Aria Sico: detailed information

Package leaflet: Information for the patient

ARIA SICO 200 BAR MEDICINAL COMPRESSED SYNTHETIC GAS

Oxygen
Please 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, pharmacist, or nurse.
If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

ARIA SICO is medicinal air containing pure medicinal gases and gas mixtures.
Medicinal air is administered by inhalation (through the nose or mouth) and provides an alternative source of air, used for its oxygen content and specific properties.
ARIA SICO is indicated in patients of all ages:

in resuscitation to support breathing (ventilatory assistance);
to assist breathing in conditions of chronic respiratory difficulty;
in anaesthesia as a carrier gas for drugs inducing sleep (volatile anaesthetics);
to administer nebulized medications;
in the management of patients with disorders of the body's defence system (immune system), such as in cases of organ transplantation,
cellular transplantation, or extensive burns;
in incubators to provide air of controlled quality;
to introduce air into a body cavity (cavitary insufflation).

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

You must not be given ARIA SICO if:
you need to be treated exclusively with pure oxygen or with other medicinal gas mixtures containing oxygen in quantities higher than those normally present in air (21%).

Warnings and precautions
Talk to your doctor or pharmacist before you are given ARIA SICO.
Before and during administration of medicinal air, you must strictly follow the safety precautions listed below.

Safety precautions
During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames close to the container.
Do not use any electrical equipment that may produce sparks near patients receiving medicinal air.
Do not use oils or greases on connectors, taps, valves, or on any material in contact with oxygen.
Never introduce air into a device that might contain combustible materials, and in particular fatty substances.
Do not tamper in any way with cylinder connectors, delivery equipment, or their accessories or components.
Avoid any contact with oil or grease.
Do not handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or various ointments.

Other medicines and ARIA SICO
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions with other medicinal products have been reported.

ARIA SICO with food and alcohol
No interactions with alcohol, tobacco, or food have been reported.

Pregnancy and breastfeeding
If you are pregnant, think you might be pregnant, planning to become pregnant, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Medicinal air at atmospheric pressure can be used during pregnancy and breastfeeding.

Driving and using machines
The use of medicinal air does not affect the ability to drive or operate machinery.

3. How ARIA SICO will be administered to you

This medicine will always be administered to you exactly as instructed by your doctor or nurse. If you have any doubts, please consult your doctor.
Medical air is generally inhaled through the nose or mouth via a facial mask or a cannula placed directly into the airways, or it may be blown through a cannula into the affected body cavity.
The dose, frequency, and duration of treatment with medical air will be determined by your doctor based on your health status.
If you are given more ARIA SICO than you should
It is highly unlikely that you will be given more ARIA SICO than required, as your doctor or nurse will monitor you during treatment.
Symptoms you might experience due to an excessive dose of pressurized medical air are: decompression sickness (due to the effects of nitrogen) and oxygen toxicity.
Treatment
If you are given more ARIA SICO than you should, your doctor will provide appropriate therapy and monitor you closely.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
The assessment of side effects is based on the following frequency data.
Very common (may affect more than 1 in 10 people):

dry mouth,
headache

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist or nurse.
You can also report side effects directly via the website
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse .
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store ARIA SICO

Store cylinders 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 ARIA SICO Contains
The cylinders contain:

The active substance is oxygen 21–22.5%
The excipient is nitrogen

Description of the Appearance of ARIA SICO and Contents of the Package
ARIA SICO medicinal synthetic compressed 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 and equipped with valves suitable for connection to a pressure reducer.
Available pack sizes include:

Steel cylinders with valves of 3, 5, 7, 10, 14, 40, 50 litres.
Steel cylinder packs: packs of 12 cylinders of 50 litres, packs of 16 cylinders of 40 litres.
Aluminium cylinders with valves of 3, 10 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
SICO Società Italiana Carburo Ossigeno S.p.A. Via Morandi, 10 – Saronno (VA)
SICO Società Italiana Carburo Ossigeno S.p.A. Via della Risaia, 238 – Crevalcore (BO)
SICO Società Italiana Carburo Ossigeno S.p.A. Via Pionieri del Commercio Barese – Zona Industriale ASI – Bari
SICO Società Italiana Carburo Ossigeno S.p.A. Via Moncalieri, 30 – Villastellone (TO)
SICO Società Italiana Carburo Ossigeno S.p.A. Via Boscalto, 47 – Resana (TV)

The following information is intended exclusively for physicians or healthcare professionals:
Dosage and Method of Administration
Dosage, frequency, and duration of treatment depend on the therapeutic indications and the patient's clinical condition.
In particular, in cases of hypoxia, the flow rate and duration of administration must be determined according to the cause of hypoxia. In these cases, artificial ventilation using medicinal air aims to:

restore the normal tidal volume of approximately 500 ml of air in adults; in children, this volume varies according to weight, height, sex, and age.
restore normal oximetry values, which normally range between 94–100%, corresponding to PaO₂ values equal to or greater than 60 mmHg. In highly premature newborns, relatively lower oximetry values may be considered acceptable during the first hours of life. When ambient air needs to be replaced, the purpose of using medicinal air is to ensure reliable delivery of a gas containing oxygen at a concentration corresponding to that of normal ambient air, without the risk of administering potentially irritating substances. Medicinal air should be mixed with medicinal oxygen to achieve the desired oxygen concentration, using the following formula:

[(litres of air/minute × 21) + (litres of oxygen/minute × 100)]
FiO₂ = ----------------------------------------------------------------------------------------------------------------
[(litres of air/minute + litres of oxygen/minute) × 100]

Method of Administration
In artificial ventilation and resuscitation stages in infants, pharmaceutical carrier use, hyperoxia/hypoxia stages, and anesthesia, medicinal air is generally administered by inhalation via facial mask or orotracheal/nasotracheal tubes, delivered through various techniques, usually by respiratory and ventilatory devices, and may be delivered via pressure-cycled or volume-cycled systems.
In cavity insufflation, medicinal air is delivered via an endoscope, which is generally equipped with a dedicated cannula.

Special Warnings and Precautions for Use
Medicinal air should be administered to patients only at atmospheric pressure or slightly positive pressures when ventilators are used. Administration of medicinal air under pressure may cause decompression sickness (due to nitrogen effects) and oxygen toxicity.
When medicinal air is mixed with other inhalation gases, the inhaled oxygen fraction (FiO₂) in the gas mixture must be maintained at least at 21%. In practice, this means that if medicinal air is a component of a gas mixture, oxygen must be one of the other components.
During use at exceptionally high flow rates, such as in incubators, medicinal air may feel cold.
Prior to and during administration of the medicinal product, strict adherence to the safety precautions described below is required.

SAFETY (see also section Instructions for Use and Handling)
It is important to remember that air itself is not flammable, but oxygen (as an oxidizer) supports combustion; it can therefore initiate combustion in the presence of combustible materials such as fats (oils, lubricants) and organic substances (fabrics, wood, paper, plastics, etc.), especially when triggered by ignition sources (sparks, open flames, ignition sources), or by adiabatic compression that may occur in pressure-reducing equipment (reducers) during sudden gas pressure reduction.

Cylinders containing medicinal air must be kept away from heat sources due to the oxidizing nature of oxygen; appropriate precautions must therefore be taken.
Oxygen can cause sudden ignition of glowing materials or embers; therefore, smoking or using unshielded open flames near cylinders and delivery systems is strictly prohibited.
Do not smoke in areas where medicinal air is being administered.
Do not place cylinders near heat sources.
Electrical equipment capable of producing sparks must not be used near patients receiving medicinal air.
Any intervention on cylinder connections, delivery equipment, or their accessories or components is strictly prohibited.
Contact with oil, grease, or other hydrocarbons must be avoided (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
It is strictly forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
Cylinders must not be used if visible damage is present or if damage is suspected, or if they have been exposed to extreme temperatures.
Only equipment suitable and compatible with the specific cylinder model may be used.
Pliers or other tools must not be used to open or close the cylinder valve to prevent damage risks.
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 gas to escape freely.
Valves on empty cylinders must remain closed.
Pressurized gas administration is not permitted.

Storage Precautions
Observe all applicable rules for the use and handling of pressurized cylinders.
Store cylinders at temperatures between -10°C and 50°C, in well-ventilated, well-lit areas using cold light sources and equipped with appropriate emergency systems, in an upright position with valves closed, protected from rain, weather, direct sunlight, heat sources, ignition sources (including static charges), and combustible materials.
Empty containers or those containing other types of gas must be stored separately.
Cylinders must be used in strict rotation order, ensuring that cylinders with earlier filling dates are used first.

Instructions for Use and Handling
All individuals handling medicinal air cylinders should have adequate knowledge of:

gas properties;
correct operational procedures for cylinders;
safety precautions and emergency actions.

Medicinal air cylinders are exclusively intended for containing/transporting inhaled air for therapeutic use. Cylinders must be transported using appropriate means to protect them from impact and falling risks.
Strictly follow these instructions:

Carefully read the cylinder instruction and user manual (packaging).
Verify that all equipment is in good condition.
Secure cylinders to maintain them in an upright position (especially smaller cylinders) and prevent accidental falls; protect them from impacts and keep them at temperatures below 50°C, ensuring adequate ventilation in areas where the product is used. Cylinders must be fitted with a protective cap/tulip over the valve.
Handle equipment with clean hands, free from traces of grease or oil.
Lift and move cylinders using only the dedicated trolley; never lift the cylinder by the valve.
Use specific, compatible connectors, connection tubes, or flexible hoses.
Exercise extreme care when attaching pressure reducers to cylinders to avoid accidental breakage risks.
Any intervention on cylinder connections, delivery equipment, or their accessories or components is strictly prohibited (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate 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.

General Instructions for Use

Remove the seal and protective cap from the outlet valve.
Ensure the cap is stored safely so it can be replaced after use.
Do not remove or discard labels attached to the cylinder/cylinder pack.
Ensure the cylinder/cylinder pack is equipped with a pressure regulator specifically designed for medicinal air, and that the connector is compatible with the cylinder/cylinder pack valve.
Ensure the regulator connector is clean.
Connect the pressure regulator, using only light pressure, and connect tubing to the regulator/flowmeter outlet.
Open the cylinder valve slowly and gradually (without forcing) and check for leaks. If leaks occur, they will be evident by a hissing sound. If the leak occurs between the valve outlet and the pressure reducer, disconnect and clean the components; reconnect the pressure reducer to the valve with moderate force. Never use sealing compounds or adhesives to stop a leak. If the leak persists, label the cylinder and return it to the manufacturer.

NOTE: FOR MORE DETAILS, CONSULT THE CYLINDER USER MANUAL
WARNING

Ensure sufficient air remains in the cylinder to guarantee complete prescribed administration.
Check that the regulator connection is clean and in good condition before attaching it to the valve.
Verify that the pressure regulator is correctly attached before opening the valve.
Open the valve gradually to avoid pressure surges.
Do not force taps or valves during opening or closing.
Do not attempt to open or repair defective valves or reducers.
Never position yourself directly in front of the gas outlet of the tap/valve; always stand to the side. Do not expose yourself or the patient to direct gas flow.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder valve.
In case of gas leakage, close the valve and notify the technical service of the supplier indicated in the cylinder user manual.
Use only cylinders suitable for medicinal air, designed for the required operating pressures and temperatures, pressure regulators designed for medicinal air, and devices intended for medicinal air administration.

During Use
When medicinal air cylinders are in use, ensure that:

they are used only as medicinal gases (not for purposes other than those prescribed by the physician);
they are handled carefully, avoiding violent movements and potential falls;
they are securely fastened in an upright position to a support;
markings, labels, or attached stickers are not altered or removed;
they are not used near people who are smoking or near heat sources. Additionally:
Do not use greasy creams or lipsticks.
Do not smoke.
Do not approach the cylinder with open flames.
Electrical equipment capable of emitting sparks must not be used near patients receiving oxygen.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen.
Never introduce air into a device that might contain combustible materials, especially greasy substances.

After Use
When the medicinal air cylinder is empty, ensure that:

valves are manually closed without forcing, using only moderate force;
the pressure regulator and/or connection are depressurized;
the protective cap is replaced and properly seated over the valve;
empty cylinders with closed valves and protective caps are stored in a designated storage area prior to return to the manufacturer.

Disposal
Medicinal air cylinders should not be disposed of as waste. Do not discharge cylinders into sewers, basements, or pits where gas accumulation could be hazardous. Cylinders must be returned to the supplier with a slight residual gas content (residual pressure prevents cylinder contamination). Any unused medicinal product residues remaining in the pressurized cylinder will be eliminated through appropriate procedures by the company responsible for subsequent refilling. If, for safety reasons, a cylinder must be emptied after use, the gas should be released into the atmosphere in a well-ventilated area. Contact the supplier for further information on cylinder emptying procedures.

Unused medicine and waste derived from this medicine must be disposed of in accordance with applicable local regulations.

Fire Safety Measures
In case of potential fire involvement:

Remove cylinders from areas likely to be affected by fire.
Close cylinder valves to prevent gas flow.
Move cylinders away from heat sources.

In case of fire involvement:

Remove cylinders and cool them with water from a safe distance.
All types of fire extinguishers may be used when dealing with fires involving medicinal gas cylinders. No toxic combustion products are released by the medicinal gas.

Measures in Case of Accidental Opening
If a large volume of air is released into the environment, no significant hazards arise.
Close the cylinder valve immediately.

Transport of Cylinders
Cylinders must be transported using appropriate equipment to protect them from impact and falling risks (e.g., trolleys equipped with chains, barriers, or rings).
Extreme care must be taken to ensure there are no leaks and that cylinder valves are securely closed; also check the secure attachment of the pressure reducer to prevent accidental breakage.
During vehicle transport, cylinders must be firmly secured, preferably in an upright position, in a compartment separate from the driver’s cabin. Continuous vehicle ventilation and a no-smoking policy must be ensured.
Ensure the driver is aware of the hazards associated with the load and knows the appropriate actions to take in case of accidents or emergencies. It is advisable to provide the driver with written instructions detailing the actions to be taken in case of an accident or emergency.