Package leaflet: information for the patient

OXYGEN SICO 200 BAR MEDICINAL COMPRESSED GAS, CRYOGENIC MEDICINAL GAS

Oxygen
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, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effect, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

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

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

Ossigeno SICO 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 SICO is indicated in patients of all ages:

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

2. What you need to know before using Oxygen SICO

Do not use Oxygen SICO
Under normal conditions, there are no absolute contraindications.
Warnings and precautions
Talk to your doctor or pharmacist before using Oxygen SICO.
Before starting oxygen therapy, you should be aware of the following:

Oxygen may have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), which will block oxygen delivery into the blood.
If you have severe chronic obstructive lung disease (COPD) resulting in impaired blood oxygenation, the oxygen flow rate will be low. Your doctor will adjust the oxygen flow rate of the oxygen therapy accordingly.
Adverse events may occur in newborns and preterm infants, such as eye damage (retinopathy). If your baby requires supplemental oxygen, the doctor will determine the appropriate oxygen concentration to administer.

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 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 or a condition that makes breathing difficult (chronic obstructive bronchopulmonary disease COPD, cystic fibrosis, morbid obesity, chest wall deformities, neuromuscular disorders)
if you have previously had lung damage caused by a medicine used to treat cancer (bleomycin)
if you have recently undergone an X-ray examination.

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

Oxygen is an oxidizing agent and promotes combustion. Smoking or open flames (e.g. pilot lights, stoves, ovens, gas heaters, sparks, candles) must not be present in areas where Oxygen SICO is used, as this increases the risk of fire.
Do not smoke or use electronic cigarettes during the entire oxygen treatment.
Do not use toasters, hair dryers, or similar electrical devices during your oxygen therapy.
Do not apply oily substances (e.g. oils, creams, lotions, lipsticks) to surfaces in contact with oxygen. Only water-based products should be used on the hands, face, or inside the nose.
The pressure regulator must be opened slowly and carefully to avoid the risk of sudden ignition.

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

Handle the cylinder carefully. Ensure that the gas cylinder is not dropped or exposed to impacts.
Damage to the equipment may cause blockage of the outlet and/or incorrect readings on the pressure gauge display regarding residual oxygen content and flow, leading to inadequate or absent oxygen delivery.
Oxygen becomes liquid at approximately -183°C. At such low temperatures, there is a risk of frostbite. Always wear protective gloves and eye protection when handling liquid medical oxygen.

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

catecholamines (e.g. 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,
anticancer medicines such as bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea, adriamycin, and actinomycin,
antimicrobial agents (e.g. nitrofurantoin), medicines used to treat microbial infections,
menadione-based supplements (a precursor of vitamin K),
medicines for mental disorders (e.g. promazine, chlorpromazine, thioridazine),
chloroquine, a medicine used to treat malaria.

Oxygen SICO and alcohol
Do not consume alcohol during treatment with Oxygen SICO.
Pregnancy and breastfeeding
Oxygen SICO may be used during pregnancy, but only when necessary due to critical conditions.
Oxygen SICO may be used during breastfeeding.
In all cases, you must inform your doctor if you are pregnant or suspect you may be pregnant.
Driving and use of machinery
You may drive and operate machinery while using Oxygen SICO, provided your doctor considers you capable of doing so.

3. How to use Oxygen SICO

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

sore throat,
cough and chest pain,
breathing difficulties (dyspnoea, hypoventilation),
damage to the bronchi and lungs,
disturbances of vision and hearing,
nausea, dizziness,
anxiety, confusion, irritability,
muscle cramps and spasms,
loss of consciousness,
uncontrolled body movements (convulsions), sometimes with loss of consciousness (epileptic seizures).

Treatment
If you have taken an excessive dose, your doctor will reduce the dose or stop administration, provide appropriate therapy, and monitor you closely.

4. Possible side effects

Like all medicines, Ossigeno SICO can cause side effects, although not everyone experiences them.
Side effects are usually observed with high concentrations and after prolonged treatment:
Very common (may affect more than 1 in 10 people):
In newborns exposed to high oxygen concentrations: eye damage (retinopathy), which may lead to visual impairment.
Frequency not known (frequency cannot be estimated from the available data):
Dryness of mucous membranes, local irritation and inflammation of the mucosa.
Pulmonary toxicity: inflammation of the airways (with breathing-related pain and dry cough), presence of fluid in the lungs (interstitial edema), presence of scar tissue (pulmonary fibrosis).
Worsening of carbon dioxide retention in the blood in patients with oxygen deficiency/excess carbon dioxide if treated with too high an amount of oxygen: reduced breathing, alteration of acid levels in the blood (respiratory acidosis), respiratory arrest.
Contact with liquid oxygen causes cold burns.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please tell your doctor or pharmacist. You may also report side effects directly via the website
www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ossigeno SICO

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 in use. This will help protect the environment.

6. Package contents and other information

What Ossigeno SICO contains

The active substance is oxygen.

Description of the appearance of Ossigeno SICO and contents of the package
Compressed medicinal gas
Ossigeno SICO 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 SICO cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas
Steel cylinders with valve of 0.5, 1, 2, 3, 5, 7, 10, 14, 17, 20, 24, 27, 30 litres; aluminium cylinders with valve of 2, 3, 5, 7, 10 litres.
Cryogenic medicinal gas
Mobile cryogenic container of 25.5, 30, 31, 33, 38, 41, 46 litres.
Not all pack sizes may be commercially available.

Marketing Authorisation Holder
SICO Società Italiana Carburo Ossigeno S.p.A
Via Giuseppe Parini, 9
Milan

Manufacturer
Compressed medicinal gas
Iron Gas Srl – Via Masserie, 1 – Monocalzati (AV)
Eurogas srl – Via Pradazzo, 22 – Castelleone (CR)
SICO Società Italiana Carburo Ossigeno SpA – Via Moncalieri, 30 – Villastellone (TO)
SICO Società Italiana Carburo Ossigeno SpA – Via Morandi, 10 – Saronno (VA)
SICO Società Italiana Carburo Ossigeno SpA – Via Mercanti 48, Zona Industriale – Montichiari (BS)
SICO Società Italiana Carburo Ossigeno SpA – Via della Risaia 238 – Crevalcore (BO)
SICO Società Italiana Carburo Ossigeno SpA – Via Martiri d’Ungheria, 21 – Camposampiero (PD)
SICO Società Italiana Carburo Ossigeno SpA – Zona Industriale – Contrada Argentieri – Bari
S.O.M. di D’Aquino Anna Rita & C snc – Via Giarre, 67 – Nunziata – Zona Ind.le - Mascali –
Catania (CT)
Pirossigeno Srl – Via Pirelli, 10 – Castrolibero (CS)
Augimeri Ossigeno di Emilio Mascalchi – Porto di Gioia Tauro – Zona Ind.le – Loc. San Ferdinando
di Rosarno – Reggio Calabria (RC)
SICO Società Italiana Carburo Ossigeno SpA – Via Boscalto, 47 – Resana (TV)

Cryogenic medicinal gas (mobile containers)
Iron Gas Srl – Via Masserie, 1 – Monocalzati (AV)
Eurogas srl – Via Pradazzo, 22 – Castelleone (CR)
SICO Società Italiana Carburo Ossigeno SpA – Via Moncalieri, 30 – Villastellone (TO)
SICO Società Italiana Carburo Ossigeno SpA – Via Morandi, 10 – Saronno (VA)
SICO Società Italiana Carburo Ossigeno SpA – Via Mercanti 48, Zona Industriale – Montichiari (BS)
SICO Società Italiana Carburo Ossigeno SpA – Via della Risaia 238 – Crevalcore (BO)
SICO Società Italiana Carburo Ossigeno SpA – Via Martiri d’Ungheria, 21 – Camposampiero (PD)
SICO Società Italiana Carburo Ossigeno SpA – Zona Industriale – Contrada Argentieri – Bari
S.O.M. di D’Aquino Anna Rita & C snc – Via Giarre, 67 – Nunziata – Zona Ind.le - Mascali –
Catania (CT)
Pirossigeno Srl – Via Pirelli, 10 – Castrolibero (CS)
Augimeri Ossigeno di Emilio Mascalchi – Porto di Gioia Tauro – Zona Ind.le – Loc. San Ferdinando
di Rosarno – Reggio Calabria (RC)
SICO Società Italiana Carburo Ossigeno SpA – Via Boscalto, 47 – Resana (TV)

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 tension at 8 kPa (60 mm Hg) should be used. Higher concentrations should be administered for the shortest possible duration, with frequent monitoring of blood gas analysis.
Before initiating oxygen therapy, the following should be considered:
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 is 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, therapy must be carefully monitored by measuring arterial oxygen tension (PaO₂), or via pulse oximetry (arterial oxygen saturation – SpO₂) and clinical assessment.
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 the alveoli faster than it is replenished by ventilation, alveolar collapse (atelectasis) may occur. This can impair arterial blood oxygenation, as gas exchange does not occur despite perfusion.
In patients with reduced sensitivity to arterial carbon dioxide pressure, high oxygen levels may cause carbon dioxide retention. In extreme cases, this may lead to carbon dioxide narcosis.
Exercise caution in neonates and premature infants to minimize the risk of adverse events such as ocular damage. If supplemental oxygen is required, administer only the amount of Ossigeno SICO recommended by the physician.

Advice regarding increased fire risk in the presence of oxygen:

Oxygen is an oxidizing agent and promotes combustion. Smoking or open flames must be strictly prohibited in areas where Ossigeno SICO is used, as it increases fire risk.
Do not use electrical equipment during administration of Ossigeno SICO.
Do not apply greasy substances (e.g. oils, creams, ointments) to surfaces in contact with Ossigeno SICO.
The pressure regulator must be opened slowly and carefully to avoid the risk of flash fire. Additionally:
Handle cylinders with care. Ensure cylinders are not dropped or subjected to impact.
Oxygen liquefies at approximately -183°C. There is a risk of cold burns at such low temperatures. Always wear gloves and protective goggles when handling liquid medicinal oxygen.

Special warnings

In hyperoxygenated environments, oxygen may saturate clothing.
Contact with frozen parts (for cryogenic containers) is strictly prohibited.
Cylinders and mobile cryogenic containers must not be used if there are visible damages, suspected damage, or exposure 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, close the cylinder valve immediately if safe to do so. If the valve cannot be closed, move the cylinder 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.
It is not permitted to vent pressurized gas.

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); the dosage is delivered to the patient independently of the medicinal gas packaging via dosing devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while expired gas and any excess oxygen exit the patient's inspiratory circuit and mix 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 anesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders contain an internal pressure of approximately 150–200 bar. This high pressure is regulated by a pressure reducer and indicated on the pressure gauge. Multiplying the pressure gauge reading by the cylinder volume (in litres) gives the amount of oxygen still available in the cylinder.

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

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 falling.
Strictly follow the instructions below:

Carefully read the instruction and user manual of the container (packaging).
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. 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 with the appropriate trolley; never lift a cylinder by its valve.
Use only oxygen-specific and compatible connectors, connecting tubes, or flexible hoses.
Particular attention must be paid to securing pressure reducers to cylinders, if not already integrated into the container closure system, to prevent accidental breakage.
NEVER tamper in any way with container connectors, delivery equipment, or their accessories or components (OIL AND GREASE MAY CATCH FIRE ON CONTACT WITH OXYGEN).
Do not grease or attempt to repair defective valves/taps.
It is strictly forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Contact with frozen parts (for cryogenic containers) is strictly prohibited.

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

Remove the protective cap if present
Ensure the delivery valve is closed
Remove the tamper-evident seal
Connect the pressure reducer to the cylinder valve and the corresponding flowmeter
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve 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 position yourself 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 service of the supplier indicated in the container’s user manual.
Use only containers suitable for the product and for the intended pressure and temperature 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 unused medicinal product in the pressurized cylinder will be safely eliminated via appropriate 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 well-ventilated sheds, avoiding the formation of hyperoxygenated atmospheres (O₂ > 21% vol), in an upright position with valves closed and protected from rain and weather, direct sunlight, and sources of heat or ignition, and away from combustible materials. Empty containers or those containing other types of gas must be stored separately.

Patient Information Leaflet

OXYGEN SICO 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 or nurse.
If you experience any side effects, including those not listed in this leaflet, inform your doctor or nurse. See section 4.

Contents of this leaflet:

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

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

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

2. What you need to know before you are given Ossigeno SICO

Oxygen at a pressure higher than atmospheric pressure (hyperbaric oxygen therapy) must not
be used in cases of untreated/un-drained pneumothorax. Pneumothorax is caused by an
accumulation of air in the pleural cavity between the two lung membranes. If you have previously had a
pneumothorax, inform your doctor.
Before starting oxygen therapy, you should be aware of the following:

Oxygen may have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), which will obstruct oxygen delivery into the blood.
If you have severe chronic obstructive pulmonary disease (COPD) resulting in impaired blood oxygenation, the oxygen flow rate will be kept low. Your doctor will adjust the oxygen flow rate of the oxygen therapy accordingly.
Adverse events may occur in newborns and preterm infants such as eye damage (retinopathy). If your baby requires additional oxygen, the doctor will determine the appropriate oxygen concentration to administer.

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

you suffer from a lung disease causing formation of lung bubbles (bullous emphysema)
you suffer from asthma
you currently have or have previously had a collapsed lung (pneumothorax)
you suffer from a lung disease making it difficult to expel air from the lungs, shortness of breath (also known as dyspnea), or a feeling of fatigue (COPD)
you suffer from lung inflammation (Pneumocystis carinii pneumonia)
you suffer from a condition 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 an optic nerve disease
you suffer from malignant tumors
you suffer from high levels of acid in the blood (acidosis)
you are taking medicines to treat tumors such as doxorubicin, adriamycin, bleomycin, daunorubicin, cis-platinum
you are taking medicines to treat inflammation such as corticosteroids
you are taking a medicine to treat alcohol dependence (disulfiram), or you consume alcohol
you have recently been exposed to toxic substances (aromatic hydrocarbons)
you smoke or use nicotine-based medications to help people quit smoking
the newborn was born prematurely.

Warnings and precautions
Consult your doctor before using Ossigeno SICO.
Inform your doctor:

if you suffer from a thyroid disease, a neck gland that is overactive (hyperthyroidism)
if you suffer from a deficiency of vitamin C and/or E or a substance called glutathione (antioxidant, i.e. 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 or a condition that makes breathing difficult (Chronic Obstructive Bronchopulmonary Disease COPD, Cystic Fibrosis, pathological obesity, chest wall deformities, neuromuscular disorders)
if you have previously experienced lung damage due to a medicine used to treat cancer (bleomycin)
if you have recently undergone an X-ray. The doctor will evaluate whether to administer oxygen in a hyperbaric chamber if:
- you suffer from recurrent ear and/or nasal inflammation (recurrent otitis and/or sinusitis)
- you suffer from heart disease (ischemic and/or congestive cardiac conditions)
- you suffer from high blood pressure and are not taking medication to treat it (untreated arterial hypertension)
- you suffer from lung diseases that prevent airflow (restrictive and/or severely restrictive lung diseases such as poorly controlled asthma, pulmonary emphysema, COPD, thoracic surgery)
- 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 impair proper insulin absorption and increase blood sugar levels (hyperglycemia);
you suffer from seizures (epilepsy)
you have high fever
you suffer from severe anxiety, mental disorders, and claustrophobia (fear of being in enclosed and confined spaces).

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

Oxygen is an oxidizing agent and promotes combustion. In areas where Ossigeno SICO is used, there must be no smoking or open flames (e.g. pilot lights, stoves, ovens, gas heaters, sparks, candles), as this increases the risk of fire.
Do not smoke or use electronic cigarettes during the entire oxygen treatment.
Do not use toasters, hair dryers, or similar electrical devices during your oxygen treatment.
Do not apply oily substances (e.g. oils, creams, lotions, lipsticks) on surfaces in contact with oxygen. Only water-based products should be used on the hands, face, or inside the nose.
The pressure regulator must be opened slowly and carefully to avoid the risk of sudden ignition.

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

Handle the cylinder with care. Ensure that the gas cylinder is not dropped or exposed to impacts.
Damage to equipment may cause blockage of the outlet and/or incorrect readings on the pressure gauge display regarding residual oxygen content and flow, leading to insufficient or missing oxygen delivery.
Oxygen becomes liquid at approximately -183°C. At such low temperatures, there is a risk of frostbite. Always wear protective gloves and goggles when handling liquid medical oxygen.

Children
In newborns and preterm infants, oxygen therapy may lead to eye damage (retinopathy of prematurity), lung damage, and brain hemorrhage. The doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your baby.
Other medicines and Ossigeno SICO
Inform your doctor if you are taking or have recently taken 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 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,
medicines to treat tumors such as bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea, adriamycin, and actinomycin,
antimicrobial agents (e.g. nitrofurantoin), medicines to treat microbial infections,
menadione-based supplements (a precursor of vitamin K),
medicines to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine),
chloroquine, a medicine to treat malaria.

Ossigeno SICO and alcohol
Do not consume alcohol during treatment with Ossigeno SICO.
Pregnancy and breastfeeding
Ossigeno SICO may be used during pregnancy, but only when necessary due to
critical conditions.
Ossigeno SICO may be used during the breastfeeding period.
In all cases, you must inform your doctor if you are pregnant or suspect you may be pregnant.
Hyperbaric oxygen therapy is contraindicated during the first trimester of pregnancy. The doctor will decide whether to administer this treatment in cases of severe carbon monoxide poisoning.
Driving and using machines
After hyperbaric oxygen chamber therapy, visual and hearing disturbances have been reported.
Do not drive vehicles or operate machinery until these symptoms have completely disappeared.

3. How SICO Oxygen will be administered to you

This medicine will be administered to you through the inhaled air, always following exactly the instructions given by your doctor or nurse. If you have any doubts, consult your doctor.
SICO Oxygen is usually inhaled through the nose and mouth via a nasal cannula or a mask.
The dose will be determined by your doctor based on your health status.
During treatment with SICO Oxygen, your doctor may perform measurements of blood gas in arterial blood and monitor levels of oxygen bound to haemoglobin, a protein that carries oxygen in the blood.

If you are given more SICO Oxygen than you should
Symptoms of an overdose you may experience include:

sore throat,
cough and chest pain,
difficulty in breathing (dyspnoea, hypoventilation),
damage to the bronchi and lungs,
disturbances of vision and hearing,
nausea, dizziness,
anxiety, confusion, irritability,
muscle cramps and spasms,
loss of consciousness,
uncontrolled body movements (convulsions), sometimes accompanied by loss of consciousness (epileptic seizures).

Treatment
If you have used excessive doses, your doctor will reduce the dose or discontinue administration, provide appropriate therapy, and monitor you closely.

4. Possible side effects

Like all medicines, Ossigeno SICO can cause side effects, although not everybody will experience them.
Side effects are usually observed with high concentrations and after prolonged treatment:
Very common (may affect more than 1 in 10 people):
In newborns exposed to high oxygen concentrations: eye damage (retinopathy), which may lead to visual impairment.
With hyperbaric treatment: ear pain, myopia, barotrauma (tissue or organ injury caused by pressure changes).
Common (may affect up to 1 in 10 people):
With hyperbaric treatment: seizures.
Uncommon (may affect up to 1 in 100 people):
With hyperbaric treatment: rupture of the eardrum.
Rare (may affect up to 1 in 1,000 people):
With hyperbaric treatment: shortness of breath, abnormally low blood sugar levels in diabetic patients.
Frequency not known (frequency cannot be estimated from the available data):
Dryness of the mucosa, local irritation and inflammation of the mucosa.
Pulmonary toxicity: inflammation of the airways (with breathing-related pain and dry cough), presence of fluid in the lungs (interstitial edema), presence of scar tissue (pulmonary fibrosis).
Worsening of carbon dioxide retention in patients with oxygen deficiency/excess carbon dioxide if treated with too high an oxygen concentration: reduced breathing, alteration in blood acid levels (respiratory acidosis), respiratory arrest.
With hyperbaric treatment: difficulty breathing, involuntary muscle contractions, dizziness, decreased hearing, acute otitis, ringing in the ears (tinnitus), nausea, abnormal behaviour, reduced peripheral vision, blurred vision, clouding of the lens (cataract).
Contact with liquid oxygen causes cold burns.
Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the website www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ossigeno SICO

6. Package Contents and Other Information

What Ossigeno SICO Contains

The active substance is oxygen.

Description of the Appearance of Ossigeno SICO and Contents of the Package
Compressed medicinal gas
Ossigeno SICO compressed medicinal gas is supplied in cylinders and cylinder packs, in the form of
compressed gas at 200 bar at 15°C. The cylinders are made of steel or aluminum alloy, equipped with
valves compatible with pressure regulators or with integrated pressure-reducing valves.
Cryogenic medicinal gas
Ossigeno SICO cryogenic medicinal gas is supplied in mobile cryogenic containers (base units) or fixed containers.

Available pack sizes:
Compressed medicinal gas
Steel cylinders with valve, 40 and 50 litres. Cylinder packs containing 16 cylinders of 40 litres, cylinder packs containing 12 and 20 cylinders of 50 litres.
Cryogenic medicinal gas
Mobile cryogenic container of 25.5, 30, 31, 33, 38, 41, 46 litres.
Cryogenic medicinal gas
Fixed cryogenic container of 1000, 1500, 2000, 3000, 5000, 6000, 10,000, 20,000 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SICO Società Italiana Carburo Ossigeno S.p.A
Via Giuseppe Parini, 9
Milan

Manufacturer
Compressed medicinal gas
Iron Gas Srl – Via Masserie, 1 – Monocalzati (AV)
Eurogas Srl – Via Pradazzo, 22 – Castelleone (CR)
SICO Società Italiana Carburo Ossigeno SpA – Via Moncalieri, 30 – Villastellone (TO)
SICO Società Italiana Carburo Ossigeno SpA – Via Morandi, 10 – Saronno (VA)
SICO Società Italiana Carburo Ossigeno SpA – Via Mercanti, 48, Industrial Zone – Montichiari (BS)
SICO Società Italiana Carburo Ossigeno SpA – Via della Risaia 238 – Crevalcore (BO)
SICO Società Italiana Carburo Ossigeno SpA – Via Martiri d’Ungheria, 21 – Camposampiero (PD)
SICO Società Italiana Carburo Ossigeno SpA – Industrial Zone – Contrada Argentieri – Bari
SOM di D’Aquino di A&C snc – Via Giarre Nunziata Z.I., 67 – Località Mascali - Catania
Pirossigeno Srl – Via Pirelli, 10 – 87040 – Castrolibero (CS)
Augimeri Ossigeno di Mascalchi Emilio - Porto di Gioia Tauro II – Industrial Zone - Reggio Calabria (RC)
SICO Società Italiana Carburo Ossigeno SpA – Via Boscalto, 47 – Resana (TV)

Cryogenic medicinal gas (mobile containers)
Iron Gas Srl – Via Masserie, 1 – Monocalzati (AV)
Eurogas Srl – Via Pradazzo, 22 – Castelleone (CR)
SICO Società Italiana Carburo Ossigeno SpA – Via Moncalieri, 30 – Villastellone (TO)
SICO Società Italiana Carburo Ossigeno SpA – Via Morandi, 10 – Saronno (VA)
SICO Società Italiana Carburo Ossigeno SpA – Via Mercanti 48, Industrial Zone – Montichiari (BS)
SICO Società Italiana Carburo Ossigeno SpA – Via della Risaia 238 – Crevalcore (BO)
SICO Società Italiana Carburo Ossigeno SpA – Via Martiri d’Ungheria, 21 – Camposampiero (PD)
SICO Società Italiana Carburo Ossigeno SpA – Industrial Zone – Contrada Argentieri – Bari
S.O.M. di D’Aquino Anna Rita & C snc – Via Giarre, 67 – Nunziata – Industrial Zone - Mascali – Catania (CT)
Pirossigeno Srl – Via Pirelli, 10 – Castrolibero (CS)
Augimeri Ossigeno di Emilio Mascalchi – Porto di Gioia Tauro – Industrial Zone – Loc. San Ferdinando di Rosarno – Reggio Calabria (RC)
SICO Società Italiana Carburo Ossigeno SpA – Via Boscalto, 47 – Resana (TV)

Cryogenic medicinal gas (fixed containers)
Air Liquide Italia Produzione Srl – Via Dante s.n.c. – 20090 Pioltello (MI)
Linde Gas Italia Srl – Via Turati, 18/a – 40010 Sala Bolognese (BO)
Linde Gas Italia Srl – Via di Servola, 1 – 34100 Trieste
Rivoira Operations Srl – Via Baiona, 107/111 – 48100 Ravenna
Sapio Produzione Idrogeno Ossigeno Srl – Via Senatore Simonetta, 27 – 20040 Caponago
Sapio Produzione Idrogeno Ossigeno Srl – Via Malcontenta, 49 (locality Porto Marghera) – 30175 Venice
SICO Società Italiana Carburo Ossigeno SpA – Via Marconato s.n.c. – 20031 Cesano Maderno
Sapio Produzione Idrogeno Ossigeno Srl – Località Caldare snc – 01028 – Orte (VT)
Linde Gas Italia Srl – Viale Brin, 218 – Terni (TR)
Sol Gas Primari Srl – Via Firmio Leonzio, 2 – 84100 – Salerno (SA)
SICO Società Italiana Carburo Ossigeno SpA – Via Boscalto, 47 – Resana (TV)

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.

Before initiating oxygen therapy, the following should be considered:
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 becomes potentially toxic after two days at concentrations exceeding 40%.

Low oxygen concentrations should be used in patients with respiratory insufficiency in whom the respiratory drive is stimulated by hypoxia. In such cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or via pulse oximetry (arterial oxygen saturation – SpO₂), 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 supplied by ventilation, alveolar collapse (atelectasis) may occur. This can impair arterial blood oxygenation, as gas exchange does not occur despite perfusion.

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

Special caution is required in neonates and premature infants to minimize the risk of adverse events such as ocular damage. If supplemental oxygen is required, administer only the amount of Ossigeno SICO recommended by the physician.

Advice Regarding Increased Fire Risk in the Presence of Oxygen:

Oxygen is an oxidizing agent and promotes combustion. Smoking or open flames must be strictly prohibited in areas where Ossigeno SICO is used, as it increases fire risk.
Do not use electrical equipment during administration of Ossigeno SICO.
Do not apply greasy substances (e.g., oils, creams, ointments) to surfaces in contact with Ossigeno SICO.
The pressure regulator must be opened slowly and cautiously to avoid the risk of flash fire.

Additionally:

Handle cylinders carefully. Ensure that gas cylinders are not dropped or subjected to impact.
Oxygen liquefies at approximately -183°C. There is a risk of cold burns at such low temperatures. Always wear gloves and protective goggles when handling liquid medicinal oxygen.

Special Warnings

In hyperoxygenated environments, oxygen may saturate clothing.
Contact with frozen parts (for cryogenic containers) is absolutely prohibited.
Cylinders and mobile cryogenic containers must not be used if visibly damaged, suspected of damage, or 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 cylinder valves 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 on 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.
Administration of pressurized gas is not permitted.

Dosage, Method, and Duration of Administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or face mask); dosing is independent of the medicinal gas packaging and is achieved using dosing devices (flowmeters).

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

In anesthesia, a special system is often used that allows rebreathing of previously exhaled gas (closed or rebreathing system).

Oxygen may also be administered directly into the blood via an oxygenator, using a cardiopulmonary bypass system in cardiac surgery and other cases requiring extracorporeal circulation.

Numerous devices are available for oxygen delivery, categorized as follows:

Low-flow systems: The simplest method for delivering an oxygen-enriched air mixture; an example is a system where oxygen is delivered via a flowmeter connected to a nasal cannula or face mask.
High-flow systems: Designed to provide the patient with a gas mixture meeting their total respiratory requirements. These systems deliver stable, constant oxygen concentrations unaffected/diluted by ambient air; an example is Venturi masks, where, once the oxygen flow is set, the air inhaled by the patient is enriched with a constant oxygen concentration.
Demand valve systems: Designed to deliver 100% oxygen without contact with ambient air. Intended for short-term use only, in emergency situations.
Hyperbaric oxygen therapy: Performed in a specially designed pressurized chamber 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 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 insufficiency, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable masks.

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

Oxygen cylinders contain an internal pressure of approximately 150–200 bar. Pressure is regulated by a pressure reducer and displayed on the manometer. Multiplying the manometer reading by the cylinder’s litre capacity gives the amount of oxygen remaining in the cylinder.

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

With assisted ventilation
The minimum FiO₂ is 21%, which may be increased up to 100%.

The therapeutic goal of oxygen therapy is to ensure that arterial oxygen partial pressure (PaO₂) is not below 8 kPa (60 mmHg) or that arterial hemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO₂).

Dosage must be 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 carry a potential risk of oxygen toxicity may be required.

Continuous monitoring of therapy and ongoing assessment of therapeutic effect are essential, through repeated measurement of PaO₂ or alternatively, arterial oxygen saturation (SpO₂).

In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should maintain PaO₂ > 8 kPa, with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), while avoiding FiO₂ values > 0.6 (i.e., >60% oxygen in the inhaled gas mixture) whenever possible.

Short-term oxygen therapy must be monitored by repeated arterial blood gas measurements (PaO₂) or transcutaneous oximetry, which provides a numerical value of hemoglobin oxygen saturation (SpO₂). In any case, these indices are only indirect measurements of tissue oxygenation. Clinical evaluation of treatment remains paramount.

For long-term therapy, the need for supplemental oxygen must be determined from arterial blood gas values. Oxygen levels in the blood must be monitored to avoid excessive carbon dioxide accumulation and to adjust oxygen therapy in patients with hypercapnia.

Low oxygen concentrations should be used in patients with respiratory insufficiency 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 pulmonary collapse. Arterial oxygen pressure (PaO₂) should be monitored; however, if PaO₂ is maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Furthermore, the risk of ocular damage may be minimized by avoiding large fluctuations in oxygenation (see also Precautions for Use).

Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy refers to treatment with 100% oxygen at pressures 1.4 times higher than atmospheric pressure at sea level (1 atm = 101.3 kPa = 760 mmHg). For safety reasons, pressure in hyperbaric oxygen therapy should not exceed 3 atm.

Oxygen must be administered in a hyperbaric chamber.

The duration of sessions in a hyperbaric chamber at 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 exterior.

Hyperbaric oxygen therapy must be performed by qualified personnel trained in this treatment.

Instructions for Use and Handling
Medical oxygen cylinders, as well as fixed and mobile cryogenic containers, are intended exclusively for containing/transporting oxygen for inhalation, for therapeutic use.

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

Strictly follow these instructions:

Carefully read the instruction and user manual of the container (packaging).
Verify that all 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/aeration of 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 and base units using the appropriate trolley only; never lift a cylinder by its valve.
Use connectors, connecting tubes, or hoses specifically designed and compatible with oxygen.
Particular attention must be paid to securing pressure reducers to cylinders, if not already integrated into the container closure system, to prevent accidental breakage.
Absolutely no intervention is permitted on container fittings, delivery equipment, or related accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN).
Do not grease or attempt to repair defective valves/taps.
It is absolutely prohibited to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Contact with frozen parts (for cryogenic containers) is absolutely prohibited.

General Instructions for Use
Cylinders equipped with a 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 MORE DETAILED INFORMATION, CONSULT THE USER MANUAL OF THE CONTAINER
WARNING

Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps or valves during opening or closing.
Never position yourself in front of the gas outlet port of the tap/valve; always stand to the side. Do not expose yourself or the patient to direct gas flow.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder valve.
In case of gas leakage, close the valve and 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.

Disposal

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

Observe all applicable rules for the use and handling of pressurized cylinders and containers holding cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated areas or well-ventilated sheds, avoiding formation of hyperoxygenated 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 types of gas must be stored separately.
Fixed cryogenic containers installed at healthcare facilities must be located outdoors.

Oxygen Sico

Package leaflet: information for the patient

OXYGEN SICO 200 BAR MEDICINAL COMPRESSED GAS, CRYOGENIC MEDICINAL GAS

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

2. What you need to know before using Oxygen SICO

3. How to use Oxygen SICO

4. Possible side effects

5. How to store Ossigeno SICO

6. Package contents and other information

Patient Information Leaflet

OXYGEN SICO 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

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

2. What you need to know before you are given Ossigeno SICO

3. How SICO Oxygen will be administered to you

4. Possible side effects

5. How to store Ossigeno SICO

6. Package Contents and Other Information