Aria Sol

Package leaflet: Information for the patient

ARIA SOL 200 Bar compressed medicinal gas

Compressed atmospheric air, ARIA SOL 200 Bar synthetic compressed medicinal gas
Oxygen
Please read carefully this leaflet before this medicine is administered to you 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 experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

ARIA SOL belongs to the group of pure medicinal gases and gas mixtures and contains compressed atmospheric air or a mixture of oxygen and nitrogen.

ARIA SOL is administered by inhalation (through the nose or mouth) and is indicated:

• in resuscitation to support breathing (ventilatory assistance);
• in conditions of chronic respiratory difficulty to provide respiratory support;
• in anaesthesia as a carrier gas for volatile anaesthetics;
• as a carrier for 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 SOL

Do not use ARIA SOL:
There are no known conditions under which this medicine cannot be used.
Warnings and precautions
Talk to your doctor or pharmacist before you are given ARIA SOL.

• Before treatment with synthetic medicinal air, ensure that it is administered at atmospheric pressure.
• Administration of pressurized synthetic medicinal air may cause decompression sickness and oxygen toxicity. Decompression sickness is a condition that occurs during the transition from high pressure to normal pressure and causes headache, nausea, confusion, and sometimes paralysis and loss of consciousness (and even death).
• If medicinal air is mixed with other inhaled gases, such gas mixtures must contain a sufficient amount of oxygen (at least 21% v/v). Therefore, mixtures of medicinal air with other gases must always include additional oxygen from other sources.
• When administered at a high flow rate, medicinal air may feel cold.
• Medicinal air must not be used where oxygen concentrations higher than atmospheric (>21%) are indicated. Before and during administration of medicinal air, you must strictly observe the safety precautions listed below.
• ARIA SOL must be administered via equipment intended for this purpose. Consider the risk of injuries due to pressure changes in the air (barotrauma) caused by pressurized gas or by the administered gas flow, particularly if the equipment lacks a pressure-reducing valve.

Safety precautions
It is important to remember that air itself is not flammable, but oxygen can promote combustion in the presence of flammable substances such as greases (oils, lubricants) and organic materials (fabrics, wood, paper, plastics, etc.), especially when an ignition source is present (spark, open flame, ignition source), or during a sudden reduction in gas pressure. Therefore:

• Do not use greasy creams or lipsticks.
• Do not smoke.
• Do not approach the cylinder with open flames.
• 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.
• Do not use pliers or other tools to open or close the cylinder valve, in order to prevent the risk of damage.
• 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.

Cylinders must not be used if there are visible damages or if you suspect they have been damaged or exposed to extreme temperatures.
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 outdoor location to allow air to escape freely.
Valves of empty cylinders must remain closed.
Paediatric population
No different warnings or precautionary measures need to be observed from those previously reported.
However, caution is required when using this medicine in children.
Other medicines and ARIA SOL
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
No interactions between this medicine and other medicines have been reported.
ARIA SOL with food and alcohol
No interactions with alcohol, tobacco, or food have been reported.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
This medicine can be used during pregnancy and while breastfeeding.
Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How ARIA SOL will be administered to you

This medicine will be administered to you strictly according to the instructions given by your doctor or
nurse. If you have any doubts, consult your doctor.
Medical air is generally inhaled through the nose or mouth via a facial mask or a tube inserted into the mouth, nose, or trachea; alternatively, for cavity insufflation, it is 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 condition.
If you are given more ARIA SOL than you should
It is highly unlikely that you will be administered more ARIA SOL than required, as your doctor or nurse will monitor you during treatment. However, if the equipment used for administering synthetic medical air lacks a pressure-reducing valve, or if synthetic medical air is administered in inadequate volumes, there is a risk of serious lung injury (sudden barotrauma).
If you forget to use ARIA SOL
Do not take a double dose to make up for a forgotten dose. Continue treatment with the prescribed amount.
If you stop treatment with ARIA SOL
The condition for which you are receiving compressed air for medical use may worsen.
If you have any questions about the use of this medicine, consult your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences them.
There are no known side effects.
However, the following side effects may occur:
decompression sickness* frequency not known
oxygen toxicity* frequency not known
*if administered under pressure (see also “Warnings and precautions” )

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 national reporting system at the following website:
http://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 SOL

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 you no longer use. This will help protect the environment.

6. Contents of the packaging and other information

What ARIA SOL contains
ARIA SOL 200 Compressed Medical Gas
Cylinders contain compressed atmospheric air
ARIA SOL 200 BAR COMPRESSED SYNTHETIC MEDICAL GAS
Cylinders contain

• The active substance is oxygen 21–22.5%
• The other component is nitrogen

Description of the appearance of ARIA SOL and contents of the packaging
Compressed medical gas and compressed synthetic medical gas
ARIA SOL compressed medical gas and compressed synthetic medical 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 that must be connected to a pressure regulator for the medicinal product to be used. Cylinders containing air intended for medical use have a white body and the upper end (shoulder) painted white – black.
Available pack sizes:
Compressed synthetic medical gas (200 bar)
Steel cylinders with valve of 1, 2, 3, 5, 7, 10, 14, 27, 40, 50 litres.
Cylinder packs containing 12, 16, 20 cylinders of 50 litres.
Compressed medical gas (200 bar)
Steel cylinders with valve of 50 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SOL S.P.A. - VIA BORGAZZI, 27 – MONZA

Manufacturer
Compressed medical gas
SOL SPA – Via Nugolaio, 4 – Pisa
Compressed synthetic medical gas
I.C.O.A. Srl Industria Calabrese Ossigeno ed Acetilene – Zona Industriale (Loc. Porto Salvo) – Vibo Valentia
SOL SPA – Via Acquaviva, 4 – Cremona
SOL SPA – Via Nugolaio, 4 – Pisa
SOL SPA – Via Vanoni, 5 – Ancona
SOL SPA – Via Giovanni Francesco Maggiò – Marcianise (CE)

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 medical air aims to:

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

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

Method of administration
In artificial ventilation and resuscitation stages in infants, pharmaceutical delivery, stages of hyperoxia/hypoxia, and anesthesia, medical air is generally administered by inhalation via facial mask or oro- and naso-tracheal tubes, delivered by various techniques, usually through breathing and ventilating devices, and may be delivered via pressure or volume-based systems.
In cavity insufflation, medical air is delivered through an endoscope, which is generally equipped with a dedicated cannula.

Special warnings and precautions for use
Medical air should be administered to patients only at atmospheric pressure or slightly positive pressures when ventilators are used. Administration of medical air under pressure could cause decompression sickness (due to nitrogen effects) and oxygen toxicity.
When medical air is mixed with other inhalation gases, the oxygen fraction in the inhaled mixture (fraction of inspired oxygen – FiO₂) must be maintained at least at 21% v/v. In practice, this means that if it is a component of a gas mixture, oxygen must be one of the other components.
At exceptionally high flow rates, such as during use in an incubator, medical air may be perceived as cold.
Medical air must not be used where oxygen concentrations higher than atmospheric (>21%) are indicated.

Paediatric population
Children differ from adults in many aspects (not only in size): for example, they have differences in respiratory pattern, tidal volume, and airway geometry. Caution is required when using this medicinal product in children.
Prior to and during administration of the medicinal product, strict adherence to the safety precautions listed 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.) due to ignition (spark, open flame, ignition source), or due to adiabatic compression that may occur in pressure-reducing equipment (regulators) during a sudden pressure drop of the gas.

• No electrical equipment capable of emitting sparks should be used near patients receiving medical air administration.
• It is absolutely 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 there are visible damages or if damage is suspected, or if they have been exposed to extreme temperatures.
• Pliers or other tools must not be used to open or close the cylinder valve to prevent the risk of 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 safer outdoor location to allow air to escape freely.

Storage precautions
Observe all relevant rules for the use and handling of pressurized cylinders.
Store cylinders at temperatures between -10°C and 50°C, in well-ventilated, cold-light illuminated areas equipped with appropriate emergency systems, in 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 so that cylinders with earlier filling dates are used first.

Instructions for use and handling
All persons handling medical air cylinders should have adequate knowledge of:

• gas properties;
• correct operational procedures for the cylinder;
• precautions and actions to take in case of emergency.

Medical air cylinders are exclusively intended to contain/transport air for inhalation, for therapeutic use. Cylinders must be transported using appropriate means to protect them from impact and fall risks. Strictly follow the instructions below:

• Read carefully the cylinder instruction and user manual (packaging)
• Ensure all equipment is in good condition
• Secure cylinders to keep them upright (especially smaller cylinders) and prevent accidental falls; protect them from impacts and maintain them at temperatures below 50°C, ensuring adequate ventilation/aeration of the 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 and compatible connectors, connecting tubes, or flexible couplings.
• Particular attention must be paid to securing pressure regulators onto cylinders to avoid risks of accidental breakage.
• It is absolutely forbidden to intervene in any way on cylinder connections, delivery equipment, and related accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN)
• Do not lubricate or attempt to repair defective valves/taps.
• It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or various ointments.

General instructions for use

1. Remove the seal and protective cap from the outlet valve
2. Ensure the cap is stored safely for reinsertion after use
3. Do not remove or discard labels attached to the cylinder/cylinder pack
4. Ensure the cylinder/cylinder pack is fitted with a pressure regulator specific for medical air and that the connector is compatible with the cylinder/cylinder pack valve
5. Ensure the regulator connector is clean
6. Connect the pressure regulator, using only slight pressure, and connect tubing to the regulator/flowmeter outlet
7. 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 connections; reconnect the pressure reducers 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
ATTENTION

• Ensure sufficient air remains in the cylinder to guarantee complete prescribed administration
• Check that the regulator connection is clean and in good condition before connecting to the valve
• Check 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 and closing
• Do not attempt to open or repair defective valves or regulators
• 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 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 support service of the supplier indicated in the Cylinder User Manual
• Use only cylinders suitable for medical air, at the required pressures and operating temperatures, pressure regulators designed for medical air, and devices designed for the administration of medical air.

During use
When medical 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 without violent movements to prevent 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 packaging with open flames
• No electrical equipment capable of emitting sparks should be used near patients receiving oxygen
• Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen
• Never introduce air into a device that could contain combustible materials, especially fatty substances

After use
When the medical air cylinder is empty, ensure that:

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

Disposal
It is recommended not to dispose of medical air cylinders 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 specific procedures by the company responsible for subsequent refilling of the cylinder.
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.
Unused medicinal product and waste materials derived from this medicinal product must be disposed of in accordance with applicable local regulations.

Fire-fighting measures
In case of potential involvement in a fire:

• Remove cylinders from areas that could be affected by fire
• Close cylinder valves to prevent gas flow
• Move cylinders away from heat sources
  In case of involvement in a fire:
• Remove cylinders and cool them with water from a safe distance
• All types of fire extinguishers may be used when dealing with fires involving medical gas cylinders. No toxic combustion products are released by the medical gas.

Measures in case of accidental opening
If a large volume of air is released into the environment, there are no particular hazards.
Close the cylinder valve.

Transport of cylinders
Cylinders must be transported using appropriate equipment to protect them from impact and fall risks (e.g., trolley 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 securing of the pressure regulator to avoid risks of accidental breakage.
During vehicle transport, cylinders must be firmly secured, preferably in an upright position, in a separate area from the driver’s cabin. Permanent vehicle ventilation and a no-smoking policy must be ensured.
Ensure the driver is aware of the load's hazard conditions and knows what 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 accident or emergency.

For further information, consult the Summary of Product Characteristics