MEDICAL OXYGEN VIVISOL 99.5% COMPRESSED MEDICAL GAS

Introduction

Package Leaflet: Information for the User

Medicinal Oxygen Gas VIVISOL 99.5% v/v, Compressed Medical Gas

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

-Keep this leaflet, you may need to read it again.

-If you have any further questions, ask your doctor, pharmacist, or nurse.

-This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

-If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Medicinal Oxygen Gas VIVISOL and what is it used for

Medicinal oxygen contains oxygen, which is essential for life. Oxygen treatments can be performed under normal pressure and under high pressure.

Normal Pressure Oxygen Treatment(normobaric oxygen treatment)

Normal pressure oxygen treatment can be used to treat:

• Low oxygen concentrations in the blood or in a specific organor to prevent them
• Cluster headache(a specific type of headache that causes short but very severe crises on one side of the head)

High-Pressure Oxygen Treatment(hyperbaric oxygen treatment)

High-pressure oxygen treatment should only be administered by qualified healthcare professionals to avoid the risk of injury from strong pressure fluctuations. High-pressure oxygen treatment can be used to:

• Treat severe carbon monoxide poisoning(e.g., when the patient is unconscious)
• Treat gas embolismcaused by a sudden drop in atmospheric pressure (decompression sickness)
• Treat obstructionin the heart or blood vessels caused by gas bubbles (air embolism)
• Supportive treatment in cases of bony lossafter radiotherapy
• Supportive treatment in cases of tissue necrosisdue to gas-producing bacterial infections

2. What you need to know before you start using Medicinal Oxygen Gas VIVISOL

Do not use Medicinal Oxygen Gas VIVISOL

Oxygen should not be used at pressures above 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

Consult your doctor or pharmacist before starting to use Medicinal Oxygen Gas VIVISOL

• Oxygen may have harmful effects at high concentrations. This could cause lung damage (alveolar collapse, lung inflation) which would obstruct the supply of oxygen to the blood.
• If you have chronic obstructive pulmonary disease (COPD) with resulting blood oxygen deficiency, the oxygen flow will be lower. Your doctor will adjust the oxygen therapy flow accordingly.
• Pay special attention when administering oxygen to newborns and premature babies. The reason is to minimize the risk of adverse events, such as eye damage. The lowest possible concentration of oxygen that is effective should be used to achieve adequate oxygenation.
• Pay special attention if your blood carbon dioxide levels have increased, as this neutralizes the effect of oxygen.
• If you have respiratory problems triggered by low oxygen levels in the blood, or if you are taking potent analgesics, close monitoring by your doctor will be necessary.
• If you have ever had lung injuries, inform your doctor.

Hyperbaric Oxygen Therapy

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

• Psychiatric problems(anxiety, psychosis)
• Claustrophobia(fear of enclosed spaces)
• Diabetes(high blood sugar 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 thoracic cavity between the two lung membranes
• Heart problems
• High blood pressure
• Eye problems
• Ear, nose, and throat disorders

Children

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

Whenever oxygen is used, there is a higher risk of fire ignition.

Using Medicinal Oxygen Gas VIVISOL with other medicines

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

If you are taking or have been prescribed bleomycin (to treat cancer), amiodarone (to treat heart disease), or nitrofurantoin (to treat infections), inform your doctor before using oxygen, as it may cause toxic effects on the lungs.

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

Using Medicinal Oxygen Gas VIVISOL with food, drinks, and alcohol

Do not consume alcoholwhile 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, it is allowed to use oxygen at normal pressure (normobaric oxygen therapy) only if necessary.
• There are no contraindications to the use of oxygen during the breastfeeding period.

High-pressure oxygen treatment (hyperbaric oxygen therapy) should only be used during pregnancy or if you think you may be pregnant if it is strictly necessary. Inform the treating doctor or specialist if this is the case.

Driving and using machines

Normal pressure medicinal oxygen (normobaric oxygen therapy) does not affect the ability to drive or use machines.

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

3. How to use Medicinal Oxygen Gas VIVISOL

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

Never change the oxygen concentration that is administered to you or your child on your own.

Dosage

Normal Pressure Oxygen Treatment(normobaric oxygen treatment)

• If the oxygen concentration in the blood or in a specific organ is too low: Your doctor will indicate the duration 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 possible concentration of oxygen that is effective. However, the actual oxygen concentration for inhalation should never be less than 21% and may be increased up to 100%.
• To treat respiratory problemswhen there are low oxygen levels in the blood (hypoxia) or as a respiratory stimulus(e.g., in lung diseases such as COPD):

The oxygen concentration will be kept below 28% and sometimes below 24%. The oxygen concentrations for inhalation in newborns should be kept below 40% and can only be increased up to 100% in very exceptional cases. The lowest possible concentration of oxygen that is effective should be used to achieve adequate oxygenation. It is recommended to avoid fluctuations in oxygen saturation.

• To treat cluster headache:

100% oxygen is administered at a flow rate of 7 liters per minute, for a period of 15 minutes, through a mask. Treatment should be started when the first symptoms occur.

How to use normal pressure oxygen treatment

• Medicinal oxygen is a gas for inhalation that is administered with special equipment, such as a nasal catheter or a mask. The excess oxygen leaves the body through exhalation and mixes with the ambient air (known as a "non-rebreathing" system).
• If you are unable to breathe on your own, you will be provided with artificial respiratory assistance. During anesthesia, special equipment with rebreathing or recycling systems is used so that the exhaled air is inhaled again (known as a "rebreathing" system).
• Oxygen can also be administered directly into the bloodstream through an oxygenator, in cases such as cardiac surgery with a heart-lung 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 pressure fluctuations.
• Depending on the 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 can last up to 30 sessions or more, with several sessions per day if necessary.
• Oxygen treatment is administered in a special pressure chamber.
• High-pressure oxygen treatment can also be provided with a tightly fitting mask and hood that covers the head or through a tube placed in the mouth.

If you use more Medicinal Oxygen Gas VIVISOL than you should

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

The toxic effects of oxygen can 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 area) than in the brain and spinal cord (central nervous system). At high pressure, the opposite occurs.

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

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

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

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

If you forget to use Medicinal Oxygen Gas VIVISOL

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

If you stop using Medicinal Oxygen Gas VIVISOL

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

Safety measures for using medicinal oxygen

Oxygen is an oxidizing product and promotes combustion. There should be no smoking or open flames (e.g., pilot lights, stoves, ovens, 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 further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

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

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

Common(may affect up to 1 in 10 people)

With hyperbaric treatment: Convulsions

Uncommon(may affect up to 1 in 100 people)

With normobaric treatment: lung collapse (atelectasis).

With hyperbaric treatment: eardrum rupture

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

With hyperbaric treatment: shortness of breath, abnormally low blood sugar levels in diabetic patients.

Frequency not known(cannot be estimated from the 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, vertigo, hearing impairment, acute serous otitis, ringing or buzzing in the ears (tinnitus), nausea, abnormal behavior, reduced peripheral vision, visual changes, cataracts.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaram.es

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

5. Storage of Medicinal Oxygen Gas VIVISOL

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

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

Medicinal oxygen gas:

-Gas cylinders can be stored at a temperature between -20 °C and +65 °C.

-They must be stored in a vertical position, except for those with a convex rear; these must be stored in a horizontal position or in a container.

-Gas cylinders must be protected from falls or mechanical impacts, for example, by securing them or placing them in a container.

-They should be stored in a well-ventilated room used exclusively for storing medical gases. This storage room must not contain any flammable materials.

-Gas cylinders containing a different type of gas or one with a different composition must be stored separately.

-Full and empty gas cylinders must be stored separately.

-They cannot be stored near heat sources.

-They must be stored covered and protected from the weather.

-The valves of the gas cylinders must be closed after use.

-When the cylinder is empty, it must be returned to the supplier.

-Clear signs of "no smoking" and "no fire" must be posted in the gas cylinder storage area.

-The emergency services must know the location of the gas cylinder storage.

6. Container Content and Additional Information

Composition of Oxígeno Medicinal Gas VIVISOL

? The active ingredient is oxygen, 100% v/v.

? It does not contain other ingredients.

Appearance of the Product and Container Content

Medical oxygen is a gas for inhalation.

It is supplied in gaseous form in a special container.

Oxygen is a colorless, tasteless, and odorless gas.

Medical oxygen gas is stored in gas cylinders in a gaseous state and under a pressure of 200 bar (at 15 °C). The gas cylinders are made of steel or aluminum. The valves are made of brass, steel, or aluminum.

The gas cylinders with a content of (x) liters supply (y) m³ of oxygen at 15 °C and at 1 bar.

The color code of the gas cylinder neck is white.

The body of the gas cylinder is white.

The gas cylinders, valves, and valve outlets comply with the relevant EU standards.

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

VIVISOL IBÉRICA, S.L.

C/ Yeso, 2

28500 Arganda del Rey (Madrid)

Spain

ManufacturerSpain

Sol B S.R.L.Zoning Ouest 15

7860 Lessines, Belgium

O

VIVISOL IBÉRICA, S.L.

C/ Yeso, 2

28500 Arganda del Rey (Madrid)

Spain

O

MESSER IBERICA DE GASES, S.A.

Autovia Tarragona-Salou, Km 3,800,

Vilaseca, 43480 Tarragona

Spain

O

MESSER IBERICA DE GASES, S.A.

Pol. Industrial La Granadina III. C/Francia esquina C/Grecia Parcela 11.

San Isidro 03349 Alicante

Spain

O

SOL FRANCE, SUCURSAL EN ESPAÑA

C/ del Telègraf 17-19, PI SOTA EL MOLI,

Montmeló, 08160 Barcelona

Date of the Last Revision of the Prospectus:

The Following Information is Intended Exclusively for Healthcare Professionals:

Posology

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

Hypoxemia is a disorder in which the partial arterial oxygen pressure (PaO2) is less than 10 kPa (<70 mmhg). an oxygen pressure level of 8 kpa (55 60 mmhg) leads to respiratory failure. hypoxemia is treated by enriching the inhaled air with additional oxygen. decision introduce therapy depends on degree and individual patient's tolerance level.< p>

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

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

Normal Pressure Oxygen Therapy (Normobaric Oxygen Therapy):

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

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

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 in concentrations above 40% after two days.

Neonates are not included in these guidelines because retrolental fibroplasia occurs with a much lower FiO2. To achieve adequate and appropriate oxygenation in neonates, 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 concentrations with a safety margin.

Treatment with high oxygen concentrations (> 60%) for short periods is indicated in cases of severe asthma, pulmonary thromboembolism, pneumonia, pulmonary fibrosis, etc.

A low oxygen concentration is indicated for the treatment of patients with chronic respiratory failure caused by chronic obstructive 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 very difficult to achieve concentrations > 60% (or 80% in the case of children) with the use of most administration devices.

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

• Patients with chronic respiratory failure:

Oxygen should be administered in flows ranging from 0.5 to 2 liters/minute, and it is necessary to adjust the flow rate based on blood gas values. The effective oxygen concentration will be maintained below 28%, and sometimes 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 is adjusted according to blood gas values. The partial arterial oxygen pressure (PaO2) should be > 60 mmHg (7.96 kPa), and the arterial 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 CO2 concentrations twice every 3 or 4 weeks or three times a month, as CO2 concentrations may increase during oxygen administration (hypercapnia).

• Patients with acute respiratory failure:

Oxygen should be administered at a rate ranging from 0.5 to 15 liters/minute, and it is necessary to adjust the flow rate based on blood gas values. In emergency cases, patients with severe respiratory distress require considerably higher doses (up to 60 liters/minute).

• Patients with mechanical ventilation:

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

Pediatric population: Newborns:

In exceptional cases, concentrations of up to 100% can be administered to newborns, however, treatment should be closely monitored. The lowest effective concentrations should be used to achieve adequate oxygenation. As a general rule, oxygen concentrations above 40% in the inhaled air should be avoided, taking into account the risk of eye damage (retinopathy) or lung collapse. Arterial oxygen pressure should be closely monitored and maintained below 13.3 kPa (100 mmHg). Fluctuations in oxygen saturation should be avoided. By preventing substantial 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 through a well-fitting facial mask. Treatment should be started in the initial stage of the crisis.

Hyperbaric Oxygen Therapy:

The doses and pressure must always be adapted to the patient's clinical picture, 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 (normally between 2 and 3 atmospheres). Hyperbaric oxygen is administered in a special pressurized room. Treatment with high-pressure oxygen can also be administered through 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.

Sometimes, acute hyperbaric oxygen therapy lasts only one or two sessions, while chronic treatment can last up to 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 falls below hazardous levels (around 5%). Hyperbaric oxygen (from 3 atmospheres) is indicated in patients with acute CO poisoning or who have been exposed to intervals of ≥24 hours. Additionally, 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 deferred treatment of carbon monoxide 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 air embolism:

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

• Patients with osteoradionecrosis:

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

• Patients with clostridial myonecrosis:

Treatment with 90 minutes at 3.0 atmospheres is recommended during the first 24 hours, followed by treatments twice a day for 4 or 5 days, until clinical improvement is observed.

Method of Administration

Normobaric Oxygen Therapy

Oxygen is administered through inhaled air, preferably with equipment designed for this purpose (e.g., a nasal catheter or mask). Through this equipment, oxygen is administered with inhaled air. Subsequently, the gas and excess oxygen exit the patient with exhaled air and mix with the ambient air (non-rebreathing system). In many cases, during anesthesia, special systems with a rebreathing or recycling system are used so that exhaled air is inhaled again (rebreathing system).

If the patient is unable to 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 so-called 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 levels are maintained within acceptable clinical ranges. After recovery of lung function, extracorporeal blood and gas flow are reduced and finally stopped. This occurs, for example, during cardiac surgery using a cardiopulmonary bypass system, as well as in other circumstances that require extracorporeal circulation, including acute respiratory failure.

Hyperbaric Oxygen Therapy

Hyperbaric oxygen therapy is administered in a special pressurized room where 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.

Preparation Before Use

Follow the provider's instructions, in particular:

• Do not use if the cylinder is visibly damaged or suspected to be damaged, or if it has been exposed to extreme temperatures.
• Avoid any contact with oils, fats, or hydrocarbons.
• Remove the valve seal and protective cap before use.
• Only use the equipment suitable for a specific gas cylinder and that specific gas.
• Check that the quick connector and regulator are clean and that the connections are in good condition.
• Open the cylinder valve slowly, at least half a turn.
• When opening and closing the valve of a gas cylinder, do not use pliers or other tools to avoid the risk of damage.
• The container shape cannot be modified.
• Check for leaks. Follow the instructions on the regulator. Do not attempt to repair the valve or equipment leak on your own unless you replace the stopper or O-ring.
• In case of a leak, close the valve and disconnect the regulator. If the gas cylinder continues to leak gas, empty the external cylinder. Mark defective gas cylinders, place them in a special area for claims, and return them to the provider.
• In cylinders with pressure-regulating valves, it is not necessary to use a separate pressure regulator. The built-in pressure-regulating valve has a quick connector to connect "on-demand" valves but also a separate outlet for constant gas flow, where the flow can be regulated.

Use of the Gas Cylinder

• It is prohibited to transfer gas under pressure.
• It is strictly prohibited to smoke and start fires in the rooms where medical oxygen treatment is carried out.
• When using the cylinder, it must be fixed in an appropriate support.
• Consider replacing the gas cylinders when the pressure in the bottle has decreased to a point where the valve indicator is in the yellow field.
• Close the valve of the gas cylinder when a small amount of gas remains in the cylinder. It is important that a small amount of pressure remains in the cylinder to prevent contaminants from entering.
• Close the valves of empty gas cylinders.
• Close the valve of the gas cylinder by hand after use. Depressurize the regulator or connection.

Detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/