Prospect: information for the user

Oxygen Medical Gas Air Liquide 99.5% v/v 300 bar compressed medical gas

Read this prospect carefully before starting to use this medication, as it contains important information for you.

• Keep this prospect, as you may need to read it again.
  If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you alone, and you must 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 not listed in this prospect. See section 4.

1. What is Oxygen Medical Gas Air Liquide 99.5% v/v 300 bar and how it is used

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

3. How to use Oxygen Medical Gas Air Liquide 99.5% v/v 300 bar

4. Possible adverse effects

5. Storage of Oxygen Medical Gas Air Liquide 99.5% v/v 300 bar

6. Contents of the container and additional information

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

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

• Correction of oxygen deficiency of different origins that require oxygen administration at normal or elevated pressure.
• Supply of respirators in anesthesia – resuscitation.
• Administration via nebulizer of inhalation medications.
• Treatment of the acute phases of Cluster Headaches (Cluster Headache or Cluster Headaches)

No useOxygen Medical Gas Air Liquide 99.5% v/v 300 bar:

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 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 Oxygen Medical Gas Air Liquide 99.5% v/v 300 bar.

Before starting oxygen therapy, you should know the following:

• Oxygen can be harmful at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), making it difficult to deliver 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 oxygen therapy flow rate.
• Adverse events may occur, such as eye damage in newborns, both term and preterm. 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 lung tissue elasticity accompanied by a severe lack of air
• Upper respiratory tract infections
• Uncontrolled asthma
• Recent ear surgery
• Recent thoracic surgery
• Uncontrolled high fever
• History of epilepsy or seizures
• Claustrophobia (fear of enclosed spaces)
• If you have ever had apneumothorax(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 agent and promotes combustion. Do not smoke or have open flames (e.g., pilot lights, kitchens, ovens, gas stoves, sparks, candles...) in rooms where this medication 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 treatment.
• 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 may occur due to accidental fires in the presence of oxygen.

Recommendations for caregivers:

• Handle the cylinder with care. Ensure there is no risk of cylinder drop and that it is not exposed to impacts.
• A 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 oxygen insufficiency or lack of administration.

Children

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

Other medications and Oxygen Medical Gas Air Liquide 99.5% v/v 300 bar

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

If you are using or have used bleomycin (to treat cancer), amiodarone (to treat heart diseases), 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 may worsen with oxygen administration. In cases of Paraquat poisoning, oxygen supply should be avoided as much as possible.

Pregnancy and breastfeeding

This medication can be used during pregnancy, but only if necessary.

This medication can be used during breastfeeding.

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

If you are pregnant or breastfeeding, believe you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and operating machines

You can drive and operate machines while using this medication as long as your doctor considers you capable of doing so.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will determine the correct dose of this medication and administer it through an appropriate system that will ensure the supply of the correct amount of oxygen.

If you estimate that the action of this medication is too strong or too weak, inform your doctor.

If you use moreMedical Oxygen Gas Air Liquide 99.5% v/v 300 bar than you should

If you have used more Medical Oxygen Gas than you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 immediately.

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

In vulnerable situations, excessive administration of this medication may affect respiratory function and, in exceptional cases, cause neurological adverse effects that may lead to loss of consciousness in extreme situations.

Prolonged use of this medication in excess may cause respiratory pain, dry cough, and even respiratory difficulty. If these overdose symptoms appear, consult your doctor or go to the nearest hospital.

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

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Adverse effects generally appear at high concentrations and after prolonged treatment:

Very frequent (can 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 (tissue or organ damage caused by a change in pressure).

Frequent (can affect up to 1 in 10 people):

With hyperbaric treatment: seizures.

Rare (can affect up to 1 in 100 people):

Pulmonary collapse

With hyperbaric treatment: eardrum rupture.

Rare (can affect up to 1 in 1,000 people):

With hyperbaric treatment: lack of air, abnormally low blood sugar levels in diabetic patients.

Unknown frequency (cannot be estimated from available data):

Respiratory-related pain and dry cough, dryness in mucous membranes, local irritation, and mucous membrane inflammation.

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect that does not appear in this prospectus. You can also report it directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

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

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

All guidelines related to the handling of pressure containers must be followed.

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

Storage of gas cylinders:

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

Transportation of gas cylinders:

• During transportation in vehicles, gas cylinders must be solidly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

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

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

It does not contain any excipients.

Appearance of the product and contents of the container

Oxygen Medical Gas Air Liquide 99.5% v/v 300 bar is a gas for inhalation that is packaged in gas cylinders at 300 bar pressure at 15°C.

* VIPR: Integrated Pressure Regulator Valve

Instructions for use of the valve:

Before use

1. Read the pressure indicator (1) and check the remaining oxygen quantity
2. Ensure that there is gas flow by turning the flow selector (2)
3. Then stop the flow by turning the flow selector (2) again to "0"

Patient administration

1. Connect the tube to the outlet flow (3)

2. Turn the flow selector (2) clockwise to the desired flow selection

3. Ensure that the patient receives oxygen

4. After each use, stop the flow by turning the flow selector (2) again to "0"

Connection of a device to the pressure outlet (4) (e.g. a ventilator)

Reminder: Do not use the outlet flow (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 already available

4. After use, it is recommended to disconnect the flexible tube from the pressure outlet (4) to avoid unwanted consumption.

Autonomy **

Depending on the pressure reading on the manometer and the selected flow

2-liter cylinder

**Indicative value

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AIR LIQUIDESantéINTERNATIONAL – 75, Quai D`Orsay

75007 Paris (FRANCE)

Manufacturing responsible persons

Air Liquide Medical

Tolhuisstraat 46

2627 Schelle

Belgium

Last review date of this leaflet: May 2024

The detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) (http://www.aemps.gob.es/)

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This information is intended solely for healthcare professionals:

Instructions for use and handling

Do not smoke.

Do not approach a flame.

Do not lubricate.

Especially:

• Do not introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy.
• Do not clean with combustible products, especially if they are greasy, or the apparatus containing this gas or the valves, joints, seals, and closure devices.
• Do not apply any greasy substance (vaseline, ointments, etc.) to the patient's face.

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

Do not expose the cylinder to a temperature 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 the sun behind a glass

Hold the cylinders with safety belts to prevent falls and impacts

Return with residual pressure

Close the valve after use

Open the valve slowly

Always keep the protective cap

May cause or aggravate a fire

Combustible

Contains compressed gas: risk of explosion in case of heating

Keep the valves and accessories free of grease and oil

Store away from combustible materials

In case of fire, stop the leak, if there is no risk of doing so

Store in a well-ventilated area

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

To avoid any incident, it is necessary to respect the following norms:

1. Verify the good condition of the material before its use.
2. Do not force the cylinder into a support that is too narrow for it.
3. Handle the material with clean and grease-free hands.
4. At the time of delivery by the manufacturer, verify that the cylinder is provided with an intact inviolability guarantee system (seal).
5. Do not lift the cylinder by the valve.
6. Use specific connections or flexible connection elements for oxygen.
7. Use a pressure reducer with a flowmeter that can accommodate a pressure of at least 1.5 times the maximum service pressure (300 bars) of the cylinder (unless there is an integrated reducer on the valve).
8. Use flexible connection elements in wall outlets provided with specific nozzles for oxygen.
9. Open the valve gradually.
10. Do not force the valve to open it, nor open it completely.
11. Purge the outlet connection of the cylinders before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the cylinder and the pressure reducer clean.
12. Do not subject the pressure reducer to multiple successive pressurizations.
13. Do not position yourself in front of the valve outlet, but always on the opposite side of the pressure reducer, behind the cylinder and towards the back. Do not expose patients to the gas flow.
14. Do not use intermediate connections to allow the connection of two devices that do not fit together.
15. Do not attempt to repair a defective valve.
16. Do not clamp the pressure reducer-flowmeter with pliers, at risk of causing damage to the seal.
17. Verify the compatibility of the materials in contact with oxygen beforehand, using in particular special seals for oxygen on the pressure reducer.
18. Close the valve of the cylinder after use, allow the pressure of the pressure reducer to decrease by leaving the flowmeter open, close the flowmeter and then loosen the adjustment screw of the pressure reducer (unless it is an integrated pressure reducer).
19. In case of a leak, close the supply valve of the circuit with a defect in tightness, and check that the emergency device is activated.
20. Do not empty a cylinder completely.
21. Keep empty cylinders with the valve closed (to avoid corrosion processes in the presence of moisture inside).
22. Do not transfer gas under pressure from one cylinder to another.
23. Ventilate, if possible, the area of use, if it is a small area (vehicles, home).