Aire Medicinal Sintetico Gas Nippon Gases 200 bar, medicinal compressed gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Aire medicinal sintético gas Nippon Gases 200 bar,

medicinal compressed gas

Oxygen

Read the entire leaflet carefully before you start using this medicine, because 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 you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Leaflet contents

1. What Aire medicinal sintético gas Nippon Gases is and what it is used for
2. What you need to know before using Aire medicinal sintético gas Nippon Gases
3. How to use Aire medicinal sintético gas Nippon Gases
4. Possible adverse effects
5. How to store Aire medicinal sintético gas Nippon Gases
6. Contents of the pack and other information

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

Aire medicinal sintético gas Nippon Gases belongs to a group of medicines called medicinal gases.

It is an inhalation gas supplied in a gas cylinder, indicated for:

• Supplying anaesthesia-reanimation ventilators.

• Transporting inhaled medications administered via nebulizer (a device that transforms liquid medications into very fine particles forming a mist or fine vapor).

2. What you need to know before using Synthetic Medicinal Air gas Nippon Gases

Do not use Synthetic Medicinal Air gas Nippon Gases

There are no known situations in which the use of medicinal air should be avoided.

Warnings and precautions

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

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

Other medicines and Synthetic Medicinal Air gas Nippon Gases

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

No interactions of medicinal air with other medicines are expected.

Use of Synthetic Medicinal Air gas Nippon Gases with food, drinks, and alcohol

Synthetic Medicinal Air does not interact with food; therefore, it can be administered with meals or at other times.

Pregnancy, breastfeeding, and fertility

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

Driving and using machines

There is no evidence that Synthetic Medicinal Air, when used at recommended doses, impairs attention, reaction capacity, or ability to drive.

3. How to use Synthetic Medical Air gas Nippon Gases

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

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

This medicine is administered at atmospheric pressure (air pressure in the atmosphere); healthcare personnel will adjust the pressure gauge or instruct you on how to do so.

Medical air is an inhalation gas delivered via a special device, such as a nasal catheter or a facial mask with a head strap, or through a tracheal tube (tracheostomy). The device must be used as described by the manufacturer. Excess oxygen leaves the body through exhalation and mixes with ambient air. During anesthesia, a special system with rebreathing or recycling equipment may be used so that exhaled air is inhaled again (a "rebreathing" system). If you are unable to breathe independently, medical air may be administered using a ventilator.

Follow the provider's instructions, especially regarding the following points:

• The gas cylinder must not be used if it is visibly damaged or if damage is suspected, or if it has been exposed to extreme temperatures.
• Any contact with oil, grease, or other hydrocarbons must be avoided.
• Only equipment suitable for the specific type of gas and gas cylinder must be used.
• To avoid the risk of injury, pliers or other tools must not be used to open or close the cylinder valve.
• The container must not be modified in shape.
• In case of leakage, close the cylinder valve immediately, provided it is safe to do so. If the valve cannot be closed, the gas cylinder must be moved to a safe outdoor location to allow the oxygen to discharge safely.
• Valves on empty gas cylinders must be closed.
• Tubing connections, valves, etc., must be clean and dry; when dirty, they must be cleaned according to the provider's instructions. Do not use solvents. Use a clean, lint-free cloth and dry the equipment thoroughly.
• Siphoning of pressurized gas is not permitted.
• Smoking or bringing open flames near the gas cylinder is strictly prohibited.

If you use more Synthetic Medical Air gas Nippon Gases than you should:

There are no known risks of overdose with medical air.

Administration of medical air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness may occur during the transition from high pressure to normal atmospheric pressure and may cause headaches, dizziness, nausea, confusion, sometimes paralysis and unconsciousness (and even death).

In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount ingested.

If you forget to use Synthetic Medical Air gas Nippon Gases

Do not take a double dose to make up for a missed dose.

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

4. Possible adverse effects

Like all medicines, this medicine may produce adverse effects, although not everyone will experience them.

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

Reporting of 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 leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Synthetic Air Gas Nippon Gases

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

Do not use this medicine after the expiry date stated on the container. The expiry date refers to the last day of the month indicated. All regulations concerning the handling of pressurized containers must be followed.

Do not store at temperatures above 50°C.

The following points should be taken into account regarding storage and transport:

Storage of gas cylinders:

Gas cylinders must be stored in well-ventilated or ventilated premises, protected from weather conditions, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and capable of being locked.

Empty gas cylinders and full gas cylinders must be stored separately.

Gas cylinders must be protected from the risk of impact or falling, as well as from sources of heat or ignition, from temperatures equal to or above 50°C, and also from combustible materials and adverse weather conditions.

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

Storage of gas cylinders at user facilities and in domestic settings:

The gas cylinder must be installed in a location that protects it from risks of impact or falling (such as a stand with securing elements), from sources of heat or ignition, from temperatures equal to or above 50°C, from combustible materials, and from adverse weather conditions.

Excessive storage should be avoided.

Transport of gas cylinders:

Gas cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from the risk of impact or falling. Special care must be taken when securing the pressure regulator to prevent accidental rupture.

During transport in vehicles, gas cylinders must be securely grouped together. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of containers and medicines that you no longer need. This will help protect the environment.

6. Contents of the container and other information

Composition of Synthetic Medicinal Air Gas Nippon Gases

• The active substance is oxygen 21.0–22.5% v/v.
• The other component is nitrogen.

Appearance of the product and contents of the container

Synthetic Medicinal Air Gas Nippon Gases is a gas for inhalation, supplied in gas cylinders at a pressure of 200 bar at 15 °C. The medicinal synthetic air is a colourless and odourless gas, available in seamless steel gas cylinders and in cylinder bundles with the following volumes expressed in litres of water: 1 l; 2 l; 3 l; 3.4 l; 5 l; 7 l; 10 l; 13 l; 20 l; 30 l; 40 l; 50 l cylinders, and cylinder bundles with total volumes of 600 l (12 cylinders of 50 l), 800 l (16 cylinders of 50 l), and 1400 l (28 cylinders of 50 l).

Not all container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

NIPPON SANSO ESPAÑA S.L.U.
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.
Calle Embajadores 474, Villaverde
28053 Madrid
Spain

Date of the latest revision of this leaflet: August 2019

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

This information is intended for healthcare professionals only.

Instructions for Use/Handling

Do not smoke.

Do not bring near a flame.

Do not grease.

In particular:

• Never introduce this gas into any apparatus suspected of containing flammable materials, especially those of a greasy nature.
• Never clean with flammable products, particularly those of a greasy nature, either the equipment containing this gas or taps, seals, gaskets, closure devices, and valves.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

The synthetic medicinal air gas cylinders from Nippom Gases are reserved exclusively for therapeutic use.

To prevent any accidents, it is mandatory to strictly follow the instructions below:

To prevent any accidents, it is mandatory to strictly follow the instructions below:

1. Check the equipment is in good condition before use.
2. Secure gas cylinders with a capacity greater than 5 L in an appropriate manner (chains, hooks, etc.) to keep them in an upright position and prevent unexpected falls.
3. Do not use gas cylinders if the pressure is below 10 bar.
4. Never force a gas cylinder into a support that is too narrow for it.
5. Handle equipment with clean hands, free from grease.
6. Handle 50 L gas cylinders or those of larger capacity using clean handling gloves and safety shoes.
7. At the time of delivery by the manufacturer, verify that the gas cylinder is equipped with an intact tamper-proof seal.
8. Do not handle a gas cylinder whose tap is not protected by a cap, except for cylinders with a capacity below 5 L.
9. Never lift the gas cylinder by the tap.
10. Use connections or flexible connection components specifically designed for oxygen.
11. Use a pressure regulator with a flowmeter capable of withstanding at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (unless the tap already incorporates a built-in reducer).
12. In the case of cylinder banks, use only pressure gauges calibrated to at least 315 bar.
13. Use flexible connection components on wall outlets equipped with nozzles specifically designed for oxygen.
14. Open the tap or valve gradually.
15. Never force the tap to open it, nor open it fully.
16. Purge the outlet connection of the gas cylinder before attaching the pressure regulator to remove any dust that may be present. Keep the connections between the gas cylinder and the pressure regulator clean.
17. Never subject the pressure regulator to multiple successive pressurizations.
18. Never stand directly in front of the tap outlet; always stand on the side opposite the pressure regulator, behind the gas cylinder and facing backward. Never expose patients to the gas flow.
19. Do not use intermediate adapters to connect two devices that do not fit together.
20. Do not attempt to repair a defective tap.
21. Never tighten the pressure regulator–flowmeter with pliers, as this may damage the seal.
22. Check in advance the compatibility of materials in contact with oxygen, using in particular connection seals specifically designed for oxygen.
23. After use, close the gas cylinder tap, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, then close the flowmeter and subsequently loosen (except in the case of integrated pressure regulators) the pressure regulator adjustment screw.
24. In case of leakage, close the tap or valve supplying the circuit with the leak and verify that the emergency device is activated.
25. Never completely empty a gas cylinder.
26. Store empty gas cylinders with the tap closed and empty cylinder banks with the valve closed (to prevent corrosion processes in the presence of moisture).
27. Never transfer pressurized gas from one gas cylinder to another.

Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).