Product Information for the User

Oxygen Medicinal Liquid Oximesa 99.5% v/v, Medical Cryogenic Gas in Portable Cryogenic Container

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

• Keep this product information, as you may need to refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only for you and should not be given to others, even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this product information.

Liquid Medical Oxygen Oximesa 99.5% v/v, gas for inhalation is a gas for inhalation thatis supplied in portable cryogenic steel containers of various capacities

It contains oxygen, in a concentration greater than 99.5% v/v.

It does not contain other excipients.

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-reanimation.
• Administration through nebulizer of medications for inhalation.

Treatment of acute cluster headache (a specific headache that causes short but very strong crises on one side of the head).

No use Oxígeno Medicinal líquido Oximesa

This medication cannot be used at high pressure in cases of untreated pulmonary collapses (untreated pneumothorax). A pulmonary collapse is an accumulation of gas in the thoracic cavity between the two lung membranes. If you have suffered a pulmonary collapse previously.

Warnings and precautions:

Consult your doctor, pharmacist or nurse before starting to use Oxígeno Medicinal Líquido Oximesa.

You must inform your doctor if you suffer from a chronic lung disease such as bronchitis, emphysema or asthma and in severe cases of oxygen deficiency.

Do not apply any fatty substance (vaseline, ointments, etc.) on the face, due to the risk of inflammation of this medication (see section 6).

In certain severe cases of oxygen deficiency, after 6 hours of exposure to a concentration of oxygen of 100%, or after 24 hours of exposure to a concentration of oxygen greater than 70%, pulmonary or neurological toxicity may appear (see sections 3 and 6). Therefore, important concentrations must be used for the shortest possible time and controlled by means of arterial blood gas analysis, at the same time as the oxygen concentration inhaled is measured. It is advisable to use in any case the smallest dose capable of maintaining the partial pressure of arterial oxygen (PaO2) at 50-60 mm Hg (i.e., at 5.65-7.96 kPa) and, after 24 hours of exposure, try to maintain, as far as possible, an oxygen concentration below 45%.

Oxygen is not a substitute for other medications prescribed for the treatment of cluster headaches.

Precautions for use:

• This medication must not be used in the presence of flammable materials: oils, lubricants, tissues, wood, paper, plastic materials (see section 6).
• If oxygen is applied at high pressure (hyperbaric oxygen therapy) there may be injuries caused by the high pressure, in the body cavities that contain air and are in communication with the outside, compression and decompression must be slow. (see section 4).

• If you are going to receive hyperbaric oxygen therapy, you must inform your doctor of any of the following situations:
• • If you suffer from COPD (chronic obstructive pulmonary disease).
  • If you suffer from a pulmonary alteration caused by the loss of elasticity of the lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema).
  • If you have any upper respiratory tract infection.
  • If you have recently undergone middle ear surgery.
  • If you have had thoracic surgery at any time in your life.
  • If you have high and uncontrolled fever.
  • If you have severe epilepsy.
  • If you have claustrophobia.
  • If you have suffered a pulmonary collapse previously (accumulation of air or gas in the thoracic cavity between the two lung membranes (pneumothorax).

Children:

In newborns, especially if they are premature, eye damage (retrolental fibroplasia) may occur with certain oxygen concentrations.

For infants who need a concentration greater than 30%, the partial pressure of arterial oxygen (PaO2) must be regularly controlled so that it does not exceed 100 mm Hg (i.e., 13.3 kPa).

Use of Oxígeno Medicinal Líquido Oximesa with other medications

Inform your doctor or pharmacist that you are taking, have taken recently or may need to take any other medication.

The toxicity of oxygen may be increased by: corticosteroids, some cancer medications, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or vitamin C and E deficiency or glutathione deficiency.

Pregnancy, breastfeeding and fertility

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

This medication has been widely used without any notable effect.

Driving and operating machines

There are no data on the effect of Oxígeno Medicinal Líquido Oximesa on driving and operating machines.

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

Your doctor will determine the correct dose of Liquid Medical Oxygen Oximesa and administer it through an appropriate system that will ensure the correct supply of oxygen.

If you estimate that the action of Liquid Medical Oxygen Oximesaes too strong or weak, inform your doctor.

If you use more Liquid Medical Oxygen Oximesa than you should:

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service, phone 91 562 04 20, indicating the medication and the amount ingested.

In case of overdose, the oxygen concentration inhaled should be reduced and symptomatic treatment is recommended.

Like all medications, Liquid Medical Oxygen Oximesamayproduce adverse effects, although not all people will experience them.

In particular, chronic respiratory failure, possibility of apnea occurrence.

Inhalation of high oxygen concentrations may cause small lung collapses.

Administration of oxygen at high pressures may cause inner ear injuries (potentially posing a risk of tympanic membrane rupture), sinuses, lungs (potentially posing a risk of pneumothorax).

Seizures have been reported after administration of 100% oxygen for more than 6 hours, particularly with high-pressure administration.

Pulmonary injuries may occur after administration of oxygen concentrations above 80%.

Patients subjected to high oxygen pressures in chambers may experience claustrophobia crises.

Other adverse effects in children

In newborns, particularly premature ones, exposed to strong oxygen concentrations (FiO2>40%; PaO2above 80 mm Hg (i.e., 10.64 kPa)) or for prolonged periods (more than 10 days at a FiO2concentration above 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, potentially experiencing regression or causing retinal detachment, or even permanent blindness.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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 not listed in this prospectus. You can also report them directly through theSpanish Medicines and Healthcare Products Agency (AEMPS):www.notificaRAM.es.By reporting adverse effects, you can contribute to providing more information on 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 packaging.

The expiration date is the last day of the month indicated.

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

The following must be taken into account in relation to storage and transportation:

Storage of containers:

Containers must be stored in well-ventilated or ventilated areas, protected from the elements, clean, without flammable materials, reserved for the storage of medical gases and capable of being locked.

Empty and full containers must be stored separately.

Containers must be protected from the risk of impacts or falls, as well as from heat sources or ignition, temperatures equal to or greater than 50°C, and combustible materials and weather conditions. They must be maintained in a vertical position, with the valves closed.

Storage of containers in the user service and at home:

The container must be installed in a location that allows it to be protected in a vertical position from the risks of impacts and falls (such as a support with fixing elements), heat sources or ignition, temperatures equal to or greater than 50°C, combustible materials, and weather conditions, as well as heat sources that cause gasification.

Excessive storage must be avoided.

Transportation of containers:

Do not park vehicles in the oxygen transfer area.

Containers must 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 impacts or falls and to maintain them in a vertical position. During transportation in vehicles, containers must be solidly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Composition of Medical Oxygen Liquid Oximesa:

• The active principle is Oxygen.
• It does not contain excipients.

Aspect of the product and content of the packaging:

The containers are portable cryogenic steel containers of various capacities.

The different sizes are classified by their approximate capacity in liters of liquid oxygen and the content of gas at a supply pressure of 1 bar at 15°C:

• Stationary Unit UE30 of approximately 30 liters with a gasifier provides 25.50 m3 of gas.
• Stationary Unit UE31 of approximately 29 liters with a gasifier provides 24.95 m3 of gas.
• Stationary Unit UE41 of approximately 39 liters with a gasifier provides 33.50 m3 of gas.
• Stationary Unit UE45 of approximately 45 liters with a gasifier provides 38.25 m3 of gas.
• Stationary Unit UE46 of approximately 45 liters with a gasifier provides 37.92 m3 of gas.
• Stationary Unit UE60 of approximately 58 liters with a gasifier provides 49.30 m3 of gas.
• Cryogenic Bottle PGS45 of approximately 147 liters with a gasifier provides 125 m3 of gas.
• Cryogenic Bottle PGS180 of approximately 165 liters with a gasifier provides 140 m3 of gas.
• Cryogenic Bottle PGS240 of approximately 200 liters with a gasifier provides 170 m3 of gas.
• Cryogenic Bottle EaseBulk 600 of approximately 600 liters with a gasifier provides 510 m3 of gas.
• Tank PT666 of approximately 626 liters with a gasifier provides 532 m3 of gas.

Not all packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization:

NIPPON GASES ESPAÑA S.L.U.

C/Orense, 11

28020 Madrid

Spain

Responsible for manufacturing:

NIPPON GASES ESPAÑA S.L.U.

Barrio de Occidente, S/N

14005- Córdoba

Spain

O

NIPPON GASES ESPAÑA S.L.U.

C/ Riu Vinalopó, 67

46930- Quart de Poblet (Valencia)

Spain

O

NIPPON GASES ESPAÑA S.L.U.

Calle Embajadores 474, Villaverde

28053 Madrid

Spain

O

NIPPON GASES ESPAÑA S.L.U.

Polígono Industrial Somonte II

33393- Gijón (Asturias)

Spain

Ó

OXIMESA S.L.

Polígono Juncaril, Parcela 303

18220- Albolote (GRANADA)

Spain

Ó

NIPPON GASES PORTUGAL, UNIPESSOAL, LDA..

Rua do Espído, S/N

4470-177 Maia (PORTUGAL)

Last review date of this prospectus: August 2019

The detailed information of 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/manipulation:

Do not smoke.

Do not approach a flame.

Do not lubricate.

For the specific case of liquid oxygen, the following additional particularities of the product must be taken into account as precautions for its use and manipulation:

• Oxygen is a gas heavier than air, which can accumulate in low points after vaporization of the liquid and make the atmosphere hazardous.
• Oxygen at atmospheric pressure is a liquid at very low temperature (around -183°C) and can cause cryogenic burns if it comes into contact with the skin in the event of splashes or manipulation of the liquid without the appropriate protective equipment.
• One liter of liquid oxygen releases 850 liters of gas by vaporization and warming to ambient temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore precautions must be taken for overpressures in closed volumes (equipment and installations) and overoxygenation of materials and the atmosphere of the premises.

The oxygen containers are reserved exclusively for therapeutic use.

To avoid any incident, the following instructions must be strictly followed:

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are of a greasy nature.
• Never clean with combustible products, especially if they are of a greasy nature, or the apparatus containing this gas or the faucets, joints, seals, closure devices, and valves.
• Never apply greasy substances (vaseline, ointments, etc.) to the patients' faces.
• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or nearby.
• Avoid exposure to heat sources (kitchens, radiators, chimneys, etc.) or prolonged solar heating.
• Ventilate if possible the place of use, if it is a reduced location (vehicles, home).
• Verify the good condition of the material before its use.
• Verify at the time of delivery by the manufacturer that the container is provided with an intact inviolability guarantee system.
• Manipulate the material with clean and grease-free hands.
• For the manipulation of cryogenic containers, use the indicated protective equipment (glasses or visors, clean gloves for that use, adaptation of clothing, etc.) and follow the instructions and precautions described for the operation.
• Group the containers and keep them in a vertical position.
• Use specific connections or flexible connection elements for oxygen.
• Use only equipment specifically approved for this product and for the pressure and temperature of use.
• Provide safety devices against overpressures in each zone of the circuit where there may be remaining liquid oxygen between two valves.
• Never touch the cold or frozen parts of the apparatus.
• Do not use intermediate connections to allow the connection of two devices that do not fit together.
• The small cryogenic containers (Stationary Units) or their auxiliary equipment (portable units or backpacks) may have attached accessory equipment for use (humidifier, flowmeter, nasal mask or goggles, etc.). These equipment will be used according to the prescription conditions (flow rates, doses, etc.).
• Open the valves slowly and close them when the product is not in use.
• Never force any part of the cryogenic container or attempt to repair faulty valves, in case of problems contact the supplier.
• Never use a container with leaks.
• If the clothing becomes saturated with oxygen, move away from the oxygen liquid source and areas that pose a risk of ignition. Remove the clothing as well.
• In the event of cryogenic burns, abundantly rinse with water.
• Do not allow the retrogression of substances into the container. Prevent water from entering the container.

Do not keep the valve of the equipment open if it is not in use.