Aria Nippon Gases

Package leaflet: Information for the patient

ARIA NIPPON GASES 200 BAR COMPRESSED MEDICINAL GAS

compressed air
ARIA NIPPON GASES 200 BAR SYNTHETIC COMPRESSED MEDICINAL GAS
ARIA NIPPON GASES 300 BAR SYNTHETIC COMPRESSED MEDICINAL GAS
oxygen
Please read carefully this leaflet 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 get 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 NIPPON GASES is and what it is used for
2. What you need to know before you are given ARIA NIPPON GASES
3. How ARIA NIPPON GASES will be administered to you
4. Possible side effects
5. How to store ARIA NIPPON GASES
6. Contents of the pack and other information

1. What ARIA NIPPON GASES is and what it is used for

ARIA NIPPON GASES 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 NIPPON GASES 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 that induce 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 (cavitary insufflation).

2. What you need to know before you are administered ARIA NIPPON GASES

You must not be administered ARIA NIPPON GASES if:

• you require treatment with pure oxygen or with other medicinal gas mixtures containing oxygen in concentrations higher than that normally present in air (21%)

Warnings and precautions
Talk to your doctor or pharmacist before you are administered ARIA NIPPON GASES.
Before and during the administration of medicinal air, you must strictly observe 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 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 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 NIPPON GASES
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 NIPPON GASES with food and alcohol
No interactions with alcohol, tobacco, or food have been reported.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning to become pregnant, or 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 NIPPON GASES will be administered to you

This medicine will always be administered to you exactly according to the instructions of 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, tubes, breathing and ventilation
equipment, or blown through a dedicated 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 NIPPON GASES than you should receive
It is very unlikely that you will be given more ARIA NIPPON GASES 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 include: decompression sickness (due to the effects of nitrogen) and oxygen toxicity.
Treatment
If you are given more ARIA NIPPON GASES than you should receive, your doctor will provide appropriate therapy and monitor you closely.
If you have any doubts about the use of this medicine, consult your doctor or nurse.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone 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 may also report side effects directly via the 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 NIPPON GASES

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 NIPPON GASES Contains
ARIA NIPPON GASES 200 BAR COMPRESSED MEDICINAL GAS
The cylinders contain compressed atmospheric air.
ARIA NIPPON GASES 200 BAR AND 300 BAR COMPRESSED SYNTHETIC MEDICINAL GAS
The cylinders contain:

• Active substance: oxygen 21–22.5%
• Excipient: nitrogen

Description of the Appearance of ARIA NIPPON GASES and Contents of the Package
Compressed medicinal gas and compressed synthetic medicinal gas
ARIA NIPPON GASES compressed medicinal gas and compressed synthetic medicinal gas is supplied in
cylinders and cylinder packs, in compressed gaseous form at 200 bar or 300 bar at 15°C. The cylinders are
made of steel and equipped with valves compatible with pressure regulators.
Cylinders containing air intended for medical use are externally color-coded according to standard convention:
white body with a white-black shoulder.

Available pack sizes:
Compressed synthetic medicinal gas (200 bar)
Steel cylinders with valve of 3, 5, 10, 14, and 50 litres.
Cylinder packs containing 12 or 16 steel cylinders with valve of 50 litres.

Compressed synthetic medicinal gas (300 bar)
Cylinder pack containing 16 steel cylinders with valve of 50 litres.

Compressed medicinal gas (200 bar)
Steel cylinders with valve of 3, 7, 14, and 50 litres.
Cylinder pack containing 16 steel cylinders with valve of 50 litres.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
NIPPON GASES PHARMA S.r.l. – Via Benigno Crespi, 19 – Milan

Manufacturer
Compressed medicinal gas
NIPPON GASES INDUSTRIAL S.r.l. – Strada Regionale 6 Casilina, 114 – Anagni (FR)
NIPPON GASES PHARMA S.r.l. – Via Martino della Torre 16 – Novara
Società Italiana Acetilene & Derivati “SIAD” S.p.A. – S.S. 525 del Brembo 1 – Osio Sopra (BG)

Compressed synthetic medicinal gas (200 bar)
NIPPON GASES INDUSTRIAL S.r.l. – Strada Regionale 6 Casilina, 114 – Anagni (FR)
NIPPON GASES PHARMA S.r.l. – Via Martino della Torre 16 – Novara
NIPPON GASES PHARMA S.r.l. – Via Circumvallazione Esterna di Napoli, 33 – Melito (NA)

Compressed synthetic medicinal gas (300 bar)
NIPPON GASES INDUSTRIAL S.r.l. – Strada Regionale 6 Casilina, 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 based on 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 oxygen saturation, with normal values between 94–100%, corresponding to PaO₂ values equal to or above 60 mmHg. In highly premature newborns, relatively lower oxygen saturation values may be considered acceptable during the first hours of life.

When ambient air replacement is required, 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 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, pharmaceutical drug delivery, hyperoxia/hypoxia conditions, and anesthesia, medicinal air is generally administered by inhalation via facial mask or orotracheal and nasotracheal tubes, delivered through various techniques, typically using respiratory and ventilatory equipment, and may be delivered via pressure- or volume-cycled systems.

In cavity insufflation, medicinal air is delivered through an endoscope, which is generally equipped with a dedicated cannula.

Pediatric Population
In artificial ventilation and resuscitation of infants, medicinal air is generally administered by inhalation via facial mask or orotracheal and nasotracheal tubes, delivered through various techniques, typically using respiratory and ventilatory equipment, and may be delivered via pressure- or volume-cycled systems.

Special Warnings and Precautions for Use
Medicinal air must be administered to patients only at atmospheric pressure or at slightly positive pressures when using ventilators. 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 (fraction of inspired oxygen – 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 outlined below is required.

SAFETY (see also section 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 or accelerate 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, which may occur in pressure-reducing equipment (regulators) during sudden gas pressure reduction.

• 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 glowing or smoldering materials; therefore, smoking or use of unshielded open flames near cylinders and delivery systems is strictly prohibited.
• Do not smoke in areas where medicinal air is administered.
• Do not place cylinders near heat sources.
• Do not use any electrical equipment capable of producing 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 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 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.
• Pressurized gas administration is not permitted.

Special Precautions for Storage
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. Cylinders must be stored upright 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 order, ensuring 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 exclusively intended 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)
• 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 maintain them at temperatures below 50°C, ensuring adequate ventilation/aeration in areas where the product is used. Cylinders must be equipped with a protective cap/tulip over the valve.
• Handle equipment with clean hands, free from grease or oil traces.
• Lift and move cylinders only using the appropriate trolley; never lift a cylinder by its valve.
• Use specific, compatible connectors, connection tubes, or flexible hoses.
• Exercise extreme care when attaching pressure regulators to cylinders to avoid 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 for reinstallation after use.
3. Do not remove or discard labels attached to the cylinder or cylinder pack.
4. Ensure that a pressure regulator specifically designed for medicinal air is associated with 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 light 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 the components and clean them thoroughly; 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 regulators
• 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 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 immediately and notify the technical service of the supplier indicated in the Cylinder User Manual
• Use only cylinders suitable for medicinal air, designed for the intended 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 preventing falls
• They are securely fastened in an upright position on 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
• Do not use any electrical equipment capable of producing 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 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
Return empty or unused containers, even if only partially empty, to the supplier.
Store empty cylinders with valves closed.
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 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
applicable local regulations.

Fire Safety Measures
In case of potential involvement in a fire:

• 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 actual 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 accidentally released into the environment, there are no particular hazards.
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 regulator 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. 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 incident or emergency.

For further information, consult the Summary of Product Characteristics.