MEDICAL LIQUID OXYGEN OXIMESA 99.5% v/v, MEDICINAL CRYOGENIC GAS IN A PORTABLE CRYOGENIC CONTAINER

Introduction

Prospectus: Information for the User

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

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

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

Contents of the Prospectus

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

1. What is Medicinal Liquid Oxygen Oximesa and what is it used for

Medicinal Liquid Oxygen Oximesa 99.5% v/v, inhalation gas is an inhalation gas that is supplied in portable stainless steel 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.

Treatment with oxygen is indicated in the following cases:

• Correction of oxygen deficiency of various origins that require the administration of oxygen at normal or high pressure.
• Feeding of respirators in anesthesia-reanimation.
• Administration of inhalation medications via nebulizer.

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

2. What you need to know before starting to use Medicinal Liquid Oxygen Oximesa

Do not use Medicinal Liquid Oxygen Oximesa

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

Warnings and precautions:

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

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

No fatty substances (vaseline, ointments, etc.) should be applied 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 occur (see sections 3 and 6). Therefore, high concentrations should be used for the shortest possible time and controlled through blood gas analysis, while measuring the inhaled oxygen concentration. It is advisable to use the lowest effective dose to maintain the arterial partial oxygen pressure (PaO2) at 50-60 mm Hg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, 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 should 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 body cavities that contain air and are in communication with the outside, and compression and decompression should be slow (see section 4).

• If you are going to receive high-pressure oxygen therapy (hyperbaric oxygen therapy), you should inform your doctor of any of the following situations:
• • If you have COPD (chronic obstructive pulmonary disease).
  • If you have a lung disorder caused by the loss of elasticity of lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema).
  • If you have an infection in the upper respiratory tract.
  • If you have recently undergone middle ear surgery.
  • If you have undergone thoracic surgery at any point in your life.
  • If you have high and uncontrolled fever.
  • If you have severe epilepsy.
  • If you have a fear of enclosed spaces (claustrophobia). If you have previously suffered a lung collapse (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 arterial partial oxygen pressure (PaO2) should be regularly controlled to not exceed 100 mm Hg (i.e., 13.3 kPa).

Use of Medicinal Liquid Oxygen Oximesa with other medications

Inform your doctor or pharmacist if 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 deficiency of vitamins C and E or glutathione.

Pregnancy, breastfeeding, and fertility

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

This medication has been widely used without any notable effects.

Driving and using machines

There is no data on the effect of Medicinal Liquid Oxygen Oximesa on driving and using machines.

3. How to use Medicinal Liquid Oxygen Oximesa

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

Your doctor will determine the correct dose of Medicinal Liquid Oxygen Oximesa 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 Liquid Oxygen Oximesa is too strong or weak, inform your doctor.

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

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

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

4. Possible adverse effects

Like all medications, Medicinal Liquid Oxygen Oximesa may cause adverse effects, although not everyone may experience them.

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

Inhalation of high concentrations of oxygen can cause small lung collapses.

Administration of oxygen at high pressures can cause injuries to the inner ear (which may pose a risk of eardrum rupture), sinuses, lungs (which may pose 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.

Lung injuries may occur after administration of oxygen concentrations greater than 80%.

Patients undergoing high-pressure oxygen therapy in chambers may experience claustrophobia crises.

Other adverse effects in children

In newborns, especially if they are premature, exposed to high oxygen concentrations (FiO2 > 40%; PaO2 greater than 80 mm Hg, i.e., 10.64 kPa) or for a prolonged period (more than 10 days at a concentration FiO2 > 30%), there is a risk of retinopathy, which appears between 3 and 6 weeks after treatment, may experience regression, or may cause retinal detachment, or even permanent blindness.

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

Reporting adverse effects

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

5. Storage of Medicinal Liquid Oxygen Oximesa

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

Do not use this medication after the expiration date indicated on the packaging.

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 containers:

Containers should be stored in well-ventilated or ventilated areas, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked.

Empty containers and full containers should be stored separately.

Containers should 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 should be kept in a vertical position, with the valves closed.

Storage of containers in the user service and at home:

The container should 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 fixation 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 should be avoided.

Transportation of containers:

Vehicles should not be parked in the oxygen transfer area.

Containers 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 impacts or falls and to keep them in a vertical position. During transportation in vehicles, containers 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 Oxigeno Medicinal Líquido Oximesa:

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

Appearance of the Product and Container Content

The containers are portable cryogenic stainless steel containers of various capacities.

The different sizes are indicated, 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 around 30 liters with a gasifier provides 25.50 m³ of gas.
• Stationary Unit UE31 of around 29 liters with a gasifier provides 24.95 m³ of gas.
• Stationary Unit UE41 of around 39 liters with a gasifier provides 33.50 m³ of gas.
• Stationary Unit UE45 of around 45 liters with a gasifier provides 38.25 m³ of gas.
• Stationary Unit UE46 of around 45 liters with a gasifier provides 37.92 m³ of gas.
• Stationary Unit UE60 of around 58 liters with a gasifier provides 49.30 m³ of gas.
• Cryogenic tank PGS45 of around 147 liters with a gasifier provides 125 m³ of gas.
• Cryogenic tank PGS180 of around 165 liters with a gasifier provides 140 m³ of gas.
• Cryogenic tank PGS240 of around 200 liters with a gasifier provides 170 m³ of gas.
• Cryogenic tank EaseBulk 600 of around 600 liters with a gasifier provides 510 m³ of gas.
• Pallet Tank PT666 of around 626 liters with a gasifier provides 532 m³ of gas.

Not all container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

NIPPON GASES ESPAÑA S.L.U.

C/Orense, 11

28020 Madrid

Spain

Manufacturer:

NIPPON GASES ESPAÑA S.L.U.

Barrio de Occidente, S/N

14005- Córdoba

Spain

Or

NIPPON GASES ESPAÑA S.L.U.

C/ Riu Vinalopó, 67

46930- Quart de Poblet (Valencia)

Spain

Or

NIPPON GASES ESPAÑA S.L.U.

Calle Embajadores 474, Villaverde

28053 Madrid

Spain

Or

NIPPON GASES ESPAÑA S.L.U.

Polígono Industrial Somonte II

33393- Gijón (Asturias)

Spain

Or

OXIMESA S.L.

Polígono Juncaril, Parcela 303

18220- Albolote (GRANADA)

Spain

Or

NIPPON GASES PORTUGAL, UNIPESSOAL, LDA.

Rua do Espído, S/N

4470-177 Maia (PORTUGAL)

Date of the Last Revision of this Prospectus:August 2019

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

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This information is intended only for healthcare professionals.

Instructions for Use/Handling

Do not smoke.

Do not approach an open flame.

Do not grease.

In the specific case of liquid oxygen, particularities of the product must also be considered, which must be taken into account as precautions for its use and handling:

• Oxygen is a gas heavier than air, which can accumulate in low points after the vaporization of the liquid and make the atmosphere dangerous.
• Oxygen at atmospheric pressure is a liquid at very low temperature (around -183°C) and can cause frostbite if it comes into contact with the skin due to splashes or handling of the liquid without adequate 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 against overpressure in closed volumes (equipment and installations) and over-oxygenation of materials and the atmosphere of the premises.

Medical Oxygen Containers are Reserved Exclusively for Therapeutic Use.

To avoid any incidents, it is necessary to strictly follow the following guidelines:

• Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are of a greasy nature.
• Never clean the devices that contain this gas or the taps, joints, gaskets, closing devices, and valves with combustible products, especially if they are of a greasy nature.
• Never apply any greasy material (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.
• Avoid exposure to heat sources (kitchens, radiators, fireplaces, etc.) or prolonged solar heating.
• Ventilate the place of use if possible, if it is a reduced location (vehicles, home).
• Check the good condition of the material before its use.
• Check at the time of delivery by the manufacturer that the container has an intact tamper-evident system.
• Handle the material with clean and grease-free hands.
• For the handling of cryogenic containers, the indicated protective equipment (glasses or visors, clean gloves intended for this use, adaptation of clothing, etc.) must be used, and the instructions and precautions described for the operation must be followed.
• 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 overpressure in each circuit area where liquid oxygen residues may remain between two valves.
• Never touch the cold or frozen parts of the devices.
• 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 utilization accessories (humidifier, flowmeter, mask or nasal goggles, etc.). These equipment must be used according to the prescription conditions (flows, 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 try to repair faulty valves; in case of problems, contact the supplier.
• Never use a container with leaks.
• If clothing becomes saturated with oxygen, move away from the liquid oxygen source and from places that present risks of inflammation. Also, remove such clothing.
• In case of cryogenic burns, rinse abundantly with water.
• Do not allow substances to flow back into the container. Entry of water into the container must be prevented.

Do not keep the valve of the equipment open if it is not being used.