Aria Linde Medicale

Patient Information Leaflet

ARIA LINDE MEDICALE 200 BAR MEDICINAL SYNTHETIC COMPRESSED GAS

Oxygen
Please 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 you experience any side effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

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

1. What ARIA LINDE MEDICALE is and what it is used for

ARIA LINDE MEDICALE is medicinal air containing a mixture of oxygen and nitrogen.
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 LINDE MEDICALE is indicated for:

• Resuscitation to support breathing (ventilatory assistance);
• Chronic respiratory conditions to provide breathing support;
• Anaesthesia, as a carrier gas for drugs inducing sleep (volatile anaesthetics);
• Nebulisation of medications;
• Management of patients with disorders of the body's defence system (immune system), such as in organ transplantation, cellular transplantation, or extensive burns;
• Incubators, to provide air of controlled quality;
• Introducing air into a body cavity (cavity insufflation).

2. What you need to know before you are administered ARIA LINDE MEDICALE

ARIA LINDE MEDICALE will not be administered to you if:
you require treatment exclusively with pure oxygen or with other medicinal gas mixtures containing oxygen at concentrations higher than normally present in air (21%).

Warnings and precautions
Consult your doctor or pharmacist before you are administered ARIA LINDE MEDICALE.
Before and during 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 approach the container with open flames.
• Do not use any electrical equipment that may emit sparks near patients receiving medicinal air.
• Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen.
• Never introduce air into equipment that may contain combustible materials, particularly greasy substances.
• Do not tamper in any way with cylinder connections, 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 ointments.

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

ARIA LINDE MEDICALE with food and alcohol
No interactions with alcohol, tobacco, or food have been reported.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are 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 LINDE MEDICALE will be administered to you

This medicine will be administered strictly according to the instructions of your doctor or nurse. If you have any doubts, consult your doctor.
Medicinal air is generally inhaled through the nose or mouth via a face mask, tubes, respiratory or ventilatory equipment, or blown through a cannula into the relevant body cavity.
The dose, frequency, and duration of treatment with medicinal air will be determined by your doctor based on your health status.

If you are administered more ARIA LINDE MEDICALE than you should
It is very unlikely that you will be given more ARIA LINDE MEDICALE than required, as your doctor or nurse will monitor you during treatment.
Symptoms that may occur due to excessive administration of pressurised medicinal air include:
decompression sickness (due to nitrogen effects) and oxygen toxicity.
Treatment
If you are administered more ARIA LINDE MEDICALE than required, your doctor will provide appropriate therapy and monitor you closely.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody experiences 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 effects, including those not listed in this leaflet, inform your doctor, pharmacist, or nurse. You may also report side effects directly via the website: 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 LINDE MEDICALE

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 medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This helps protect the environment.

6. Contents of the pack and other information

What ARIA LINDE MEDICALE contains

• The active substance is oxygen 21–22.5%
• The excipient is nitrogen

Description of the appearance of ARIA LINDE MEDICALE and contents of the pack
ARIA LINDE MEDICALE synthetic compressed medicinal gas is supplied in cylinders and cylinder packs, in compressed gas form at 200 bar at 15°C. Cylinders are made of steel or aluminium, equipped with valves compatible with pressure regulators.
Available in the following pack sizes:

• Steel cylinders of 0.5, 1, 2, 3, 5, 7, 10, 14, 20, 40, and 50 litres.
• Aluminium cylinders of 2, 5, and 10 litres.
• Steel cylinders with integrated pressure-reducing valve of 5 and 7 litres.
• Cylinder packs of 12 steel cylinders of 40 and 50 litres.
• Cylinder packs of 16 steel cylinders of 40 and 50 litres.

Not all pack sizes may be marketed.
Marketing Authorisation Holder
LINDE MEDICALE S.r.l. – Via Guido Rossa, 3 – 20004 Arluno (MI)
Manufacturer
Linde Gas Italia Srl - Via Pio Semeghini, 38 - Roma

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 indication 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 oximetry values, which range between 94–100%, corresponding to PaO₂ values equal to or greater than 60 mmHg. In highly premature newborns, relatively lower oximetry values may be acceptable in 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 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:

[(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 of infants, pharmaceutical vehicle delivery, hyperoxia/hypoxia stages, and anaesthesia, medicinal air is generally administered by inhalation via face mask or oro- and naso-tracheal tubes, delivered by various techniques, usually through respiratory and ventilatory equipment, and may be delivered via pressure or volume-controlled systems.
In cavity insufflation, medicinal air is delivered via an endoscope, typically equipped with a dedicated cannula.

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 fraction of oxygen 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.
At exceptionally high flow rates, such as during use in an incubator, medicinal air may feel cold.
Before and during administration of the medicine, strict adherence to the safety precautions listed below is required.

SAFETY (see also section Instructions for use and handling)
It is important to remember that air itself is not flammable, but oxygen (as an oxidiser) supports combustion and may initiate combustion in the presence of combustible materials such as fats (oils, lubricants) and organic substances (fabrics, wood, paper, plastics, etc.) due to ignition (spark, open flame, ignition source) or adiabatic compression that may occur in pressure-reducing equipment (regulators) during sudden gas pressure reduction.

• Medicinal air cylinders must be kept away from heat sources due to the oxidising nature of oxygen; appropriate precautions must be taken.
• Oxygen may cause sudden ignition of glowing materials or embers; therefore, smoking or use of unshielded open flames is prohibited near cylinders and delivery systems.
• Do not smoke in areas where medicinal air is administered.
• Do not place cylinders near heat sources.
• Do not use any electrical equipment that may emit sparks near patients receiving medicinal air.
• It is strictly forbidden to tamper 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 IN 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 compatible and suitable 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 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 gas to escape freely.
• Valves of empty cylinders must be kept closed.
• Administration of pressurised gas is not permitted.

Storage precautions
Observe all relevant rules for the use and handling of pressurised cylinders.
Store cylinders at temperatures between -10°C and 50°C, in well-ventilated, cold-light illuminated areas equipped with appropriate emergency systems, in upright position 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 so that cylinders with earlier filling dates are used first.

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

• Gas properties;
• Correct operational procedures for cylinders;
• Precautions and emergency actions.

Medicinal air cylinders are exclusively intended to contain/transport 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 upright position (especially smaller cylinders) and prevent accidental falls; protect them from impacts and maintain temperature below 50°C, ensuring adequate ventilation/aeration of areas 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 handle cylinders only using the appropriate trolley; never lift the cylinder by the valve.
• Use specific, compatible connectors, connecting tubes, or flexible hoses.
• Exercise extreme care when attaching pressure regulators to cylinders to avoid accidental breakage risks.
• It is strictly forbidden to tamper 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 strictly 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 reinsertion after use
3. Do not remove or discard labels attached to the cylinder/cylinder pack
4. Ensure the cylinder/cylinder pack is fitted with a pressure regulator specific for medicinal air 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 pressure reducer, disconnect and clean the components; reconnect the pressure reducer to the valve with moderate force. Never use sealants 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 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 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, at the required pressures and operating temperatures, pressure regulators designed for medicinal air, and devices designed for 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 doctor)
• They are handled carefully, avoiding violent movements and falls
• They are securely fixed in upright position on a support
• Markings, labels, or stickers are not altered or removed
• They are not used near people who smoke or near heat sources

Additionally:

• Do not use greasy creams and lipsticks
• Do not smoke
• Do not approach the container with open flames
• Do not use any electrical equipment that may emit 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 equipment that may 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
• The pressure regulator and/or connection is depressurised
• The protective cap is replaced over the valve, properly seated
• Empty cylinders with closed valves and protective caps are placed in a designated storage area before return to the manufacturer

Disposal
Medicinal air cylinders should not be disposed of as waste. Do not discharge cylinders into sewers, basements, or pits where gas accumulation may be hazardous.
Cylinders must be returned to the supplier with slight residual gas pressure (residual pressure prevents cylinder contamination).
Any unused medicinal product residue in the pressurised cylinder will be eliminated via specific procedures by the company responsible for subsequent refilling.
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 local regulations.

Firefighting measures
In case of potential fire involvement:

• Remove cylinders from the area likely to be affected by fire
• Close cylinder valves to prevent gas flow
• Move cylinders away from heat sources

In case of fire involvement:

• 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 risks.
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).
Extreme care must be taken to ensure there are no leaks and that cylinder valves are securely closed; also check the attachment of the pressure regulator to prevent accidental breakage.
During vehicle transport, cylinders must be securely fastened, preferably in upright position, in a separate area from the driver’s cabin. Permanent vehicle ventilation and smoking prohibition must be ensured.
Ensure the driver is aware of the load’s hazards and knows what to do in case of accidents or emergencies. It is advisable to provide the driver with written instructions detailing actions to take in case of incident or emergency.