MEDICAL OXYGEN GAS SOLGROUP 99.5% V/V GAS FOR INHALATION

Introduction

Package Leaflet: Information for the User

Medicinal Oxygen Gas Solgroup 99.5% v/v Gas for Inhalation

Oxygen

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 or pharmacist.

• 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 get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

The full name of this medicine is Oxygen medicinal Gas Solgroup 99.5% v/v Gas for Inhalation.

For ease of reference, this medicine will be referred to as Oxygen medicinal throughout this leaflet.

1. What Oxygen medicinal is and what it is used for

Oxygen medicinal contains oxygen, which is essential for life. Oxygen treatment can be carried out under normal pressure and under high pressure.

Treatment with oxygen at normal pressure(normobaric oxygen treatment).

Treatment with oxygen at normal pressure can be used to treat:

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

Treatment with oxygen at high pressure(hyperbaric oxygen treatment).

Treatment with oxygen at high pressure should only be administered by qualified healthcare professionals to avoid the risk of injury from strong pressure fluctuations. Treatment with oxygen at high pressure can 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 blockage in the heart or blood vessels caused by gas bubbles (air embolism)
• Supportive treatment in cases of bone loss after radiation therapy
• For supportive treatment in cases of tissue necrosis due to infected wounds with gas-producing bacteria.

2. What you need to know before you use Oxygen medicinal

Do not use Oxygen medicinal

Oxygen at pressures above atmospheric pressure (hyperbaric oxygen therapy) should not be used 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 oxygen treatment, you should be aware of the following information:

• Oxygen may have harmful effects at high concentrations. This could cause lung damage (alveolar collapse, lung inflammation) which would obstruct the supply of oxygen to the blood.
• If you have chronic obstructive pulmonary disease (COPD) with resulting deficiency in blood oxygenation, the oxygen flow will be lower. Your doctor will adjust the oxygen 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 concentration of oxygen possible 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 that have been triggered by a reduced level of oxygen 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.

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

Hyperbaric oxygen therapy

Before starting treatment with oxygen at high pressure, 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 babies and newborns, oxygen therapy can cause eye damage (retinopathy of prematurity). Your doctor will determine the appropriate concentration of oxygen to be administered to ensure that your baby receives the correct treatment.

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

Using Oxygen medicinal with other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might take 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 there is a possibility that it may cause toxic effects on the lungs.

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

Using Oxygen medicinal with food, drinks, and alcohol

Do not consumealcoholwhile using this medicine. Alcohol may cause respiratory depression.

Pregnancy, breast-feeding, and fertility

• During pregnancy, it is permitted 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.

Treatment with oxygen at high pressure (hyperbaric oxygen therapy) should only be used during pregnancy or if you think you may be pregnant, in cases where it is strictly necessary. Inform the treating doctor or specialist if this is the case.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before taking any medicine.

Driving and using machines

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

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

3. How to use Oxygen medicinal

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

Dosage

Treatment with oxygen at normal pressure(normobaric oxygen treatment)

• If the concentration of oxygen 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 Oxygen medicinal, as the dose may vary depending on each patient. The goal is always to use the lowest concentration of oxygen possible 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 problems when oxygen levels are reduced in the blood (hypoxia) or as a respiratory stimulant (e.g., in lung diseases such as COPD):

The oxygen concentration will be maintained below 28% and sometimes below 24%. Oxygen concentrations for inhalation in newborns should be maintained below 40% and can only be increased up to 100% in very exceptional cases. The lowest concentration of oxygen possible 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 treatment with oxygen at normal pressure

• Oxygen medicinal is a gas for inhalation that is administered with special equipment, such as a nasal catheter or 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 treatment with oxygen at high pressure

• Treatment with oxygen at high pressure should only be administered by healthcare professionals to avoid the risk of injury from strong pressure fluctuations.
• Depending on your situation, treatment with oxygen at high pressure 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.
• Treatment with oxygen is administered in a special pressure chamber.
• Treatment with oxygen at high pressure can also be provided 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 Oxygen medicinal 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 medicine and the amount inhaled.

The toxic effects of oxygen can vary depending on the pressure of the inhaled oxygen 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, auditory and visual disturbances, nausea, dizziness, anxiety, and confusion, localized muscle spasms (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 symptoms should be initiated.

If you forget to use Oxygen medicinal

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; Oxygen medicinal could be harmful at high concentrations.

If you stop using Oxygen medicinal

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

Safety measures for the use of oxygen medicinal

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 oxygen medicinal 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 product, 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 by changes 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, dizziness, 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 or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Oxygen medicinal

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

Do not use Oxygen medicinal after the expiry date stated on the gas bottle after the abbreviation EXP. The expiry date is the last day of the month indicated.

• The gas bottles can be stored at a temperature between -20 °C and +65 °C.
• They must be stored in an upright position, except for those with a convex rear; these must be stored in a horizontal position or in a container.
• The gas bottles 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.
• Bottles containing different types of gas or gas with a different composition must be stored separately.
• Full and empty gas bottles must be stored separately.
• They should not be stored near heat sources. If there is a risk of fire, they should be taken to a safe place.
• Store covered and protected from the weather.
• The valves of the gas bottles should be closed after use.
• Return the bottle when it is empty to the supplier.
• Clear signs of "no smoking" and "no fire" should be posted in the gas bottle storage area.
• Emergency services should know the location of the gas bottle storage.

6. Container Contents and Additional Information

Composition of Medicinal Oxygen

• The active ingredient is oxygen, in a concentration greater than 99.5% v/v.
• It does not contain excipients.

Appearance of the Product and Container Contents

Medicinal Oxygen Gas Solgroup is a gas for inhalation.

It is supplied in gaseous form in a special container.

Oxygen is a colorless, odorless, and tasteless gas.

In liquid form, it is blue in color.

Medicinal Oxygen Gas Solgroup is stored in gas bottles in gaseous form and under a pressure of 150, 200, or 300 bar (at 15 °C). The gas bottles are made of steel or aluminum. The valves are made of brass, steel, or aluminum.

*7l, 40l, and 47l available for 150 bar filling pressure only.

The gas bottles meet the requirements of Dir. 1999/36/EC.

The color markings comply with the EN 1089-3 standard: white body and neck.

The valves meet the requirements of the EN ISO 10297 standard.

The traditional and step-down valves comply with the NEN 3268 (NL), DIN 477 (DE), BS 341-3 (UK), NBN 226 (BE), EN ISO 407, and ISO 5145 standards.

The pressure regulator valves also comply with the EN ISO 10524-3 standard.

The gas bottles with a content of (x) liters contain (y) kg of gas and supply (z) m³ of oxygen at 15°C and 1 bar when filled up to 150 bar.

The gas bottles with a content of (x) liters contain (y) kg of gas and supply (z) m³ of oxygen at 15°C and 1 bar when filled up to 200 bar.

The gas bottles with a content of (x) liters contain (y) kg of gas and supply (z) m³ of oxygen at 15°C and 1 bar when filled up to 300 bar.

Only some package sizes may be marketed.

Marketing Authorization Holder

SOL S.p.A.

Via Borgazzi 27

20900 Monza

Italy

Local Representative:

Sol France Branch in Spain

Calle Yeso, number 2

28500 Arganda del Rey (Madrid)

Manufacturer

SOL B srl

Zoning Ouest, 15

7860 Lessines

Belgium

Vivisol Ibérica S.L.

Calle Yeso, Polígono Velasco

Arganda del Rey

28500 Madrid

Spain

SOL S.p.A.

(Via Acquaviva 4

26100 Cremona

Italy

SOL Bulgaria JSC

12 Vladaiska Reka Str.

1510 Sofia

Bulgaria

SPG - SOL Plin Gorenjska d.o.o.

Cesta Zelezarjev 8

4270 Jesenice

Slovenia

SOL Technische Gase GmbH

Marie-Curie Strasse 1

2700 Wiener Neustadt

Austria

Dolby Medical Home Respiratory Care Limited

Unit 18, Arkwright Road Industrial Estate

Arkwright Road

Bedford

MK42 0LQ

United Kingdom

Dolby Medical Home Respiratory Care Limited

Unit 2

Broadleys Road

Springkerse Industrial Estate

Stirling

FK7 7ST

United Kingdom

SOL Bulgaria EAD

South industrial zone, complex Agropolichim AD

9160 Devnja

Bulgaria

Sol France, branch in Spain (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 Hungary Kft.

Mechwart Andràs utca 6

Dunaharaszti, 2330, Hungary

SOL Hellas S.A.

Sindos, 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 under the following names:

Belgium: Oxygène Médicinal Gazeux SOL

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

Czech Republic: Kyslík medicinální plynný SOL, 100%, Medicinální plyn, stlacený

Greece: Φαρμακευτικ? Οξυγ?νο σε α?ρια μορφ? SOL

Hungary: Oxigén SOL

Luxembourg: Oxygène Médicinal Gazeux SOL

Portugal: Oxygénio medicinal gasoso SOL

Romania: Oxigen SOL

Slovakia: Medicinálny kyslík plynný SOL

Slovenia: Medicinski kisik SOL 100% medicinski plin, stisnjeni

Spain: Oxígeno medicinal gas Solgroup

United Kingdom: Medical Oxygen

Date of the last revision of this prospectus:

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This information is intended only for healthcare professionals:

Dosage

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

Hypoxemia is a disorder in which the arterial partial pressure of oxygen (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. The decision to introduce oxygen therapy depends on the degree of hypoxemia and the individual patient's tolerance level.

In all cases, the goal 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%.

Normobaric oxygen therapy:

Oxygen administration must be carried out with caution. The dose must be adapted to the individual needs of the patient, the oxygen pressure must be maintained above 8.0 kPa (or 60 mmHg), and the oxygen saturation of hemoglobin must be > 90%. It is necessary to regularly monitor the arterial oxygen pressure (PaO2) or pulse oximetry (arterial oxygen saturation [SpO2]) and clinical signs. The goal is that the inhaled air always has 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% for 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.

• Patient 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.

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

Low-concentration oxygen therapy is indicated for the treatment of patients with chronic respiratory failure caused by chronic obstructive pulmonary 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 concentrations of oxygen (up to 100%) although it is very difficult to obtain concentrations > 60% (or 80% in the case of children) with the use of most administration devices.

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

• Patient with chronic respiratory failure:

Oxygen should be administered at 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 should 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 arterial partial pressure of oxygen (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 monitor CO2 concentrations twice every 3 or 4 weeks or three times a month, as CO2 concentrations may increase during oxygen administration (hypercapnia).

• Patient 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 situations, patients with severe respiratory distress require considerably higher doses (up to 60 liters/minute).

• Patient 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, considering the risk of eye damage (retinopathy) or lung collapse. The oxygen pressure in the arterial blood 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 at the initial stage of the crisis.

Hyperbaric oxygen therapy:

The doses and pressure should always be adapted to the patient's clinical picture, and treatment can only be administered after medical consultation. However, some recommendations based on current knowledge are as follows:

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. High-pressure oxygen treatment 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 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 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 treatment can be administered two or three times a day.

Normobaric oxygen therapy

Oxygen is administered through inhaled air, preferably using equipment designed for this purpose (e.g., a nasal catheter or mask). Using this equipment, oxygen is administered with the inhaled air. Subsequently, the gas and excess oxygen exit the patient with the 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 the 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 using an 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, the extracorporeal blood and gas flow are reduced and eventually 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 treatment is administered in a special pressurized room where ambient pressure can be multiplied up to three times the atmospheric pressure. Hyperbaric oxygen treatment can also be administered through a tightly 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 gas bottle 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 suitable equipment for a specific gas bottle and that specific gas.
• Check that the quick connector and regulator are clean and that the connections are in good condition.
• Slowly open the valve on the gas bottle, at least half a turn.
• When opening and closing the valve on a gas bottle, do not use pliers or other tools to avoid the risk of damage.
• Do not modify the shape of the container.
• 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 bottle continues to leak gas, empty the outer bottle. Mark the defective gas bottles, place them in a special area for claims, and return them to the provider.
• In bottles with pressure-regulating valves, it is not necessary to use a separate pressure regulator. The built-in pressure-regulating valve has a quick connector for connecting "on-demand" valves but also a separate outlet for constant gas flow, where the flow can be regulated.

Use of the gas bottle

• Transferring gas under pressure is prohibited.
• Smoking and starting fires in the rooms where medical oxygen treatment is being carried out are strictly prohibited.
• When using the bottle, it must be fixed in a suitable support.
• Consider replacing the gas bottles when the pressure in the bottle has decreased to a point where the valve indicator is in the yellow field.
• Close the valve on the gas bottle when a small amount of gas remains in the bottle.

It is important to leave a small amount of pressure in the gas bottle to prevent contaminants from entering.

• Close the valves on empty gas bottles.
• Manually close the valve on the gas bottle 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/