MEDICAL OXYGEN AIR LIQUIDE 200 BAR COMPRESSED MEDICAL GAS IN GAS CYLINDER

Introduction

Package Leaflet: Information for the User

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

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 or pharmacist.
• This medication has been prescribed to 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 side effects, consult your doctor or pharmacist, even if they are not listed in this package leaflet. See section 4.

Contents of the package leaflet:

1. What is Medicinal Oxygen Air Liquide 200 bar and what is it used for
2. What you need to know before starting to use Medicinal Oxygen Air Liquide 200 bar
3. How to use Medicinal Oxygen Air Liquide 200 bar
4. Possible side effects
5. Storage of Medicinal Oxygen Air Liquide 200 bar
6. Package contents and additional information

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

Medicinal Oxygen Air Liquide 200 bar is an inhalation gas packaged in a gas cylinder at 200 bar pressure 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 that require the administration of oxygen at normal or elevated pressure.
• Feeding of respirators in anesthesia - resuscitation.
• Administration of inhalation medications via nebulizer.
• Treatment of acute phases of Cluster Headaches (Cluster Headache or Headaches in cluster)

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

Do not useMedicinal Oxygen 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 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 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
• High uncontrolled 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 lung membranes)
• Heart problems

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

• Oxygen is an oxidizing product and favors combustion. You should not smoke or have open flames (e.g., pilot lights, stoves, ovens, gas burners, sparks, candles...) in the rooms where Medicinal Oxygen 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 carefully to avoid the risk of fire.

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

Recommendations for caregivers:

• Handle the cylinder with care. Ensure that there is no risk of the cylinder 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.

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 Medicinal Oxygen 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

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

Medicinal Oxygen 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 Medicinal Oxygen Air Liquide, as long as your doctor considers you able to do so.

3. How to use Medicinal Oxygen Air Liquide

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

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

If you think the effect of Medicinal Oxygen Air Liquide 200 bar is too strong or too weak, tell your doctor.

.

If you use moreMedicinal Oxygen Air Liquidethan you should

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

The oxygen concentration inhaled should be decreased, and treatment of symptoms is recommended.

In situations of vulnerability, excessive administration of Medicinal Oxygen 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 Medicinal Oxygen Air Liquide in excess can cause pain associated with breathing, dry cough, and even difficulty breathing. If these symptoms of overdose appear, consult your doctor or go to the nearest hospital.

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

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 unknown (cannot be estimated from available data):

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

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

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 Medication Surveillance System for Human Use: www.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Medicinal Oxygen Air Liquide 200 bar

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

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

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

Regarding storage and transportation, the following should be taken into account:

Storage of gas cylinders:

• Gas cylinders should be stored in a well-ventilated or ventilated area, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked.
• Empty gas cylinders and full gas cylinders should be stored separately.
• Gas cylinders should be protected from the risk of shocks or falls, as well as from heat sources or ignition, temperatures equal to or above 50°C, and combustible materials and weather conditions.
• Gas cylinders with a capacity greater than 5 liters should be kept in a vertical position, with the valves closed.

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

• The gas cylinder should be installed in a location that allows it to be protected from the risk of shocks and falls (such as a support with fixation chains), heat sources or ignition, temperatures equal to or above 50°C, combustible materials, and weather conditions.
• Excessive storage of containers should be avoided.

Transportation of gas cylinders:

• Gas cylinders should be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of shocks or falls. Particular attention should be paid to securing the reducer to avoid accidental rupture risks.
• During transportation in vehicles, gas cylinders should be securely grouped. Permanent ventilation of the vehicle is mandatory, and smoking should be strictly prohibited.

6. Container Content and Additional Information

Composition of Oxígeno Medicinal Air Liquide 200 bar

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

It does not contain other components.

Product Appearance and Container Content

Oxígeno Medicinal Air Liquide 200 bar is an inhalation gas 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:

Valve Type Legend:

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 gauge reading (1) and the selected flow rate (2)

2-liter cylinder

*Indicative value

5-liter cylinder

*Indicative value

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

AIR LIQUIDE HealthcareINTERNATIONAL – 75, Quai D`Orsay

75007 Paris (FRANCE)

Manufacturers

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 the last revision of this prospectus: 04/2024

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This information is intended only for healthcare professionals:

Instructions for Use and Handling

Do not smoke.

Do not approach a flame.

Do not grease.

In particular:

• Never introduce this gas into a device that may contain combustible materials, especially if they are greasy.
• Never clean the devices that contain this gas or the valves, gaskets, seals, and closure devices with combustible products, especially if they are greasy.
• Never apply any greasy substance (vaseline, ointments, etc.) to the face of patients.

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

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

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

1. Verify the good condition of the material before use.
2. Group the gas cylinders with a capacity greater than 5 liters with a suitable means (chains, hooks, etc.) to keep them in a vertical position and avoid any accidental fall. Do not use the gas cylinders if the pressure is less than 10 bar.
3. Never force a gas cylinder into a support that is too narrow for it.
4. Handle the material with clean and grease-free hands.
5. Handle gas cylinders with a capacity of 50 liters or more with clean handling gloves and safety shoes.
6. At the time of delivery by the manufacturer, verify that the gas cylinder is equipped with an intact tamper-evident 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 holding the valve.
9. Use connections or flexible connection elements specifically designed for oxygen.
10. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (unless there is a reducer incorporated into the valve).
11. In the case of blocks of gas cylinders, use only manometers graduated to at least 315 bar.
12. Use flexible connection elements in wall outlets equipped with oxygen-specific nozzles.
13. Open the valve progressively.
14. Never force the valve to open, nor open it completely.
15. Purge the outlet connection of the gas cylinders before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the gas cylinder and the manoreducer clean.
16. Never subject the manoreducer to several successive pressurizations.
17. Never position yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the gas cylinder, and backwards. Never 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 faulty valve.
20. Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.
21. Verify the compatibility of the materials in contact with oxygen, using in particular oxygen-specific connection gaskets for the manoreducer.
22. Close the valve of the gas cylinder after use, allow the pressure of the manoreducer to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated manoreducers) the manoreducer regulation screw.
23. In case of leakage, close the valve of the circuit that has a leak, and check that the emergency device is activated.
24. Never completely empty a gas cylinder.
25. Store empty gas cylinders with the valve closed (to avoid corrosion processes in the presence of humidity inside).
26. Do not transfer gas under pressure from one gas cylinder to another.
27. Ventilate, if possible, the place of use, if it is a reduced location (vehicle, home).