Aria Siad

Package leaflet: Information for the patient

ARIA SIAD 200 BAR COMPRESSED MEDICINAL GAS, SYNTHETIC COMPRESSED

compressed atmospheric air
oxygen
Please read all of this leaflet carefully before you are given 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, 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 SIAD is and what it is used for
2. What you need to know before you are given ARIA SIAD
3. How ARIA SIAD will be administered to you
4. Possible side effects
5. How to store ARIA SIAD
6. Contents of the pack and other information

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

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

• ARIA SIAD is administered by inhalation (through the nose or mouth) and is indicated:
• in resuscitation to support respiration (ventilatory assistance);
• in conditions of chronic breathing difficulty to provide respiratory support;
• in anaesthesia as a carrier gas for volatile anaesthetics;
• as a carrier to administer nebulized medications;
• in the management of patients with disorders of the body's defence system (immune system), such as in organ transplantation, cellular transplantation, or extensive burns;
• in incubators to provide controlled quality air flows;
• for introducing air into a body cavity (cavitary insufflation).

2. What you need to know before you are administered ARIA SIAD

Do not be administered ARIA SIAD if:
you must be treated exclusively with pure oxygen or with other medicinal gas mixtures containing oxygen in quantities higher than that normally present in air (21%).

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

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 fats (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:

During use

• Do not use greasy creams or lipsticks.
• Do not smoke.
• Do not bring open flames near 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 flammable 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.

Other medicines and ARIA SIAD
Inform 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 SIAD with food and alcohol
No interactions with alcohol, tobacco, or food have been reported.

Pregnancy, breastfeeding and fertility
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.
Medicinal air at atmospheric pressure may 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 SIAD 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, consult your doctor.
Medical air is generally inhaled through the nose or mouth via a face mask or a tube
inserted into the mouth, nose, trachea, or through a cannula, or 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 condition.
If you are given more ARIA SIAD than you should receive
It is highly unlikely that you will be given more ARIA SIAD than required, as your doctor or
nurse will monitor you during treatment.
Symptoms that may occur due to an overdose of pressurized medical air are: decompression sickness (due to the effects of nitrogen) and oxygen toxicity.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common

• 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 through the national reporting system at: 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 SIAD

Store the 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 required. This will help protect the environment.

6. Package contents and other information

What ARIA SIAD contains
ARIA SIAD 200 BAR COMPRESSED MEDICINAL GAS
The cylinders contain compressed atmospheric air
ARIA SIAD 200 BAR COMPRESSED SYNTHETIC MEDICINAL GAS
The cylinders contain:

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

Description of the appearance of ARIA SIAD and contents of the pack
Compressed medicinal gas and compressed synthetic medicinal gas
ARIA SIAD compressed medicinal gas and compressed synthetic medicinal gas is supplied in steel cylinders and cylinder packs, in compressed gaseous form at 200 bar at 15°C. The cylinders are equipped with valves compatible with pressure regulators.
Available pack sizes:
Compressed synthetic medicinal gas (200 bar)
Steel cylinders with valve of 3, 10, 14, 40 litres.
Cylinder packs of 16 or 25 cylinders of 40 litres.
Compressed medicinal gas (200 bar)
Steel cylinders with valve of 3, 10, 14, 40 litres.
Cylinder packs of 16 or 25 cylinders of 40 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SOCIETA’ ITALIANA ACETILENE & DERIVATI “SIAD” S.p.A
Via San Bernardino, 92 - 24126 Bergamo

Manufacturer
Compressed medicinal gas
Società Italiana Acetilene & Derivati “SIAD” S.p.A. - S.S. 525 del Brembo 1 - Osio Sopra (BG)
Nippon Gases Pharma S.r.l. Via Martino della Torre 16 - Novara
Nippon Gases Industrial S.r.l. - Via Strada Regionale Casilina 6, n.114 - Anagni (FR)
Compressed synthetic medicinal gas
Nippol Gases Pharma S.r.l. Via Martino della Torre 16 - Novara
Nippon Gases Industrial S.r.l. - Via Strada Regionale Casilina 6, n.114 - Anagni (FR)

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 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 a reliable administration of gas containing oxygen at a concentration corresponding to that of normal ambient air, without the risk of delivering 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 delivery, hyperoxia/hypoxia stages, and anaesthesia, medicinal air is generally administered by inhalation via facial mask or orotracheal and nasotracheal tubes, delivered by various techniques, usually through breathing and ventilating devices, and may be delivered via pressure-cycled or volume-cycled systems.
In cavity insufflation, medicinal air is delivered through an endoscope, which is generally equipped with a dedicated cannula.

Special warnings and precautions for use
Medicinal air must be administered to patients only at atmospheric pressure or at 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 oxygen fraction in the inhaled gas mixture (inhaled oxygen fraction – FiO₂) 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.), either due to an ignition source (spark, open flame, ignition source) or due to adiabatic compression that may occur in pressure-reducing equipment (regulators) during a sudden drop in gas pressure.

• Cylinders containing medicinal air must be kept away from sources of heat due to the oxidizing nature of oxygen; appropriate precautions must therefore be taken.
• Oxygen can cause sudden ignition of incandescent materials or embers; therefore, smoking or using unshielded open flames near cylinders and delivery systems is prohibited.
• Do not smoke in the environment where medicinal air is administered.
• Do not place cylinders near sources of heat.
• Do not use any electrical equipment capable of emitting sparks near patients receiving medicinal air.
• It is absolutely forbidden to tamper in any way with cylinder connections, delivery equipment, or their accessories or components.
• Any contact with oil, grease, or other hydrocarbons must be avoided (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN).
• 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.
• Only suitable and compatible equipment may be used for the specific cylinder model.
• 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 safe outdoor location to allow the gas to escape freely.
• Valves of empty cylinders must remain closed.
• It is not permitted to administer the gas under pressure.

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 areas, illuminated with cold light sources, and equipped with appropriate emergency systems. Cylinders must be stored upright with valves closed, protected from rain, weather, direct sunlight, sources of heat or ignition (including electrostatic charges), and combustible materials.
Empty cylinders 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 individuals handling medicinal air cylinders should have adequate knowledge of:

• Gas properties;
• Correct operational procedures for cylinders;
• Precautions and emergency actions.

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

• Carefully read the cylinder instruction and user manual (packaging).
• Verify that 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 rooms where the product is used. Cylinders must be equipped with a protective cap/tulip over the valve.
• Handle equipment with clean hands, free from traces of grease or oil.
• Lift and move cylinders only using the appropriate trolley; never lift the cylinder by the valve.
• Use specific, compatible connectors, connection tubes, or flexible hoses.
• Pay particular attention to the secure attachment of pressure regulators to cylinders to prevent accidental breakage.
• It is absolutely forbidden to tamper in any way with cylinder connections, delivery equipment, or their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN).
• Do not lubricate or attempt to repair defective valves/taps.
• It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.

General instructions for use

1. Remove the seal and protective cap from the outlet valve.
2. Ensure the cap is stored safely so it can be reinstalled after use.
3. Do not remove or discard labels attached to the cylinder/cylinder pack.
4. Ensure that a pressure regulator specific for medicinal air is attached to the cylinder/cylinder pack and that the connector is compatible with the cylinder/cylinder pack valve.
5. Ensure that the regulator connector is clean.
6. Connect the pressure regulator, using only moderate 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 regulator, disconnect and clean the components; reconnect the pressure regulator to the valve with moderate force. Never use sealants 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 that sufficient air remains in the cylinder to guarantee complete prescribed administration.
• Check that the regulator connection is clean and in good condition before connecting 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 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 intervention service of the supplier indicated in the cylinder user manual.
• Use only cylinders suitable for medicinal air, at the required operating pressures and temperatures, pressure regulators designed for medicinal air, and devices designed for the administration of medicinal air.

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

• They are used only as medicinal gases (do not use for purposes other than those prescribed by the physician).
• They are handled carefully, avoiding violent movements to prevent falls.
• They are securely fixed upright to a support.
• Markings, labels, or stickers are not altered or removed.
• They are not used near people who are smoking or near sources of heat.
  Additionally:
• Do not use greasy creams or lipsticks.
• Do not smoke.
• Do not approach the cylinder pack with open flames.
• Do not use any electrical equipment capable of emitting sparks 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, particularly greasy substances.

After use
When the medicinal 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 are depressurized.
• The protective cap is replaced over the valves and 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 medicinal air cylinders as waste. Do not release 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 removed through appropriate 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 derived from this medicinal product must be disposed of in accordance with local regulations.

Firefighting 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 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, there are no particular risks.
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 properly closed; also check the secure attachment of the pressure regulator to prevent accidental breakage.
During transport in vehicles, cylinders must be securely fastened, preferably in an upright position, in a compartment separate from the driver’s cabin. Permanent vehicle ventilation and a no-smoking policy must be ensured.
Ensure that the driver is aware of the hazards associated with the load 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