Leaflet: Information for the user

Liquid Medical Oxygen Solspa 99.5 % v/v, gas for inhalation

Oxygen

Read this 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, consult your doctor or pharmacist.

• This medicine has been prescribed for you only, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor or pharmacist even if they are not listed in this leaflet. See section 4.

1.What is Medical Oxygen and how it is used.

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

3.How to use Medical Oxygen.

4.Possible side effects.

5.Storage of Medical Oxygen.

6.Contents of the container and additional information.

The full name of this medicine is Liquid Medical Oxygen Solspa 99.5 % v/v gas for inhalation.

To make it easier for you to find information, it will be referred to as Medical Oxygen throughout this leaflet.

Medical Oxygen contains oxygen, which is an essential gas for life. Oxygen treatment can be performed at normal pressure and at elevated pressure.

Oxygen Treatment at Normal Pressure(normobaric oxygen treatment).

Oxygen treatment at normal pressure can be used to treat:

•Low oxygen concentrations in the blood or in a specific organor to prevent them.

•Cluster Headaches(a specific headache that causes short but very strong crises on one side of the head).

Oxygen Treatment at High Pressure(hyperbaric oxygen treatment).

Oxygen treatment at elevated pressure should only be administered by qualified healthcare professionals to avoid the risk of injuries from strong pressure fluctuations. Oxygen treatment at elevated pressure can be used for:

•Treatment ofSevere Carbon Monoxide Poisoning(e.g., when the patient is unconscious)

•Gas Embolism caused by a sudden decrease in atmospheric pressure (Decompression Sickness)

•Treatment ofObstructionin the heart or blood vessels caused by gas bubbles (aeroembolism)

•Treatment ofBone Lossafter radiation therapy

•Supportive treatment in cases ofTissue Necrosisdue to infected wounds with gas-producing bacteria.

Do not use Medical Oxygen

Do not use oxygen 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 thoracic cavity between the two lung membranes. If you have ever had pneumothorax, inform your doctor.

Warnings and Precautions

Before starting treatment with oxygen, you should know the following information:

•Oxygen may have harmful effects inhigh concentrations. This could cause lung damage (alveolar collapse, lung inflammation) which would obstruct oxygen supply to the blood.

•If you have chronic obstructive pulmonary disease (COPD) with consequent blood oxygen deficiency, the oxygen flow will be less. Your doctor will adjust the appropriate oxygen flow rate.

•Pay special attention when administering oxygen tonewborns and premature babies. The reason is to minimize the risk of adverse events, such as eye damage. Use the lowest oxygen concentration possible that is effective to achieve adequate oxygenation.

•Pay special attention ifyour blood carbon dioxide levels have increased, as this neutralizes the effect of oxygen.

•If you have respiratory problems triggered by low blood oxygen levels or if you are taking potent analgesics, you will need close monitoring by your doctor.

•If you have ever had lung injuries, inform your doctor.

Consult your doctor or pharmacist before starting to use medical oxygen.

Hyperbaric Oxygen Therapy

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

• Mental health problems(anxiety, psychosis)
• Claustrophobia (fear of enclosed spaces)
• Diabetes(high blood glucose levels); due to the risk of hypoglycemia, blood sugar levels should be measured between two hyperbaric therapy sessions
• Respiratory problems
• If you have ever hadpneumothorax, which is an accumulation of air in the thoracic cavity between the two lung membranes
• Cardiac problems
• High blood pressure
• Eye problems
• Ear, nose, and throat problems

Newborns

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

When using oxygen, always be aware of the increased risk of fire ignition.

Using Medical Oxygen with Other Medications

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication.

If you are takingor have been prescribed bleomycin (to treat cancer), amiodarone(to treat heart conditions), nitrofurantoin (to treat infections), inform your doctor before using oxygen, as there is a possibility of causing lung toxicity.

Oxygen can exacerbate previous lung damage caused by the pesticide Paraquat. In cases of Paraquat poisoning, additional oxygen administration should be avoided as much as possible.

Using Medical Oxygen with Food, Drinks, andalcohol

Do not consumealcoholwhile using this medication. Alcohol can cause respiratory depression.

Pregnancy, Breastfeeding, and Fertility

•During pregnancy, it is permitted to use oxygen at normal pressure (normobaric oxygen therapy) only if necessary.

•There are no contraindications for using oxygen during breastfeeding.

Hyperbaric oxygen therapy should only be used if strictly necessary during pregnancy. Inform your treating doctor or specialist if this is the case.

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

Driving and Operating Machines

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

After receiving treatment with high-pressure oxygen, you may experience visual and auditory disturbances that may affect your ability to drive and operate machines.

Follow exactly the administration instructions of this medication indicated by your doctor or pharmacist. In case of doubt, consult your doctor or pharmacist again. Under no circumstances should you change the oxygen concentration administered to you or your child yourself.

Dosage

Treatment with normal pressure oxygen(normobaric oxygen treatment)

•If the blood or organ oxygen concentration is too low:

Your doctor will indicate the time period and how many times a day you should administer the 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 should never be less than 21% and may be increased up to 100%.

•To treat respiratory problems when blood oxygen levels are reduced (hypoxia) or as a respiratory stimulant (e.g., in pulmonary diseases such as COPD):

The oxygen concentration will be maintained below 28% and sometimes below 24%. Oxygen concentrations for inhalation in the case of newborn babies should be maintained below 40% and may only be increased up to 100% in exceptional cases. The lowest effective oxygen concentration possible should be used to achieve adequate oxygenation. It is recommended to avoid fluctuations in oxygen saturation.

•To treat cluster headaches:

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

How to use normal pressure oxygen treatment

•Medicinal oxygen is a gas for inhalation that is administered with a special device, such as a nasal catheter or a mask. Excess oxygen leaves the body through exhalation and mixes with the ambient air (known as the “no rebreathing” system).

•If you cannot breathe on your own, you will be provided with artificial respiratory assistance. During anesthesia, a special device with rebreathing or recycling systems is used, so that the exhaled air is inhaled again (known as the “rebreathing” system).

•Oxygen can also be administered directly into the bloodstream through the so-called “oxygenator”, in cases such as, for example, cardiac surgery with a cardiopulmonary machine and other situations that require extracorporeal circulation.

How to receive high-pressure oxygen treatment

•High-pressure oxygen treatment should only be administered by healthcare professionals to avoid the risk of injury from strong fluctuations in pressure.

•Depending on your situation, high-pressure oxygen treatment lasts between 45 and 300 minutes per session. Treatment may consist of one or two sessions, but long-term treatment may last up to 30 sessions or more with multiple sessions per day if necessary.

•High-pressure oxygen treatment is administered in a special pressurization room.

•High-pressure oxygen treatment can also be supplied with a mask perfectly fitted to the face and a hood that covers the head or through a tube placed in the mouth.

If you use more medicinal oxygen than you should

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount inhaled.

The toxic effects of oxygen may vary depending on the oxygen pressure inhaled and the duration of exposure. At low pressure (0.5 to 2.0 bars), it is more likely that toxic effects will occur in the lungs (pulmonary zone) than in the brain and spinal cord (central nervous system). At high pressure, the opposite occurs.

The effects on the lungs (pulmonary zone) include respiratory difficulties, coughing, and chest pain.

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

The effects on the eyes include blurred vision and reduced peripheral vision (“tunnel vision”).

In case of oxygen intoxication due to hyperoxia, oxygen therapy should be reduced or, if possible, interrupted and treatment of symptoms initiated.

If you forget to use medicinal oxygen

Use the oxygen as described in the dosage section of the prospectus. Do not use a double dose to compensate for the missed dose, as medicinal oxygen may be harmful at high concentrations.

If you interrupt medicinal oxygen treatment

Do not interrupt treatment with this medication on your own initiative. Consult your doctor or pharmacist.

Precautions for the use of medicinal oxygen

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

Handle the cylinder with care. Ensure that the gas cylinder does not suffer falls or is exposed to blows.

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

Like all medications, this medication may produce adverse effects, although not all people may experience them.

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

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

With hyperbaric treatment:Ear pain, myopia, barotrauma (injuries caused in the body's tissues or organs by a change in pressure).

Frequent(may affect up to 1 in 10 people)

With hyperbaric treatment:Seizures

Not Very Frequent(may affect up to 1 in 100 people)

With normobaric treatment:Pulmonary collapse (atelectasis).

With hyperbaric treatment:Tympanic membrane rupture

Rare(may affect up to 1 in 1000 people)

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

Unknown Frequency(cannot be estimated from available data)

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

With hyperbaric treatment:Difficulty breathing, involuntary muscle contractions, vertigo, auditory alteration, acute serous otitis, ringing or buzzing in the ears (tinnitus), nausea, abnormal behavior, reduced peripheral vision, visual changes, opacity of the crystalline lens (cataracts).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect that does not appear in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

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

Do not use the Medical Oxygen after its expiration date, which appears on the container, after the abbreviation CAD. The expiration date is the last day of the month indicated.

Keep the container/storage area in a well-ventilated zone with a temperature range of -20 °C and +50 °C. Keep it away from flammable and combustible materials, heat sources, or fires. If there is a risk of fire, it should be taken to a safe place.

Do not smoke near the container.

Transportation should be conducted in accordance with international regulations for transporting hazardous materials.

Avoid any contact with oils, fats, or hydrocarbons.

Medical Oxygen Composition

•The active ingredient is oxygen, in a concentration of more than 99.5% v/v.

•No contains excipients.

Aspect of the product and content of the packaging

Medical Oxygen liquid Solspa is a gas for inhalation.

It is supplied in liquid form in a special container.

Oxygen is a colorless, odorless, and tasteless gas.

In liquid form, it is blue.

Medical Oxygen liquid is packaged in cryogenic mobile containers. The cryogenic mobile containers consist of an outer and an inner stainless steel container, with insulation panels between them that produce a vacuum. They are also equipped with a filling port and a return tube. The valves are made of brass, stainless steel, and bronze and are specially designed for low temperatures.

These containers contain liquid oxygen at very low temperatures.

The contents of the containers vary from 10 to 1,100 liters.

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

Only some sizes of containers may be commercially available.

Holder of the marketing authorization

SOL S.p.A.

Via Borgazzi 27

20900 Monza

Italy

Local representative:

Sol France Sucursal en España

Calle Yeso, número 2

28500 Arganda del Rey (Madrid)

Responsible for manufacturing

SOL B srl

Zoning Ouest, 15

7860 Lessines

Belgium

Vivisol Ibérica S.L.

C/ Yeso, 2

Polígono Velasco

Arganda del Rey

28500 Madrid

Spain

SOL Bulgaria JSC.

12 Vladaiska Reka Str.,

1510 Sofia

Bulgaria

SPG - SOLPlin Gorenjska d.o.o.

Cesta Zelezarjev 8,

4270 Jesenice

Slovenia

Dolby Medical Home Respiratory Care Limited

Unit 18, Arkwright Industrial Estate

Arkright Road

Bedford

MK42 0LQ

UK

Dolby Medical Home Respiratory Care Limited

Unit 2, Broadleys Road

Springkerse Industrial Estate

Stirling

FK7 7ST

UK

SOL Bulgaria EAD

South industrial zone, complex Agropolichim AD

9160 Devnja

Bulgaria

Sol France, sucursal España (SOLFSE)

Calle Telégraf, s/n, Nt.17-19,

Polígono Industrial Sota el Molí,

08160 Montmeló, (Barcelona),

Spain

The Irish Company Oxygen ltd.

Waterfall Road, Cork, T12 PP40,

Ireland

SOL Hellas S.A.

ElladosSindos, Industrial zone Sindos

12th km Thessaloniki-Edessa,

Thessaloniki, GR-570 08,

Greece.

SOL Hellas S.A.

Thesi Stefani,ASPROPYRGOS ATTIKI,

GR-193 00, Greece

This medicinal product is authorized in the Member States of the European Economic Area with the following names:

Belgium: Oxygène Médicinal Liquide SOL.

Bulgaria: ?????????? ????????, ????? SOL

Czech Republic: Kyslík medicinální kapalný SOL,100%, Medicinální plyn, kryogenní

Greece: Φαρμακευτικ? Οξυγ?νο σε υγρ? μορφ? SOL

Hungary: Oxigén BTG

Luxembourg: Oxygène Médicinal Liquide SOL

Portugal: Oxygénio medicinal liquid SOL

Romania: Oxigen SOL

Slovakia: Medicinálny kyslík kvapalný SOL

Slovenia: Medicinski kisik SOL 100% medicinski plin, kriogenski

Spain: Oxígeno medicinal líquido Solspa

UK: Liquid Medical Oxygen

Last update date of this leaflet:

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This information is intended solely for healthcare professionals:

Dosage

The concentration, flow rate, and duration of treatment should be determined by a doctor, in accordance with the characteristics of each pathology.

Hypoxemia is a disorder in which the arterial partial pressure of oxygen (PaO2) is less than 10 kPa (<70>

Hypoxemia is treated by enriching the air inhaled by the patient with additional oxygen. The decision to introduce oxygen treatment depends on the degree of hypoxemia and the individual tolerance level of the patient.

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

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

Normobaric oxygen therapy:

Oxygen administration should be done with caution. The dose should be adapted to the individual needs of the patient, the oxygen pressure should be maintained above 8.0 kPa (or 60 mmHg), and the oxygen saturation of hemoglobin should be > 90%. Regularly monitor the arterial oxygen pressure (PaO2) or pulse oximetry (arterial oxygen saturation [SpO2]) and clinical signs. The goal is to have the air inhaled by each patient always have the lowest effective oxygen concentration possible, which is the minimum dose to maintain a pressure of 8 kPa (60 mmHg)/saturation > 90%. High-concentration administration should be as brief as possible, under strict control of blood gas values.

Oxygen can be administered safely in the following concentrations and for the indicated periods:

Up to 100% for less than 6 hours.

Between 60 and 70% for 24 hours.

Between 40 and 50% for the second 24-hour period.

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

Newborns are not included in these guidelines because retrolental fibroplasia occurs with a FiO2much lower. To achieve adequate and appropriate oxygenation in newborns, the lowest effective concentrations should be selected.

•Patients with spontaneous breathing:

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

High-oxygen treatment (> 60%) for short periods is indicated in cases of severe asthma crisis, pulmonary embolism, pneumonia, pulmonary fibrosis, etc.

Low-oxygen treatment is indicated for the treatment of patients with chronic respiratory insufficiency caused by obstructive chronic respiratory disease or other causes. The oxygen concentration should not exceed 28%, and for some patients, even 24% may be excessive.

It is possible to administer higher oxygen concentrations (in some cases up to 100%) although it is difficult to obtain concentrations > 60% (or 80% in the case of children) with the use of most oxygen administration devices.

The dose should be adapted to the individual needs of the patient, at flows ranging from 1 to 10 liters of gas per minute.

•Patients with chronic respiratory insufficiency:

Oxygen should be administered at flows ranging from 0.5 to 2 liters/minute and the flow rate should be adjusted according to blood gas values. The effective oxygen concentration will 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 insufficiency caused by chronic obstructive pulmonary disease (COPD) or other diseases.

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

The most frequent administration rate is 1 to 3 liters/minute for 15 to 24 hours/day, which also includes paradoxical sleep (the most sensitive period to hypoxemia during the day). During a stable period of the disease, it is recommended to control CO2concentrations twice every 3 or 4 weeks or 3 times a month, as CO2concentrations may increase during oxygen administration (hypercapnia).

•Acute respiratory insufficiency:

Oxygen should be administered at a rate ranging from 0.5 to 15 liters/minute and the flow rate should be adjusted according to blood gas values. In emergency cases, patients with severe respiratory difficulties require significantly higher doses (up to 60 liters/minute).

•Patients with mechanical ventilation:

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

•Pediatric population: Newborns:

In exceptional cases, up to 100% oxygen can be administered to newborns, however, treatment should be closely monitored. The lowest effective concentrations should be used to achieve adequate oxygenation. Generally, oxygen concentrations above 40% in the inhaled air should be avoided, taking into account the risk of eye damage (retinopathy) or pulmonary collapse. Arterial oxygen pressure should be closely monitored and maintained below 13.3 kPa (100 mmHg). Significant fluctuations in oxygen saturation should be avoided. By preventing significant fluctuations in oxygenation, the risk of eye damage can be reduced. (See also section 4.4).

•Cluster headache:

In the case of cluster headache, 100% oxygen is administered at a flow rate of 7 liters/minute for 15 minutes using a well-fitting facial mask. Treatment should be started in the initial phase of the crisis.

Hyperbaric oxygen therapy:

Doses and pressure should always be adapted to the clinical condition of the patient 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), between 1.4 and 3.0 atmospheres (usually between 2 and 3 atmospheres). Hyperbaric oxygen is administered in a special pressurized room. Hyperbaric oxygen therapy can also be administered using a well-fitting facial mask with a hood that covers the head or through a tracheal tube.

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

In some cases, acute hyperbaric oxygen therapy lasts only one or two sessions, while chronic therapy can reach 30 sessions or more. If necessary, sessions can be repeated two or three times a day.

•Carbon monoxide poisoning:

If carbon monoxide poisoning occurs, oxygen should be administered as soon as possible in high concentrations (100%), until the carboxyhemoglobin concentration decreases below dangerous levels (around 5%). Hyperbaric oxygen (from 3atmospheres) is indicated in patients with acute CO poisoning or those who have been exposed at intervals of ≥24 hours. Pregnant patients, patients with loss of consciousness, or those with higher carboxyhemoglobin levels justify hyperbaric oxygen treatment. 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 that uses multiple low-dose oxygen treatments.

•Patients with decompression sickness:

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

•Patients with air embolism:

In this case, doses are adapted to the clinical condition of the patient and blood gas values. The target values are: PaO2> 8 kPa or 60 mmHg, hemoglobin saturation > 90%.

•Patients with osteoradionecrosis:

Hyperbaric oxygen therapy of radiation lesions typically consists of daily sessions of 90 to 120 minutes at between 2.0 and 2.5 atmospheres for about 40 days.

•Patients with clostridial myonecrosis:

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

Administration form

Normobaric oxygen therapy

Oxygen is administered through the inhaled air, preferably with an equipment designed for this purpose (e.g. a nasal catheter or a mask). Through this equipment, oxygen is administered with the inhaled air. Subsequently, the gas and excess oxygen leave the patient with the exhaled air and mix with the ambient air (system "without rebreathing"). In many cases, during anesthesia, special systems are used with a rebreathing or recycling system so that the exhaled air is inhaled again (rebreathing system).

If the patient cannot breathe on their own, they can be provided with artificial respiratory assistance. On the other hand, oxygen can be injected directly into the bloodstream through the oxygenator. The application 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 better oxygen transfer, and therefore, blood gas values remain within acceptable clinical intervals. After recovery of pulmonary function, extracorporeal blood and gas flow are reduced and finally stopped. This occurs, for example, during cardiac surgery that uses a cardiopulmonary bypass system, as well as in other circumstances that require extracorporeal circulation, including acute respiratory insufficiency.

Hyperbaric oxygen therapy

Hyperbaric oxygen therapy is administered in a special pressurized room where the ambient pressure can be multiplied up to three times the atmospheric pressure. Hyperbaric oxygen therapy can also be administered through a well-fitting facial mask with a hood that covers the head or through a tracheal tube.

General

Medical gases should only be used for medical purposes.

Different types of gases and gas qualities should be separated from each other.

Full and empty containers should be stored separately.

Never use grease, oil, or similar substances to lubricate stuck or difficult-to-connect threaded parts.

Handle valves and devices with clean hands and without any type of grease (hand cream, etc.).

Only use standard equipment designed for medical oxygen.

Preparation for use

Only use dose administration devices designed for medical oxygen.

Check that the automatic coupling and dose administration device are clean and that the joints function properly. Never use tools with pressure/regulators designed for manual connection, as this can damage the coupling.

Slowly open the valve: at least half a turn.

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

In case of a leak, close the valve and disconnect the regulator. Mark the defective containers, store them separately, and return them to the supplier.

Use

It is strictly forbidden to smoke and start fires in rooms where hyperbaric oxygen therapy is performed.

If not used or in case of fire, the device should be closed.

Take it to a safe place in case of fire.

Larger containers should be transported by specific vehicles for this purpose.

Pay special attention to connected devices so that they do not accidentally disconnect.

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

The detailed and updated information on this medicinal product is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/