ARIA 200 BAR Компрессированный медицинский газ

Содержание инструкции

1. ARIA SIAD 200 BAR COMPRESSED MEDICAL GAS, SYNTHETIC COMPRESSED
   1. What is ARIA SIAD and what is it used for
   2. What you need to know before you are given ARIA SIAD
   3. How ARIA SIAD will be administered to you
   4. Possible side effects
   5. How to store ARIA SIAD
   6. Content of the pack and other information

ARIA SIAD 200 BAR COMPRESSED MEDICAL GAS, SYNTHETIC COMPRESSED

compressed atmospheric air

oxygen

Read this leaflet carefully before this medicine is administered to you, 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 SIAD is and what it is used for
• 2. What you need to know before ARIA SIAD is administered to you
• 3. How ARIA SIAD will be administered to you
• 4. Possible side effects
• 5. How to store ARIA SIAD
• 6. Contents of the pack and other information

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

ARIA SIAD belongs to the group of pure medical gases and gas mixtures and contains compressed atmospheric air or a mixture of oxygen and nitrogen.

• ARIA SIAD 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 to administer drugs for nebulization;
• 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 flows;
• to introduce air into a body cavity (cavity insufflation).

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

ARIA SIAD will not be given to you if:
you need to be treated exclusively with pure oxygen or with other medicinal gas mixtures containing
anyway oxygen in an amount greater than normally present in the air (21%)

Warnings and precautions
Consult your doctor or pharmacist before you are given ARIA SIAD.
Preliminary and during the administration of medicinal air, it is necessary that you strictly adhere to the
safety precautions reported below.

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

During use

• Do not use greasy creams and lipsticks.
• Do not smoke.
• Do not approach the package with open flames.
• Do not use any electrical equipment that can emit sparks near patients receiving medicinal air.
• Do not use oils or fats on fittings, taps, valves and on any material in contact with oxygen
• Never introduce air into an apparatus that may contain combustible materials and in particular fatty substances.
• Do not intervene in any way on the connections of the cylinders, on the delivery equipment and on the 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.

Other medicines and ARIA SIAD
Inform your doctor or pharmacist if you are taking, have recently taken or may take any
other medicine.
No interactions with other drugs have been found.

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

Pregnancy, breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy or if you are breastfeeding with breast milk
ask your doctor or pharmacist for advice before taking this medicine.
Medicinal air at atmospheric pressure can be used during pregnancy and during breastfeeding.

Driving and operating machinery
The use of medicinal air does not alter the ability to drive vehicles or operate machinery.

3. How ARIA SIAD 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 a cannula, or 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
state of health.

If you are given too much ARIA SIAD
It is very unlikely that you will be given too much ARIA SIAD because your doctor or
nurse will monitor you during treatment.
The symptoms you may experience due to a dosage of medical air under pressure are: decompression sickness (due to the effects of nitrogen) and oxygen toxicity.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Very common

• dry mouth,
• headache

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: 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 SIAD

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. Content of the pack and other information

What ARIA SIAD contains

ARIA SIAD 200 BAR COMPRESSED MEDICINAL GAS
The cylinders contain compressed atmospheric air

ARIA SIAD 200 BAR COMPRESSED SYNTHETIC MEDICINAL GAS
The cylinders contain

• The active ingredient is oxygen 21-22.5%
• The excipient is nitrogen

Description of the appearance of ARIA SIAD and contents of the pack

Compressed medicinal gas and compressed synthetic medicinal gas
ARIA SIAD compressed medicinal gas and compressed synthetic medicinal gas is packaged in cylinders and
cylinder packs, in the form of compressed gas at 200 bar at 15°C. The cylinders are made of steel, equipped with valves
capable of connecting to a pressure regulator.
It is available in the following packs:

Compressed synthetic medicinal gas (200 bar)
Steel cylinders with valve of 3, 10, 14, 40 liters.
Cylinder pack of 16, 25 cylinders of 40 liters.

Compressed medicinal gas (200 bar)
Steel cylinders with valve of 3, 10, 14, 40 liters.
Cylinder pack of 16, 25 cylinders of 40 liters.
It is possible that not all packs are marketed.

Marketing Authorisation Holder
SOCIETA’ ITALIANA ACETILENE & DERIVATI “SIAD” S.p.A
Via San Bernardino, 92- 24126 Bergamo

Manufacturer

Compressed medicinal gas
Società Italiana Acetilene & Derivati “SIAD” S.p.A. - S.S. 525 del Brembo 1 - Osio Sopra (BG)
Nippon Gases Pharma S.r.l. Via Martino della Torre 16 - Novara
Nippon Gases Industrial S.r.l. - Via Strada Regionale Casilina 6, n.114 - Anagni (FR)

Compressed synthetic medicinal gas
Nippon Gases Pharma S.r.l. Via Martino della Torre 16 - Novara
Nippon Gases Industrial S.r.l. - Via Strada Regionale Casilina 6, n.114 - Anagni (FR)
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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 clinical condition
of the patient.
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 via 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 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 medical oxygen in order 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, typically from breathing and ventilation equipment and can be delivered with pressure or volumetric type 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. Administering medicinal air under pressure can 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 gas mixture (inspired oxygen fraction – FiO ) 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 during use in an incubator, medicinal air
may be perceived as cold.
Preliminary and during taking the medicine, it is recalled to the scrupulous respect of the safety
precautions reported subsequently.

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.

• Cylinders of medicinal air must be kept away from sources of heat, due to the combustibility of oxygen: appropriate precautions must therefore be taken.
• Oxygen can cause the sudden ignition of incandescent materials or embers; for this reason it is not permitted to smoke or keep open and unprotected flames near the cylinders and delivery systems.
• Do not smoke in the environment where medicinal air is administered.
• Do not place cylinders near sources of heat.
• No electrical equipment that can emit sparks should be used near patients receiving medicinal air.
• It is strictly forbidden to intervene in any way on the connections of the cylinders, on the delivery equipment and its accessories or components.
• Any contact with oil, grease or other hydrocarbons must be avoided (OIL AND GREASE CANIGNITE SPONTANEOUSLY IN CONTACT WITH OXYGEN).
• It is strictly forbidden to handle the equipment or components with hands or clothes or face soiled with grease, oil, creams and various ointments. Do not use greasy lipsticks.
• Cylinders cannot be used if there is obvious damage or if they are suspected of being damaged or have been exposed to extreme temperatures.
• Only equipment suitable and compatible with the specific cylinder model can be used.
• Pliers or other tools must not be used to open or close the cylinder valve, in order 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.
• The valves of empty cylinders must be kept closed.
• It is not permitted to administer the gas under pressure.

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
a cold light source and equipped with appropriate emergency systems, in a vertical position with the valves
closed, protected from rain, weather, 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 rigid 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 impact and falling.
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 untimely falls, protect them from impacts and keep them at a temperature below 50°C, ensuring adequate ventilation/aeration of the premises where the product is used. The 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 taking it by the valve.
• Use fittings, connecting tubes or flexible connecting hoses specific 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 connections of the cylinders, on the delivery equipment and its accessories or components (OIL AND GREASE CAN TAKESPONTANEOUSLY FIRE IN CONTACT WITH OXYGEN)
• Do not grease or attempt to repair defective valves/taps.
• It is strictly forbidden to handle the 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.Make sure that the cylinder/cylinder pack is associated with a pressure regulator specific for medicinal air and 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 outlet of the valve and the pressure regulator, remove the connections and clean them; reconnect the pressure regulators to the valve with moderate energy. Never use adhesive or otherwise adhesive compounds to plug 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 that there is a sufficient amount of air remaining in the cylinder to guarantee the prescribed complete 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
• 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 of 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 User Manual
• Use only cylinders suitable for medical air, at the specified operating pressures and temperatures, pressure regulators designed for medical air and devices designed for the administration 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 prescribed 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
• it is not allowed to alter or remove markings, labels or adhesives attached to them
• 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 connections, taps, valves and on any material in contact with oxygen
• Never introduce air into an apparatus that may 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 being returned to the manufacturer

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.
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 unused medicinal product residues 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 the atmosphere in a well-ventilated area.
Contact the supplier if further information on emptying the cylinders is needed.

Unused medicine and waste derived from that medicine must be disposed of in accordance with
current local regulations.
Firefighting measures
In case of a possible involvement in a fire:

• Remove the cylinders from the area that may 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 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 the valves
tightly closed; also check the fixing of the pressure reducer, to avoid the risk of accidental breakage.
During transport on vehicles, the cylinders must be securely fixed, preferably in a vertical position, in an area separate from the driver's cabin. Permanent ventilation
of the vehicle and a prohibition on smoking must be ensured.
Ensure that the driver is aware of the hazards of the load and knows what to do in the event of accidents
or emergencies. It is advisable to provide the driver with written instructions detailing the actions to
be taken in the event of an accident or emergency.

For further information, consult the Summary of Product Characteristics