Oxigeno Medicinal Air Liquide 200 bar medicinal compressed gas in gas cylinder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire 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 should not give it to others, even if they have the same symptoms, 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 Air Liquide 200 bar is and what it is used for
2. What you need to know before using Oxígeno Medicinal Air Liquide 200 bar
3. How to use Oxígeno Medicinal Air Liquide 200 bar
4. Possible adverse effects
5. How to store Oxígeno Medicinal Air Liquide 200 bar
6. Contents of the pack and other information

1. What Oxígeno Medicinal Air Liquide 200 bar is and what it is used for

Oxígeno Medicinal Air Liquide 200 bar is a gas for inhalation, supplied in gas cylinders at a pressure of 200 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.
• Delivery via nebulizer of inhaled medications.
• Treatment of acute phases of Cluster Headache (Cluster Headache or Cluster-type headaches).

2. What you need to know before using Oxígeno Medicinal Air Liquide

Do not use Oxígeno Medicinal Air Liquide:

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

Talk to your doctor, pharmacist, or nurse before starting to use Oxígeno Medicinal 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 may impair oxygen delivery to 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 caution 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 (severe) lack 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 fire risk 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 Oxígeno Medicinal Air Liquide is being 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 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 a 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 the remaining oxygen content and delivered flow, potentially leading to inadequate or interrupted oxygen supply.

Children

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

Other medicines and Oxígeno Medicinal 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 toxic effects in the lungs.

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 Air Liquide may be used during pregnancy, but only if necessary.

Oxígeno Medicinal 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 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 Oxígeno Medicinal Air Liquide, provided your doctor considers you fit to do so.

3. How to use Oxígeno Medicinal Air Liquide

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

Your doctor will determine the correct dose of Oxígeno Medicinal Air Liquide 200 bar and will administer it using a system suitable for your needs, ensuring the delivery of the correct amount of oxygen.

If you feel that the effect of Oxígeno Medicinal Air Liquide is too strong or too weak, inform your doctor.

If you use more Oxígeno Medicinal Air Liquide than you should

If you have used more Oxígeno Medicinal Air Liquide 200 bar than you should have, contact your doctor, pharmacist, or call the Toxicology Information Service immediately at telephone number 91 562 04 20.

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

In vulnerable situations, excessive administration of Oxígeno Medicinal Air Liquide 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 Oxígeno Medicinal Air Liquide 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 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 oxygen concentrations: eye damage, which may lead to vision problems.

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

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 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 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 contractions, dizziness, hearing disturbances, acute serous otitis, nausea, abnormal behaviour, decreased peripheral vision, visual changes, lens clouding (cataract).

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 Medicinal Oxygen Air Liquide 200 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 is the last day of the month indicated.

All regulations relating to the handling of pressure vessels must be observed.

The following points must be taken into account 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 for the storage of medical gases, and capable of being locked.
• 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.
• Gas cylinders with a capacity greater than 5 liters must be kept in an upright position with valves closed.

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

• The gas cylinder must be installed in a location that protects it from risks of 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 suitable equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling. Special 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 Air Liquide 200 bar

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

Medicinal Oxygen Air Liquide 200 bar is a gas for inhalation, packaged in gas cylinders at a pressure of 200 bar at 15°C. The gas cylinders may be made of steel, aluminum, or alloys, with the following volumes:

Valve type legend:

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

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

3 Container available with pin index valve.

Duration *

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

2-liter cylinder

*Indicative value

5-liter can

*Indicative value

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 El Prado, C/ Zaragoza, nº 43, 06800
Mérida, Badajoz – 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.
Polígono Industrial Moncada III, C/ Moroder, 1, 46113
Moncada, Valencia – Spain

Or

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

Or

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

Date of latest revision of this leaflet: 04/2024

This information is intended for healthcare professionals only:

Instructions for use and handling

Do not smoke.
Do not bring near a flame.
Do not grease.

In particular:

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

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

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

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

Medical Oxygen gas cylinders are reserved exclusively for therapeutic use.

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

1. Check the equipment is in good condition before use.
2. Secure gas cylinders with a capacity greater than 5 liters in an upright position using appropriate means (chains, hooks, etc.) to prevent unexpected falls. Do not use gas cylinders if their pressure is below 10 bar.
3. Never force a gas cylinder into a holder that is too narrow.
4. Handle equipment with clean, grease-free hands.
5. Handle 50-liter or larger gas cylinders with clean handling gloves and safety shoes.
6. Upon delivery by the manufacturer, verify that the gas cylinder is equipped with an intact tamper-proof seal (security seal).
7. Do not handle a gas cylinder whose valve is not protected by a valve cap, except for cylinders with a capacity below 5 liters.
8. Never lift a gas cylinder by the valve.
9. Use connections or flexible connecting components specifically designed for oxygen.
10. Use a pressure regulator with a flowmeter capable of withstanding at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (unless the valve has an integrated regulator).
11. For gas cylinder banks, use only pressure gauges calibrated to at least 315 bar.
12. Use flexible connecting components on wall outlets equipped with nozzles specifically designed for oxygen.
13. Open the valve gradually.
14. Never force the valve to open it, nor open it fully.
15. Purge the outlet connection of the gas cylinder before attaching the pressure regulator to remove any dust that may be present. Keep the connections between the gas cylinder and the pressure regulator clean.
16. Never subject the pressure regulator to repeated pressurization cycles.
17. Never stand directly in front of the valve outlet; always position yourself on the side opposite the pressure regulator, behind the gas cylinder and slightly to the rear. Never expose patients directly to the gas flow.
18. Do not use intermediate adapters to connect two devices that are not compatible.
19. Do not attempt to repair a defective valve.
20. Never tighten the pressure regulator-flowmeter with pliers, as this may damage the gasket.
21. Verify in advance the compatibility of materials in contact with oxygen, particularly by using oxygen-specific gaskets for the pressure regulator connections.
22. After use, close the gas cylinder valve, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, then close the flowmeter and subsequently loosen (except for integrated pressure regulators) the pressure regulator adjustment screw.
23. In case of leakage, close the supply valve of the circuit with the leak and verify that the emergency device activates.
24. Never completely empty a gas cylinder.
25. Store empty gas cylinders with the valve closed (to prevent corrosion processes due to internal moisture).
26. Never transfer pressurized gas from one cylinder to another.
27. Ventilate the area of use whenever possible, especially in confined spaces (vehicles, homes).