Leaflet: information for the user

Oxígeno Medicinal Air Liquide 200 bar compressed medicinal gas in gas cartridge.

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 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 Oxígeno Medicinal Air Liquide 200 bar and how it is used

2. What you need to know before starting to use Oxígeno Medicinal Air Liquide 200 bar

3. How to use Oxígeno Medicinal Air Liquide 200 bar

4. Possible side effects

5. Storage of Oxígeno Medicinal Air Liquide 200 bar

6. Contents of the container and additional information

Medical Oxygen Air Liquide 200 bar, is an inhalation gas that is packaged in gas cylinders at 200 bars of pressure at 15°C.

Oxygen is an essential element for the body. Oxygen treatment is indicated in the following cases:

• Correction of oxygen deficiency from various sources requiring oxygen administration at normal or elevated pressure.
• Supplying ventilators in anesthesia – resuscitation.
• Administration of inhalation medications via nebulizer.
• Treatment of acute phases of Cluster Headaches (Cluster Headache or Cluster Headaches)

No useOxygen Medical Air Liquide:

Oxygen at a pressure greater than atmospheric pressure (Hyperbaric Oxygen Therapy) should not be used in cases of untreated or undrained pneumothorax. A pneumothorax is due to the accumulation of air in the thoracic cavity between the two lung membranes. If you have ever had a pneumothorax, inform your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Oxygen Medical Air Liquide

Before starting oxygen therapy, you should know the following:

• Oxygen can have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), making it difficult to deliver oxygen to the blood.
• If you have severe chronic obstructive pulmonary disease (COPD) that causes insufficient blood oxygenation, oxygen will be supplied at a low flow rate. Your doctor will adjust the appropriate oxygen therapy flow rate.
• Adverse events may occur, such as eye damage in newborns, both full-term and premature. If your baby requires oxygen, your doctor will determine the appropriate oxygen concentration to administer.

Hyperbaric oxygen therapy requires precautions in the following cases:

• Chronic obstructive pulmonary disease(COPD)
• Pulmonary emphysema: a lung disorder due to loss of lung tissue elasticity accompanied by a severe lack of air
• Upper respiratory tract infections
• Uncontrolled asthma
• Recent ear surgery
• Recent thoracic surgery
• Uncontrolled high fever
• History of epilepsy or seizures
• Claustrophobia(fear of enclosed spaces)
• If you have ever had apneumothorax(accumulation of air or gas in the thoracic cavity between the two lung membranes)
• Heart problems

Recommendations related to the increased risk of fire in the presence of oxygen:

• Oxygen is an oxidizing agent and promotes combustion. Do not smoke or have open flames (e.g., pilot lights, kitchens, ovens, gas stoves, sparks, candles...) in rooms where Oxygen Medical Air Liquide is used, as this increases the risk of fire.

• Do not smoke or use electronic cigarettes during the entire oxygen treatment.
• Do not use toasters, hair dryers, or similar electrical equipment during oxygen treatment.
• Do not apply greasy substances (e.g., oils, creams, ointments) to surfaces in contact with oxygen. Only water-based products should be used on hands and face or inside the nose while using oxygen.
• The pressure regulator should be opened slowly and carefully to avoid the risk of fire.

Burns can occur due to accidental fires in the presence of oxygen.

Recommendations for caregivers:

• Handle the cylinder with care. Ensure there is no risk of cylinder drop and that it is not exposed to impacts.
• Damage to the equipment can cause obstruction in the outlet and/or incorrect information displayed on the manometer regarding the remaining oxygen content and the supplied flow, leading to oxygen insufficiency or lack of administration.

Children

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

Other medications and Oxygen Medical Air Liquide

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

If you are using or have used bleomycin (to treat cancer), amiodarone (to treat heart disease), nitrofurantoin (to treat an infection), inform your doctor before using oxygen, as there is a possibility of toxic effects on the lungs.

Prior lung damage caused by the pesticide Paraquat can worsen with oxygen administration. In cases of Paraquat poisoning, oxygen supply should be avoided as much as possible.

Pregnancy and breastfeeding

Oxygen Medical Air Liquide can be used during pregnancy, but only if necessary.

Oxygen Medical Air Liquide can be used during breastfeeding.

In all cases, inform your doctor if you are pregnant or suspect you may be.

If you are pregnant, breastfeeding, suspect you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

You can drive and use machines while using Oxygen Medical Air Liquide, provided your doctor considers you capable of doing so.

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

Your doctor will determine the correct dose of Medical Air Liquide Oxygen 200 bar and administer it through an appropriate system that will ensure the correct supply of oxygen.

If you estimate that the action of Medical Air Liquide Oxygen 200 bar is too strong or too weak, inform your doctor.

.

If you use moreMedical Air Liquide Oxygenthan you should

If you have used more Medical Air Liquide Oxygen 200 bar than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 immediately.

The oxygen concentration inhaled should be reduced and symptomatic treatment is recommended.

In vulnerable situations, excessive administration ofMedical Air Liquide Oxygenmay affect respiratory function and, in exceptional cases, cause neurological adverse effects that may lead to loss of consciousness in extreme situations.

Prolonged use ofMedical Air Liquide Oxygenin excess may cause respiratory pain, dry cough, and even respiratory difficulty. If these overdose symptoms appear, consult your doctor or go to the nearest hospital.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Adverse effects generally appear at high concentrations and after prolonged treatment:

Very Frequent (can affect more than 1 in 10 people):

In newborns exposed to high oxygen concentrations: eye damage, which can result in vision problems.

With hyperbaric treatment: ear pain, myopia, barotrauma (tissue or organ damage caused by a change in pressure).

Frequent (can affect up to 1 in 10 people):

With hyperbaric treatment: seizures.

Infrequent (can affect up to 1 in 100 people):

Pulmonary collapse

With hyperbaric treatment: eardrum rupture.

Rare (can affect up to 1 in 1,000 people):

With hyperbaric treatment: lack of air, abnormally low blood sugar levels in diabetic patients.

Unknown Frequency (cannot be estimated from available data):

Respiratory-related pain and dry cough, dry mucous membranes, local irritation, and mucous membrane inflammation.

With hyperbaric treatment: breathing difficulty, involuntary muscle contraction, dizziness, auditory alteration, acute serous otitis, nausea, abnormal behavior, peripheral vision decrease, visual changes, clouding of the lens (cataract).

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it 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 about the safety of this medication.

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

Do not use this medication after the expiration date that appears on the label. The expiration date is the last day of the month indicated.

All guidelines related to the handling of pressure vessels must be followed.

The following must be taken into account in relation to storage and transportation:

Storage of gas cylinders:

Storage of gas cylinders at the user's site and at home:

Transportation of gas cylinders:

Composition of Medical Oxygen Air Liquide 200 bar

The active ingredient is medical oxygen. The concentration of medical oxygen is greater than 99.5% v/v.

It does not contain other components.

Appearance of the product and contents of the container

Medical Oxygen Air Liquide 200 bar is an inhalation gas that is packaged in gas cylinders at 200 bar pressure at 15°C. The gas cylinders can be made of steel, aluminum, or alloys of the following volumes:

Legend of valve type:

1Container available with valve without integrated pressure regulator (Standard RPV valves).

2Container available with valve with integrated digital or analog pressure regulator (Compact G2 (Compact and Takeo) and XO (Oyan and Oyan Smart) valves).

3Container available with pin index valve.

Autonomy*

Depending on the pressure reading on the manometer (1) and the selected flow rate (2)

2-liter cylinder

*Indicative value

5-liter cylinder

*Indicative value

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AIR LIQUIDESantéINTERNATIONAL – 75, Quai D`Orsay

75007 Paris (FRANCE)

Manufacturing responsible

Air Liquide Healthcare España, S.L.

Polígono Industrial El Prado, C/ Zaragoza, nº 43, 06800

Mérida, Badajoz – Spain

Ó

Air Liquide Healthcare España, S.L.

Polígono Industrial Güimar, Manzana III, Parcela 16-17, 38509

Candelaria, Sta. Cruz de Tenerife – Spain

Ó

Air Liquide Healthcare España, S.L.

Polígono Industrial Moncada III, C/ Moroder, 1, 46113

Moncada, Valencia – Spain

Ó

Air Liquide Medicinal S.A.

Avenida Vasco da Gama nº 7375, 4430-755

Avintes -Portugal

Ó

Air Liquide Healthcare España, S.L.

C/ San Norberto, 23, 28021

Villaverde, Madrid - Spain

Last review date of this prospectus: 04/2024

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This information is intended solely for healthcare professionals:

Instructions for use and handling

Do not smoke.

Do not approach a flame.

Do not grease.

Particularly:

• Do not introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy in nature.
• Do not clean with combustible products, especially if they are greasy in nature, or the apparatus containing this gas or the valves, joints, gaskets, and closure devices.
• Do not apply any greasy substance (vaseline, ointments, etc.) to the patient's face.

• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

The medical oxygen gas cylinders are reserved exclusively for therapeutic use.

To avoid any incidents, it is necessary to respect the following rules:

1. Verify the good condition of the material before its use.
2. Group the gas cylinders with a capacity greater than 5 liters with an appropriate medium (chains, hooks, etc.) to keep them in a vertical position and prevent any accidental fall, do not use the gas cylinders if their pressure is less than 10 bars.
3. Do not force the gas cylinder into a support that is too narrow for it.
4. Handle the material with clean and grease-free hands.
5. Handle the 50-liter capacity gas cylinders or larger with clean and grease-free gloves and safety shoes.
6. At the time of delivery by the manufacturer, verify that the gas cylinder is provided with an intact inviolability guarantee system (seal).
7. Do not handle a gas cylinder whose valve is not protected by a tulip, except for gas cylinders with a capacity less than 5 liters.
8. Do not lift the gas cylinder by the valve.
9. Use specific connections or flexible connection elements for oxygen.
10. Use a pressure reducer with a flow meter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bars) of the gas cylinder (except if there is an integrated reducer in the valve).
11. In the case of gas cylinder blocks, use only manometers graduated at least to 315 bars.
12. Use flexible connection elements in wall-mounted outlets provided with specific oxygen nozzles.
13. Open the valve gradually.
14. Do not force the valve to open it, nor open it completely.
15. Purge the outlet connection of the gas cylinders before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the gas cylinder and the pressure reducer clean.
16. Do not subject the pressure reducer to multiple successive pressurizations.
17. Do not position yourself in front of the valve outlet, but always on the opposite side of the pressure reducer, behind the gas cylinder, and to the rear. Do not expose patients to the gas flow.
18. Do not use intermediate connections to allow the connection of two devices that do not fit together.
19. Do not attempt to repair a defective valve.
20. Do not tighten the pressure reducer-flow meter with pliers, at the risk of causing damage to the seal.
21. Verify the compatibility of the materials in contact with oxygen beforehand, using in particular special seals for oxygen connections on the pressure reducer.
22. Close the valve of the gas cylinder after its use, allow the pressure of the pressure reducer to decrease while leaving the flow meter open, close the flow meter, and then loosen the adjustment screw of the pressure reducer (except in the case of integrated pressure reducers).
23. In case of leakage, close the valve of the feeding circuit that has a defect in tightness, and check that the emergency device is activated.
24. Do not empty a gas cylinder completely.
25. Store empty gas cylinders with the valve closed (to prevent corrosion processes in the presence of moisture inside).
26. Do not transfer gas under pressure from one gas cylinder to another.
27. Ventilate, if possible, the area of use, if it is a small area (vehicles, home).