Product Information for the User

Oxygen Medicinal Liquid Nippon Gases 99.5% v/v, Medical Cryogenic Gas in Portable 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 refer to it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medication has been prescribed only to you and should not be given 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, 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, a medicinal cryogenic gas, is an inhalation gas supplied in stainless steel portable cryogenic 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 requiring oxygen administration at normal or elevated pressure.
• Supply of respirators in anesthesia-reanimation.
• Administration of inhalation medications via nebulizer.

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

No use Oxígeno Medicinal líquido Nippon Gases

This medicine 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 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.

You must not apply any fatty substance (vaseline, ointments, etc.) to the face, due to the risk of inflammation of this medicine (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 medicine 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 suffer from severe epilepsy.
  • If you have a fear of enclosed spaces (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, 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 to ensure it does not exceed 100 mm Hg (i.e., 13.3 kPa).

Other medications and Oxígeno Medicinal Líquido Nippon Gases

Inform your doctor or pharmacist that you are taking, have recently taken, 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 medicine has been widely used without any notable effect.

Driving and operating machinery

There is no information on the effect of Oxígeno Medicinal Líquido Nippon Gases on driving and operating machinery.

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, Liquid Medical Oxygen Nippon Gases may produce adverse effects, although not all people will experience them.

Particularly in chronic respiratory failure, there is a possibility of apnea.

Inhalation of high oxygen concentrations may cause small lung collapses.

Administration of oxygen at high pressures may cause inner ear injuries (possibly posing a risk of tympanic membrane rupture), sinuses, lungs (possibly 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%; PaO2 above 80 mm Hg, that is, 10.64 kPa) or for a prolonged period (more than 10 days at a concentration FiO2 > 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, possibly 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 that does not appear 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.

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 at the user's 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 Nippon Gases:

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

Appearance of the product and contents 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 gas content 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

Ó

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

O

NIPPON GASES PORTUGAL, UNIPESSOAL, LDA.

Rua do Espído, S/N

4470-177 Maia (PORTUGAL)

Last review date of this prospectus:July 2015

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.

Usage/Handling Instructions

Do not smoke.

Do not bring near a flame.

Do not grease.

For the specific case of liquid oxygen, the following additional product-specific precautions should 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 (around -183°C) and can cause cryogenic burns 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 warming to ambient temperature. The expansion of liquid oxygen by heating is 850 times its liquid volume, and therefore precautions should be taken for overpressures in closed volumes (equipment and installations) and overoxygenation of materials and the atmosphere of the premises.

The oxygen medical containers are reserved exclusively for therapeutic use.

To avoid any incidents, the following instructions must be strictly respected:

• 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 apparatuses that contain this gas nor 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.
• Try to ventilate the area 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.
• Handle 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 apparatuses.
• 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 be equipped with additional use elements (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 present a risk of ignition. Remove the clothing as well.
• In the event of a cryogenic burn, abundantly rinse with water.
• Do not allow the backflow of substances into the container. Prevent water from entering the container.

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