Prospect: information for the user

Synthetic medicinal gas Nippon Gases 200 bar, medicinal compressed gas

Oxygen

Nitrogen

Read this prospect carefully before starting to use this medication, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist or nurse.
• This medication has been prescribed only to you, and you must not give it to other people 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 prospect. See section 4.

1. What it is and what it is used forAir medicinal sintético gas Nippon Gases

2. What you need to know before starting to useAire medicinal sintético gas Nippon Gases

3. How to useAire medicinal sintético gas Nippon Gases

4. Possible adverse effects

5. Storage ofAire medicinal sintético gas Nippon Gases

6. Contents of the container and additional information

Synthetic Medical Air Gas Nippon Gases belongs to a group of medications called medical gases.

It is an inhalation gas in a gas cartridge, indicated for:

• Supplying ventilators in anesthesia-reanimation.

Transport of inhalation medications administered via nebulizer (device that transforms liquid medications into extremely fine particles forming a cloud or fine vapor).

Do not useSynthetic Medical Air Nippon Gases

No known situations exist in which this air should not be used.

Warnings and precautions:

Consult your doctor, pharmacist, or nurse before starting to use synthetic medical air.

• Before starting treatment with synthetic medical air, ensure that it is administered at atmospheric pressure (air pressure in the atmosphere), the healthcare staff will adjust the manometer or instruct you on how to do it.
• Administration of synthetic medical air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness may occur during the transition from excessive pressure to normal pressure and may cause headaches, dizziness, nausea, confusion, sometimes paralysis and unconsciousness (and even death).
• If synthetic medical air is mixed with other inhalation gases, the gas mixture must always have sufficient oxygen presence (at least 21.0% v/v). Therefore, synthetic medical air mixtures with other gases must always include additional oxygen from other sources.
• If you administer synthetic medical air at high flow rates, you may feel cold to the touch.

Other medications and Synthetic Medical Air Nippon Gases:

Inform your doctor or pharmacist if you are taking, have taken recently, or may need to take any other medication, including those acquired without a prescription.

No interaction is expected between synthetic medical air and other medications.

Use of Synthetic Medical Air Nippon Gases with food, drinks, and alcohol:

Synthetic medical air does not interact with food, so it can be administered with meals or outside of them.

Pregnancy, breastfeeding, and fertility:

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

Driving and operating machinery:

No evidence has been shown that synthetic medical air, used at recommended doses, produces attention, reaction ability, and driving ability impairments.

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

The normal dose will vary depending on the circumstances for which the medicinal air is used.

This medication is administered at atmospheric pressure (air pressure in the atmosphere), the healthcare staff will adjust the manometer or indicate how you should do it.

Medicinal air is an inhalation gas that is administered through a special device, such as a nasal catheter or a facial mask, with a mask that fits around the head or with a tube in the trachea (tracheotomy). The device must be used as described by the manufacturer. Excess oxygen is eliminated from the body through exhalation and is mixed with the ambient air. During anesthesia, a special device is used with recycling or re-inspiration systems so that the exhaled air is inhaled again (a re-inspiration system). If you cannot breathe autonomously, you may be administered medicinal air through a ventilation machine.

Follow the provider's instructions, especially those related to the following points:

• The gas cartridge cannot be used if it is visibly damaged or if it is suspected to have suffered any damage or has been exposed to extreme temperatures.
• Avoid any contact with oil, grease, or other hydrocarbons.
• Only use suitable equipment for the specific type of gas and gas cartridge.
• To avoid the risk of damage, do not use pliers or other tools to open or close the gas cartridge valve.
• Do not modify the shape of the container.
• In case of a leak, immediately close the gas cartridge valve, if it is safe to do so. If the valve cannot be closed, the gas cartridge must be moved to a safe outdoor location to discharge the oxygen.
• Closing the valves of empty gas cartridges.
• The connections for tubes, valves, etc. must be clean and dry and, when dirty, must be cleaned according to the provider's instructions. Do not use solvents. Use a clean, lint-free cloth and dry the equipment.
• It is not permitted to siphon gas under pressure.
• It is not permitted to smoke or bring open flames near the gas cartridge.

If you use moreMedicinal Air Synthetic Gas Nippon Gasesthan you should:

No known risks of overdose are associated with medicinal air.

The administration of medicinal air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness can occur during the transition from excessive pressure to normal pressure and may cause headaches, dizziness, nausea, confusion, sometimes paralysis and unconsciousness (and even death).

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.

If you forgot to useMedicinal Air Synthetic Gas Nippon Gases

Do not take a double dose to compensate for the missed doses.

If you forget a dose, do not worry. Take another as soon as you remember. Then, continue as before.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

No adverse effects are known. If you experience adverse effects, consult your doctor, pharmacist, or nurse.

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 listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.norificaram.es. By reporting adverse effects, you can contribute to providing more information about 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 for handling pressure containers must be followed.

Do not store at a temperature above 50?°C.

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, without 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 above 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 above 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 paid 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.

Medicines must not be throwndown the drains or in the trash. Ask your pharmacist how to dispose of the packaging and medications that you no longer need. In this way, you will help protect the environment.

Composition ofNippon Gases Medical Synthetic Air Gas

- The active ingredient is oxygen 21.0-22.5% v/v.

- The other component is nitrogen.

Appearance of the product and packaging content

Nippon Gases Medical Synthetic Air Gasis an inhalation gas that is packaged in steel gas cylinders at 200 bar pressure at 15 °C. The synthetic medical air is an odorless and colorless gas, presented in steel gas cylinders without welding and in blocks of gas cylinders of the following volumes expressed in liters of water: 1 l gas cylinders; 2 l; 3 l; 3.4 l; 5 l; 7 l; 10 l; 13 l; 20 l; 30 l; 40 l; 50 l and blocks of gas cylinders with a total volume of 600 (12 x 50 l) l; 800 l (16 x 50 l) and 1400 l (28 x 50 l).

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

O

NIPPON GASES ESPAÑA S.L.U.

Calle Embajadores 474, Villaverde

28053 Madrid

Spain

Last review date of this leaflet: 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/).

This information is intended solely for healthcare professionals.

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not lubricate.

Specifically:

• Do not introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy,
• Do not clean with combustible products, especially if they are greasy, the apparatus containing this gas or the valves, joints, gaskets, closure devices, and valves,
• Do not 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.

The Nippon Gases Medical Synthetic Air Gas cylinders are reserved exclusively for therapeutic use.

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

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

1. Verify the good condition of the material before its use.
2. Group the gas cylinders with a capacity greater than5 lwith an appropriate medium (chains, hooks, etc.) to keep them in a vertical position and prevent any unexpected fall.
3. Do not use gas cylinders if their pressure is less than 10 bar.
4. Do not force a gas cylinder into a too narrow support.
5. Manipulate the material with clean and grease-free hands.
6. Manipulate the50 lor larger capacity gas cylinders with clean manipulation gloves and safety shoes.
7. Verify at the time of delivery by the manufacturer that the gas cylinder is provided with an intact inviolability guarantee system.
8. Do not manipulate a gas cylinder whose valve is not protected by a tulip, except for gas cylinders with a capacity less than5 liters.
9. Do not lift the gas cylinder by the valve.
10. Use specific oxygen connections or flexible connection elements.
11. Use a pressure reducer with a flowmeter that can accommodate a pressure of at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (except if there is already a built-in reducer on the valve).
12. For blocks of gas cylinders, use only pressure gauges graduated at least to 315 bar.
13. Use flexible connection elements on wall-mounted outlets provided with specific oxygen nozzles.
14. Open the valve or valve gradually.
15. Do not force the valve to open it, nor open it completely
16. Purge the outlet connection of the gas cylinder before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the gas cylinder and the pressure reducer clean.
17. Do not subject the pressure reducer to multiple successive pressurizations.
18. Do not position yourself in front of the valve outlet, but always on the opposite side of the pressure reducer, behind the gas cylinder 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 valve.
21. Do not tighten the pressure reducer-flowmeter with pliers, under 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 on the pressure reducer.
23. Close the valve of the gas cylinder after its use, allow the pressure of the pressure reducer to decrease by leaving the flowmeter open, close the flowmeter and then loosen (except in the case of integrated reducers) the adjustment screw of the pressure reducer.
24. In case of leakage, close the valve or the supply valve of the circuit with a defect in tightness and check that the emergency device is activated.
25. Do not empty a gas cylinder completely.
26. Keep the empty gas cylinders with the valve closed and the empty blocks of gas cylinders with the valve closed (to prevent corrosion processes in the presence of humidity).
27. Do not transfer gas under pressure from one gas cylinder to another.

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