Oxygen gas Technici Foligno: detailed information

Package leaflet: Information for the patient

OXYGEN GAS TECNICI FOLIGNO, COMPRESSED MEDICINAL GAS 150 BAR, COMPRESSED MEDICINAL GAS 200 BAR, CRYOGENIC MEDICINAL GAS

Oxygen
Please read this leaflet carefully before using this medicine because 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 pharmacist.
This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet:

What OXYGEN GAS TECNICI FOLIGNO is and what it is used for
What you need to know before using OXYGEN GAS TECNICI FOLIGNO
How to use OXYGEN GAS TECNICI FOLIGNO
Possible side effects
How to store OXYGEN GAS TECNICI FOLIGNO
Contents of the pack and other information

1. What OSSIGENO GAS TECNICI FOLIGNO is and what it is used for

OSSIGENO GAS TECNICI FOLIGNO contains oxygen, a gas naturally present in the air we breathe.
Medicinal oxygen increases the delivery of oxygen to all body tissues.
OSSIGENO GAS TECNICI FOLIGNO is indicated in patients of all ages:

for the treatment of respiratory disorders (acute and chronic respiratory failure).

2. What you need to know before using OSSIGENO GAS TECNICI FOLIGNO

Under normal conditions, there are no contraindications.
Warnings and precautions
Talk to your doctor or pharmacist before using OSSIGENO GAS TECNICI FOLIGNO.
Inform your doctor:

if you suffer from a thyroid disease, a gland located in the neck that is overactive (hyperthyroidism)
if you have vitamin C and/or vitamin E deficiency, or if you have anemia caused by a deficiency of a substance called glutathione (an antioxidant that counteracts aging)
if you have undergone treatment for paraquat poisoning (a herbicide)
if you consume alcohol
if you are taking medicines for epilepsy (barbiturates) and/or pain (opioids)
if you suffer from airway inflammation making breathing difficult (Chronic Obstructive Pulmonary Disease, COPD)
if you have certain specific diseases (e.g. COPD; cystic fibrosis, pathological obesity, chest wall deformities, neuromuscular disorders, drug overdoses that depress breathing), which may reduce sensitivity to carbon dioxide pressure in the blood or lead to increased carbon dioxide concentration in the blood (hypercapnic respiratory failure)
if you have had lung injury caused by bleomycin use
if you have recently undergone radiography.

Children
In premature infants and full-term newborns, oxygen therapy may cause eye damage (retinopathy of prematurity), lung damage, and brain hemorrhages. The doctor will determine the appropriate oxygen concentration to administer to the newborn for optimal treatment.
Safety precautions
During transport, storage, and use of cylinders

Avoid contact of oils and greases with cylinders: for example, avoid touching cylinders with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Do not use greasy creams or lipsticks.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen ( OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN ).
Do not touch frozen parts.
Use only containers that show no visible damage or that have not been damaged or exposed to extreme temperatures.
Use only equipment suitable and compatible with the specific container model.
Keep cylinders away from heat sources and open flames.
Do not smoke in the area where cylinders are located, especially while oxygen is being administered to the patient.
Do not use any electrical equipment that could produce sparks near the cylinders, especially while oxygen is being administered to the patient.
Never introduce oxygen into a device that might contain materials that could catch fire, particularly fatty substances.
Do not use pliers or other tools to open or close the cylinder valve.
Do not alter the shape of the container.
In case of leakage, immediately close the cylinder valve and, if safe to do so, move the cylinder to a safer outdoor location to allow oxygen to escape freely.
Close valves on empty cylinders.
Do not administer pressurized gas.

During transport, storage, and use of cryogenic oxygen

Liquid oxygen may cause cold burns. If liquid oxygen comes into contact with skin or eyes, wash the affected area with abundant cold water or apply cold compresses. Seek immediate medical advice.

Other medicines and OSSIGENO GAS TECNICI FOLIGNO
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor or pharmacist if you are taking:

catecholamines (e.g. epinephrine, norepinephrine), medicines that affect multiple body organs and are generally used in emergency treatment of sudden allergic reactions
corticosteroids (e.g. dexamethasone, methylprednisolone), medicines used to treat inflammation
hormones (e.g. testosterone, thyroxine)
amiodarone, a medicine used to treat heart rhythm disorders
chemotherapeutic agents (e.g. bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors
antimicrobial agents (e.g. nitrofurantoin)
antibiotics (e.g. bleomycin, actinomycin), medicines used to treat infections
medicines for mental disorders (e.g. promazine, chlorpromazine, thioridazine)
vitamin K supplements (menadione)
chloroquine, a medicine used to treat malaria.

OSSIGENO GAS TECNICI FOLIGNO and alcohol
Do not consume alcohol during treatment with OSSIGENO GAS TECNICI FOLIGNO, as oxygen increases respiratory depression (breathing difficulties) caused by alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Oxygen may be used during pregnancy only when necessary due to life-threatening indications, critical conditions, or hypoxemia (inadequate blood oxygenation).
Breastfeeding
There are no contraindications for the use of oxygen during breastfeeding.
Driving and using machines
OSSIGENO GAS TECNICI FOLIGNO does not affect, or affects only negligibly, the ability to drive vehicles and use machinery.
Avoid driving vehicles and operating machinery until any negative effects on attention and alertness have completely disappeared.

3. How to use OSSIGENO GAS TECNICI FOLIGNO

Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor.
If you do not suffer from respiratory insufficiency, OSSIGENO GAS TECNICI FOLIGNO will be inhaled through the nose and mouth via a nasal cannula or a mask.
If you suffer from respiratory insufficiency or are undergoing anesthesia, OSSIGENO GAS TECNICI FOLIGNO will be administered via assisted ventilation.
The dose will be determined by your doctor based on your health status.
During treatment with OSSIGENO GAS TECNICI FOLIGNO, your doctor may perform measurements of blood gases (oxygen and carbon dioxide) in arterial blood and monitor levels of oxygen bound to haemoglobin, a protein that carries oxygen in the blood.

If you use more OSSIGENO GAS TECNICI FOLIGNO than you should
If you use more OSSIGENO GAS TECNICI FOLIGNO than you should, contact your doctor or go to hospital immediately.
Symptoms of an overdose you may experience include:

sore throat,
cough and chest pain,
difficulty breathing (dyspnoea, hypoventilation) and bluish skin (cyanosis),
damage to bronchi and lungs,
uncoordinated movements,
tingling in limbs,
disturbances of vision and hearing,
nausea, dizziness,
anxiety, confusion and irritability,
muscle cramps and spasms,
loss of consciousness,
uncontrolled body movements (convulsions), sometimes with loss of consciousness (epileptic seizures),
eye damage (retinopathy of prematurity) in premature infants,
respiratory depression and increased blood acidity in patients at risk of high carbon dioxide concentration in the blood (hypercapnic respiratory failure).

Treatment
If you have used excessive doses, your doctor will administer appropriate therapy and monitor you closely.
In most cases, symptoms resolve after 4 hours of stopping treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are the side effects associated with OSSIGENO GAS TECNICI FOLIGNO.

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

Eye damage (retinopathy of prematurity)

Not known (frequency cannot be estimated from the available data)

Pulmonary toxicity characterized by:
Airway infection characterized by pain beneath the sternum and dry cough (tracheobronchitis)
Fluid accumulation in the tissues lining the lung alveoli (interstitial edema)
Respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis)
Increased carbon dioxide in the blood (hypercapnia), leading to:
hypoventilation
increased acidity in the blood (respiratory acidosis)
respiratory arrest
Dryness and irritation of mucous membranes (congestion or obstruction of the paranasal sinuses with pain and bleeding)
Local irritation and inflammation of the mucosa

Other reported side effects:

Mild reduction in heart rate and cardiac output
Failure of lung expansion (atelectasis)
Lung injury
Dryness and irritation of the eyes
Slowed clearance of nasal secretions

For the cryogenic formulation only
Cold burns may occur following direct contact with liquid oxygen (see section Warnings and precautions).

Reporting of suspected adverse reactions
If you experience any side effect, including those not listed in this leaflet, tell your doctor or pharmacist.
You can also report adverse reactions directly via 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 OSSIGENO GAS TECNICI FOLIGNO

Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C.
Keep this medicinal product out of sight and reach of children.
Do not use this medicinal product 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 any medicinal product into wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What OSSIGENO GAS TECNICI FOLIGNO contains

The active substance is oxygen.

Description of the appearance of OSSIGENO GAS TECNICI FOLIGNO and package contents
Compressed medicinal gas (150 bar)
OSSIGENO GAS TECNICI FOLIGNO compressed medicinal gas is supplied in cylinders in a compressed state at 150 bar at 15°C. The cylinders are made of steel and equipped with valves and integrated pressure regulators.
Compressed medicinal gas (200 bar)
OSSIGENO GAS TECNICI FOLIGNO compressed medicinal gas is supplied in cylinders in a compressed state at 200 bar at 15°C. The cylinders are made of steel and equipped with valves suitable for connection to an external pressure regulator or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO GAS TECNICI FOLIGNO cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).

Available pack sizes:
Compressed medicinal gas (150 bar)
Steel cylinders with valve, 7 litres.
Compressed medicinal gas (200 bar)
Steel cylinders with valve, 1, 2, 3, 5, 7, 10, 14, 20, 30 litres.
Cryogenic medicinal gas
Mobile cryogenic container, 18, 20, 25, 30, 31, 37, 40, 41, 45 litres.

Not all pack sizes may be marketed.

Marketing Authorization Holder
GAS TECNICI FOLIGNO S.r.l.
Via delle Industrie, 17
06034 Foligno (PG)

Manufacturer
Compressed medicinal gas
GAS TECNICI FOLIGNO Srl – Via delle Industrie, 17 – Foligno (PG)
GAS TECNICI FOLIGNO Srl – Loc. Santa Sabina, Strada Lacugnana, 3/C – Perugia
Cryogenic medicinal gas (mobile containers)
GAS TECNICI FOLIGNO Srl – Via delle Industrie, 17 – Foligno (PG)
GAS TECNICI FOLIGNO Srl – Loc. Santa Sabina, Strada Lacugnana, 3/C – Perugia

The following information is intended exclusively for physicians or healthcare professionals:

Precautions for Use
Oxygen must be administered with caution, adjusting the dose according to the individual patient's needs. The lowest possible dose that maintains arterial oxygen pressure at 8 kPa (60 mmHg) should be administered.
Higher concentrations should be given for the shortest possible duration, with frequent monitoring of blood gas analysis.
Oxygen can be safely administered at the following concentrations and for the following durations:

Up to 100% for less than 6 hours
60–70% for 24 hours
40–50% during the second 24-hour period.
Oxygen may become potentially toxic after two days at concentrations exceeding 40%.
Low oxygen concentrations should be used in patients with respiratory insufficiency in whom hypoxia is the primary respiratory stimulus. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂) and clinical assessment.
Administering oxygen to patients with drug-induced respiratory failure (e.g., opioids, barbiturates) or chronic obstructive pulmonary disease (COPD) may further worsen respiratory insufficiency due to hypercapnia caused by elevated carbon dioxide levels in the blood, which overrides receptor stimulation.
High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also reduces nitrogen levels in tissues and lungs (alveoli). If oxygen is absorbed into the blood through the alveoli faster than it is replenished by ventilation, alveolar collapse (atelectasis) may occur. This can impair arterial blood oxygenation, as gas exchange does not occur despite adequate perfusion.
In patients with reduced sensitivity to arterial carbon dioxide pressure, high oxygen levels may cause carbon dioxide retention. In extreme cases, this may lead to carbon dioxide narcosis.

Patients at Risk of Hypercapnic Respiratory Failure
Particular precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide pressure or those at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive pulmonary disease (COPD), cystic fibrosis, morbid obesity, chest wall deformities, neuromuscular disorders, or respiratory depressant drug overdose).
Supplemental oxygen administration may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.

Special Precautions in Patients with Bleomycin-Induced Lung Injury
Pulmonary toxicity from high-dose oxygen therapy may exacerbate existing lung damage, even years after the initial lung injury caused by bleomycin. The target oxygen saturation in these patients may need to be lower than in others.

Pediatric Population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective oxygen concentration should be administered to achieve adequate oxygenation in neonates.
In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity, chronic lung disease, and intraventricular hemorrhage. It is recommended to initiate resuscitation of term or near-term newborns with room air rather than 100% oxygen.
In preterm neonates, the optimal oxygen concentration and target oxygen levels are not precisely defined. If supplemental oxygen is required, it must be carefully monitored and guided by pulse oximetry.
In both term and preterm neonates, administering oxygen at concentrations above 30–40% may result in insufficient production of endogenous antioxidant enzymes, impairing the body’s ability to counteract the production and toxic effects of reactive oxygen species. In such cases, the lowest effective oxygen concentration should be administered, and arterial oxygen pressure must be closely monitored and maintained below 13.3 kPa (100 mmHg).

Special Warnings

In hyperoxic environments, oxygen may saturate clothing.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).
Cylinders and mobile cryogenic containers must not be used if there is visible damage, suspected damage, or exposure to extreme temperatures.
Only oxygen-compatible and suitable equipment specific to the container model may be used.
Clamps or other tools must not be used to open or close cylinder valves to prevent damage.
In case of leakage, the cylinder valve must be closed immediately if safe to do so. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to vent freely.
Valves on empty cylinders must remain closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. Therefore, special precautions are required for handling and storage of containers.
It is not permitted to release pressurized gas.

For the cryogenic formulation
Cold burns from direct contact with liquid oxygen
Oxygen becomes liquid at approximately -183°C. At such low temperatures, direct contact of liquid oxygen with skin or mucous membranes may cause cold burns. Special safety precautions must be taken when handling cryogenic containers: appropriate protective clothing (gloves, goggles, loose-fitting clothing, and pants covering shoes) must be worn. If liquid oxygen contacts the skin or eyes, the affected areas must be rinsed thoroughly with large amounts of cold water or cold compresses applied; immediate medical assistance must be sought.

Dosage, Method, and Duration of Administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or face mask). The dosage is delivered independently of the medicinal gas packaging using dosing devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while expired gas and excess oxygen exit the patient’s inspiratory circuit and mix with ambient air (open system or anti-rebreathing system).

Normobaric Oxygen Therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air—i.e., with an inspired oxygen fraction (FiO₂) exceeding 21%—at a partial pressure between 0.21 and 1 atmosphere (0.213 to 1.013 bar).
In patients without respiratory insufficiency, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable face masks.
In patients with respiratory insufficiency or under anesthesia, oxygen must be administered via assisted ventilation.

Oxygen cylinders contain an internal pressure of approximately 150–200 bar. This high pressure is regulated by a pressure reducer and displayed on the pressure gauge. Multiplying the gauge reading by the cylinder volume in liters gives the remaining oxygen volume available.
(Example: Content calculation: a cylinder has a volume of 10 liters and the gauge reads 200 bar, resulting in 2000 liters of oxygen. At a consumption rate of 2 liters per minute, the cylinder will be empty after approximately 16 hours.)

With spontaneous ventilation

Patients with chronic respiratory insufficiency: administer oxygen at a flow rate of 0.5 to 2 liters/minute, adjustable according to blood gas analysis.
Patients with acute respiratory insufficiency: administer oxygen at a flow rate of 0.5 to 15 liters/minute, adjustable according to blood gas analysis.

Pediatric Population
Neonates may receive 100% oxygen when necessary. However, careful monitoring during treatment is essential. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or pulmonary collapse. Arterial oxygen pressure (PaO₂) must be monitored; however, if maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Additionally, the risk of ocular damage may be minimized by avoiding significant fluctuations in oxygenation (see also Precautions for Use).

Instructions for Use and Handling
Medical oxygen cylinders and cryogenic containers are intended exclusively for containing/transporting oxygen for inhalation and therapeutic use.
Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from impact and falls.
Strictly follow these instructions:

Carefully read the instruction and user manual for the container (packaging).
Ensure all equipment is in good condition.
Secure cylinders and base units in an upright position to prevent falls; protect containers from impact and maintain them at temperatures below 50°C; ensure adequate ventilation in areas where the product is used. Cylinders must be fitted with a protective cap or shroud over the valve.
Handle equipment with clean hands, free of grease or oil.
Lift and move cylinders and base units only with the appropriate trolley; never lift a cylinder by its valve.
Use only oxygen-specific and compatible connectors, tubing, or flexible hoses.
Particular care must be taken when attaching pressure regulators to cylinders, especially if not integrated into the container closure system, to prevent accidental breakage.
It is absolutely forbidden to modify or tamper with delivery equipment and its accessories or components (OIL AND GREASE MAY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves or taps.
It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).

General Instructions for Use

Cylinders equipped with shut-off valve only

Remove the protective cap, if present
Ensure that the delivery valve is closed
Remove the tamper-proof seal
Connect the pressure reducer to the cylinder valve and the corresponding flowmeter
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve until fully open
Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped with integrated pressure-reducing valve

Ensure that the valve is closed
Remove the tamper-proof seal
Ensure that the flow indicator is set to zero
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Slowly open the main valve until fully open
Adjust the flowmeter to the required flow rate (litres/minute)

Mobile cryogenic containers

Ensure that the flow indicator is set to zero
Remove the tamper-proof seal
Connect the humidifier/bubbler
Connect the cannula with mask or goggles to the humidifier
Set the flow regulator to the required flow rate (litres/minute)

NOTE: FOR MORE DETAILED INFORMATION, PLEASE CONSULT THE CONTAINER'S USER MANUAL
WARNING

Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps and valves when opening or closing.
Never stand directly in front of the gas outlet of the tap/valve; always remain on the opposite side. Do not expose yourself or the patient to the direct gas stream.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder tap.
In case of gas leakage, close the tap immediately and notify the technical service of the supplier indicated in the container's User Manual.
Use only containers suitable for the product, and compatible with the required operating pressure and temperature.

During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not approach the container with open flames.
No electrical equipment capable of producing sparks shall be used near patients receiving oxygen.
Do not use oils or greases on fittings, taps, valves, or any materials in contact with oxygen.
Never introduce oxygen into a device that might contain combustible materials, especially greasy substances.

Disposal

Store empty cylinders with valves closed.
Do not discharge into sewers, basements, or excavations where gas accumulation could be hazardous.
Return empty or unused containers, even if only partially empty, to the supplier. Any residual medicinal product remaining in the pressurized cylinder will be safely eliminated, via appropriate procedures, in a well-ventilated area by the company responsible for the subsequent refilling of the container.
Unused medicinal product and waste derived from such medicinal product must be disposed of in accordance with applicable local regulations.

Observe all relevant rules regarding the use and handling of pressurized cylinders and
containers containing cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in
well-ventilated areas or well-ventilated sheds, avoiding the formation of oxygen-enriched atmospheres (O₂ > 21% vol). Keep them upright with valves closed, protected from rain and weather conditions, direct sunlight, and kept away from sources of heat or ignition and from combustible materials.
Empty containers or those containing other types of gas must be stored separately.
Fixed cryogenic containers installed at healthcare facilities must be located outdoors.

Patient Information Leaflet

OXYGEN GAS TECNICI FOLIGNO, MEDICINAL COMPRESSED GAS 200 BAR, MEDICINAL COMPRESSED GAS 300 BAR

Oxygen
Please read this leaflet carefully before this medicine is administered to you
because 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, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

What OXYGEN GAS TECNICI FOLIGNO is and what it is used for
What you need to know before you are administered OXYGEN GAS TECNICI FOLIGNO
How OXYGEN GAS TECNICI FOLIGNO will be administered to you
Possible side effects
How to store OXYGEN GAS TECNICI FOLIGNO
Contents of the pack and other information

1. What OSSIGENO GAS TECNICI FOLIGNO is and what it is used for.

OSSIGENO GAS TECNICI FOLIGNO contains oxygen, a gas naturally present in the air we breathe.
Medicinal oxygen increases the delivery of oxygen to all tissues of the body.
OSSIGENO GAS TECNICI FOLIGNO is indicated in patients of all ages:

for the treatment of respiratory disorders (acute and chronic respiratory failure),
for use in anaesthesia,
in intensive care, a hospital unit where seriously ill patients are treated,
in a hyperbaric chamber, a room where air pressure is higher than atmospheric pressure.

2. What you should know before being administered OSSIGENO GAS TECNICI FOLIGNO.

Normobaric oxygen therapy
Under normal conditions, there are no contraindications.

Hyperbaric oxygen therapy
You will not be administered OSSIGENO GAS TECNICI FOLIGNO in a hyperbaric chamber if:

you suffer from a lung disease causing the formation of lung bubbles (bullous emphysema)
you suffer from asthma
you currently have or have previously had lung collapse (pneumothorax)
you suffer from a lung disease causing obstruction of the airways, making it difficult to expel air from the lungs, resulting in shortness of breath (also known as dyspnea) (COPD)
you suffer from lung inflammation (Pneumocystis carinii pneumonia)
you suffer from a condition characterized by uncontrolled body movements (epilepsy)
you have fear of enclosed spaces (claustrophobia)
you are in the first 3 months of pregnancy and do not have a serious illness
you have an upper respiratory tract infection
you have heat stroke (hyperthermia)
you suffer from a red blood cell disorder, a type of blood cell (hereditary spherocytosis)
you suffer from an optic nerve disease
you suffer from malignant tumors
you suffer from high levels of acid in the blood (acidosis)
you are taking medications to treat tumors such as doxorubicin, adriamycin, daunorubicin, bleomycin, cis-platinum (see section “Other medicines and OSSIGENO GAS TECNICI FOLIGNO”)
you are taking medications to treat inflammation such as corticosteroids (see section “Other medicines and OSSIGENO GAS TECNICI FOLIGNO”)
you are taking a medication to treat alcohol dependence (disulfiram – see section “Other medicines and OSSIGENO GAS TECNICI FOLIGNO”)
you consume alcohol
you have recently been exposed to toxic substances (aromatic hydrocarbons)
you smoke or take medications containing nicotine to help people quit smoking
the newborn was born prematurely.

Warnings and precautions
Consult your doctor, pharmacist, or nurse before being administered OSSIGENO GAS TECNICI FOLIGNO.
Inform your doctor:

if you suffer from a thyroid disease, a gland located in the neck that is overactive (hyperthyroidism)
if you have a deficiency in vitamin C and/or vitamin E, or if you suffer from anemia caused by a deficiency of a substance called glutathione (an antioxidant that counteracts aging)
if you have undergone treatment for paraquat poisoning (a herbicide)
if you consume alcohol
if you are taking medications to treat epilepsy (barbiturates) and/or pain (opioids)
if you suffer from airway inflammation making breathing difficult (Chronic Obstructive Bronchopneumopathy COPD)
if you suffer from specific diseases (e.g., COPD; cystic fibrosis; pathological obesity; chest wall deformities; neuromuscular disorders; respiratory depressant drug overdose), which may reduce sensitivity to carbon dioxide pressure in the blood or lead to increased carbon dioxide concentration in the blood (hypercapnic respiratory failure)
if you have experienced lung injury caused by bleomycin use
if you have recently undergone an X-ray examination.

Hyperbaric oxygen therapy (HBOT)
The doctor will carefully evaluate whether to administer oxygen in a hyperbaric chamber if you have:

inflammation of the ears and/or nose (recurrent otitis and/or sinusitis, laryngocele, mastoid cavity, vestibular syndrome, hearing loss, or recent middle ear surgery)
a heart disease (ischemic and/or congestive heart conditions)
untreated high blood pressure (untreated arterial hypertension)
lung diseases that prevent airflow (restrictive and/or severely restrictive pulmonary conditions)
an eye disease characterized by high pressure of the fluid inside the eyes (glaucoma), retinal detachment, or a membrane in the eye, even if surgically treated (compensation maneuvers)
a history of uncontrolled body movements (seizures), sometimes with loss of consciousness (epileptic seizures)
diabetes mellitus, as hyperbaric therapy may counteract the effect of insulin and increase your blood sugar levels (hyperglycemia)
uncontrolled high fever
severe anxiety, altered perception of reality (psychosis), or fear of confined spaces (claustrophobia)
respiratory disorders (e.g., uncontrolled asthma, pulmonary emphysema, chronic obstructive bronchopneumopathy (COPD)), or recent thoracic surgery.

Safety precautions
During transport, storage, and use of cylinders

Avoid contact of oils and greases with the cylinders: for example, do not touch the cylinders with hands, clothing, or face contaminated with grease, oil, creams, or ointments
Do not use greasy creams or lipsticks
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN)
Use only containers without visible damage or that have not been damaged or exposed to extreme temperatures
Use only equipment suitable and compatible with the specific cylinder model
Keep cylinders away from heat sources and open flames
Do not smoke in the area where cylinders are located, especially while oxygen is being administered to the patient
Do not use any electrical equipment that could produce sparks near the cylinders, especially while oxygen is being administered to the patient
Never introduce oxygen into a device that might contain materials that could ignite, particularly greasy substances
Do not use pliers or other tools to open or close the cylinder valve
Do not alter the shape of the container
In case of leakage, immediately close the cylinder valve and, if safely possible, move the cylinder to a safer outdoor location to allow oxygen to escape freely
Close valves on empty cylinders
Do not administer pressurized gas

Other medicines and OSSIGENO GAS TECNICI FOLIGNO
Inform your doctor, nurse, or pharmacist if you are taking, have recently taken, or might take any other medicine.
In particular, inform your doctor, nurse, or pharmacist if you are taking:

catecholamines (e.g., epinephrine, norepinephrine), medicines that affect multiple organs in the body and are generally used for emergency treatment of sudden allergic reactions
corticosteroids (e.g., dexamethasone, methylprednisolone), medicines used to treat inflammation
hormones (e.g., testosterone, thyroxine)
amiodarone, a medicine used to treat heart rhythm disorders
chemotherapeutic agents (e.g., bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors
antimicrobial agents (e.g., nitrofurantoin)
antibiotics (e.g., bleomycin, actinomycin), medicines used to treat infections
medicines to treat mental disorders (e.g., promazine, chlorpromazine, thioridazine)
vitamin K supplements (menadione)
chloroquine (a medicine used to treat malaria)

OSSIGENO GAS TECNICI FOLIGNO and alcohol
Do not consume alcohol during treatment with OSSIGENO GAS TECNICI FOLIGNO, as oxygen increases the respiratory depression (difficulty breathing) caused by alcohol.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning to become pregnant, or breastfeeding, consult your doctor, pharmacist, or nurse before taking this medicine.

Pregnancy
Normobaric oxygen therapy
Oxygen may be used during pregnancy only when necessary, in cases of life-threatening indications, critical conditions, or hypoxemia (inadequate blood oxygenation).
Hyperbaric oxygen therapy
Hyperbaric treatment is contraindicated during the first trimester of pregnancy for non-acute conditions.

Breastfeeding
There are no contraindications for the use of oxygen during breastfeeding.

Driving and using machines
Normobaric oxygen therapy
OSSIGENO GAS TECNICI FOLIGNO does not affect, or affects only negligibly, the ability to drive vehicles and use machinery.
Avoid driving vehicles and using machinery until any negative effects on attention and vigilance have completely disappeared.

Hyperbaric oxygen therapy
Visual and hearing disturbances that may affect the ability to drive vehicles and use machinery have been reported after oxygen administration.
Avoid driving vehicles and using machinery until any negative effects on attention and vigilance have completely disappeared.

3. How OSSIGENO GAS TECNICI FOLIGNO will be administered to you

This medicine will be administered to you through inhaled air, always following the doctor's or nurse's instructions exactly. If you have any doubts, consult your doctor.
If you do not have respiratory insufficiency, Ossigeno SOL OSSIGENO GAS TECNICI FOLIGNO will be inhaled through the nose and mouth via a nasal cannula or a mask.
If you suffer from respiratory insufficiency or are under anesthesia, Ossigeno SOL will be administered via assisted ventilation.
The dose will be determined by your doctor based on your health status.
During treatment with OSSIGENO GAS TECNICI FOLIGNO, your doctor may perform measurements of blood gases (oxygen and carbon dioxide) in arterial blood and monitor oxygen levels bound to haemoglobin, a protein that carries oxygen in the blood.

If you are given more OSSIGENO GAS TECNICI FOLIGNO than you should
It is very unlikely that you will be given more OSSIGENO GAS TECNICI FOLIGNO than required, as your doctor or nurse will monitor you during treatment.
Symptoms of an overdose that you might experience include:

sore throat,
cough and chest pain,
difficulty breathing (dyspnoea, hypoventilation) and bluish skin (cyanosis),
damage to the bronchi and lungs,
uncoordinated movements,
tingling in the limbs,
disturbances of vision and hearing,
nausea, dizziness,
anxiety, confusion and irritability,
muscle cramps and spasms,
loss of consciousness,
uncontrolled body movements (convulsions), sometimes with loss of consciousness (epileptic seizures),
eye damage (retinopathy of prematurity) in premature infants,
respiratory depression and increased blood acidity in patients at risk of high carbon dioxide levels in the blood (hypercapnic respiratory insufficiency).

Treatment
If you are given high doses, your doctor will provide appropriate treatment and monitor you closely.
In most cases, symptoms resolve within 4 hours after stopping treatment.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Below are the adverse reactions associated with OSSIGENO GAS TECNICI FOLIGNO.

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

Eye damage (retinopathy of prematurity)

Unknown frequency (cannot be estimated from available data)

Pulmonary toxicity characterized by:
Airway infection characterized by substernal pain and dry cough (tracheobronchitis)
Fluid accumulation occurring in the tissues lining the lung alveoli (interstitial edema)
Respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis)
Increased carbon dioxide in the blood (hypercapnia), leading to:
hypoventilation
increased acid levels in the blood (respiratory acidosis)
respiratory arrest
Dryness and irritation of mucous membranes (congestion or obstruction of the paranasal sinuses with pain and bleeding)
Local irritation and inflammation of the mucosa

Other reported adverse reactions:

Mild reduction in heart rate and cardiac output
Failure of lung expansion (atelectasis)
Lung injury
Dryness and irritation of the eyes
Slowed elimination of nasal secretions

Adverse reactions associated with hyperbaric oxygen therapy:
Very common (may affect more than 1 in 10 people)

Ear pain
Progressive myopia
Tissue damage caused by imbalance between the pressure of air within a body cavity and the surrounding environmental pressure (barotrauma), which may manifest as ear pain and possible bleeding, toothache, gas emission from the intestine (flatulence), colic pain.

Common (may affect up to 1 in 10 people)

Uncontrolled body movements (convulsions)

Uncommon (may affect up to 1 in 100 people)

Tympanic membrane perforation

Rare (may affect up to 1 in 1,000 people)

Breathing difficulties (dyspnea)
Decreased blood glucose levels (hypoglycemia) in diabetic patients

Unknown frequency (cannot be estimated from available data)

Respiratory disorders
Involuntary muscle contractions (localized muscle spasms)
Dizziness (vertigo)
Ringing in the ears (tinnitus)
Hearing loss
Inflammation of the middle ear (acute serous otitis media)
Nausea
Abnormal behaviour
Reduced visual field (decreased peripheral vision)
Blurred vision
Cataract

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse.
You may also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. How to store OSSIGENO GAS TECNICI FOLIGNO

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

6. Package contents and other information

What OSSIGENO GAS TECNICI FOLIGNO contains

The active substance is oxygen.

Description of the appearance of OSSIGENO GAS TECNICI FOLIGNO and contents of the pack
Compressed medicinal gas
OSSIGENO GAS TECNICI FOLIGNO compressed medicinal gas is supplied in cylinders and cylinder packs, in compressed gaseous form at 200 bar or 300 bar at 15°C. The cylinders are made of steel and fitted with VI or VP valves.
The following pack sizes are available:
Compressed medicinal gas (200 bar)
Steel cylinders with 40-litre capacity, fitted with valve.
Compressed medicinal gas (300 bar)
Cylinder pack containing 20 cylinders of 50-litre capacity.
It is possible that not all pack sizes are marketed.

Marketing Authorization Holder
GAS TECNICI FOLIGNO srl
Via delle Industrie, 17
FOLIGNO

Manufacturer
Compressed medicinal gas
GAS TECNICI FOLIGNO srl – Via delle Industrie, 17 – Foligno (PG);
GAS TECNICI FOLIGNO srl – Loc. Santa Sabina Strada Lacugnana, 3/C – Perugia;

The following information is intended exclusively for physicians or healthcare professionals:

Precautions for use
Oxygen must be administered with caution, adjusted according to the individual needs of each patient. The lowest effective dose that maintains arterial oxygen tension at 8 kPa (60 mmHg) should be administered. Higher concentrations should be given for the shortest possible duration, with frequent monitoring of blood gas analysis.

Oxygen can be safely administered at the following concentrations and for the following durations:

Up to 100% for less than 6 hours
60–70% for 24 hours
40–50% during the second 24-hour period

Oxygen becomes potentially toxic after two days when administered at concentrations exceeding 40%.

Low concentrations of oxygen should be used in patients with respiratory failure in whom the respiratory drive is stimulated by hypoxia. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂) and clinical assessment.

Administering oxygen to patients with respiratory failure induced by drugs (e.g., opioids, barbiturates) or chronic obstructive pulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia caused by elevated levels of carbon dioxide in the blood, which overrides the respiratory drive.

High concentrations of oxygen in inhaled air or gas reduce the concentration and partial pressure of nitrogen. This also reduces nitrogen levels in tissues and alveoli. If oxygen is absorbed into the blood through the alveoli faster than it is replenished by ventilation, alveolar collapse (atelectasis) may occur. This impairs arterial blood oxygenation, as gas exchange cannot occur despite adequate perfusion.

In patients with reduced sensitivity to arterial carbon dioxide tension, high oxygen levels may cause carbon dioxide retention. In extreme cases, this may lead to carbon dioxide narcosis.

Patients at risk of hypercapnic respiratory failure:
Particular precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide tension or those at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive bronchopulmonary disease (COPD), cystic fibrosis, morbid obesity, thoracic wall deformities, neuromuscular disorders, or respiratory depressant drug overdose).

Supplemental oxygen administration may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis. In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.

Special precautions in patients with bleomycin-induced lung injury
High-dose oxygen therapy may potentiate pulmonary toxicity and worsen existing lung damage, even years after the initial bleomycin-induced lung injury. The target oxygen saturation in these patients may need to be lower than in others.

Paediatric population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective oxygen concentration should be administered to achieve adequate oxygenation in neonates.

In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity, chronic lung disease, and intraventricular haemorrhage. It is recommended to initiate resuscitation of term or near-term neonates with air rather than 100% oxygen. In preterm neonates, the optimal oxygen concentration and target oxygen levels are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.

In both term and preterm neonates, administering oxygen at concentrations above 30–40% may lead to insufficient production of endogenous antioxidant enzymes, impairing the ability to counteract the production and toxic effects of reactive oxygen species. In these cases, the lowest effective oxygen concentration should be administered, and arterial oxygen tension should be closely monitored and maintained below 13.3 kPa (100 mmHg).

Special warnings

In hyperoxic environments, oxygen may saturate clothing.
Cylinders must not be used if visibly damaged or if damage is suspected, or if they have been exposed to extreme temperatures.
Only oxygen-compatible and suitable equipment for the specific cylinder model may be used.
Forceps 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 safe to do so. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
Valves on empty cylinders must remain closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. Therefore, special precautions are required for handling and storage of oxygen cylinders.
Pressurized gas must not be administered directly.

Dosage, route and duration of administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or facial mask). The dosage is delivered independently of the medicinal gas packaging via dosing devices (flowmeters).

With these systems, oxygen is delivered through the inspired air, while exhaled gas and any excess oxygen leave the patient’s inspiratory circuit and mix with the surrounding air (open or anti-rebreathing system).

In anaesthesia, a special system is often used that allows rebreathing of previously exhaled gas (closed or rebreathing system).

Oxygen may also be administered directly into the blood via an oxygenator, using a cardiopulmonary bypass system in cardiac surgery and other cases requiring extracorporeal circulation.

Numerous oxygen delivery devices exist, and they are classified as follows:

Low-flow systems: The simplest method for delivering an oxygen-air mixture to the inspired air. An example is a system where oxygen is delivered via a flowmeter connected to a nasal cannula or facial mask.
High-flow systems: Designed to provide the patient with a defined gas mixture that meets their total respiratory requirements. These systems deliver stable and constant oxygen concentrations that are not diluted by ambient air. An example is Venturi masks, where, once the oxygen flow is set, the air inspired by the patient is enriched with a constant oxygen concentration.
Demand valve systems: Designed to deliver 100% oxygen without contact with ambient air. Intended for short-term use only, in emergencies.
Hyperbaric oxygen therapy

Hyperbaric oxygen therapy is performed in a specially designed pressurized chamber capable of maintaining pressures up to three times atmospheric pressure. Hyperbaric oxygen therapy may also be administered via a tightly sealed mask, helmet, or endotracheal tube.

Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air, i.e., with an inspired oxygen fraction (FiO₂) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).

In patients without respiratory failure, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable masks.

In patients with respiratory failure or under anaesthesia, oxygen must be administered via assisted ventilation.

Oxygen cylinders contain an internal pressure of approximately 200–300 bar. Pressure is regulated by a pressure reducer and displayed on a pressure gauge. Multiplying the gauge reading by the cylinder’s volume (in litres) gives the remaining oxygen content.

(Example: Approximate content calculation: a cylinder with a 10-litre capacity shows 200 bar on the gauge, resulting in 2000 litres of oxygen. At a consumption rate of 2 litres per minute, the cylinder will be empty in approximately 16 hours.)

With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate of 0.5 to 2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 litres/minute, adjustable according to blood gas analysis.

With assisted ventilation
The minimum FiO₂ is 21%, and it may be increased up to 100%.

The therapeutic goal of oxygen therapy is to ensure that arterial oxygen partial pressure (PaO₂) is not below 8 kPa (60 mmHg), or that arterial haemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO₂).

Dosage must be individualized according to each patient’s needs. The general recommendation is to use the lowest FiO₂ necessary to achieve the desired therapeutic effect, i.e., normal PaO₂ values. In cases of severe hypoxaemia, higher FiO₂ values associated with a potential risk of oxygen toxicity may be justified.

Continuous monitoring of therapy and ongoing assessment of therapeutic effect are essential, via measurement of PaO₂ or alternatively, arterial oxygen saturation (SpO₂).

In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should be sufficient to maintain PaO₂ > 8 kPa, with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), while avoiding FiO₂ values > 0.6 (i.e., > 60% oxygen in the inhaled gas mixture) whenever possible.

Short-term oxygen therapy should be monitored via repeated arterial blood gas measurements (PaO₂) or transcutaneous oximetry, which provides a numerical value of haemoglobin oxygen saturation (SpO₂). In any case, these indices are only indirect measures of tissue oxygenation. Clinical evaluation of treatment remains paramount.

For long-term therapy, the need for supplemental oxygen must be determined based on arterial blood gas values. Blood oxygen levels must be monitored to avoid excessive carbon dioxide accumulation and to adjust oxygen therapy in patients with hypercapnia.

Low oxygen concentrations should be used in patients with respiratory failure whose respiratory drive depends on hypoxia (e.g., due to COPD). The oxygen concentration in inhaled air should not exceed 28%; in some patients, even 24% may be excessive.

If oxygen is mixed with other gases, its concentration in the inhaled gas mixture must be maintained at least at 21%. In practice, levels below 30% are generally avoided. When necessary, the inspired oxygen fraction may be increased up to 100%.

Paediatric population
Neonates may receive 100% oxygen when necessary. However, careful monitoring during treatment is essential. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or pulmonary collapse. Arterial oxygen tension (PaO₂) must be monitored; however, if maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Additionally, the risk of ocular damage may be minimized by avoiding marked fluctuations in oxygenation (see also Precautions for use).

Hyperbaric oxygen therapy
Hyperbaric oxygen therapy refers to treatment with 100% oxygen at pressures exceeding 1.4 times atmospheric pressure at sea level (1 atm = 101.3 kPa = 760 mmHg). For safety reasons, pressure in hyperbaric oxygen therapy should not exceed 3 atm.

Oxygen must be administered inside a hyperbaric chamber.

Treatment sessions at 2 to 3 atmospheres pressure (i.e., between 2.026 and 3.039 bar) last between 60 minutes and 4–6 hours. These sessions may be repeated 2 to 4 times daily, depending on the patient’s clinical condition.

Compression and decompression should be performed slowly, in accordance with standard procedures, to avoid barotrauma to air-containing anatomical cavities communicating with the outside.

Hyperbaric oxygen therapy must be administered by qualified personnel trained in this procedure.

Instructions for use and handling
Medical oxygen cylinders are intended exclusively for containing and transporting oxygen for inhalation, for therapeutic use.

Cylinders (Base Units) must be transported using appropriate means to protect them from impact and falls.

Strictly follow these instructions:

Carefully read the instruction and user manual for the container (packaging).
Ensure all equipment is in good condition.
Secure cylinders and base units in an upright position to prevent falls. Protect containers from impact and keep them at temperatures below 50°C. Ensure adequate ventilation in rooms where the product is used. Cylinders must be fitted with a protective cap or tulip cover over the valve.
Handle equipment with clean hands, free of grease or oil traces.
Lift and move cylinders and base units only with the appropriate trolley. Never lift a cylinder by the valve.
Use only oxygen-specific, compatible connectors, hoses, or flexible couplings.
Exercise extreme care when attaching pressure reducers to cylinders, especially if not integrated into the container’s closure system, to prevent accidental breakage.
Absolutely no modifications are permitted to cylinder connectors, delivery equipment, or their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE IN CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair a defective valve.
Do not handle equipment or components with greasy hands, clothing, or face, or with oily creams and ointments.

General instructions for use
Cylinders equipped with a single shut-off valve

Remove the protective cap, if present
Ensure the delivery valve is closed
Remove the tamper-evident seal
Connect the pressure reducer to the cylinder valve and attach the flowmeter
Connect the humidifier/bubbler
Connect the nasal cannula with mask or goggles to the humidifier
Slowly open the main valve fully
Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped with integrated pressure-reducing valve

Ensure the valve is closed
Remove the tamper-evident seal
Ensure the flow indicator is set to zero
Connect the humidifier/bubbler
Connect the nasal cannula with mask or goggles to the humidifier
Slowly open the main valve fully
Adjust the flowmeter to the required flow rate (litres/minute)

NOTE: FOR MORE DETAILS, CONSULT THE CONTAINER’S USER MANUAL
WARNING

Open cylinder closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps or valves during opening or closing.
Never stand directly 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 container’s user manual.
Use only containers suitable for the product and compatible with the required pressure and temperature conditions.

During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames near the container.
No electrical equipment capable of producing sparks should be used near patients receiving oxygen.
Do not apply oil or grease to connectors, taps, valves, or any material in contact with oxygen.
Never introduce oxygen into a device that may contain combustible materials, especially greasy substances.

Disposal

Store empty cylinders with valves closed.
Do not discharge into sewers, basements, or pits where accumulation may be hazardous.
Return empty or unused containers, even if only partially empty, to the supplier. Any residual medicinal product in the pressurized cylinder will be safely eliminated via appropriate procedures in a well-ventilated area by the company responsible for refilling.
Unused medicinal product and waste derived from this medicine must be disposed of in accordance with local regulations.

Observe all relevant rules for the use and handling of pressurized cylinders.
Store cylinders at temperatures between -10°C and 50°C, in well-ventilated areas or ventilated sheds, avoiding the formation of hyperoxic atmospheres (O₂ > 21% vol). Store vertically with valves closed and protected from rain and weather, direct sunlight, and away from heat or ignition sources and combustible materials. Empty containers or those containing other gases must be stored separately.