Oxygen Cer Medical: detailed information

Package leaflet: Information for the patient

OXYGEN CER MEDICAL 110 BAR COMPRESSED MEDICINAL GAS, 200 BAR COMPRESSED MEDICAL GAS, CRYOGENIC MEDICINAL GAS

Oxygen
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, consult 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, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

What Ossigeno CER MEDICAL is and what it is used for
What you need to know before using Ossigeno CER MEDICAL
How to use Ossigeno CER MEDICAL
Possible side effects
How to store Ossigeno CER MEDICAL
Contents of the pack and other information

1. What Ossigeno CER MEDICAL is and what it is used for

Ossigeno CER MEDICAL contains oxygen, a gas naturally present in the air we breathe.
Medical oxygen increases the amount of oxygen in the blood, which is then distributed to all
tissues of the body.
Ossigeno CER MEDICAL is indicated in patients of all ages:

for the treatment of acute and chronic respiratory insufficiency.

2. What you need to know before using Ossigeno CER MEDICAL

Do not use Ossigeno CER MEDICAL
There are no absolute contraindications.
Warnings and precautions
Talk to your doctor or pharmacist before using Ossigeno CER MEDICAL.
Oxygen may have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), which will obstruct oxygen delivery into the blood.
Inform your doctor:

if you have lung injuries caused by a medicine called bleomycin (used for certain tumours);
if you have difficulty breathing due to certain conditions, e.g.: chronic lung disease characterized by slow obstruction of the airways (chronic obstructive pulmonary disease - COPD), cystic fibrosis (a severe genetic disease), genetically-based excess weight (pathological obesity), deformities of the chest wall, neuromuscular diseases (nervous system or muscle disorders manifesting as reduced muscle strength or muscle paralysis),
overdose of medicines causing severe breathing problems.

In these cases, the oxygen concentration and oxygen flow rate will be kept low.
Your doctor will adjust the oxygen flow rate of oxygen therapy accordingly.
Safety precautions
During use

Do not use greasy creams or lipsticks.
Do not smoke.
In over-oxygenated environments, oxygen may saturate clothing.
Do not approach the equipment with open flames; do not keep cylinders and containers near sources of heat.
Do not use any electrical equipment that may produce sparks near patients receiving oxygen.
Do not use oils or greases on connectors, taps, valves, or on any material in contact with oxygen; do not handle equipment or components with hands, clothes, or face contaminated with grease, oil, creams, or ointments.
Never introduce oxygen into a device that might contain materials capable of catching fire, especially fatty substances.
Do not use pliers or other tools to open or close the cylinder valve, to prevent the risk of damage.
In case of leakage, immediately close the cylinder valve if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer outdoor location to allow oxygen to escape freely.
Always keep valves of empty cylinders closed.
Handle the cylinder carefully. Ensure that the gas cylinder is not dropped or exposed to impacts; do not use cylinders or cryogenic containers if they are damaged or if you suspect they have been damaged.
- Oxygen becomes liquid at approximately -183°C. At such low temperatures, there is a risk of cold burns. If liquid oxygen comes into contact with the skin or eyes, the affected areas must be washed with large amounts of cold water or cold compresses applied; if such injuries occur, immediate medical assistance must be sought.
In the presence of oxygen, thermal burns related to accidental fire may occur.

Children
In newborns, the doctor will administer the lowest effective oxygen concentration to avoid possible adverse effects that may occur following oxygen administration in neonates (visual defects, chronic lung diseases, intracranial bleeding).
Other medicines and Ossigeno CER MEDICAL
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 body organs 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 tumours;
antimicrobial agents (e.g. nitrofurantoin), medicines used to treat bacterial infections;
antineoplastic antibiotics (e.g. actinomycin);
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 recently undergone an X-ray examination;
- you have undergone treatment for paraquat poisoning (a herbicide);
- you suffer from hyperthyroidism or deficiency in vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

Ossigeno CER MEDICAL and alcohol
Oxygen may worsen respiratory depression induced by alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor or pharmacist before taking this medicine.
During pregnancy, Ossigeno CER MEDICAL should be used only if absolutely necessary.
Ossigeno CER MEDICAL may be used during breastfeeding.
Driving and using machines
Oxygen does not affect or affects negligibly the ability to drive vehicles and use machines. Consult your doctor before driving vehicles or operating machinery.

3. How to use Oxygen CER MEDICAL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor.
Oxygen CER MEDICAL is usually inhaled through the nose and mouth via a
nasal cannula or a face mask.
The dose will be determined by your doctor based on your health condition.
During treatment with Oxygen CER MEDICAL, your doctor may perform
measurements of arterial blood gases and monitor haemoglobin-bound oxygen levels, a
protein that carries oxygen in the blood.

Use in newborns
In newborns, the doctor will administer the lowest effective oxygen concentration to avoid
potential adverse effects that may occur following oxygen administration in neonates (visual defects, chronic lung diseases, intracranial bleeding).

If you use more Oxygen CER MEDICAL than you should
If you use more Oxygen CER MEDICAL than you should, contact your doctor or go to hospital
immediately.
Symptoms of overdose may affect the respiratory system:
inflammation of the trachea and bronchi (tracheobronchitis with dry cough and chest pain),

sore throat,
difficulty in breathing (dyspnoea, hypoventilation),
bluish skin (cyanosis),
pulmonary fibrosis,
interstitial oedema (fluid accumulation in tissues).

If you are a patient at risk of respiratory failure, administration of supplemental oxygen
may cause severe respiratory problems (respiratory depression) and increased blood acidity
(respiratory acidosis).
In premature newborns, a high oxygen concentration may cause eye damage (retinopathy of prematurity).
If any of these signs of overdose occur, always contact your doctor or the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following are side effects associated with Ossigeno CER MEDICAL:

Very common (may affect more than 1 in 10 people):
temporary or permanent visual damage (retinopathy of prematurity) in newborns (especially premature infants) exposed to high oxygen concentrations or for prolonged periods;

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

respiratory discomfort and dry cough, interstitial edema, pulmonary fibrosis
worsening of hypercapnia (excess carbon dioxide in body fluids, particularly in the blood, leading to hypoventilation, respiratory acidosis, respiratory arrest)
dryness of the mucosa; local irritation and inflammation of the mucosa

Additional side effects in newborns

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

Additional side effects
Oxygen administration may cause a slight reduction in heart rate and cardiac output.

Risk of burns

thermal burns (the risk of fire increases in the presence of high oxygen concentrations and ignition sources);
cold burns (in case of direct contact with liquid oxygen).

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 may also report side effects directly via the national reporting system at: http://www.agenziafarmaco.gov.it/come-segnalare-una-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ossigeno CER MEDICAL

Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C.
Keep this medicinal product out of the 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.

6. Package Contents and Other Information

What Ossigeno CER MEDICAL Contains

The active substance is oxygen.

Description of the Appearance of Ossigeno CER MEDICAL and Contents of the Package
Compressed medicinal gas (110 bar)
OSSIGENO CER MEDICAL compressed medicinal gas is supplied in cylinders in a compressed gaseous state at 110 bar at 15°C. The cylinders are made of steel and equipped with valves featuring an integrated flow regulator.
Compressed medicinal gas (200 bar)
OSSIGENO CER MEDICAL compressed medicinal gas is supplied in cylinders in a compressed gaseous state at 200 bar at 15°C. The cylinders are made of steel or aluminum alloy and equipped with valves compatible with a pressure reducer or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO CER MEDICAL cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).

Available pack sizes:
Compressed medicinal gas (110 bar)
Steel cylinders with pressure-reducing valve (VR) of 0.66, 0.95 litres.
Compressed medicinal gas (200 bar)
Steel and aluminum cylinders with pressure-reducing valve (VR) of 0.5 litres.
Steel and aluminum cylinders with pressure-reducing valve (VR) or shut-off valve (VI) of 1, 2, 3, 5, 7, 14 litres.
Steel cylinders with pressure-reducing valve (VR) or shut-off valve (VI) of 10 litres.
Cryogenic medicinal gas
Mobile cryogenic containers of 25, 31, 37, 500 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
CER MEDICAL S.r.l
Via Torretta, 13
40012 Calderara di Reno (BO)

Manufacturer
Compressed medicinal gas 110 bar
Argon S.r.l. – Via Alessandro Volta 13, 42024, Castelnuovo di Sotto (RE)
Compressed medicinal gas 200 bar
CER Medical S.r.l. – Via Torretta, 13 – Calderara di Reno (BO)
Cryogenic medicinal gas (mobile containers)
CER Medical S.r.l. – Via Torretta, 13 – Calderara di Reno (BO)

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 patient's 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% during the second 24-hour period.
Oxygen may become toxic after two days at concentrations exceeding 40%.

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

High oxygen concentrations in the inhaled air or gas mixture cause a decrease in nitrogen concentration and partial pressure. 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 can impair arterial blood oxygenation, as gas exchange does not occur despite 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.

Special Warnings

In hyperoxic environments, oxygen may saturate clothing.
Contact with frozen parts (for cryogenic containers) is strictly prohibited.
Cylinders and mobile cryogenic containers must not be used if visible damage is present, if damage is suspected, or if they have been exposed to extreme temperatures.
Only oxygen-compatible and suitable equipment specific to the container model may be used.
Pliers or other tools must not be used to open or close the cylinder valve to prevent damage.
In case of leakage, the cylinder valve must be closed immediately, if 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 when handling and storing containers.
Pressure release of gas is not permitted.
Take special safety precautions when handling cryogenic containers to avoid cold burns. Wear appropriate protective clothing (gloves, goggles, loose clothing, and pants covering shoes). If liquid oxygen contacts skin or eyes, wash affected areas with abundant cold water or apply cold compresses; seek immediate medical attention.

Dosage, Method, and Duration of Administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal catheter or facial mask); dosing is adjusted independently of the medicinal gas packaging using dosing devices (flowmeters).

With these systems, oxygen is delivered via inspired air, while expired gas and excess oxygen exit the patient’s inspiratory circuit, mixing with surrounding air (open or anti-rebreathing system).

Various oxygen delivery devices exist and are categorized as follows:
Low-flow systems:
The simplest method for delivering an oxygen-enriched air mixture; for example, oxygen delivered via a flowmeter connected to a nasal cannula or facial mask.
High-flow systems:
Designed to meet the patient’s total respiratory gas requirements. These systems deliver a constant, predetermined oxygen concentration unaffected/diluted by ambient air; an example is Venturi masks, where, once the oxygen flow is set, the patient’s inspired air 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.

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 anesthesia, oxygen must be administered via assisted ventilation.

Oxygen cylinders contain an internal pressure of approximately 110–200 bar. This high pressure is regulated by a pressure reducer and indicated on the pressure gauge. Multiplying the gauge reading by the cylinder’s volume in litres gives the remaining oxygen volume available in the cylinder.

(Example: Content calculation: a cylinder has a volume of 10 litres and the pressure 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 of 0.5 to 2 litres/minute, adjustable based on blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 litres/minute, adjustable based on blood gas analysis.

With assisted ventilation
The minimum FiO₂ is 21%, and may increase 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 tailored to the individual 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 hypoxemia, FiO₂ values that pose a potential risk of oxygen toxicity may be indicated.

Continuous therapy monitoring and ongoing assessment of therapeutic effect are essential, through repeated measurement of PaO₂ 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), while avoiding FiO₂ > 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 remains paramount.

For long-term therapy, the need for supplemental oxygen must be determined from arterial blood gas values. To prevent excessive carbon dioxide accumulation, blood oxygen levels must be monitored to adjust oxygen therapy in patients with hypercapnia.

Low oxygen concentrations should be used in patients with respiratory failure in whom hypoxia is the respiratory stimulus (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%.

Children
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 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 marked oxygenation fluctuations.

Overdose
In cases of oxygen toxicity related to hyperoxia, oxygen therapy should be reduced or, if possible, discontinued, and symptomatic treatment initiated.

Instructions for Use and Handling
Medical oxygen cylinders and 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 these instructions:

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 of rooms where the product is used. Cylinders must be fitted with a protective cap/tulip over the valve.
Handle equipment with clean hands, free of grease or oil traces.
Lift and move cylinders and base units only using the appropriate trolley; never lift a cylinder by its valve.
Use only oxygen-specific and compatible connectors, connecting tubes, or flexible couplings.
Pay particular attention to securing pressure reducers to cylinders, if not already integrated into the container closure system, to prevent accidental breakage.
Absolutely no intervention of any kind is permitted on delivery equipment and related accessories or components (OIL AND GREASE MAY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves/taps.
It is strictly prohibited to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Contact with frozen parts (for cryogenic containers) is strictly prohibited.

General Instructions for Use
Cylinders equipped only with shut-off valve

Remove protective cap, if present
Ensure the delivery valve is closed
Remove tamper-evident 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 fully
Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped with integrated pressure-reducing valve

Ensure the valve is closed
Remove 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 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)

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 tap.
In case of gas leakage, close the tap and notify the technical service of the supplier indicated in the container’s user manual.
Use only containers suitable for the product and intended operating pressure and temperature.

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 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.

Observe all applicable rules for the use and handling of pressurized cylinders and containers holding 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 hyperoxic atmospheres (O₂ > 21% vol), in an upright position with valves closed and protected from rain and weather, direct sunlight, heat or ignition sources, and flammable materials. Empty containers or those containing other types of gas must be stored separately.

Patient information leaflet: information for the patient

OXYGEN CER MEDICAL 200 BAR MEDICINAL COMPRESSED GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read this leaflet carefully before you are administered this medicine, as it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
This medicine has been prescribed for you only. Do not give it to others, even if their symptoms are the same as yours, as it could be harmful.
If you experience any adverse reaction, including those not listed in this leaflet, consult your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Ossigeno CER MEDICAL is and what it is used for
What you need to know before using Ossigeno CER MEDICAL
How to use Ossigeno CER MEDICAL
Possible side effects
How to store Ossigeno CER MEDICAL
Contents of the pack and other information

1. What Ossigeno CER MEDICAL is and what it is used for

Ossigeno CER MEDICAL contains oxygen, a gas naturally present in the air we breathe.
Medical oxygen increases the amount of oxygen in the blood, which is then distributed to all tissues
of the body.
Ossigeno CER MEDICAL is indicated in patients of all ages:

for the treatment of acute and chronic respiratory insufficiency;
for use in anaesthesia;
in intensive care therapy;
in hyperbaric chambers, which are rooms where air pressure is higher than atmospheric pressure.

2. What you should know before using Ossigeno CER MEDICAL

Normobaric oxygen therapy
There are no absolute contraindications.
Hyperbaric oxygen therapy (oxygen administered at a pressure higher than atmospheric pressure)
You will not be administered Ossigeno CER MEDICAL in a hyperbaric chamber if:

you suffer from a lung disease causing the formation of lung bubbles (bullous emphysema);
you have asthma;
you currently have or have previously had a collapsed lung (pneumothorax);
you suffer from a lung disease that makes it difficult to expel air from the lungs, shortness of breath (also known as dyspnea), or a feeling of fatigue (chronic obstructive bronchopulmonary disease - COPD);
you have an inflammation of the lungs (Pneumocystis carinii pneumonia);
you are experiencing status epilepticus;
you suffer from 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 (hereditary spherocytosis);
you have a disease of the optic nerve;
you have malignant tumors;
you have high levels of acid in the blood (acidosis);
you are taking medications to treat tumors such as doxorubicin, adriamycin, daunorubicin, bleomycin, cisplatin (see section “Other medicines and Ossigeno CER MEDICAL”);
you are taking medications to treat inflammation such as steroids (see section “Other medicines and Ossigeno CER MEDICAL”);
you are taking a medication to treat alcohol dependence (disulfiram - see section “Other medicines and Ossigeno CER MEDICAL”);
you consume alcohol;
aromatic hydrocarbons (toxic substances) or nicotine are administered;
the newborn was premature.

Warnings and precautions
Consult your doctor or pharmacist before Ossigeno CER MEDICAL is administered to you.
Oxygen may have harmful effects at high concentrations. This may cause lung damage (alveolar collapse, lung inflammation), which will obstruct oxygen delivery into the blood.
Inform your doctor:

if you have lung damage caused by a medication called bleomycin (used for certain tumors);
if you have difficulty breathing due to certain conditions, e.g.: chronic lung disease characterized by slow obstruction of the airways (chronic obstructive bronchopulmonary diseases - COPD), cystic fibrosis (a severe genetic disease), genetic obesity (pathological obesity), chest wall deformities, neuromuscular diseases (nervous system or muscle disorders manifesting as reduced muscle strength or muscle paralysis), overdose of medications causing severe respiratory problems. In these cases, the oxygen concentration and oxygen flow rate will be low. Your doctor will adjust the oxygen flow rate of oxygen therapy. Your doctor will evaluate whether to administer oxygen in a hyperbaric chamber if:
you have recurrent ear and/or nasal inflammation (recurrent otitis and/or sinusitis);
you have heart disease (ischemic and/or congestive heart conditions);
you have untreated high blood pressure (arterial hypertension not pharmacologically treated);
you have lung diseases that prevent air passage (restrictive and/or highly restrictive pulmonary diseases);
you have high intraocular pressure (glaucoma) or retinal detachment;
you have seizures or epileptic attacks;
you have uncontrolled high fever;
you have diabetes mellitus, as hyperbaric therapy may counteract the effect of insulin and increase your blood sugar levels (hyperglycemia).

Safety precautions
During use

Do not use greasy creams or lipsticks.
Do not smoke.
In oxygen-enriched environments, oxygen may saturate clothing; do not place cylinders and containers near heat sources.
Do not approach the container with open flames.
Do not use any electrical equipment that may produce sparks near patients receiving oxygen; do not handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or various ointments.
Do not use oils or greases on connectors, taps, valves, or any material in contact with oxygen.
Never introduce oxygen into a device that might contain materials capable of catching fire, especially fatty substances.
Do not use pliers or other tools to open or close the cylinder valve, to prevent the risk of damage.
In case of leakage, immediately close the cylinder valve if it can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer outdoor location to allow oxygen to escape freely.
Always keep valves of empty cylinders closed.
Handle the cylinder carefully. Ensure that gas cylinders are not dropped or subjected to impacts; do not use cylinders or cryogenic containers if they are damaged or if you suspect they have been damaged.
• Oxygen becomes liquid at approximately -183°C. At such low temperatures, there is a risk of cold burns. If liquid oxygen comes into contact with the skin or eyes, the affected areas must be washed with abundant cold water or cold compresses applied; if such injuries occur, immediate medical assistance must be sought.
In the presence of oxygen, thermal burns related to accidental fire may occur.

Children
In newborns, the doctor will administer the lowest effective oxygen concentration to avoid possible adverse effects that may occur following oxygen administration in newborns (visual defects, chronic lung diseases, brain hemorrhage).
Hyperbaric oxygen therapy is contraindicated in premature infants.
Other medicines and Ossigeno CER MEDICAL
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 organs 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), medicines used to treat bacterial infections;
neoplastic antibiotics (e.g., actinomycin);
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 have recently undergone an X-ray;
you have undergone treatment for paraquat poisoning (a herbicide);
you suffer from hyperthyroidism or deficiency of vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

Ossigeno CER MEDICAL and alcohol
Oxygen may worsen respiratory depression induced by alcohol.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, plan to become pregnant, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Normobaric oxygen therapy:
Ossigeno CER MEDICAL may be used during pregnancy, but only when necessary.
Inform your doctor if you are pregnant or suspect pregnancy.
Hyperbaric oxygen therapy:
Ossigeno CER MEDICAL will not be administered to you in a hyperbaric chamber during the first 3 months of pregnancy unless you are in a serious condition.
Ossigeno CER MEDICAL may be used during breastfeeding.
Driving and using machines
Normobaric oxygen therapy:
Ossigeno CER MEDICAL does not alter or alters negligibly the ability to drive and use machines. Consult your doctor before driving or operating machinery.
Hyperbaric oxygen therapy:
If the medicine is administered in a hyperbaric chamber, visual and hearing disturbances may occur that could affect your ability to drive and use machines. In this case, do not drive or operate machinery until symptoms have completely disappeared.

3. How to use Ossigeno CER MEDICAL

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor.
.
Ossigeno CER MEDICAL is usually inhaled through the nose and mouth via a nasal
cannula or a face mask.
The dose will be determined by your doctor based on your health condition.
During treatment with Ossigeno CER MEDICAL, your doctor may perform arterial blood gas measurements and monitor oxygen levels bound to haemoglobin, a protein that carries oxygen in the blood.
If you use more Ossigeno CER MEDICAL than you should
If you use more Ossigeno CER MEDICAL than you should, contact your doctor or go to hospital
immediately.
It is very unlikely that you will be given more Ossigeno CER MEDICAL than required, as your
doctor or nurse will monitor you during treatment.
Symptoms of an overdose may affect the respiratory system:

inflammation of the trachea and bronchi (tracheobronchitis with dry cough and chest pain),
sore throat,
difficulty breathing (dyspnoea, hypoventilation),
bluish skin (cyanosis),
pulmonary fibrosis,
interstitial oedema (fluid accumulation in tissues).

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

ringing in the ears (tinnitus),
visual and hearing disturbances,
cramps, localized muscle spasms (particularly in eyes, mouth, forehead),
nausea, dizziness,
anxiety, confusion, irritability,
loss of consciousness,
uncoordinated movements and convulsions. In premature infants, a high oxygen concentration can cause eye damage (retinopathy of prematurity).

If you are a patient at risk of respiratory failure, administration of supplemental oxygen
may cause severe breathing problems (respiratory depression), increased blood acidity
(respiratory acidosis).
If you experience any of these signs of overdose, always contact your doctor or the nearest hospital.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
The following are the side effects associated with Ossigeno CER MEDICAL.

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

temporary or permanent visual damage (retinopathy of prematurity) in newborns (especially premature infants) exposed to high oxygen concentrations or for prolonged periods;

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

breathing-related pain and dry cough, interstitial edema, pulmonary fibrosis
worsening of hypercapnia (excess carbon dioxide in body fluids, especially in the blood with hypoventilation, respiratory acidosis, respiratory arrest)
dryness of the mucosa; local irritation and inflammation of the mucosa

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

ear pain, progressive myopia, barotrauma (tissue or organ injury caused by changes in pressure).

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

seizures.

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

rupture of the eardrum.

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

shortness of breath, low blood sugar levels in diabetic patients.

Frequency not known (frequency cannot be estimated from the available data):
difficulty breathing, involuntary muscle twitching, dizziness, decreased hearing,
tinnitus, acute serous otitis, nausea, abnormal behaviour, reduced peripheral vision,
visual disturbances, cataract.

Additional side effects in newborns

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

Additional side effects

oxygen administration may cause a slight reduction in heart rate and cardiac output.

Risk of burns

thermal burns (risk of fire increases in the presence of high oxygen concentrations and ignition sources);
cold burns (in case of direct contact with liquid oxygen).

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 www.agenziafarmaco.gov.it/content/come-segnalare-una-sospetta-reazione-avversa. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Ossigeno CER MEDICAL

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 packaging 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. Contents of the pack and other information

What Ossigeno CER MEDICAL contains

The active substance is oxygen.

Description of the appearance of Ossigeno CER MEDICAL and contents of the pack
Compressed medicinal gas
OSSIGENO CER MEDICAL compressed medicinal gas is supplied in cylinders and cylinder packs, in compressed gaseous form at 200 bar at 15°C. The cylinders are made of steel and equipped with valves compatible with a pressure reducer.
Cryogenic medicinal gas
OSSIGENO CER MEDICAL cryogenic medicinal gas is supplied in fixed cryogenic containers.
Available pack sizes:
Compressed medicinal gas
Steel cylinders with shut-off valve (SOV) of 40 litres; cylinder packs containing 12 steel cylinders with shut-off valve (SOV) of 40 litres; cylinder pack containing 16 steel cylinders with shut-off valve (SOV) of 50 litres.
Cryogenic medicinal gas
Fixed cryogenic container of 1,000, 1,500, 2,000, 3,000, 4,000, 5,000, and 10,000 litres.
Not all pack sizes may be marketed.
Marketing Authorization Holder
CER MEDICAL S.r.l.
Via Torretta, 13
40012 Calderara di Reno (BO)
Manufacturer
Compressed medicinal gas 200 bar
CER Medical srl – Via Torretta, 13 – Calderara di Reno (BO)
Cryogenic medicinal gas (fixed containers)
Linde Gas Italia srl – Via Turati, 18/a – Sala Bolognese (BO)
Sapio Produzione Idrogeno Ossigeno srl – Via Senatore Simonetta, 27 – Caponago (MI)
Sapio Produzione Idrogeno Ossigeno srl – Via Malcontenta, 49 (locality Porto Marghera) – Venice

The following information is intended exclusively for physicians or healthcare professionals:
Precautions for use
Oxygen (compressed or cryogenic) must be administered with caution, adjusted according to the individual patient's needs. The lowest effective dose that maintains a partial pressure of at least 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 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 at concentrations exceeding 40%.
Low oxygen concentrations should be used in patients with respiratory failure in whom hypoxia provides the respiratory drive. In such cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂), along with clinical assessment.
In full-term and premature neonates, administration of oxygen at concentrations above 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, resulting in an inability 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 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 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 ongoing 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.
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 equipment suitable for the specific container model may be used.
Pliers or other tools must not be used to open or close the cylinder valve to prevent the risk of 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 is a strong oxidizing agent and may react violently with organic substances. Therefore, special precautions are required during handling and storage of containers.
Pressurized gas administration is not permitted.

Dosage, method and duration of administration
With these systems, oxygen is delivered via the inspired air, while expired gas and excess oxygen exit the patient's inspiratory circuit and mix with the surrounding 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 can 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 delivery, categorized as follows:

Low-flow systems The simplest method for delivering an oxygen-enriched air mixture; an example is oxygen delivery via a flowmeter connected to a nasal catheter or facial mask.
High-flow systems Systems designed to meet the patient's total respiratory gas requirements. These systems deliver a constant, predetermined oxygen concentration 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 oxygen concentration.
Demand valve systems Systems designed to deliver 100% oxygen without contact with ambient air. Intended for short-term use only, in emergency situations.
Hyperbaric oxygen therapy Hyperbaric oxygen therapy is performed in a specially designed pressurized chamber where pressures up to three times atmospheric pressure can be maintained. 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 (0.213–1.013 bar).
In patients without respiratory failure, oxygen can 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 a maximum internal pressure of 200 bar. Pressure is regulated by a pressure reducer and displayed on a pressure gauge. Multiplying the gauge reading by the cylinder volume (in litres) gives the remaining oxygen volume available.
(Example: Approximate content calculation: a cylinder has a volume of 10 litres and the pressure gauge reads 200 bar, resulting in 2,000 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 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 may be increased up to 100%.
The therapeutic goal of oxygen therapy is to ensure that arterial oxygen partial pressure (PaO₂) does not fall below 8 kPa (60 mmHg), or that arterial hemoglobin oxygen saturation does not fall 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 hypoxemia, higher FiO₂ values that carry a potential risk of oxygen toxicity may be indicated.
Continuous monitoring of therapy 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), while avoiding FiO₂ > 0.6 (i.e., >60% oxygen in the inhaled gas mixture) whenever possible.
For long-term treatment, the need for supplemental oxygen must be determined from arterial blood gas measurements. To prevent excessive carbon dioxide accumulation, blood oxygen levels must be monitored to allow adjustment of oxygen therapy in hypercapnic patients.
Low oxygen concentrations should be used in patients with respiratory failure in whom hypoxia provides the respiratory drive (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 remain at least 21%. In practice, levels below 30% are generally avoided. When necessary, the inspired oxygen fraction may be increased up to 100%.
Children
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 marked 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.
Treatment sessions at 2 to 3 atmospheres pressure (i.e., 2.026–3.039 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 according to standard procedures to avoid barotrauma risk to air-containing anatomical cavities communicating with the external environment.
Hyperbaric oxygen therapy must be administered by qualified personnel trained in this treatment.
Overdose
In case of oxygen toxicity related to hyperoxia, oxygen therapy should be reduced or, if possible, discontinued, and symptomatic treatment initiated.
Instructions for use and handling
Medicinal oxygen cylinders are intended exclusively for containing/transporting oxygen for inhalation, for therapeutic use.
Cylinders must be transported using appropriate means to protect them from impact and falling risks.
Strictly follow these instructions:

Carefully read the instruction and user manual of the container (packaging).
Verify that all equipment is in good condition.
Secure cylinders to maintain them in an upright position and prevent falls; protect containers from impact and keep them at temperatures below 50°C, ensuring adequate ventilation/aeration of rooms where the product is used. Cylinders must be fitted with a protective cap/tulip over the valve.
Handle equipment with clean hands, free of grease or oil traces.
Lift and move cylinders only using the appropriate trolley; never lift a cylinder by the valve.
Use connectors, connecting tubes, or flexible hoses specifically designed and compatible with oxygen.
Particular attention must be paid to securing pressure reducers to cylinders, especially if not already integrated into the container closure system, to prevent accidental breakage.
It is absolutely forbidden to modify in any way the container connectors, 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.

General instructions for use
Cylinders equipped with shut-off valve only

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 the corresponding flowmeter
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)

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)

NOTE: FOR FURTHER 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 position yourself in front of the gas outlet of the tap/valve; always stand to the side. Do not expose yourself or the patient to direct gas flow.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder valve.
In case of gas leakage, close the valve and contact the technical service of the supplier indicated in the container’s user manual.
Use only containers suitable for the product, and for the intended pressure and temperature conditions.

Disposal

Store empty cylinders with valves closed.
Do not discharge into sewers, basements, or pits where 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 through appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling of the container.

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