SYNTHETIC MEDICINAL AIR OXYGEN SALUD 22% V/V COMPRESSED MEDICINAL GAS

Package leaflet: Information for the user

Introduction

MEDICINAL SYNTHETIC AIR OXYGEN SALUD, 22 % v/v, compressed medicinal gas

(Oxygen)

Read this 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, ask your doctor or pharmacist.
• This medicine has been prescribed for you only and must not be given to other people, even if they have the same symptoms as you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are effects not listed in this leaflet.

Leaflet contents:

1. What AIRE MEDICINAL SINTÉTICO OXIGEN SALUD is and what it is used for
2. What you need to know before using AIRE MEDICINAL SINTÉTICO OXIGEN SALUD
3. How to use AIRE MEDICINAL SINTÉTICO OXIGEN SALUD
4. Possible adverse effects
5. Storage of AIRE MEDICINAL SINTÉTICO OXIGEN SALUD
6. Contents of the pack and other information

1. What AIRE MEDICINAL SINTÉTICO OXIGEN SALUD is and what it is used for

Aire Medicinal Sintético Oxigen Salud belongs to a group of medicines called medicinal gases.

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

• Ventilator feed in anesthesia and resuscitation.
• Transport of 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 starting to use SYNTHETIC MEDICINAL AIR OXIGEN SALUD

Do not use SYNTHETIC MEDICAL AIR OXIGEN SALUD

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

Warnings and precautions

• Before starting treatment with medicinal air, ensure that it is administered at atmospheric pressure (air pressure in the atmosphere); healthcare personnel will adjust the pressure gauge for you or instruct you on how to do it.
• 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, sometimes paralysis and unconsciousness (and even death).
• If medicinal air is mixed with other inhalation gases, the gas mixture must always contain sufficient oxygen (at least 22% 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 (high flow velocity), it may feel cold to the touch.

Interaction of SYNTHETIC MEDICINAL AIR OXIGEN SALUD with other medicines:

Inform your doctor or pharmacist if you are using or have recently used any other medicines, including those obtained without a prescription.

No interactions of medicinal air with other medicines are expected.

SYNTHETIC MEDICINAL AIR OXIGEN SALUD with food and drink

Medicinal air does not interact with food; therefore, it can be administered with meals or independently of them.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

Medicinal air may be used during pregnancy and breastfeeding.

Driving and using machines

Medicinal air does not affect the ability to drive or operate machinery.

3. How to use MEDICINAL AIR SYNTHETIC OXYGEN SALUD

Follow exactly the administration instructions for Medicinal Air as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

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

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

If you need to use Medicinal Air for a prolonged period, it is recommended that the Medicinal Air be humidified (with moisture); healthcare personnel will perform this or instruct you on how to do it.

Medicinal Air is an inhalation gas administered via a special device, such as a nasal catheter or a facial mask, a mask that fits around the head, or a tube inserted into the trachea (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 device with rebreathing or recycling systems may be used so that the exhaled air is inhaled again (a "rebreathing" system). If you are unable to breathe independently, medicinal air may be administered using a ventilator machine.

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 should be used.
• To avoid the risk of injury, do not use pliers or other tools to open or close the cylinder valve.
• The container must not be modified in shape.
• In case of a leak, close the cylinder valve immediately, provided it is safe to do so. If the valve cannot be closed, the cylinder must be moved to a safe outdoor location to allow the oxygen to discharge safely.
• Close the valves on empty gas cylinders.
• 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 MEDICINAL AIR SYNTHETIC OXYGEN SALUD than you should

There are no known risks of overdose with medicinal air.

Administering Medicinal Air under pressure may cause decompression illness and oxygen toxicity. Decompression illness 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).

If you forget to use MEDICINAL AIR SYNTHETIC OXYGEN SALUD

Use the medicinal air as soon as you remember. Do not use a double dose to make up for forgotten doses.

4. Possible adverse effects

No adverse effects are known.

If you experience any adverse effects, consult your doctor or pharmacist.

5. STORAGE OF MEDICINAL SYNTHETIC OXYGEN AIR SALUD

Keep out of the reach and sight of children.

Do not use medicinal air after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

Do not store above 50°C.

When storing gas cylinders, the following safety rules must be observed:

• Keep containers in an upright position.
• Store in a well-ventilated area.
• Keep away from flammable materials.
• Protect from falls and other impacts.
• Cylinders containing different types of gas must be stored separately.
• Full and empty gas cylinders must be stored separately.
• Store under cover and well protected from adverse weather conditions.
• Close cylinder valves.
• Return the cylinder to the supplier when empty.

6. Contents of the container and other information

Composition of AIRE MEDICINAL SINTÉTICO OXIGEN SALUD

• The active substance of Aire Medicinal Sintético Oxigen Salud, compressed medicinal gas in gas cylinder, is oxygen 22% v/v.
• The other component is nitrogen.

Aire Medicinal Sintético Oxigen Salud is an inhalation gas packaged in gas cylinders at a pressure of 200 bar at 15ºC.

The medicinal synthetic air is supplied in gas cylinders with colors defined according to current legislation. At the time of this revision, the gas cylinders have a white-and-black quartered shoulder.

The gas cylinders contain the following volumes:

0.75 L, 1 L, 1.4 L, 1.6 L, 2 L, 2.5 L, 2.75 L, 3 L, 3.5 L, 4 L, 4.55 L, 4.7 L, 5 L, 6.7 L,

7 L, 10 L, 10.7 L, 13 L, 13.4 L, 15 L, 20 L, 30 L, 40 L, 50 L,

GAS CYLINDER BUNDLE 600 L (12x50 L)

GAS CYLINDER BUNDLE 900 L (18x50 L)

Only some container sizes may be marketed.

Marketing Authorization Holder

OXIGEN SALUD S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

Manufacturer

OXIGEN SALUD S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

OR

OXIGEN SALUD, S. A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos)

This leaflet was approved in November 2022

Detailed and up-to-date 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/