Aria Sapio Life: detailed information

Package leaflet: Information for the patient

ARIA SAPIO LIFE 200 BAR MEDICINAL COMPRESSED, SYNTHETIC COMPRESSED GAS

Compressed atmospheric air/Oxygen
Equivalent medicine
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 experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

1. What ARIA SAPIO LIFE is and what it is used for

ARIA SAPIO LIFE 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 SAPIO LIFE is indicated in patients of all ages:

in resuscitation to support breathing (ventilatory assistance);
in conditions of chronic breathing difficulty to provide respiratory support;
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 organ transplantation, cellular transplantation, or extensive burns;
in incubators to provide air of controlled quality;
to introduce air into a body cavity (cavity insufflation).

2. What you need to know before you are administered ARIA SAPIO LIFE

You must not be administered ARIA SAPIO LIFE if:
you require treatment 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
Please consult your doctor or pharmacist before you are administered ARIA SAPIO LIFE.
Before and during administration of medicinal air, you must strictly observe the safety precautions listed below.

Safety precautions
During use

Do not use oily creams or lipsticks.
Do not smoke.
Do not approach the container with open flames.
Do not use any electrical equipment that may generate 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 may 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 SAPIO LIFE
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 SAPIO LIFE 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.
Medicinal air at atmospheric pressure may be used during pregnancy and breastfeeding.

Driving and using machines
ARIA SAPIO LIFE does not impair the ability to drive vehicles or operate machinery.

3. How ARIA SAPIO LIFE 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 facial mask or a cannula, 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 SAPIO LIFE than you should receive
It is highly unlikely that you will be given more ARIA SAPIO LIFE than required, as your doctor or nurse will monitor you during treatment.
Symptoms you might experience due to an overdose of pressurized medical air include: decompression sickness (due to the effects of nitrogen) and oxygen toxicity.
Treatment
If you are given more ARIA SAPIO LIFE than you should receive, 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 gets 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 effects, 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 SAPIO LIFE

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. Package contents and other information

What ARIA SAPIO LIFE contains
ARIA SAIO LIFE 200 BAR COMPRESSED MEDICINAL GAS
The cylinders contain compressed atmospheric air.
ARIA SAPIO LIFE 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 SAPIO LIFE and contents of the pack
Compressed medicinal gas and compressed synthetic medicinal gas
ARIA SAPIO LIFE compressed medicinal gas and compressed synthetic medicinal gas is supplied in
cylinders and cylinder packs, in the form of compressed gas at 200 bar at 15°C. The cylinders are made of
steel or aluminium and are equipped with valves compatible with pressure regulators.
Available pack sizes:
Compressed synthetic medicinal gas (200 bar)
Steel cylinders with valve of 1, 2, 3, 5, 7, 10, 14, 27, 40, 50 litres.
Cylinder packs of 12 or 16 steel cylinders of 40 or 50 litres.
Cylinder pack of 8 steel cylinders of 50 litres.
Aluminium cylinders with valve of 3, 5, 10 litres.
Compressed medicinal gas (200 bar)
Steel cylinders with valve of 1, 2, 3, 5, 7, 10, 14, 27, 40, 50 litres.
Cylinder packs of 12 or 16 steel cylinders of 40 or 50 litres.
Cylinder pack of 8 steel cylinders of 50 litres.
Aluminium cylinders with valve of 3, 5, 10 litres.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SAPIO LIFE S.r.l. - Via Silvio Pellico, 48 – Monza (MB)
Manufacturer
Compressed medicinal gas
Sapio Produzione Idrogeno Ossigeno S.r.l. - Via Senatore Simonetta 27 - Caponago (MB)
Compressed synthetic medicinal gas
CER Medical S.r.l. – Via Torretta, 13 – Calderara di Reno (BO)
Sapio Produzione Idrogeno Ossigeno S.r.l. – Via Metaponto - Taranto
Medical Gas Criogenici S.r.l. - Viale Delle Industrie, Snc - Zona Industriale ASI - Aragona (AG)
Giannitrapani S.r.l. – 1° Dorsale, 8 Z.I.R. – Trapani (TP)

The following information is intended exclusively for physicians or healthcare professionals:
Dosage and method of administration
Dosage
Dosage, frequency, and duration of treatment depend on the therapeutic indications and the patient's clinical condition.
In particular, in cases of hypoxia, 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 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 acceptable during the first hours of life. When replacement of ambient air is required, the purpose of using medicinal air is to ensure reliable administration 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:
[ \text{FiO}_2 = \frac{(\text{litres of air/min} \times 21) + (\text{litres of oxygen/min} \times 100)}{(\text{litres of air/min} + \text{litres of oxygen/min}) \times 100} ]

Method of administration
In artificial ventilation and resuscitation stages in infants, pharmaceutical carrier, hyperoxia/hypoxia stages, and anaesthesia, medicinal air is generally administered by inhalation via facial mask or oro- and naso-tracheal tubes, delivered by various techniques, usually using respiratory and ventilatory equipment, and may be delivered via pressure- 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 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 (inspired oxygen fraction – FiO₂) must be maintained at least at 21%. Practically, 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.
Before and during administration of the medicinal product, strict adherence to the safety precautions described below is required.

SAFETY (see also section “Special precautions for disposal and handling”)
It is important to remember that air itself is not flammable, but oxygen (as an oxidizer) supports combustion; it may therefore initiate combustion in the presence of combustible materials such as fats (oils, lubricants) and organic substances (fabrics, wood, paper, plastics, etc.), either by ignition (spark, open flame, ignition source) or by adiabatic compression, which may occur in pressure-reducing equipment (regulators) during a sudden drop in gas pressure.

Cylinders of medicinal air must be kept away from heat sources due to the oxidizing properties of oxygen; appropriate precautions must therefore be taken.
Oxygen may cause sudden ignition of incandescent materials or embers; therefore, smoking or the use of unshielded open flames near cylinders and delivery systems is strictly prohibited.
Do not smoke in the environment where medicinal air is administered.
Do not place cylinders near heat sources.
Do not use any electrical equipment that may produce sparks near patients receiving medicinal air.
Any intervention on cylinder connections, delivery equipment, or related accessories or components is strictly prohibited.
Contact with oil, grease, or other hydrocarbons must be avoided (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN 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 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 damage.
In case of leakage, the cylinder valve must be closed immediately, if safe to do so. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow gas to escape freely.
Valves of empty cylinders must remain closed.
Administration of gas under pressure is not permitted.

Special precautions for storage
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 equipped with appropriate emergency systems, in upright position with valves closed, protected from rain, weather, direct sunlight, heat or ignition sources (including static electricity), 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.

Special precautions for disposal and handling
All personnel 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 intended exclusively for containing/transporting inhalation 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).
Ensure all equipment is in good condition.
Secure cylinders in upright position (especially smaller cylinders) to prevent accidental falls, protect them from impacts, and maintain temperatures below 50°C, ensuring adequate ventilation/aeration in areas where the product is used. Cylinders must be fitted with protective caps/tulips 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 and compatible connectors, connecting tubes, or flexible couplings.
Particular attention must be paid to securing pressure regulators to cylinders to avoid risks of accidental breakage.
Any intervention on cylinder connections, delivery equipment, or related accessories or components is strictly prohibited (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN 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 for reinsertion after use.
Do not remove or discard labels attached to the cylinder or cylinder pack.
Ensure the cylinder or cylinder pack is equipped with a pressure regulator specific for medicinal air and that the connector is compatible with the cylinder or cylinder pack valve.
Ensure the regulator connector is clean.
Connect the pressure regulator using only moderate force, 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 regulator, disconnect the components and clean them; reconnect the pressure regulator 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 regulators.
Never stand 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 support service indicated in the cylinder user manual.
Use only cylinders suitable for medicinal air, designed for the required pressures and operating 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 (do not use for purposes other than those prescribed by the physician).
They are handled carefully, avoiding violent movements and preventing falls.
They are securely fastened in upright position to a support.
Markings, labels, or attached stickers are not altered or removed.
They are not used near smokers or heat sources. Additionally:
Do not use greasy creams or lipsticks.
Do not smoke.
Do not approach the pack with open flames.
Do not use any electrical equipment that may produce 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, 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 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 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 residue remaining in the pressurized cylinder will be removed via 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.
Unused medicine and waste derived from this medicine must be disposed of in accordance with local regulations.

Firefighting measures
In case of potential involvement in a fire:

Remove cylinders from areas that may 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 release
If a large volume of air is accidentally 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 falling 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 secure attachment of the pressure regulator to prevent accidental breakage.
During transport in vehicles, cylinders must be securely fastened, preferably in upright position, in a compartment separate from the driver’s cabin. Permanent vehicle ventilation and a no-smoking policy must be ensured.
Ensure 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.