OSSIGENO 200 BAR Inhalation gas

Treść ulotki

1. OSSIGENO SICO 200 BAR GAS MEDICINALE COMPRESSO
   1. What is Ossigeno SICO and what is it used for?
   2. What you need to know before using Ossigeno SICO
   3. How to use Ossigeno SICO
   4. Possible side effects
   5. How to store Ossigeno SICO
   6. Contents of the pack and other information
2. OSSIGENO SICO 200 BAR GAS MEDICINALE COMPRESSO
   1. What is Ossigeno SICO and what is it used for
   2. What you need to know before you are given Oxygen SICO
   3. How Ossigeno SICO will be administered to you
   4. Possible side effects
   5. How to store Ossigeno SICO
   6. Contents of the pack and other information

OSSIGENO SICO 200 BAR GAS MEDICINALE COMPRESSO

OSSIGENO SICO CRYOGENIC MEDICINAL GAS

Oxygen

Read this leaflet carefully before using this medicine 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

• 1. What OSSIGENO SICO is and what it is used for
• 2. What you need to know before using OSSIGENO SICO
• 3. How to use OSSIGENO SICO
• 4. Possible side effects
• 5. How to store OSSIGENO SICO
• 6. Contents of the pack and other information

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

Ossigeno SICO contains oxygen, a gas naturally present in the air you breathe.
Medicinal oxygen promotes the transport of more 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 Ossigeno SICO

Do not use Ossigeno SICO
Under normal conditions, there are no absolute contraindications.

Warnings and precautions
Consult your doctor or pharmacist before using Ossigeno SICO.
Before starting oxygen therapy, you should know the following:

• Oxygen can have harmful effects at high concentrations. This can cause lung damage (collapse of the alveoli, inflammation of the lung), which will obstruct the supply of oxygen to the blood.
• If you have severe chronic obstructive pulmonary disease (COPD) resulting in impaired blood oxygenation, the oxygen flow rate will be low. The doctor will adjust the oxygen flow rate of the oxygen therapy.
• Adverse events may occur in newborns and premature infants such as eye damage (retinopathy). If your child needs extra oxygen, the doctor will determine the appropriate concentration of oxygen to administer.

Inform your doctor:

• if you suffer from a thyroid disease, a gland in the neck, that is overactive (hyperthyroidism)
• if you suffer from a deficiency of vitamin C and/or E or a substance called glutathione (antioxidant, i.e. that counteracts aging)
• if you have undergone treatment for paraquat poisoning (a herbicide)
• if you drink alcohol
• if you take medications to treat epilepsy (barbiturates) and/or pain (opioids)
• if you suffer from inflammation of the airways or a condition that makes breathing difficult (Chronic Obstructive Bronchopneumonia COPD, Cystic Fibrosis, pathological obesity, chest wall deformity, neuromuscular disorders)
• if you have previously suffered lung damage due to a medicine used to treat cancer (bleomycin)
• if you have recently had an X-ray.

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

• Oxygen is an oxidizing product and promotes combustion. In environments where Ossigeno SICO is used, there must be no smoke or open flames (e.g. pilot lights, stoves, ovens, gas stoves, 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 appliances during your oxygen treatment.
• Do not apply greasy substances (e.g. oils, creams, lotions, lipsticks) to surfaces in contact with oxygen. Only water-based products should be used on hands and face or inside the nose.
• The pressure regulator must be opened slowly and carefully to avoid the risk of sudden flames.

Thermal burns related to accidental fire have occurred in the presence of oxygen.

Advice for those caring for patients:

• Handle the cylinder with care. Make sure the gas cylinder is not dropped or exposed to shocks.
• Damage to the equipment can cause an obstruction of the opening and/or incorrect information on the manometer display regarding the residual oxygen content and flow, leading to insufficient or missing oxygen administration.
• Oxygen becomes a liquid at approximately -183°C. At such low temperatures, there is a risk of burns. Always wear gloves and eye protection when working with liquid medical oxygen.

Children
In newborns and premature infants, oxygen therapy can 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 Ossigeno SICO
Tell your doctor or pharmacist if you are taking or have recently taken any other
medicines. In particular, tell your doctor if you are taking:

• catecholamines (e.g. epinephrine, norepinephrine), medicines that have effects on multiple organs of the body and are generally used for the 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 e.g. bleomycin, cyclophosphamide, 1,3-bis(2- chloroethyl)-1-nitrosourea), adriamycin and actinomycin,
• antimicrobial agents (e.g. nitrofurantoin), medicines to treat germ infestations,
• menadione-based supplements (precursor of vitamin K),
• medicines to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine),
• chloroquine, a medicine to treat malaria.

Ossigeno SICO and alcohol
Donot drink alcohol during treatment with Ossigeno SICO.

Pregnancy and breastfeeding
Ossigeno SICO can be used during pregnancy, but only when necessary due to
critical conditions.
Ossigeno SICO can be used during breastfeeding.
In all situations, you should inform your doctor if you are pregnant or suspect you are pregnant.

Driving and operating machinery
You can drive and operate machinery while using Ossigeno SICO as long as your doctor considers
you capable of doing so.

3. How to use Ossigeno SICO

Use this medicine following the instructions of your doctor or pharmacist exactly. If you have any
doubts, consult your doctor.
Usually Ossigeno SICO is inhaled through the nose and mouth via a nasal cannula or a
mask.
The dose will be established by the doctor based on your health condition.
It is possible that during treatment with Ossigeno SICO the doctor will perform arterial blood gas
measurements and monitor oxygen levels bound to hemoglobin, a protein that carries
oxygen in the blood.

If you use more Ossigeno SICO than you should
contact your doctor or go to hospital immediately.
The symptoms of an overdose that you may experience are:

• inflammation of the throat,
• cough and chest pain,
• difficulty breathing (dyspnea, hypoventilation)
• damage to the bronchi and lungs,
• visual and auditory disturbances,
• nausea, dizziness,
• anxiety, confusion, irritability
• cramps and muscle spasms,
• loss of consciousness,
• uncontrolled body movements (convulsions), sometimes even with loss of awareness (seizures). Treatment If you use high doses, the doctor will reduce the dose or stop administration, administer appropriate therapy and monitor you carefully.

4. Possible side effects

Like all medicines, Ossigeno SICO can cause side effects, although not everybody gets 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: damage to the eyes (retinopathy), which can lead to
impaired vision.

Frequency not known (the frequency cannot be estimated from the available data):
Dryness of the mucous membranes, local irritation and inflammation of the mucosa.
Pulmonary toxicity: inflammation of the airways (with pain related to breathing and dry cough), presence of
fluid in the lungs (interstitial edema), presence of scar tissue (pulmonary fibrosis).
Worsening of carbon dioxide levels in the blood in patients with oxygen deficiency/excess carbon dioxide if
treated with too much oxygen: reduced breathing, alteration of the acid content in the blood (respiratory
acidosis), respiratory arrest.
Contact with liquid oxygen causes cold burns.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also
report side effects directly through 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 which is stated on the label after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ossigeno SICO contains

• The active ingredient is oxygen.

Description of the appearance of Ossigeno SICO and contents of the pack

Compressed medicinal gas
Ossigeno SICO compressed medicinal gas is packaged in cylinders in a compressed gas state at
200 bar at 15°C. The cylinders are made of steel or aluminum alloy, equipped with valves capable of
connecting to a pressure regulator or reducing valves with an integrated pressure regulator.

Cryogenic medicinal gas
Ossigeno SICO cryogenic medicinal gas is packaged in mobile cryogenic containers (base units).
It is available in the following packs:

Compressed medicinal gas
Steel cylinders with a valve of 0.5, 1, 2, 3, 5, 7, 10, 14, 17, 20, 24, 27, 30 liters; aluminum cylinders with a
valve of 2, 3, 5, 7, 10 liters.

Cryogenic medicinal gas
mobile cryogenic container of 25.5, 30, 31, 33, 38, 41, 46 liters.
It is possible that not all packs are marketed.

Holder of the marketing authorization
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)
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The following information is intended exclusively for doctors or healthcare professionals:
Precautions for use
Oxygen must be administered with caution, with adjustments based on the individual patient's needs. The lowest dose that allows maintaining the pressure at 8 kPa (60 mm Hg) must be administered. Higher concentrations must be administered for the shortest possible period, frequently monitoring blood gas analysis values.
Before starting oxygen therapy, you should know the following:
Oxygen can be safely administered at the following concentrations and for the following periods of time:
Up to 100%: less than 6 hours
60-70%: 24 hours
40-50%: over the second 24-hour period.
Oxygen is potentially toxic after two days at concentrations higher than 40%.
Low concentrations of oxygen should be used for patients with respiratory failure where the stimulus for breathing is represented by hypoxia. In these cases, treatment must be carefully monitored, measuring arterial oxygen tension (PaO), or via pulse oximetry (arterial oxygen saturation – SpO) and clinical assessments.
High concentrations of oxygen in the air or inhaled gas determine the decrease in the concentration and pressure of nitrogen. This also reduces the concentration of nitrogen in the tissues and lungs (alveoli). If oxygen is absorbed into the blood through the alveoli faster than it is supplied through ventilation, the alveoli may collapse (atelectasis). This can hinder the oxygenation of arterial blood, because gas exchange does not occur despite perfusion.
In patients with reduced sensitivity to the pressure of carbon dioxide in arterial blood, high levels of oxygen can cause carbon dioxide retention. In extreme cases, this can lead to carbon dioxide narcosis.
Be careful in newborns and premature infantsto minimize the risk of adverse events such as ocular damage. If the child requires supplemental oxygen, give only the amount of Ossigeno SICO recommended by the doctor.

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

• Oxygen is an oxidizing product and promotes combustion. There must be no smoke or open flames in areas where Ossigeno SICO is used, as it increases the risk of fire.
• Do not use electrical appliances during the 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 flashback. Furthermore:
• Handle the cylinder carefully. Ensure that the gas cylinder is not dropped or exposed to shocks.
• Oxygen becomes liquid at approximately -183°C. There is a risk of cold burns at such low temperatures. Always wear gloves and protective goggles when handling liquid medicinal oxygen.

Special warnings

• In oxygen-enriched environments, oxygen can saturate clothing.
• It is strictly forbidden to touch frozen parts (for cryogenic containers).
• Cylinders and cryogenic mobile containers cannot be used if there is obvious damage or if they are suspected of being damaged or exposed to extreme temperatures.
• Only equipment suitable and compatible with oxygen for the specific model of container can be used.
• Pliers or other tools must not be used to open or close the cylinder valve, in order to prevent the risk of damage.
• In case of leakage, the cylinder valve must be closed immediately, if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer place outdoors to allow the oxygen to escape freely.
• The valves of empty cylinders must be kept closed.
• Oxygen has a strong oxidizing effect and can react violently with organic substances. This is why the handling and storage of containers require special precautions.
• It is not permitted to release gas under pressure.

Dosage, method and time of administration
Oxygen (compressed or cryogenic) is administered through the inhaled air, preferably using dedicated devices (such as a nasal catheter or a face mask); the dosage to the patient is carried out independently of the packaging of the medicinal gas using dosing devices (flowmeters).
With these systems, oxygen is administered through the inspired air, while the exhaled gas and any excess oxygen leave the patient's inspiratory circuit mixing with the surrounding air (open or anti-rebreathingsystem).

Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than that of atmospheric air, containing a percentage of oxygen in the inspired air (FiO) greater than 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
In patients not affected by respiratory failure, oxygen can be administered with spontaneous ventilation via nasal cannulae, nasopharyngeal probes or suitable masks.
In patients with respiratory failure or anesthetized, oxygen must be administered with assisted ventilation.
Oxygen cylinders have a pressure of approximately 150-200 bar inside. The high pressure is regulated by a regulator and is detectable on the manometer. Multiplying the figure indicated by the manometer by the content in liters of the cylinder 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 liters/minute, adjustable based on blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 liters/minute, adjustable based on blood gas analysis.

Instructions for use and handling
Medicinal oxygen cylinders, as well as cryogenic containers, are reserved 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 the risk of shocks and falls.
Imperatively respect the following instructions:

• Read the container (pack) instruction and use manual carefully
• Verify that all material is in good condition.
• Secure the cylinders and base units to keep them in a vertical position and prevent falls, protect the containers from shocks and keep them at a temperature below 50°C, ensuring adequate ventilation/aeration of the premises where the product is used. Cylinders must be equipped with a cap/tulip to protect the valve.
• Handle the material with clean hands, free of traces of grease or oil.
• Lift and move the cylinders and base units using only the appropriate trolley, do not lift the cylinder by the valve.
• Use fittings, connecting tubes or flexible connecting hoses specifically designed and compatible with oxygen.
• Particular attention must be paid to the fixing of pressure regulators on the cylinders, if not already integrated into the container closing system, in order to avoid the risk of accidental breakage.
• It is strictly forbidden to intervene in any way on the fittings of the containers, on the dispensing equipment and related accessories or components (OIL AND GREASE CAN CATCH FIRE WHEN IN CONTACT WITH OXYGEN).
• Do not grease or attempt to repair faulty valves/taps.
• It is strictly forbidden to handle the equipment or components with hands or clothes or face soiled with grease, oil, creams and various ointments.
• It is strictly forbidden to touch frozen parts (for cryogenic containers).

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

• 1. Remove the protective cap if present
• 2. Make sure the dispensing valve is closed
• 3. Remove the tamper-evident seal
• 4. Connect the regulator to the cylinder valve and the related flowmeter
• 5. Connect the humidifier/bubbler
• 6. Connect the cannula with mask or goggles to the humidifier
• 7. Slowly open the main valve until fully open
• 8. Adjust the flowmeter to the required flow rates (liters/minute) Cylinders equipped with an integrated reducing valve
• 1. Make sure the valve is closed
• 2. Remove the tamper-evident seal
• 3. Make sure the flow indicator is set to zero
• 4. Connect the humidifier/bubbler
• 5. Connect the cannula with mask or goggles to the humidifier
• 6. Slowly open the main valve until fully open
• 7. Adjust the flowmeter to the required flow rates (liters/minute)

Mobile cryogenic containers

• 1. Make sure the flow indicator is set to zero
• 2. Remove the tamper-evident seal
• 3. Connect the humidifier /bubbler
• 4. Connect the cannula with mask or goggles to the humidifier
• 5. Position the flow regulator to the required flow rates (liters/minute)

NOTE: FOR MORE DETAILS, CONSULT THE CONTAINER’S USER MANUAL
WARNING

• Gradually open the container closure systems (valve or tap) to avoid pressure surges.
• Do not force taps and valves during opening and 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 flow of gas.
• Do not use oil or grease in contact with the gas.
• Do not completely empty the container.
• After use, close the cylinder tap.
• In case of gas leakage, close the tap and notify the technical intervention service of the supplier indicated in the Container’s User Manual.
• Use only containers suitable for the product, at the foreseen operating pressure and temperature.

Disposal

• Store empty cylinders with the valves closed.
• Do not discharge into sewers, basements or excavations where accumulation may be dangerous.
• Return empty or no longer used containers, even if only partially empty, to the supplier. Any residual medicinal product present in the pressure cylinder will be eliminated, through appropriate procedures, in a well-ventilated area by the company that will subsequently refill the same container.

Observe all rules pertaining to the use and handling of pressurized cylinders and
containers containing cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in
well-ventilated environments, or in well-ventilated sheds, avoiding the formation of
hyperoxygenated atmospheres (O > 21% vol), in a vertical position with the valves closed and protected from rain and
inclement weather, from exposure to direct sunlight and away from sources of heat or ignition, from
combustible materials. Empty containers or those containing other types of gas must be stored
separately.

OSSIGENO SICO 200 BAR GAS MEDICINALE COMPRESSO

OSSIGENO SICO CRYOGENIC MEDICINAL GAS

Oxygen

Read this leaflet carefully before you are given 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 nurse.
• If any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What is Ossigeno SICO and what it is used for
• 2. What you need to know before you are given Ossigeno SICO
• 3. How you will be given Ossigeno SICO
• 4. Possible side effects
• 5. How to store Ossigeno SICO
• 6. Contents of the pack and other information

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

Ossigeno SICO contains oxygen, a gas naturally present in the air we breathe.
Medicinal oxygen causes more oxygen to be transported 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),
• for treatment in anesthesia,
• in intensive care, a place in the hospital where seriously ill patients are admitted,
• in a hyperbaric chamber, a room where the air pressure is higher than that in the atmosphere.

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

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

• Oxygen can have harmful effects at high concentrations. This can cause lung damage (collapse of the alveoli, lung inflammation), which will obstruct the oxygen supply in the blood.
• If you have severe chronic obstructive pulmonary disease (COPD) with resulting impaired blood oxygenation, the oxygen flow rate will be low. The doctor will adjust the oxygen flow rate of the oxygen therapy.
• Adverse events may occur in newborns and premature infants such as eye damage (retinopathy). If your child needs extra oxygen, the doctor will determine the appropriate concentration of oxygen to administer.

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

• you suffer from a lung disease that causes the formation of blisters in the lungs (bullous emphysema)
• you suffer from asthma
• you suffer from or have suffered from a collapsed lung (pneumothorax)
• you suffer from a lung disease that makes it difficult to empty air from the lungs, shortness of breath (also called dyspnea) or feeling tired (COPD)
• you suffer from a lung inflammation (Pneumocystis carinii pneumonia)
• you suffer from a disease characterized by uncontrolled body movements (epilepsy)
• you are afraid 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 heatstroke (hyperthermia)
• you suffer from a disease of the red blood cells, a type of blood cell (hereditary spherocytosis)
• you suffer from a disease of the optic nerve
• you suffer from malignant tumors
• you suffer from high levels of acid in the blood (acidosis)
• you are taking medications to treat tumors such as doxorubicin, adriamycin, bleomycin, daunorubicin, cis-platinum,
• you are taking medications to treat inflammation such as corticosteroids
• you are taking a medication to treat alcohol dependence (disulfiram), and consume alcohol
• you have recently been exposed to toxic substances (aromatic hydrocarbons)
• you smoke or use medications to help people quit smoking based on nicotine
• the newborn was premature.

Warnings and precautions
Consult your doctor before using Oxygen SICO.

• if you suffer from a thyroid disease, a gland in the neck, that is overactive (hyperthyroidism)
• if you suffer from a deficiency of vitamin C and/or E or a substance called glutathione (antioxidant, i.e. that counteracts aging)
• if you have undergone treatment for paraquat poisoning (a herbicide)
• if you consume alcohol
• if you are taking medications to treat epilepsy (barbiturates) and/or pain (opioids)
• if you are affected by inflammation of the airways or a condition that makes breathing difficult (Chronic Obstructive Bronchopneumonia COPD, Cystic Fibrosis, pathological obesity, chest wall deformity, neuromuscular disorders)
• if you have previously suffered lung damage due to a medication used to treat cancer (bleomycin)
• if you have recently had an X-ray. The doctor will assess whether to administer oxygen in a hyperbaric chamber if:
• you suffer from inflammation of the ears and/or nose (recurrent otitis and/or sinusitis)
• you suffer from a heart disease (ischemic and/or congestive heart disease)
• you suffer from high blood pressure and are not taking medication to treat it (untreated arterial hypertension)
• you suffer from lung diseases that prevent the passage of air (restrictive and/or severe 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 contained in the eyes (glaucoma), or retinal detachment, a membrane of the eye
• you suffer from diabetes mellitus, as hyperbaric therapy may prevent the correct absorption of insulin and increase blood sugar levels (hyperglycemia);
• you suffer from seizures (epilepsy)
• you have a high fever
• you suffer from severe anxiety, mental disorders and claustrophobia (fear of being in closed and confined spaces).

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

• Oxygen is an oxidizing product and promotes combustion. In environments where Oxygen SICO is used, there must be no smoke or open flames (e.g. pilot lights, stoves, ovens, gas stoves, 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 greasy substances (e.g. oils, creams, lotions, lipsticks) to surfaces in contact with oxygen. Only water-based products should be used on hands and face or inside the nose.
• The pressure regulator must be opened slowly and carefully to avoid the risk of sudden flames.

Thermal burns related to accidental fire have occurred in the presence of oxygen.

Advice for those caring for patients:

• Handle the cylinder with care. Make sure the gas cylinder is not dropped or exposed to impacts.
• Damage to the equipment can cause an obstruction of the opening and/or incorrect information on the manometer display regarding the residual oxygen content and flow, leading to insufficient or missing oxygen administration.
• Oxygen becomes a liquid at about -183°C. At such low temperatures, there is a risk of burns. Always wear gloves and eye protection when working with liquid medical oxygen.

Children
In newborns and premature infants, oxygen therapy can lead to eye damage (retinopathy of
premature infants), lung damage and brain hemorrhages. The doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your child.

Other medications and Oxygen SICO
Tell your doctor if you are taking or have recently taken any other medications.
In particular, tell your doctor if you are taking:

• catecholamines (e.g. epinephrine, norepinephrine), medications that have effects on multiple organs of the body and are generally used for emergency treatment of sudden allergic reactions, corticosteroids (e.g. dexamethasone, methylprednisolone), medications to treat inflammation,
• hormones (e.g. testosterone, thyroxine),
• amiodarone, a medication to treat heart rhythm disorders,
• medications to treat tumors such as bleomycin, cyclophosphamide, 1,3-bis(2- chloroethyl)-1-nitrosourea, adriamycin and actinomycin,
• antimicrobial agents (e.g. nitrofurantoin), medications to treat germ infestations,
• menadione-based supplements (precursor to vitamin K),
• medications to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine),
• chloroquine, a medication to treat malaria.

Oxygen SICO and alcohol
Donot consume alcohol during treatment with Oxygen SICO.

Pregnancy and breastfeeding
Oxygen SICO can be used during pregnancy, but only when necessary due to
critical conditions.
Oxygen SICO can be used during the breastfeeding period.
In all situations, you must inform your doctor if you are pregnant or suspect you are pregnant.
Hyperbaric oxygen therapy is contraindicated in the first trimester of pregnancy. The doctor will decide whether
to administer this treatment in case of severe carbon monoxide poisoning.

Driving and operating machinery
Visual and auditory disturbances have been reported after hyperbaric oxygen therapy.
Do not drive vehicles or use machinery until these symptoms have completely
disappeared.

3. How Ossigeno SICO will be administered to you

This medicine will be administered to you through inhaled air, always following the doctor's or nurse's instructions exactly. If you have any doubts, consult your doctor.
Usually Ossigeno SICO is inhaled through the nose and mouth via a nasal cannula or a
mask.
The dose will be established by the doctor based on your state of health.
It is possible that during treatment with Ossigeno SICO the doctor will perform arterial blood gas measurements and monitor oxygen levels bound to hemoglobin, a protein that carries
oxygen in the blood.

If you are given more Ossigeno SICO than you should

• inflammation of the throat,
• cough and chest pain,
• difficulty breathing (dyspnea, hypoventilation),
• damage to the bronchi and lungs,
• visual and auditory disturbances,
• nausea, dizziness,
• anxiety, confusion, irritability
• cramps and muscle spasms,
• loss of consciousness,
• uncontrolled body movements (convulsions), sometimes even with loss of awareness (seizures).

Treatment
If you use high doses, the doctor will reduce the dose or stop administration, will administer appropriate therapy and will monitor you carefully.

4. Possible side effects

Like all medicines, Ossigeno SICO can cause side effects although not everybody gets 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: damage to the eyes (retinopathy), which can lead to
impaired vision.
With hyperbaric treatment: ear pain, myopia, barotrauma (injury caused to the body's tissues or
organs by changes in pressure).

Common (may affect up to 1 in 10 people)
With hyperbaric treatment: convulsions.

Uncommon (may affect up to 1 in 100 people):
With hyperbaric treatment: eardrum rupture.

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 (the frequency cannot be estimated from the available data):,
Dryness of the mucous membrane, local irritation and inflammation of the mucous membrane.
Pulmonary toxicity: inflammation of the airways (with pain related to breathing and
dry cough), presence of fluid in the lungs (interstitial edema), presence of scar tissue
(pulmonary fibrosis).
Worsening of carbon dioxide levels in the blood in patients with oxygen deficiency/excess carbon dioxide if treated with too much oxygen: reduced
breathing, alteration of the acid content of the blood (respiratory acidosis), respiratory arrest.
With hyperbaric treatment: difficulty breathing, involuntary muscle contraction, dizziness,
hearing loss, acute otitis media, ringing in the ears (tinnitus), nausea, abnormal behavior,
reduction of peripheral vision, blurred vision, clouding of the lens (cataract).
Contact with liquid oxygen causes cold burns.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through 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 which is stated on the label after SCAD. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how
to dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Ossigeno SICO contains

• The active ingredient is oxygen

Description of the appearance of Ossigeno SICO and contents of the pack

Compressed medicinal gas
Ossigeno SICO compressed medicinal gas is packaged in cylinders and cylinder packs, in the state of
compressed gas at 200 bar at 15°C. The cylinders are made of steel or aluminum alloy, equipped with
valves capable of connecting to a pressure regulator or reducing valves with an integrated pressure regulator.

Cryogenic medicinal gas
Ossigeno SICO cryogenic medicinal gas is packaged in mobile (base units) or fixed cryogenic containers.
It is available in the following packs:

Compressed medicinal gas
Steel cylinders with 40 and 50 liter valve. Cylinder pack of 16 cylinders of 40 liters, cylinder pack of 12 and 20 cylinders of 50 liters.

Cryogenic medicinal gas
mobile cryogenic container of 25.5, 30, 31, 33, 38, 41, 46

Cryogenic medicinal gas
fixed cryogenic container of 1000, 1500, 2000, 3000, 5000, 6000, 10,000, 20,000 liters.
It is possible that not all packs are marketed.

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 Industrial Area – 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 Area – Contrada Argentieri – Bari
SOM di D’Aquino di A&C snc – Via Giarre Nunziata Z.I., 67 – Locality Mascali - Catania
Pirossigeno Srl – Via Pirelli, 10 – 87040 – Castroliberi (CS)
Augimeri Ossigeno di Mascalchi Emilio - Porto di Gioia Tauro II – Industrial Area - 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 Area – 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 Area – Contrada Argentieri – Bari
S.O.M. di D’Aquino Anna Rita & C snc – Via Giarre, 67 – Nunziata – Industrial Area - Mascali –
Catania (CT)
Pirossigeno Srl – Via Pirelli, 10 – Castrolibero (CS)
Augimeri Ossigeno di Emilio Mascalchi – Porto di Gioia Tauro – Industrial Area – 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 – Locality 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)
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The following information is intended exclusively for doctors or healthcare professionals:
Precautions for use
Oxygen must be administered with caution, with adjustments based on the individual patient's needs. The lowest dose that allows maintaining the pressure at 8 kPa (60 mm Hg) must be administered. Higher concentrations must be administered for the shortest possible period, frequently monitoring blood gas values.
Before starting oxygen therapy, you must know the following:
Oxygen can be administered safely at the following concentrations and for the following periods of time:
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 greater than 40%.
Low concentrations of oxygen should be used for patients with respiratory failure in whom the stimulus for breathing is represented by hypoxia. In these cases, treatment must be carefully monitored, measuring arterial oxygen tension (PaO2), or via pulse oximetry (arterial oxygen saturation – SpO2) and clinical assessments.
High concentrations of oxygen in the air or inhaled gas determine the decrease in the concentration and pressure of nitrogen. This also reduces the concentration of nitrogen in tissues and in the lungs (alveoli). If oxygen is absorbed into the blood through the alveoli faster than it is supplied through ventilation, the alveoli may collapse (atelectasis). This can hinder the oxygenation of arterial blood, because gas exchange does not occur despite perfusion.
In patients with reduced sensitivity to arterial carbon dioxide pressure, high levels of oxygen can cause carbon dioxide retention. In extreme cases, this can lead to carbon dioxide narcosis.
Be careful in newborns and premature infantsto minimize the risk of adverse events such as retinal damage. If the child requires supplemental oxygen, give only the amount of Ossigeno SICO recommended by the doctor.

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

• Oxygen is an oxidizing product and promotes combustion. There must be no smoke or open flames in areas where Ossigeno SICO is used, as it increases the risk of fire.
• Do not use electrical appliances during the 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 flashback.

Furthermore:

• Handle the cylinder carefully. Ensure that the gas cylinder is not dropped or exposed to shocks.
• Oxygen becomes liquid at approximately -183°C. There is a risk of cold burns at such low temperatures. Always wear gloves and protective goggles when handling liquid medicinal oxygen.

Special warnings

• In overoxygenated environments, oxygen can saturate clothing.
• It is strictly forbidden to touch the frozen parts (for cryogenic containers).
• Cylinders and mobile cryogenic containers cannot be used if there is obvious damage or if they are suspected of being damaged or exposed to extreme temperatures.
• Only equipment suitable and compatible with oxygen for the specific model of container can be used.
• Pliers or other tools must not be used to open or close the cylinder valve, in order to prevent the risk of damage.
• In case of leakage, the cylinder valve must be closed immediately, if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer place outdoors to allow the oxygen to escape freely.
• The valves of empty cylinders must be kept closed.
• Oxygen has a strong oxidizing effect and can react violently with organic substances. This is why the handling and storage of containers require special precautions.
• It is not permitted to administer the gas under pressure.

Dosage, method and time of administration
Oxygen (compressed or cryogenic) is administered through inhaled air, preferably using dedicated devices (such as, for example, a nasal cannula or a face mask); the dosage to the patient is carried out independently of the medicinal gas pack through dosing devices (flow meters).
With these systems, oxygen is administered through the inspired air, while the expired gas and any excess oxygen leave the patient's inspiratory circuit mixing with the surrounding air (open or anti-rebreathingsystem).
In anesthesia, a particular system is often used that allows the previously exhaled gas from the patient to be inhaled again (closed or rebreathingsystem).
Oxygen can also be administered directly into the blood through an oxygenator, with a cardiopulmonary bypass system in cardiac surgery and in other cases where extracorporeal circulation is required.
There are numerous devices designed for the administration of oxygen, and they are distinguished into:

• Low flow systemsIt is the simplest system for administering a mixture of oxygen in the inspired air, an example is the system in which oxygen is administered via a flow meter connected to a nasal cannula or face mask.
• High flow systemsSystems designed to provide the patient with a mixture of gases guaranteeing their total respiratory requirement. These systems are designed to release established and constant concentrations of oxygen that are not affected/diluted by the surrounding air, such as Venturi masks where, the oxygen flow being established, the air inspired by the patient is enriched with that constant concentration of oxygen.
• Systems with demand valveSystems designed to deliver 100% oxygen without coming into contact with the ambient air. It is intended for a short time, only when necessary.
• Hyperbaric oxygen therapyHyperbaric oxygen therapy is performed in a special pressurized chamber designed specifically where a pressure 3 times higher than atmospheric pressure can be maintained. Hyperbaric oxygen therapy can also be administered through 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 that of atmospheric air, i.e., containing a percentage of oxygen in the inspired air (FiO₂) greater than 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
Patients not affected by respiratory failure can be administered oxygen with spontaneous ventilation via nasal cannulas, nasopharyngeal probes, or suitable masks.
Patients with respiratory failure or those under anesthesia must be administered oxygen with assisted ventilation.
Oxygen cylinders have a maximum internal pressure of approximately 150-200 bar. The pressure is regulated by a regulator and is detectable on the manometer. Multiplying the figure indicated by the manometer by the cylinder's capacity in liters yields 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 liters/minute, adjustable based on blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate between 0.5 and 15 liters/minute, adjustable based on blood gas analysis.

With Assisted Ventilation
The minimum value of FiO₂ is 21% and can rise to 100%.
The therapeutic purpose of oxygen therapy is to ensure that the partial arterial pressure of oxygen (PaO₂) is not less than 8 kPa (60 mmHg) or that the hemoglobin saturated with oxygen in arterial blood is not less than 90% by regulating the fraction of inspired oxygen (FiO₂).
The dose must be adjusted according to the individual needs of each patient.
The general recommendation is to use the minimum FiO₂ value necessary to achieve the desired therapeutic effect, i.e., PaO₂ values within the normal range. In conditions of severe hypoxemia, FiO₂ values that entail a potential risk of oxygen toxicity may also be indicated.
Continuous monitoring of therapy and constant assessment of the therapeutic effect are necessary, through measurement of PaO₂ levels or, alternatively, arterial oxygen saturation (SpO₂).
In short-term oxygen therapy, the fraction of inspired oxygen (FiO₂) must be such as to maintain a PaO₂ level > 8 kPa with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), possibly avoiding FiO₂ values > 0.6, i.e., 60% oxygen in the inhaled gas mixture.
Short-term oxygen therapy must be monitored with repeated measurements of arterial blood gas (PaO₂) or by transcutaneous oximetry, which provides a numerical value of hemoglobin saturation with oxygen (SpO₂). In any case, these indices are only indirect measurements of tissue oxygenation. Clinical assessment of treatment is of paramount importance.
For long-term treatments, the need for supplemental oxygen must be determined by the values of the gas itself measured in arterial blood. To avoid excessive accumulations of carbon dioxide, oxygen in the blood must be monitored, so as to regulate oxygen therapy in patients with hypercapnia.
Low levels of oxygen concentration must be used in patients with respiratory failure in whom the stimulus for breathing is represented by hypoxia (e.g., due to COPD).
The concentration of oxygen in the inhaled air must 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, it is generally not advisable to fall below 30%. If necessary, the fraction of inspired oxygen can be increased to 100%.
Infants can receive 100% oxygen when necessary. However, careful monitoring must be carried out during treatment. It is still recommended to avoid an oxygen concentration exceeding 40% to reduce the risk of damage to the lens or pulmonary collapse. The partial pressure of oxygen in arterial blood (PaO₂) must be monitored, however, if it is maintained below 13.3 kPa (100 mmHg) and significant variations in oxygenation are avoided, the risk of ocular damage is reduced. Furthermore, the risk of ocular damage can be reduced by avoiding significant fluctuations in oxygenation (see also Precautions for Use).

Hyperbaric Oxygen Therapy
Hyperbaric oxygen therapy refers to a treatment with 100% oxygen at pressures 1.4 times greater than atmospheric pressure at sea level (1 atm = 101.3 kPa = 760 mmHg). For safety reasons, the 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) is between 60 minutes and 4-6 hours. These sessions can be repeated 2 to 4 times a day, depending on the patient's clinical condition.
Compression and decompression should be carried out slowly in accordance with commonly adopted procedures, in order to avoid the risk of pressure damage (barotrauma) to air-containing anatomical cavities communicating with the outside.
Hyperbaric oxygen therapy must be performed by qualified personnel for this treatment.

Instructions for Use and Handling
Medical oxygen cylinders, as well as fixed and mobile cryogenic containers, are reserved exclusively for containing/transporting oxygen for inhalation, for therapeutic use.
Mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from the risk of shocks and falls.
Imperatively respect the following instructions:

• Read the container (packaging) instruction and use manual carefully.
• Verify that all material is in good condition.
• Secure the cylinders and base units to keep them in a vertical position and prevent falls, protect the containers from shocks and keep them at a temperature below 50°C, ensuring

adequate ventilation/aeration of the premises where the product is used. Cylinders must be fitted with a cap/tulip to protect the valve.

• Handle the material with clean hands, free of traces of grease or oil.
• Lift and move the cylinders and base units using only the appropriate trolley, do not lift the cylinder by the valve.
• Use fittings, connecting tubes or flexible connecting hoses specifically designed and compatible with oxygen.
• Particular attention must absolutely be paid to the fixing of pressure regulators on the cylinders, if not already integrated into the container's closing system, in order to avoid the risk of accidental breakage.
• It is strictly forbidden to intervene in any way on the fittings of the containers, on the delivery equipment and related accessories or components (OIL AND GREASE CAN SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN).
• Do not grease or attempt to repair defective valves/taps.
• It is strictly forbidden to handle the equipment or components with hands or clothing or face soiled with grease, oil, creams and various ointments.
• It is strictly forbidden to touch the frozen parts (for cryogenic containers).

General Instructions for Use
Cylinders fitted with a shut-off valve only

• 1. Remove the protective cap if present
• 2. Ensure that the flow control valve is closed
• 3. Remove the tamper-proof seal
• 4. Connect the regulator to the cylinder valve and the relative flowmeter
• 5. Connect the humidifier/bubbler
• 6. Connect the cannula with mask or goggles to the humidifier
• 7. Slowly open the main valve until fully open
• 8. Adjust the flowmeter to the required flow rates (liters/minute)

Cylinders fitted with an integrated reducing valve

• 1. Ensure that the valve is closed
• 2. Remove the tamper-proof seal
• 3. Ensure that the flow indicator is positioned at zero
• 4. Connect the humidifier/bubbler
• 5. Connect the cannula with mask or goggles to the humidifier
• 6. Slowly open the main valve until fully open
• 7. Adjust the flowmeter to the required flow rates (liters/minute)

Mobile cryogenic containers

• 1. Ensure that the flow indicator is positioned at zero
• 2. Remove the tamper-proof seal
• 3. Connect the humidifier /bubbler
• 4. Connect the cannula with mask or goggles to the humidifier
• 5. Position the flow regulator to the required flow rates (liters/minute)

NOTE: FOR MORE DETAILS CONSULT THE CONTAINER USAGE MANUAL
WARNING

• Gradually open the closing systems of the containers (the valve or tap) to avoid pressure surges.
• Do not force taps and valves during opening and closing.
• Never position yourself in front of the gas outlet from the tap/valve, but always on the opposite side. Do not expose yourself or the patient to the direct flow of gas.
• 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 intervention service of the supplier indicated on the Container Usage Manual.
• Use only containers suitable for the product, at the foreseen pressure and temperature of use.

Disposal

• Store empty cylinders with the valves closed.
• Do not discharge into sewers, basements or excavations where accumulation may be dangerous.
• Return empty or no longer used containers, even if only partially empty, to the supplier. Any unused medicinal product residue present in the pressure cylinder will be disposed of, via appropriate procedures, in a well-ventilated area by the company that will then refill the same container.

Observe all rules pertaining to the use and handling of pressure cylinders and containers containing cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated environments, or in well-ventilated sheds, avoiding the formation of over-oxygenated atmospheres (O > 21% vol), in a vertical position with the valves closed and protected from rain and bad weather, from exposure to direct sunlight and away from sources of heat or ignition, from combustible materials. Empty containers or those containing other types of gas must be stored separately.
Fixed cryogenic containers, installed in healthcare facilities, must be located outdoors.