Aria Air Liquide Sanità: detailed information

PACKAGE LEAFLET

ARIA AIR LIQUIDE SANITÀ 200 BAR MEDICINAL SYNTHETIC COMPRESSED GAS

Pharmacotherapeutic category
Pure medicinal gases and mixtures of gases.
Therapeutic indications

In resuscitation for ventilatory support;
In conditions of chronic respiratory deficiency to provide respiratory support;
In anaesthesia as a carrier gas for volatile anaesthetics;
In nebulization therapy as a carrier for pharmaceutical substances;
In the management of immunocompromised patients, such as in organ transplantation, cellular transplantation, or extensive burns;
In incubators to provide controlled-quality air flows;
For cavity insufflation.

Contraindications
Medicinal air is contraindicated where pure oxygen or other medicinal gas mixtures (containing at least 21% oxygen) are instead indicated.
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 (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.
At exceptionally high flow rates—for example, during use in an incubator—medicinal air may be perceived as cold.
Prior to and during administration of the medicinal product, strict adherence to the safety precautions described below is required.
Interactions
Generally, no interactions have been reported with other medicinal products, alcohol, tobacco, or food.
Special warnings
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 (tissues, wood, paper, plastics, etc.), especially when triggered by a 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.

Medicinal air cylinders must be kept away from sources of heat due to the oxidizing nature of oxygen; appropriate precautions must therefore be taken.
Oxygen may cause spontaneous ignition of smouldering or glowing materials; therefore, smoking or use of 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.
No electrical equipment capable of producing sparks should be used 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 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 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 safer outdoor location to allow the gas to escape freely.
Valves of empty cylinders must be kept closed.
Administration of pressurized gas is not permitted. Pregnancy and lactation There are no contraindications for the use of medicinal air at atmospheric pressure during pregnancy or breastfeeding. Effects on ability to drive or use machinery The use of medicinal air does not impair the ability to drive or operate machines/equipment. Dosage, method and duration of administration Dosage, frequency, and duration of treatment depend on the therapeutic indication 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 via 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 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 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 must 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, 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 through respiratory and ventilatory devices, and may be delivered via pressure or volume-based systems.
For cavity insufflation, medicinal air is delivered via an endoscope, typically equipped with a dedicated cannula.
Instructions for use and handling
All individuals handling medicinal air cylinders should have adequate knowledge of:
o gas properties;
o correct operational procedures for the cylinder;
o safety precautions and emergency actions.
Medicinal air cylinders are exclusively intended for containing/transporting air for inhalation, for therapeutic use.
Cylinders must be transported using appropriate means to protect them from impact and falling 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 maintain them in an upright position (especially smaller cylinders), prevent accidental falls, protect them from impacts, and keep them at temperatures below 50°C, ensuring adequate ventilation/aeration of rooms where the product is used. Cylinders must be fitted with a protective cap/hood over the valve.
Handle equipment with clean hands, free from traces of grease or oil.
Lift and move cylinders using only the dedicated trolley; do not 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 prevent 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 ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves/taps.
It is strictly forbidden to manipulate 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 set aside so it can be replaced after use.
3. Do not remove or discard labels attached to the cylinder or cylinder pack.
4. Ensure a pressure regulator specific to medicinal air is associated with the cylinder/pack, and that the connector is compatible with the cylinder/pack valve.
5. Ensure 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 is 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 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; 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 intended pressures and temperatures, pressure regulators designed for medicinal air, and devices intended 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 and preventing falls
they are securely fixed in an upright position to a support
markings, labels, or attached stickers are not altered or removed
they are not used near smokers or near sources of heat In addition:
Do not use greasy creams or lipsticks.
Do not smoke.
Do not approach the cylinder with open flames.
No electrical equipment capable of producing 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 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 to close the valve.
the pressure regulator and/or connection is depressurized.
the protective cap is replaced over the valves, seated in its proper position.
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 gas into sewers, basements, or pits where 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 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 medicine and waste derived from this medicine must be disposed of in accordance with applicable local regulations.
Fire precautions
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 position.
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 problems:
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).
Particular attention must be paid to ensure there are no leaks and that cylinder valves are properly closed; also check the securing of the pressure regulator to prevent risks of accidental breakage.
During transport in vehicles, cylinders must be securely fastened, 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 hazards associated with the load and knows what to do in case of accidents or emergencies. It is advisable to provide the driver with written instructions detailing the actions to take in case of accident or emergency.
Overdose
Not applicable, although administration of medicinal air under pressure may cause decompression sickness (due to nitrogen effects) and oxygen may be toxic.
Undesirable effects
Like all medicines, oxygen can cause undesirable effects, although not everyone experiences them.
Very common undesirable effects: dry mouth, headache
Following the instructions in this leaflet reduces the risk of undesirable effects.
Expiry date and storage
Expiry date: see the expiry date indicated on the packaging.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Attention: Do not use the medicine after the expiry date stated on the packaging.
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, well-lit areas with cold light sources, equipped with appropriate emergency systems, in an upright position with valves closed, protected from rain, weather, direct sunlight, heat or ignition sources (including static charges), and combustible materials.
Empty containers or those containing other types of gases must be stored separately.
Cylinders must be used in strict rotation so that cylinders with earlier filling dates are used first.
Unused medicine and waste derived from this medicine must be disposed of in accordance with applicable local regulations (see also instructions for use - Disposal).
Keep the medicine out of the reach and sight of children.
Composition
Cylinders contain
Active substance: Oxygen 21–22.5%
Excipients: nitrogen
Pharmaceutical form and contents
Compressed synthetic medicinal gas
ARIA AIR LIQUIDE SANITÀ compressed synthetic medicinal gas is supplied in cylinders and cylinder packs, in compressed gaseous form at 200 bar at 15°C. Cylinders are made of steel or aluminium alloy, equipped with shut-off and delivery valves compatible with pressure regulators to allow use of the medicinal product.
Cylinders containing air intended for medical use have a conventional external colour identification, with a white body and a white-black shoulder.
Marketing Authorization Holder
AIR LIQUIDE SANTE’ (INTERNATIONAL) - 75 Quai d'Orsay 75007 - Paris, FRANCE
Manufacturer
Air Liquide Sanità Service S.p.A. - Via Lussemburgo, 17 - 37135 Verona
Air Liquide Sanità Service S.p.A. - Via Campobello, 7 bis 00040 Pomezia (RM)