Medicinal oxygen gas Vivisol 99.5% compressed medicinal gas: detailed information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno Medicinal gas VIVISOL 99.5% v/v, medicinal compressed gas

Read this entire leaflet carefully before you start using this medicine, as 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; do not pass it on to others, even if they have the same symptoms as you, as it may 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.

Contents of this leaflet

What Oxígeno Medicinal gas VIVISOL is and what it is used for
What you need to know before using Oxígeno Medicinal gas VIVISOL
How to use Oxígeno Medicinal gas VIVISOL
Possible adverse effects
How to store Oxígeno Medicinal gas VIVISOL
Contents of the pack and other information

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

Medicinal oxygen contains oxygen, a gas essential for life. Oxygen treatments can be administered under normal pressure and 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
Treat 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)
Adjunctive treatment in cases of bone necrosis following radiotherapy
Adjunctive treatment in cases of tissue necrosis due to infections with gas-producing bacteria

2. What you need to know before using Oxígeno Medicinal gas VIVISOL

Do not use Oxígeno Medicinal gas VIVISOL

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 accumulation of air in the pleural cavity between the two lung membranes. If you have ever had pneumothorax, inform your doctor.

Warnings and precautions

Talk to your doctor or pharmacist before starting to use Oxígeno Medicinal gas VIVISOL

Oxygen may have harmful effects at high concentrations. This could cause lung damage (alveolar collapse, lung inflation), which would impair oxygen delivery to the blood.
If you suffer from chronic obstructive pulmonary disease (COPD) with resulting low blood oxygenation, the oxygen flow rate will need to be lower. Your doctor will adjust the appropriate oxygen flow.
Special care must be taken when administering oxygen to newborn and premature infants, in order to minimize the risk of adverse events such as eye damage. The lowest effective oxygen concentration that ensures adequate oxygenation should be used.
Pay special attention if your blood carbon dioxide levels are elevated, as this may counteract the effects of oxygen.
If you have respiratory problems triggered by low blood oxygen levels, or if you are taking strong painkillers, close medical supervision will be required.
If you have ever had lung injuries, 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); 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). Your 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 Oxígeno Medicinal gas VIVISOL 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 (for cancer treatment), amiodarone (for heart conditions), or nitrofurantoin (for infections), inform your doctor before using oxygen, as these may increase the risk of pulmonary toxicity.

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

Use of Oxígeno Medicinal gas VIVISOL 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 are planning to become pregnant, consult your doctor or pharmacist before using any medicine.

During pregnancy, oxygen at normal pressure (normobaric oxygen therapy) may be used 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 it is strictly necessary. Inform the treating physician or specialist if this applies.

Driving and using machines

Medicinal 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 Medicinal Oxygen gas VIVISOL

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

Under no circumstances should you change by yourself the oxygen concentration being administered to you or your child.

Dosage

Oxygen therapy at normal pressure (normobaric oxygen therapy)

If the oxygen concentration in the blood or in a specific organ is too low: Your doctor will indicate how long and how many times per day you should receive oxygen, as the dose may vary depending on the individual 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%. For newborn infants, inhaled oxygen concentrations 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 whenever possible.

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 a mask. 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 independently, artificial respiratory support will be provided. During anesthesia, special equipment with rebreathing or recycling systems is used so that exhaled air is inhaled again (known as a "rebreathing" system).
Oxygen may also be administered directly into the bloodstream using what is known as an 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 due to significant pressure fluctuations.
Depending on the situation, hyperbaric oxygen therapy sessions last between 45 and 300 minutes each. Treatment may consist of one or two sessions, but long-term treatment may require up to 30 or more sessions, possibly with multiple sessions per day if necessary.
Hyperbaric oxygen therapy is administered in a special pressurized chamber.
Hyperbaric oxygen therapy may also be delivered via a tightly fitted face mask, a hood covering the head, or a tube placed in the mouth.

If you use more Medicinal Oxygen gas VIVISOL than you should

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the name of 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 affect the lungs (pulmonary effects) than the brain and spinal cord (central nervous system). At high pressure, the opposite occurs.

Effects on the lungs (pulmonary effects) include difficulty breathing, coughing, and chest pain.

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

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 symptomatic treatment initiated.

If you forget to use Medicinal Oxygen gas VIVISOL

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 Medicinal Oxygen gas VIVISOL

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. Smoking and open flames (e.g., pilot lights, stoves, ovens, gas fireplaces, sparks, candles, etc.) must not be present in 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 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 may 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 twitching, dizziness, hearing disturbances, acute serous otitis, noise or ringing in the ears (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 it is a possible adverse effect not listed in this leaflet.

You can 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 Medicinal Oxygen Gas VIVISOL

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.

Medicinal oxygen gas:

Gas cylinders may be stored at temperatures between -20 °C and +65 °C.
They must be stored in an upright position, except for those with a convex back; these must be stored horizontally 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 must be stored in a well-ventilated room used exclusively for the storage of medicinal gases. This storage room must not contain any flammable materials.
Gas cylinders containing different types of gas or gases with different compositions must be stored separately.
Full and empty gas cylinders must be stored separately.
They must not be stored near sources of heat.
They must be stored covered and protected from weather conditions.
The valves on gas cylinders must be closed after use.
When the cylinder is empty, it must be returned to the supplier.
Clear warning signs indicating "No smoking" and "No open flames" must be displayed in the storage area.
Emergency services must be informed of the location of the gas cylinder storage.

6. Contents of the pack and other information

Composition of Medicinal Oxygen Gas VIVISOL

• 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 gaseous form in a special container.

Oxygen is a colourless, tasteless and odourless gas.

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

Gas cylinders with a content of (x) litres provide (y) m³ of oxygen at 15 °C and 1 bar.

Content in liters (x)	1	2	3	5	7	10	14
Number of m³ of oxygen (y)	0.212	0.425	0.636	1.125	1.484	2.12	2.96

Content in liters (x)	15	20	30	40	47	50
Number of cubic meters of oxygen (y)	3.18	4.33	6.37	8.48	9.96	10.61

The neck collar colour code of the gas cylinder is white.

The body of the gas cylinder is white.

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

Only certain package sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

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

Manufacturer Spain

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

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

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

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

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

Date of the most recent revision of the leaflet:

The following information is intended exclusively for healthcare professionals:

Dosage

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

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

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 concentration of oxygen in the inspired air (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; oxygen pressure should be maintained above 8.0 kPa (or 60 mmHg), and hemoglobin oxygen saturation should be > 90%. Regular monitoring of arterial oxygen pressure (PaO₂) or pulse oximetry (arterial oxygen saturation [SpO₂]) and clinical signs is required. The aim is that the inhaled air for each patient always contains the lowest effective oxygen concentration possible, i.e., the minimum dose required to maintain a pressure of 8 kPa (60 mmHg)/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 the 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 occurs at much lower FiO₂ levels. 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%. Typically, a minimum of 30% oxygen is administered to ensure therapeutic concentrations with a safety margin.

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

Low oxygen concentration is indicated for the treatment of patients with chronic respiratory failure caused by chronic obstructive airway disorder 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 it is very difficult to achieve concentrations > 60% (or 80% in children) with most delivery devices.

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

Patients with chronic respiratory failure:

Oxygen should be administered at flow rates ranging from 0.5 to 2 litres/minute, and the flow rate must be adjusted according to blood gas values. The effective oxygen concentration should be maintained below 28%, and in some cases even below 24% for 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. The 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 litres/minute for 15 to 24 hours/day, including paradoxical sleep (the period most sensitive to hypoxemia during a day). During a stable disease phase, CO₂ concentrations should be monitored 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 flow rate ranging from 0.5 to 15 litres/minute, and the flow rate must be adjusted according to blood gas values. In emergencies, patients with severe respiratory distress may require considerably higher doses (up to 60 litres/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%.

Paediatric 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. As a general rule, oxygen concentrations above 40% in the inhaled air should be avoided, considering the risk of ocular damage (retinopathy) or lung 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 litres/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 administered in a specially designed pressurized chamber. High-pressure oxygen therapy can also be delivered 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.

In some cases, acute hyperbaric oxygen therapy lasts only one or two sessions, while chronic treatment may involve up to 30 sessions or more. If necessary, sessions may be repeated two or three times daily.

Carbon monoxide poisoning:

In cases of carbon monoxide poisoning, oxygen should be administered as soon as possible at high concentrations (100%) until carboxyhemoglobin concentration falls below dangerous levels (approximately 5%). Hyperbaric oxygen (from 3 atmospheres) is indicated in patients with acute CO poisoning or those exposed at intervals ≥24 hours. Additionally, pregnant women, patients who lost 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 using multiple low-dose oxygen treatments.

Patients with decompression sickness:

Rapid treatment at 2.8 atmospheres is recommended, repeated up to 10 times 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 therapy 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 inhaled air, preferably using equipment designed for this purpose (e.g., a nasal cannula or face mask). Through this equipment, oxygen is delivered with inhaled air. Excess gas and oxygen are then exhaled and mix with ambient air ("non-rebreathing" system). In many cases during anaesthesia, special systems with rebreathing or recycling are used so that exhaled air is re-inhaled ("rebreathing" system).

If the patient cannot breathe independently, artificial respiratory support may be provided. Alternatively, oxygen can be injected directly into the bloodstream via an oxygenator. The use of extracorporeal gas exchange devices facilitates oxygenation and decarboxylation without the damage associated with aggressive mechanical ventilation strategies. The oxygenator, acting as an artificial lung, provides improved oxygen transfer, thus maintaining blood gas levels within acceptable clinical ranges. After recovery of lung function, extracorporeal blood and gas flow are gradually reduced and eventually stopped. This occurs, for example, during cardiac surgery using a cardiopulmonary bypass system, as well as in other situations requiring extracorporeal circulation, including acute respiratory failure.

Hyperbaric oxygen therapy

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

Preparation prior to use

Follow the supplier's instructions, particularly:

Do not use if the cylinder is visibly damaged or suspected of being damaged, or if it has been exposed to extreme temperatures.
Avoid all contact with oils, greases or hydrocarbons.
Remove the valve seal and protective cap before use.
Only use equipment suitable for a specific gas cylinder and that specific gas.
Ensure the quick connector and regulator are clean and connections are in good condition.
Open the cylinder valve slowly, at least half a turn.
Do not use pliers or other tools to open or close the gas cylinder valve to avoid risk of damage.
Do not modify the container's shape.
Check for leaks. Follow instructions provided with the regulator. Do not attempt to repair valve or equipment leaks yourself unless replacing the seal or O-ring.
In case of leakage, close the valve and disconnect the regulator. If the gas cylinder continues to leak, empty the outer cylinder. Mark defective cylinders, place them in a designated area for claims and return them to the supplier.
For cylinders with pressure-regulating valves, a separate pressure regulator is not required. The built-in pressure-regulating valve has a quick connector for "on-demand" valves, as well as a separate outlet for constant gas flow, where flow can be regulated.

Use of the gas cylinder

Transfer of pressurized gas is prohibited.
Smoking and ignition of flames are strictly prohibited in rooms where medicinal oxygen treatment is administered.
When in use, the cylinder must be secured in an appropriate stand.
Consider replacing gas cylinders when pressure in the cylinder has decreased to the point where the valve indicator enters the yellow zone.
Close the gas cylinder valve when only a small amount of gas remains. It is important that a small amount of pressure remains in the cylinder to prevent entry of contaminants.
Close valves on empty gas cylinders.
Close the gas cylinder valve by hand after use. Depressurize the regulator or connection.

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