivery, which can be categorized as follows:

Low-flow systems: This is the simplest system for delivering an oxygen-enriched gas mixture in the inspired air. An example is a system where oxygen is administered via a flowmeter connected to a nasal cannula or facial mask.
High-flow systems: Systems designed to provide the patient with a gas mixture that meets their total respiratory demand. These systems are designed to deliver stable and constant oxygen concentrations that are not influenced or diluted by the 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 concentration of oxygen.
Demand valve systems: Systems designed to deliver 100% oxygen without contact with ambient air. These are intended for short-term use only, and solely for emergency purposes.

Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air—i.e., containing an inspired oxygen fraction (FiO₂) greater than 21%—at a partial pressure between 0.21 and 1 atmosphere (0.213–1.013 bar).
In patients without respiratory insufficiency, oxygen can be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or appropriate masks.
In patients with respiratory insufficiency or under anesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders contain an internal pressure of approximately 124–200 bar. This high pressure is regulated by a pressure-reducing valve and can be read on the pressure gauge. Multiplying the gauge reading by the cylinder’s volume in liters gives the amount of oxygen remaining in the cylinder.
(Example: Calculation of content: a cylinder has a volume of 10 liters and the pressure gauge reads 200 bar; thus, the cylinder contains 2000 liters of oxygen. 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 insufficiency: administer oxygen at a flow rate of 0.5 to 2 liters/minute, adjustable according to blood gas analysis.
- Patients with acute respiratory insufficiency: administer oxygen at a flow rate of 0.5 to 15 liters/minute, adjustable according to blood gas analysis.
With assisted ventilation
The minimum FiO₂ concentration is 21%, and it can be increased up to 100%.
The therapeutic goal of oxygen therapy is to ensure that the arterial partial pressure of oxygen (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 dosage must be tailored to the individual needs of each patient.
The general recommendation is to use the lowest FiO₂ dose necessary to achieve the desired therapeutic effect—i.e., PaO₂ values within the normal range. In cases of severe hypoxemia, higher FiO₂ values may be indicated, even though they carry a potential risk of oxygen toxicity.
Continuous monitoring of therapy and ongoing assessment of therapeutic effect are essential, 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 an arterial partial pressure of oxygen (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., more than 60% oxygen in the inhaled gas mixture) whenever possible.
Short-term oxygen therapy must be monitored through 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 remains of paramount importance.
For long-term therapy, the need for supplemental oxygen must be determined based on arterial blood gas values. To avoid excessive carbon dioxide accumulation, blood oxygen levels must be monitored to allow proper adjustment of oxygen therapy in patients with hypercapnia.
Low oxygen concentrations should be used in patients with respiratory insufficiency in whom hypoxia is the primary respiratory drive (e.g., due to COPD). The oxygen concentration in the 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 can be increased up to 100%.
Neonates may receive 100% oxygen when clinically indicated. However, careful monitoring during treatment is essential. It is nevertheless 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 PaO₂ is 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 injury can be minimized by avoiding marked fluctuations in oxygenation (see also section 4.4).

Precautions for use
Oxygen must be administered cautiously, with adjustments based on individual patient needs. The lowest effective dose that maintains PaO₂ 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 durations:

Up to 100% for less than 6 hours
60–70% for 24 hours
40–50% during a subsequent 24-hour period

Oxygen is potentially toxic after two days at concentrations above 40%.
Low oxygen concentrations should be used in patients with respiratory insufficiency where hypoxia is the primary respiratory stimulus. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), pulse oximetry (arterial oxygen saturation – SpO₂), and clinical assessment.
Administering 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 blood carbon dioxide levels, which overrides the normal respiratory drive.
High oxygen concentrations in the air or in the inhaled gas reduce nitrogen concentration and partial pressure. This also reduces 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 blood oxygenation, as gas exchange is prevented 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.

SAFETY
Oxygen is an oxidizing agent and therefore supports combustion. In the presence of combustible materials such as fats (oils, lubricants) and organic substances (fabrics, wood, paper, plastics, etc.), oxygen can spontaneously ignite—due to an ignition source (spark, open flame, heat source) or as a result of adiabatic compression, which may occur in pressure-reducing equipment (regulators) during a sudden drop in gas pressure—leading to combustion. Therefore, all materials coming into contact with oxygen must be classified as compatible with the product under normal operating conditions.

Any oxygen delivery system or container must be kept away from heat sources due to oxygen’s oxidizing properties. Appropriate precautions must be taken both in hospital and home settings where medical oxygen is used.
Oxygen can cause the sudden ignition of smoldering materials or embers; therefore, smoking or using unshielded open flames near oxygen 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.
Do not use any electrical equipment that may produce sparks near patients receiving oxygen.
It is absolutely forbidden to tamper with container connections, delivery equipment, or their accessories or components (OIL AND GREASE CAN SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN).
Avoid any contact with oil, grease, or other hydrocarbons.
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 an oxygen-enriched environment, oxygen may saturate clothing.
It is absolutely forbidden to touch frozen parts (in cryogenic containers).
Cylinders and mobile cryogenic containers must not be used if visible damage is present 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 cylinder valves, to prevent damage.
In case of leakage, the cylinder valve must be closed immediately, 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.
Valves on empty cylinders must be kept 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.
Cylinders and base units must be secured in an upright position to prevent falling. Containers must be protected from impact and kept at temperatures below 50°C, with adequate ventilation in areas where the product is used. Cylinders must be equipped with a protective cap or tulip valve cover.
Cylinders and base units must be lifted and moved using only the designated trolley; cylinders must never be lifted by the valve.
Particular attention must be paid to the secure attachment of pressure-reducing regulators to cylinders, especially when not integrated into the container closure system, to prevent accidental breakage.

It is not permitted to administer pressurized gas.

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 completely
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 completely
Adjust the flowmeter to the required flow rate (litres/minute)

Mobile cryogenic containers

Ensure that 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 FURTHER DETAILS, CONSULT THE INSTRUCTION MANUAL OF THE CONTAINER
ATTENTION

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, but always on the opposite side. Do not expose yourself or the patient to the direct gas stream.
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 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.

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 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 the subsequent refilling of the same container.

Observe all applicable rules concerning 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 hyperoxic atmospheres (O₂ > 21% vol), in an upright position with valves closed and protected from rain and weather, direct sunlight, and kept away from heat or ignition sources and combustible materials. Empty containers or those containing other types of gas must be stored separately.