Aria Medicaire

PACKAGE LEAFLET

ARIA MEDICAIR 200 bar medicinal compressed gas

Pharmacotherapeutic category
Pure medicinal gases and gas mixtures
Therapeutic indications

• In resuscitation for ventilatory support;
• In chronic respiratory deficiency conditions 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 (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 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 with other medicinal products, alcohol, tobacco, or food have been reported.
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.), either by ignition (spark, open flame, ignition source) or by adiabatic compression, which may occur in pressure-reducing equipment (reducers) during a sudden reduction in gas pressure.

• Medicinal air cylinders must be kept away from sources of heat due to the oxidizing properties of oxygen: appropriate precautions must therefore be taken.
• Oxygen may cause sudden ignition of glowing materials or embers; therefore, smoking or the 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 emitting sparks should be used 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 ON 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 safer outdoor location to allow the air 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 vehicles or operate 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 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 via 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 above 60 mmHg. In highly premature newborns, relatively lower oximetry values may be considered acceptable in 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 in 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:

[(liters of air/minute × 21) + (liters of oxygen/minute × 100)]
FiO₂ =
[(liters of air/minute + liters of oxygen/minute) × 100]
Method of administration
In artificial ventilation and resuscitation stages of infarction, 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, which is generally equipped with a dedicated cannula.
Instructions for use and handling
All persons handling medicinal air cylinders should have adequate knowledge of:

• Gas properties;
• Correct operational procedures for the cylinder;
• Precautions and emergency actions to be taken. Medicinal 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:
• Carefully read the cylinder instruction and user manual (packaging)
• Verify that all equipment is in good condition
• Secure cylinders to keep 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 of the rooms 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; do not lift the cylinder by the valve.
• Use specific and compatible connectors, connection tubes, or flexible hoses.
• Particular attention must be paid to securing pressure reducers to cylinders to prevent accidental breakage risks.
• 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 ON CONTACT WITH OXYGEN)
• Do not lubricate, nor 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 set aside so it can be reinstalled after use.
3. Do not remove or discard labels attached to the cylinder/packaged cylinder.
4. Ensure that a pressure regulator specific for medicinal air is associated with the cylinder/packaged cylinder and that the connector is compatible with that of the cylinder/packaged cylinder 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 from a hissing sound; if the leak occurs between the valve outlet and the pressure reducer, remove the connections and clean them; reconnect the pressure reducers to the valve with moderate force. Never use adhesive compounds or sealants 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 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.
• 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 when opening or closing.
• Do not attempt to open or repair defective valves or reducers.
• 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 the 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 pressures and operating 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 established by the physician).
• they are handled carefully without violent movements to prevent falls
• they are securely fixed in an upright position on 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. In addition:
• 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 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 cap is replaced over the valves, properly seated in place
• empty cylinders with closed valves and protective caps are placed in a designated storage area before being returned to the manufacturer.

Disposal
It is recommended not to dispose of medicinal air cylinders as waste. Do not discharge into sewers, basements, or pits where accumulation may be hazardous.
Cylinders must be returned to the supplier with a slight residual gas content (residual pressure prevents contamination of the cylinder).
Any unused medicinal product residues remaining in the pressurized cylinder will be eliminated, through appropriate procedures, by the company responsible for the subsequent refilling of the cylinder.
If, for safety reasons, a cylinder must be emptied after use, the gas should be released into a well-ventilated atmosphere.
Contact the supplier if further information on cylinder emptying is required.
Unused medicine and waste derived from such medicine must be disposed of in accordance with local regulations.
Fire prevention measures
In case of risk of involvement in a fire:

• remove cylinders from the area that could be affected by fire.
• Close cylinder valves to prevent gas flow.
• Move cylinders away from the heat source. 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 a fire 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 fall 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 reducer to prevent accidental breakage risks.
During transport in vehicles, cylinders must be securely fastened, preferably in an upright position, in a compartment separated 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 to do 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.
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 medicinal products, oxygen may 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 and storage
Expiry: see expiry date indicated on the packaging.
The expiry date indicated refers to the product in intact packaging, correctly stored.
Attention: do not use the medicinal product after the expiry date indicated 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, illuminated areas with cold light sources and equipped with appropriate emergency systems, in an upright position with valves closed, protected from rain, weather, direct sunlight, sources of heat or ignition (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 such medicine must be disposed of in accordance with local regulations (see also Instructions for use – Disposal).
Keep the medicine out of the reach and sight of children
Composition
Cylinders contain compressed atmospheric air
Pharmaceutical form and contents
Medicinal compressed gas
ARIA MEDICAIR medicinal compressed gas is packaged in cylinders and cylinder packs, in compressed gas form at 200 bar at 15°C. The cylinders are made of steel and equipped with shut-off and delivery valves capable of connecting to a pressure reducer so that the medicinal product can be used.
Cylinders containing air intended for medical use have a conventional chromatic identification characterized externally by a white body and a white-neo painted shoulder.
Marketing Authorization Holder
MEDICAIR ITALIA S.R.L. – VIA T. TASSO 29 - POGLIANO MILANESE
Manufacturer
Medicair Italia srl- Via T. Tasso 29 – 20010 Pogliano Milanese (MI)
25-10-2012