OXIGENO 100% V/V Pulmonary Inhalation

Contents of the leaflet

1. Introduction
2. What is Medicinal Oxygen Gas Oximesa and what is it used for
3. What you need to know before starting to use Medicinal Oxygen Gas Oximesa
4. How to use Medicinal Oxygen Gas Oximesa
5. Possible Side Effects
6. Storage of Medicinal Oxygen Gas Oximesa
7. Container Content and Additional Information

Introduction

Package Leaflet: Information for the User

Medicinal Oxygen Gas Oximesa 200 bar compressed medicinal gas in gas cylinder

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

• Keep this package leaflet, as you may need to read it again.
• If you have any questions, 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 side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

Contents of the Package Leaflet

1. What is Medicinal Oxygen Gas Oximesa and what is it used for.
2. What you need to know before starting to use Medicinal Oxygen Gas Oximesa
3. How to use Medicinal Oxygen Gas Oximesa
4. Possible side effects.
5. Storage of Medicinal Oxygen Gas Oximesa
6. Package Contents and Additional Information

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

Medicinal Oxygen Gas Oximesa 200 bar compressed medicinal gas in gas cylinder, is an inhalation gas that is packaged in gas cylinders at 200 bar pressure at 15°C. It contains oxygen, in a concentration greater than 99.5%.

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-resuscitation.
• Administration of medications for inhalation via nebulizer.
• Treatment of acute cluster headache attacks (a specific 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 Oxygen Gas Oximesa

Do not use Medicinal Oxygen Gas 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 had a lung collapse in the past, inform your doctor.

Warnings and Precautions:

Consult your doctor, pharmacist, or nurse before starting to use Medicinal Oxygen Gas 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 greasy 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. To avoid risks, 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 condition 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 had thoracic surgery at any point in your life.
• If you have a high and uncontrolled fever.
• If you have severe epilepsy.
• If you have a fear of enclosed spaces (claustrophobia).
• If you have had a lung collapse in the past (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 concentrations of oxygen.

For infants who need a concentration greater than 30%, the arterial partial oxygen pressure (PaO2) should be regularly monitored to ensure it does not exceed 100 mm Hg (i.e., 13.3 kPa).

Using Medicinal Oxygen Gas Oximesa with other medications

Tell 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, 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 are no data on the effect of Medicinal Oxygen Gas Oximesa on driving and using machines.

3. How to use Medicinal Oxygen Gas Oximesa

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

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

If you use more Medicinal Oxygen Gas 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 decreased, and symptomatic treatment is recommended.

4. Possible Side Effects

Like all medications, Medicinal Oxygen Gas Oximesa can cause side effects, although not everyone will experience them.

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

Inhaling high concentrations of oxygen can cause small lung collapses.

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

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

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

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

Other Side Effects in Children

In newborns, especially if they are premature, exposed to high concentrations of oxygen (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 retinopathies such as fibroplasia, which can appear between 3 and 6 weeks after treatment, and may experience regression or cause retinal detachment, or even permanent blindness.

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

Reporting Side Effects

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

5. Storage of Medicinal Oxygen Gas Oximesa

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

Do not use this medication after the expiration date stated 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 gas cylinders:

Gas cylinders 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 gas cylinders and full gas cylinders should be stored separately.

Gas cylinders should be protected from the risk of shocks or falls, as well as from heat sources or ignition, temperatures equal to or greater than 50°C, and combustible materials and weather conditions.

Gas cylinders with a capacity greater than 5 liters should be kept in a vertical position, with the valves closed.

Storage of gas cylinders in the user service and at home:

The gas cylinder should be installed in a location that allows it to be protected from the risks of shocks 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.

Excessive storage should be avoided.

Transportation of gas cylinders:

Gas cylinders 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 shocks or falls. Special attention should be paid to securing the reducer to avoid accidental rupture risks.

During transportation in vehicles, gas cylinders 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 Medicinal Oxygen Gas Oximesa

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

Appearance of the Product and Container Content

• Gas cylinder

The gas cylinders are made of seamless steel or aluminum, in various sizes. The gas cylinders are identified by the colors defined by the legislation specific to the product, which, as of this revision, are a white body and white tip.

• Blocks of gas cylinders

All gas cylinders are made of seamless steel and are interconnected by a copper collector with a single general outlet valve for the block. The set of gas cylinders is grouped within a metal protection structure that configures the block.

• Sizes

The different sizes are indicated, classified by their geometric capacity in liters and the gas content at a filling pressure of 200 bar at 15°C:

1L gas cylinder that provides 0.21 m3 of gas

2L gas cylinder that provides 0.42 m3 of gas

3L gas cylinder that provides 0.64 m3 of gas

3.4L gas cylinder that provides 0.72 m3 of gas

5L gas cylinder that provides 1.06 m3 of gas

5L gas cylinder with regulation valve, pressure, and flow that provides 1.06 m3 of gas

7L gas cylinder that provides 1.48 m3 of gas

10L gas cylinder that provides 2.12 m3 of gas

13L gas cylinder that provides 2.76 m3 of gas

20L gas cylinder that provides 4.24 m3 of gas

30L gas cylinder that provides 6.36 m3 of gas

40L gas cylinder that provides 8.48 m3 of gas

50L gas cylinder that provides 10.60 m3 of gas

Blocks of 12 gas cylinders of 50L that provide 127.20 m3 of gas

Blocks of 16 gas cylinders of 50L that provide 169.60 m3 of gas

Blocks of 28 gas cylinders of 50L that provide 296.80 m3 of gas

Not all container sizes may be marketed.

• Outlet devices

The gas cylinder or block of gas cylinders has at its outlet:

• A brass valve or tap with a standardized thread for use with oxygen, to which a pressure-reducing equipment will be attached for regulating the pressure of use or a connection hose to a fixed installation of regulation and control of the piped network. This final system will be connected to the accessories of the network or the equipment at the pre-set pressure.
• In some small gas cylinders, an integrated regulator and flowmeter valve for connection to accessories.

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 de 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: July 2015

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 particular:

• Never introduce this gas into a device that may contain combustible materials, especially if they are greasy in nature,

• Never clean with combustible products, especially if they are greasy in nature, either the devices that contain this gas or the taps, joints, gaskets, closing devices, and valves,

• Never apply any greasy material (vaseline, ointments, etc.) to the face of patients,

• Never use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

Medicinal oxygen gas cylinders are reserved exclusively for therapeutic use.

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

1. Verify the good condition of the material before its use.

1. Group gas cylinders with a capacity greater than 5L with a suitable means (chains, hooks, etc.) to keep them in a vertical position and avoid any unexpected fall.

1. Do not use gas cylinders if their pressure is less than 10 bar.

1. Never force a gas cylinder into a support that is too narrow for it.

1. Handle the material with clean and grease-free hands.

1. Handle gas cylinders of 50L or greater capacity with clean handling gloves and safety shoes.

1. Verify at the time of delivery by the manufacturer that the gas cylinder is provided with an intact tamper-evident system.

1. Do not handle a gas cylinder whose tap is not protected by a tulip, except in gas cylinders with a capacity of less than 5 liters.

1. Do not lift the gas cylinder by holding the tap.

1. Use connections or flexible connection elements specific to oxygen.

1. Use a pressure-reducing valve with a flowmeter that allows a pressure of at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (unless there is already a reducer incorporated into the tap).

1. In the case of blocks of gas cylinders, use only manometers graduated to at least 315 bar.

1. Use flexible connection elements in wall outlets provided with oxygen-specific nozzles.

1. Open the tap or valve progressively.

1. Never force the tap to open it, nor open it completely.

1. Purge the outlet connection of the gas cylinder before incorporating the pressure-reducing valve to eliminate any dust that may be present. Keep the connections between the gas cylinder and the pressure-reducing valve clean.

1. Never subject the pressure-reducing valve to several successive pressurizations.

1. Never place yourself in front of the outlet of the tap, but always on the opposite side of the pressure-reducing valve, behind the gas cylinder, and facing backwards. Never expose patients to the gas flow.

1. Do not use intermediate connections to allow the connection of two devices that do not fit together.

1. Do not attempt to repair a faulty tap.

1. Never tighten the pressure-reducing valve-flowmeter with pliers, under the risk of causing damage to the gasket.

1. Verify beforehand the compatibility of the materials in contact with oxygen, using in particular oxygen-specific connection gaskets for the pressure-reducing valve.

1. Close the tap of the gas cylinder after its use, allow the pressure of the pressure-reducing valve to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure-reducing valves) the adjustment screw of the pressure-reducing valve.

1. In case of a leak, close the tap or valve that supplies the circuit with the leak and verify that the emergency device is activated.

1. Never completely empty a gas cylinder.

1. Keep empty gas cylinders with the tap closed and empty blocks of gas cylinders with the valve closed (to avoid corrosion processes in the presence of humidity).

1. Never transfer gas under pressure from one gas cylinder to another.

1. Ventilate the place of use, if possible, if it is a reduced location (vehicles, home).