Leaflet: information for the user

Oxygen Medical Gas Oximesa 200 bar gascompressed medicinal gasin gas cartridge

Read this leaflet carefully before starting to use this medicine, as it contains important information for you.

- Keep this leaflet, as you may need to read it again.

- If you have any questions, consult your doctor, pharmacist or nurse.

- This medicine has been prescribed only for 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 leaflet.

1. What is Oxygen Medical Gas Oximesa and how it is used.

2. What you need to know before starting to use Oxygen Medical Gas Oximesa

3. How to use Oxygen Medical Gas Oximesa

4. Possible adverse effects.

5. Storage of Oxygen Medical Gas Oximesa

6. Contents of the package and additional information

Medical Oxygen Gas Oximesa 200 bar gascompressed medicinal in gas cartridge,is a gas for inhalation that is packaged in gas cartridges at 200 bar pressure at 15°C. It contains oxygen, in a concentration of over 99.5 %.

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.

• Feeding 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 use Oxygen Medical Gas 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 had a pulmonary collapse previously, inform your doctor.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Oxygen Medical Gas Oximesa.

You must inform your doctor if you suffer from 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 should be used for the shortest possible time and controlled by blood arterial 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., 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 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 the 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 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 infection in the upper respiratory tract.

-If you have recently undergone middle ear surgery.

-If at any time in your life you have undergone thoracic surgery.

-If you have high and uncontrolled fever.

-If you suffer from severe epilepsy.

-If you have claustrophobia.

-If you have had 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, damage to the eyes (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 to ensure it does not exceed 100 mm Hg (i.e., 13.3 kPa).

Use of Oxygen Medical Gas 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, lactation, and fertility

If you are pregnant or breastfeeding, 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 are no data on the effect of Oximesa on driving and using machines.

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

Your doctor will determine the correct dose of Medical Oxygen Gas Oximesa and will administer it through an appropriate system tailored to your needs, ensuring the supply of the correct amount of oxygen.

If you estimate that the action of Medical Oxygen Gas Oximesa is too strong or too weak, inform your doctor.

If you use more Medical Oxygen Gas 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, Medical Oxygen Gas Oximesa can produce adverse effects, although not all people will experience them.

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

Inhalation of high oxygen concentrations can cause small lung collapses.

Administration of oxygen at high pressures can 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 can 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 (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 appearing 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 not appearing in this prospectus. You can also report them directly through theSpanish System for Pharmacovigilance of Medicines 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 containers must be followed.

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

Storage of gas cylinders:

Gas cylinders 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 that can be locked.

Empty and full gas cylinders must be stored separately.

Gas cylinders 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.

Gas cylinders with a capacity greater than 5 liters must be kept in an upright position, with the valves closed.

Storage of gas cylinders at the user's service and at home:

The gas cylinder must be installed in a location that allows it to be protected 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.

Excessive storage must be avoided.

Transportation of gas cylinders:

Gas cylinders 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. Special attention must be given to securing the reducer to avoid accidental rupture risks.

During transportation in vehicles, gas cylinders must be solidly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Composition of Medical Oxygen Gas Oximesa

- The active principle is Oxygen

- It does not contain excipients

Aspect of the product and content of the packaging

• Oxygen gas cylinder

Oxygen gas cylinders are made of welded steel or aluminum, of various sizes. The oxygen gas cylinders are identified because they present the colors defined by the specific legislation for the product, which, as of this review, are the white body and white tip.

• Cylinder blocks

All oxygen gas cylinders are made of welded steel and are interconnected with each other through a copper collector with a single outlet valve for the block. The set of oxygen gas cylinders are grouped within a metal protective structure that configures the block.

• Sizes

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

Oxygen gas cylinder of 1L that provides 0.21 m3 of gas

Oxygen gas cylinder of 2L that provides 0.42 m3 of gas

Oxygen gas cylinder of 3L that provides 0.64 m3 of gas

Oxygen gas cylinder of 3.4L that provides 0.72 m3 of gas

Oxygen gas cylinder of 5L that provides 1.06 m3 of gas

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

Oxygen gas cylinder of 7L that provides 1.48 m3 of gas

Oxygen gas cylinder of 10L that provides 2.12 m3 of gas

Oxygen gas cylinder of 13L that provides 2.76 m3 of gas

Oxygen gas cylinder of 20L that provides 4.24 m3 of gas

Oxygen gas cylinder of 30L that provides 6.36 m3 of gas

Oxygen gas cylinder of 40L that provides 8.48 m3 of gas

Oxygen gas cylinder of 50L that provides 10.60 m3 of gas

Block of 12 oxygen gas cylinders of 50L that provides 127.20 m3 of gas

Block of 16 oxygen gas cylinders of 50L that provides 169.60 m3 of gas

Block of 28 oxygen gas cylinders of 50L that provides 296.80 m3 of gas

Not all packaging sizes may be commercially available.

• Outlet devices

The oxygen gas cylinder or block of oxygen gas cylinders are equipped with:

- A brass valve or tap with a normalized thread for use with oxygen, to which a flow regulator or a fixed installation connection with a pressure and flow control system will be connected. This final system will be connected to the accessories of the network or the equipment at the pre-set pressure.

- In some small oxygen gas cylinders, an integrated regulator and flowmeter valve for connection to accessories.

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

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

Ó

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 medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.

-------------------------------------------------------------------------------------------------------------------------------

This information is intended solely for healthcare professionals.

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not lubricate.

In particular:

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy,

• Never clean with combustible products, especially if they are greasy, the apparatus containing this gas or the taps, joints, seals, devices, and valves,

• Never apply greasy substances (vaseline, ointments, etc.) to the patients' faces,

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

Oxygen gas cylinders are reserved exclusively for therapeutic use.

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

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

2.Agrupar las bala de gas de capacidad superior a 5 l con un medio adecuado (cadenas, ganchos, etc.) para mantenerlas en posición vertical y evitar cualquier caída inesperada.

3.Do not use the oxygen gas cylinders if their pressure is less than 10 bar.

4.Do not force the oxygen gas cylinder into a support that is too narrow for it

5.Manipulate the material with clean and grease-free hands.

6.Manipulate the oxygen gas cylinders of 50L or more capacity with clean and protective gloves and safety shoes.

7.Verify at the time of delivery by the manufacturer that the oxygen gas cylinder is provided with an intact inviolability guarantee system.

8.Do not manipulate an oxygen gas cylinder whose tap is not protected by a tulip, except for oxygen gas cylinders with a capacity of less than 5 liters.

9.Do not lift the oxygen gas cylinder by the tap.

10.Use connections or intermediate elements specific to oxygen.

11.Use a flow regulator with a flowmeter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bar) of the oxygen gas cylinder (except if there is already a built-in reducer on the tap)

12.Use only pressure gauges graduated at least to 315 bar in the case of cylinder blocks.

13.Use flexible connection elements in wall outlets provided with specific nozzles for oxygen.

14.Open the tap or valve gradually.

15.Do not force the tap to open it, nor open it completely.

16.Purge the outlet connection of the oxygen gas cylinder before incorporating the flow regulator to eliminate any dust that may have accumulated. Keep the connections between the oxygen gas cylinder and the flow regulator clean.

17.Do not subject the flow regulator to multiple successive pressurizations.

18.Do not position yourself in front of the tap outlet, but always on the opposite side of the flow regulator, behind the oxygen gas cylinder, and to the rear. Do not expose patients to the gas flow.

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

20.Do not attempt to repair a defective tap.

21.Do not tighten the flow regulator – flowmeter with pliers, under risk of causing defects in the seal.

22.Verify the compatibility of the materials in contact with oxygen beforehand, using in particular special seals for oxygen on the flow regulator.

23.Close the tap of the oxygen gas cylinder after its use, allow the pressure of the flow regulator to decrease, leaving the flowmeter open, close the flowmeter, and then loosen the adjustment screw of the flow regulator (except in the case of integrated reducers).

24.In case of leakage, close the tap or the supply valve of the circuit with a defect in tightness and check that the emergency device is activated

25.Never empty an oxygen gas cylinder completely

26.Store empty oxygen gas cylinders with the tap closed and cylinder blocks with the valve closed (to prevent corrosion in the presence of humidity).

27.Never transfer gas under pressure from one oxygen gas cylinder to another.

28.Ventilate the place of use, if possible, in small locations (vehicles, home).