ARIA 200 BAR Ингаляционный газ

Содержание инструкции

1. ARIA SOL 200 Bar compressed medicinal gas
   1. What is ARIA SOL and what is it used for
   2. What you need to know before you are given ARIA SOL
   3. How ARIA SOL will be administered to you
   4. Possible side effects
   5. How to store ARIA SOL
   6. Contents of the pack and other information

ARIA SOL 200 Bar compressed medicinal gas

Compressed atmospheric air, ARIA SOL 200 Bar synthetic compressed medicinal gas

Oxygen

Read this leaflet carefully before you are administered 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 any side effects occur, including those not listed in this leaflet, ask your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

• 1. What ARIA SOL is and what it is used for
• 2. What you need to know before ARIA SOL is administered to you
• 3. How ARIA SOL will be administered to you
• 4. Possible side effects
• 5. How to store ARIA SOL
• 6. Contents of the pack and other information

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

ARIA SOL belongs to the group of pure medicinal gases and gas mixtures and contains compressed atmospheric air or a mixture of oxygen and nitrogen.
.
ARIA SOL is administered by inhalation (through the nose or mouth) and is indicated:

• in resuscitation to support breathing (ventilatory support);
• in conditions of permanent breathing difficulties to provide assistance with breathing;
• in anesthesia as a carrier gas for volatile anesthetics;
• as a carrier for administering drugs to be nebulized;
• in the management of patients with disorders of the body's defense system (immune system), such as in cases of organ transplantation, cell transplantation or extensive burns;
• in incubators to provide controlled quality air;
• to introduce air into a body cavity (cavity insufflation).

2. What you need to know before you are given ARIA SOL

Do not use ARIA SOL:
There are no known situations where this medicine cannot be used.

Warnings and precautions
Talk to your doctor or pharmacist before you are given ARIA SOL.

• Before treatment with synthetic medical air, make sure it is administered at atmospheric pressure.
• Administration of pressurized synthetic medical air may cause decompression sickness and oxygen toxicity. Decompression sickness is a condition that occurs during the transition from high pressure to normal pressure and causes headache, nausea, confusion, and sometimes paralysis and loss of consciousness (and even death).
• If the medical air is mixed with other gases for inhalation, this gas mixture must contain a sufficient amount of oxygen (at least 21% v/v). Therefore, mixtures of medical air with other gases must always include additional oxygen from other sources.
• Administering the medical air at a high flow rate may cause it to feel cold.
• Medical air should not be used where oxygen concentrations higher than atmospheric (>21%) are indicated. Before and during the use of medical air, you must strictly adhere to the safety precautions reported below.
• ARIA SOL must be administered via equipment intended for this purpose. Account must be taken of the risk of injury resulting from a change in air pressure (barotrauma) caused by pressurized gas or the flow of gas administered, particularly in the case of equipment not equipped with a reducing valve.

Safety precautions
It is important to remember that air itself is not flammable, but oxygen can activate combustion in
the presence of flammable substances such as fats (oils, lubricants) and organic substances (tissues, wood, paper,
plastics, etc.) due to an ignition source (spark, open flame, source of ignition), or
during a sudden drop in gas pressure. Therefore:

• Do not use greasy creams and lipsticks.
• Do not smoke.
• Do not approach the cylinder with open flames.
• Do not use any electrical equipment that can emit sparks near patients receiving medical air.
• Do not use oils or greases on fittings, taps, valves, and any material in contact with oxygen.
• Never introduce air into an apparatus that may contain flammable materials and in particular fatty substances.
• Do not interfere in any way with the cylinder fittings, delivery equipment and related 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 or clothes or face soiled with grease, oil, creams and various ointments.

Cylinders cannot be used if there is obvious damage or if they are suspected of being damaged or
have been exposed to extreme temperatures.
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 place outdoors to
allow the air to escape freely.
Valves of empty cylinders must be kept closed.

Paediatric population
No different warnings or precautionary measures need to be observed than those reported above.
However, caution is required when used in children.

Other medicines and ARIA SOL
Tell your doctor or pharmacist if you are taking, have recently taken or might take any
other medicines.
No interactions with other medicines have been reported.

ARIA SOL with food and alcohol
No interactions with alcohol, tobacco and food have been found.

Pregnancy and breastfeeding
If you are pregnant, suspect you are pregnant or are planning a pregnancy, or if you are breastfeeding,
ask your doctor or pharmacist for advice before taking this medicine.
This medicine can be used during pregnancy and breastfeeding.

Driving and using machines
This medicine does not impair the ability to drive or operate machinery.

3. How ARIA SOL will be administered to you

This medicine will be administered to you always following the doctor's or
nurse's instructions exactly. If you have any doubts, consult your doctor.
The medical air is generally inhaled through the nose or mouth via a face mask or a
tube inserted into the mouth, nose, trachea or, in cavity insufflation, it is blown through a
cannula into the cavity of the affected body part.
The dose, frequency and duration of treatment with medical air will be established by the doctor based on
your health condition.

If you are given more ARIA SOL than you should
It is very unlikely that you will be given more ARIA SOL than you should because your doctor or
nurse will monitor you during treatment. However, if the equipment used for the
administration of synthetic medical air does not have a pressure reducer or if the synthetic medical
air is administered at inadequate volumes, the risk of serious lung injury (sudden barotrauma) should be considered.

If you forget to use ARIA SOL
Do not take a double dose to make up for a missed dose. Continue treatment with the
prescribed amount.

If you stop taking ARIA SOL
The condition for which you are taking compressed medical air may worsen.
If you have any doubts about using this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
No known side effects have been reported.
However, the following side effects may occur: decompression sickness* frequency not known
oxygen toxicity* frequency not known
*if administered under pressure (see also “Warnings and precautions”)

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. You can also report side effects directly through the
national reporting system at
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 SOL

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 which is stated on the label after EXP. The expiry
date refers to the last day of that month.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to dispose of
medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What ARIA SOL contains

ARIA SOL 200 Bar medicinal compressed gas
The cylinders contain compressed atmospheric air

ARIA SOL 200 BAR SYNTHETIC MEDICINAL COMPRESSED GAS
The cylinders contain

• The active ingredient is oxygen 21-22.5%
• The other component is nitrogen

Description of the appearance of ARIA SOLand contents of the pack

Compressed medicinal gas and synthetic compressed medicinal gas
ARIA SOL compressed medicinal gas and synthetic compressed medicinal gas is packaged in cylinders and
cylinder packs, in the state of compressed gas at 200 bar at 15°C. The cylinders are made of steel, equipped with
valves that must be connected to a pressure regulator so that the medicinal product can be
used. The cylinders containing air intended for medicinal use have a white body and the upper end (ogive) painted in white - black.
It is available in the following packs:

Synthetic compressed medicinal gas (200 bar)
Steel cylinders with a valve of 1, 2, 3, 5, 7, 10, 14, 27, 40, 50 liters.
Cylinder pack of 12, 16, 20 cylinders of 50 liters.

Compressed medicinal gas (200 bar)
Steel cylinders with a valve of 50 liters.
It is possible that not all packs are marketed.

Marketing Authorisation Holder
SOL S.P.A. - VIA BORGAZZI, 27 – MONZA

Manufacturer

Compressed medicinal gas

SOL SPA – Via Nugolaio, 4 – Pisa

Synthetic compressed medicinal gas
I.C.O.A. Srl Industria Calabrese Ossigeno ed Acetilene – Zona Industriale (Loc. Porto Salvo) – Vibo Valentia
SOL SPA – Via Acquaviva, 4 – Cremona
SOL SPA – Via Nugolaio, 4 – Pisa
SOL SPA – Via Vanoni, 5 – Ancona
SOL SPA – Via Giovanni Francesco Maggiò – Marcianise (CE)
---------------------------------------------------------------------------------------------------------------------------

The following information is intended exclusively for doctors or healthcare professionals:
Dosage and 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 application must be established according to
the cause of the hypoxia. In these cases, artificial ventilation with medicinal air aims:

• to restore the normal tidal volume of approximately 500 ml of air in adults; in children this volume varies depending on weight, height, sex and age.
• to restore normal oximetry, the normal values of which are between 94-100%, corresponding to PaO values greater than or equal to 60%. In highly premature infants, values relatively lower than oximetry are considered acceptable in the first hours of life. When replacement of ambient air is necessary, the purpose of using medicinal air is to ensure a reliable supply of 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 obtain the desired oxygen concentration using the following formula:

[(number of liters of air/minute x 21) + (number of liters of oxygen/minute x 100)]
FiO = ----------------------------------------------------------------------------------------------------------
[(number of liters of air/minute + number of liters of oxygen/minute) x 100]
Method of administration
In artificial ventilation and resuscitation stages of infants, pharmaceutical vehicle, in stages
of hyperoxia/hypoxia and in anesthesia, medicinal air is generally administered by inhalation through
face masks or oro- and naso-tracheal tubes, administered with various techniques, generally from
breathing and ventilation equipment and can be delivered with pressure or volumetric systems.
In cavity insufflation, medicinal air is conveyed through the endoscope, which is generally equipped
with a special cannula.

Special warnings and precautions for use
Medicinal air must be administered to patients only at atmospheric pressure or at slightly positive pressures in the case of using ventilators. The administration of medicinal air under
pressure could cause decompression sickness (as a result of the effects of nitrogen) and oxygen toxicity.
If medicinal air is mixed with other gases for inhalation, the oxygen fraction in the inhaled mixture (fraction of inspired oxygen – FiO ) must be maintained at least at 21 v/v. In practice, this
means that, if it is a component of a gas mixture, oxygen must be one of the other components.
At exceptionally high flow rates, such as during use in an incubator, medicinal air may
be perceived as cold.
Medicinal air should not be used where oxygen concentrations higher than
atmospheric (>21%) are indicated.
Paediatric population
Children are different from adults in many respects (not only in size): for example
they present differences in terms of breathing pattern, tidal volume and geometry of the airways. Caution is
required when used in children.
Preliminary and during the intake of the medicine, we recall strict adherence to the safety precautions
reported below.

SAFETY (see also section Instructions for use and handling)
It is important to remember that air itself is not flammable, but oxygen (as an oxidant) supports
combustion; it can, therefore, activate a combustion in the presence of combustible substances such as fats (oils,
lubricants) and organic substances (tissues, wood, paper, plastics, etc.) due to an ignition
(spark, open flame, ignition source), or due to adiabatic compression that can
occur in pressure reducing equipment (regulators) during a sudden drop in
gas pressure.

• No electrical equipment that can emit sparks should be used near patients receiving medicinal air.
• It is strictly forbidden to handle equipment or components with hands or clothes or face soiled with grease, oil, creams and various ointments. Do not use greasy creams and lipsticks.
• Cylinders must not be used if there is obvious damage or if they are suspected of being damaged or have been exposed to extreme temperatures.
• 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 it can be done safely. If the valve cannot be closed, the cylinder must be taken to a safer place outdoors to allow the air to escape freely.

Precautions for storage
Observe all relevant rules for the use and handling of pressure cylinders.
Store cylinders at temperatures between -10°C and 50°C, in well-ventilated areas, illuminated with
cold light source and equipped with appropriate emergency systems, in a vertical position with the valves
closed, protected from rain, weathering, exposure to direct sunlight, away from sources of heat or
ignition (including electrostatic charges) and combustible material.
Empty containers or those containing other types of gas must be stored separately.
Cylinders must be used on a strict rotation basis so that cylinders with an earlier filling date
are used first.

Instructions for use and handling
All persons handling medicinal air cylinders should have adequate knowledge of:

• properties of the gas;
• correct operating procedures for the cylinder;
• precautions and actions to be taken in case of emergency. Medicinal air cylinders are reserved exclusively for containing/ transporting air for inhalation, for therapeutic use. Cylinders must be transported using appropriate means to protect them from the risk of shocks and falls. Imperatively respect the following instructions:
• Read the cylinder (pack) instruction and use manual carefully
• Verify that all material is in good condition
• Secure the cylinders to keep them in a vertical position (especially the smaller cylinders) and avoid accidental falls, protect them from shocks and keep them at a temperature below 50°C, ensuring adequate ventilation/aeration of the premises where the product is used. Cylinders must be equipped with a cap/tulip to protect the valve.
• Handle the material with clean hands, free of traces of grease or oil.
• Lift and move the cylinders using only the appropriate trolley, do not lift the cylinder by the valve.
• Use fittings, connecting tubes or flexible connecting hoses specifically designed and compatible.
• Particular attention must be paid to the fixing of pressure regulators on the cylinders, in order to avoid the risk of accidental breakage.
• It is strictly forbidden to intervene in any way on the fittings of the cylinders, on the delivery equipment and related accessories or components (OIL AND GREASE CAN SPONTANEOUSLYIGNITE IN CONTACT WITH OXYGEN)
• Do not grease or attempt to repair faulty valves/taps.
• It is strictly forbidden to handle equipment or components with hands or clothes or face soiled with grease oil, creams and various ointments.

General instructions for use

• 1.Remove the seal and the protective cap of the outlet valve
• 2.Make sure the cap is put aside so that it can be reinserted after use
• 3.Do not remove or discard labels attached to the cylinder/cylinder pack
• 4.Ensure that the cylinder/cylinder pack is associated with a pressure regulator specific for medicinal air and that the connection is compatible with that of the cylinder/cylinder pack valve
• 5.Make sure the connection on the regulator is clean

• 6.Connect the pressure regulator, using only a modest pressure and connect the tubing to the outlet of the regulator/flow meter.
• 7.Open the cylinder valve slowly and gradually (without forcing) and check for leaks. If there are leaks, they will be made evident by a hiss; if the leak occurs between the valve outlet and the pressure regulator, remove the connections and clean them; reconnect the pressure regulators to the valve with moderate force. Never use adhesive compounds or otherwise adhesives to plug a leak. If the leak persists, label the cylinder and return it to the manufacturer.

NOTE: FOR MORE DETAILS, PLEASE CONSULT THE CYLINDER'S USER MANUAL
ATTENTION

• Ensure that there is a sufficient amount of air remaining in the cylinder to guarantee the prescribed complete delivery
• 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
• Gradually open the valve to avoid pressure surges
• Do not force taps and valves during opening and closing
• Do not attempt to open or repair defective valves or reducers
• 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 the direct flow of gas
• 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's User Manual
• Use only cylinders suitable for medical air, at the foreseen operating pressures and temperatures, pressure regulators designed for medical air and devices designed for the delivery of medical air. During use When medical air cylinders are in use, ensure that:
• they are used only as medical gases (do not use for purposes other than those established by the doctor)
• they are handled with care without violent movements to avoid dropping them
• they are securely fixed in a vertical position to a support
• marking, labeling or adhesives connected to them are not altered or removed
• they are not used near people who are smoking or near sources of heat Furthermore:
• Do not use greasy creams and lipsticks
• Do not smoke
• Do not approach the package with open flames
• No electrical equipment that can emit sparks should be used near patients receiving oxygen
• Do not use oils or greases on fittings, taps, valves and on any material in contact with oxygen
• Never introduce air into an apparatus that could contain combustible materials and in particular fatty substances

After use
When the medical air cylinder is empty, ensure that:

• the valves are closed manually 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, fitting it into its seat
• empty cylinders with closed valves and the protective cap are placed in a designated

storage area before their return to the manufacturer
Disposal
It is recommended not to dispose of medical air cylinders as waste. Do not discharge cylinders into
sewers, basements or excavations where accumulation may be dangerous.
The cylinders must be returned to the supplier with a slight presence of residual gas (the presence of residual
pressure prevents contamination of the cylinder).
Any residual unused medicinal product present in the pressure cylinder will be eliminated,
through appropriate procedures, by the company that will subsequently refill the same cylinder.
If, for safety reasons, a cylinder must be emptied after use, the gas should be released into
a well-ventilated area.
Contact the supplier if further information on emptying the cylinders is needed.

Unused medicine and waste derived from this medicine must be disposed of in accordance with
current local regulations.
Firefighting measures
In case of a possibility of being involved in a fire:

• Remove the cylinders from the area that could be affected by the fire
• Close the cylinder valves to prevent gas flow
• Move the cylinders away from the heat source In case of involvement in a fire:
• Remove the cylinders and cool them with water from a safe position
• All types of fire extinguishers can be used when dealing with a fire involving medical gas cylinders. No toxic combustion products are released from the medical 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 material to protect them from the risk of impact and
falling (e.g. trolley with chains, barriers or rings).
Particular attention must be paid to ensure that there are no leaks and that the cylinders have
valves tightly closed; also check the fixing of the pressure reducer, to avoid the risk of accidental breakage.
During transport on vehicles, cylinders must be securely fastened, preferably in a vertical
position, in an area separate from the driver's cabin. Permanent ventilation of the vehicle and a smoking ban must be ensured.
Ensure that the driver is aware of the hazards of the load and knows what to do in case of accidents
or emergencies. It is advisable to provide the driver with written instructions explaining in detail the actions to
be taken in the event of an accident or emergency.

For further information, please consult the Summary of Product Characteristics