Oxygen Sapio Life: detailed information

PACKAGE LEAFLET

Package leaflet: information for the patient

OXYGEN SAPIO LIFE 200 BAR COMPRESSED MEDICINAL GAS, 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 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 adverse reactions, including those not listed in this leaflet, consult your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OXYGEN SAPIO LIFE is and what it is used for
What you need to know before using OXYGEN SAPIO LIFE
How to use OXYGEN SAPIO LIFE
Possible adverse reactions
How to store OXYGEN SAPIO LIFE
Contents of the packaging and other information

1. What Ossigeno SAPIO LIFE is and what it is used for

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

in the treatment of acute and chronic respiratory failure, in anaesthesia, in intensive care therapy, and in hyperbaric chamber treatment.

2. What you should know before using Ossigeno SAPIO LIFE

You will not be given Ossigeno SAPIO LIFE in a hyperbaric chamber if:

you suffer from a lung disease causing the formation of lung bubbles (bullous emphysema);
you suffer from progressive asthma;
you have collapse of a lung (pneumothorax);
you suffer from a chronic lung condition characterized by slow airway obstruction (chronic obstructive bronchopulmonary disease - COPD);
you suffer from lung inflammation (Pneumocystis carinii pneumonia);
you suffer from a disease characterized by uncontrolled body movements (epilepsy);
you have fear of enclosed spaces (claustrophobia);
you are in the first 3 months of pregnancy and do not have a serious illness;
you have an upper respiratory tract infection;
you have heat stroke (hyperthermia);
you suffer from a red blood cell disorder, a type of blood cell (hereditary spherocytosis);
you suffer from a disease of the optic nerve (optic neuritis);
you suffer from malignant tumors;
you have high levels of acids in the blood (acidosis);
you are taking medicines to treat tumors such as doxorubicin, adriamycin, daunorubicin, bleomycin, cisplatin (see section “Other medicines and Ossigeno SAPIO LIFE”);
you are taking anti-inflammatory medicines such as corticosteroids (see section “Other medicines and Ossigeno SAPIO LIFE”);
you are taking a medicine to treat alcohol dependence (disulfiram) (see section “Other medicines and Ossigeno SAPIO LIFE”);
you consume alcohol;
you have recently been exposed to toxic substances (aromatic hydrocarbons);
you smoke or take nicotine-based medications to help quit smoking;
the newborn was premature.

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

if you are taking medicines to treat epilepsy (barbiturates) and/or pain (opioids);
if you have lung damage caused by a medicine called bleomycin (used for certain tumors);
if you have difficulty breathing due to certain conditions, e.g.: a chronic lung condition characterized by slow airway obstruction (chronic obstructive bronchopulmonary disease - COPD), cystic fibrosis (a serious genetic disease), genetic overweight (pathological obesity), deformity of the chest wall, neuromuscular diseases (nervous system or muscle damage manifesting as reduced muscle strength or muscle paralysis), overdose of medicines causing severe breathing problems. The doctor will evaluate whether to administer oxygen in a hyperbaric chamber if:
you suffer from recurrent inflammation of the ears and/or nose (recurrent otitis and/or sinusitis);
you suffer from heart disease (ischemic and/or congestive heart disease);
you suffer from high blood pressure and are not taking medication for it (untreated arterial hypertension);
you suffer from lung diseases that prevent air passage (restrictive and/or highly restrictive lung diseases);
you suffer from an eye disease characterized by high pressure of the fluid inside the eyes (glaucoma), or retinal detachment, a membrane of the eye;
you suffer from diabetes mellitus, as hyperbaric therapy may counteract the effect of insulin and increase your blood sugar levels (hyperglycemia).

Safety precautions
During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not approach the container with open flames.
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.
Never introduce oxygen into a device that might contain materials capable of catching fire, particularly fatty substances.

Children
In newborns, the doctor will administer the lowest effective oxygen concentration to avoid possible adverse effects that may occur following oxygen administration in newborns, such as visual defects (retinopathy), chronic lung diseases, or bleeding within the brain (intraventricular hemorrhage).
Other medicines and Ossigeno SAPIO LIFE
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. epinephrine, norepinephrine), medicines that affect multiple body organs and are generally used for emergency treatment of sudden allergic reactions;
corticosteroids (e.g. dexamethasone, methylprednisolone), medicines to treat inflammation;
hormones (e.g. testosterone, thyroxine);
amiodarone, a medicine to treat heart rhythm disorders;
chemotherapeutic agents (e.g. bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines to treat tumors;
antimicrobial agents (e.g. nitrofurantoin), medicines to treat germ infestations;
antibiotics (e.g. actinomycin, nitrofurantoin), medicines to treat infections;
menadione-based supplements;
medicines to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine);
chloroquine, a medicine to treat malaria.

Also inform your doctor if:

you have recently undergone an X-ray;
you suffer from a thyroid gland disease of the neck that is overactive (hyperthyroidism);
you suffer from deficiency of vitamin C and/or E or of a substance called glutathione (an antioxidant, i.e. one that counteracts aging);
you have undergone treatment for paraquat poisoning (a herbicide);
you consume alcohol.

Ossigeno SAPIO LIFE and alcohol
Do not consume alcohol during treatment with Ossigeno SAPIO LIFE.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, Ossigeno SAPIO LIFE should be used only if absolutely necessary and after evaluation of the benefit-risk ratio by your doctor.
Ossigeno SAPIO LIFE is contraindicated in the first three months of pregnancy in a hyperbaric chamber.
The use of hyperbaric therapy during pregnancy may induce oxidative stress with potential harm to the fetus. In cases of severe carbon monoxide poisoning, the doctor will assess the benefit-risk balance.
Ossigeno SAPIO LIFE may be used during breastfeeding.
Driving and use of machines
Ossigeno SAPIO LIFE does not alter or alters negligibly the ability to drive or operate machinery.
If the medicine is administered in a hyperbaric chamber, visual and hearing disturbances may occur that could affect the ability to drive or operate machinery. In this case, do not drive or operate machinery until symptoms have completely resolved.

3. How to use Ossigeno SAPIO LIFE

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor.
Ossigeno SAPIO LIFE is usually inhaled through the nose and mouth via a nasal cannula
or a mask; the dosage is administered using dosing devices (flowmeters).
Your doctor will determine the appropriate dose based on your health condition.
During treatment with Ossigeno SAPIO LIFE, your doctor may perform measurements
of arterial blood gases and monitor levels of oxygen bound to haemoglobin, a protein that
transports oxygen in the blood.

Use in newborns
In newborns, your doctor will administer the lowest effective oxygen concentration to avoid
potential adverse effects that may occur following oxygen administration in newborns (visual defects, chronic lung diseases, bleeding within the brain).

If you use more Ossigeno SAPIO LIFE than you should
If you use more Ossigeno SAPIO LIFE than you should, contact your doctor or go to hospital
immediately.
Symptoms of overdose that you may experience include:

hyperoxia,
inflammation of the trachea and bronchi (tracheobronchitis),
interstitial edema,
pulmonary fibrosis.

Symptoms of overdose that may occur following hyperbaric chamber therapy include:

ringing in the ears (tinnitus),
disturbances of vision and hearing,
localized muscle spasms (particularly in eyes, mouth, forehead),
nausea, dizziness,
anxiety, confusion, irritability,
loss of consciousness,
uncontrolled body movements (convulsions).

In premature newborns, a high oxygen concentration may cause visual damage (retinopathy of prematurity).
If you are a patient at risk of respiratory insufficiency, the administration of supplemental oxygen
may cause serious breathing problems (respiratory depression), increased blood acidity
(respiratory acidosis), and reduced or stopped breathing (respiratory arrest).

Treatment
If you have used excessive doses, your doctor will administer appropriate treatment and monitor you closely.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are the side effects of OXYGEN SAPIO LIFE. There are insufficient data available to determine the frequency of the individual listed effects.
The tissues most sensitive to this medicine are the lungs, brain and eyes.

Effects related to respiration:

inflammation of the trachea and bronchi (tracheobronchitis);
chest pain;
dry cough;
atelectasis due to decreased nitrogen in the alveoli and the direct effect of oxygen on alveolar surfactant;
mixing within the lung of blood rich in carbon dioxide with blood rich in oxygen (intrapulmonary shunt);
worsening of respiratory problems in patients affected by respiratory depression induced by medicines (opioids, barbiturates) or by chronic obstructive bronchopulmonary diseases (COPD).

Effects related to the nervous system:

visual disturbances (blurred vision, decreased peripheral vision);
ringing in the ears (tinnitus);
respiratory disturbances;
localized muscle spasms (particularly of the eyes, mouth and forehead);
dizziness and nausea;
changes in behaviour (anxiety, confusion, irritability);
decreased level of consciousness (up to loss of consciousness);
side effects caused by excessive oxygen administration are reversible and do not cause any neurological damage, disappearing when the partial pressure of inspired oxygen is reduced.

Side effects related to hyperbaric oxygen therapy (hyperbaric oxygen therapy - HBOT):

confinement anxiety (due to the relatively small size of some hyperbaric chambers, not due to a direct effect of oxygen).

Side effects related to ocular toxicity:

progressive visual damage (progressive myopia) in cases of multiple hyperbaric treatments.

Side effects in children:

lung diseases (bronchopulmonary dysplasia, pulmonary fibrosis, up to inability to maintain adequate respiration). In newborns, particularly premature infants:
temporary or permanent eye damage (retinopathy of prematurity) in newborns (particularly premature infants) exposed to high oxygen concentrations or for prolonged periods.

Risk of burns

thermal burns (the risk of fire increases in the presence of high oxygen concentrations and sources of ignition);
cold burns (in case of direct contact with liquid oxygen).

The following side effects (with their respective frequencies) are associated with normobaric oxygen therapy:

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

temporary or permanent visual damage (retinopathy of prematurity) in newborns (particularly premature infants) exposed to high oxygen concentrations or for prolonged periods.

Respiratory, thoracic and mediastinal disorders
Not known (frequency cannot be estimated from the available data):

inflammation of the trachea and bronchi (tracheobronchitis);
chest pain;
dry cough;
interstitial edema (swelling);
pulmonary fibrosis;
severe respiratory problems (respiratory depression), increased blood acidity (respiratory acidosis) and cessation of breathing (respiratory arrest) in patients with long-term diseases associated with oxygen deficiency.

General disorders and administration site conditions
Not known (frequency cannot be estimated from the available data):

dryness and irritation of the mucous membranes of the airways.

The following side effects (with their respective frequencies) are associated with hyperbaric oxygen therapy:

Respiratory, thoracic and mediastinal disorders
Rare (may affect up to 1 in 1,000 people):

difficulty breathing (dyspnea).

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

respiratory disturbances.

Nervous system disorders
Common (may affect up to 1 in 10 people):

uncontrolled body movements (convulsions).

Musculoskeletal and connective tissue disorders
Not known (frequency cannot be estimated from the available data), including:

localized muscle spasms.

Ear and labyrinth disorders
Very common (may affect more than 1 in 10 people):

ear pain.

Uncommon (may affect up to 1 in 100 people):

perforation of the tympanic membrane.

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

dizziness;
hearing loss;
acute serous otitis media (acute infection of the middle ear in which a serous collection forms and becomes infected by bacteria or viruses originating from the nasopharynx);
ringing in the ears (tinnitus).

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

nausea.

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

abnormal behaviour.

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

progressive visual damage (progressive myopia) in cases of multiple hyperbaric treatments.

Side effects with frequency not known (frequency cannot be estimated from the available data), including:

visual disturbances (blurred vision, decreased peripheral vision);
cataract.

Injury, poisoning and procedural complications
Very common (may affect more than 1 in 10 people):

tissue injury caused by imbalance between the pressure of air contained in a body cavity and the pressure of the surrounding environment (barotrauma), which may manifest as pain and possible bleeding from the ear (with risk of swelling or rupture of the tympanic membrane), damage to the paranasal sinuses, lung damage, toothache.

Metabolism and nutrition disorders
Rare (may affect up to 1 in 1,000 people):

hypoglycaemia (low blood sugar levels) in diabetic patients.

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 national reporting system at the following website: http://www.agenziafarmaco.gov.it/come-segnalare-una-reazione-avversa . By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ossigeno SAPIO LIFE

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

6. Package contents and other information

What Ossigeno SAPIO LIFE contains

The active substance is 100% oxygen.

Description of the appearance of Ossigeno SAPIO LIFE and contents of the package
Compressed medicinal gas
OSSIGENO SAPIO LIFE compressed medicinal gas is supplied in cylinders in compressed gaseous form at 200 bar at 15°C. The cylinders are made of steel or aluminium alloy and are equipped with valves compatible with pressure regulators or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO SAPIO LIFE cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas
Steel cylinders of 0.5, 1, 2, 3, 5, 7, 10, 14, 20, 27 litres; aluminium cylinders of 0.5, 1, 2, 3, 5, 7, 10, 14, 20 litres.
Steel cylinders with integrated pressure-reducing valve of 0.5, 1, 2, 3, 5, 7, 10, 14, 20, 27 litres; aluminium cylinders with integrated pressure-reducing valve of 0.5, 1, 2, 3, 5, 7, 10, 14 litres.
Cryogenic medicinal gas
Mobile cryogenic containers of 10, 21, 31, 32, 36, 41, 46, 160, 180, 230 litres.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SAPIO LIFE S.r.l
Via Silvio Pellico, 48
Monza (MB)

Manufacturer
Compressed medicinal gas and cryogenic medicinal gas (mobile containers)
Sapio Produzione Idrogeno Ossigeno srl – Via De Amicis, 140 – 10093 Collegno (TO)
Sapio Produzione Idrogeno Ossigeno srl – Via Senatore Simonetta 27 – 20867 Caponago (MB)
Sapio Produzione Idrogeno Ossigeno srl – Corso Stati Uniti 21 – 35100 Padova (PD)
Sapio Produzione Idrogeno Ossigeno srl – Via P. Belizzi 77/79 – 29100 Piacenza (PC)
Sapio Produzione Idrogeno Ossigeno srl – Loc. Poggio Bagnoli – 52020 Pergine Valdarno (AR)
Sapio Produzione Idrogeno Ossigeno srl – Contrada Camera 90/A – 63023 Fermo (AP)
Sapio Produzione Idrogeno Ossigeno srl – Via Metaponto, 8700 – 74123 Taranto (TA)
Sapio Produzione Idrogeno Ossigeno srl – Località Passo Vecchio – 88074 Crotone (KR)
Sapio Produzione Idrogeno Ossigeno srl – Via Enrico Alberto D’Albertis 25 – 07046 Porto Torres (SS)
Puglia Life S.r.l. – Zona Industriale P.I.P. Lotto Nr. 5 – 72023 Mesagne (BR)
Oxygen Center Di Coluccia Giuseppina &C S.A.S. – Zona Artigianale – 73028 Otranto (LE)
Salentossigeno Srl – Via Veglie – Zona Artigianale – 73045 Leverano (LE)
Utengas srl – Via Marconi 56/58 – 24040 Comun Nuovo (BG)
Medical Gas Criogenici srl - Viale Delle Industrie, Snc - Zona Industriale ASI - 92021 Aragona (AG)
Oxyplus srl – Via Maremmana Inferiore km. 0.5 Fraz. Villa Adriana – 00019 Tivoli (RM)
Eubios srl – Via Linara 3 – 82030 Limatola (BN)
Oxy Live srl – Via Nuova del Bosco km. 2 – 80034 Marigliano (NA)
Giannitrapani srl – 1° Dorsale, 8 Z.I.R. – 91100 Trapani (TP)
Giannitrapani srl – Via Ugo La Malfa – Contrada Cutelli – 90014 Casteldaccia (PA)
CER Medical S.r.l. – Via Torretta, 13 – 40012 – Calderara di Reno (BO)
MEDICAIR CENTRO S.r.l. - Via della Magliana, 1098/1102 - 00100 - Roma (RM)
CRIOSERVICE SRL - Via Madre Teresa di Calcutta (loc. Zona Commerciale Signora Porzia) 74045 - Leverano (LE)
Cryogenic medicinal gas (mobile containers)
T.S.A. S.A.S. Di Piani Alessandro Jr. E C. – Via Ezio Vanoni S.N.C. – 23037 Tirano (SO)
Di Maio Carmine – Contrada San Cataldo – 87010 Castrovillari (CS)
Agenzia KAPPA SAS di Fiore Paola E C. - Contrada Gabella S.N.C.- 85050 – Tito (PZ)
SAPIO PLINI d.o.o. - Bukovžlak 107, Teharje, Celje, 3000, Slovenia

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Oxygen must be administered cautiously, with adjustments according to the individual patient's needs. The lowest effective dose that maintains arterial oxygen pressure at 8 kPa (60 mm Hg) 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%: less than 6 hours
60-70%: 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 main respiratory drive. In such cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂) and clinical assessment.
High oxygen concentrations in the air or inhaled gas reduce nitrogen concentration and partial pressure. This also reduces nitrogen concentration in tissues and lungs (alveoli). If oxygen is absorbed into the blood through the alveoli faster than it is supplied by ventilation, alveolar collapse (atelectasis) may occur. This may 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.
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, chest wall deformities, neuromuscular disorders, respiratory depressant drug overdose). Administration of supplemental oxygen may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.
Special precautions in patients with bleomycin-induced lung injury
Pulmonary toxicity from high-dose oxygen therapy may exacerbate lung injury, even years after the initial lung damage caused by bleomycin, and the target oxygen saturation may need to be lower than in other patients. (See section “Other medicines and Ossigeno SAPIO LIFE”).
Paediatric population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective oxygen concentration should be administered to achieve adequate oxygenation in neonates.
In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity (see section “Possible side effects”), chronic lung disease, and intraventricular haemorrhage. It is recommended to initiate resuscitation of term or near-term neonates with air rather than 100% oxygen. In preterm neonates, the optimal oxygen concentration and target oxygen levels are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.
Hyperbaric oxygen therapy (HBOT)
Administration of oxygen in a hyperbaric chamber must be carefully evaluated based on the benefit/risk ratio in cases of:

Recurrent otitis and/or sinusitis, laryngocele, mastoid cavities, vestibular syndrome, hearing loss, and recent middle ear surgery
Ischemic and/or congestive cardiac diseases; in patients with acute coronary syndrome or acute myocardial infarction who also require hyperbaric therapy (e.g. in CO poisoning), hyperbaric treatment must be performed cautiously due to potential vasoconstriction from hyperoxia in the coronary circulation
Untreated arterial hypertension
Severe restrictive and/or obstructive lung diseases
Glaucoma, retinal detachment (even if surgically treated) (compensation maneuvers)
History of seizures, epilepsy
Uncontrolled high fever
Severe anxiety, psychosis, claustrophobia

Patients with diabetes mellitus
Hyperbaric therapy may interfere with glucose metabolism. The vasoconstrictive effects of hyperbaric therapy may also impair subcutaneous insulin absorption, leading to hyperglycaemia.
Blood glucose monitoring between hyperbaric therapy sessions may be considered.
Respiratory disorders
Due to decompression, at the end of a hyperbaric session, gas volume increases as pressure in the chamber decreases, potentially causing partial pneumothorax or worsening of an underlying pneumothorax. In a patient with undrained pneumothorax, decompression may lead to tension pneumothorax.
Furthermore, considering the risk of gas expansion during the decompression phase of hyperbaric therapy, the benefit/risk ratio of hyperbaric therapy must be carefully evaluated in patients with poorly controlled asthma, pulmonary emphysema, chronic obstructive bronchopneumopathy (COPD), or recent thoracic surgery.
Special warnings

In a hyperoxic environment, oxygen may saturate clothing.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).
Cylinders and mobile cryogenic containers must not be used if there are visible damages or if damage is suspected, or if they have been exposed to extreme temperatures.
Only oxygen-compatible and suitable equipment may be used for the specific container model.
Pliers or other tools must not be used to open or close the cylinder valve to prevent damage.
In case of leakage, the cylinder valve must be closed immediately, if this can be done safely. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
Valves of empty cylinders must remain closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. For this reason, handling and storage of containers require special precautions.
It is not permitted to vent pressurized gas.
Take special safety precautions when handling cryogenic containers to avoid cold burns. Wear appropriate protective clothing (gloves, goggles, loose clothing, and pants covering shoes). If liquid oxygen contacts skin or eyes, wash affected areas with abundant cold water or apply cold compresses; seek immediate medical assistance.

Dosage, method and duration of administration
With these systems, oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g. nasal cannula or facial mask); dosing is independent of the medicinal gas packaging and is regulated via dosing devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while expired gas and any excess oxygen leave the patient's inspiratory circuit, mixing with the surrounding air (open system or anti-rebreathing system).
Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air, i.e. with an inspired oxygen fraction (FiO₂) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
In patients without respiratory failure, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable masks.
In patients with respiratory failure or under anaesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders contain an internal pressure of approximately 200 bar. This high pressure is regulated by a pressure reducer and displayed on the pressure gauge. Multiplying the pressure gauge reading by the cylinder's 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 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.
Hyperbaric oxygen therapy
Hyperbaric oxygen therapy refers to treatment with 100% oxygen at pressures 1.4 times higher than atmospheric pressure at sea level (1 atm = 101.3 kPa = 760 mmHg). For safety reasons, pressure in hyperbaric oxygen therapy should not exceed 3 atm.
Oxygen must be administered in a hyperbaric chamber.
The duration of sessions in a hyperbaric chamber at a pressure of 2 to 3 atmospheres (i.e. between 2.026 and 3.039 bar) ranges from 60 minutes to 4-6 hours. These sessions may be repeated 2 to 4 times daily, depending on the patient's clinical condition.
Compression and decompression should be performed slowly according to standard procedures to avoid barotrauma risk to air-containing anatomical cavities communicating with the outside.
Hyperbaric oxygen therapy must be performed by qualified personnel trained in this treatment.
Overdose
In case of oxygen toxicity related to hyperoxia, oxygen therapy should be reduced or, if possible, interrupted, and symptomatic treatment initiated.
Instructions for use and handling
Medical oxygen cylinders, as well as cryogenic containers, are exclusively intended 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’s instruction and user manual (packaging).
Check that 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, ensuring 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 using the appropriate trolley only; never lift the cylinder by the valve.
Use connectors, connecting tubes or hoses specifically designed and compatible with oxygen.
Particular attention must be paid to securing pressure reducers to cylinders, especially when not integrated into the container closure system, to prevent accidental breakage.
It is absolutely forbidden to modify in any way the delivery equipment and related accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves/taps.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).

General instructions for use
Cylinders equipped with simple shut-off valve only

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)

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 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 of the tap/valve, but always on 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 service of the supplier indicated in the container’s user manual.
Use only containers suitable for the product and for the intended operating pressure and temperature.

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 remaining in the pressurized cylinder will be safely eliminated via 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 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 or ignition sources and combustible materials. Empty containers or those containing other types of gas must be stored separately.

Package leaflet: information for the patient

OXYGEN SAPIO LIFE 200 BAR COMPRESSED MEDICINAL GAS, 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 effect, including those not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What Ossigeno SAPIO LIFE is and what it is used for

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

in the treatment of acute and chronic respiratory failure,
in anaesthesia,
in intensive care,
in hyperbaric chamber treatment.

2. What you should know before being administered Ossigeno SAPIO LIFE

You will not be administered Ossigeno SAPIO LIFE in a hyperbaric chamber if:

you suffer from a lung disease causing the formation of lung bubbles (bullous emphysema);
you suffer from progressive asthma;
you have a collapsed lung (pneumothorax);
you suffer from a chronic lung disease characterized by slow obstruction of the airways (chronic obstructive pulmonary disease - COPD);
you suffer from lung inflammation (Pneumocystis carinii pneumonia);
you suffer from a disease characterized by uncontrolled 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 an upper respiratory tract infection;
you have heat stroke (hyperthermia);
you suffer from a red blood cell disorder, a type of blood cell (hereditary spherocytosis);
you suffer from a disease of the optic nerve (optic neuritis);
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, daunorubicin, bleomycin, cisplatin (see section “Other medicines and Ossigeno SAPIO LIFE”);
you are taking anti-inflammatory medications such as corticosteroids (see section “Other medicines and Ossigeno SAPIO LIFE”);
you are taking a medication to treat alcohol dependence (disulfiram) (see section “Other medicines and Ossigeno SAPIO LIFE”);
you consume alcohol;
you have recently been exposed to toxic substances (aromatic hydrocarbons);
you smoke or use nicotine-based medications to help quit smoking;
the newborn was born prematurely.

Warnings and precautions
Talk to your doctor or pharmacist before receiving Ossigeno SAPIO LIFE.
Inform your doctor:

if you are taking medications to treat epilepsy (barbiturates) and/or pain (opioids).

Your doctor will evaluate whether to administer hyperbaric oxygen therapy if:

you suffer from recurrent ear and/or nasal inflammation (recurrent otitis and/or sinusitis);
you suffer from heart disease (ischemic and/or congestive heart conditions);
you suffer from untreated high blood pressure (pharmacologically untreated arterial hypertension);
you suffer from lung diseases that restrict airflow (restrictive and/or severely restrictive pulmonary diseases);
you suffer from an eye disease characterized by high pressure of the fluid inside the eyes (glaucoma), or from retinal detachment, a membrane of the eye;
you suffer from diabetes mellitus, as hyperbaric therapy may counteract the effect of insulin and increase your blood sugar levels (hyperglycemia).

Safety precautions
During use

Do not use oily creams or lipsticks.
Do not smoke.
Do not approach the packaging with open flames.
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.
Never introduce oxygen into a device that might contain materials capable of catching fire, especially fatty substances.

Other medicines and Ossigeno SAPIO LIFE
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. epinephrine, norepinephrine), medicines that affect multiple 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 microbial infections;
antibiotics (e.g. actinomycin, nitrofurantoin), medicines used to treat infections;
menadione-based supplements;
medicines used to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine);
chloroquine, a medicine used to treat malaria.

Additionally, inform your doctor if:

you have recently undergone an X-ray examination;
you suffer from an overactive thyroid gland (hyperthyroidism);
you have a deficiency in vitamin C and/or E or in a substance called glutathione (an antioxidant, i.e. one that counteracts aging);
you have undergone treatment for paraquat poisoning (a herbicide);
you consume alcohol.

Ossigeno SAPIO LIFE and alcohol
Do not consume alcohol during treatment with Ossigeno SAPIO LIFE.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
Ossigeno SAPIO LIFE is contraindicated during the first three months of pregnancy when administered in a hyperbaric chamber.
The use of hyperbaric therapy during pregnancy may induce oxidative stress causing harm to the fetus. In cases of severe carbon monoxide poisoning, your doctor will assess the benefit-risk ratio.
Ossigeno SAPIO LIFE may be used during breastfeeding.
Driving and using machines
Ossigeno SAPIO LIFE does not affect or affects negligibly the ability to drive and use machines.
If the medicine is administered in a hyperbaric chamber, visual and hearing disturbances may occur that could affect your ability to drive or operate machinery. In such cases, do not drive or operate machinery until symptoms have completely resolved.

3. How Ossigeno SAPIO LIFE 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, please consult your doctor.
Ossigeno SAPIO LIFE is usually inhaled through the nose and mouth via a nasal cannula or a face mask. The dosage is delivered using measuring devices (flowmeters).
Your doctor will determine the dose based on your health condition.
During treatment with Ossigeno SAPIO LIFE, 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 are given more Ossigeno SAPIO LIFE than you should
It is highly unlikely that you will receive more Ossigeno SAPIO LIFE than required, as your doctor or nurse will monitor you during treatment.
Symptoms of excessive dosage that you may experience include:

hyperoxia,
inflammation of the trachea and bronchi (tracheobronchitis),
interstitial edema,
pulmonary fibrosis.

Symptoms of excessive dosage that may occur following hyperbaric chamber therapy include:

ringing in the ears (tinnitus),
visual and hearing disturbances,
localized muscle spasms (particularly in eyes, mouth, forehead),
nausea, dizziness,
anxiety, confusion, irritability,
loss of consciousness,
uncontrolled body movements (convulsions). In premature infants, a high oxygen concentration can cause visual damage (retinopathy of prematurity).

If you are a patient at risk of respiratory failure, administration of supplemental oxygen may cause serious breathing problems (respiratory depression), increased blood acidity (respiratory acidosis), and reduced or stopped breathing (respiratory arrest).

Treatment
If you are given excessive doses, your doctor will provide appropriate therapy and monitor you closely.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below are the adverse reactions associated with Ossigeno SAPIO LIFE. There are insufficient data to determine the frequency of the individual adverse reactions listed.
The tissues most sensitive to this medicine are the lungs, brain, and eyes.

Effects related to respiration:

inflammation of the trachea and bronchi (tracheobronchitis);
chest pain;
dry cough;
atelectasis due to reduced nitrogen levels in the alveoli and the direct effect of oxygen on alveolar surfactant;
mixing within the lung of carbon dioxide-rich blood with oxygen-rich blood (intrapulmonary shunt);
worsening of respiratory problems in patients with respiratory depression induced by medicinal products (opioids, barbiturates) or chronic obstructive bronchopulmonary diseases (COPD).

Effects related to the nervous system:

visual disturbances (blurred vision, reduced peripheral vision);
ringing in the ears (tinnitus);
respiratory disturbances;
localized muscle spasms (particularly of the eyes, mouth, and forehead);
dizziness and nausea;
behavioral changes (anxiety, confusion, irritability);
decreased level of consciousness (up to loss of consciousness);
adverse reactions caused by excessive oxygen administration are reversible and do not cause any neurological damage, resolving once the partial pressure of inspired oxygen is reduced.

Adverse reactions related to hyperbaric oxygen therapy (hyperbaric oxygen therapy - HBOT):

confinement anxiety (due to the relatively small size of some hyperbaric chambers, not to a direct effect of oxygen).

Effects related to ocular toxicity:

progressive visual damage (progressive myopia) in cases of multiple hyperbaric treatments.

Adverse reactions in children:

lung diseases (bronchopulmonary dysplasia, pulmonary fibrosis, up to respiratory insufficiency). In newborns, and particularly in preterm infants:
temporary or permanent eye damage (retinopathy of prematurity) in newborns (especially preterm infants) exposed to high oxygen concentrations or for prolonged periods;

Risk of burns

thermal burns (the risk of fire increases in the presence of high oxygen concentrations and ignition sources);
cold burns (in case of direct contact with liquid oxygen).

The following adverse reactions (with their respective frequencies) are associated with normobaric oxygen therapy:

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

temporary or permanent visual damage (retinopathy of prematurity) in newborns (especially preterm infants) exposed to high oxygen concentrations or for prolonged periods;

Respiratory, thoracic and mediastinal disorders
Not known (frequency cannot be estimated from the available data):

inflammation of the trachea and bronchi (tracheobronchitis);
chest pain;
dry cough;
interstitial edema;
pulmonary fibrosis;
severe respiratory problems (respiratory depression), increased blood acidity (acidosis)

respiratory) and	cessation of breathing
conditions associated with oxygen deficiency.		.

respiratory) and cessation of breathing (respiratory arrest) in patients with chronic respiratory diseases.

Systemic disorders and conditions related to the site of administration
Not known (frequency cannot be estimated from the available data):

Dryness and irritation of the airway mucous membranes.

The following adverse reactions (with their respective frequencies) are associated with hyperbaric oxygen therapy:

Respiratory, thoracic and mediastinal disorders
Rare (may affect up to 1 in 1,000 people):

Difficulty breathing (dyspnea);
Not known (frequency cannot be estimated from the available data):
Respiratory disorders.

Nervous system disorders
Common (may affect up to 1 in 10 people):

Uncontrolled body movements (convulsions).

Musculoskeletal and connective tissue disorders
Not known (frequency cannot be estimated from the available data):

Localized muscle spasms.

Ear and labyrinth disorders
Very common (may affect more than 1 in 10 people):

Ear pain.
Uncommon (may affect up to 1 in 100 people):
Perforation of the tympanic membrane.
Not known (frequency cannot be estimated from the available data):
Dizziness;
Hearing loss;
Acute serous otitis media (acute infection of the middle ear with formation of a serous collection that becomes infected by bacteria or viruses originating from the nasopharynx);
Ringing in the ears (tinnitus).

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

Nausea.

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

Abnormal behaviour.

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

Progressive visual disturbances (progressive myopia) in cases of multiple hyperbaric treatments;
Not known (frequency cannot be estimated from the available data), including:
Visual disturbances (blurred vision, decreased peripheral vision);
Cataract.

Injury, poisoning and procedural complications
Very common (may affect more than 1 in 10 people):

Tissue injury caused by imbalance between the pressure of air contained within a body cavity and the pressure of the surrounding environment (barotrauma), which may manifest as ear pain and possible ear bleeding (with risk of swelling or rupture of the tympanic membrane), damage to the paranasal sinuses, lung damage, toothache.

Metabolism and nutrition disorders
Rare (may affect up to 1 in 1,000 people):

Hypoglycaemia (low blood sugar levels) in diabetic patients.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse. You can also report adverse reactions directly via the national reporting system at www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store Ossigeno SAPIO LIFE

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 SAPIO LIFE Contains

The active substance is 100% oxygen.

Description of the Appearance of Ossigeno SAPIO LIFE and Contents of the Package
Medicinal Compressed Gas
Ossigeno SAPIO LIFE 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 or aluminum alloy and are equipped with valves compatible with a
pressure regulator.

Medicinal Cryogenic Gas
OSSIGENO SAPIO LIFE cryogenic medicinal gas is supplied in fixed cryogenic containers.
Available pack sizes:

Medicinal Compressed Gas
Steel cylinders of 40 and 50 litres. Cylinder packs containing 12, 16, or 20 cylinders of 40 litres; cylinder packs containing 12 or 16 cylinders of 50 litres; cylinder pack containing 16 cylinders of 60 litres.

Medicinal Cryogenic Gas
Fixed cryogenic containers of 1000, 1500, 2000, 2500, 3000, 4000, 5000, 6000, 10000, 12000, 15000,
20000, 30000, 40000 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SAPIO LIFE S.R.L
Via Silvio Pellico, 48
Monza (MB)

Manufacturer
Medicinal Compressed Gas
Sapio Produzione Idrogeno Ossigeno srl – Via De Amicis, 140 – 10093 Collegno (TO)
Sapio Produzione Idrogeno Ossigeno srl – Via Senatore Simonetta 27 – 20867 Caponago (MB)
Sapio Produzione Idrogeno Ossigeno srl – Corso Stati Uniti 21 – 35100 Padova (PD)
Sapio Produzione Idrogeno Ossigeno srl – Via P. Belizzi 77/79 – 29100 Piacenza (PC)
Sapio Produzione Idrogeno Ossigeno srl – Loc. Poggio Bagnoli – 52020 Pergine Valdarno (AR)
Sapio Produzione Idrogeno Ossigeno srl – Contrada Camera 90/A – 63023 Fermo (AP)
Sapio Produzione Idrogeno Ossigeno srl – Via Metaponto, 8700 – 74123 Taranto (TA)
Sapio Produzione Idrogeno Ossigeno srl – Località Passo Vecchio – 88074 Crotone (KR)
Sapio Produzione Idrogeno Ossigeno srl – Via Enrico Alberto D’Albertis 25 – 07046 Porto Torres (SS)
Puglia Life S.r.l. srl – Zona Industriale P.I.P. Lotto Nr. 5 – 72023 Mesagne (BR)
Oxygen Center Di Coluccia Giuseppina &C S.A.S. – Zona Artigianale – 73028 Otranto (LE)
Salentossigeno Srl – Via Veglie – Zona Artigianale – 73045 Leverano (LE)
Utengas srl – Via Marconi 56/58 – 24040 Comun Nuovo (BG)
Medical Gas Criogenici srl – Viale Delle Industrie, Snc - Zona Industriale ASI - 92021 Aragona (AG)
Oxyplus srl – Via Maremmana Inferiore km. 0,5 Fraz. Villa Adriana – 00019 Tivoli (RM)
Eubios srl – Via Linara 3 – 82030 Limatola (BN)
Oxy Live srl – Via Nuova del Bosco km. 2 – 80034 Marigliano (NA)
Giannitrapani srl – 1° Dorsale, 8 Z.I.R. – 91100 Trapani (TP)
Giannitrapani srl – Via Ugo La Malfa – Contrada Cutelli – 90014 Casteldaccia (PA)
CER Medical S.r.l. – Via Torretta, 13 – 40012 – Calderara di Reno (BO)
MEDICAIR CENTRO S.r.l. - Via della Magliana, 1098/1102 - 00100 - Roma (RM)
CRIOSERVICE SRL - Via Madre Teresa di Calcutta (loc. Zona Commerciale Signora Porzia) 74045 - Leverano (LE)

Medicinal Cryogenic Gas (fixed containers)
Air Liquide Italia Produzione srl – Via Industrie, 28 – 37014 – Castelnuovo del Garda (VR)
Air Liquide Italia Produzione srl – Via Vigonovese, 79 – 35100 – Padova
Air Liquide Italia Produzione srl – Via Dante s.n.c. – 20090 – Pioltello (MI)
Air Liquide Italia Produzione srl – Contrada Biggemi ex S.S. 114 – 96010 – Priolo Gargallo (SR)
Chemgas srl – Via E. Fermi – 72100 – Brindisi
Linde Gas Italia srl – Via Turati, 18/a – 40010 – Sala Bolognese (BO)
Linde Gas Italia srl – Via di Servola, 1 – 34100 – Trieste
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." SpA – S.S. del Brembo, 1 – 24040 – Osio Sopra (BG)
Sol Gas Primari S.r.l. – Via Firmio Leonzio, 2 – 84100 – Salerno
SICO Società Italiana Carburo Ossigeno SpA – Via Marconato s.n.c. – 20031 – Cesano Maderno (MB)
Sapio Produzione Idrogeno Ossigeno srl – Via Senatore Simonetta, 27 – 20867 – Caponago (MB)
Sapio Produzione Idrogeno Ossigeno srl – Via Malcontenta, 49 (locality Porto Marghera) – 30175 Venezia
Sapio Produzione Idrogeno Ossigeno srl – Località Caldare, s.n.c. – 01028 – Orte (VT)
Medical Gas Criogenici S.r.l. – Viale delle Industrie, SNC – Zona Industriale ASI – 92021 Aragona (AG)
MEDICAIR ITALIA S.R.L. – Contrada S. Benedetto – Zona ASI – 92026 – FAVARA (AG)

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 durations:
Up to 100%: less than 6 hours
60-70%: 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 these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), pulse oximetry (arterial oxygen saturation – SpO₂), and clinical assessment.

High concentrations of oxygen 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 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.

Patients at Risk of Hypercapnic Respiratory Failure:
Particular precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide pressure or at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive bronchopulmonary disease (COPD), cystic fibrosis, morbid obesity, thoracic wall deformities, neuromuscular disorders, or respiratory depressant drug overdose). Administration of supplemental oxygen may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.

Special Precautions in Patients with Bleomycin-Induced Lung Injury
High-dose oxygen therapy may potentiate pulmonary toxicity, even years after the initial lung injury caused by bleomycin. The target oxygen saturation in these patients may be lower than in others (see section “Other Medicines and Ossigeno SAPIO LIFE”).

Paediatric Population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective oxygen concentration should be administered to achieve adequate oxygenation in neonates.
In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity (see section “Possible Side Effects”), chronic lung disease, and intraventricular haemorrhage. It is recommended to initiate resuscitation of term or near-term neonates with air rather than 100% oxygen. In preterm neonates, the optimal oxygen concentration and target saturation are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.

Hyperbaric Oxygen Therapy (HBOT)
Administration of oxygen in a hyperbaric chamber must be carefully evaluated based on the risk/benefit ratio in the following conditions:

Recurrent otitis and/or sinusitis, laryngocele, mastoid cavities, vestibular syndrome, hearing loss, and recent middle ear surgery
Ischemic and/or congestive cardiac diseases; in patients with acute coronary syndrome or acute myocardial infarction requiring hyperbaric therapy (e.g., in cases of CO poisoning), hyperbaric therapy must be conducted cautiously due to potential vasoconstriction from hyperoxia in the coronary circulation
Untreated arterial hypertension
Moderate to severe restrictive lung diseases
Glaucoma, retinal detachment (even if surgically treated) (compensation maneuvers)
History of seizures, epilepsy
Uncontrolled high fever
Severe anxiety, psychosis, claustrophobia

Patients with Diabetes Mellitus
Hyperbaric therapy may interfere with glucose metabolism. The vasoconstrictive effects of hyperbaric therapy may also impair subcutaneous insulin absorption, leading to hyperglycemia.
Blood glucose monitoring between hyperbaric therapy sessions may be considered.

Respiratory Disorders
Due to decompression at the end of a hyperbaric session, gas volume increases as chamber pressure decreases, potentially causing partial pneumothorax or worsening of an underlying pneumothorax. In a patient with undrained pneumothorax, decompression may lead to tension pneumothorax.
Furthermore, considering the risk of gas expansion during decompression, the benefit/risk ratio of hyperbaric therapy must be carefully evaluated in patients with poorly controlled asthma, pulmonary emphysema, chronic obstructive bronchopulmonary disease (COPD), or recent thoracic surgery.

Special Warnings

In an oxygen-enriched environment, oxygen may saturate clothing.
Contact with frozen parts (for cryogenic containers) is strictly prohibited.
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 safely possible. 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 be kept closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. Therefore, special precautions are required when handling and storing containers.
Pressurized gas administration is not permitted.
Take special safety precautions when handling cryogenic containers to avoid cold burns. Wear appropriate protective clothing (gloves, goggles, loose clothing, and trousers covering shoes). If liquid oxygen contacts skin or eyes, wash affected areas with abundant cold water or apply cold compresses; seek immediate medical assistance.

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

Low-flow systems: The simplest method for delivering an oxygen-air mixture to the inspired air; for example, oxygen delivered via a flowmeter connected to a nasal cannula or face mask.
High-flow systems: Systems designed to meet the patient's total respiratory demand by providing a stable and constant oxygen concentration unaffected/diluted by ambient air; for example, Venturi masks, where, once the oxygen flow is set, the patient's inspired air is enriched with a constant oxygen concentration.
Demand valve systems: Systems designed to deliver 100% oxygen without contact with ambient air. Intended for short-term use only, in emergencies.
Hyperbaric oxygen therapy: 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 tight-fitting mask, helmet, or endotracheal tube.

Normobaric Oxygen Therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air, i.e., with an inspired oxygen fraction (FiO₂) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
In patients without respiratory failure, oxygen may be administered via spontaneous ventilation using nasal 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 indicated on the gauge. Multiplying the gauge 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 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 hemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO₂).
Dosage must be adjusted according to individual patient needs.
The general recommendation is to use the lowest FiO₂ necessary to achieve the desired therapeutic effect, i.e., normal PaO₂ values. In cases of severe hypoxemia, FiO₂ levels that may pose a risk of oxygen toxicity may be indicated.
Continuous therapy monitoring and ongoing assessment of therapeutic effect are required, through measurement of PaO₂ levels or alternatively, arterial oxygen saturation (SpO₂).
In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should maintain PaO₂ > 8 kPa, with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), preferably avoiding FiO₂ > 0.6 (i.e., more than 60% oxygen in the inhaled gas mixture).
For long-term treatment, 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 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%.
Neonates may receive 100% oxygen when required. 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 blood oxygen pressure (PaO₂) should be monitored; however, if maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Additionally, the risk of ocular damage may be reduced by avoiding significant fluctuations in oxygenation (see also Precautions for Use).

Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy refers to treatment with 100% oxygen at pressures exceeding 1.4 times 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-filled anatomical cavities communicating with the external environment.
Hyperbaric oxygen therapy must be performed by qualified personnel trained in this treatment.

Overdose
In cases of oxygen toxicity related to hyperoxia, oxygen therapy should be reduced or, if possible, discontinued, and symptomatic treatment initiated.

Instructions for Use and Handling
Medical oxygen cylinders and fixed cryogenic containers are intended exclusively for containing/transporting oxygen for inhalation, for therapeutic use.
Cylinders must be transported using appropriate means to protect them from impact and falling risks.
Strictly follow these instructions:

Read the container (package) instruction and user manual carefully.
Ensure all equipment is in good condition.
Secure cylinders in an upright position to prevent falls; protect containers from impact and maintain them at temperatures below 50°C, ensuring adequate ventilation/aeration 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.
Lift and move cylinders using only the appropriate trolley; never lift a cylinder by the valve.
Use connectors, connecting tubes, or flexible hoses specifically designed and compatible with oxygen.
Pay particular attention to securing pressure reducers to cylinders, if not already integrated into the container closure system, to prevent accidental breakage.
Absolutely avoid any intervention on container connectors, delivery equipment, or related accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair a defective valve.
Absolutely avoid handling equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Absolutely avoid touching frozen parts (for cryogenic containers).

General Instructions for Use
Cylinders equipped with valve only:

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 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)

NOTE: FOR MORE DETAILS, CONSULT THE CONTAINER 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 position yourself 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 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 user manual.
Use only containers suitable for the product, and for the intended pressure and temperature conditions.

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 present in the pressurized cylinder will be eliminated through appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling of the same 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 ventilated sheds, avoiding the formation of oxygen-enriched atmospheres (O₂ > 21% vol), in an upright position with valves closed, protected from rain and weather, direct sunlight, heat or ignition sources, and away from combustible materials. Empty containers or those containing other types of gas must be stored separately.
Fixed cryogenic containers installed at healthcare facilities must be located outdoors.