Product Information for the User

Nippon Gases Medical Liquid Oxygen 99.5% v/v, Medical Cryogenic Gas in Fixed Cryogenic Container

Oxygen

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 read 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.

6.Contents of the Container and Additional Information.

Liquid Medical Oxygen Nippon Gases 99.5% v/v, inhalation gas is an inhalation gas that is supplied in fixed cryogenic steel stainless 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 via nebulizer of inhalation medications.

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

No useOxygen Medicinal Liquid Nippon Gases

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 pulmonary membranes. If you have suffered a pulmonary collapse previously.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Oxygen Medicinal Liquid Nippon Gases.

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.) to 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 analyzing the arterial blood gases at the same time as measuring the inhaled oxygen concentration. 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., 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 pulmonary 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 suffer from 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 pulmonary membranes (pneumothorax).

Children:

In newborns, especially if they are premature, it may cause eye damage (retrolental fibroplasia) 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).

Other medications and Oxygen Medicinal Liquid Nippon Gases

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 using machines

There is no information on the effect of Oxygen Medicinal Liquid Nippon Gasesondriving and using machines.

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

Your doctor will determine the correct dose of Liquid Medical Oxygen Nippon Gases 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 Liquid Medical Oxygen Nippon Gases is too strong or weak, inform your doctor.

If you use more Liquid Medical Oxygen Nippon Gases 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, Oxígeno Medicinal Líquido Nippon Gasesmayproduce adverse effects, although not all people will experience them.

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

The inhalation of high oxygen concentrations may cause small lung collapses.

The 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 oxygen with a concentration of 100% 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 an extended period (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 appearing in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicinal Products for Human Use: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 vessels must be followed.

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

Storage of containers:

Containers must be installed in well-ventilated areas, the installation location must be surrounded by a fence that can be locked, and the enclosure must be kept clean and free of flammable materials.

Containers must be protected from heat sources or ignition, temperatures equal to or greater than 50º C, and combustible materials, and prevent water from entering the containers.

Transportation of containers:

Do not park vehicles in the oxygen transfer area.

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Composition of Medical Oxygen Liquid Nippon Gases:

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

Aspect of the product and content of the packaging

The containers are fixed cryogenic steel containers of various capacities.

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

• Cryogenic fixed container 2200 liters provides 1870 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 3300 liters provides 2805 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 6100 liters provides 5185 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 11000 liters provides 9350 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 13400 liters provides 11390 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 17000 liters provides 14450 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 20000 liters provides 17000 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 28000 liters provides 23800 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 32000 liters provides 27200 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 37000 liters provides 31450 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 41000 liters provides 34850 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 50000 liters provides 42500 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 60000 liters provides 51000 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 230 liters provides 182 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 600 liters provides 500 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 600 liters provides 510 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 1000 liters provides 756 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 1500 liters provides 1156 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 2000 liters provides 1541 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 3000 liters provides 2250 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 5000 liters provides 4250 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 12700 liters provides 10795 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic fixed container 27000 liters provides 22950 m³ of gas at a pressure of 1 bar at 15°C
• Cryogenic transportable container 13600 liters provides 12970 m³ of gas at a pressure of 1 bar at 15°C

Not all container 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.

Ctra. Madrid-Irun, Km. 418

20212 Olaberria (Guipúzcoa)

Spain

Or

NIPPON GASES ESPAÑA S.L.U.

Pasaje del Metal 14-15

Pol. Ind. San Vicente

08755 Castellbisbal (Barcelona)

Spain

Or

NIPPON GASES ESPAÑA S.L.U.

C/ Gavilanes, 12

Pol. Ind. La Estación

28320 Pinto (Madrid)

Spain

Or

NIPPON GASES ESPAÑA S.L.U.

Pol. Ind. Somonte II

33393 Gijón (Asturias)

Spain

Or

SE CARBUROS METÁLICOS S.A.

C/ Aragón 300, 08009 Barcelona

Spain

Ó

ANDALUZA DE GASES S.A (AGSA)

Pol. Ind. Hacienda de Dolores, Crta Sevilla-Málaga km 6,3

41500 Alcalá de Guadaira, Sevilla.

Spain

Ó

GASES OXINORTE A.I.E C/ Buen Pastor s/n

48903 Baracaldo (Vizcaya)Spain

Ó

SOCIEDAD PORTUGUESA DE OXIGENIO, LDA (SPO)

Rua Professor Antonio Marques, 99. Apartado 1188- Lugar de São Frutuoso-Folgosa

4425-390 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 grease.

For the specific case of liquid oxygen, the following additional product-specific precautions must be considered for its use and handling:

• Oxygen is a heavier gas 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 (around­183°C) and can cause frostbite if it comes into contact with the skin in the event of splashes or handling of the liquid without the appropriate protective equipment.
• One liter of liquid oxygen releases 850 liters of gas by vaporization and heating 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, it is necessary to respect the following instructions:

• 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, nor the apparatus that contains this gas nor the faucets, joints, seals, closure devices, and valves.
• Never apply greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or nearby.
• Verify the good condition of the material before its use.
• 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 intended for that use, adaptation of clothing, etc.) and follow the instructions and precautions described for the operation.
• 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.

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