SYNTHETIC MEDICAL AIR NIPPON GASES 200 BAR, COMPRESSED MEDICAL GAS

Introduction

Package Leaflet: Information for the User

Medicinal Synthetic Air Gas Nippon Gases 200 bar,

Compressed Medicinal Gas

Oxygen

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Medicinal Synthetic Air Gas Nippon Gases and what is it used for

Medicinal Synthetic Air Gas Nippon Gases belongs to a group of medicines called medicinal gases.

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

• Feeding respirators in anesthesia-resuscitation.

Transport of inhalation medications administered through a nebulizer (a device that turns liquid medications into very fine particles that form a kind of mist or fine vapor).

2. What you need to know before you use Medicinal Synthetic Air Gas Nippon Gases

Do not useMedicinal Synthetic Air Gas Nippon Gases

There are no known situations in which medicinal air should not be used.

Warnings and Precautions:

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

• Before starting treatment with medicinal air, make sure it is administered at atmospheric pressure (air pressure in the atmosphere), healthcare personnel will adjust the manometer or indicate how to do it.
• The administration of medicinal air under pressure can cause decompression sickness and oxygen toxicity. Decompression sickness can occur during the transition from excess pressure to normal pressure and can cause headaches, dizziness, nausea, confusion, sometimes paralysis, and unconsciousness (even death).
• If the medicinal air is mixed with other inhalation gases, the gas mixture should always contain sufficient oxygen presence (at least 21.0% v/v). Consequently, mixtures of medicinal air with other gases should always include additional oxygen from other sources.
• If you administer medicinal air at high flow rates, you may feel cold to the touch.

Other Medicines and Medicinal Synthetic Air Gas Nippon Gases:

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines, including those bought without a prescription.

It is not expected that medicinal air will have effects with other medicines.

Using Medicinal Synthetic Air Gas Nippon Gases with Food, Drinks, and Alcohol:

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

Pregnancy, Breast-feeding, and Fertility:

If you are pregnant or breast-feeding, or think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before using this medicine.

Driving and Using Machines:

No evidence has been shown that Medicinal Synthetic Air, used at the recommended doses, produces alterations in attention, reaction capacity, and ability to drive.

3. How to use Medicinal Synthetic Air Gas Nippon Gases

Follow exactly the administration instructions of this medicine 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 medicine is administered at atmospheric pressure (air pressure in the atmosphere), healthcare personnel will adjust the manometer or indicate how to do it.

Medicinal air is an inhalation gas that is administered through special equipment, 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. The excess oxygen leaves the body through exhalation and mixes with the ambient air. During anesthesia, special equipment is used with re-inspiration or recycling systems so that the exhaled air is inhaled again (a "re-inspiration" system). If you cannot breathe on your own, you may be given medicinal air through a ventilation machine.

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

• The gas cylinder cannot be used if it is visibly damaged or if it is suspected to have been damaged or exposed to extreme temperatures.
• Any contact with oil, grease, or other hydrocarbons should be avoided.
• Only suitable equipment for the specific type of gas and gas cylinder should be used.
• To avoid the risk of damage, pliers or other tools should not be used to open or close the gas cylinder valve.
• The container shape should not be modified.
• In case of a leak, the gas cylinder valve should be closed immediately, as long as it is safe to do so. If the valve cannot be closed, the gas cylinder should be moved to a safe outdoor location to discharge the oxygen.
• Empty gas cylinders should have their valves closed.
• Tube connections, valves, etc. should be clean and dry, and when dirty, should be cleaned according to the provider's instructions. Do not use solvents. Use a clean, lint-free cloth, and dry the equipment.
• Siphoning gas under pressure is not allowed.
• Smoking or bringing open flames near the gas cylinder is not allowed.

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

There are no known risks of overdose with medicinal air.

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

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 medicine and the amount ingested.

If you forget to useMedicinal Synthetic Air Gas Nippon Gases

Do not take a double dose to make up for forgotten doses.

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

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

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

Reporting of Side Effects.

If you experience any type of side effect, consult your doctor, pharmacist, or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish Medicines and Healthcare Products Agency (AEMPS) website: www.aemps.gob.es. By reporting side 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 which is stated on the packaging. The expiry date is the last day of the month stated. All rules regarding the handling of pressure vessels must be followed.

Do not store above 50°C.

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

Storage of gas cylinders:

Gas cylinders should be stored in ventilated or air-conditioned rooms, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked with a key.

Empty 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 above 50°C, and also from 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 above 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 firmly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of the packaging and any unused medicines. This will help protect the environment.

6. Package Contents and Additional Information

Composition ofMedicinal Synthetic Air Gas Nippon Gases

• The active principle is oxygen 21.0 - 22.5% v/v.
• The other component is nitrogen.

Appearance of the Product and Package Contents

Medicinal Synthetic Air Gas Nippon Gases is an inhalation gas that is packaged in gas cylinders at 200 bar pressure at 15°C. The Medicinal Synthetic Air is a colorless and odorless gas, which is presented in seamless steel gas cylinders and in blocks of gas cylinders of the following volumes expressed in liters 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 and blocks of gas cylinders with a total volume of 600 (12 cylinders of 50 l) l; 800 l (16 cylinders of 50 l) and 1400 l (28 cylinders of 50 l).

Not all package sizes may be marketed.

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.

Calle Embajadores 474, Villaverde

28053 Madrid

Spain

Date of the Last Revision of this Leaflet: August 2019

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

This information is intended only for healthcare professionals.

Instructions for Use/Handling

Do not smoke.

Do not bring near an open flame.

Do not grease.

In particular:

• Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are greasy in nature,
• Never clean the devices that contain this gas or the valves, joints, gaskets, closing devices, and valves with combustible products, especially if they are greasy in nature,
• Never apply any greasy material (vaseline, pomades, etc.) to the face of patients,
• Never use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

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

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

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

1. Verify the good condition of the material before its use.
2. Group gas cylinders with a capacity greater than 5 liters with a suitable means (chains, hooks, etc.) to keep them in a vertical position and avoid any unexpected falls.
3. Do not use gas cylinders if their pressure is less than 10 bar.
4. Never force a gas cylinder into a support that is too narrow for it.
5. Handle the material with clean and grease-free hands.
6. Handle gas cylinders with a capacity of 50 liters or more with clean handling gloves and safety shoes.
7. Verify at the time of delivery by the manufacturer that the gas cylinder is equipped with an intact tamper-evident system.
8. Do not handle a gas cylinder whose valve is not protected by a tulip, except for gas cylinders with a capacity less than 5 liters.
9. Do not lift the gas cylinder by holding the valve.
10. Use connections or flexible connection elements specifically designed for oxygen.
11. Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (200 bar) of the gas cylinder (unless a reducer is already incorporated into the valve).
12. In the case of blocks of gas cylinders, use only manometers graduated to at least 315 bar.
13. Use flexible connection elements in wall outlets equipped with oxygen-specific nozzles.
14. Open the valve or valve progressively.
15. Never force the valve to open, nor open it all the way
16. Purge the outlet connection of the gas cylinder before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the gas cylinder and the manoreducer clean.
17. Never subject the manoreducer to several successive pressurizations.
18. Never place yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the gas cylinder, and backwards. Never 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 faulty valve.
21. Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.
22. Verify beforehand the compatibility of materials in contact with oxygen, using in particular oxygen-specific connection gaskets for the manoreducer.
23. Close the gas cylinder valve after use, allow the pressure of the manoreducer to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated manoreducers) the manoreducer adjustment screw.
24. In case of a leak, close the valve or feed circuit valve that has a leak and verify that the emergency device is activated.
25. Never completely empty a gas cylinder.
26. Keep empty gas cylinders with the valve closed and empty blocks of gas cylinders with the valve closed (to avoid corrosion processes in the presence of humidity).
27. Do not transfer gas under pressure from one gas cylinder to another.

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