Oxygen Vitalaire

Patient Information Leaflet

OXYGEN VITALAIRE 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor, pharmacist or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

1. What Oxygene Vitalaire is and what it is used for
2. What you need to know before being administered Oxygene Vitalaire
3. How Oxygene Vitalaire will be administered to you
4. Possible side effects
5. How to store Oxygene Vitalaire
6. Contents of the pack and other information

1. What Ossigeno Vitalaire is and what it is used for

Ossigeno Vitalaire contains oxygen, a gas naturally present in the air we breathe.
Medical oxygen increases the amount of oxygen in the blood and its distribution to all body tissues.
Ossigeno Vitalaire is indicated in patients of all ages:

• for the treatment of acute and chronic respiratory insufficiency

2. What you should know before being administered Ossigeno Vitalaire

Do not use OSSIGENO VITALAIRE
There are no absolute contraindications.
Warnings and precautions
Talk to your doctor or pharmacist before using OSSIGENO VITALAIRE.
Before starting oxygen therapy, you should be aware of the following:

• Oxygen may have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), which will impair oxygen delivery to the blood.
• If you have severe chronic obstructive pulmonary disease (COPD) leading to impaired blood oxygenation, cystic fibrosis, morbid obesity, chest wall deformity, neuromuscular disorders, respiratory depression due to drug overdose, administration of supplemental oxygen may cause respiratory problems. In these cases, the oxygen concentration and oxygen flow rate will be low. Your doctor will adjust the oxygen flow rate of the oxygen therapy accordingly.
• If you have pulmonary lesions due to bleomycin, high-dose oxygen therapy may enhance lung injury, even if administered several years later.
• Adverse events may occur in newborns and preterm infants, such as eye damage. If your baby requires extra oxygen, your doctor will determine the appropriate oxygen concentration to administer.

Advice regarding increased risk of fire in the presence of oxygen:

• Oxygen is an oxidizing agent and promotes combustion. In areas where OSSIGENO VITALAIRE is used, there must be no sources of heat, smoking, or open flames (e.g., pilot lights, stoves, ovens, gas heaters, sparks, candles), as this increases the risk of fire.
• Do not smoke in the environment where oxygen therapy is being administered.
• Do not use electrical devices during your oxygen treatment.
• In oxygen-enriched environments, oxygen may saturate clothing.
• Do not apply oily substances (e.g., oils, creams, lotions) to surfaces in contact with oxygen. Only water-based products should be used on hands, face, or inside the nose.
• Do not use pliers or other tools to open or close the cylinder valve, to prevent the risk of damage.
• The pressure regulator should be opened slowly and carefully to avoid the risk of sudden ignition.
• 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 safe outdoor location to allow oxygen to escape freely.
• Always keep valves of empty cylinders closed.

Thermal burns related to accidental fire have occurred in the presence of oxygen.
Advice for caregivers:

• Handle the cylinder carefully. Ensure that the gas cylinder is not dropped or subjected to impact.
• Damage to equipment may cause blockage of the outlet and/or incorrect readings on the pressure gauge regarding residual oxygen content and flow, leading to insufficient or absent oxygen delivery.
• Oxygen becomes liquid at approximately -183°C. At such low temperatures, there is a risk of frostbite. Always wear gloves and protective goggles when handling liquid medical oxygen. 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.

Children
In newborns and preterm infants, oxygen therapy may lead to eye damage (retinopathy of prematurity). Your doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your baby.
Other medicines and Ossigeno Vitalaire
Inform your doctor or pharmacist if you are taking or have recently taken 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 cancer,
• antimicrobial agents (e.g., nitrofurantoin), medicines used to treat bacterial infections,
• antineoplastic antibiotics (e.g., adriamycin, 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 received treatment for paraquat poisoning (a herbicide),
• you have hyperthyroidism or deficiency in vitamin C, vitamin E, or glutathione (an antioxidant substance), as these may increase oxygen toxicity.

Ossigeno Vitalaire 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 using this medicine.
OSSIGENO VITALAIRE may be used during pregnancy, but only if necessary. Inform your doctor if you are pregnant or suspect you may be pregnant.
OSSIGENO VITALAIRE may be used during breastfeeding.
Driving and using machines
Ossigeno Vitalaire does not affect, or has a negligible effect on, the ability to drive vehicles and operate machinery. Consult your doctor before driving or operating machinery.

3. How Vitalaire Oxygen will be administered to you

This medicine will be administered to you through the inhaled air, always following exactly the instructions given by your doctor or nurse. If you have any doubts, consult your doctor.
Vitalaire Oxygen is usually inhaled through the nose and mouth using a nasal cannula or a face mask.
Your doctor will determine the dose based on your health condition.
During treatment with Vitalaire Oxygen, 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 use more Vitalaire Oxygen than you should If you use more Vitalaire Oxygen than you should, contact your doctor or go to hospital immediately.
An excessive dose of Vitalaire Oxygen may affect respiratory function (substernal pain, dry cough, interstitial edema, pulmonary fibrosis, shortness of breath) and, in exceptional cases, cause neurological adverse effects that could lead to loss of consciousness in extreme situations. If these signs of overdose occur, always contact your doctor or the nearest hospital.
In premature infants, eye problems (retinopathy) may occur.

4. Possible side effects

Like all medicines, OSSIGENO VITALAIRE can cause side effects, although not everyone experiences them.
Pay attention if the following adverse reactions occur:
After approximately 4 hours of exposure to 95% oxygen at ambient atmospheric pressure, tracheobronchitis, substernal pain, and dry cough may appear. Exposure to 100% oxygen may lead to a reduction in total volume of expired air after 8-12 hours of exposure, but serious injuries require much longer exposure times.
Inhalation of high concentrations of oxygen can cause lung collapse (atelectasis) due to decreased nitrogen in the alveoli, thereby compromising oxygen delivery to the blood.
Administration of excessively high oxygen concentrations may cause respiratory depression in cases of severe chronic obstructive pulmonary disease (COPD) or when taking medications that depress respiration (opioids, barbiturates).

Listed below are the side effects of Ossigeno Vitalaire:
Very common (may affect more than 1 in 10 people):
Retinopathy in premature infants

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

• Respiratory-related pain and dry cough, interstitial edema, pulmonary fibrosis
• Worsening of hypercapnia (excess carbon dioxide in body fluids, particularly in the blood) with hypoventilation, respiratory acidosis, respiratory arrest
• Dryness of the mucosa; local irritation and inflammation of the mucosa

Oxygen administration may cause a slight reduction in heart rate and cardiac output.
Contact with liquid oxygen causes cold burns.

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 through 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 Vitalaire Oxygen

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 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 required. This will help protect the environment.

6. Package contents and other information

What Ossigeno VITALAIRE contains

• The active substance is oxygen.

Description of the appearance of Ossigeno VITALAIRE and contents of the pack
Compressed medicinal gas
OSSIGENO VITALAIRE compressed medicinal gas is supplied in cylinders in compressed gaseous form at 200 bar at 15°C. The cylinders are made of steel or aluminum alloy and are equipped with valves suitable for connection to a pressure regulator or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO VITALAIRE cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas
Steel cylinders with valve of 2, 5, 7, 11, 14, 20, 27 litres; aluminum cylinders with valve of 2, 5, 7, 11, 14 litres.
Cryogenic medicinal gas
Mobile cryogenic container of 20, 31, 32, 33, 36, 44 litres.
Not all pack sizes may be marketed.

Marketing Authorization Holder
VITALAIRE ITALIA S.p.A
Via Calabria, 31
20148 Milano

Manufacturer
Compressed medicinal gas
Air Liquide Sanità Service SpA - Via Lussemburgo 17 – 37135 Verona
Air Liquide Sanità Service SpA - Via Campobello, 7 – 00040 Pomezia (RM)
Cryogenic medicinal gas (mobile containers)
Air Liquide Sanità Service S.p.A. - Stradale Giovanni Agnelli, 10 – 95121 Catania
Air Liquide Sanità Service S.p.A. - Via Lussemburgo 17 – 37135 Verona
VITALAIRE Italia S.p.A. - Via della Stazione, 2 - 81030 Gricignano d’Aversa (CE)
VITALAIRE Italia S.p.A. - Viale F. de Blasio, 27 - 70100 Bari
VITALAIRE Italia S.p.A. - Via Masetti, 16 - 40069 Zola Predosa (BO)
VITALAIRE Italia S.p.A. - Via Sernagiotto 1 Z.I. Casic - 09034 Elmas (CA)
VITALAIRE Italia S.p.A. - SS 54, 53 – 33047 Remanzacco (UD)
VITALAIRE Italia S.p.A. - Via Edison, 50 - 20090 Trezzano sul Naviglio (MI)
VITALAIRE Italia S.p.A - Via della Fisica, 5 - 00065 - Fiano Romano (ROMA)
VITALAIRE Italia S.p.A. - Via Postiglione, 12 - 10024 Moncalieri (TO)
VITALAIRE Italia S.p.A. - Via N. Savarese, 27 – 90147 Palermo

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 used. Higher concentrations should be administered 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 may become toxic after two days at concentrations exceeding 40%.

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

High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also decreases 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 adequate perfusion.

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

Children
In newborns and premature infants, oxygen therapy may cause eye damage (retrolental fibroplasia). The risk of such damage can be reduced by appropriate selection of oxygen concentration by the physician.

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

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

Several oxygen delivery devices are available, classified as follows:

• Low-flow systems: The simplest method for delivering an oxygen-enriched mixture in inspired air. An example is a system where oxygen is delivered via a flowmeter connected to a nasal cannula or face mask.
• High-flow systems: Designed to provide the patient with a defined gas mixture meeting their total respiratory demand. These systems deliver stable and constant oxygen concentrations unaffected or diluted by ambient air. An example is Venturi masks, where, once the oxygen flow is set, the air inspired by the patient is enriched with a constant oxygen concentration.
• Demand valve systems: Designed to deliver 100% oxygen without mixing with ambient air. Intended for short-term use only, in emergency situations.

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 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 contain gas under a pressure of approximately 200 bar. This high pressure is regulated by a pressure reducer and can be read on the pressure gauge. Multiplying the gauge reading by the cylinder’s volume in litres gives the amount of oxygen remaining in the cylinder.

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

With assisted ventilation
The minimum FiO₂ is 21%, and it can be increased up to 100%. The therapeutic goal of oxygen therapy is to ensure that arterial oxygen partial pressure (PaO₂) is not below 8 kPa (60 mmHg) or that arterial hemoglobin oxygen saturation is not below 90%, achieved by adjusting the inspired oxygen fraction (FiO₂). The dose 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 may carry a potential risk of oxygen toxicity may be required. Continuous monitoring of therapy 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 be sufficient to maintain PaO₂ > 8 kPa, with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), while avoiding FiO₂ values > 0.6 (i.e., more than 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, which provides a numerical value of hemoglobin oxygen saturation (SpO₂). In any case, these parameters are only indirect indicators of tissue oxygenation. Clinical evaluation of treatment remains of paramount importance.

For long-term therapy, the need for supplemental oxygen must be determined based on arterial blood gas measurements. To prevent excessive carbon dioxide retention, blood oxygen levels must be monitored to allow proper adjustment of oxygen therapy in patients with hypercapnia. Low oxygen concentrations should be used in patients with respiratory failure in whom hypoxia is the main 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 remain at least 21%. In practice, concentrations below 30% are generally avoided. When necessary, the inhaled oxygen fraction may be increased up to 100%.

Instructions for use and handling
Medicinal oxygen cylinders and cryogenic containers are intended exclusively for the storage and transport of 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 falls.

Strictly follow these instructions:
Carefully read the instruction and user manual of the container (packaging) for further details.
Check 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. Ensure adequate ventilation in rooms where the product is used. Cylinders must be fitted with protective caps or bonnets to cover the valve.
Lift and handle cylinders and base units only with the appropriate trolley. Never lift a cylinder by its valve.
Use only oxygen-compatible, specific connectors, connecting tubes, or flexible hoses.
Particular care must be taken when attaching pressure reducers to cylinders, especially if not already integrated into the container closure system, to prevent accidental breakage.
Do not oil or attempt to repair defective valves or taps.
Oxygen liquefies at approximately -183°C. There is a risk of cold burns at such low temperatures. Always wear protective gloves and eye protection when handling medicinal liquid oxygen.

General Instructions for Use

Cylinders equipped with a shut-off valve only

1. Remove the protective cap, if present
2. Ensure that the delivery valve is closed
3. Remove the tamper-evident seal
4. Connect the pressure regulator to the cylinder valve and the corresponding flowmeter
5. Connect the humidifier/bubbler
6. Connect the cannula with mask or goggles to the humidifier
7. Slowly open the main valve completely
8. Adjust the flowmeter to the required flow rate (litres/minute)

Cylinders equipped with integrated pressure-reducing valve

1. Ensure that the valve is closed
2. Remove the tamper-evident seal
3. Ensure that the flow indicator is set to zero
4. Connect the humidifier/bubbler
5. Connect the cannula with mask or goggles to the humidifier
6. Slowly open the main valve completely
7. Adjust the flowmeter to the required flow rate (litres/minute)

Mobile cryogenic containers

1. Ensure that the flow indicator is set to zero
2. Remove the tamper-evident seal
3. Connect the humidifier/bubbler
4. Connect the cannula with mask or goggles to the humidifier
5. Set the flow regulator to the required flow rate (litres/minute)

WARNING
Open container closure systems (valve or tap) gradually to avoid pressure surges.
Do not force taps or valves when opening or closing.
Never stand in front of the gas outlet of the tap/valve, but always 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 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 of use.

Disposal
Keep empty cylinders with valves closed.
Do not discharge into sewers, basements, or excavations 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 eliminated, via appropriate procedures, in a well-ventilated area by the company responsible for subsequent refilling of the same container.
Observe all relevant rules concerning 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 in well-ventilated sheds, avoiding the formation of oxygen-enriched atmospheres (O₂ > 21% vol). Keep them upright with valves closed, 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. 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, appropriate for the specific container model.