Oxygen Nippon Gases

Italy
Brand name Oxygen Nippon Gases
Form gas, compressed
Active substance / Dosage
OXYGEN
Prescription type Prescription only
ATC code
V03AN01
Registration number 038944
Manufacturer NIPPON GASES PHARMA S.R.L.

Table of Contents

OXYGEN NIPPON GASES

Package leaflet: Information for the user

OXYGEN NIPPON GASES 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, 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 OXYGEN NIPPON GASES is and what it is used for
  2. What you need to know before using OXYGEN NIPPON GASES
  3. How to use OXYGEN NIPPON GASES
  4. Possible side effects
  5. How to store OXYGEN NIPPON GASES
  6. Contents of the pack and other information

1. What Ossigeno NIPPON GASES is and what it is used for

Ossigeno NIPPON GASES contains oxygen, a gas naturally present in the air we breathe. Medical oxygen increases the amount of oxygen reaching the lungs and consequently the tissues. Ossigeno NIPPON GASES is indicated:

  • for the treatment of respiratory disease (acute and chronic respiratory insufficiency),
  • for use in anaesthesia,
  • in intensive care therapy,
  • in hyperbaric chambers, which are rooms where the air pressure is higher than that in the atmosphere.

2. What you need to know before using OXYGEN NIPPON GASES

Normobaric oxygen therapy (administration of oxygen at atmospheric pressure levels) has no contraindications.
Hyperbaric oxygen therapy, which involves administering oxygen at a pressure higher than atmospheric pressure, must not be used if:

  • you suffer from bullous emphysema (you have air bubbles in the lungs),
  • you have advanced asthma (progressive constriction and inflammation of the bronchi),
  • you have or have previously had pneumothorax (accumulation of air in the pleural cavity (the space between the lungs and the pleura, a membrane surrounding the lungs)),
  • you suffer from chronic obstructive pulmonary disease (a chronic lung disease with inflammation and narrowing of the bronchi),
  • you suffer from Pneumocystis carinii pneumonia (a lung inflammation caused by a fungus),
  • the person to be treated is experiencing status epilepticus (very prolonged epileptic seizures or multiple closely spaced seizures),
  • you suffer from claustrophobia (fear of being in enclosed spaces),
  • you are undergoing treatment with certain drugs used to treat tumors, immune system disorders, or for managing alcohol and smoking withdrawal,
  • you are in the first 3 months of pregnancy and do not have a serious illness,
  • you have an upper respiratory tract infection (nose and throat),
  • you suffer from hyperthermia (elevated body temperature),
  • you suffer from hereditary spherocytosis (a red blood cell disorder, a type of blood cell disease),
  • you suffer from optic neuritis (a disease of the optic nerve),
  • you suffer from malignant tumors,
  • you are in a state of acidosis (accumulation of acids in the body),
  • you are taking medications to treat tumors such as doxorubicin, adriamycin, daunorubicin, cis-platinum,
  • you are taking medications to treat inflammation such as corticosteroids,
  • you are taking a medication to treat alcohol dependence (disulfiram),
  • you consume alcohol,
  • you have recently been exposed to toxic substances (aromatic hydrocarbons),
  • you smoke or take nicotine-based medications to help quit smoking,
  • the person to be treated is a premature newborn (born before term).

Warnings and precautions

Talk to your doctor or pharmacist before receiving OXYGEN NIPPON GASES.
Oxygen will be administered cautiously, adjusted according to your needs and at the lowest effective dose. If a higher dose is required, it will be administered for the shortest possible time and you will be monitored frequently.

Inform your doctor:

  • if you have respiratory insufficiency (a condition impairing gas exchange between air and blood);
  • if you are taking medications for epilepsy (barbiturates) and/or pain (opioids) and have difficulty breathing;
  • if you suffer from chronic obstructive bronchopneumopathy (a chronic lung disease with inflammation and narrowing of the bronchi);
  • if you suffer from cystic fibrosis (a hereditary disease);
  • if you have severe obesity;
  • if you have chest wall deformity;
  • if you have neuromuscular disorders (diseases affecting motor function);
  • if you have reduced respiratory capacity due to excessive intake of certain medications;
  • if you are being treated with bleomycin for lung cancer;
  • if the person to be treated is a newborn. Your doctor will evaluate whether to administer oxygen in a hyperbaric chamber if:
    • you suffer from recurrent otitis and/or sinusitis (ear and/or nasal inflammation recurring after treatment),
    • you have a laryngocele (a laryngeal malformation),
    • you have mastoiditis (inflammation of the mastoid, a bone behind the ear),
    • you have vestibular syndrome (balance disorders),
    • you have hearing loss,
    • you have recently undergone ear surgery,

OXYGEN NIPPON GASES

  • if you suffer from acute coronary syndrome (a heart disease),
  • if you have had a heart attack,
  • if you have high blood pressure and are not taking medication for it,
  • if you suffer from lung diseases that impair airflow (restrictive and/or severely restrictive lung diseases),
  • if you suffer from glaucoma (an eye disease characterized by high intraocular pressure),
  • if you have had retinal detachment (a serious eye disease), even if surgically treated,
  • if you have previously experienced seizures,
  • if you suffer from epilepsy,
  • if you have uncontrolled high fever,
  • if you suffer from anxiety,
  • if you suffer from psychosis (mental disorders),
  • if you suffer from claustrophobia (fear of being in enclosed spaces),
  • if you suffer from diabetes,
  • if you suffer from respiratory disorders (pneumothorax, asthma, emphysema, chronic obstructive bronchopneumopathy),
  • if you have recently undergone chest surgery.

Safety precautions
Oxygen enhances combustion: it may spontaneously or through ignition trigger combustion.
During use

  • any oxygen delivery system or container must be kept away from heat sources
  • smoking or having open, unshielded flames near containers and delivery systems is not permitted
  • do not place cylinders or containers near heat sources
  • do not use any electrical equipment that may produce sparks nearby
  • do not tamper in any way with container fittings (OIL AND GREASE MAY SPONTANEOUSLY CATCH FIRE ON CONTACT WITH OXYGEN)
  • avoid any contact with oil or grease
  • it is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
  • 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.
  • pliers or other tools must not be used to open or close cylinder valves to prevent the risk of damage.
  • in case of leakage, the cylinder valve must be closed immediately, if safely possible. If the valve cannot be closed, the cylinder must be moved to a safer outdoor location to allow oxygen to escape freely.
  • valves of empty cylinders must be kept closed.
    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 comes into contact with skin or eyes, the affected areas must be washed with abundant cold water or cold compresses applied; immediate medical assistance must be sought.

Other medicines and OXYGEN NIPPON GASES
Inform your doctor or pharmacist if you are taking or have recently taken any other medicine.
In particular, inform your doctor if you are taking:

  • catecholamines (e.g., adrenaline, noradrenaline), medicines used in emergencies to treat severe 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,
  • antibiotics (e.g., actinomycin, nitrofurantoin), medicines to treat bacterial infections,
  • menadione-based supplements (vitamin K),
  • medicines to treat mental disorders (e.g., promazine, chlorpromazine, thioridazine),
  • chloroquine, a medicine to treat malaria,
  • nitric oxide (a medicinal gas used for pulmonary hypertension). Also inform your doctor if:
  • you have recently undergone an X-ray examination,
  • you have a deficiency in vitamin C, E, or glutathione (an antioxidant),
  • you have been treated for paraquat poisoning (a herbicide).

OXYGEN NIPPON GASES and alcohol
Do not consume alcohol during treatment with OXYGEN NIPPON GASES.

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

Pregnancy
Oxygen at atmospheric pressure may be used during pregnancy, but only when necessary. Your doctor will prescribe OXYGEN NIPPON GASES only if clearly needed.
Oxygen in hyperbaric treatment (involving administration of oxygen at pressures higher than atmospheric) is contraindicated during the first trimester of pregnancy.
Your doctor will prescribe OXYGEN NIPPON GASES only after careful clinical evaluation.

Breastfeeding
OXYGEN NIPPON GASES may be used during breastfeeding.

Fertility
There are no known effects on male or female fertility following oxygen administration.

Driving and use of machines
The use of OXYGEN NIPPON GASES in normobaric oxygen therapy (at atmospheric pressure) does not affect or affects negligibly the ability to drive vehicles and operate machinery.
The use of OXYGEN NIPPON GASES in hyperbaric treatment (involving administration of oxygen at pressures higher than atmospheric) may cause visual and hearing disturbances that could affect the ability to drive vehicles and operate machinery. Avoid driving vehicles and operating machinery until all negative effects on attention and vigilance have completely disappeared.

0. How Ossigeno NIPPON GASES will be administered to you

Use this medicinal product exactly as instructed by your doctor or nurse. If you have
any doubts, consult your doctor.
Ossigeno NIPPON GASES is inhaled through the air, via a nasal cannula or a
facial mask.
The dose will be determined by your doctor based on your health condition.
If you are given more Ossigeno NIPPON GASES than you should receive
The toxic effects of oxygen vary depending on the inhaled oxygen pressure and the duration
of exposure.
Symptoms of oxygen toxicity include chest pain and dry cough.
With hyperbaric oxygen therapy, overdose may cause:
tinnitus (persistent perception of noise in the ear),
visual and hearing disturbances,
muscle spasms (involuntary muscle contractions), particularly localized in the eyes, mouth,
and forehead,
dizziness,
nausea,
anxiety,
confusion,
irritability,
loss of consciousness,
convulsions,
blurred vision,
reduced vision.
In newborns, retinopathy (an eye disease) may occur.
In some at-risk individuals, it may cause respiratory depression and onset of respiratory acidosis
(reduction in the amount of carbon dioxide eliminated by the lungs).
In case of oxygen toxicity, oxygen therapy will be reduced and, if possible, discontinued; symptomatic treatment will be initiated (therapy will be started to relieve symptoms).

3. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people):
With normobaric treatment:
visual impairment in premature newborns (retinopathy of prematurity).
With hyperbaric treatment:
OXYGEN NIPPON GASES
ear pain, myopia, barotrauma (tissue or organ injury caused by changes in pressure).
Common (may affect up to 1 in 10 people):
With hyperbaric treatment:
seizures.
Uncommon (may affect up to 1 in 100 people):
With hyperbaric treatment:
rupture of the eardrum.
Rare (may affect up to 1 in 1,000 people):
With hyperbaric treatment:
difficulty breathing (dyspnoea), reduced blood sugar levels (hypoglycaemia) in diabetic patients.
Frequency not known (frequency cannot be estimated from the available data):
With normobaric treatment:
chest pain and dry cough (tracheobronchitis), lung impairment (interstitial oedema, pulmonary fibrosis, hypoventilation, respiratory acidosis, respiratory arrest), dryness of mucous membranes, local irritation and inflammation of the mucous membranes.
With hyperbaric treatment:
respiratory disorders, involuntary muscle contractions (localized muscle spasms), dizziness, hearing loss, acute serous otitis, persistent perception of ringing or noise in the ears (tinnitus), nausea, abnormal behaviour, reduced peripheral vision, blurred vision, clouding of the lens (cataract).
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 the following address
.
By reporting side effects, you can help provide more information on the safety of this medicine.

4. How to store OXYGEN NIPPON GASES

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.

5. Package contents and other information

What Ossigeno NIPPON GASES contains

  • The active substance is oxygen.

OSSIGENO NIPPON GASES
Description of the appearance of Ossigeno NIPPON GASES and pack contents
Compressed medicinal gas
OSSIGENO NIPPON GASES compressed medicinal gas is supplied in cylinders and cylinder packs,
in compressed gas form at 200 bar pressure at 15°C. The cylinders are made of steel and equipped with valves suitable for connection to a pressure regulator.
Cryogenic medicinal gas
OSSIGENO NIPPON GASES cryogenic medicinal gas is supplied in mobile and fixed cryogenic containers.

Available pack sizes:
Compressed medicinal gas
Steel cylinders with VI or VP valve, 33, 40, 50 litres; cylinder packs containing 12 or 16 cylinders of 40 or 50 litres.
Mobile cryogenic medicinal gas
Hospital mobile cryogenic container, 200, 220 litres.
Fixed cryogenic medicinal gas
Fixed cryogenic container, 1000, 1500, 2000, 3000, 5000, 6,000, 10,000, 12,000, 15,000, 20,000, 30,000, 40,000, 50,000 litres.

Not all pack sizes may be marketed.

Marketing Authorization Holder
NIPPON GASES PHARMA S.r.l
Via Benigno Crespi, 19
Milan

Manufacturer
Compressed medicinal gas (200 bar)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via della Libertà, 17 – Ozzano dell’Emilia (BO)

Compressed medicinal gas (200 bar) and cryogenic medicinal gas (mobile containers)
NIPPON GASES INDUSTRIAL srl – Strada Regionale 6 Casilina, n°114 – Anagni (FR)
NIPPON GASES PHARMA srl – Via Martino della Torre, 16 – Novara
NIPPON GASES PHARMA srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES INDUSTRIAL srl – Via Pacinotti, 8 – Messina
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 – Genoa
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. Tossilo – Macomer (NU)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Vitorchiano, 99 – Rome
NIPPON GASES PHARMA srl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate Case Rosse – Zona ASI – Salerno
GAS TECNICI FOLIGNO srl – Via delle Industrie, 17 – Foligno (PG)
GAS TECNICI FOLIGNO srl – Loc. Santa Sabina Strada Lacugnana, 3/C – Perugia
NIPPON GASES PHARMA Srl – Via Circumvallazione Esterna 33 – Melito di Napoli (NA)
OSSIGENO NIPPON GASES
MEDICAIR SUD Srl – Viale de Blasio – Bari
MEDICAIR SUD Srl – Via Cosmo Mollica d’Alagona – Catania
MEDICAIR SUD SRL – Contrada Canna Masche – Termini Imerese (PA)
MEDICAIR ITALIA Srl – Via Spagna – Vigonza (PD)

Cryogenic medicinal gas (mobile containers)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Andorra, 13/15 Loc. Camin – Padua
MEDICAIR ITALIA S.r.l. - Via Coazze, Ang. Via Avigliana – Rivalta di Torino (TO)
NIPPON GASES PHARMA srl – Via Cavalier Virginio Tedeschi, 1 – Settimo Torinese (TO)
MEDICAIR CENTRO S.r.l. – Via del Gomito, 5/3 - Bologna

Cryogenic medicinal gas (fixed containers)
Sol Gas Primari Srl – Via Firmio Leonzio, 2 – 84100 – Salerno
Air Liquide Italia Produzione srl – Via Industrie, 28 – 37014 – Castelnuovo del Garda (VR)
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
Sapio Produzione Idrogeno Ossigeno srl – Via Senatore Simonetta, 27 – 20040 – Caponago (MB)
Sapio Produzione Idrogeno Ossigeno srl – Via Malcontenta, 49 (locality Porto Marghera) – 30175 – Venice
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. 525 del Brembo, 1 – 24040 – Osio Sopra (BG)
Air Liquide Italia Produzione srl - Contrada Biggemi Ex S.S. 114 - Priolo Gargallo (SR)
SICO Società Italiana Carburo Ossigeno SpA – Via Marconato s.n.c. – 20031 – Cesano Maderno (MI)
IGAT Ind. Gas Tecnici SpA – S.S. Appia km 192,500 – Pignataro Maggiore (CE)
Linde Gas Italia srl - V.le B. Brin 218- 05100 Terni
Medicair Sud Srl - Contrada S. Benedetto zona ASI - Favara (AG)
SOL GAS PRIMARI SRL – Contrada Marcellino C.P. 119 SNC – AUGUSTA (SR)
NIPPON GASES OPERATIONS Srl – Via S. Isidoro n. 10 – 04014 Pontinia (LT)

The following information is intended exclusively for healthcare professionals:

Dosage, method and duration of administration
Oxygen (compressed or cryogenic) is administered via the inhaled air, preferably using dedicated devices (such as, for example, a nasal cannula or a face mask). The dosage delivered to the patient is regulated independently of the medicinal gas packaging, by means of dosing devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while the expired gas and any excess oxygen leave the patient's inspiratory circuit, mixing with the surrounding air (open system or anti-rebreathing system).
In anesthesia, a special system is often used that allows rebreathing of gas previously exhaled by the patient (closed system or rebreathing system).
OSSIGENO NIPPON GASES
Oxygen may also be administered directly into the blood through an oxygenator, using a cardiopulmonary bypass system in cardiac surgery and in other cases requiring extracorporeal circulation.
Numerous devices are available for oxygen administration, and they can be classified as follows:

  • Low-flow systems This is the simplest system for delivering an oxygen-enriched mixture in the 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 Systems designed to provide the patient with a gas mixture ensuring complete respiratory requirements. These systems deliver a stable and constant concentration of oxygen that is not influenced or diluted by the surrounding air. An example is Venturi masks, where, once the oxygen flow is set, the air inhaled by the patient is enriched with a constant concentration of oxygen.
  • Demand valve systems Systems designed to deliver 100% oxygen without contact with ambient air. These are intended for short-term use only, and only when strictly necessary.
  • Hyperbaric oxygen therapy Hyperbaric oxygen therapy is performed inside a specially designed pressurized chamber, where pressures up to three times higher than atmospheric pressure can be maintained. Hyperbaric oxygen therapy can also be administered via a tightly sealed mask, a hood, or an endotracheal tube. Normobaric oxygen therapy Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air—i.e., containing an oxygen fraction in the inspired air (FiO₂) greater than 21%—at a partial pressure between 0.21 and 1 atmosphere (0.213–1.013 bar). In patients without respiratory failure, oxygen 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 an internal pressure of approximately 124–200 bar. This high pressure is regulated by a pressure reducer and can be read on the pressure gauge. Multiplying the pressure gauge reading by the cylinder’s volume in liters gives the amount of oxygen still available in the cylinder. (Example: Content calculation: a cylinder has a volume of 10 liters and the pressure gauge reads 200 bar, resulting in 2000 liters of oxygen available. With an oxygen consumption rate of 2 liters 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 liters/minute, adjustable according to blood gas analysis. Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 liters/minute, adjustable according to blood gas analysis.
    • With assisted ventilation The minimum FiO₂ concentration is 21%, and it can increase up to 100%. The therapeutic goal of oxygen therapy is to ensure that arterial partial pressure of oxygen (PaO₂) is not below 8 kPa (60 mmHg), or that arterial hemoglobin oxygen saturation is not below 90%, achieved by adjusting the fraction of inspired oxygen (FiO₂).

OSSIGENO NIPPON GASES
(FiO₂).
Dosage must be adjusted according to the individual needs of each patient.
The general recommendation is to use the lowest FiO₂ concentration necessary to achieve the desired therapeutic effect, i.e., normal PaO₂ values. In cases of severe hypoxemia, FiO₂ levels that may carry a potential risk of oxygen toxicity may be indicated.
Continuous monitoring of therapy and constant evaluation of the therapeutic effect are required, through measurement of PaO₂ levels or, alternatively, arterial oxygen saturation (SpO₂).
In short-term oxygen therapy, the fraction of inspired oxygen (FiO₂) should be sufficient to maintain an arterial partial pressure of oxygen (PaO₂) > 8 kPa, with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), while avoiding, if possible, FiO₂ values > 0.6 (i.e., more than 60% oxygen in the inhaled gas mixture).
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 indices are only indirect measurements of tissue oxygenation. Clinical assessment of treatment remains of paramount importance.
For long-term therapy, the need for supplemental oxygen must be determined based on 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 should be used in patients with respiratory failure in whom the respiratory drive is stimulated by hypoxia (e.g., due to COPD). The oxygen concentration in the inhaled air should not exceed 28%; in some patients, even 24% may be excessive.
If oxygen is mixed with other gases, its concentration in the inhaled gas mixture must be maintained at least at 21%. In practice, levels below 30% are generally avoided. When necessary, the fraction of inspired oxygen can be increased up to 100%.
Newborns 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 lung collapse.
Arterial blood oxygen pressure (PaO₂) must be monitored; however, if it is maintained below 13.3 kPa (100 mmHg) and significant fluctuations in oxygenation are avoided, the risk of ocular damage is reduced. Furthermore, the risk of ocular damage can be minimized by avoiding large fluctuations in oxygenation (see also section 4.4).
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 inside a hyperbaric chamber.
The duration of sessions in a hyperbaric chamber at pressures between 2 and 3 atmospheres (i.e., between 202.6 and 303.9 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, in accordance with standard procedures, to avoid the risk of barotrauma to air-containing anatomical cavities that communicate with the external environment.
OSSIGENO NIPPON GASES
Hyperbaric oxygen therapy must be administered by qualified personnel trained in this treatment. Precautions for use
Oxygen must be administered cautiously, with adjustments based on individual patient 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 blood gas analysis monitoring.
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 subsequent 24-hour period.
Oxygen becomes potentially toxic after two days at concentrations above 40%.
Low oxygen concentrations should be used in patients with respiratory failure whose respiratory drive depends on hypoxia. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), pulse oximetry (arterial oxygen saturation – SpO₂), and clinical evaluation.
In full-term and premature newborns, administration of oxygen at concentrations above 30–40% may cause adverse effects such as retrolental fibroplasia, chronic lung disease, and intraventricular hemorrhage. This is due to insufficient production of endogenous antioxidant enzymes, resulting in an inability to counteract the production and toxic effects of reactive oxygen species. In these cases, the lowest effective oxygen concentration should be administered, and arterial oxygen pressure must be closely monitored and maintained below 13.3 kPa (100 mmHg).
High oxygen concentrations in the air or in the inhaled 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 the alveoli faster than it is supplied 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.
SAFETY
Oxygen is an oxidizing agent and therefore supports combustion. In the presence of combustible materials such as fats (oils, lubricants) and organic substances (fabrics, wood, paper, plastics, etc.), oxygen may spontaneously ignite—due to an ignition source (spark, open flame, ignition source)—or due to adiabatic compression, which may occur in pressure-reducing equipment (reducers) during a sudden drop in gas pressure. Therefore, all materials in contact with oxygen must be classified as compatible with the product under normal conditions of use.
⚫ Any oxygen delivery system or container must be kept away from heat sources due to oxygen’s oxidizing properties. Appropriate precautions must be taken both in hospital and domestic settings where medical oxygen is in use.
⚫ Oxygen may cause sudden ignition of smoldering materials or embers; therefore, smoking or the use of unshielded open flames near containers and delivery systems is strictly prohibited.
OSSIGENO NIPPON GASES
⚫ Do not smoke in any environment where oxygen therapy is administered.
⚫ Do not place cylinders or containers near heat sources.
⚫ No electrical equipment capable of producing sparks should be used near patients receiving oxygen.
⚫ It is absolutely forbidden to tamper in any way with container connections, delivery equipment, or their accessories or components (OIL AND GREASE MAY SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
⚫ Any contact with oil, grease, or other hydrocarbons must be avoided.
⚫ It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
⚫ In an oxygen-enriched environment, 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 they show visible damage or if damage or exposure to extreme temperatures is suspected.
⚫ 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 the risk of damage.
⚫ In case of leakage, the cylinder valve must be closed immediately, if this can be done safely. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
⚫ Valves of empty cylinders must be kept closed.
⚫ Oxygen has a strong oxidizing effect and may react violently with organic substances. This is why handling and storage of containers require special precautions.
⚫ It is not permitted to administer gas under pressure.
General instructions for use
Cylinders equipped only with a shut-off valve

  1. Remove the protective cap, if present
  2. Ensure the delivery valve is closed
  3. Remove the tamper-evident seal
  4. Connect the pressure reducer 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 fully
  8. Adjust the flowmeter to the required flow rate (liters/minute)
    Cylinders equipped with integrated pressure-reducing valve
  9. Ensure the valve is closed
  10. Remove the tamper-evident seal
  11. Ensure the flow indicator is set to zero
  12. Connect the humidifier/bubbler
  13. Connect the cannula with mask or goggles to the humidifier
  14. Slowly open the main valve fully
  15. Adjust the flowmeter to the required flow rate (liters/minute)
    Mobile cryogenic containers
  16. Ensure the flow indicator is set to zero
  17. Remove the tamper-evident seal
  18. Connect the humidifier/bubbler
  19. Connect the cannula with mask or goggles to the humidifier
  20. Set the flow regulator to the required flow rate (liters/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 directly in front of the gas outlet of the tap/valve; always stand to the side. Do not expose yourself or the patient to the direct gas flow.
    • Do not use oil or grease in contact with the gas.
    • Do not completely empty the container.
    • After use, close the cylinder valve.
    • In case of gas leakage, close the valve and notify the technical service of the supplier indicated in the container’s user manual.
    • Use only containers suitable for the product and for the intended pressure and temperature conditions. Disposal
    • Store empty cylinders with valves closed.
    • Do not discharge into sewers, basements, or pits where accumulation may be hazardous.
    • Return empty or unused containers—even if only partially empty—to the supplier. Any residual unused medicinal product in the pressurized cylinder will be safely eliminated, via 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 with 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 oxygen-enriched 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. Fixed cryogenic containers installed in healthcare facilities must be located outdoors.

OSSIGENO NIPPON GASES

Package leaflet: Information for the user

OXYGEN NIPPON GASES 124 BAR COMPRESSED MEDICINAL GAS, 200 BAR COMPRESSED MEDICAL 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, consult your doctor or pharmacist.
  • This medicine has been prescribed for you only. Do not give it to other people, even if their symptoms are the same as yours, as it may be harmful.
  • If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or pharmacist. See section 4.

Contents of this leaflet:

  1. What Ossigeno Nippon Gases is and what it is used for
  2. What you need to know before using Ossigeno Nippon Gases
  3. How to use Ossigeno Nippon Gases
  4. Possible side effects
  5. How to store Ossigeno Nippon Gases
  6. Package contents and other information

1. What Ossigeno Nippon Gases is and what it is used for

Ossigeno Nippon Gases contains oxygen, a gas naturally present in the air we breathe. Medical oxygen increases the amount of oxygen reaching the lungs and consequently the tissues. Ossigeno Nippon Gases is indicated:

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

2. What you need to know before using Ossigeno Nippon Gases

Normobaric oxygen therapy (administration of oxygen at atmospheric pressure levels) has no contraindications.
Warnings and precautions
Consult your doctor or pharmacist before using Ossigeno Nippon Gases.
Oxygen will be administered cautiously, adjusted according to your needs and at the lowest effective dose. If a higher dose is required, it will be given for the shortest possible time and you will be monitored frequently.
Inform your doctor:

  • if you have respiratory insufficiency (a disease impairing gas exchange between air and blood);
  • if you are taking medicines for epilepsy (barbiturates) and/or pain (opioids) and have difficulty breathing;

OSSIGENO NIPPON GASES

  • if you suffer from chronic obstructive bronchopneumopathy (a chronic lung disease with inflammation and constriction of the bronchi);
  • if you suffer from cystic fibrosis (a hereditary disease);
  • if you have severe obesity;
  • if you have a chest wall deformity;
  • if you have neuromuscular disorders (diseases affecting motor abilities);
  • if you have reduced respiratory capacity due to excessive intake of certain medications;
  • if you are undergoing treatment with bleomycin for lung cancer;
  • if the patient to be treated is a newborn. 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 must be worn (gloves, goggles, loose clothing, and trousers covering the shoes). If liquid oxygen comes into contact with skin or eyes, the affected areas must be washed with abundant cold water or cold compresses applied; immediate medical assistance must be sought.

Other medicines and Ossigeno Nippon Gases
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 used in emergencies to treat severe allergic reactions,
  • corticosteroids (e.g. dexamethasone, methylprednisolone), medicines to treat inflammation,
  • hormones (e.g. testosterone, thyroxine),
  • amiodarone, a medicine for treating heart rhythm disorders,
  • chemotherapeutic agents (e.g. bleomycin, cyclophosphamide, 1,3-bis(2-chloroethyl)-1-nitrosourea) and adriamycin, medicines for treating tumors,
  • antibiotics (e.g. actinomycin, nitrofurantoin), medicines for treating bacterial infections,
  • menadione-based supplements (vitamin K),
  • medicines for treating mental disorders (e.g. promazine, chlorpromazine, thioridazine),
  • chloroquine, a medicine for treating malaria,
  • nitric oxide (a medicinal gas used for pulmonary hypertension). Also inform your doctor if:
  • you have recently undergone an X-ray,
  • you have a deficiency in vitamin C, E or glutathione (an antioxidant),
  • you have been treated for paraquat poisoning (a herbicide).

Ossigeno Nippon Gases and alcohol
Do not consume alcohol during treatment with Ossigeno Nippon Gases.
Pregnancy, breastfeeding and fertility
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.
OSSIGENO NIPPON GASES
Pregnancy
OSSIGENO NIPPON GASES may be used during pregnancy, but only when necessary. Your doctor will prescribe OSSIGENO NIPPON GASES only if clearly needed.
Breastfeeding
OSSIGENO NIPPON GASES may be used during breastfeeding.
In all cases, you must inform your doctor if you are pregnant or suspect you may be pregnant.
Fertility
There are no known effects on male or female fertility following oxygen administration.
Driving and using machines
OSSIGENO NIPPON GASES does not affect, or affects negligibly, the ability to drive vehicles and use machinery.

0. How to use Ossigeno Nippon Gases

Use this medicine exactly as instructed by your doctor or nurse. If
you have any doubts, consult your doctor.
Ossigeno Nippon Gases is administered through the inhaled air, via a nasal cannula or a
facial mask.
The dose will be determined by your doctor based on your health condition.
If you use more Ossigeno Nippon Gases than you should
The toxic effects of oxygen vary depending on the pressure of the inhaled oxygen and the duration
of exposure.
Symptoms of oxygen toxicity include chest pain and dry cough.
In case of toxicity, oxygen therapy will be reduced and, if possible, discontinued, and symptomatic treatment will be initiated (therapy to relieve symptoms will be started).

3. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
Very common (may affect more than 1 in 10 people):
visual impairment in preterm newborns (retinopathy of prematurity).
Frequency not known (frequency cannot be estimated from the available data):
chest pain and dry cough (tracheobronchitis), lung impairment (interstitial edema, pulmonary fibrosis, hypoventilation, respiratory acidosis, respiratory arrest), dryness of mucous membranes, local irritation and inflammation of mucous membranes.
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 the following address:
www.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.

4. How to store Ossigeno Nippon Gases

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.
OSSIGENO NIPPON GASES
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 Nippon Gases contains

  • The active substance is oxygen.

Description of the appearance of Ossigeno Nippon Gases and contents of the pack
Compressed medicinal gas
OSSIGENO NIPPON GASES compressed medicinal gas is supplied in cylinders in compressed gaseous form at 124 or 200 bar at 15°C. The cylinders are made of steel or aluminum alloy, fitted with valves suitable for connection to a pressure regulator or with integrated pressure-reducing valves.
Cryogenic medicinal gas
OSSIGENO NIPPON GASES cryogenic medicinal gas is supplied in mobile cryogenic containers (base units).

Available pack sizes:
Compressed medicinal gas (200 bar)
Steel cylinders with VI or VP valve: 0.5, 1, 2, 3, 5, 7, 10, 14, 20, 27, 30 litres;
Steel cylinders with pressure-reducing valve: 2, 3, 5, 7, 10, 14, 20, 27 litres;
Aluminum cylinders with VI or VP valve: 3, 5, 14 litres;
Aluminum cylinders with pressure-reducing valve: 5 litres.

Compressed medicinal gas (124 bar)
Steel cylinders with pressure-reducing valve: 8.75 and 23.6 litres.

Cryogenic medicinal gas
Mobile cryogenic containers: 15, 21, 25, 31, 37, 41, 45 litres.

Not all pack sizes may be marketed.

Marketing Authorization Holder
NIPPON GASES PHARMA s.r.l.
Via B. Crespi, 19
Milan

Manufacturer
Compressed medicinal gas (124 bar)
NIPPON GASES INDUSTRIAL srl – Strada Regionale 6 Casilina, n°114 – Anagni (FR)

Compressed medicinal gas (200 bar)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via della Libertà, 17 – Ozzano dell’Emilia (BO)

Compressed medicinal gas (200 bar) and cryogenic medicinal gas (mobile containers)
NIPPON GASES INDUSTRIAL srl – Strada Regionale 6 Casilina, n°114 – Anagni (FR)
NIPPON GASES PHARMA srl – Via Martino della Torre, 16 – Novara
NIPPON GASES PHARMA srl – Via dei Gigli, 23 – Modugno (BA)
NIPPON GASES INDUSTRIAL srl – Via Pacinotti, 8 – Messina
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Strada Settimo, 342 – San Mauro Torinese (TO)
OSSIGENO NIPPON GASES
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via del 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. Tossilo – Macomer (NU)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Vitorchiano, 99 – Roma
NIPPON GASES PHARMA srl – Via Aterno, 56 – Pescara
MAGALDI LIFE srl – Via Scavate Case Rosse – Zona ASI – Salerno
GAS TECNICI FOLIGNO srl – Via delle Industrie, 17 – Foligno (PG)
GAS TECNICI FOLIGNO srl – Loc. Santa Sabina Strada Lacugnana, 3/C – Perugia
NIPPON GASES PHARMA srl – Via Circumvallazione Esterna 33 – Melito di Napoli (NA)
MEDICAIR SUD Srl - Viale de Blasio - Bari
MEDICAIR SUD Srl - Via Cosmo Mollica d’Alagona - Catania
MEDICAIR SUD SRL - Contrada Canna Masche - Termini Imerese (PA)
MEDICAIR ITALIA Srl - Via Spagna - Vigonza (PD)

Cryogenic medicinal gas (mobile containers)
Società Italiana Acetilene & Derivati "S.I.A.D." SpA – Via Andorra, 13/15 Loc. Camin – Padova
MEDICAIR ITALIA S.r.l. - Via Coazze, Ang. Via Avigliana – Rivalta di Torino (TO)
NIPPON GASES PHARMA srl – Via Cavalier Virginio Tedeschi, 1 – Settimo Torinese (TO)
MEDICAIR CENTRO S.r.l. – Via del Gomito, 5/3 - Bologna

The following information is intended exclusively for healthcare professionals:

Dosage, method, and duration of administration
Oxygen (compressed or cryogenic) is administered via the inhaled air, preferably using dedicated devices (such as, for example, a nasal cannula or a face mask). The dosage delivered to the patient is regulated independently from the medicinal gas packaging by means of dosing devices (flowmeters).
With these systems, oxygen is delivered through the inspired air, while the exhaled gas and any excess oxygen leave the patient's inspiratory circuit, mixing with the surrounding air (open system or anti-rebreathing system).
In anesthesia, a special system is often used that allows rebreathing of previously exhaled gas from the patient (closed system or rebreathing system).
Oxygen may also be administered directly into the blood through an oxygenator, using a cardiopulmonary bypass system in cardiac surgery and in other cases requiring extracorporeal circulation.
There are numerous devices designed for oxygen delivery, which can be classified as follows:

  • Low-flow systems This is the simplest system for delivering an oxygen-enriched mixture in the inspired air. An example is a system where oxygen is administered via a flowmeter connected to a nasal cannula or face mask.
  • High-flow systems

OSSIGENO NIPPON GASES
Systems designed to provide the patient with a gas mixture ensuring their total respiratory needs. These systems are engineered to deliver stable and constant oxygen concentrations that are not influenced 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 concentration of oxygen.

  • Demand valve systems Systems designed to deliver 100% oxygen without contact with ambient air. These are intended for short-term use only, and solely for emergency purposes.

Normobaric oxygen therapy
Normobaric oxygen therapy refers to the administration of a gas mixture richer in oxygen than atmospheric air—i.e., containing an inspired oxygen fraction (FiO₂) greater than 21%—at a partial pressure between 0.21 and 1 atmosphere (0.213–1.013 bar). In patients without respiratory failure, oxygen 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 an internal pressure of approximately 124–200 bar. This high pressure is regulated by a pressure reducer and can be read on the pressure gauge. Multiplying the value indicated on the pressure gauge by the cylinder volume in liters gives the amount of oxygen still available in the cylinder. (Example: Content calculation: a cylinder has a volume of 10 liters and the pressure gauge reads 200 bar; this results in 2000 liters of oxygen available: with an oxygen consumption of 2 liters 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 liters/minute, adjustable according to blood gas analysis.
Patients with acute respiratory failure: administer oxygen at a flow rate of 0.5 to 15 liters/minute, adjustable according to blood gas analysis.

With assisted ventilation
The minimum FiO₂ concentration 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%, by adjusting the inspired oxygen fraction (FiO₂). The dose must be tailored to the individual needs of each patient. The general recommendation is to use the lowest FiO₂ dose necessary to achieve the desired therapeutic effect, i.e., normal PaO₂ values. In cases of severe hypoxemia, FiO₂ levels that may carry a potential risk of oxygen toxicity may be indicated. Continuous monitoring of therapy and ongoing assessment of therapeutic effect are required, through measurement of PaO₂ levels or alternatively, arterial oxygen saturation (SpO₂). In short-term oxygen therapy, the inspired oxygen fraction (FiO₂) should be sufficient to maintain arterial partial pressure of oxygen (PaO₂) > 8 kPa, with or without positive end-expiratory pressure (PEEP) or continuous positive airway pressure (CPAP), while avoiding, if possible, FiO₂ values > 0.6 (i.e., more than 60% oxygen in the inhaled gas mixture). Short-term oxygen therapy must be monitored through repeated arterial blood gas measurements (PaO₂) or transcutaneous oximetry, which provides a numerical value of hemoglobin oxygen saturation (SpO₂). In any case, these indices are only indirect measurements of tissue oxygenation. Clinical evaluation of treatment remains of paramount importance.

For long-term treatment, the need for supplemental oxygen must be determined based on 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 should be used in patients with respiratory failure in whom the respiratory drive is stimulated by hypoxia (e.g., due to COPD). The oxygen concentration in the inhaled air should not exceed 28%; in some patients, even 24% may be excessive.

If oxygen is mixed with other gases, its concentration in the inhaled gas mixture must be maintained at least at 21%. In practice, levels below 30% are generally avoided. When necessary, the inspired oxygen fraction can 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) should be monitored; however, if it is 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 injury can be minimized by avoiding significant fluctuations in oxygenation (see also section 4.4).

Precautions for use
Oxygen must be administered cautiously, with adjustments based on individual patient needs. The lowest 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 blood gas analysis monitoring.

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 is potentially toxic after two days at concentrations above 40%.

Low oxygen concentrations should be used in patients with respiratory failure whose respiratory drive depends on hypoxia. In these cases, treatment must be closely monitored by measuring arterial oxygen tension (PaO₂), pulse oximetry (arterial oxygen saturation – SpO₂), and clinical assessment.

High oxygen concentrations in the air or in the inhaled 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 supplied 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.

SAFETY
OSSIGENO NIPPON GASES
Oxygen is an oxidizing agent and therefore supports combustion. In the presence of combustible materials such as fats (oils, lubricants) and organic substances (fabrics, wood, paper, plastics, etc.), oxygen can spontaneously ignite—due to an ignition source (spark, open flame, ignition source) or due to adiabatic compression that may occur in pressure-reducing equipment (reducers) during a sudden drop in gas pressure—triggering combustion. Consequently, all materials coming into contact with oxygen must be classified as compatible with the product under normal conditions of use.

⚫ Any oxygen delivery system or container must be kept away from heat sources due to oxygen’s oxidizing properties; appropriate precautions must therefore be taken both in hospital and domestic environments where medical oxygen is used.
⚫ Oxygen can cause sudden ignition of smoldering materials or embers; therefore, smoking or using unshielded open flames near containers and delivery systems is strictly prohibited.
⚫ Do not smoke in areas where oxygen therapy is administered.
⚫ Do not place cylinders or containers near heat sources.
⚫ No electrical equipment capable of producing sparks should be used near patients receiving oxygen.
⚫ It is absolutely forbidden to tamper in any way with container connections, delivery equipment, or their accessories or components (OIL AND GREASE CAN SPONTANEOUSLY IGNITE ON CONTACT WITH OXYGEN).
⚫ Any contact with oil, grease, or other hydrocarbons must be avoided.
⚫ It is absolutely forbidden to handle equipment or components with hands, clothing, or face contaminated with grease, oil, creams, or ointments. Do not use greasy creams or lipsticks.
⚫ In an oxygen-enriched environment, oxygen can saturate clothing.
⚫ It is absolutely forbidden to touch frozen parts (for cryogenic containers).
⚫ Cylinders and mobile cryogenic containers must not be used if visible damage is present or if damage is suspected, or if they have been exposed to extreme temperatures.
⚫ Only oxygen-compatible 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 risk.
⚫ In case of leakage, the cylinder valve must be closed immediately, if this can be done safely. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow oxygen to escape freely.
⚫ Valves of empty cylinders must remain closed.
⚫ Oxygen has a strong oxidizing effect and may react violently with organic substances. This is why handling and storage of containers require special precautions.

It is not permitted to administer pressurized gas

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

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

Cylinders equipped with integrated pressure-reducing valve

  1. Ensure the valve is closed
  2. Remove the tamper-evident seal
  3. Ensure 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 fully
  7. Adjust the flowmeter to the required flow rate (liters/minute)

Mobile cryogenic containers

  1. Ensure 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 (liters/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 when 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 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 appropriate for the intended pressure and temperature of use.

Disposal

  • Store empty cylinders with valves closed.
  • Do not discharge into sewers, basements, or pits where accumulation could be hazardous.
  • Return empty or unused containers, even if only partially empty, to the supplier. Any residual unused medicinal product in the pressurized cylinder will be safely eliminated through appropriate procedures in a well-ventilated area by the company responsible for subsequent refilling of the container.
    Observe all applicable rules regarding the use and handling of high-pressure 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 oxygen-enriched atmospheres (O₂ > 21% vol), in an upright position with valves closed, protected from rain and weather, direct sunlight, and kept away from heat or ignition sources and combustible materials. Empty containers or those containing other types of gases must be stored separately.