Package leaflet: Information for the patient

OXYGEN SIAD 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

Oxygen
Please read this leaflet carefully before you are administered 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, pharmacist or nurse.
If you experience any side effects, including those not listed in this leaflet, tell your doctor, pharmacist or nurse. See section 4.

Contents of this leaflet:

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

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

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

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

2. What you should know before being administered Ossigeno SIAD

You will not be administered Ossigeno SIAD 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, shortness of breath (also called dyspnea), or a feeling of fatigue (COPD)
you suffer from lung inflammation (Pneumocystis carinii pneumonia)
you suffer from a condition characterized by uncontrolled 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 suffer from high levels of acid in the blood (acidosis)
you are taking medications to treat tumors such as doxorubicin, adriamycin, daunorubicin, bleomycin, cis-platinum (see section Other medicines and Ossigeno SIAD),
you are taking medications to treat inflammation such as corticosteroids (see section Other medicines and Ossigeno SIAD),
you are taking a medication to treat alcohol dependence (disulfiram - see section Other medicines and Ossigeno SIAD),
you consume alcohol,
you have recently been exposed to toxic substances (aromatic hydrocarbons),
you smoke or take medications to help quit smoking containing nicotine
the newborn was premature

Warnings and precautions
Consult your doctor or pharmacist before being administered Ossigeno SIAD.
Before starting oxygen therapy (not in a hyperbaric chamber), you should know the following:

if you have respiratory problems such as chronic obstructive bronchopulmonary disease (COPD) or cystic fibrosis,
if you have severe obesity,
if you have a chest deformity,
if you have muscle problems due to nervous system disorders (neuromuscular disorders),
in case of overdose of medications that depress breathing, your doctor will advise you to use low oxygen flows, as high flows may cause breathing problems (respiratory depression).

Inform your doctor:

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 gland disease, a neck gland that is overactive (hyperthyroidism)
if you suffer from a deficiency of vitamin C and/or vitamin E or of 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 take medications to treat epilepsy (barbiturates) and/or pain (opioids).

Also inform your doctor if:

you have recently undergone an X-ray.

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

you have ear problems such as ear inflammation (otitis), vestibular syndrome (a disease causing dizziness and balance problems), mastoid cavities, hearing loss, or if you have previously undergone surgery on the middle ear
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 diseases)
you suffer from high blood pressure and are not taking medications to treat it (untreated arterial hypertension)
you suffer from lung diseases that prevent air passage (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 previously had seizures, sometimes even with loss of consciousness (epileptic seizures)
you have uncontrolled high fever despite therapy
you suffer from severe anxiety or altered perception of reality (psychosis), fear of confined or enclosed spaces (claustrophobia)
respiratory system disorders (poorly controlled asthma, pulmonary emphysema, chronic obstructive bronchopneumopathy (COPD)), or recent thoracic surgery.

Safety precautions
During use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames near the packaging.
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 any material in contact with oxygen.
Never introduce oxygen into a device that might contain materials that could catch fire, particularly greasy substances.

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

Ossigeno SIAD and alcohol
Do not consume alcohol during treatment with Ossigeno SIAD, as oxygen may worsen respiratory depression (difficulty breathing) caused by alcohol.

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

Pregnancy
Normobaric oxygen therapy
Ossigeno SIAD will be administered during pregnancy only if necessary.

Hyperbaric oxygen therapy
Ossigeno SIAD will not be administered in a hyperbaric chamber during the first 3 months of pregnancy.

Breastfeeding
Ossigeno SIAD may be used during the breastfeeding period.

Driving and using machines
Normobaric oxygen therapy
OSSIGENO SIAD does not affect, or affects only to a negligible extent, the ability to drive vehicles and use machines.
Avoid driving vehicles and using machines until any adverse effects on attention and vigilance have completely disappeared.

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

3. How Ossigeno SIAD will be administered to you

This medicine will be administered to you via the inhaled air, always following exactly the instructions given by your doctor or nurse. If you have any doubts, consult your doctor.
Ossigeno SIAD 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 SIAD, your doctor may perform measurements of blood gases (oxygen and carbon dioxide) in arterial blood and will monitor levels of oxygen bound to haemoglobin, a protein that carries oxygen in the blood.

If you are given more Ossigeno SIAD than you should receive
It is very unlikely that you will be given more Ossigeno SIAD than required, as your doctor or nurse will monitor you during treatment.
Symptoms of an overdose 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,
nausea, dizziness,
anxiety, irritability and confusion,
muscle cramps and spasms,
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 acid levels in the blood in patients at risk of high carbon dioxide concentration in the blood (hypercapnic respiratory failure).

Treatment
If you are given excessive doses, your doctor will 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.
The following are the side effects associated with Ossigeno SIAD.

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

Eye damage (retinopathy of prematurity)

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

Pulmonary toxicity characterized by:
- Airway infection characterized by pain beneath the sternum and dry cough (tracheobronchitis)
- Accumulation of fluid occurring in the tissues lining the lung alveoli (interstitial edema)
- Respiratory disease characterized by the formation of scar tissue replacing normal lung tissue (pulmonary fibrosis)
Increased carbon dioxide levels in the blood (hypercapnia), leading to:
- Reduced ventilation (hypoventilation)
- Increased acid levels in the blood (respiratory acidosis)
- Respiratory arrest
Dryness and irritation of mucous membranes (sinus congestion or blockage with pain and bleeding)
Local irritation and inflammation of the mucosa

Other reported side effects:

Mild reduction in heart rate and cardiac output
Small areas of the lung not receiving air (atelectasis)
Lung injury
Dryness and irritation of the eyes
Slowed clearance of nasal secretions

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

Ear pain
Progressive myopia
Tissue injury 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, gas release from the intestine (flatulence), and colic pain.

Common (may affect up to 1 in 10 people)

Uncontrollable body movements (convulsions)

Uncommon (may affect up to 1 in 100 people)

Tympanic membrane perforation

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

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

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

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

Contact with liquid oxygen (contained in Ossigeno SIAD 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 website 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 SIAD

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 SIAD Contains

The active substance is oxygen

Description of the Appearance of Ossigeno SIAD and Package Contents
Compressed medicinal gas
OSSIGENO SIAD compressed medicinal gas is supplied in cylinders and cylinder packs, in a compressed
gaseous state at 200 bar and 15°C. The cylinders are made of steel or aluminum alloy, fitted with valves
compatible with a pressure reducer or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO SIAD cryogenic medicinal gas is supplied in fixed cryogenic containers.
Available pack sizes:
Compressed medicinal gas
Steel cylinders with valve, 40, 50 litres; aluminum cylinders with valve, 40 litres; cylinder packs of 12,
16, 25 cylinders of 40 litres and packs of 16 cylinders of 50 litres.
Cryogenic medicinal gas
Fixed cryogenic containers of 800, 1500, 2000, 3000, 5000, 6000, 10,000, 12,000, 15,000, 20,000,
30,000 litres.
Not all pack sizes may be commercially available.

Marketing Authorization Holder
SOCIETA' ITALIANA ACETILENE & DERIVATI "S.I.A.D." S.p.A.
Via S. Bernardino, 92
Bergamo

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 Srl – 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 Srl – Via Strada regionale Casilina 6, n.114 – Anagni (FR)
NIPPON GASES PHARMA Srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA Srl – Via Martino della Torre, 16 – Novara

Cryogenic medicinal gas (fixed containers)
Sol Gas Primari Srl – Via Firmio Leonzio, 2 – 84100 – Salerno
Air Liquide Italia Produzione srl – S.S. 195, km 17.200 – 09018 – Sarroch (CA)
Air Liquide Italia Produzione srl – Via Dante s.n.c. – 20090 – Pioltello (MI)
Chemgas srl – Via E. Fermi – 72100 – Brindisi
Linde Gas Italia srl – Via Turati, 18/a – 40010 – Sala Bolognese (BO)
Linde Gas Italia srl – Via di Servola, 1 – 34100 – Trieste
Linde Gas Italia srl – Viale Brin 218, 05100 Terni
Sapio Produzione Idrogeno Ossigeno srl – Via Senatore Simonetta, 27 – 20040 – Caponago (MI)
Sapio Produzione Idrogeno Ossigeno srl – Via Malcontenta, 49 (locality Porto Marghera) – 30175 –
Venezia
NIPPON GASES Operations Srl – Via Glair, 30 – 11029 – Verres (AO)
NIPPON GASES Operations Srl – Via Baiona, 107/111 – 48100 – Ravenna
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – S.S. del Brembo, 1 – 24040 – Osio Sopra (BG)
IGAT Ind. Gas Tecnici S.p.A. – S.S. Appia km 192.500 – Pignataro Maggiore (CS)

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 should be administered to maintain arterial oxygen pressure at 8 kPa (60 mmHg).
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 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 insufficiency in whom the
respiratory drive is stimulated by hypoxia. In such cases, treatment must be closely monitored by
measuring arterial oxygen tension (PaO₂), or via pulse oximetry (arterial oxygen saturation – SpO₂) and
clinical assessment.

Administering oxygen to patients with drug-induced respiratory insufficiency (opioids, barbiturates) or
chronic obstructive pulmonary disease (COPD) may further worsen respiratory failure due to
hypercapnia caused by elevated carbon dioxide levels in the blood, which counteracts receptor effects.

High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure.
This also reduces nitrogen levels in tissues and lungs (alveoli). If oxygen is absorbed into the blood
through alveoli faster than it is supplied via ventilation, alveoli may collapse (atelectasis). This may
impair arterial blood oxygenation, as gas exchange does not occur despite perfusion.

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

Patients at Risk of Hypercapnic Respiratory Failure
Special precautions must be taken in patients with reduced sensitivity to arterial blood carbon dioxide
pressure or at risk of hypercapnic respiratory failure ("hypoxic drive") (e.g., patients with chronic
obstructive bronchopulmonary disease (COPD), cystic fibrosis, morbid obesity, 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 toxicity, even when administered several years
after initial lung injury caused by bleomycin. The target oxygen saturation may need to be lower than
in other patients.

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

In term and preterm neonates, oxygen administration at concentrations exceeding 30–40% may cause
adverse effects such as retinopathy of prematurity, 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 should be
closely monitored, and maintained below 13.3 kPa (100 mmHg).

It is recommended to initiate resuscitation of term or near-term neonates with air rather than 100%
oxygen. In preterm neonates, the optimal oxygen concentration and target are not precisely defined. If
needed, supplemental oxygen should be carefully monitored and guided by pulse oximetry.

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 visibly damaged, suspected of damage, or 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 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.

For cryogenic formulation
Cold burns from direct contact with liquid oxygen (limited to cryogenic formulations)
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
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.

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

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

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, categorized as follows:

Low-flow systems: The simplest method for delivering an oxygen-air mixture; an example is a system where oxygen is delivered via a flowmeter connected to a nasal catheter or face 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, in emergencies.
Hyperbaric oxygen therapy: Performed in a specially designed pressurized chamber where pressure can be maintained up to three times atmospheric pressure. Hyperbaric oxygen therapy may also be administered via a tightly sealed mask, helmet, or endotracheal tube.

Normobaric Oxygen Therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than
atmospheric air, containing an inspired oxygen fraction (FiO₂) greater than 21%, at a partial pressure
between 0.21 and 1 atmosphere (0.213 and 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 contain a maximum internal pressure of approximately 150–200 bar. Pressure is
regulated by a reducer and indicated on the pressure gauge. Multiplying the pressure gauge reading by
the cylinder's volume in litres gives the remaining oxygen quantity in the cylinder.

(Example: Approximate 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 insufficiency: administer oxygen at a flow rate of 0.5 to 2
litres/minute, adjustable based on blood gas analysis.
Patients with acute respiratory insufficiency: 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 rise up to 100%.

The therapeutic goal of oxygen therapy is to ensure 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., PaO₂ values within normal range. In cases of severe hypoxaemia, FiO₂ values that may
carry a potential risk of oxygen toxicity may be indicated.

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

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

Short-term oxygen therapy should be monitored by 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 assessment
of treatment is of paramount importance.

For long-term treatment, the need for supplemental oxygen must be determined by arterial blood gas
measurements. To avoid 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 insufficiency in whom the
respiratory drive is stimulated by hypoxia (e.g., due to COPD). Inspired oxygen concentration should
not exceed 28%; in some patients, even 24% may be excessive.

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

Neonates may receive 100% oxygen when needed. However, careful monitoring during treatment is
required. It is recommended to avoid oxygen concentrations exceeding 40% to reduce the risk of
lens damage or pulmonary collapse. Arterial blood oxygen pressure (PaO₂) 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 according to standard procedures to
avoid barotrauma risk to air-containing anatomical cavities communicating with the outside.

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

Instructions for Use and Handling
Medicinal oxygen cylinders, as well as fixed and mobile cryogenic containers, are intended exclusively
for containing/transporting oxygen for inhalation, for therapeutic use.

Cylinders and mobile cryogenic containers (Base Units) must be transported using appropriate means
to protect them from impact and 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 and base units in an upright position to prevent falls; protect containers from impacts 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 using the appropriate trolley only; never lift a cylinder by its 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, if not already integrated into the container closure system, to avoid risks of accidental breakage.
Absolutely no intervention of any kind is permitted on container connectors, delivery equipment, or related 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 strictly forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or various ointments.
Contact with frozen parts (for cryogenic containers) is strictly prohibited.

General Instructions for Use
Cylinders equipped with simple 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)

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 position yourself in front of the gas outlet of the tap/valve, but always on the opposite side. Do not expose yourself or the patient to 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 intervention service of the supplier indicated in the container's 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.
No electrical equipment capable of producing 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 same container.

Observe all applicable rules for the use and handling of pressurized cylinders and containers containing cryogenic liquids.
Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C, in well-ventilated areas or well-ventilated sheds, avoiding formation of 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.
Fixed cryogenic containers installed at healthcare facilities must be placed outdoors.

Patient information leaflet

OXYGEN SIAD 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

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

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

Contents of this leaflet:

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

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

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

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

2. What you need to know before using Ossigeno SIAD

Do not use Ossigeno SIAD
Under normal conditions, there are no absolute contraindications.
Warnings and precautions
Talk to your doctor or pharmacist before using Ossigeno SIAD.
Before starting oxygen therapy, you should be aware of the following:

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),
in case of overdose of medications that depress breathing, your doctor will advise you to use low oxygen flow rates, as high flow rates may cause breathing problems (respiratory depression).

Inform your doctor:

if you have previously had lung problems caused by bleomycin (a medicine used to treat certain types of tumors);
if you suffer from a thyroid disease, a neck gland that is overactive (hyperthyroidism);
if you suffer from a deficiency of vitamin C and/or vitamin E or of 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 medicines for epilepsy (barbiturates) and/or pain (opioids).

Additionally, inform your doctor if:

you have recently undergone an X-ray examination.

Safety precautions
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 that may produce 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 might contain materials that could catch fire, particularly greasy substances.

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 Ossigeno SIAD
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. 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 microbial infections;
antibiotics (e.g. actinomycin, 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.

Ossigeno SIAD and alcohol
Do not consume alcohol during treatment with Ossigeno SIAD, as oxygen may worsen respiratory depression (difficulty breathing) caused by alcohol.
Pregnancy and breastfeeding
If you are pregnant, think you may be pregnant, are planning a pregnancy, or are breastfeeding, consult your doctor or pharmacist before taking this medicine.
Pregnancy
Ossigeno SIAD may be used during pregnancy only when necessary.
Breastfeeding
Ossigeno SIAD may be used during breastfeeding.
Driving and using machines
Ossigeno SIAD does not affect, or affects only to a negligible extent, the ability to drive and use machines.
Avoid driving and operating machinery until any negative effects on attention and vigilance have completely disappeared.

3. How to use Oxygen SIAD

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

If you use more Oxygen SIAD than you should
If you use more Oxygen SIAD than recommended, contact your doctor or go to hospital immediately.
Symptoms of an overdose may include:

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

Treatment
If you have used excessive doses, your doctor will administer appropriate treatment 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 everybody experiences them.
The following are the side effects reported for Ossigeno SIAD.:

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

Eye damage (retinopathy of prematurity)

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

Pulmonary toxicity characterized by:
( respiratory tract infection associated with pain on breathing and dry cough (tracheobronchitis),
( presence of fluid in the lungs (interstitial edema),
( respiratory disease characterized by formation of scar tissue replacing normal lung tissue (pulmonary fibrosis)
Increased carbon dioxide in the blood (hypercapnia), leading to:
( increased acidity in the blood (respiratory acidosis),
( reduced ventilation (hypoventilation),
( respiratory arrest
Dryness and irritation of mucous membranes (sinus congestion or obstruction with pain and bleeding)
Local irritation and inflammation of the mucosa

Other reported side effects:
( mild reduction in heart rate and strength of heartbeat (cardiac output)
( small areas of the lung not receiving air (atelectasis)
( lung injury
( dryness and irritation of the eyes
( slowed clearance of nasal secretions

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

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 website 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 Oxygen SIAD

Store cylinders and mobile cryogenic containers at temperatures between -10°C and 50°C.
Keep this medicinal product out of sight and reach of children.
Do not use this medicinal product after the expiry date stated on the label after EXP. The expiry date refers to the last day of that month.
Do not dispose of any medicinal product 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 SIAD Contains

The active substance is oxygen.

Description of the Appearance of Ossigeno SIAD and Package Contents
Compressed medicinal gas
OSSIGENO SIAD compressed medicinal gas is supplied in cylinders in compressed gaseous form at 200 bar and 15°C. The cylinders are made of steel or aluminum alloy and are equipped with valves compatible with pressure regulators or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO SIAD cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).
Available pack sizes:
Compressed medicinal gas
Steel cylinders with vi or vp valves: 0.74, 1, 1.34, 2, 3, 4, 5, 7, 10, 14, 18, 20, 27, 30 liters;
Steel cylinders with integrated pressure-reducing valves: 0.74, 1, 1.34, 2, 3, 4, 5, 7, 10, 14, 27 liters;
Aluminum cylinders with vi or vp valves: 1, 2, 5, 7, 10, 14, 15, 20 liters;
Aluminum cylinders with integrated pressure-reducing valves: 1, 2, 5, 7, 10, 14, 15 liters.
Cryogenic medicinal gas
Mobile cryogenic container: 10.7, 31, 41 liters.
Not all pack sizes may be marketed.

Marketing Authorization Holder
SOCIETA' ITALIANA ACETILENE & DERIVATI "S.I.A.D." S.p.A.
Via S. Bernardino, 92
Bergamo

Manufacturer
Compressed medicinal gas 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 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 Srl – 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 Srl – Via Strada regionale Casilina 6, n.114 – Anagni (FR)
NIPPON GASES PHARMA Srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES PHARMA Srl – Via Martino della Torre, 16 – Novara
Cryogenic medicinal gas (mobile containers)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Andorra, 13/15 Loc. Camin – Padova

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 insufficiency in whom the respiratory drive is stimulated by hypoxia. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), or via pulse oximetry (arterial oxygen saturation – SpO₂), along with clinical assessment. Administering oxygen to patients with drug-induced respiratory insufficiency (e.g., opioids, barbiturates) or chronic obstructive pulmonary disease (COPD) may further worsen respiratory failure due to hypercapnia caused by elevated carbon dioxide levels in the blood, which overrides receptor stimulation.

High oxygen concentrations in inhaled air or gas reduce nitrogen concentration and partial pressure. This also reduces nitrogen levels in tissues and 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 cannot occur despite adequate perfusion.

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

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

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

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

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, administering oxygen at concentrations above 30–40% may cause adverse effects such as retinopathy of prematurity, chronic lung disease, and intraventricular hemorrhage. 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 should be closely monitored, and maintained below 13.3 kPa (100 mmHg).

It is recommended to initiate resuscitation of term or near-term newborns with air rather than 100% oxygen. In preterm neonates, the optimal oxygen concentration and target oxygenation 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.
Contact with frozen parts (for cryogenic containers) is strictly prohibited.
Cylinders and mobile cryogenic containers must not be used if visibly damaged, suspected of damage, or 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 of empty cylinders must remain closed.
Oxygen has a strong oxidizing effect and may react violently with organic substances. Therefore, handling and storage of containers require special precautions.
Depressurization of gas under pressure is not permitted.

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

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

Normobaric Oxygen Therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air, i.e., with an inspired oxygen fraction (FiO₂) exceeding 21%, at a partial pressure between 0.21 and 1 atmosphere (0.213 and 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 anesthesia, 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 liters gives the amount of oxygen remaining in the cylinder.

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

Instructions for Use and Handling
Medicinal oxygen cylinders and 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 (packaging).
Ensure all equipment is in good condition.
Secure cylinders and base units in an upright position to prevent falls; protect containers from impact and keep them at temperatures below 50°C, 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.
Lift and move cylinders and base units only using the appropriate trolley; never lift a cylinder by its valve.
Use connectors, tubing, or hoses specifically designed and compatible with oxygen.
Special attention must be paid 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 CATCH FIRE ON CONTACT WITH OXYGEN).
Do not lubricate or attempt to repair defective valves/taps.
It is strictly forbidden 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 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 (liters/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 (liters/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 (liters/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 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 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 compatible with the intended pressure and temperature conditions.

During Use

Do not use greasy creams or lipsticks.
Do not smoke.
Do not bring open flames near the container.
No electrical equipment capable of producing sparks should be used near patients receiving oxygen.
Do not 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 safely eliminated through appropriate procedures in a well-ventilated area by the company responsible for refilling the 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 the formation of hyperoxic 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.

Oxygen Siad

Package leaflet: Information for the patient

OXYGEN SIAD 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

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

2. What you should know before being administered Ossigeno SIAD

3. How Ossigeno SIAD will be administered to you

4. Possible side effects

5. How to store Ossigeno SIAD

6. Package Contents and Other Information

Patient information leaflet

OXYGEN SIAD 200 BAR COMPRESSED MEDICINAL GAS, CRYOGENIC MEDICINAL GAS

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

2. What you need to know before using Ossigeno SIAD

3. How to use Oxygen SIAD

4. Possible side effects

5. How to store Oxygen SIAD

6. Package Contents and Other Information