OSP

Patient Information Leaflet: Information for the Patient

OXYGEN DOMOLIFE 200 BAR MEDICINAL COMPRESSED 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, consult your doctor, pharmacist, or nurse.
If you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ossigeno Domolife is and what it is used for

Ossigeno Domolife contains oxygen, a gas naturally present in the air we breathe.
Medicinal oxygen increases the delivery of oxygen to all tissues of the body.
Ossigeno Domolife is indicated in patients of all ages:

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 treated,
in a hyperbaric chamber, a room where air pressure is higher than atmospheric pressure.

2. What you should know before you are given Ossigeno Domolife

Normobaric oxygen therapy
There are no absolute contraindications.

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

you suffer from a lung disease causing the formation of air bubbles in the lungs (bullous emphysema)
you suffer from asthma
you currently have or have previously had lung collapse (pneumothorax)
you suffer from a lung disease that makes it difficult to expel air from the lungs, shortness of breath (also called dyspnea), or a feeling of fatigue (COPD)
you suffer from lung inflammation (Pneumocystis carinii pneumonia)
you suffer from a disease characterized by uncontrollable body movements (epilepsy)
you are claustrophobic (fear of enclosed spaces)
you are in the first 3 months of pregnancy and do not have a serious illness
you have a 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 medications to treat tumors such as doxorubicin, adriamycin, bleomycin, daunorubicin, cis-platin (see section “Other medicines and Ossigeno Domolife”)
you are taking medications to treat inflammation such as corticosteroids (see section “Other medicines and Ossigeno Domolife”)
you are taking a medication to treat alcohol dependence (disulfiram) (see section “Other medicines and Ossigeno Domolife”)
you consume alcohol
you have recently been exposed to toxic substances (aromatic hydrocarbons)
you smoke or use nicotine-containing medications to help quit smoking
the newborn was premature.

Warnings and precautions
Talk to your doctor or nurse before you are given Ossigeno Domolife.
Inform your doctor:

if you suffer from a thyroid disease, a neck gland that is overactive (hyperthyroidism)
if you have a deficiency in vitamin C and/or vitamin E or a substance called glutathione (an antioxidant, i.e. one that counteracts aging)
if you have undergone treatment for paraquat poisoning (a herbicide)
if you consume alcohol
if you are taking medications to treat epilepsy (barbiturates) and/or pain (opioids)
if you suffer from airway inflammation that makes breathing difficult (Chronic Obstructive Pulmonary Disease, COPD)
if you suffer from specific diseases (e.g. COPD; cystic fibrosis, pathological obesity, chest wall deformities, neuromuscular disorders, respiratory depressant drug overdose), which may reduce sensitivity to carbon dioxide pressure in the blood or lead to increased carbon dioxide concentration in the blood (hypercapnic respiratory failure)
if you have sustained lung injury due to bleomycin use

Additionally, inform your doctor if you have recently undergone an X-ray.

Children:
In premature and full-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 the newborn for optimal treatment.

Hyperbaric oxygen therapy (HBOT)
The doctor will carefully evaluate whether to administer oxygen in a hyperbaric chamber based on the risk/benefit ratio if you have:

ear and/or nasal inflammation (recurrent otitis and/or sinusitis, laryngocele, mastoid cavity, vestibular syndrome, hearing loss, or recent middle ear surgery)
heart disease (ischemic and/or congestive cardiac conditions)
high blood pressure and are not taking medication to treat it (untreated arterial hypertension)
lung diseases that prevent air passage (restrictive and/or severely restrictive pulmonary diseases)
an eye disease characterized by high pressure of the fluid inside the eyes (glaucoma), or retinal detachment even if surgically treated (compensation maneuvers)
diabetes mellitus, as hyperbaric therapy may counteract the effect of insulin and increase your blood sugar levels (hyperglycemia)
uncontrolled high fever
severe anxiety, altered perception of reality (psychosis), fear of confined or enclosed spaces (claustrophobia)
respiratory system disorders (insufficiently controlled asthma, pulmonary emphysema, chronic obstructive bronchopneumopathy (COPD)), or recent thoracic surgery

Safety precautions
During transport, storage, and use of cylinders

Avoid contact of oils and greases with the cylinders: for example, do not touch the cylinders with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Do not use greasy creams or lipsticks.
Do not smoke in the area where cylinders are located, especially while oxygen is being administered to the patient.
Do not approach the cylinder with open flames or heat sources.
Do not use any electrical equipment that could produce sparks near patients receiving oxygen.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Do not touch frozen parts.
Use only equipment suitable and compatible with the specific container model.
Use only containers that show no visible damage or that have not been damaged or exposed to extreme temperatures.
Do not use pliers or other tools to open or close the cylinder valve.
Never introduce oxygen into a device that might contain materials that could ignite, particularly fatty substances.
In case of leakage, close the cylinder valve immediately if it is safe to do so; otherwise, move the cylinder to a safer outdoor location to allow oxygen to escape freely.
Close valves on empty cylinders.
Do not administer pressurized gas.

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.

Other medicines and Ossigeno Domolife
Inform your doctor or nurse 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. 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, adriamycin, actinomycin), medicines used to treat tumors
antibiotics and antimicrobial agents (e.g. 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

Ossigeno Domolife and alcohol
Do not consume alcohol during treatment with Ossigeno Domolife, as oxygen may worsen respiratory depression (difficulty breathing) caused by alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or nurse before taking this medicine.

Pregnancy
Normobaric oxygen therapy
Oxygen may be used during pregnancy only when necessary.

Hyperbaric oxygen therapy
Hyperbaric treatment is contraindicated during the first trimester of pregnancy. The doctor will decide whether to administer this treatment in case of critical conditions (e.g. severe carbon monoxide poisoning).

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

Driving and using machines
Normobaric oxygen therapy
Ossigeno Domolife does not affect, or affects only negligibly, the ability to drive and use machines.
Avoid driving and operating machinery until any adverse effects on attention and vigilance have completely disappeared.

Hyperbaric oxygen therapy
Visual and auditory disturbances that may affect the ability to drive and use machines have been reported after oxygen administration.
Avoid driving and operating machinery until any adverse effects on attention and vigilance have completely disappeared.

3. How Oxygen Domolife 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.
Oxygen Domolife is usually inhaled through the nose and mouth using a nasal cannula or a face mask.
The dose will be determined by your doctor based on your health condition.
During treatment with Oxygen Domolife, 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 Oxygen Domolife than you should
It is very unlikely that you will receive more Oxygen Domolife than required, as your doctor or nurse will monitor you during treatment.
Symptoms that could occur due to an overdose include:

sore throat,
cough and chest pain,
difficulty breathing (dyspnoea, hypoventilation) and bluish skin (cyanosis),
damage to the bronchi and lungs,
uncoordinated movements,
tingling in the limbs,
visual and hearing disturbances,
nausea, dizziness,
anxiety, confusion and 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 acid levels in the blood in patients at risk of high carbon dioxide concentration in the blood (hypercapnic respiratory failure).

Treatment
If you are given excessive doses, your doctor will provide appropriate therapy and monitor you closely.
In most patients, symptoms resolve within 4 hours after stopping treatment.

4. Possible side effects

Like all medicines, Ossigeno Domolife may cause side effects, although not everybody gets them.
Tissues show different sensitivity to hyperoxia, with the lungs, brain and eyes being the most sensitive.
The following are side effects associated with Ossigeno Domolife:

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

Eye damage (retinopathy of prematurity)

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

Pulmonary toxicity characterized by:
- airway infection characterized by substernal pain and dry cough (tracheobronchitis)
- fluid accumulation occurring in the tissues lining the lung alveoli (interstitial edema)
- respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis)
Increased carbon dioxide in the blood (hypercapnia), leading to:
- hypoventilation
- increased acid levels in the blood (respiratory acidosis)
- respiratory arrest
Dryness and irritation of mucous membranes (congestion or obstruction of the paranasal sinuses with pain and bleeding)
Local irritation and inflammation of the mucosa

Other reported side effects:

Mild reduction in heart rate and cardiac output.
Failure of lung expansion (atelectasis)
Lung injury
Dryness and irritation of the eyes
Slowed elimination of nasal secretions

Hyperbaric oxygen therapy:

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

Ear pain
Progressive myopia
Tissue injury caused by imbalance between the pressure of air contained in a body cavity and the surrounding environmental pressure (barotrauma), which may manifest as ear pain and possible bleeding, toothache, intestinal gas release (flatulence), or colic pain.

Common (may affect up to 1 in 10 people)

Uncontrolled body movements (seizures)

Uncommon (may affect up to 1 in 100 people)

Tympanic membrane perforation

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

Breathing difficulties (dyspnea)
Decreased blood glucose levels (hypoglycemia) in diabetic patients

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

Respiratory disorders
Involuntary muscle contractions (localized muscle spasms)
Dizziness (vertigo)
Ringing in the ears (tinnitus)
Hearing loss
Inflammation of the middle ear (acute serous otitis media)
Nausea
Abnormal behaviour
Reduced field of vision (decreased peripheral vision)
Blurred vision
Cataract

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 via the 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 Domolife

Store cylinders and mobile cryogenic containers 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 no longer required. This will help protect the environment.

6. Package Contents and Other Information

What Ossigeno Domolife Contains

The active substance is oxygen

Description of the Appearance of Ossigeno Domolife and Contents of the Package
Compressed medicinal gas
OSSIGENO Domolife compressed medicinal gas is supplied in cylinders and cylinder packs, in a
compressed gaseous state at 200 bar at 15°C. The cylinders are made of steel and equipped with valves compatible with pressure regulators.
Available pack sizes:
Compressed medicinal gas
Steel cylinders with valve, 40 litres; cylinder packs of 12 cylinders, 50 and 40 litres.

Marketing Authorization Holder
Nippon Gases Pharma S.r.l.
Via Benigno Crespi, 19
20159 Milan

Manufacturer
Compressed medicinal gas
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 del 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 dell’Emilia (BO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via G. Bruzzo, 4 – 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 PHARMA srl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate Case Rosse – Zona ASI – Salerno
NIPPON GASES INDUSTRIAL srl – Via Casilina, km 57,800 – Anagni (FR)
NIPPON GASES PHARMA srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA srl – Via Martino della Torre, 18 – Novara
NIPPON GASES INDUSTRIAL srl – Via Pacinotti, 8 – Messina

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 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 values.
Oxygen may 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 becomes potentially toxic after two days at concentrations exceeding 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 assessment.
Administering oxygen to patients with respiratory failure 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 receptor stimulation.
High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also reduces nitrogen levels in tissues and alveoli. If oxygen is absorbed into the blood through alveoli faster than it is replenished by ventilation, alveolar collapse (atelectasis) may occur. This impairs 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.

Patients at Risk of Hypercapnic Respiratory Failure:
Special 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 bronchopulmonary disease (COPD), cystic fibrosis, morbid obesity, thoracic wall deformities, neuromuscular disorders, or respiratory depressant drug overdose).
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 and worsen existing lung damage, even years after the initial bleomycin-induced lung injury. 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 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 haemorrhage. Neonatal resuscitation should begin with air rather than 100% oxygen in term or near-term infants. In preterm neonates, optimal oxygen concentration and targets are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.
In term and preterm neonates, administering oxygen at concentrations above 30-40% overwhelms endogenous antioxidant enzyme production, impairing the ability to counteract reactive oxygen species and their toxic effects. In such cases, the lowest effective oxygen concentration should be used, arterial oxygen pressure (PaO₂) should be closely monitored, and maintained below 13.3 kPa (100 mmHg).

Special Warnings

In hyperoxic environments, oxygen may saturate clothing.
Cylinders must not be used if visibly damaged or if damage is suspected, or if they have been exposed to extreme temperatures.
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 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 escape freely.
Valves of empty cylinders must remain closed.
Oxygen has a strong oxidizing effect 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.

Dosage, Method, and Duration of Administration
Compressed oxygen is administered via inhaled air using dedicated devices (e.g., nasal cannula or face mask). Dosage is delivered independently of the medicinal gas packaging via dosing devices (flowmeters).
With these systems, oxygen is delivered through inhaled air, while exhaled gas and excess oxygen exit the patient's inspiratory circuit, mixing with ambient air (open or anti-rebreathing system).
In anaesthesia, a special system allowing rebreathing of previously exhaled gas (closed or rebreathing system) is often used.
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 oxygen delivery devices exist, categorized as:

Low-flow systems: The simplest method for delivering an oxygen-air mixture, e.g., oxygen administered via a flowmeter connected to a nasal cannula or face mask.
High-flow systems: Designed to meet the patient's total respiratory gas requirements. These systems deliver a constant, predetermined oxygen concentration unaffected/diluted by ambient air, e.g., Venturi masks, where inspired air is enriched with a constant oxygen concentration once flow is set.
Demand valve systems: Designed to deliver 100% oxygen without contact with ambient air. Intended for short-term use only, in emergencies.
Hyperbaric oxygen therapy: Performed in a specially designed pressurized chamber where pressure can be maintained at 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 administration of an oxygen-enriched gas mixture (inspired oxygen fraction, FiO₂ > 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 anaesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders have an internal pressure of up to 200 bar. Pressure is regulated by a reducer and displayed on the pressure gauge. Multiplying the gauge reading by the cylinder's litre capacity gives the remaining oxygen volume available.

With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate of 0.5 to 2 litres/minute, adjustable based on blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 litres/minute, adjustable based on blood gas analysis.

With assisted ventilation
The minimum FiO₂ is 21%, and may rise up to 100%.
The therapeutic goal of oxygen therapy is to ensure arterial oxygen partial pressure (PaO₂) is not below 8 kPa (60 mmHg) or 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 severe hypoxaemia, FiO₂ levels that pose a potential risk of oxygen toxicity may be indicated.
Continuous therapy monitoring and ongoing assessment of therapeutic effect are required, via measurement of PaO₂ 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), avoiding FiO₂ > 0.6 (60% oxygen in the inhaled gas mixture) when possible.
Short-term oxygen therapy must be monitored via 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 measures of tissue oxygenation. Clinical evaluation of treatment is of paramount importance.
For long-term therapy, the need for supplemental oxygen must be determined by arterial blood gas measurements. To avoid excessive carbon dioxide accumulation, blood oxygen levels must be monitored to adjust oxygen therapy in hypercapnic patients.
Low oxygen concentrations must be used in patients with respiratory failure where hypoxia is the primary respiratory stimulus (e.g., due to COPD). Inspired oxygen concentration 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 essential. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or pulmonary collapse. Arterial oxygen pressure (PaO₂) must be monitored; keeping it below 13.3 kPa (100 mmHg) and avoiding significant oxygenation fluctuations reduces the risk of ocular damage. Additionally, the risk of ocular damage may be reduced by avoiding large oxygenation fluctuations (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.
Session duration in a hyperbaric chamber at pressures 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 to air-containing anatomical cavities communicating with the external environment.
Hyperbaric oxygen therapy must be performed by qualified personnel trained in this treatment.

Instructions for Use and Handling
Medicinal oxygen cylinders 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 container (package) instruction and user manual.
Verify that 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, ensuring adequate ventilation in areas where the product is used. Cylinders must be fitted with a protective cap/tulip over the valve.
Handle equipment with clean hands, free from grease or oil traces.
Lift and move cylinders and base units using the appropriate trolley only; never lift a cylinder by its valve.
Use only oxygen-specific, compatible connectors, connecting tubes, or flexible hoses.
Exercise extreme care when attaching pressure reducers to cylinders, especially if not integrated into the container closure system, to prevent accidental breakage.
Absolutely no intervention is permitted on container fittings, delivery equipment, or related accessories (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Do not oil or attempt to repair a defective valve.
Absolutely avoid handling equipment or components with greasy hands, clothing, or face, including creams and ointments.

General Instructions for Use
Cylinders equipped with simple 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 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 fully
Adjust the flowmeter to the required flow rate (litres/minute)

NOTE: FOR FURTHER DETAILS, CONSULT THE CONTAINER'S USER MANUAL
WARNING

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 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 notify the technical service of the supplier indicated in the container's user manual.
Use only containers suitable for the product and intended operating pressure and temperature. During use
Do not use greasy creams or lipsticks.
Do not smoke.
Keep open flames away from the container.
No electrical equipment capable of emitting sparks should be used near patients receiving oxygen.
Do not apply oils or grease to 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 partially filled, to the supplier. Any residual medicinal product in the pressurized cylinder will be safely eliminated through appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling.
Unused medicinal product and waste derived from this medicinal product must be disposed of in accordance with applicable local regulations.

Observe all relevant rules for the use and handling of pressurized cylinders.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated areas or well-ventilated sheds, avoiding formation of hyperoxic atmospheres (O₂ > 21% vol), in 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 gases must be stored separately.
RR

Package leaflet: Information for the patient

OXYGEN DOMOLIFE 200 BAR MEDICINAL COMPRESSED GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read this leaflet carefully before 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, consult 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 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 DOMOLIFE is and what it is used for
What you need to know before using OXYGEN DOMOLIFE
How to use OXYGEN DOMOLIFE
Possible side effects
How to store OXYGEN DOMOLIFE
Contents of the pack and other information

1. What Ossigeno DOMOLIFE is and what it is used for

Ossigeno DOMOLIFE contains oxygen, a gas naturally present in the air we breathe.
Medical oxygen increases the delivery of oxygen to all tissues of the body.
Ossigeno DOMOLIFE is indicated in patients of all ages:

for the treatment of respiratory disorders (acute and chronic respiratory insufficiency).

2. What you should know before using Ossigeno DOMOLIFE

Do not use Ossigeno DOMOLIFE
Under normal conditions, there are no absolute contraindications.
Warnings and precautions
Talk to your doctor or pharmacist before using Ossigeno DOMOLIFE.
Inform your doctor:

if you have a thyroid disease, a gland in the neck that is overactive (hyperthyroidism)
if you have a deficiency in vitamin C and/or vitamin E or in a substance called glutathione (an antioxidant, i.e. one that counteracts aging)
if you have undergone treatment for paraquat poisoning (a herbicide)
if you consume alcohol
if you are taking medicines to treat epilepsy (barbiturates) and/or pain (opioids)
if you suffer from airway inflammation making breathing difficult (Chronic Obstructive Pulmonary Disease, COPD)
if you have specific diseases (e.g. COPD; cystic fibrosis, pathological obesity, chest wall deformities, neuromuscular disorders, respiratory depressant drug overdose), which may reduce sensitivity to carbon dioxide pressure in the blood or lead to increased carbon dioxide concentration in the blood (hypercapnic respiratory failure)
if you have previously had lung injury caused by bleomycin use

Additionally, inform your doctor if you have recently undergone an X-ray examination.
Children
In premature infants and full-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 the newborn for optimal treatment.
Safety precautions
During transport, storage, and use of gas cylinders

Avoid contact of oils and greases with the cylinders: for example, do not touch the cylinders with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Do not use greasy creams or lipsticks.
Do not smoke in the area where the cylinders are located, especially while oxygen is being administered to the patient. Do not bring open flames or heat sources near the cylinder.
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 (OIL AND GREASE MAY SPONTANEOUSLY CATCH FIRE ON CONTACT WITH OXYGEN).
Use only equipment suitable and compatible with the specific cylinder model.
Use only containers that show no visible damage or that have not been damaged or exposed to extreme temperatures.
Do not use pliers or other tools to open or close the cylinder valve.
Never introduce oxygen into a device that might contain materials capable of catching fire, particularly fatty substances.
In case of leakage, close the cylinder valve immediately if it is safe to do so; otherwise, move the cylinder to a safer outdoor location to allow oxygen to escape freely.
Close the valves of empty cylinders.
Do not administer pressurized gas.

During transport, storage, and use of cryogenic oxygen

Liquid oxygen can cause cold burns.
If liquid oxygen comes into contact with the skin or eyes, wash the affected area with abundant cold water or apply cold compresses. Seek immediate medical attention.

Advice for caregivers:

Handle the cylinder carefully. Ensure 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 regarding residual oxygen content and flow, leading to insufficient or no oxygen delivery.
Oxygen liquefies at approximately -183°C. At such low temperatures, there is a risk of cold burns. Always wear protective gloves and eye protection when handling liquid medical oxygen.

Other medicines and Ossigeno DOMOLIFE
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor 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, actinomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea, adriamycin), medicines used to treat tumors,
antibiotics and antimicrobial agents (e.g. 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.

Ossigeno DOMOLIFE and alcohol
Do not consume alcohol during treatment with Ossigeno DOMOLIFE, as oxygen may worsen respiratory depression (difficulty breathing) caused by alcohol.
Pregnancy and breastfeeding
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 may be used during pregnancy, but only when necessary due to critical conditions or hypoxemia (inadequate blood oxygenation).
Breastfeeding
There are no contraindications for the use of oxygen during breastfeeding.
Driving and using machines
Ossigeno DOMOLIFE does not affect, or affects only negligibly, the ability to drive or use machinery.
Avoid driving and operating machinery until any adverse effects on attention and alertness have completely disappeared.

3. How to use Ossigeno DOMOLIFE

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
doubts, consult your doctor.
Ossigeno DOMOLIFE is usually inhaled through the nose and mouth via a nasal cannula
or a face mask.
The dose will be determined by your doctor based on your health condition.
During treatment with Ossigeno DOMOLIFE, your doctor may perform measurements
of arterial blood gases (oxygen and carbon dioxide) and monitor oxygen levels bound to
haemoglobin, a protein that carries oxygen in the blood.
If you use more Ossigeno DOMOLIFE than you should
If you use more Ossigeno DOMOLIFE than prescribed, contact your doctor or go to
hospital immediately.
Symptoms of an overdose you may experience are:

sore throat,
cough and chest pain,
difficulty breathing (dyspnoea, hypoventilation) and bluish skin (cyanosis),
damage to the bronchi and lungs,
uncoordinated movements,
tingling in the limbs,
visual and hearing disturbances,
nausea, dizziness,
anxiety and confusion,
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).

Treatment
If you have used excessive doses, your doctor will administer appropriate therapy and monitor you
closely.
In most cases, symptoms resolve after 4 hours of stopping treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Tissues show different sensitivity to hyperoxia, with the lungs, brain, and eyes being the most sensitive.
Side effects are usually observed with high concentrations and after prolonged treatment:

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

Eye damage (retinopathy of prematurity)

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

Pulmonary toxicity characterized by:
- airway infection characterized by pain behind the sternum and dry cough (tracheobronchitis)
- accumulation of fluid in the tissues lining the lung alveoli (interstitial edema)
- respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis)
Increased carbon dioxide in the blood (hypercapnia), leading to:
- hypoventilation
- increased acid levels in the blood (respiratory acidosis)
- respiratory arrest
Dryness and irritation of mucous membranes (congestion or obstruction of the paranasal sinuses with pain and bleeding)
Local irritation and inflammation of the mucosa

Other reported side effects:

Slight reduction in heart rate and cardiac output.
Failure of lung expansion (atelectasis)
Lung injuries
Dryness and irritation of the eyes
Slowed clearance of nasal secretions

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 via the 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 DOMOLIFE

Store cylinders and mobile cryogenic containers 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 Ossigeno DOMOLIFE Contains

The active substance is oxygen.

Description of the Appearance of Ossigeno DOMOLIFE and Contents of the Package
Compressed medicinal gas (200 bar)
Ossigeno DOMOLIFE compressed medicinal gas is supplied in cylinders as compressed gas at 200 bar pressure at 15°C. The cylinders are made of steel and equipped with valves compatible with pressure regulators or with integrated pressure-reducing valves.
Cryogenic medicinal gas
Ossigeno DOMOLIFE cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas (200 bar)
Steel cylinders with valve of 0.5, 3, 5, 7, 10, 14, 20, 27, 30 litres.
Cryogenic medicinal gas
Mobile cryogenic container of 10.7, 25, 31, 37, 41, 45 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
Nippon Gases Pharma S.r.l.
Via Benigno Crespi, 19
20159 Milano

Manufacturer
Compressed medicinal gas (200 bar) and cryogenic medicinal gas (mobile containers)
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 del 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 G. Bruzzo, 4 – 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, 97/99 – Roma
NIPPON GASES PHARMA SUD srl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate Case Rosse – Zona ASl – Salerno
NIPPON GASES INDUSTRIAL srl – Via Casilina, km 57.800 – Anagni (FR)
NIPPON GASES PHARMA srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA srl – Via Martino della Torre, 18 – Novara
NIPPON GASES INDUSTRIAL srl – Via Pacinotti, 8 – Messina
Compressed medicinal gas (200 bar)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via della Libertà, 17 – Ozzano dell’Emilia (BO)
Cryogenic medicinal gas (mobile containers)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Andorra, 13/15 Loc. Camin – Padova

The following information is intended exclusively for healthcare professionals:
Precautions for Use
Oxygen must be administered with caution, adjusted 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 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 hypoxia is the primary respiratory drive. In such cases, careful monitoring is required, including measurement of arterial oxygen tension (PaO₂), pulse oximetry (arterial oxygen saturation – SpO₂), and clinical assessment.

Administration of 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 stimulation.

High oxygen concentrations in 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 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 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.

Patients at Risk of Hypercapnic Respiratory Failure:
Special precautions are required 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 bronchopulmonary disease (COPD), cystic fibrosis, morbid obesity, chest wall deformities, neuromuscular disorders, or respiratory depressant drug overdose).
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 initial lung injury 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 oxygen concentration should be administered 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 are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.
In term and preterm newborns, administration of oxygen at concentrations above 30–40% may impair endogenous antioxidant enzyme production, resulting in inability to counteract reactive oxygen species and their toxic effects. In such cases, the lowest effective oxygen concentration should be administered, arterial oxygen pressure (PaO₂) should be closely monitored, and maintained below 13.3 kPa (100 mmHg).

Special Warnings

In hyperoxic environments, oxygen may saturate clothing.
Contact with cold surfaces (for cryogenic containers) is strictly prohibited.
Cylinders and mobile cryogenic containers must not be used if visibly damaged, suspected of damage, or exposed to extreme temperatures.
Only oxygen-compatible and suitable equipment 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 safe to do so. 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 has a strong oxidizing effect and may react violently with organic substances. Therefore, special precautions are required during handling and storage of containers.
Depressurization of gas under pressure is not permitted.

For the cryogenic formulation
Cold burns from direct contact with liquid oxygen
Oxygen liquefies at approximately -183°C. At such low temperatures, direct contact of liquid oxygen with skin or mucous membranes may cause cold burns. Appropriate safety precautions must be taken when handling cryogenic containers: suitable protective clothing (gloves, goggles, loose clothing, and pants covering shoes) must be worn. If liquid oxygen contacts skin or eyes, the affected areas must be washed with copious amounts of cold water or cold compresses applied, and 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). Dosage is delivered independently of the medicinal gas packaging via dosing devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while exhaled gas and excess oxygen exit the patient's inspiratory circuit and mix with ambient air (open 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) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213–1.013 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 200 bar pressure. This high pressure is regulated by a pressure reducer, and the pressure is indicated on the manometer. Multiplying the manometer reading by the cylinder 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.

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 lung collapse. Arterial oxygen pressure (PaO₂) should be monitored; maintaining levels below 13.3 kPa (100 mmHg) and avoiding significant fluctuations in oxygenation reduces the risk of ocular damage. Additionally, the risk of ocular damage may be reduced by avoiding marked fluctuations in oxygenation (see also Precautions for Use).

Instructions for Use and Handling
Medicinal oxygen cylinders and 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 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/tulip over the valve.
Handle equipment 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 hoses.
Exercise extreme caution when attaching pressure regulators to cylinders, especially if not integrated into the container closure system, to prevent accidental breakage.
Absolutely no intervention of any kind is permitted on delivery equipment and related accessories or components (OIL AND GREASE MAY IGNITE IN CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves/taps.
Do not handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Contact with cold parts (for cryogenic containers) is strictly prohibited.

General Instructions for Use
Cylinders equipped 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 attach the 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 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 CONTAINER’S USER MANUAL
WARNING

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 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 compatible with the required pressure and temperature conditions.

During Use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames near the container.
No electrical equipment capable of producing sparks should be used 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 medicinal product in the pressurized cylinder will be safely eliminated via appropriate procedures in a well-ventilated area by the company responsible for refilling.
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 holding cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated areas or ventilated sheds, avoiding the formation of hyperoxic atmospheres (O₂ > 21% vol). Keep them upright with valves closed, protected from rain and weather, direct sunlight, heat sources, ignition sources, and combustible materials. Empty containers or those containing other gases must be stored separately.