Oxygen Magaldi Life: detailed information

Package leaflet: Information for the patient

OSSIGENO MAGALDI LIFE 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What Ossigeno MAGALDI LIFE is and what it is used for

Ossigeno MAGALDI LIFE contains oxygen, a gas naturally present in the air we breathe.
Medical oxygen increases the delivery of oxygen to all body tissues.
Ossigeno MAGALDI LIFE is indicated in patients of all ages:

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

2. What you should know before using OXYGEN MAGALDI LIFE

Do not use OXYGEN MAGALDI LIFE
Under normal conditions (atmospheric pressure), there are no absolute contraindications.

Warnings and precautions
Talk to your doctor or pharmacist before using OXYGEN MAGALDI LIFE.
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 problems due to disorders of the nervous system (neuromuscular disorders);
if you are taking medicines that may affect breathing;
if you have previously had lung problems caused by bleomycin (a medicine used to treat certain types of tumours);
if you suffer from a thyroid disease, a gland in the neck that is overactive (hyperthyroidism);
if you have a deficiency of vitamin C and/or E or of a substance called glutathione (an antioxidant, i.e. one that counteracts ageing);
if you have undergone treatment for paraquat poisoning (a herbicide);
if you consume alcohol;
if you are taking medicines to treat epilepsy (barbiturates) and/or pain (opioids);
if you have recently undergone an X-ray examination.

Safety precautions
During transport, storage and use of cylinders

Avoid contact of oils and greases with the cylinders: for example, avoid touching the cylinders with hands, clothes or face contaminated with grease, oil, creams or ointments.
Do not use greasy creams or lipsticks.
Do not smoke in the environment where the cylinders are located, especially while oxygen is being administered to the patient.
Do not approach the container with open flames or 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 on 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, particularly greasy substances.
In case of leakage, close the cylinder valve immediately and, if safe to do so, 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

Free oxygen can cause cold burns. Always wear gloves and protective goggles when handling liquid medical oxygen. If liquid oxygen comes into contact with the skin or eyes, wash the affected area with abundant cold water or apply cold compresses. Seek immediate medical advice.

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 child.

Other medicines and OXYGEN MAGALDI LIFE
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 of the body and are generally used in the 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 tumours;
antibiotics and antimicrobials (e.g. nitrofurantoin), medicines used to treat infections;
vitamin K supplements (menadione);
medicines used to treat mental disorders (e.g. promazine, chlorpromazine, thioridazine);
chloroquine, a medicine used to treat malaria.

OXYGEN MAGALDI LIFE and alcohol
Do not consume alcohol during treatment with OXYGEN MAGALDI LIFE.

Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, are planning a pregnancy, or are breastfeeding, ask your doctor or pharmacist for advice before taking this medicine.
Normobaric oxygen therapy
OXYGEN MAGALDI LIFE will be administered during pregnancy only if necessary.
OXYGEN MAGALDI LIFE can be used during breastfeeding.

Driving and using machines
Normobaric oxygen therapy
OXYGEN MAGALDI LIFE does not alter or alters negligibly the ability to drive and use machines.
Avoid driving vehicles and operating machinery until any adverse effects on attention and vigilance have completely disappeared.

3. How to use Ossigeno MAGALDI LIFE

Use this medicine exactly as instructed by your doctor or pharmacist. If you have
any doubts, consult your doctor.
Ossigeno MAGALDI LIFE is usually inhaled through the nose and mouth using a nasal cannula
or a face mask.
The dose will be determined by your doctor based on your health condition.
During treatment with Ossigeno MAGALDI LIFE, 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 MAGALDI LIFE than you should
If you use more Ossigeno MAGALDI LIFE than recommended, contact your doctor or go to hospital
immediately.
An excessive dose of Ossigeno MAGALDI LIFE may affect respiratory function and, in rare cases,
cause neurological adverse effects that could lead to loss of consciousness in extreme situations.
Symptoms of an overdose that you may experience include:

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

Prolonged use of excessive doses of Ossigeno MAGALDI LIFE may cause breathing-related pain, dry cough, and shortness of breath.
Treatment
If you have used excessive doses, your doctor will reduce the oxygen dose, administer appropriate therapy, and monitor you closely.
In most cases, symptoms resolve within 4 hours after stopping treatment.

4. Possible side effects

Like all medicines, this medicinal product can cause side effects, although not everyone experiences them.
Below are the side effects associated with Ossigeno MAGALDI LIFE. Tissues vary in sensitivity to hyperoxia, with the lungs, brain, and eyes being the most sensitive.

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

Lung problems, such as:
( pain related to breathing and dry cough,
( presence of fluid (edema) in the lungs,
( respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis),
( increase in carbon dioxide in the blood (hypercapnia), leading to an increase in blood acidity (acidosis),
( reduced ventilation (hypoventilation), respiratory arrest,
( dryness and irritation of mucous membranes (nasal congestion or sinus blockage with pain and bleeding)

Other side effects reported with normobaric therapy:
( mild reduction in heart rate and cardiac output
( small areas of the lung not properly ventilated (atelectasis)
( lung damage
( dryness and irritation of the eyes
( slowed clearance of nasal secretions

Additional side effects in children
In newborns, particularly premature infants:

Very common (may affect more than 1 in 10 people):
Eye damage in premature infants (retinopathy of prematurity). With exposure to high oxygen concentrations: eye injury that may lead to visual impairment

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

Retinal detachment (a membrane of the eye), and even permanent blindness
Lung disease (bronchopulmonary dysplasia)
Brain hemorrhage
Disease leading to intestinal death (necrotizing enterocolitis) in premature infants

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

Lung diseases (bronchopulmonary dysplasia; pulmonary fibrosis, up to respiratory failure)

Contact with liquid oxygen (contained in Ossigeno Magaldi Life MEDICINAL CRYOGENIC GAS) causes cold burns.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You can also report side effects directly via the national reporting system at http://aifa.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 MAGALDI LIFE

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

6. Package contents and other information

What Ossigeno MAGALDI LIFE contains

The active substance is oxygen.

Description of the appearance of Ossigeno MAGALDI LIFE and contents of the package
Compressed medicinal gas (200 bar)
OSSIGENO MAGALDI LIFE compressed medicinal gas is packaged in cylinders in a compressed gaseous state at 200 bar at 15°C. The cylinders are made of steel and equipped with valves compatible with pressure regulators or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO MAGALDI LIFE cryogenic medicinal gas is packaged in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas (200 bar)
Steel cylinders with valve of 1, 2, 5, 7, 10, 14, 27 litres.
Cryogenic medicinal gas
Mobile cryogenic container of 20, 31, 45 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
MAGALDI LIFE S.r.l.
Via Case Rosse, 19/A
84131 Salerno

Manufacturer *
Compressed medicinal gas 200 bar and cryogenic medicinal gas (mobile containers)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada Settimo, 342 – San Mauro Torinese (TO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via dei Lavoratori, 117 – Cinisello Balsamo (MI)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – S.S. 525 del Brembo,1 – Osio Sopra (BG)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Rose, 13 – Brescia
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada al Monte d’oro, 1 – Trieste
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via G. Bruzzo, 4 – Genova
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Viale D. Zaccagna, 37 – Avenza (MS)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Zona Industr. Loc. Tossillo – Macomer (NU)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Vitorchiano, 99 – Roma
NIPPON GASES INDUSTRIAL S.r.l. – Via Pacinotti, 8 – Messina
NIPPON GASES PHARMA SUDrl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate Case Rosse – Zona ASl – Salerno
NIPPON GASES INDUSTRIAL S.r.l. – Via Strada regionale Casilina 6, n.114 – Anagni (FR)
NIPPON GASES PHARMA S.r.l. – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA S.r.l. – Via Martino della Torre,16 – Novara
NIPPON GASES PHARMA S.r.l. – Via Circumvallazione esterna – Melito di Napoli (NA)
Compressed medicinal gas 200 bar
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via della Libertà, 17 – Ozzano nell’Emilia (BO)
Cryogenic medicinal gas (mobile containers)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Andorra, 13/15 Loc. Camin – Padova
* In the FI mock-up implemented in production, only the facility responsible for batch release will be indicated.

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

Precautions for use
Oxygen must be administered with caution, with adjustments based on individual patient needs. The lowest effective dose maintaining 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 whose respiratory drive is hypoxia-dependent. In such cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or by pulse oximetry (arterial oxygen saturation – SpO₂) and clinical assessment.
High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also reduces nitrogen concentration 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 may 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.

Patients at risk of hypercapnic respiratory failure
Particular 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, or 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 injury, even when administered several years after initial lung damage caused by bleomycin. The target oxygen saturation in these patients may need to be lower than in others.

Paediatric population
Due to the newborn's increased sensitivity to supplemental oxygen, the lowest effective oxygen concentration should be administered to achieve adequate oxygenation in neonates.
In term and preterm neonates, administration of oxygen exceeding 30–40% may cause adverse effects such as retrolental fibroplasia, chronic lung disease, and intraventricular haemorrhage. This is due to insufficient production of endogenous antioxidant enzymes, resulting in inability 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). In preterm and term neonates, increased PaO₂ may lead to retinopathy of prematurity (see section 4.8), 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 oxygen target are not precisely defined. If supplemental oxygen is required, it should be carefully monitored and guided by pulse oximetry.

Special warnings

In hyperoxic environments, oxygen may saturate clothing.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).
Cylinders and mobile cryogenic containers must not be used if there are visible damages or if damage is suspected, or if they have been exposed to extreme temperatures.
Only equipment suitable and compatible with oxygen 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.
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 of empty cylinders must be kept closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. For this reason, handling and storage of containers require special precautions.
It is not permitted to release gas under pressure.

Only for OSSIGENO MAGALDI LIFE CRYOGENIC MEDICINAL GAS
Cold burns from direct contact with liquid oxygen
Oxygen becomes liquid at approximately -183°C. At such low temperatures, 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 pants covering shoes) must be worn. If liquid oxygen contacts skin or eyes, the affected areas must be washed with large amounts of cold water or cold compresses applied; immediate medical assistance must be sought.

Dosage, method and duration of administration
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or facial mask); dosing is performed independently of the medicinal gas packaging using dosing devices (flowmeters).
Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal catheter or facial mask); dosing is performed independently of the medicinal gas packaging using dosing devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while expired gas and any excess oxygen leave the patient's inspiratory circuit, mixing with the surrounding air (open system or anti-rebreathing system).

Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air, i.e., with an inspired oxygen fraction (FiO₂) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 1.013 bar).
In patients without respiratory failure, oxygen may be administered via spontaneous ventilation using nasal cannulae, nasopharyngeal catheters, or suitable masks.
In patients with respiratory failure or under anaesthesia, oxygen must be administered via assisted ventilation.
Oxygen cylinders contain an internal pressure of approximately 200 bar. This high pressure is regulated by a pressure reducer and displayed 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: 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 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.

Instructions for use and handling
Medicinal oxygen cylinders, as well as cryogenic containers, are exclusively intended 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 instruction and user manual of the container (package).
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 keep them at temperatures below 50°C, ensuring adequate ventilation 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 only using the dedicated trolley; never lift the 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 when not integrated into the container closure system, to avoid risks of accidental breakage.
It is absolutely forbidden to modify in any way the delivery equipment and its accessories or components (OIL AND GREASE MAY IGNITE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves/taps.
It is absolutely forbidden to handle equipment or components with hands, clothing or face contaminated with grease, oil, creams or ointments.
It is absolutely forbidden to touch frozen parts (for cryogenic containers).

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

Remove the protective cap if present
Ensure the delivery valve is closed
Remove the tamper-evident seal
Connect the pressure reducer to the cylinder valve and 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)

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)

NOTE: FOR MORE DETAILS, CONSULT THE CONTAINER'S USER MANUAL
ATTENTION

Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps or valves during opening or closing.
Never stand in front of the gas outlet of the tap/valve; always stand on the opposite 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 support service indicated in the container's user manual.
Use only containers suitable for the product, and for the intended pressure and temperature of use.

During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames near the container.
No electrical equipment that may emit 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, especially greasy substances.

Disposal

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

Observe all applicable rules regarding 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 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.

Patient Information Leaflet

OXYGEN MAGALDI LIFE 200 BAR MEDICINAL COMPRESSED GAS

Oxygen
Read this entire leaflet carefully before this medicine is administered to you, as it
contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any questions, ask your doctor, pharmacist, or nurse.
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor, pharmacist, or nurse. See section 4.

Contents of this leaflet:

What Oxygen Magaldi Life is and what it is used for
What you need to know before being administered Oxygen Magaldi Life
How Oxygen Magaldi Life will be administered to you
Possible side effects
How to store Oxygen Magaldi Life
Contents of the pack and other information

1. What Ossigeno Magaldi Life is and what it is used for

Ossigeno Magaldi Life contains oxygen, a gas naturally present in the air we breathe.
Medicinal oxygen increases the delivery of oxygen to all body tissues.
Ossigeno Magaldi Life is indicated in patients of all ages:

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

2. What you need to know before you are given Ossigeno Magaldi Life

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

Hyperbaric oxygen therapy
You will not be given Ossigeno Magaldi Life in a hyperbaric chamber if:

you suffer from a lung disease causing the formation of lung bubbles (bullous emphysema)
you suffer from asthma
you currently have or have previously had a collapsed lung (pneumothorax)
you suffer from a lung disease that makes it difficult to expel air from the lungs, with shortness of breath (also known as dyspnea) or a feeling of fatigue (Chronic Obstructive Pulmonary Disease - COPD)
you suffer from lung inflammation (Pneumocystis carinii pneumonia)
you suffer from a condition characterized by uncontrollable body movements (epilepsy)
you are afraid of enclosed spaces (claustrophobia)
you are in the first 3 months of pregnancy and do not have a serious illness
you have an upper respiratory tract infection
you have heat stroke (hyperthermia)
you suffer from a red blood cell disorder, a type of blood cell (hereditary spherocytosis)
you suffer from an optic nerve disease
you suffer from malignant tumors
you have high levels of acid in the blood (acidosis)
you are taking medications to treat tumors such as doxorubicin, adriamycin, daunorubicin, bleomycin, cis-platinum (see section "Other medicines and Ossigeno Magaldi Life")
you are taking medications to treat inflammation such as corticosteroids (see section "Other medicines and Ossigeno Magaldi Life")
you are taking a medicine to treat alcohol dependence (disulfiram - see section "Other medicines and Ossigeno Magaldi Life")
you are consuming alcohol
you have recently been exposed to toxic substances (aromatic hydrocarbons)
you smoke or use nicotine-based medications to help quit smoking
the newborn was premature

Warnings and precautions
Talk to your doctor, pharmacist, or nurse before you are given Ossigeno Magaldi Life.
Inform your doctor:

if you have respiratory problems such as: chronic obstructive bronchopulmonary diseases (COPD) or cystic fibrosis
if you have severe obesity
if you have a chest deformity
if you have muscle problems due to nervous system disorders (neuromuscular disorders)
if you are taking medications that may affect breathing
if you have previously had lung problems caused by bleomycin (a drug used to treat certain types of tumors)
if you suffer from a thyroid disease, a neck gland that is overactive (hyperthyroidism)
if you have a deficiency in vitamin C and/or E or in a substance called glutathione (an antioxidant, i.e. one that counteracts aging)
if you have undergone treatment for paraquat poisoning (a herbicide)
if you consume alcohol
if you are taking medications to treat epilepsy (barbiturates) and/or pain (opioids)
if you have recently undergone an X-ray examination

Hyperbaric oxygen therapy (HBOT)
Your doctor will evaluate whether to administer oxygen in a hyperbaric chamber if:

you suffer from ear problems such as: ear inflammation (otitis), vestibular syndrome (a disease causing dizziness and balance problems), mastoid cavity, hearing loss, or if you have recently undergone middle ear surgery
you suffer from nasal inflammation (recurrent sinusitis)
you have a laryngeal condition (throat) called laryngocele
you suffer from heart diseases (such as ischemic and/or congestive heart disease, acute coronary syndrome, or acute myocardial infarction)
you suffer from untreated high blood pressure (untreated arterial hypertension)
you suffer from lung diseases that hinder airflow (restrictive and/or severely restrictive pulmonary diseases)
you suffer from an eye disease characterized by high pressure of the fluid inside the eyes (glaucoma), or retinal detachment, a membrane of the eye
you suffer from diabetes mellitus, as hyperbaric therapy may counteract the effect of insulin and increase your blood sugar levels (hyperglycemia)
you have had previous episodes of seizures or epilepsy
you have uncontrolled high fever despite treatment
you suffer from severe anxiety, psychosis, or claustrophobia.

Safety Precautions 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 oily creams or lipsticks. • Do not smoke in the environment where cylinders are located, especially while oxygen is being administered to the patient. • Do not approach the cylinder with open flames or sources of heat. • Do not use any electrical equipment that may generate 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 subjected to extreme temperatures. • Do not use pliers or other tools to open or close the cylinder valve. • Do not apply oils or greases to 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, particularly greasy substances. • In case of leakage, immediately close the cylinder valve and, if safe to do so, move the cylinder to a safer outdoor location to allow oxygen to escape freely. • Close valves on empty cylinders. • Do not administer pressurized gas. During Transport, Storage, and Use of Cryogenic Oxygen • Free oxygen can cause cold burns. Always wear gloves and protective goggles when handling liquid medical oxygen. If liquid oxygen comes into contact with skin or eyes, wash the affected area thoroughly with cold water or apply cold compresses. Seek immediate medical attention.

Other medicines and Oxygen Magaldi Life
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 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 tumours,
antibiotics and antimicrobials (e.g. nitrofurantoin), medicines used to treat infections,
vitamin K supplements (menadione),
medicines for mental disorders (e.g. promazine, chlorpromazine, thioridazine),
chloroquine, a medicine used to treat malaria.

Oxygen Magaldi Life and alcohol
Do not consume alcohol during treatment with Oxygen Magaldi Life.

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.

Normobaric oxygen therapy
Oxygen Magaldi Life will be administered during pregnancy only if necessary.

Hyperbaric oxygen therapy
Administration of oxygen in a hyperbaric chamber is contraindicated during the first 3 months of pregnancy for non-acute conditions.
Oxygen Magaldi Life can be used during breastfeeding.

Driving and using machines
Normobaric oxygen therapy
OXYGEN MAGALDI LIFE does not affect or affects negligibly the ability to drive and use machines.

Hyperbaric oxygen therapy
After administration of oxygen in a hyperbaric chamber, disturbances of vision and hearing have been reported, which may affect the ability to drive and use machines.
Avoid driving and operating machinery until any adverse effects on attention and alertness have completely resolved.

3. How Ossigeno Magaldi Life will be administered to you

This medicine will be administered to you through the inhaled air, always following the instructions given by your doctor or nurse exactly. If you have any doubts, consult your doctor.
Ossigeno Magaldi Life is usually inhaled through the nose and mouth using a nasal cannula or a mask.
The dose will be determined by your doctor based on your health condition.
During treatment with Ossigeno Magaldi Life, your doctor may perform measurements of arterial blood gases and monitor oxygen levels bound to haemoglobin, a protein that carries oxygen in the blood.

If you are given more Ossigeno Magaldi Life than you should receive
It is very unlikely that you will be given more Ossigeno Magaldi Life than required, as your doctor or nurse will monitor you throughout the treatment.

An excessive dose of Ossigeno Magaldi Life may affect respiratory function and, in exceptional cases, cause neurological adverse effects that could lead to loss of consciousness in extreme situations.

Symptoms of an overdose that you might experience include:

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

Prolonged use of excessive doses of Ossigeno Magaldi Life may cause breathing-related pain, dry cough, and shortness of breath.

Treatment
If you are given an excessive dose, your doctor will reduce the oxygen dose, provide appropriate therapy, and monitor you closely.
In most cases, symptoms resolve within 4 hours after stopping treatment.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Below are the side effects associated with Ossigeno Magaldi Life. Tissues show different sensitivity to hyperoxia, with the lungs, brain, and eyes being the most sensitive.

Normobaric oxygen therapy:

Frequency not known (frequency cannot be estimated based on available data):
lung problems, such as:

pain related to breathing and dry cough,
presence of fluid (edema) in the lungs,
respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis),
increased carbon dioxide levels in the blood (hypercapnia), leading to increased acidity in the blood (acidosis), reduced ventilation (hypoventilation), respiratory arrest,
dryness and irritation of mucous membranes (sinus congestion or blockage with pain and bleeding).

Other side effects reported with normobaric therapy:

slight reduction in heart rate and cardiac output,
small areas of the lung not reached by air (atelectasis),
lung injury,
dryness and irritation of the eyes,
slowed clearance of nasal secretions.

Hyperbaric oxygen therapy:

Very common (may affect more than 1 in 10 people):
During hyperbaric treatment: ear pain, myopia, tissue damage caused by imbalance between the pressure of air in a body cavity and the surrounding environmental pressure (barotrauma), which may manifest as ear pain and possible bleeding, toothache, intestinal gas release (flatulence), colic pain.

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

uncontrolled body movements (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 (dyspnea),
decreased blood glucose levels (hypoglycemia) in diabetic patients.

Frequency not known (frequency cannot be estimated based on available data):

respiratory disorders,
involuntary muscle contractions (localized muscle spasms),
dizziness,
hearing impairment,
inflammation of the ear (acute serous otitis),
ringing in the ears (tinnitus),
nausea,
abnormal behavior,
reduced visual field (decreased peripheral vision),
blurred vision,
cataract.

Other side effects reported with hyperbaric therapy:

panic attacks due to fear of confined spaces (claustrophobia).

Additional side effects in children

In newborns, particularly premature infants:

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

eye damage in premature infants (retinopathy of prematurity). With exposure to high oxygen concentrations: eye injury, potentially leading to visual impairment.

Frequency not known (frequency cannot be estimated based on available data):

retinal detachment (of a membrane in the eye), and even permanent blindness,
lung disease (bronchopulmonary dysplasia),
brain hemorrhage,
disease leading to intestinal death (necrotizing enterocolitis).

In preterm infants:

Frequency not known (frequency cannot be estimated based on available data):

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

Contact with liquid oxygen (contained in Ossigeno Magaldi Life MEDICINAL CRYOGENIC GAS) causes cold burns.

Reporting of side effects

If you experience any side effect, including those not listed in this leaflet, talk to your doctor, pharmacist, or nurse. You may also report side effects directly via the national reporting system at http://aifa.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 Magaldi Life

Store cylinders at temperatures between -10°C and 50°C.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
Do not dispose of 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 Magaldi Life Contains

The active substance is oxygen

Description of the Appearance of Ossigeno Magaldi Life and Contents of the Package
Compressed medicinal gas
OSSIGENO Magaldi Life compressed medicinal gas is supplied in cylinders and cylinder packs, in a compressed gaseous state at 200 bar at 15°C. The cylinders are made of steel and equipped with VI or VP valves.
Available pack sizes:
Compressed medicinal gas
Steel cylinders with 40-litre capacity, cylinder packs containing 16 or 25 cylinders of 40 litres each.
Not all pack sizes may be marketed.

Marketing Authorization Holder

Salerno MAGALDI LIFE S.R.L., Via Case Rosse, 19/A 84131

Manufacturer *
Compressed medicinal gas
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada Settimo, 342 – San Mauro Torinese (TO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via dei Lavoratori, 117 – Cinisello Balsamo (MI)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – S.S. 525 del Brembo,1 – Osio Sopra (BG)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Rose, 13 – Brescia
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada al Monte d’oro, 1 – Trieste
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via della Libertà, 17 – Ozzano dell’Emilia (BO)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via G. Bruzzo, 4 – Genova
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Viale D. Zaccagna, 37 – Avenza (MS)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Zona Industr. Loc. Tossillo – Macomer (NU)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Vitorchiano, 99 – Roma
NIPPON GASES INDUSTRIAL S.r.l. – Via Pacinotti, 8 – Messina
NIPPON GASES PHARMA SUD Srl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate Case Rosse – Zona ASI – Salerno
NIPPON GASES INDUSTRIAL S.r.l. – Via Strada regionale Casilina 6, n.114 – Anagni (FR)
NIPPON GASES PHARMA S.r.l. – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA S.r.l. – Via Martino della Torre, 16 – Novara
NIPPON GASES PHARMA S.r.l. – Via Circumvallazione esterna – Melito di Napoli (NA)
* In the FI mock-up implemented in production, only the manufacturing site responsible for batch release will be indicated.

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

Precautions for Use

Oxygen must be administered with caution, with adjustments based on 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 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 insufficiency where hypoxia provides the respiratory drive. In such cases, treatment must be carefully monitored by measuring arterial oxygen tension (PaO₂), or via pulse oximetry (arterial oxygen saturation – SpO₂), along with clinical assessment.

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 alveoli faster than it is replenished by ventilation, alveolar collapse (atelectasis) may occur. This impairs arterial blood oxygenation, as gas exchange cannot 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.

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, thoracic wall deformities, neuromuscular disorders, or respiratory depressant drug overdose). Administration of supplemental oxygen may cause respiratory depression and increased PaCO₂, leading to symptomatic respiratory acidosis (see section 4.8). In these patients, oxygen therapy must be carefully titrated; the target oxygen saturation may be lower than in other patients, and oxygen should be administered at low flow rates.

Special Precautions in Patients with Bleomycin-Induced Lung Injury

Pulmonary toxicity from high-dose oxygen therapy may exacerbate lung injury, even years after the initial bleomycin-induced lung damage. The target oxygen saturation in these patients may need to be lower than in others (see section 4.5).

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 full-term and premature infants, oxygen concentrations above 30–40% may cause adverse effects such as retrolental fibroplasia, chronic lung disease, and intraventricular haemorrhage. 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 such cases, the lowest effective oxygen concentration should be administered, and arterial oxygen pressure should be closely monitored and maintained below 13.3 kPa (100 mmHg). In preterm and full-term neonates, increased PaO₂ may lead to retinopathy of prematurity (see section 4.8), 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 saturation 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 the risk/benefit ratio in the following conditions:

Recurrent otitis and/or sinusitis, laryngocele, mastoid cavities, vestibular syndrome, hearing loss, or recent middle ear surgery
Ischemic and/or congestive heart disease; in patients with acute coronary syndrome or acute myocardial infarction requiring hyperbaric therapy (e.g., for CO poisoning), hyperbaric treatment should be performed cautiously due to potential hyperoxic vasoconstriction in the coronary circulation
Untreated arterial hypertension
Restrictive and/or severely restrictive pulmonary diseases
Glaucoma, retinal detachment (even if surgically treated) (compensation maneuvers)
History of seizures or 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 hyperglycaemia. Blood glucose monitoring between hyperbaric therapy sessions may be considered.

Respiratory Disorders

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 may lead to tension pneumothorax.

Furthermore, considering the risk of gas expansion during decompression in hyperbaric therapy, the benefit/risk ratio must be carefully evaluated in patients with poorly controlled asthma, pulmonary emphysema, chronic obstructive bronchopulmonary disease (COPD), or recent thoracic surgery.

Special Warnings

In hyperoxygenated environments, oxygen may saturate clothing.
Cylinders must not be used if visibly damaged or if damage is suspected, or if they have been exposed to extreme temperatures.
Only oxygen-compatible and suitable equipment 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.
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 of empty cylinders must remain closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. Therefore, special precautions are required for handling and storage of containers.
Pressurized gas administration is not permitted.

Only for OSSIGENO MAGALDI LIFE CRYOGENIC MEDICINAL GAS

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 contacts skin or eyes, affected areas must be washed with abundant cold water or cold compresses applied; immediate medical assistance must be sought.

Dosage, Route, and Duration of Administration

Oxygen (compressed or cryogenic) is administered via inhaled air, preferably using dedicated devices (e.g., nasal cannula or facial mask); dosing is independent of the medicinal gas packaging and is delivered via dosing devices (flowmeters).

With these systems, oxygen is delivered through inspired air, while expired gas and excess oxygen exit the patient's inspiratory circuit and mix with ambient air (open system or anti-rebreathing system).

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

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

Numerous oxygen delivery devices exist, classified as:

Low-flow systems: The simplest method for delivering an oxygen-air mixture to inspired air; an example is 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 stable, constant oxygen concentrations unaffected/diluted by ambient air; examples include Venturi masks, where, once 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, as needed.
Hyperbaric oxygen therapy: Performed in a specially designed pressurized chamber capable of maintaining pressures up to three times atmospheric pressure. Hyperbaric oxygen therapy may also be administered via a tightly sealed mask, helmet, or endotracheal tube.

Normobaric Oxygen Therapy

Normobaric oxygen therapy refers to 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 insufficiency, oxygen may be administered via spontaneous ventilation using nasal cannulas, nasopharyngeal catheters, or suitable masks. In patients with respiratory insufficiency or under anaesthesia, 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 the pressure gauge. Multiplying the gauge reading by the cylinder volume (in litres) gives the remaining oxygen volume available.

(Example: Approximate content calculation: a cylinder with a 10-litre capacity showing 200 bar on the gauge contains 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 insufficiency: administer oxygen at a flow rate of 0.5–2 litres/minute, adjustable according to blood gas analysis.
Patients with acute respiratory insufficiency: administer oxygen at a flow rate of 0.5–15 litres/minute, adjustable according to 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 haemoglobin 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 necessary to achieve the desired therapeutic effect, i.e., normal PaO₂ values. In cases of severe hypoxemia, FiO₂ levels that pose a potential risk of oxygen toxicity may be indicated.

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

In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should 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) when possible.

Short-term oxygen therapy must be monitored via repeated arterial blood gas measurements (PaO₂) or transcutaneous oximetry providing a numerical value of haemoglobin oxygen saturation (SpO₂). In any case, these indices are only indirect measurements of tissue oxygenation. Clinical evaluation of treatment is of paramount importance. For long-term treatment, the need for supplemental oxygen must be determined from arterial blood gas values. To avoid excessive carbon dioxide accumulation, blood oxygen levels must be monitored to adjust oxygen therapy in patients with hypercapnia.

Low oxygen concentrations must be used in patients with respiratory insufficiency where hypoxia provides the respiratory drive (e.g., in COPD). The oxygen concentration in inhaled air must 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%.

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 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.

The duration of sessions in a hyperbaric chamber at pressures 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, following standard procedures, to avoid barotrauma to air-containing anatomical cavities communicating with the external environment.

Hyperbaric oxygen therapy must be performed by qualified personnel trained in this treatment.

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 falls.

Strictly follow these instructions:

Carefully read the container (package) instruction and user manual.
Ensure 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 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 of grease or oil.
Lift and move cylinders only using the appropriate trolley; never lift a cylinder by its valve.
Use connectors, connecting tubes, or hoses specifically designed and compatible with oxygen.
Particular attention must be paid to securing pressure reducers to cylinders, especially if not integrated into the container closure system, to prevent accidental breakage.
Absolutely no intervention of any kind is permitted on 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.
Absolutely do not handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments.
Absolutely do not touch frozen parts (for cryogenic containers).

General Instructions for Use

Cylinders equipped with only a shut-off valve

Remove the protective cap, if present
Ensure the delivery valve is closed
Remove the tamper-evident seal
Connect the pressure reducer to the cylinder valve and 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)

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)

NOTE: FOR FURTHER DETAILS, CONSULT THE CONTAINER USER MANUAL
ATTENTION

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; always stand to the side. Do not expose yourself or the patient to direct gas flow.
Do not use oil or grease in contact with the gas.
Do not completely empty the container.
After use, close the cylinder valve.
In case of gas leakage, close the valve and notify the technical support service indicated in the container user manual.
Use only containers suitable for the product and intended operating pressure and temperature.

During Use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames near the container.
Do not use any 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 only partially empty, to the supplier. Any residual medicinal product in the pressurized cylinder will be eliminated via appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling.
Unused medicinal product and waste derived from this medicinal product must be disposed of in accordance with current local regulations.

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 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.