Oxygen Medicinal Liquid Air Liquide 99.5% v/v cryogenic medicinal gas in mobile containers

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MEDICINAL LIQUID OXYGENAIR LIQUIDE 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers

Medicinal oxygen

Read all of 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents:

1. What Oxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers is and what it is used for
2. What you need to know before you start using Oxígeno Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers
3. How to use Oxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers
4. Possible side effects
5. How to store Oxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers
6. Contents of the pack and other information

1. What Oxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas in mobile cryogenic containers is and what it is used for

Oxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas in mobile cryogenic containers is an inhalation gas packaged in liquid form in mobile cryogenic containers.

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

• Correction of oxygen deficiency of various origins requiring oxygen administration at normal or increased pressure.
• Supplying anaesthesia and resuscitation respirators.

Administration via nebulizer of inhaled medications.

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

Do not use Oxígeno Medicinal Líquido Air Liquide:

Hyperbaric oxygen therapy (oxygen at a pressure higher than atmospheric pressure) must not be used in cases of untreated or undrained pneumothorax. A pneumothorax is caused by the accumulation of air in the pleural cavity between the two lung membranes. If you have ever had a pneumothorax, inform your doctor.

Warnings and precautions

Talk to your doctor, pharmacist, or nurse before starting to use Oxígeno Medicinal Líquido Air Liquide.

Before starting oxygen therapy, you should be aware of the following:

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

Hyperbaric oxygen therapy requires caution in the following cases:

• Chronic obstructive pulmonary disease (COPD)
• Pulmonary emphysema: a lung disorder due to loss of elasticity of lung tissue, accompanied by (severe) air shortage
• Upper respiratory tract infections
• Poorly controlled asthma
• Recent middle ear surgery
• Recent thoracic surgery
• Uncontrolled high fever
• History of epilepsy or seizures
• Fear of confined spaces (claustrophobia)
• If you have ever had a pneumothorax (accumulation of air or gas in the pleural cavity between the two lung membranes)
• Heart problems

Recommendations regarding increased risk of fire in the presence of oxygen:

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

• Do not smoke or use electronic cigarettes at any time during oxygen treatment.

• Do not use toasters, hair dryers, or similar electrical appliances during oxygen therapy.

• Do not apply oily substances (e.g., oils, creams, ointments) to surfaces in contact with oxygen. Only water-based products should be used on the hands and face or inside the nose while using oxygen.

• The pressure regulator must be opened slowly and carefully to avoid the risk of fire surge.

Thermal burns may result from accidental fires in the presence of oxygen.

Recommendations for caregivers:

• Handle the cylinder carefully. Ensure there is no risk of the cylinder falling and that it is not exposed to impacts.
• Damage to the equipment may cause blockage at the outlet and/or incorrect readings on the pressure gauge regarding remaining oxygen content and delivered flow, potentially leading to inadequate or interrupted oxygen supply.
• Oxygen becomes liquid at approximately -183 °C. There is a risk of frostbite at such low temperatures. Always wear gloves and protective goggles when handling medicinal liquid oxygen.

Children

In premature infants and newborns, oxygen therapy may cause eye damage (retinopathy of prematurity). The doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your baby.

Other medicines and Oxígeno Medicinal Líquido Air Liquide

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

If you are taking or have taken bleomycin (used to treat cancer), amiodarone (used to treat heart conditions), or nitrofurantoin (used to treat infection), inform your doctor before using oxygen, as there is a risk of developing pulmonary toxicity.

Lung damage previously caused by the pesticide paraquat may worsen with oxygen administration. In cases of paraquat poisoning, oxygen supply should be avoided as much as possible.

Pregnancy and breastfeeding

Oxígeno Medicinal Líquido Air Liquide may be used during pregnancy, but only if clearly necessary.

Oxígeno Medicinal Líquido Air Liquide may be used during breastfeeding.

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

If you are pregnant or breastfeeding, think you might be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may drive and operate machinery while using Oxígeno Medicinal Líquido Air Liquide, provided your doctor considers you fit to do so.

3. How to use Air Liquide Medicinal Liquid Oxygen

Follow exactly the administration instructions for this medicine provided by your doctor. If in doubt, consult your doctor again.

Your doctor will determine the correct dose of Air Liquide Medicinal Liquid Oxygen 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers and will administer it to you through a system appropriate to your needs, ensuring the delivery of the correct amount of oxygen.

If you feel that the effect of Air Liquide Medicinal Liquid Oxygen 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers is too strong or too weak, inform your doctor.

If you use more Air Liquide Medicinal Liquid Oxygen than you should

If you have used more Air Liquide Medicinal Liquid Oxygen 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers than you should, contact your doctor, pharmacist immediately, or call the Toxicology Information Service at telephone number 91 562 04 20.

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

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

Prolonged excessive use of Air Liquide Medicinal Liquid Oxygen may cause breathing-related pain, dry cough, and even difficulty breathing. If these overdose symptoms occur, consult your doctor or go to the nearest hospital.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

Adverse effects generally occur 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 may lead to vision problems.

With hyperbaric treatment: ear pain, myopia, barotrauma (tissue or organ damage 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):

Pulmonary collapse.

With hyperbaric treatment: rupture of the tympanic membrane.

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 available data):

Breathing-related pain and dry cough, dryness of mucous membranes, local irritation and inflammation of the mucosa.

With hyperbaric treatment: difficulty breathing, involuntary muscle twitching, dizziness, hearing disturbance, acute serous otitis, nausea, abnormal behaviour, reduced peripheral vision, visual changes, clouding of the lens (cataract).

Contact with liquid oxygen causes frostbite injuries.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report it 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 Air Liquide Medicinal Liquid Oxygen 99.5% v/v Cryogenic Medicinal Gas in Mobile Cryogenic Containers

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

Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month indicated.

Special storage precautions:

• Mobile cryogenic containers must be placed in clean, well-ventilated areas free from flammable materials. Storage of gases intended for medicinal use must be kept separate from gases intended for other purposes.
• Mobile cryogenic containers must be protected from impacts and falls, particularly the filling, emptying, and safety components, as well as from sources of ignition or heat, temperatures above 50°C, and combustible materials.
• During transport of mobile cryogenic containers, potential risks caused by overoxygenation must be monitored and controlled.

Parking must not be allowed in the filling area of mobile cryogenic containers.

6. Contents of the container and other information

Composition of Air Liquide Medicinal Oxygen Liquid 99.5% v/v, cryogenic medicinal gas in mobile cryogenic containers

The active substance is medicinal oxygen. The concentration of medicinal oxygen is greater than 99.5% v/v.

It contains no other components.

Appearance of the product and contents of the container

Air Liquide Medicinal Oxygen Liquid 99.5% v/v, cryogenic medicinal gas in mobile cryogenic containers is a gas for inhalation supplied in liquid form in mobile cryogenic containers. The containers may be made of stainless steel with the following volumes:

Marketing Authorization Holder and Manufacturing Responsible Party

Marketing Authorization Holder

AIR LIQUIDE Santé INTERNATIONAL – 75, Quai D'Orsay
75007 Paris (FRANCE)

Manufacturing Responsible Parties

Air Liquide Healthcare España, S.L.
Polígono Industrial A Uceira, Vial 7, parcela B12-13, 32500
O Carballiño, Ourense – Spain

Air Liquide Healthcare España, S.L.
Polígono Industrial Son Llaüt, calle Guillem Bujosa i Rosselló, nº 26, 07320
Santa María del Camí, Baleares – Spain

Air Liquide Healthcare España, S.L.
Polígono Industrial El Prado, C/ Zaragoza, nº 43, 06800
Mérida, Badajoz – Spain

Air Liquide Healthcare España, S.L.
Polígono Industrial Güimar, Manzana III, Parcela 16-17, 38509
Candelaria, Sta. Cruz de Tenerife – Spain

Air Liquide Healthcare España, S.L.
Polígono Industrial Moncada III, C/ Moroder, 1, 46113
Moncada, Valencia – Spain

Air Liquide Healthcare España, S.L.
Polígono Industrial El Sabinar, Parcela 19, 50290
Épila, Zaragoza – Spain

Air Liquide Medicinal S.A.
Avenida Vasco da Gama nº 7375, 4430-755
Avintes - Portugal

Air Liquide Healthcare España, S.L.
C/ Eduardo Maristany, 107-117, 08930
Sant Adrià del Besós, Barcelona – Spain

Air Liquide Healthcare España, S.L.
Polígono Industrial La Polvorista C/ Calasparra sn, 30500
Molina de Segura, Murcia – Spain

Air Liquide Healthcare España, S.L.
Parque Tecnológico de Andalucía, C/ Severo Ochoa, 17, Parcela 8-1 y 8-2, 29590
Campanillas, Málaga – Spain

Air Liquide Healthcare España, S.L.
C/ San Norberto, 23, 28021
Villaverde, Madrid - Spain

Air Liquide Healthcare España, S.L.
P.I. de Arinaga Manzana 2, Fase I
C/ Las Mimosas nº 29 B, Agüimes, 35118
Las Palmas – Spain

S.E. de Carburos Metálicos S.A.
Polígono Industrial Son Rubiol,
C/ Celleters, 142, 07141
Marratxi, Baleares - Spain

Additional Information for the Patient

To prevent accidents, please follow these instructions:

• Never adjust the flow rate without a new prescription from your doctor.

• Check the external condition of the containers before use.

• Ensure your hands are clean and free of grease before handling cryogenic mobile containers and their accessories.

• Do not force any part of the cryogenic mobile container; if you experience any problems, contact the manufacturer immediately. Any unauthorized manipulation by the user may compromise safety.

• Do not smoke near the containers.

• Do not place containers near sparks or sources of heat (e.g., stoves, radiators, etc.).

• Use oxygen in a well-ventilated or spacious room. Never store cryogenic mobile containers, even when empty, in cabinets, car trunks, etc.

• Never use a container that is leaking.

• If transporting a cryogenic mobile container inside a vehicle, keep a window slightly open at all times.

• Do not leave the mobile container in the car longer than necessary for the journey.

• Secure cryogenic mobile containers inside the vehicle to prevent movement.

• Never expose containers to temperatures above 50°C.

• Do not heat cryogenic mobile containers.

• Do not place the cryogenic mobile container in direct sunlight behind glass.

• Avoid storing an excessive number of containers.

• Never use the product if you notice any malfunction in the container or if, upon delivery, the tamper-evident seal is not intact; in such cases, reject the container and notify the manufacturer immediately.

• Do not touch cold or frosted parts of the container.

• If clothing becomes saturated with oxygen, move away from the liquid oxygen source and from areas with fire risk, and remove the clothing immediately.

• Wear protective goggles and clean gloves designated for this purpose when performing any handling on liquid oxygen cryogenic mobile containers.

• Check the condition of the area where cryogenic mobile containers will be placed.

• In case of cryogenic burns, rinse thoroughly with abundant water.

• Use specific oxygen-compatible intermediate connections.

• Install overpressure protection devices in each section of the liquid oxygen circuit where residual liquid oxygen may remain trapped between two valves.

• Keep the usage area well ventilated.

Date of latest review of this leaflet: 06/2023

This information is intended exclusively for healthcare professionals:

Instructions for Use and Handling

General safety precautions when using mobile cryogenic containers filled with Liquid Medicinal Oxygen:

• Use equipment in good condition.
• Use appropriate connectors for oxygen.
• Verify in advance the compatibility of materials in contact with Medicinal Oxygen, particularly those used in seals and gaskets exposed to the gas.
• Intermediate connections allowing attachment of incompatible devices must never be used.
• Patients must be advised never to use oxygen while applying facial creams or applying vaseline to the nasal passages or lips.

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