MEDICAL LIQUID OXYGEN AIR LIQUIDE 99.5% v/v, MEDICINAL CRYOGENIC GAS IN FIXED CONTAINERS

Introduction

Package Leaflet: Information for the User

Oxygen Medicinal Liquid Air Liquide 99.5% v/v, Cryogenic Medicinal Gas in Fixed Containers

Read the entire package leaflet carefully before starting to use this medication, as it contains important information for you.

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed to you only, and you should not give it to others, even if they have the same symptoms as you, as it may harm them.
• If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. See section 4.

Contents of the Package Leaflet

1. What Oxygen Medicinal Liquid Air Liquide is and what it is used for
2. What you need to know before starting to use Oxygen Medicinal Liquid Air Liquide
3. How to use Oxygen Medicinal Liquid Air Liquide
4. Possible side effects
5. Storage of Oxygen Medicinal Liquid Air Liquide
6. Contents of the packaging and additional information

1. What Oxygen Medicinal Liquid Air Liquide is and what it is used for

Oxygen Medicinal Liquid Air Liquide is an inhalation gas that belongs to a group of medications called medicinal gases. It is packaged in cryogenic containers that contain only pure oxygen.

Oxygen is an essential element for the body and is administered to increase its levels in the blood and, as a consequence, achieve greater transport of oxygen to all body tissues.

Treatment with oxygen is indicated in the following cases:

• Correction of oxygen deficiency of various origins that require the administration of oxygen at normal or elevated pressure.
• Feeding of respirators in anesthesia-reanimation.
• Administration of inhalation medications via a nebulizer.

2. What you need to know before starting to use Oxygen Medicinal Liquid Air Liquide

Do not useOxygen Medicinal Liquid 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 caused by the accumulation of air in the thoracic cavity between the two pulmonary 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 Medicinal Liquid 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 supply 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. The doctor will adjust the appropriate flow rate of oxygen therapy.
• Adverse events such as eye damage in newborns, both full-term and premature, may occur. If your baby requires oxygen, the doctor will determine the appropriate concentration of oxygen to be administered.

Hyperbaric oxygen therapy requires precautions in cases of:

• Chronic Obstructive Pulmonary Disease(COPD)
• Pulmonary emphysema: a lung disorder due to the loss of elasticity of lung tissue accompanied by a severe lack of air
• Upper Respiratory Tract Infections
• Asthmathat is not well controlled
• Recent Middle Ear Surgery
• Recent Thoracic Surgery
• Uncontrolled High Fever
• History of Epilepsy or Seizures
• Fear of Enclosed Spaces(claustrophobia)
• If you have ever had a pneumothorax(accumulation of air or gas in the thoracic cavity between the two pulmonary membranes)
• Heart Problems

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

• Oxygen is an oxidizing product and favors combustion. Do not smoke or have open flames (e.g., pilot lights, stoves, gas burners, sparks, candles...) in rooms where Oxygen Medicinal Liquid Air Liquide is used, as this increases the risk of fire.

• Do not smoke or use electronic cigarettes during oxygen therapy.
• Do not use toasters, hair dryers, or similar electrical equipment during oxygen therapy.
• 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 with care to avoid the risk of fire.

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

Recommendations for caregivers:

• Handle the tank with care. Ensure that there is no risk of the tank falling and that it is not exposed to shocks.
• 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 insufficient or lack of oxygen administration.
• Oxygen becomes liquid at around -183 °C. There is a risk of frostbite at such low temperatures. Always wear protective gloves and goggles when working with liquid medicinal oxygen.

Children

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

Other medications and Oxygen Medicinal Liquid Air Liquide

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

If you are using or have used bleomycin (to treat cancer), amiodarone (to treat heart disease), or 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 case of Paraquat poisoning, oxygen supply should be avoided as much as possible.

Pregnancy and Breastfeeding

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

Oxygen Medicinal Liquid Air Liquide can be used during breastfeeding.

In all situations, you should inform your doctor if you are pregnant or think you may be pregnant.

If you are pregnant or breastfeeding, think you may be pregnant, or plan 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 Medicinal Liquid Air Liquide, provided your doctor considers you able to do so.

3. How to use Oxygen Medicinal Liquid Air Liquide

Follow your doctor's instructions for administering this medication exactly. If you are unsure, consult your doctor or pharmacist.

Your doctor will determine the correct dose of Oxygen Medicinal Liquid Air Liquide and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen.

Dosage

The usual dose is:

• In patients who breathe spontaneously (spontaneous ventilation) and have acute respiratory failure, oxygen is administered at a flow rate of 0.5 to 15 liters/minute. This may vary depending on the results of the analyses performed (gasometry).
• In patients who breathe spontaneously (spontaneous ventilation) and have chronic respiratory failure, oxygen is administered at a flow rate of 0.5 to 2 liters/minute. This may vary depending on the results of the analyses performed (gasometry).
• In patients who require help breathing (assisted ventilation), oxygen should be administered at a dose that allows achieving a minimum oxygen concentration of 21%, which can reach up to 100%.

Method of Administration

The method of administration is by inhalation.

• In patients without ventilation problems: oxygen can be administered by spontaneous ventilation with the help of nasal glasses, a nasopharyngeal tube, or a mask, which should be adapted to the oxygen flow.
• In patients with ventilation problems or who are anesthetized, oxygen is administered through special devices such as an endotracheal tube, laryngeal mask, through a tracheotomy that allows connection to assisted ventilation, or other devices.
• Administration of oxygen at elevated pressure (hyperbaric oxygen therapy) is performed in a hyperbaric chamber at a pressure of 2 to 3 atmospheres, and the duration of the sessions is between 90 minutes and 2 hours. These sessions can be repeated 2 to 4 times a day, depending on the indications and the patient's clinical condition.

If you think the effect of Oxygen Medicinal Liquid Air Liquide is too strong or too weak, tell your doctor.

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

If you use moreOxygen Medicinal Air Liquidethan you should

If you have used more Oxygen Medicinal Liquid Air Liquide than you should, consult your doctor, pharmacist, or call the Toxicology Information Service, phone 91 562 04 20.

It is necessary to decrease the inhaled oxygen concentration, and treatment of the symptoms is recommended.

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

In situations of vulnerability, excessive administration of Oxygen Medicinal Air Liquide can affect respiratory function and, in exceptional cases, cause adverse neurological effects that can lead to loss of consciousness in extreme situations.

Prolonged use of Oxygen Medicinal Air Liquide in excess can cause pain associated with breathing, dry cough, and even breathing difficulties. If these symptoms of overdose appear, consult your doctor or go to the nearest hospital.

4. Possible Side Effects

Like all medications, this medication can cause side effects, although not everyone will experience them.

Side effects usually appear at high concentrations and after prolonged treatment:

Very Common (may affect more than 1 in 10 people):

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

With hyperbaric treatment: ear pain, myopia, barotrauma (damage caused to body tissues or organs 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):

Lung collapse

With hyperbaric treatment: rupture of the eardrum.

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):

Pain related to breathing and dry cough, dryness in the mucous membranes, local irritation, and inflammation of the mucosa.

With hyperbaric treatment: breathing difficulties, involuntary muscle contraction, dizziness, hearing impairment, acute serous otitis, nausea, abnormal behavior, decreased peripheral vision, visual changes, clouding of the lens (cataract).

Contact with liquid oxygen causes frostbite injuries

Reporting Side Effects

If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Oxygen Medicinal Liquid Air Liquide 99.5% v/v, Cryogenic Medicinal Gas in Fixed Containers

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

Do not use this medication after the expiration date stated on the packaging, after CAD. The expiration date is the last day of the month indicated.

All regulations regarding the handling of pressure vessels must be followed.

• Fixed containers must be installed in clean, well-ventilated areas without flammable materials; the storage of gases intended for medical use must be separate from gases intended for other uses.
• Fixed containers will be protected from ignition sources or heat and from combustible materials.
• Fixed containers will be protected from the risk of shocks, particularly filling, emptying, and safety elements.
• No parking should be allowed in the area where the fixed containers are filled.

6. Container Contents and Additional Information

Composition ofLiquid Medical Oxygen Air Liquide

• The active ingredient is oxygen. The concentration of medicinal oxygen is greater than or equal to 99.5% v/v.
• It does not contain other components.

Appearance of the Product and Container Contents

Liquid Medical Oxygen Air Liquide is an inhalation gas that is transferred to fixed cryogenic containers. The cryogenic containers can be of the following volumes:

Type 800 container contains 680 m3 or 800 liters of gas

Type 1,200 container contains 1,020 m3 or 1,200 liters of gas

Type 3,000 container contains 2,550 m3 or 3,000 liters of gas

Type 5,000 container contains 4,250 m3 or 5,000 liters of gas

Type 7,500 container contains 6,375 m3 or 7,500 liters of gas

Type 10,000 container contains 8,500 m3 or 10,000 liters of gas

Type 15,000 container contains 12,750 m3 or 15,000 liters of gas

Type 20,000 container contains 17,000 m3 or 20,000 liters of gas

Type 32,000 container contains 27,200 m3 or 32,000 liters of gas

Type 50,000 container contains 42,500 m3 or 50,000 liters of gas

Type 63,000 container contains 53,550 m3 or 63,000 liters of gas

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AIR LIQUIDE HealthINTERNATIONAL – 75, Quai D`Orsay

75007 Paris (FRANCE)

Manufacturers

Air Liquide Healthcare España, S.L.

Polígono Industrial A Uceira, Vial 7, parcela B12-13, 32500

O Carballiño, Ourense – Spain

or

Air Liquide Healthcare España, S.L.

Polígono Industrial Son Llaüt, calle Guillem Bujosa i Rosselló, nº 26, 07320

Santa María del Camí, Baleares – Spain

or

Air Liquide Healthcare España, S.L.

Parque Tecnológico de Andalucía, C/ Severo Ochoa, 17, Parcela 8-1 y 8-2, 29590

Campanillas, Málaga – Spain

or

Air Liquide Healthcare España, S.L.

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

Mérida, Badajoz – Spain

or

Air Liquide Healthcare España, S.L.

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

Moncada, Valencia – Spain

or

Air Liquide Healthcare España, S.L.

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

Candelaria, Sta. Cruz de Tenerife – Spain

or

Air Liquide Healthcare España, S.L.

C/ Eduardo Maristany, 107-117, 08930

San Adríán del Besós, Barcelona – Spain

or

Air Liquide Healthcare España, S.L.

Polígono Industrial La Quinta, Avda. Castilla La Mancha 21, 19171

Cabanillas del Campo, Guadalajara - Spain

or

Air Liquide Healthcare España, S.L.

Polígono Industrial Sepes

C/Galileo Galilei, s/n, 46520

Sagunto, Valencia - Spain

or

Air Liquide Healthcare España, S.L.

Ctra Cartagena – Alhama de Murcia, km 13, 30390

La Aljorra, Cartagena, Murcia - Spain

or

GASES OXINORTE, A.E.I

Buen Pastor s/n, 48903

Baracaldo, Vizcaya – Spain

or

Air Liquide Medicinal, S.A.

Avenida Vasco da Gama nº 7375,

4430-755 Avintes – Portugal

or

Air Liquide Medicinal S.A.

Zona Industrial Das Corredouras, 2630-369

Arruda Dos Vinhos – Portugal

Date of the Last Revision of this Prospectus: 05/2025

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

This information is intended solely for healthcare professionals:

Instructions for Use and Handling

1. Verify the correct condition of all materials before use.
2. To perform any handling of the fixed liquid oxygen containers, protective glasses and clean gloves intended for this use must be worn.
3. Verify the condition of the area where the fixed containers will be located.
4. Never touch the cold or frosty parts of the material.
5. In case of cryogenic burn, rinse with plenty of water.
6. Use specific oxygen fittings.
7. If clothing is saturated with oxygen, move away from the liquid oxygen source and from areas that present fire hazards, and remove the clothing.
8. Do not use intermediate fittings that allow connecting two devices that do not fit.
9. Do not smoke near the containers.
10. The containers will be kept away from flames.
11. Greases will not be applied.
12. Gas will never be introduced into a container that is suspected to have combustible bodies inside, especially greasy substances.
13. The containers will never be cleaned with combustible substances, specifically greasy substances.
14. Aerosol generators (hair spray, deodorant, etc.), solvents (alcohol, gasoline, etc.) will not be used on the material or in its vicinity.
15. In case of a leak, close the feed valve of the circuit that presents a leak and check the commissioning of the emergency system.