Oxygen Medicinal Liquid Vivisol 99.5% medicinal cryogenic gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

VIVISOL Medicinal Liquid Oxygen 99.5% v/v, medicinal cryogenic gas

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What VIVISOL Medicinal Liquid Oxygen is and what it is used for
2. What you need to know before using VIVISOL Medicinal Liquid Oxygen
3. How to use VIVISOL Medicinal Liquid Oxygen
4. Possible side effects
5. How to store VIVISOL Medicinal Liquid Oxygen
6. Contents of the pack and other information

1. What Oxígeno Medicinal líquido VIVISOL is and what it is used for

Medicinal oxygen contains oxygen, a gas essential for life. Oxygen treatment can be administered under normal pressure or under elevated pressure.

Oxygen treatment under normal pressure (normobaric oxygen therapy)

Oxygen treatment under normal pressure may be used to treat or prevent:

• Low oxygen levels in the blood or in a specific organ
• Cluster headache (a specific type of headache causing short but very severe attacks on one side of the head)

Oxygen treatment under elevated pressure (hyperbaric oxygen therapy)

Hyperbaric oxygen treatment must only be administered by qualified healthcare professionals to avoid the risk of injury due to significant pressure fluctuations. Hyperbaric oxygen treatment may be used for:

• Treatment of severe carbon monoxide poisoning (e.g., when the patient is unconscious)
• Gas embolism caused by a sudden drop in atmospheric pressure (decompression sickness)
• Treatment of obstruction in the heart or blood vessels caused by gas bubbles (arterial gas embolism)
• Supportive treatment in cases of radiation-induced bone loss
• Supportive treatment in cases of tissue necrosis due to infections with gas-producing bacteria

2. What you need to know before starting to use VIVISOL Liquid Medical Oxygen

Do not use VIVISOL Liquid Medical Oxygen

Oxygen must not be used at pressures higher than atmospheric pressure (hyperbaric oxygen therapy) in cases of untreated or undrained pneumothorax. Pneumothorax occurs due to the accumulation of air in the pleural cavity between the two lung membranes. If you have ever had pneumothorax, inform your doctor.

Warnings and precautions

Consult your doctor or pharmacist before starting to use VIVISOL Liquid Medical Oxygen:

• Oxygen may have harmful effects at high concentrations. This could cause lung damage (alveolar collapse (lung inflammation)) which would impair oxygen supply to the blood.
• If you suffer from chronic obstructive pulmonary disease (COPD) with consequent blood oxygenation deficiency, the oxygen flow rate will need to be lower. Your doctor will adjust the appropriate oxygen flow rate for oxygen therapy.
• Exercise special caution when administering oxygen to newborn infants and premature babies. The aim is to minimize the risk of adverse events, such as eye damage. The lowest effective oxygen concentration that ensures adequate oxygenation should be used.
• Exercise special caution if your blood carbon dioxide levels are elevated, as this may counteract the effect of oxygen.
• If you have respiratory problems triggered by low blood oxygen levels, or if you are taking strong analgesics, strict medical supervision will be required.
• If you have ever had lung injury, inform your doctor.

Hyperbaric oxygen therapy

Before starting treatment with high-pressure oxygen, inform your doctor if you have:

• Psychiatric disorders (anxiety, psychosis)
• Fear of enclosed spaces (claustrophobia)
• Diabetes (high blood glucose levels); due to the risk of hypoglycemia, blood sugar levels should be measured between hyperbaric therapy sessions
• Respiratory disorders
• If you have ever had pneumothorax, which is an accumulation of air in the pleural cavity between the two lung membranes
• Heart problems
• High blood pressure
• Eye problems
• Ear, nose, and throat disorders

Children

In premature infants and newborns, oxygen therapy may cause eye damage (retinopathy of prematurity). The doctor will determine the appropriate oxygen concentration to ensure your baby receives correct treatment.

Whenever oxygen is used, the increased risk of fire ignition must always be taken into account.

Use of VIVISOL Liquid Medical Oxygen with other medicines

Inform your doctor or pharmacist if you are using, have recently used, or might need to use any other medicines.

If you are taking or have been prescribed bleomycin (to treat cancer), amiodarone (to treat heart conditions), or nitrofurantoin (to treat infections), inform your doctor before using oxygen, as these may increase the risk of pulmonary toxic effects.

Oxygen may worsen pre-existing lung damage caused by the pesticide Paraquat. In cases of Paraquat poisoning, administration of additional oxygen should be avoided as much as possible.

Use of VIVISOL Liquid Medical Oxygen with food, drinks, and alcohol

Do not consume alcohol while using this medicine. Alcohol may cause respiratory depression.

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using any medicine.

• During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) is permitted only if necessary.
• There are no contraindications for the use of oxygen during breastfeeding.

Treatment with high-pressure oxygen (hyperbaric oxygen therapy) should only be used during pregnancy or if you suspect you may be pregnant if strictly necessary. Inform the treating physician or specialist if this applies.

Driving and use of machines

Medical oxygen at normal pressure (normobaric oxygen therapy) does not affect the ability to drive or operate machinery.

After receiving high-pressure oxygen treatment (hyperbaric oxygen therapy), you may experience visual and auditory disturbances that could affect your ability to drive or operate machinery.

3. How to use VIVISOL Liquid Medicinal Oxygen

Follow exactly the instructions for administration of this medicine as given by your doctor. If in doubt, consult your doctor or pharmacist again.

Under no circumstances should you change the oxygen concentration of your own administration or that of your child.

Dosage

Oxygen therapy at normal pressure (normobaric oxygen therapy)

• If blood oxygen concentration or that of a specific organ is too low: Your doctor will indicate how long and how many times per day you should administer medicinal oxygen, as the dose may vary depending on each patient. The goal is always to use the lowest effective oxygen concentration possible. However, the actual oxygen concentration for inhalation must never be less than 21% and may be increased up to 100%.
• For treating respiratory problems when blood oxygen levels are reduced (hypoxia) or as a respiratory stimulant (e.g., in lung diseases such as COPD):

The oxygen concentration should be maintained below 28%, and sometimes below 24%. Oxygen concentrations for inhalation in newborn infants should be kept below 40% and may only be increased to 100% in very exceptional cases. The lowest effective oxygen concentration that achieves adequate oxygenation should be used. Fluctuations in oxygen saturation should be avoided.

• For treating cluster headache:

100% oxygen is administered at a flow rate of 7 liters per minute for a period of 15 minutes via a mask. Treatment should begin at the onset of the first symptoms.

How to administer normobaric oxygen therapy

• Medicinal oxygen is a gas for inhalation administered using special equipment such as a nasal cannula or mask. Excess oxygen leaves the body through exhalation and mixes with ambient air (known as a "non-rebreathing" system).
• If you are unable to breathe independently, artificial respiratory support will be provided. During anesthesia, special equipment with rebreathing or recycling systems is used so that exhaled air is re-inhaled (known as a "rebreathing" system).
• Oxygen may also be administered directly into the bloodstream using a so-called "oxygenator," for example during cardiac surgery with cardiopulmonary bypass and other situations requiring extracorporeal circulation.

How to receive hyperbaric oxygen therapy

• Hyperbaric oxygen therapy must only be administered by healthcare professionals to avoid the risk of injury from significant pressure fluctuations.
• Depending on your condition, hyperbaric oxygen therapy lasts between 45 and 300 minutes per session. The treatment may consist of one or two sessions, but long-term treatment may extend to 30 sessions or more, with multiple sessions per day if necessary.
• Hyperbaric oxygen therapy is administered in a special pressurization chamber.
• Hyperbaric oxygen may also be delivered via a tightly fitted face mask, hood covering the head, or through a tube placed in the mouth.

If you use more VIVISOL Liquid Medicinal Oxygen than you should

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone 91 562 04 20, indicating the medicine and the amount inhaled.

The toxic effects of oxygen may vary depending on the pressure of the inhaled oxygen and the duration of exposure. At low pressure (0.5 to 2.0 bar), toxic effects are more likely to occur in the lungs (pulmonary system) than in the brain and spinal cord (central nervous system). At elevated pressure, the opposite is true.

Effects on the lungs (pulmonary system) include breathing difficulties, cough, and chest pain.

Effects on the brain and spinal cord (central nervous system) include tinnitus, hearing and visual disturbances, nausea, dizziness, anxiety, confusion, localized muscle cramps (around eyes, mouth, and forehead), fainting, and convulsions (epileptic seizures).

Ocular effects include blurred vision and reduced peripheral vision ("tunnel vision").

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

If you forget to use VIVISOL Liquid Medicinal Oxygen

Use oxygen as described in the dosage section of this leaflet. Do not use a double dose to make up for a missed dose. This is because medicinal oxygen could be harmful at high concentrations.

If you stop using VIVISOL Liquid Medicinal Oxygen

Do not stop treatment with this medicine on your own initiative. Consult your doctor or pharmacist.

Safety measures for the use of medicinal oxygen

Oxygen is an oxidizing agent and promotes combustion. There must be no smoking or open flames (e.g., pilot lights, stoves, ovens, gas fireplaces, sparks, candles, etc.) in rooms where medicinal oxygen is used, as this increases the risk of fire.

Handle the cylinder with care. Ensure the gas cylinder does not fall or suffer impacts.

If you have any further questions about the use of this medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

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

With normobaric treatment: In newborns exposed to high oxygen concentrations: eye damage, which may lead to vision impairment.

With hyperbaric treatment: ear pain, myopia, barotrauma (tissue or organ injuries caused by a change 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 normobaric treatment: Pulmonary collapse (atelectasis).

With hyperbaric treatment: Rupture of the eardrum

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

With hyperbaric treatment: Dyspnea, abnormally low blood sugar levels in diabetic patients.

Frequency not known (cannot be estimated from available data)

With normobaric treatment: Pulmonary toxicity, worsening of excess carbon dioxide in the blood (hypercapnia), dryness of the mucous membrane, local irritation, and inflammation of the mucosa.

With hyperbaric treatment: Difficulty breathing, involuntary muscle contractions, dizziness, hearing disturbances, acute serous otitis, ear noise or ringing (tinnitus), nausea, abnormal behavior, reduced peripheral vision, visual changes, lens opacity (cataracts).

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if they are possible adverse effects not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaram.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of VIVISOL Liquid Medicinal Oxygen

Keep this medicine out of the sight and reach of children.

Do not use medicinal oxygen after the expiry date stated on the gas cylinder/container/reservoir, following the abbreviation CAD. The expiry date refers to the last day of the month indicated.

Liquid medicinal oxygen

Keep the container/reservoir in a well-ventilated area within a temperature range of -20 °C to +50 °C.

Keep it away from flammable and combustible materials, heat sources, and flames.

Do not smoke near the container/reservoir.

Transport must be carried out in accordance with international regulations for the transport of dangerous goods.

Avoid any contact with oils, greases, or hydrocarbons.

6. Contents of the container and other information

Composition of VIVISOL Medicinal Liquid Oxygen

• The active substance is oxygen, 100% v/v.

• Contains no other active substances.

Appearance of the product and contents of the container

Medicinal oxygen is a gas for inhalation.

It is supplied in liquid form in a special container.

Oxygen is a colorless, tasteless, and odorless gas.

Liquid oxygen is blue in color.

Nominal container capacity in liters	Equivalent amount of gaseous oxygen in m³ at 15°C and 1 atm	Weight of stored product (Kg)
10 L	8.53 m³	11.4 Kg
20 L	17.06 m³	22.8 Kg
21 L	17.91 m³	23.94 Kg
30 L	25.59 m³	34.2 Kg
31 L	26.44 m³	35.34 Kg
35 L	29.85 m³	39.9 Kg
36 L	30.70 m³	41.04 Kg
37 L	31.56 m³	42.18 Kg
41 L	34.97 m³	46.74 Kg
45 L	38.38 m³	51.3 Kg
46 L	39.23 m³	52.44 Kg
60 L	51.18 m³	68.4 Kg
120 L	102.36 m³	136.8 Kg
160 L	136.48 m³	182.4 Kg
180 L	153.54 m³	205.2 Kg
200 L	170.6 m³	228 Kg
220 L	187.66 m³	250.8 Kg
230 L	196.19 m³	262.2 Kg
260 L	221.78 m³	296.4 Kg
280 L	238.84 m³	319.2 Kg
300 L	255.9 m³	342 Kg
320 L	272.96 m³	364.8 Kg
450 L	383.85 m³	513 Kg
600 L	511.8 m³	684 Kg
700 L	597.1 m³	798 Kg
800 L	682.4 m³	912 Kg
1000 L	853 m³	1140 Kg

Medicinal liquid oxygen:

Medicinal liquid oxygen is packaged in mobile cryogenic containers. Mobile cryogenic containers consist of an outer and an inner stainless steel vessel, with vacuum insulation panels between them, and are equipped with a filling port and a retractable tube connection.

These containers hold oxygen in liquid form at very low temperatures.

The container contents range from 10 to 1000 liters.

Each liter of liquid oxygen provides 853 liters of gaseous oxygen at 15 °C and 1 bar.

Only certain container sizes may be commercially available.

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

VIVISOL IBÉRICA, S.L.
C/ Yeso, 2
28500 Arganda del Rey (Madrid)
Spain

Manufacturer

Sol B S.R.L.
Zoning Ouest 15
7860 Lessines, Belgium

Or

VIVISOL IBÉRICA, S.L.
C/ Yeso, 2
28500 Arganda del Rey (Madrid)
Spain

Or

MESSER IBERICA DE GASES, S.A.
Autovia Tarragona-Salou, Km 3.800
Vilaseca, 43480 Tarragona
Spain

Or

MESSER IBERICA DE GASES, S.A.
Pol. Industrial La Granadina III. C/Francia esquina C/Grecia Parcela 11
San Isidro 03349 Alicante
Spain

Or

SOL FRANCE, SUCURSAL EN ESPAÑA
C/ del Telègraf 17-19, PI SOTA EL MOLI
Montmeló, 08160 Barcelona
Spain

Date of most recent review of the package leaflet: September 2020.

This information is intended for healthcare professionals only:

Dosage

The concentration, flow rate, and duration of treatment must be determined by a physician according to the characteristics of each specific pathology.

Hypoxemia is a disorder in which arterial partial pressure of oxygen (PaO₂) is below 10 kPa (< 70 mmHg). An oxygen pressure level of 8 kPa (55–60 mmHg) indicates respiratory failure.

Hypoxemia is treated by enriching the air inhaled by the patient with additional oxygen. The decision to initiate oxygen therapy depends on the degree of hypoxemia and the patient's individual tolerance.

In all cases, the goal of oxygen therapy is to maintain a PaO₂ > 60 mmHg (7.96 kPa) or arterial blood oxygen saturation ≥ 90%.

If oxygen is administered diluted in another gas, the inspired oxygen concentration (FiO₂) must be at least 21%.

Oxygen therapy at normal pressure (normobaric oxygen therapy):

Oxygen administration must be performed with caution. The dose should be adjusted to the individual patient's needs, maintaining oxygen pressure above 8.0 kPa (or 60 mmHg), and hemoglobin oxygen saturation above 90%. Regular monitoring of arterial oxygen pressure (PaO₂), pulse oximetry (arterial oxygen saturation [SpO₂]), and clinical signs is required. The goal is to deliver to each patient the lowest effective oxygen concentration necessary, i.e., the minimum dose required to maintain an oxygen pressure of 8 kPa (60 mmHg) or saturation > 90%. Administration of high oxygen concentrations should be as brief as possible and under strict control of blood gas values.

Oxygen can be safely administered at the following concentrations and for the indicated durations:

• Up to 100% for less than 6 hours.
• 60–70% for 24 hours.
• 40–50% during a second 24-hour period.

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

Neonates are not included in these guidelines because retrolental fibroplasia can occur at much lower FiO₂ levels. To achieve appropriate oxygenation in neonates, the lowest effective oxygen concentrations should be selected.

• Patients with spontaneous breathing:

The effective oxygen concentration is at least 24%. Typically, a minimum of 30% oxygen is administered to ensure therapeutic concentrations with a safety margin.

Short-term administration of high oxygen concentration (> 60%) is indicated in cases of severe asthma attack, pulmonary embolism, pneumonia, pulmonary fibrosis, etc.

Low oxygen concentration is indicated for treating patients with chronic respiratory failure due to chronic obstructive airway disorders or other causes. The oxygen concentration should not exceed 28%, and for some patients, even 24% may be excessive.

Higher oxygen concentrations (in some cases up to 100%) may be administered, although achieving concentrations > 60% (or > 80% in children) is very difficult with most delivery devices.

The dose should be adjusted to the individual patient's needs, with flow rates ranging from 1 to 10 liters of gas per minute.

• Patients with chronic respiratory failure:

Oxygen should be administered at flow rates between 0.5 and 2 liters/minute, and the flow rate must be adjusted according to blood gas values. Effective oxygen concentration should be maintained below 28%, and in some cases even below 24%, in patients with respiratory disorders who depend on hypoxia as a respiratory stimulus.

• Chronic respiratory failure caused by chronic obstructive pulmonary disease (COPD) or other diseases:

Treatment should be adjusted according to blood gas values. Arterial partial pressure of oxygen (PaO₂) should be > 60 mmHg (7.96 kPa) and arterial blood oxygen saturation ≥ 90%.

The most common administration rate is 1 to 3 liters/minute for 15 to 24 hours/day, including paradoxical sleep (the most hypoxemia-sensitive period during the day). During a stable disease phase, CO₂ levels should be monitored twice every 3 or 4 weeks, or three times per month, as CO₂ levels may rise during oxygen administration (hypercapnia).

• Patients with acute respiratory failure:

Oxygen should be administered at a rate between 0.5 and 15 liters/minute, with flow rate adjusted according to blood gas values. In emergencies, patients with severe respiratory distress may require considerably higher doses (up to 60 liters/minute).

• Patients on mechanical ventilation:

If oxygen is mixed with other gases, the fraction of oxygen in the inhaled gas mixture (FiO₂) must not fall below 21%. In practice, 30% tends to be the lower limit. If necessary, the inhaled oxygen fraction can be increased up to 100%.

• Pediatric population: Newborns:

In exceptional cases, newborn infants may receive oxygen concentrations up to 100%, but treatment must be closely supervised. The lowest effective concentrations should be used to achieve adequate oxygenation. In general, oxygen concentrations above 40% in the inhaled air should be avoided, considering the risk of ocular damage (retinopathy) or pulmonary collapse. Arterial blood oxygen pressure must be carefully monitored and maintained below 13.3 kPa (100 mmHg). Fluctuations in oxygen saturation should be avoided. Preventing substantial fluctuations in oxygenation may reduce the risk of ocular damage. (See also section 4.4).

• Cluster headache:

In cluster headache, 100% oxygen is administered at a flow rate of 7 liters/minute for 15 minutes via a tightly fitted face mask. Treatment should be initiated at the onset of the attack.

Hyperbaric oxygen therapy:

Doses and pressure must always be adapted to the patient's clinical condition, and treatment can only be administered after medical consultation. However, the following recommendations are based on current knowledge:

Hyperbaric oxygen therapy is administered at pressures above 1 atmosphere (1.013 bar), typically between 1.4 and 3.0 atmospheres (usually between 2 and 3 atmospheres). Hyperbaric oxygen is delivered in a specially designed pressurized chamber. High-pressure oxygen therapy may also be administered via a tightly fitted face mask with a hood covering the head or via a tracheal tube.

Each treatment session lasts from 45 to 300 minutes, depending on the indication.

Acute hyperbaric oxygen therapy may last only one or two sessions, whereas chronic treatment may require up to 30 sessions or more. If necessary, sessions may be repeated two or three times per day.

• Carbon monoxide poisoning:

In cases of carbon monoxide poisoning, oxygen should be administered as soon as possible at high concentrations (100%) until carboxyhemoglobin levels fall below dangerous levels (approximately 5%). Hyperbaric oxygen (starting at 3 atmospheres) is indicated in patients with acute CO poisoning or those exposed for ≥24-hour intervals. Additionally, hyperbaric oxygen therapy is justified in pregnant patients, patients who have lost consciousness, or those with higher carboxyhemoglobin levels. Normobaric oxygen should not be used between hyperbaric oxygen treatments, as it may contribute to toxicity. Hyperbaric oxygen also appears to have potential for delayed treatment of CO poisoning using multiple low-dose oxygen treatments.

• Patients with decompression sickness:

Rapid treatment at 2.8 atmospheres is recommended, with up to 10 repetitions if symptoms persist.

• Patients with arterial gas embolism:

In this case, doses are adjusted according to the patient's clinical condition and blood gas values. Target values are: PaO₂ > 8 kPa or 60 mmHg, hemoglobin saturation > 90%.

• Patients with osteoradionecrosis:

Hyperbaric oxygen treatment for radiation-induced lesions typically consists of daily 90- to 120-minute sessions at 2.0 to 2.5 atmospheres for approximately 40 days.

• Patients with clostridial myonecrosis:

A 90-minute treatment at 3.0 atmospheres is recommended during the first 24 hours, followed by twice-daily treatments for 4 or 5 days, until clinical improvement is observed.

Method of administration

Normobaric oxygen therapy

Oxygen is administered via the inhaled air, preferably using equipment designed for this purpose (e.g., a nasal cannula or a mask). Using this equipment, oxygen is delivered together with the inhaled air. Subsequently, the expired gas and excess oxygen leave the patient with the exhaled air and mix with the ambient air (a "non-rebreathing" system). In many cases, during anesthesia, special systems with rebreathing or gas recycling are used so that the exhaled air is inhaled again (a "rebreathing" system).

If the patient is unable to breathe independently, artificial respiratory support can be provided. Alternatively, oxygen can be injected directly into the bloodstream using a device known as an oxygenator. The use of extracorporeal gas exchange devices facilitates oxygenation and decarboxylation without the damage associated with aggressive mechanical ventilation strategies. The oxygenator, which acts as an artificial lung, provides improved oxygen transfer, thus maintaining blood gas levels within acceptable clinical ranges. After recovery of lung function, extracorporeal blood flow and gas flow are gradually reduced and finally stopped. This occurs, for example, during cardiac surgery using a cardiopulmonary bypass system, as well as in other circumstances requiring extracorporeal circulation, including acute respiratory failure.

Hyperbaric Oxygen Therapy

Hyperbaric oxygen treatment is administered in a specially pressurized chamber where ambient pressure can be increased up to three times the atmospheric pressure. Hyperbaric oxygen therapy can also be delivered via a tightly fitted facial mask, a hood covering the head, or through a tracheal tube.

General

Medical gases must be used only for medical purposes.

Different types and grades of gases must be stored separately.

Full and empty containers must be stored separately.

Never use grease, oil, or similar substances to lubricate threaded connections that are stuck or difficult to assemble.

Handle valves and devices only with clean, grease-free hands (without hand creams, etc.).

Use only standard equipment designed for medicinal oxygen.

Preparation for Use

Use only administration devices specifically designed for medicinal oxygen.

Ensure that the automatic coupling and administration device are clean and that seals are functioning properly. Never use pressure regulators or flow regulators designed for manual connection, as these may damage the coupling.

Open the valve slowly: at least half a turn.

Check for leaks according to the instructions provided with the regulator.

If a leak is detected, close the valve and disconnect the regulator. Clearly mark defective containers, store them separately, and return them to the supplier.

Use

Smoking and open flames are strictly prohibited in rooms where oxygen treatment is administered.

If not in use, or in case of fire, the device must be turned off.

In case of fire, move it to a safe location.

Large containers must be transported using vehicles specifically designed for this purpose.

Pay special attention to connected devices to prevent accidental disconnection.

When the container is empty, gas flow will cease. Close the outlet valve and remove the couplings after releasing the pressure.

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/