Leaflet: information for the user

Oxygen Medical Gas Nippon Gases 200 bar gas forcompressed medicinalgas cylinder

Oxygen

Read this leaflet carefully before you start using 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 for 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 any side effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet.

6.Contents of the pack and additional information.

Medical Oxygen Gas Nippon Gases 200 bar gascompressed medicinal in gas cartridge, is an inhalation gas that is packaged in gas cartridges at 200 bar pressure at 15°C. It contains oxygen, in a concentration greater than 99.5 %.

Oxygen is an essential element for the organism.

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 medications for inhalation.

•Treatmentofacuteattackofmigraineinclusters(a specific type of headache that causes short but very strong crises on one side of thehead).

No use Oxígeno Medicinal Gas Nippon Gases

This medication should not 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 in the past, inform your doctor.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use Oxígeno Medicinal Gas 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 should 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 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 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 have severe epilepsy.
  • If you have claustrophobia.
  • If you have had a pulmonary 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, certain oxygen concentrations may cause eye damage (retrolental fibroplasia).

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

Other medications and Oxígeno Medicinal Gas 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, 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 effect.

Driving and operating machinery

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

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 Nippon Gases Medical Oxygen Gas 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 Nippon Gases Medical Oxygen Gas is too strong or weak, inform your doctor.

If you use more Nippon Gases Medical Oxygen Gas 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 Nippon Gases may produce adverse effects, although not all people will experience them.

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

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

The administration of oxygen at high pressures can cause inner ear injuries (which may pose a risk of tympanic membrane 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.

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 greater than 80 mm Hg (that is, 10.64 kPa)) or for a prolonged period (more than 10 days at a FiO2 concentration > 30%), there is a risk of retinopathies such as fibroplasia that appear between 3 and 6 weeks after treatment, which may experience regression or cause 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 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 vessels must be followed.

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

Storage of gas cylinders:

Gas cylinders must be stored in well-ventilated or ventilated areas, protected from the elements, clean, free from flammable materials, reserved for the storage of medical gases, and capable of being 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 Nippon Gases

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

Appearance of the product and contents of the packaging

• Gas balls

The gas balls are made of seamless steel or aluminum, of various sizes. The gas balls are identified by the colors defined by the specific legislation, which, as of this review, are the white body and white tip.

• Blocks of gas balls

All gas balls are made of seamless steel and are interconnected by a copper collector with a single outlet valve. The gas ball set is grouped within a metal protective structure that forms 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:

Gas balls of 1L that provide 0.21 m3 of gas

Gas balls of 1.5L that provide 0.32 m3 of gas

Gas balls of 2L that provide 0.42 m3 of gas

Gas balls of 3L that provide 0.64 m3 of gas

Gas balls of 3.4L that provide 0.72 m3 of gas

Gas balls of 5L that provide 1.06 m3 of gas

Gas balls of 5L with a regulation valve, pressure, and flow rate that provide 1.06 m3 of gas

Gas balls of 7L that provide 1.48 m3 of gas

Gas balls of 10L that provide 2.12 m3 of gas

Gas balls of 13L that provide 2.76 m3 of gas

Gas balls of 20L that provide 4.24 m3 of gas

Gas balls of 30L that provide 6.36 m3 of gas

Gas balls of 40L that provide 8.48 m3 of gas

Gas balls of 50L that provide 10.60 m3 of gas

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

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

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

Not all packaging sizes may be commercially available.

• Discharge devices

The gas ball or block of gas balls are equipped with the following discharge devices:

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

O

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.UPolígono Industrial Somonte II

33393- Gijón (Asturias)

Spain

Ó

NIPPON GASES PORTUGAL, UNIPESSOAL, LDA.

Rua do Espído, S/N

4470-177 Maia (PORTUGAL)

Date of the last review of this prospectus:August 2019

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.

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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 lubricate.

Especially:

• 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, or the apparatus containing this gas or the faucets, joints, seals, devices, and valves.
• Do not 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 near it.

The oxygen medical gas balls are reserved exclusively for therapeutic use.

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

1. Verify the good condition of the material before its use.
2. Group gas balls with a capacity greater than 5L with an appropriate medium (chains, hooks, etc.) to keep them in a vertical position and prevent any unexpected fall.
3. Do not use gas balls if their pressure is less than 10 bar.
4. Do not force a gas ball into a too narrow support.
5. Manipulate the material with clean and grease-free hands.
6. Manipulate gas balls of 50L or more capacity with clean manipulation gloves and safety shoes.
7. Verify in the moment of delivery by the manufacturer that the gas ball is provided with an intact inviolability guarantee system.
8. Do not manipulate a gas ball whose faucet is not protected by a tulip, except for gas balls with a capacity less than 5L.
9. Do not lift the gas ball by the faucet.
10. Use connections or specific flexible connection elements for oxygen.
11. Use a flow regulator with a flow meter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bar) of the gas ball (except if there is already a built-in reducer on the faucet).
12. For blocks of gas balls, use only pressure gauges graduated at least to 315 bar.
13. Use flexible connection elements in wall-mounted outlets provided with specific oxygen nozzles.
14. Open the faucet or valve gradually.
15. Do not force the faucet to open it, nor open it completely.
16. Purge the outlet connection of the gas ball before incorporating the flow regulator to eliminate any dust that may have accumulated. Keep the connections between the gas ball 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 outlet of the faucet, but always on the opposite side of the flow regulator, behind the gas ball and backwards. 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 faucet.
21. Do not tighten the flow regulator-caudalímetro with pliers, under the risk of causing defects in the joint.
22. Verify in advance the compatibility of the materials in contact with oxygen, using in particular special connection joints for oxygen.
23. Closing the faucet of the gas ball after use, allowing the pressure of the flow regulator to decrease while leaving the flow meter open, closing the flow meter and then loosening (except in the case of integrated reducers) the adjustment screw of the flow regulator.
24. In case of leakage, close the faucet or valve of the circuit with a defect in tightness and check that the emergency device is activated.
25. Do not empty a gas ball completely.
26. Keep empty gas balls with the faucet closed and empty blocks of gas balls with the valve closed (to prevent corrosion processes in the presence of humidity).
27. Do not transfer gas under pressure from one gas ball to another.

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