INALOSSIN 400 PPM Compressed medical gas

Зміст інструкції

1. INALOSSIN 400 ppm mol/mol medicinal gas compressed, 800 ppm mol/mol medicinal gas compressed
   1. What is INALOSSIN and what is it used for
   2. What you need to know before using INALOSSIN
   3. How to use INALOSSIN
2. INALOSSIN will be administered to you by medical personnel or experienced healthcare professionals who
   1. Possible side effects
   2. How to store INALOSSIN
   3. Contents of the pack and other information

INALOSSIN 400 ppm mol/mol medicinal gas compressed, 800 ppm mol/mol medicinal gas compressed

nitric oxide

Read this leaflet carefully before using 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 or nurse.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What INALOSSIN is and what it is used for
• 2. What you need to know before using INALOSSIN
• 3. How to use INALOSSIN
• 4. Possible side effects
• 5. How to store INALOSSIN
• 6. Contents of the pack and other information

1. What is INALOSSIN and what is it used for

INALOSSIN is a medicinal gas containing nitric oxide. Nitric oxide is an element produced by the
cells of the human body, which intervenes in many processes that occur within the
body, for example, it promotes the dilation of blood vessels.
INALOSSIN is used to treat:

• breathing difficulties in newborns (neonatal respiratory failure), also associated with high blood pressure in the lungs (persistent pulmonary hypertension of the newborn (PPHN)).
• breathing difficulties in children and adults, associated with high blood pressure in the lungs (pulmonary hypertension of different etiology) thus increasing the amount of oxygen circulating (improvement of oxygenation).

INALOSSIN is administered only in hospitals by medical personnel or experienced healthcare
operators.

2. What you need to know before using INALOSSIN

Do not use INALOSSIN if:

• you are allergic to the active ingredient or to nitrogen (another component of this medicine);
• you have a heart problem called left ventricular dysfunction;
• the newborn has abnormal blood circulation within the heart (right-to-left or significant left-to-right shunt);
• the newborn suffers from a disease known as favism or fava bean disease, which causes a decrease in red blood cells (glucose-6-phosphate dehydrogenase deficiency);
• high blood pressure in the lungs (pulmonary hypertension) is caused by an increase in blood flow to the lungs (pulmonary overcirculation);
• you are pregnant or breastfeeding.

Warnings and precautions
Tell your doctor if:

• you have heart problems, for example, problems with the heart ventricle or suffer from diseases that cause blood to pass from the left side to the right side of the heart (left-to-right shunt), increasing the amount of blood that reaches the lungs (pulmonary overcirculation). In such cases, the doctor will perform specific tests, such as an echocardiogram, before using INALOSSIN.

Be careful with INALOSSIN
INALOSSIN contains nitric oxide:

• nitric oxide can cause an increase in the levels in the blood of a protein called methemoglobin. If this occurs, the blood is no longer able to carry oxygen;
• nitric oxide in contact with oxygen can be converted into nitrogen dioxide, an irritant to the bronchi and which can cause lung damage. During treatment with INALOSSIN, the doctor will regularly take blood samples to assess methemoglobin and check the value of nitrogen dioxide: if these parameters should be altered, the doctor will appropriately modify the therapy, reducing the dose of INALOSSIN.
• Nitric oxide can have a weak effect on platelets (components that contribute to blood coagulation). During treatment with INALOSSIN, the doctor will check for any symptoms of bleeding or bruising. If signs or symptoms that may be associated with bleeding are detected, inform your doctor immediately.

No effects of inhaled nitric oxide have been documented in newborns with malformations
due to an incomplete diaphragm, the so-called “congenital diaphragmatic hernias”.
In newborns with particular heart malformations, those that doctors call “congenital
heart defects”, inhaled nitric oxide can cause a worsening of
circulation.

Children
The safety and efficacy of INALOSSIN in premature infants with less than 34 weeks of
gestation has not yet been determined.

Other medicines and INALOSSIN
Tell your doctor if you are taking, have recently taken or might take any
other medicines, as some drugs can interact with INALOSSIN or increase the risk
of adverse events, even serious.
In particular, tell your doctor if you are taking:

• medicines called “nitric oxide donors” such as sodium nitroprusside or nitroglycerin, used to dilate blood vessels;
• medicines that can cause methemoglobin such as alkyl nitrates, sulfonamides (a type of antibiotic), prilocaine (a type of local anesthetic used to relieve pain);
• zaprinast or other drugs that dilate blood vessels;
• dipiridamole, a drug that affects blood coagulation;
• sildenafil, a drug used in erectile dysfunction;
• prostacyclin and its analogues, drugs that dilate blood vessels and affect blood coagulation.

Pregnancy and breastfeeding
INALOSSIN should not be used during pregnancy and breastfeeding. If you are pregnant, if
you suspect you are pregnant or are breastfeeding, tell your doctor.

Driving and using machines
Not applicable.

3. How to use INALOSSIN

INALOSSIN will be administered to you by medical personnel or experienced healthcare professionals who

know the
correct way to use this medicine. The doctor will determine the dose and duration of
treatment based on the severity of your condition and your age.
The usual dose of INALOSSIN ranges from 2 ppm (i.e. parts per million to be inhaled) up to a
maximum of 20 ppm. The doctor will use the minimum effective dose, for the time necessary to
achieve improvement in your respiratory condition.
During treatment with INALOSSIN, the doctor will regularly take blood samples to
check the level of methemoglobin and will monitor the amount of nitrogen dioxide: if these
parameters should be altered, the doctor will appropriately modify the
therapy, reducing the dose of INALOSSIN (see section 2, “Pay attention with
INALOSSIN”).

Method of administration
INALOSSIN is a medicine that is administered to the lungs through the mouth and nose (inhalation
route), for example using a mask.
The administration of INALOSSIN takes place through a particular system, called
mechanical ventilation, which delivers the correct amount of nitric oxide by diluting
INALOSSIN with an oxygen/air mixture immediately before administration. The
mechanical ventilation system is equipped with devices that constantly measure the
amount of nitric oxide, oxygen and nitrogen dioxide you are inhaling, to guarantee the
safety of the therapy.
In some clinical situations, the administration of nitric oxide is possible using
CPAP ventilation (continuous positive airway pressure). The amount of nitric oxide inhaled aims to
achieve the same effects as mechanical ventilation.

If you are given more INALOSSIN than you should, the blood is no longer able to
transport oxygen (due to an increase in methemoglobin levels); it is also possible
that lung injury or fluid (edema) in the lungs may occur (due to an
increase in nitrogen dioxide levels).
If doses of INALOSSIN that are too high are used, the doctor will perform blood tests and, if
necessary, will implement appropriate measures to improve the blood's ability to transport
oxygen (symptomatic treatment of breathing problems, administration of medicines
such as vitamin C or methylene blue, blood transfusion).

If you stop treatment with INALOSSIN
Treatment with INALOSSIN should not be stopped abruptly. If this were to
happen, a decrease in oxygen concentration in the
blood and/or an increase in pulmonary pressure could occur. At the end of treatment, the doctor
will slowly lower (approximately every 30-60 minutes) the amount of INALOSSIN administered, in
order for circulation in the lungs to return to normal without the use of INALOSSIN.

If you have any doubts about the use of this medicine, ask your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Inform your doctor if you experience any of the following during therapy with INALOSSIN:

Very common side effects(may affect more than 1 in 10 people)

• decreased number of platelets in the blood (thrombocytopenia).

Common side effects(may affect up to 1 in 10 people)

• increased levels of sugar (hyperglycemia) or bilirubin (hyperbilirubinemia) in the blood,
• decreased levels of potassium (hypokalaemia) in the blood;
• decreased blood pressure (hypotension);
• decreased air in the lungs (atelectasis);
• inflammation of the tissue under the skin (cellulitis);
• presence of blood in the urine (hematuria).

Uncommon side effects(may affect between 1 in 100 and 1 in

• 1,000)
• increased levels in the blood of a protein called methemoglobin, with reduced oxygen carrying capacity.

Side effects with unknown frequency(frequency cannot be estimated from available data)

• bradycardia (slow heart rate) or oxygen levels too low in the blood (oxygen desaturation/hypoxemia) when treatment is suddenly stopped;
• headache, dizziness, dry throat or shortness of breath (hypoxia) or difficulty breathing (dyspnea) following accidental exposure to environmental nitrous oxide (e.g. following a leak from equipment or the cylinder).

Immediately inform staff if you experience migraines when near
the child undergoing therapy with INALOSSIN.
If any side effect gets worse, or if you notice any side effect not listed in this leaflet, even after discharge, you or the child, inform
your doctor.

Reporting of side effects
If you get any side effects, talk to your doctor or pharmacist. 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 INALOSSIN

Keep this medicine out of the sight and reach of children.
The storage of INALOSSIN cylinders is the responsibility of the hospital.
The cylinder must be protected to avoid breakage or falling and must be kept away
from flammable or combustible materials and from humidity, protected from rain and exposure
to direct sunlight. Maintain the cylinder at a temperature between –10°C and +
50°C.
The cylinders must be secured so as to be kept in a vertical position and must
be stored in a well-ventilated, clean and locked area, reserved exclusively
for the storage of medical gases.
Do not use this medicine after the expiry date which is stated on the label. The expiry date
refers to the last day of that month.
When the cylinder is empty, do not dispose of it. Empty cylinders are collected by the supplier.

6. Contents of the pack and other information

What INALOSSIN contains
The active ingredient is: nitric oxide.
INALOSSIN 400 - 800 ppm mol/mol compressed medical gas contains: 400 - 800 ppm mol/mol
of nitric oxide.
The other component is: nitrogen.

Description of the appearance of INALOSSIN and contents of the pack
INALOSSIN 400 - 800 ppm mol/mol compressed medical gas is available in cylinders in
aluminium of 2 - 5 – 10 – 20 liters, fitted with a valve.
A 2-liter cylinder of INALOSSIN delivers 0.3 m of gas at a pressure of 1 bar at 15°C
A 5-liter cylinder of INALOSSIN delivers 0.75 m of gas at a pressure of 1 bar at 15°C
A 10-liter cylinder of INALOSSIN delivers 1.5 m of gas at a pressure of 1 bar at 15°C
A 20-liter cylinder of INALOSSIN delivers 3 m of gas at a pressure of 1 bar at 15°C

Marketing Authorisation Holder
Società Italiana Acetilene & Derivati "S.I.A.D." S.p.A. – Via S. Bernardino, 92 – Bergamo

Manufacturer
Società Italiana Acetilene & Derivati “S.I.A.D.” S.p.A. - S.S. 525 del Brembo, 1 - Osio Sopra
(Bergamo)
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INFORMATION EXCLUSIVELY FOR PHYSICIANS OR HEALTHCARE PROFESSIONALS. FOR
FURTHER DETAILS, CONSULT THE PRODUCT CHARACTERISTICS SUMMARY.
Discontinuation of therapy
The administration of nitric oxide must not be stopped abruptly, in order to avoid
inducing rebound hypoxemia and/or the risk of increased pulmonary arterial pressure (PAP) and/or worsening of blood oxygenation (PaO ). A
deterioration of oxygenation and an increase in PAP can occur even in
patients without an evident response to treatment.
Proceed with caution with the gradual cessation of therapy with nitric oxide. In the case of
patients undergoing treatment with inhaled nitric oxide, who require further medical care with
transfer to another hospital, it is recommended to administer inhaled nitric oxide also during
transport. The physician should have access to a reserve delivery system for nitric
oxide next to the patient's bed.
NO Formation
NO is rapidly formed within gas mixtures containing nitric oxide and O and as such nitric oxide may cause inflammation and injury to the respiratory tract. The
dose of nitric oxide should be reduced if the concentration of NO should exceed 0.5 ppm.
The prescription of nitric oxide must be subject to the supervision of an expert. The
prescription should be limited to units that have received adequate training in the use
of nitric oxide delivery systems.
Administration
Nitric oxide is delivered to the patient via mechanical ventilation, after dilution with a
mixture of oxygen/air, with the aid of an approved nitric oxide delivery system (marked with CE). Before starting therapy, during preparation,
ensure that the device settings comply with the gas concentration in the
cylinder. The system used for administration must allow the inhalation of a
stable concentration of nitric oxide, regardless of the ventilator used. It is also
advisable to minimize the contact time between nitric oxide and oxygen in the inspiratory circuit, to limit the risk of formation of toxic oxidation byproducts of the inhaled gas
(see paragraph 4.4).
In the presence of “continuous flow” ventilators (conventional or high-frequency oscillatory), recommended in neonatology, nitric oxide can be administered in continuous
flow in the inspiratory act or in the Y-piece, and in any case as close as possible to the patient below
the humidifier. The flow of a continuous ventilator must be such as to limit the formation of
toxic byproducts. In the presence of intermittent sequential high-flow ventilators, the
nitric oxide delivery system must be able to manage the peak gas concentration.
During the inspiratory phase, sequential synchronized delivery is recommended
to avoid peak concentrations of nitric oxide and the bolus effect induced by the continuous
administration of the gas.
In some clinical situations, the administration of nitric oxide is possible via
CPAP (continuous positive airway pressure) ventilation. The amount of nitric oxide inhaled has
the goal of achieving the same effects as mechanical ventilation.
Avoid direct intratracheal administration to minimize local injury that
may occur with contact between nitric oxide and the mucous membrane.
Treatment Monitoring
The inspired concentration of nitric oxide must be measured continuously within
the inspiratory act of the circuit near the patient. It is also necessary to measure the
concentration of nitrogen dioxide (NO ) and FiO , at the same site, using calibrated and CE-marked monitoring devices. For patient safety, appropriate alarms must be set for nitric oxide (± 2 ppm of the prescribed dose), NO (1 ppm) and
FiO (± 0.05). The pressure of the nitric oxide cylinder must be displayed to allow
prompt replacement without interruption of therapy. Reserve cylinders must be
available to allow prompt replacement and nitric oxide therapy must be
available for manual ventilation, e.g. in case of suction, patient transport and
resuscitation.
In the event of system failure or power failure, a battery backup and a reserve delivery system for
nitric oxide must be available. The power supply for the monitoring devices must be independent of
the function of the delivery device.
The upper exposure limit (average exposure) to nitric oxide by personnel,
as defined by legislation for workers, is 25 ppm for 8 hours (30 mg/m ) in
most countries of the world, while the corresponding limit for NO is 2-3 ppm (4-6
mg/m ).

Training for administration
The essential elements to be covered in the training of hospital personnel are listed
below.
Preparation and correct connections

• Connections to the gas cylinder and the patient's ventilator respiratory circuit.

Operation

• Checklist procedure before use (a series of steps necessary immediately before starting therapy in each patient, to ensure the correct functioning of the system and the elimination of NO2 from the system itself).
• Setting the device according to the correct concentration of nitric oxide to be administered.
• Setting the monitoring devices for NO, NO2 and O2, for high and low alarm limits.
• Use of the manual reserve delivery system.
• Procedures for the correct replacement of gas cylinders and for purging the system.
• Fault location alarms.
• Calibration of the monitoring devices for NO, NO2 and O2.
• Procedures for monthly system performance checks.

Monitoring of methemoglobin formation (MetHb)
After inhalation, the final products of nitric oxide found in the systemic circulation are
mainly MetHb and nitrate.
It is known that newborns and infants have lower MetHb reductase activity compared to
adults.
It is advisable to check the concentration of methemoglobin in the blood of patients treated
with nitric oxide within one hour of starting therapy with INALOSSIN, using an
analyzer capable of reliably distinguishing fetal hemoglobin from
methemoglobin. Although a significant increase in methemoglobin is unusual
when the initial level is low, it should still be checked before
treatment and then regularly during administration.
If the level of methemoglobin exceeds 2.5%, the dose of nitric oxide should be reduced. It is
also possible to consider the administration of reducing drugs such as methylene blue.
Although significant increases in methemoglobin levels are unusual if the initial
level is low, it is still prudent to repeat methemoglobin measurements daily
or every other day.
In adults undergoing cardiac surgery, the level of methemoglobin should be
measured within one hour of starting INALOSSIN therapy. If the fraction of methemoglobin
rises to a level that potentially compromises adequate oxygen delivery, the dose of
INALOSSIN should be reduced and the administration of
reducing drugs, such as methylene blue, may be considered.
Monitoring of nitrogen dioxide (NO ) formation
Immediately before delivery to each patient, follow the correct procedure to
eliminate NO from the system. Keep the concentration of NO as low as possible and in
any case always <0.5 ppm. If NO is >0.5 ppm, examine the delivery system
to rule out any malfunctions, recalibrate the NO analyzer and reduce if possible the amount of
nitric oxide and/or FiO2. If an unexpected change in the concentration of nitric
oxide is noted, verify that the delivery system is not faulty and recalibrate the analyzer.
Gradual discontinuation of therapy
Treatment with INALOSSIN should not be stopped abruptly in order to avoid the risk of
rebound effect. The following tapering technique may be proposed: reduce the dose
progressively by 1 ppm every 30 min – 1 hour, constantly monitoring the
pulmonary arterial pressure. If an increase in pulmonary arterial pressure is recorded following discontinuation of treatment, nitric oxide should be readministered at 5
ppm. The tapering procedure can then be repeated. The described method should
be considered valid regardless of the patient's age.

Overdosage
An overdose of nitric oxide causes an increase in methemoglobin and NO levels.
A high concentration of NO can cause acute lung injury and cases of pulmonary edema
have been reported following the administration of high concentrations of nitric oxide. Increases in methemoglobinemia reduce the capacity for oxygen delivery of the
circulation.
In clinical studies, NO2 levels > 3 ppm or methemoglobin levels > 7% have been treated
by reducing the dose of INALOSSIN, or by completely interrupting the treatment with INALOSSIN.

Actions to be taken in case of accidental overdose

• Symptomatic treatment of respiratory disorders.
• In case of persistent methemoglobinemia, despite reduction or interruption of treatment, intravenous injection of vitamin C or methylene blue, or a blood transfusion should be considered, depending on the patient's clinical condition.

Actions to be taken in case of massive inhalation due to accidental leakage

• Keep the patient under medical observation for at least 24 hours in case of respiratory disorders, symptomatic treatment should be administered. In case of methemoglobinemia, specific treatment should be administered (methylene blue).

Instructions for use and handling
All personnel handling cylinders containing nitric oxide should have
adequate knowledge of:

• gas properties;
• correct operating procedures for the cylinder;
• precautions and actions to be taken in emergency situations.

Cylinders containing nitric oxide are reserved exclusively for containing/transporting
this gas for inhalation, for therapeutic use.

Imperatively respect the following instructions:

• Read the instruction and use manual of the cylinder (package) carefully.
• Verify that all the material is in good condition before using it.
• Securely fasten the gas cylinders with chains or locks to the shelf to keep them in a vertical position (especially the smaller cylinders) and prevent any 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 fitted with a closed or tulip-shaped cap to protect the valve. The cylinders must be kept with the taps closed.
• Never open the cylinder valve abruptly.
• Do not handle or use a cylinder whose valve is missing a cap to protect the valve itself.
• At each new use, purge the flowmeter/pressure reducer three times using nitrous oxide.
• Handle the material with clean and dry hands.
• Lift and move the cylinders using only the appropriate trolley, do not lift the cylinder by the valve.
• Use fittings, connecting tubes or flexible connectors that are specific and compatible.
• Particular attention must absolutely be paid to the fastening of pressure reducers to the cylinders, by screwing them on, in order to avoid the risk of accidental breakage or the reducer coming loose from the valve thread.
• It is strictly forbidden to intervene in any way on the fittings of the cylinders, on the dispensing equipment and their accessories or components.
• Do not attempt to repair faulty valves/taps. In this case, the cylinder must be returned to the distributor/manufacturer.
• Do not screw the pressure reducer/flowmeter onto the valve thread by forcing it with unsuitable tools, otherwise the gasket may break, thus damaging the dispensing device.
• Evacuate the exhaled gases to the outside (avoiding their accumulation in confined areas where the gas could accumulate). Before use, check that the room has an adequate ventilation system for the gases in case of accidents or accidental leaks.
• Since nitrous oxide is colorless and odorless, it is recommended to use a detection system in all rooms where it is used or stored.
• Exposure limits for personnel (see paragraph 4.2).

General instructions for use

• 1. Remove the seal and the protective cap of the outlet valve.
• 2. Make sure that the cap is put aside so that it can be reinserted after use.
• 3. Do not remove, damage or throw away the labels attached to the cylinder.
• 4. Make sure that the cylinder is associated with a regulator/pressure reducer specific for nitrous oxide and that the connection is compatible with that of the cylinder valve.
• 5. Make sure that the connection on the regulator/pressure reducer is clean.
• 6. Screw on the regulator/pressure reducer, using moderate force and connect the pipes to the outlet of the regulator/pressure reducer. Connect the flow meter.
• 7. When in use, the valve must be fully open avoiding opening it with force. Then open the cylinder valve slowly and gradually (without forcing) and check for any leaks. If there are leaks, they will be made evident by a hissing sound. Soapy water can be used to highlight small leaks. If the leak occurs between the outlet of the valve and the pressure reducer, remove the latter and check the presence of correct and clean gaskets. Clean the gaskets present and reconnect the regulator/reducer. Never use adhesive compounds or similar to plug a leak. If the leak persists, label the cylinder describing the problem found and return it to the manufacturer.

WARNING

• Make sure that there is a sufficient amount of nitrous oxide remaining in the cylinder to guarantee the 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 tightened 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 faulty valves or reducers.
• Never position yourself in front of the gas outlet from the tap/valve, but always on the opposite side or laterally. Do not expose yourself or the patient to the direct flow of 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.
• Use only cylinders suitable for nitrous oxide, maintained at the prescribed pressures and operating temperatures, pressure regulators designed for medical air and devices designed for the administration of medical air.

During use
When nitrous oxide cylinders are in use, make sure 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 in order to avoid their falling.
• they are well fixed in a vertical position on a support.
• it is not allowed that markings, labels or adhesives connected to them are altered or removed.
• they are not used near people who are smoking or near sources of heat.

After use
When the nitrous oxide cylinder is empty, make sure that:

• the valves are closed manually without forcing, using only moderate force to close the valve.
• the pressure regulator and/or the connection is depressurized.
• the cap is put back on top of the valves, fitting it into its seat.
• empty cylinders with the valves closed and the protective cap are placed in a special storage area before being returned to the manufacturer.

Disposal
It is recommended not to dispose of nitrous oxide cylinders as waste. Do not discharge into sewers,
basements or excavations where accumulation may be dangerous.
Do not dispose of the empty gas cylinder as empty cylinders will be collected by the
supplier.
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 unused medicinal product residues present in the pressure cylinder will be disposed of, through appropriate procedures, by the company that will proceed with the subsequent
refilling of 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 is needed on emptying the
cylinders.
The unused medicine and waste derived from such medicine must be disposed of in
compliance with local regulations in force.
Firefighting measures
In case of possibility of being involved in a fire:

• Remove the cylinders from the place that may be affected by the fire.
• Close the cylinder valves to prevent the gas from flowing.
• Move the cylinders away from the heat source.

In case of being involved in a fire:

• Immediately remove the cylinders by moving them away from the heat source. If this is not possible, cool them with water while remaining in a safe position; remove the cylinders only later when they are at room temperature.
• All types of extinguishers can be used in case of fire involving medical gas cylinders. There are no toxic combustion products released from the medical gas.

Measures in case of accidental opening
Close the cylinder valve.

Transport of cylinders
Cylinders must be transported using appropriate equipment to protect them from the
risk of impact and falling (e.g. trolley with chains, barriers or rings).
Particular attention must absolutely be paid to ensuring that there are no leaks and the cylinders
have the valves tightly closed.
During transport on vehicles, the cylinders must be firmly secured, preferably in
a vertical position, in an area separate from the driver's cabin. Permanent ventilation of the vehicle and a ban on smoking 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.

Incompatibilities
All equipment, including connectors, tubes and circuits, used in the delivery of nitrous oxide,
must be made of materials compatible with the gas. From the point of view of corrosion, the
delivery system can be divided into two different zones:

• 1) from the cylinder valve to the humidifier (dry gas)
• 2) from the humidifier to the outlet point (wet gas which may contain NO ). Tests show that nitrous oxide “dry” can be used with most materials. However, the presence of nitrogen dioxide and humidity creates an aggressive atmosphere. Therefore, among the metallic construction materials, only stainless steel is recommended. Polymers examined and found suitable for use in nitrous oxide delivery systems include polyethylene (PE) and polypropylene (PP).

Do not use butyl rubber, polyamide or polyurethane.
Polytetrafluoroethylene, hexafluoropropylene-vinilidene copolymer and polytetrafluoroethylene have been extensively used, together with pure nitrous oxide and other corrosive gases. These
materials were considered inert to the point of requiring no testing.

Storage
Observe all relevant rules for the use and handling of pressure cylinders.
Store the cylinders at temperatures between -10°C and 50°C, in well-ventilated environments,
illuminated with a 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 heat or ignition sources (including electrostatic charges) and
combustible material.
Empty containers or containing other types of gas must be stored separately.
The cylinders must be used so that the cylinders with the earlier filling date
are used first.
Protect gas cylinders from impacts, falling, oxidation and flammable materials, humidity,
sources of heat or ignition.
Storage in the pharmacy department
Store the cylinders in a ventilated, clean and locked place, reserved exclusively
for the storage of medical gases. Within this room, assign a separate area
for the storage of nitrous oxide cylinders.
Storage in the medical department
Place the cylinder in a equipped site, with appropriate material in order to keep the cylinder
in a vertical position.

Transport of gas cylinders
Transport gas cylinders with appropriate tools, in order to protect them from the risk of impact and
falls. During intra-hospital or extra-hospital transfers of patients treated with
nitrous oxide, firmly secure the cylinders so as to keep them in a vertical position. Pay
particular attention also to securing the pressure regulator/reducer to exclude the risk of accidental failures.