Oxigeno Medicinal Gas Air Liquide 99,5% V/V 300 BAR medicinal compressed gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar medicinal compressed gas

Read the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, as it may 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 Gas Air Liquide 99.5% v/v 300 bar is and what it is used for
2. What you need to know before using Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar
3. How to use Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar
4. Possible adverse effects
5. How to store Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar
6. Contents of the pack and other information

1. What Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar is and what it is used for

Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar is an inhalation gas packaged in a gas cylinder at a pressure of 300 bar at 15°C.

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

• Correction of oxygen deficiency of various origins requiring administration of oxygen at normal or increased pressure.
• Supplying anaesthesia and resuscitation ventilators.
• Administration via nebulizer of medications for inhalation.
• Treatment of acute phases of Cluster Headache (Cluster Headaches or Trigeminal Autonomic Cephalalgias).

2. What you need to know before starting to use Medicinal Oxygen Gas Air Liquide 99.5% v/v 300 bar

Do not use Medicinal Oxygen Gas Air Liquide 99.5% v/v 300 bar:

Oxygen at a pressure higher than atmospheric pressure (Hyperbaric Oxygen Therapy) 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

Consult your doctor, pharmacist, or nurse before starting to use Medicinal Oxygen Gas Air Liquide 99.5% v/v 300 bar.

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 will make it more difficult for oxygen to reach 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.
• Adverse events such as eye damage may occur in both full-term and premature newborns. If your baby requires oxygen, the 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 elasticity in lung tissue, accompanied by a lack (severe) of air
• 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. Smoking or open flames (e.g., pilot lights, stoves, ovens, gas burners, sparks, candles, etc.) must not be present in rooms where this medicine 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 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 insufficient or interrupted oxygen delivery.

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 Medicinal Oxygen Gas Air Liquide 99.5% v/v 300 bar

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 infections), inform your doctor before using oxygen, as there is a risk of developing toxic effects in the lungs.

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

Pregnancy and breastfeeding

This medicine may be used during pregnancy, but only if necessary.

This medicine 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 may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Driving and using machines

You may drive and operate machinery while using this medicine, provided your doctor considers you fit to do so.

3. How to use Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar

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

Your doctor will determine the correct dose of this medicine and will administer it through a system suitable for your needs, ensuring the delivery of the correct amount of oxygen.

If you feel that the effect of this medicine is too strong or too weak, inform your doctor.

If you use more Oxígeno Medicinal Gas Air Liquide 99.5% v/v 300 bar than you should

If you have used more medicinal oxygen gas than you should have, contact your doctor, pharmacist, or call the Toxicology Information Service immediately 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 this medicine may impair respiratory function and, in exceptional cases, cause neurological adverse effects that could lead to loss of consciousness in extreme situations.

Prolonged excessive use of this medicine 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 medicine, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience 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):

Respiratory-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 disturbances, acute serous otitis, nausea, abnormal behaviour, decreased peripheral vision, visual disturbances, lens clouding (cataract).

Reporting of adverse effects

If you experience any type of adverse effect, talk to 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 Medicinal Products: 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 Air Liquide 99.5% v/v 300 bar

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.

All regulations concerning the handling of pressure vessels must be observed.

The following considerations apply regarding storage and transport:

Storage of gas cylinders:

• Gas cylinders must be stored in a well-ventilated or ventilated area, protected from weather conditions, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and capable of being secured with a lock.
• Empty and full gas cylinders must be stored separately.
• Gas cylinders must be protected against impact or falling, as well as from sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

Storage of gas cylinders at user facilities and in domestic settings:

• The gas cylinder must be installed in a location that provides protection against impact or falling (such as a stand with securing chains), sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.
• Excessive storage of containers should be avoided.

Transport of gas cylinders:

• Gas cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling. Particular attention must be paid to securing the pressure regulator to prevent accidental rupture.

• During transport in vehicles, gas cylinders must be securely grouped together. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

6. Contents of the container and other information

Composition of Medicinal Oxygen Gas Air Liquide 99.5% v/v 300 bar

The active substance is Oxygen, with a concentration greater than 99.5% v/v and compressed at a pressure of 300 bar (15°C).

It contains no excipients.

Appearance of the product and contents of the container

Medicinal Oxygen Gas Air Liquide 99.5% v/v 300 bar is an inhalation gas packaged in gas cylinders at a pressure of 300 bar at 15°C.

• VIPR: Valve with integrated pressure regulator

Valve instructions for use:

Before use

1. Read the pressure gauge (1) and check the amount of remaining oxygen
2. Ensure gas flow by turning the flow selector (2)
3. Then stop the flow by turning the flow selector (2) back to "0"

Administration to the patient

1. Connect the tube to the flow outlet (3)
2. Turn the flow selector (2) clockwise to the desired flow setting
3. Ensure the patient is receiving oxygen
4. After each use, stop the flow by turning the flow selector (2) back to "0"

Connecting a device to the pressure outlet (4) (e.g., a ventilator)

Reminder: Do not use the flow outlet (3) and the pressure outlet (4) simultaneously

1. First, connect the flexible tube to the device
2. Then, connect the flexible tube to the pressure outlet (4)
3. Oxygen is immediately available
4. After use, it is recommended to disconnect the flexible tube from the pressure outlet (4) to prevent unwanted oxygen consumption

Autonomy **

Depending on the pressure reading on the gauge and the selected flow rate

2-liter cylinder

**Indicative value

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AIR LIQUIDE Santé INTERNATIONAL – 75, Quai D'Orsay

75007 Paris (FRANCE)

Manufacturers

Air Liquide Medical

Tolhuisstraat 46

2627 Schelle

Belgium

Date of latest revision of this leaflet: May 2024

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

This information is intended solely for healthcare professionals:

Instructions for use and handling

Do not smoke.

Do not bring near flame.

Do not grease.

In particular:

• Never introduce this gas into equipment suspected of containing combustible materials, especially those of a greasy nature.

• Never clean with combustible products, especially those of a greasy nature, either the equipment containing this gas or the valves, seals, gaskets, or closure devices.

• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.

• Do not use aerosols (hairspray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

Never expose the cylinder to temperatures above 50°C.

Do not force any part of the cylinder; in case of problems, contact the manufacturer immediately.

Do not place the cylinder in direct sunlight behind glass.

Secure cylinders with safety belts to prevent falls and impacts.

Return cylinders with residual pressure.

Close the valve after use.

Open the valve slowly.

Always keep the protective cap in place.

May cause or intensify fire.

Oxidizing.

Contains gas under pressure: risk of explosion if heated.

Keep valves and accessories free from grease and oil.

Store away from combustible materials.

In case of fire, stop the leak if it can be done safely.

Store in a well-ventilated area.

The cylinders of Medicinal Oxygen Gas Air Liquide 99.5% v/v 300 bar are reserved exclusively for therapeutic use.

To prevent any incidents, the following rules must be strictly observed:

1. Check the equipment is in good condition before use.
2. Never force a gas cylinder into a holder that is too narrow.
3. Handle equipment with clean, grease-free hands.
4. At delivery from the manufacturer, verify that the gas cylinder is equipped with an intact tamper-proof seal.
5. Never lift the gas cylinder by the valve.
6. Use connections or flexible connecting elements specifically designed for oxygen.
7. Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the maximum service pressure (300 bar) of the gas cylinder (unless a regulator is integrated into the valve).
8. Use flexible connecting elements on wall outlets equipped with oxygen-specific nozzles.
9. Open the valve gradually.
10. Never force the valve to open it, nor open it fully.
11. Purge the outlet connection of the gas cylinder before attaching the pressure regulator to remove any dust. Keep connections between the gas cylinder and the pressure regulator clean.
12. Never subject the pressure regulator to multiple successive pressurizations.
13. Never stand directly in front of the valve outlet; always stand to the side opposite the pressure regulator, behind the gas cylinder and to the rear. Never expose patients to the gas flow.
14. Do not use intermediate adapters to connect two devices that do not fit together.
15. Do not attempt to repair a defective valve.
16. Never tighten the pressure regulator-flowmeter with pliers, as this may damage the seal.
17. Check beforehand the compatibility of materials in contact with oxygen, particularly by using oxygen-specific seals for the pressure regulator connections.
18. After use, close the gas cylinder valve, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure regulators) the pressure regulator adjustment screw.
19. In case of leakage, close the supply valve of the circuit with the leak and verify that the emergency device is activated.
20. Never completely empty a gas cylinder.
21. Store empty gas cylinders with the valve closed (to prevent corrosion processes due to internal moisture).
22. Never transfer pressurized gas from one cylinder to another.
23. Ventilate, if possible, the area of use, especially in confined spaces (vehicles, homes).