Oxygen Pharma Gas Medical and Technical Gases: detailed information

Package leaflet: Information for the user (RR)

OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read all of 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 they have the same symptoms as yours, as it may be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet

What OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is and what it is used for
What you need to know before using OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
How to use OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Possible side effects
How to store OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Contents of the pack and other information

1. What OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is and what it is used for

OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES contains oxygen, a gas naturally
present in the air we breathe. Medical oxygen enables the delivery of increased oxygen to all
tissues of the body. OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is indicated in patients
of all ages:

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

2. What you should know before using OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES

There are no absolute contraindications for oxygen therapy under normal (normobaric) pressure conditions.
Warnings and precautions
Consult your doctor or pharmacist before using OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES.
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES must be administered with caution, as it may have harmful effects at high concentrations.
Inform your doctor:

if you have respiratory problems such as chronic obstructive pulmonary disease (COPD) or cystic fibrosis;
if you have severe obesity;
if you have a chest wall deformity;
if you have muscle disorders due to neurological diseases (neuromuscular disorders);
if you are taking medications that may affect breathing;
if you have previously experienced lung problems caused by bleomycin (a drug used to treat certain types of tumors).

Children
In newborns and preterm infants, oxygen therapy may cause eye damage (retinopathy of prematurity), chronic lung disease, and brain hemorrhages. The appropriate oxygen concentration will be determined by the doctor to ensure optimal treatment for the child.
Safety precautions
Oxygen is an oxidizing agent and promotes combustion.
In the presence of combustible substances such as fats (oils, lubricants) and organic materials (fabrics, wood, paper, plastics, etc.), oxygen may initiate combustion.
During transport, storage, and use of cylinders

Avoid contact of oils and greases with cylinders: for example, do not touch cylinders with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Do not use greasy creams or lipsticks.
Do not smoke in the area where cylinders are located.
Do not approach the container with open flames.
Do not place cylinders near sources of heat.
Do not use any electrical equipment that may produce sparks near patients receiving oxygen.
Use only equipment suitable and compatible with the specific container model.
Use only containers that show no visible damage or that have not been damaged or exposed to extreme temperatures.
Do not use pliers or other tools to open or close the cylinder valve.
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).
Never introduce oxygen into a device that might contain materials capable of catching fire, especially greasy substances.
In case of leakage, close the cylinder valve immediately if it is safe to do so. If the valve cannot be closed, 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
Direct contact of skin or mucous membranes with liquid oxygen may cause cold burns. Always wear gloves, protective goggles, loose clothing, and pants covering shoes when handling liquid medical oxygen. 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 attention.

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

catecholamines (e.g., adrenaline, noradrenaline), medicines that affect multiple 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., actinomycin, bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors;
antibiotics and antimicrobials (e.g., actinomycin, nitrofurantoin), medicines used to treat infections;
menadione-based supplements;
medicines used to treat mental disorders (e.g., promazine, chlorpromazine, thioridazine);
chloroquine, a medicine used to treat malaria. Also inform your doctor if:
you have a thyroid disease (a neck gland that is overactive, i.e., hyperthyroidism);
you have a deficiency of vitamin C, vitamin E, and/or glutathione (an antioxidant substance);
you have undergone treatment for paraquat poisoning (a herbicide);
you consume alcohol;
you take medicines for epilepsy (barbiturates) and/or pain (opioids);
you have recently undergone an X-ray examination.

OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES and alcohol
Do not consume alcohol during treatment with OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES will be administered during pregnancy only if absolutely necessary.
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES may be used during breastfeeding.
Driving and use of machines
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OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES does not alter or alters only negligibly the ability to drive vehicles and use machinery. Consult your doctor before driving or operating machinery.

How to use OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Use this medicine exactly as directed by your doctor or pharmacist. If you have any doubts, consult your doctor.
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is usually inhaled through the nose and mouth via a nasal cannula or face mask. The dose will be determined by your doctor based on your health condition. During treatment with OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES, your doctor may perform blood oxygen measurements and monitor oxygen levels bound to hemoglobin, a protein that carries oxygen in the blood.

If you use more OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES than you should
If you use more than the prescribed amount of OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES, contact your doctor or go to the hospital immediately.
An excessive dose of OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES may affect breathing (sternal pain and dry cough), cause interstitial edema (fluid accumulation in the lungs), and pulmonary fibrosis (a form of pneumonia).
In premature infants, high oxygen concentrations may cause vision damage (retinopathy of prematurity).

If you are a patient at risk of hypercapnic respiratory failure caused by high levels of carbon dioxide in the blood, administration of supplemental oxygen may cause severe respiratory problems (respiratory depression) and increased blood acidity (respiratory acidosis).
If these symptoms occur, always contact your doctor or the nearest hospital.
Treatment
If high doses are used, your doctor will reduce the oxygen dose or discontinue therapy, administer appropriate treatment, and monitor you closely.
If you forget to use OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Do not use a double dose to make up for a missed dose, as OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES may be harmful at high concentrations.
If you stop oxygen therapy
Do not stop using this medicine on your own initiative. If you have any doubts about using this medicine, consult your doctor or pharmacist.
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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Below are the side effects reported for OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES.
The tissues most sensitive to high oxygen levels in the blood are the lungs, brain, and eyes.

Frequency not known (frequency cannot be determined from available data):
lung problems, such as:

tracheobronchitis (sternal pain and dry cough),
presence of fluid (edema) in the lungs,
pulmonary fibrosis (a respiratory disease characterized by scarring of lung tissue),
worsening of hypercapnia (excess carbon dioxide in the blood leading to acidosis (increased blood acidity), hypoventilation (reduced ventilation), respiratory arrest),
dryness and irritation of mucous membranes.

Other side effects:

mild reduction in heart rate (number of heartbeats) and cardiac output (amount of blood pumped by the heart),
small areas of the lung not reached by air (atelectasis).

Additional side effects in children
In newborns, and particularly in premature infants:
Very common (may affect more than 1 in 10 people):

eye damage in premature infants (retinopathy of prematurity).

Additional side effects in premature infants:

lung diseases (bronchopulmonary dysplasia, pulmonary fibrosis, and respiratory failure).

Risk of burns
Contact with liquid oxygen (contained in OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES MEDICINAL CRYOGENIC GAS) causes cold burns.
Thermal burns: the risk of fire increases in the presence of high oxygen concentrations and sources of ignition.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please contact your doctor, pharmacist, or nurse. You can also report side effects 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.

How to store OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated areas, protected from rain, weather conditions, and direct sunlight. Keep away from heat sources and combustible materials. Empty containers or those containing other types of gases must be stored separately. 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 no longer in use. This will help protect the environment.

6. Package Contents and Other Information

What OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES Contains
The active substance is oxygen.
Description of the appearance of OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES and package contents
Compressed medicinal gas
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES compressed medicinal gas is supplied
in cylinders in compressed gaseous form at 200 bar at 15°C. The cylinders are made of steel and equipped with
pressure-reducing valves with integrated pressure regulators.
Cryogenic medicinal gas
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES cryogenic medicinal gas is supplied
in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas (200 bar)
Steel cylinders with pressure-reducing valve of 3, 5, 7, 10, 14, 30 and 40 litres
Cryogenic medicinal gas
Mobile cryogenic container of 31.5 and 50 litres
Marketing Authorization Holder and Manufacturer
Marketing Authorization Holder
FARMA GAS - MEDICAL AND TECHNICAL GASES SRL
Via A. Fortunato 51
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84084 FISCIANO (SA) – ITALY
Manufacturer
Euro Ossigeno S.r.l. – Loc. 40 Moggi Zona Industriale – 80029 – Sant’Antimo (NA)
_______________________________________________________________________________
The following information is intended exclusively for physicians or healthcare professionals:
Precautions for Use
Oxygen must be administered with caution, with adjustments based on the individual patient's needs. The lowest effective dose that maintains arterial 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 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 via pulse oximetry (arterial oxygen saturation - SpO₂), along with clinical assessment.
Administration of oxygen to patients with drug-induced respiratory failure (opioids, barbiturates) or chronic obstructive bronchopulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia caused by elevated carbon dioxide levels in blood (plasma), thereby neutralizing receptor effects.
High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also decreases 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 may impair arterial blood oxygenation, as gas exchange does not occur despite adequate perfusion.
In patients with reduced sensitivity to arterial blood 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: special precautions must be taken in patients with reduced sensitivity to arterial carbon dioxide pressure or at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic obstructive bronchopulmonary disease (COPD), cystic fibrosis, morbid obesity, chest wall deformities, neuromuscular disorders, respiratory depressant drug overdose). Administration of supplemental oxygen 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, even when administered several years after the initial lung injury caused by bleomycin; the target oxygen saturation may need to be lower than in other patients.
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 saturation are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.
Special Warnings
Oxygen is an oxidizing agent and therefore supports combustion. In the presence of combustible materials such as fats (oils, lubricants) and organic substances (fabrics, wood, paper, plastics, etc.), oxygen may spontaneously ignite, either due to an ignition source (spark, open flame, ignition source) or due to adiabatic compression that may occur in pressure-reducing equipment (regulators) during a sudden drop in gas pressure. Therefore, all materials in contact with oxygen must be classified as compatible with the product under normal conditions of use.

Any oxygen delivery system or container must be kept away from heat sources due to oxygen's oxidizing properties; appropriate precautions must be taken both in hospital and domestic settings where medicinal oxygen is used.
Oxygen may cause sudden ignition of glowing materials or embers; therefore, smoking or use of unshielded open flames near containers and delivery systems is strictly prohibited.
Do not smoke in environments where oxygen therapy is administered.
Do not place cylinders or containers near heat sources.
Electrical equipment capable of producing sparks must not be used near patients receiving oxygen.
It is absolutely forbidden to tamper in any way with container connections, delivery equipment, or their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Any contact with oil, grease, or other hydrocarbons must be avoided.

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It is absolutely 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.
In hyperoxygenated 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 visible damage is present or if damage is suspected, or if they have been exposed to extreme temperatures.
Only oxygen-compatible and suitable equipment may be used for the specific container model.
Pliers or other tools must not be used to open or close the cylinder valve to prevent damage risk.
The container's shape must not be altered.
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 oxygen to escape freely.
Valves of empty cylinders must be kept closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. This is why handling and storage of containers require special precautions.
Pressurized gas administration is not permitted.

Cryogenic formulations
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 clothing, and trousers covering shoes) must be worn. If liquid oxygen comes into contact with skin or eyes, the affected areas must be washed with abundant 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); dosing is controlled 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, mixing with the surrounding air (open 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., containing an oxygen fraction in inspired air (FiO₂) greater than 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 - 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 anesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders have an internal maximum pressure of approximately 150-200 bar. Pressure is regulated by a reducer and can be read on the pressure gauge. Multiplying the pressure gauge reading by the cylinder's volume in litres gives the amount of oxygen remaining in the cylinder.
(Example: Approximate content calculation: a cylinder has a volume of 10 litres and the pressure gauge reads 200 bar, resulting in a content of 2000 litres of oxygen. With a consumption rate of 2 litres per minute, the cylinder will be empty after approximately 16 hours).
With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate between 0.5 and 2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate between 0.5 and 15 litres/minute, adjustable according to blood gas analysis.
Paediatric population
Neonates may receive 100% oxygen when necessary. However, careful monitoring during treatment is required. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of lens damage or pulmonary collapse. Arterial blood oxygen pressure (PaO₂) should 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 reduced by avoiding significant fluctuations in oxygenation (see also Precautions for Use).
Instructions for Use and Handling
Medicinal oxygen cylinders, as well as cryogenic containers, are intended exclusively for containing/transporting oxygen for inhalation, for therapeutic use.
Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from impact and falling risks.
Strictly follow the instructions below:

Carefully read the container's instruction and user manual (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, ensuring adequate ventilation/aeration in areas where the product is used. Cylinders must be fitted with a protective cap/tulip over the valve.

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Handle equipment with clean hands, free from traces of grease or oil.
Lift and move cylinders and base units using only the appropriate trolley; do not lift the cylinder by the valve.
Use connectors, connecting tubes, or hoses specifically designed and compatible with oxygen.
Particular attention must be paid to securing pressure reducers onto cylinders, especially if not already integrated into the container closure system, to prevent accidental breakage risks.
It is absolutely forbidden to tamper in any way with container connections, delivery equipment, or their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair a defective valve.
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). Tissues show different sensitivities to hyperoxia; the most sensitive are the lungs, brain, and eyes. Monitor for risk of temporary or permanent fibroplastic retrolental retinopathy (retinopathy of prematurity).

Fire risk: The risk of fire increases in the presence of high oxygen concentrations and ignition sources, which may cause thermal burns.
General Instructions for Use
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 cannula with mask or goggles to the humidifier.
Slowly open the main valve fully.
Adjust the flowmeter to the required flow rate (litres/minute). Mobile cryogenic containers
Ensure the flow indicator is set to zero.
Remove the tamper-evident 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).

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NOTE: FOR MORE DETAILS, CONSULT THE CONTAINER'S USER MANUAL
WARNING
Open container 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 contact the technical support service of the supplier indicated in the container's user manual.
Use only containers suitable for the product, and for the intended operating pressures and temperatures.
During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames near the container.
Do not use electrical equipment capable of producing sparks near patients receiving oxygen.
Do not use oils or greases on 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 partially full, to the supplier. Any residual medicinal product remaining in the pressurized cylinder will be eliminated via appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling of the same container.

EXPIRY DATE AND STORAGE
Expiry date: see the expiry date indicated on the packaging.
The indicated expiry date refers to the product in intact packaging, correctly stored.
Warning: Do not use the medicinal product after the expiry date stated on the packaging.
Storage
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Observe all relevant rules for 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 in well-ventilated sheds, avoiding the formation of hyperoxygenated atmospheres (O₂ > 21% vol.), in an upright position 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 types of gas must be stored separately.
Unused medicinal product and waste derived from this medicinal product must be disposed of in accordance with applicable local regulations (see also Instructions for Use - Disposal).
Keep the medicinal product out of the reach and sight of children
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Patient Information Leaflet: Information for the User (OSP)

OXYGEN FARMA MEDICAL AND TECHNICAL GASES 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

Please 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, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if they have the same symptoms as you, because it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is and what it is used for
What you need to know before using OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
How to use OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Possible side effects
How to store OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Contents of the pack and other information

1. What OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is and what it is used for

OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES contains oxygen, a gas naturally present in the air we breathe. Medical oxygen enables the delivery of increased oxygen to all body tissues. OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is indicated in patients of all ages:

for the treatment of breathing disorders (acute and chronic respiratory failure).
for use in anesthesia, intensive care, and hyperbaric chambers.

2. What you need to know before using OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES

Under normal pressure conditions (normobaric), there are no absolute contraindications.
You will not be administered OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES under conditions of increased pressure (hyperbaric chamber) if:

you suffer from bullous emphysema (a condition causing the formation of bullae in the lungs),
you suffer from progressive asthma,
you currently have or have previously had pneumothorax (collapsed lung),
you suffer from chronic obstructive bronchopulmonary disease (COPD – slow obstruction of the airways),
you suffer from Pneumocystis carinii pneumonia (a lung infection),
you are experiencing status epilepticus (epileptic seizures),
you suffer from claustrophobia (fear of enclosed spaces),
you are in the first trimester of pregnancy and do not have serious illnesses,
you have upper respiratory tract infections,
you are experiencing hyperthermia (heat stroke),
you suffer from hereditary spherocytosis (a disease causing abnormal shape of red blood cells),
you suffer from optic neuritis (inflammation of the optic nerve),
you suffer from malignant tumors,
you suffer from acidosis (elevated levels of acid in the blood),
you are taking medications to treat tumors (e.g., doxorubicin, adriamycin, daunorubicin, bleomycin, cisplatin) (see section “Other medicines and OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES”),
you are taking steroids (medications to treat inflammation) (see section “Other medicines and OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES”),
you are taking disulfiram (a medication used to treat alcohol dependence) (see section “Other medicines and OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES”),
you consume alcohol,
you smoke or use nicotine-containing medications to quit smoking, or aromatic hydrocarbons,
the newborn was premature.

Warnings and precautions
Please consult your doctor, pharmacist, or nurse before receiving OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES.
Inform your doctor:

if you have respiratory problems such as chronic obstructive bronchopulmonary disease (COPD) or cystic fibrosis;
if you have severe obesity;
if you have a chest wall deformity;
if you have muscle problems due to neurological disorders (neuromuscular disorders);
if you are taking medications that may affect breathing (e.g., opioids, barbiturates);
if you have previously experienced lung problems caused by bleomycin (a drug used to treat certain types of cancer).

Your doctor will evaluate whether to administer oxygen in a hyperbaric chamber if:

you suffer from recurrent otitis and/or sinusitis (ear and/or nasal inflammation), laryngocele (alteration of the laryngeal mucosa), mastoid cavities, balance problems due to a neurological condition called vestibular syndrome, hearing loss, or if you have recently undergone middle ear surgery;
you suffer from heart problems (ischemic and/or congestive cardiac diseases);
you suffer from high blood pressure and are not receiving pharmacological treatment for it (untreated arterial hypertension);
you suffer from lung diseases that impair airflow (restrictive and/or severely restrictive pulmonary diseases);
you suffer from an eye disease characterized by high pressure in the fluid inside the eye (glaucoma), or retinal detachment (a membrane in the eye);
you suffer from diabetes mellitus;
you have experienced seizures or suffer from epilepsy;
you have high fever;
you suffer from severe anxiety, psychosis, or claustrophobia.

Children
In newborns and preterm infants, oxygen therapy may cause eye damage (retinopathy of prematurity). The doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your baby.

Safety precautions
During transport, storage, and use of gas 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 smoke in the area where the cylinders are located.
Do not bring open flames near the cylinders.
Do not place cylinders near sources of heat.
Do not use any electrical equipment that may produce sparks near patients receiving oxygen.
Use only equipment suitable and compatible with the specific cylinder model.
Use only containers that show no visible damage or that have not been damaged or exposed to extreme temperatures.
Do not use pliers or other tools to open or close the cylinder valve.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
Never introduce oxygen into a device that might contain materials capable of catching fire, especially greasy substances.
In case of leakage, close the cylinder valve immediately if it is safe to do so. If the valve cannot be closed, move the cylinder to a safer outdoor location to allow oxygen to escape freely.
Close the valves of empty cylinders.
Do not administer pressurized gas.

During transport, storage, and use of cryogenic oxygen

Direct contact of skin or mucous membranes with liquid oxygen may cause frostbite. Always wear gloves, protective goggles, loose clothing, and pants covering the shoes when handling liquid medical oxygen. 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 attention.

Other medicines and OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES
Inform your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
In particular, inform your doctor if you are taking:

catecholamines (e.g., adrenaline, noradrenaline), 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., actinomycin, bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines used to treat tumors,
antibiotics and antimicrobials (e.g., actinomycin, nitrofurantoin), medicines used to treat infections,
menadione-based supplements,
medicines used to treat mental disorders (e.g., promazine, chlorpromazine, thioridazine),
chloroquine, a medicine used to treat malaria.

Additionally, inform your doctor if:

you suffer from a thyroid gland disease (a neck gland that is overactive – hyperthyroidism),
you have a deficiency in vitamin C, vitamin E, and/or glutathione (an antioxidant substance),
you have undergone treatment for paraquat poisoning (a herbicide),
you consume alcohol,
you are taking medicines to treat epilepsy (barbiturates) and/or pain (opioids),
you have recently undergone an X-ray examination.

OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES and alcohol
Do not consume alcohol during treatment with OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES.

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

Pregnancy
Normobaric oxygen therapy
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES will be administered during pregnancy only if necessary.

Hyperbaric oxygen therapy
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES will not be administered in a hyperbaric chamber during the first 3 months of pregnancy unless you are in a serious condition.
Hyperbaric therapy during pregnancy may cause harm to the fetus. In cases of severe carbon monoxide poisoning, the decision will be made by your doctor.

Breastfeeding
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES may be used during breastfeeding.

Driving and using machines
Normobaric oxygen therapy
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES does not affect or affects negligibly the ability to drive and use machines.

Hyperbaric oxygen therapy
Visual and hearing disturbances may occur that could affect the ability to drive and use machines. Avoid driving and operating machinery until all negative effects on attention and alertness have completely disappeared.

3. How to use OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES

Use this medicine exactly as instructed by your doctor or nurse. If you have any doubts, consult your doctor.
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES is usually inhaled through the nose and mouth via a nasal cannula or a mask.
The dose will be determined by your doctor based on your health condition.
During treatment with OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES, your doctor may perform blood oxygen measurements and monitor oxygen levels bound to haemoglobin, a protein that carries oxygen in the blood.

If you use more OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES than you should
If you use more OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES than prescribed, contact your doctor or go to hospital immediately.
An excessive dose of OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES may affect breathing (pain behind the breastbone and dry cough), cause interstitial oedema (fluid accumulation in the lungs), and pulmonary fibrosis (a form of pneumonia).

Symptoms of an overdose that may occur following hyperbaric oxygen therapy include:

tinnitus (ringing in the ears);
visual and hearing disturbances;
localized muscle spasms (particularly in eyes, mouth, forehead);
dizziness and nausea;
anxiety, confusion, irritability;
loss of consciousness; seizures (uncontrolled body movements)

In premature infants, a high oxygen concentration may cause eye damage (retinopathy of prematurity).
If you are a patient at risk of hypercapnic respiratory failure, caused by high levels of carbon dioxide in the blood, administration of supplemental oxygen may lead to serious breathing problems (respiratory depression) and increased blood acidity (respiratory acidosis).
If you experience any of these signs, always contact your doctor or the nearest hospital.

Treatment
If you are given high doses, your doctor will reduce the oxygen dose or stop the treatment, administer appropriate therapy, and monitor you closely.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
Below are the side effects reported for OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES. The tissues most sensitive to high oxygen levels in the blood are the lungs, brain, and eyes.

Normobaric oxygen therapy:
Frequency not known (frequency cannot be estimated from the available data):
lung-related problems such as:

tracheobronchitis (sternal pain and dry cough),
presence of fluid (edema) in the lungs,
pulmonary fibrosis (a respiratory disease characterized by scarring in the lungs),
worsening of hypercapnia (excess carbon dioxide in the blood leading to acidosis, i.e. increased acidity in the blood),
hypoventilation (reduced ventilation), respiratory arrest,
dryness and irritation of mucous membranes.

Other side effects reported with normobaric oxygen therapy:

mild decrease in heart rate (number of heartbeats) and cardiac output (amount of blood pumped by the heart),
small areas of the lung not properly ventilated (atelectasis).

Side effects in children
Very common (may affect more than 1 in 10 people):

eye damage in newborns, particularly in premature infants (retinopathy of prematurity).

Side effects related to hyperbaric oxygen therapy (hyperbaric oxygen treatment):
Very common (may affect more than 1 in 10 people):

ear pain;
progressive myopia;
barotrauma (tissue damage due to pressure changes, e.g. in sinuses, ears, lungs, teeth, etc.).

Common (may affect up to 1 in 10 people):

seizures (uncontrolled body movements).

Uncommon (may affect up to 1 in 100 people):

perforation of the tympanic membrane (eardrum injury).

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

dyspnea (shortness of breath);
hypoglycemia (low blood glucose levels) in diabetic patients.

Frequency not known (frequency cannot be estimated from the available data):

breathing disturbances;
muscle twitching (muscle spasms);
dizziness;
hearing loss;
ear inflammation (acute serous otitis media);
ringing in the ears (tinnitus);
nausea;
abnormal behaviour;
reduced vision;
blurred vision;
cataract.

Additional side effects in newborns

lung diseases (bronchopulmonary dysplasia, pulmonary fibrosis, up to respiratory insufficiency).

Risk of burns
Contact with liquid oxygen (contained in OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES MEDICINALE CRIOGENICO) causes cold burns (frostbite).
Thermal burns: the risk of fire increases in the presence of high oxygen concentrations and ignition sources.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, please inform your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at the following 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 OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES

Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in
well-ventilated areas, protected from rain, adverse weather conditions, and direct sunlight.
Keep away from sources of heat and from combustible materials.
Empty containers or those containing other types of gases must be stored separately.
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 via wastewater or household waste. Ask your pharmacist how
to dispose of medicines no longer in use. This will help protect the environment.
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6. Package contents and other information

What OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES contains
The active substance is 100% Oxygen
Description of the appearance of OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES and package contents
Compressed medicinal gas
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES compressed medicinal gas is supplied
in cylinders in compressed gaseous form at 200 bar at 15°C. The cylinders are made of steel and equipped with
pressure-reducing valves with integrated pressure regulators.
Cryogenic medicinal gas
OSSIGENO FARMA GAS MEDICAL AND TECHNICAL GASES cryogenic medicinal gas is supplied
in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas (200 bar)
Steel cylinders with pressure-reducing valve of 3, 5, 7, 10, 14, 30 and 40 litres
Cryogenic medicinal gas
Mobile cryogenic container of 31.5 and 50 litres
Marketing Authorization Holder and Manufacturer
FARMA GAS - MEDICAL AND TECHNICAL GASES SRL
Via A. Fortunato 51
84084 FISCIANO (SA) – ITALY
Manufacturer
Euro Ossigeno S.r.l. – Loc. 40 Moggi Zona Industriale – 80029 – Sant’Antimo (NA)
_______________________________________________________________________________
The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Oxygen must be administered with caution, adjusting dosage according to individual patient needs.
The lowest effective 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% over the subsequent 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 failure whose respiratory drive is hypoxia-dependent.
In these cases, treatment must be carefully 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 caused by drugs (opioids, barbiturates)
or chronic obstructive bronchopulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia
resulting from elevated carbon dioxide levels in blood (plasma), thereby neutralizing receptor effects.
In full-term and premature neonates, administration of oxygen at concentrations exceeding 30-40%
may cause adverse effects such as retrolental fibroplasia, chronic lung disease, and intraventricular hemorrhage.
This is due to insufficient production of endogenous antioxidant enzymes, making it impossible to counteract
the production and toxic effects of reactive oxygen species. In such cases, the lowest effective oxygen concentration should be administered,
arterial oxygen pressure must be closely monitored, and maintained below 13.3 kPa (100 mmHg).
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 alveoli faster than it is supplied via ventilation, alveolar collapse (atelectasis) may occur.
This can impair arterial blood oxygenation, as gas exchange does not occur despite perfusion.
In patients with reduced sensitivity to arterial blood 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:
Special precautions must be taken in patients with reduced sensitivity to arterial blood carbon dioxide pressure
or 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, respiratory depressant drug overdose).
Administration of supplemental oxygen 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.
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Special precautions in patients with bleomycin-induced lung injury:
Pulmonary toxicity from high-dose oxygen therapy may exacerbate lung injury, even if administered several years after the initial lung damage caused by bleomycin.
The target oxygen saturation may need to be lower than in other patients.
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 preterm and full-term neonates, increased PaO2 may lead to retinopathy of prematurity, chronic lung disease, and intraventricular haemorrhage.
It is recommended to initiate resuscitation of full-term or near-term neonates with air rather than 100% oxygen.
In preterm neonates, the optimal oxygen concentration and target are not precisely defined.
If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.
Hyperbaric oxygen therapy (HBOT):
Administration of oxygen in a hyperbaric chamber must be carefully evaluated based on risk/benefit ratio in cases of:

Recurrent otitis and/or sinusitis
Laryngocele
Mastoid cavity
Vestibular syndrome
Hearing loss and recent middle ear surgery
Ischemic and/or congestive heart diseases; in patients with acute coronary syndrome or acute myocardial infarction who also require hyperbaric therapy (e.g., in CO poisoning), hyperbaric therapy must be conducted cautiously due to potential vasoconstriction from hyperoxia in the coronary circulation
Untreated arterial hypertension
Severe restrictive and/or obstructive pulmonary diseases
Glaucoma, retinal detachment (even if surgically treated) (compensation maneuvers)
History of seizures, epilepsy
Uncontrolled high fever
Severe anxiety, psychosis, claustrophobia

Patients with diabetes mellitus
Hyperbaric therapy may interfere with glucose metabolism. The vasoconstrictive effects of hyperbaric therapy may also impair subcutaneous insulin absorption, leading to hyperglycemia.
Blood glucose monitoring between hyperbaric therapy sessions may be considered.
Respiratory disorders
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Due to decompression at the end of a hyperbaric session, gas volume increases as chamber pressure decreases, potentially causing partial pneumothorax or worsening of underlying pneumothorax.
In a patient with undrained pneumothorax, decompression could lead to development of tension pneumothorax.
Moreover, considering the risk of gas expansion during the decompression phase of hyperbaric therapy,
the benefit-risk ratio of hyperbaric therapy must be carefully evaluated in patients with poorly controlled asthma, pulmonary emphysema, chronic obstructive bronchopulmonary disease (COPD), or recent thoracic surgery.
Interactions
Oxygen must not be administered concomitantly with drugs that increase its toxicity, such as catecholamines (e.g., epinephrine, norepinephrine), corticosteroids (e.g., dexamethasone, methylprednisolone), hormones (e.g., testosterone, thyroxine), chemotherapeutic agents (bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea), and antimicrobial agents (e.g., nitrofurantoin).
X-rays may increase oxygen toxicity. Hyperthyroidism and deficiency of vitamin C, vitamin E, or glutathione may have the same effect.
Pulmonary toxicity associated with drugs such as bleomycin, actinomycin, amiodarone, nitrofurantoin, and similar antibiotics may be increased by concomitant inhalation of high oxygen concentrations.
In patients previously treated for free radical-induced lung damage, oxygen-based therapy may worsen the injury, for example in paraquat poisoning treatment.
Oxygen may also worsen respiratory depression induced by alcohol.
Drugs known to induce adverse events include: adriamycin, menadione, promazine, chlorpromazine, thioridazine, and chloroquine.
Effects will be particularly pronounced in tissues with high oxygen levels, especially the lungs.
Special warnings
Oxygen is an oxidizing agent and therefore supports combustion. In the presence of combustible materials such as fats (oils, lubricants) and organic substances (tissues, wood, paper, plastics, etc.), oxygen may spontaneously ignite—due to a spark, open flame, ignition source—or due to adiabatic compression that may occur in pressure-reducing equipment (regulators) during a sudden drop in gas pressure, thereby initiating combustion.
Consequently, all substances coming into contact with oxygen must be classified as compatible with the product under normal conditions of use.

Any oxygen delivery system or container must be kept away from heat sources due to oxygen’s oxidizing properties; appropriate precautions must therefore be taken both in hospital and domestic settings where medicinal oxygen is used.
Oxygen may cause sudden ignition of smoldering materials or embers; therefore, smoking or use of unshielded open flames near containers and delivery systems is prohibited.

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Do not smoke in the environment where oxygen therapy is administered.
Do not place cylinders or containers near heat sources.
No electrical equipment capable of emitting sparks should be used near patients receiving oxygen.
It is absolutely forbidden to tamper in any way with container connections, delivery equipment, and their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY CATCH FIRE ON CONTACT WITH OXYGEN).
Any contact with oil, grease, or other hydrocarbons must be avoided.
It is absolutely 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.
In oxygen-enriched 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 are visible damages or if damage is suspected, or if they have been exposed to extreme temperatures.
Only oxygen-compatible and suitable equipment must be used for the specific container model.
Pliers or other tools must not be used to open or close the cylinder valve to prevent damage risk.
In case of leakage, the cylinder valve must be closed immediately, if safely possible. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
Valves of empty cylinders must be kept closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. This is why handling and storage of containers require special precautions.
It is not permitted to administer the gas under pressure.

Cryogenic formulations
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 clothing, and trousers covering shoes) must be worn.
If liquid oxygen comes into contact with skin or eyes, affected areas must be washed with abundant 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 facial mask);
dosage is delivered independently of the medicinal gas packaging via dosing devices (flowmeters).
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With these systems, oxygen is delivered through the inhaled air, while exhaled gas and any excess oxygen leave the patient’s inspiratory circuit, mixing with ambient air (open or anti-rebreathing system).
In anesthesia, 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 devices are available for oxygen administration, categorized as:

Low-flow systems This is the simplest system 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 Systems designed to provide the patient with a gas mixture meeting their total respiratory demand. These systems deliver stable and constant oxygen concentrations unaffected/diluted by ambient air; an example is Venturi masks, where, once the oxygen flow is set, the air inhaled by the patient is enriched with a constant concentration of oxygen.
Demand valve systems 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 where pressure can be maintained at 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 administration of a gas mixture richer in oxygen than atmospheric air, i.e., containing 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 anesthesia, oxygen must be administered via assisted ventilation.
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Oxygen cylinders have an internal maximum pressure of approximately 150-200 bar. Pressure is regulated by a reducer and displayed on the pressure gauge.
Multiplying the gauge reading by the cylinder’s litre capacity gives the amount of oxygen remaining in the cylinder.
(Example: Approximate content calculation: a cylinder has a capacity of 10 litres and the gauge reads 200 bar, resulting in 2000 litres of oxygen. At a consumption rate of 2 litres per minute, the cylinder will be empty after approximately 16 hours.)
With spontaneous ventilation
Patients with chronic respiratory failure: administer oxygen at a flow rate between 0.5 and 2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate between 0.5 and 15 litres/minute, adjustable according to blood gas analysis.
With assisted ventilation
The minimum FiO2 value is 21%, and may rise 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 hemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO2).
Dosage must be adjusted according to individual patient needs. The general recommendation is to use the lowest FiO2 value necessary to achieve the desired therapeutic effect, i.e., normal PaO2 values. In cases of severe hypoxemia, FiO2 values that carry a potential risk of oxygen toxicity may be indicated.
Continuous therapy monitoring and ongoing assessment of therapeutic effect are required, through measurement of PaO2 levels or alternatively, arterial oxygen saturation (SpO2).
In short-term oxygen therapy, the inspired oxygen fraction (FiO2) should maintain PaO2 > 8 kPa, with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), avoiding FiO2 values > 0.6 (i.e., >60% oxygen in the inhaled gas mixture) whenever possible.
Short-term oxygen therapy must be monitored by repeated arterial blood gas measurements (PaO2) or transcutaneous oximetry providing a numerical value of hemoglobin oxygen saturation (SpO2). In any case, these indices are only indirect measurements of tissue oxygenation. Clinical evaluation of treatment is of utmost importance.
For long-term treatments, the need for supplemental oxygen must be determined from arterial blood gas measurements. To avoid excessive carbon dioxide accumulation, blood oxygen levels must be monitored to adjust oxygen therapy in patients with hypercapnia.
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Low oxygen concentrations should be used in patients with respiratory failure whose respiratory drive is hypoxia-dependent (e.g., due to chronic obstructive bronchopulmonary disease - COPD). Inspired oxygen concentration 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, values below 30% are generally avoided. When necessary, the inspired oxygen fraction may be increased up to 100%.
Neonates may receive 100% oxygen when required. 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 blood oxygen pressure (PaO2) must be monitored; however, if kept below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage may be reduced. Additionally, the risk of ocular damage may be reduced by avoiding significant fluctuations in oxygenation (see also Precautions for use).
Hyperbaric oxygen therapy
Hyperbaric oxygen therapy refers to treatment with 100% oxygen at pressures 1.4 times higher than 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 in a hyperbaric chamber.
Session duration in a hyperbaric chamber at a pressure of 2 to 3 atmospheres (i.e., between 2.026 and 3.039 bar) ranges from 60 minutes to 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 according to standard procedures to avoid barotrauma risk to air-containing anatomical cavities communicating with the outside.
Hyperbaric oxygen therapy must be performed by qualified personnel trained in this treatment.
Instructions for use and handling
Medicinal oxygen cylinders, as well as fixed and mobile cryogenic containers, are intended exclusively for containing/transporting oxygen for inhalation, for therapeutic use.
Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means to protect them from impact and fall risks.
Strictly follow the instructions below:

Carefully read the container (package) instruction and user manual.
Verify that 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, ensuring

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adequate ventilation/aeration in 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 grease or oil traces.
Lift and move cylinders and base units using the appropriate trolley only; do not lift the cylinder by the valve.
Use specific connectors, connecting tubes, or hoses compatible with oxygen.
Particular attention must be paid to securing pressure reducers on cylinders, if not already integrated into the container closure system, to avoid risks of accidental breakage.
It is absolutely forbidden to tamper in any way with container connections, delivery equipment, and their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY CATCH FIRE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair a defective valve.
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).

Fire hazard: The risk of fire increases in the presence of high oxygen concentrations and ignition sources, which may cause thermal burns.
General instructions for use
Cylinders equipped with integrated pressure-reducing valve

Ensure the valve is closed.
Remove the tamper-proof seal.
Ensure 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 fully.
Adjust the flowmeter to the required flow rate (litres/minute). Mobile cryogenic containers
Ensure 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 DETAILS CONSULT THE CONTAINER USER MANUAL
ATTENTION
Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps and valves during opening and closing.
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Never position yourself in front of the gas outlet of the tap/valve, but always on the opposite side. Do not expose yourself or the patient to the direct 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 contact the technical service of the supplier indicated in the container user manual.
Use only containers suitable for the product, and for the intended operating pressures and temperatures.
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 emitting sparks should be used near patients receiving oxygen.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen.
Never introduce oxygen into a device that may contain combustible materials, particularly 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 unused medicinal product in the pressurized cylinder will be eliminated via appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling of the same container.

EXPIRY AND STORAGE
Expiry date: see expiry date indicated on the packaging.
The indicated expiry date refers to the product in intact packaging, correctly stored.
Attention: Do not use the medicinal product after the expiry date indicated on the packaging.
Storage
Observe all relevant rules for 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 formation of oxygen-enriched atmospheres (O2 > 21% vol), in upright position 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 types of gases must be stored separately.
Unused medicinal product and waste derived from this medicinal product must be disposed of in accordance with applicable local regulations (see also Instructions for use - Disposal).
Keep the medicinal product out of the reach and sight of children
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