SYNTHETIC MEDICAL OXYGEN AIR HEALTH, 22% v/v, compressed medicinal gas

(Oxygen)

Read this 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 or pharmacist.

- This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms of illness as you, as it may harm them.

- If you experience any side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet.

1. What is SYNTHETIC MEDICAL OXYGEN AIR HEALTH and how it is used

2. What you need to know before starting to use SYNTHETIC MEDICAL OXYGEN AIR HEALTH

3. How to use SYNTHETIC MEDICAL OXYGEN AIR HEALTH

4. Possible side effects

5. Storage of SYNTHETIC MEDICAL OXYGEN AIR HEALTH

6. Contents of the container and additional informationl

Synthetic Medical Air Oxygen Health belongs to a group of medications called medicinal gases.

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

•Supplying ventilators in anesthesia-reanimation.

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

Do not use SYNTHETIC MEDICAL OXYGEN HEALTH OXYGEN

No known situations exist in which the medical oxygen should not be used.

Warnings and precautions

•Before starting treatment with medical oxygen, ensure that it is administered at atmospheric pressure (air pressure in the atmosphere), the healthcare staff will adjust the manometer or indicate how to do it.

•The administration of medical oxygen 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 medical oxygen is mixed with other gases for inhalation, the gas mixture must always have sufficient oxygen presence (at least 22% v/v). Therefore, medical oxygen mixtures with other gases must always include additional oxygen from other sources.

•If you administer medical oxygen at high flow rates (high speed in the flow), you may feel cold to the touch.

Interaction of SYNTHETIC MEDICAL OXYGEN HEALTH OXYGEN with other medications:

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

No interaction is expected between medical oxygen and other medications.

SYNTHETIC MEDICAL OXYGEN HEALTH OXYGEN and food and drinks

Medical oxygen does not interact with food, so it can be administered with meals or outside of them.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medication.

Medical oxygen can be used during pregnancy and breastfeeding.

Driving and using machines

Medical oxygen does not affect the ability to drive or use machines.

Follow exactly the administration instructions for Medical Air 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 Medical Air is used.

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

If you must use Medical Air for a prolonged period, it is recommended that Medical Air be humidified (with moisture), the healthcare staff will do it or indicate the way to do it.

Medical 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 exhaled from the body through exhalation and mixes with the ambient air. During anesthesia, a special device with respiration or recycling systems is used so that the exhaled air is inhaled again (a "respiration" system). If you cannot breathe autonomously, you may be administered Medical Air through a ventilation machine

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

•The gas bottle cannot be used if it is visibly damaged or if it is suspected to have been damaged or 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 bottle.

•To avoid the risk of damage, do not use pliers or other tools to open or close the valve on the bottle.

•Do not modify the container shape.

•In case of a leak, immediately close the bottle valve, if it is safe to do so. If the valve cannot be closed, the bottle must be moved to a safe outdoor location to discharge the oxygen.

•Closed the gas bottle valves when empty.

•The connections for tubes, valves, etc. must be clean and dry, and 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.

•It is not permitted to siphon gas under pressure.

•It is not permitted to smoke or bring open flames near the gas bottle.

If you use more MEDICAL AIR SYNTHETIC OXYGEN HEALTH than you should

No known risks of overdose have been reported for Medical Air.

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

If you forgot to use MEDICAL AIR SYNTHETIC OXGEN HEALTH

Use Medical Air as soon as you remember. Do not use a double dose to compensate for the missed doses.

No adverse effects are known.

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

Keep out of reach and sight of children.

Do not use the medicinal air after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

Do not store at a temperature above 122°F.

During the storage of gas bottles, the following safety standards must be followed:

•Store the containers in an upright position.

•Store in a well-ventilated area.

•Keep away from flammable products.

•Protect from falls and other impacts.

•Bottles containing a different type of gas must be stored separately.

•Full and empty gas bottles must be stored separately.

•Store covered and well-protected from adverse atmospheric conditions.

•Close the valves on the bottles.

•Return the empty bottle to the supplier.

Composition of MEDICAL SYNTHETIC OXYGEN HEALTH AIR

•The active ingredient of Medical Synthetic Oxygen Health Air, compressed medicinal gas in gas cartridges is oxygen 22% v/v.

•The other component is nitrogen.

Medical Synthetic Oxygen Health Airis an inhalation gas that is packaged in gas cartridges at 200 bar pressure at 15°C.

Medical synthetic air is presented in gas cartridges of defined colors by current legislation. As of this review, the gas cartridges have a white and black quartered tip.

The gas cartridges 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,

BLOCK OF BOTTLES 600L (12x50 L)

BLOCK OF BOTTLES 900L (18x50 L)

Only some sizes of packaging may be commercially marketed.

Holder of the marketing authorization

OXIGEN SALUD S.A.

Carretera Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

Responsible for manufacturing

OXIGEN SALUD S.A.

Carretera Rubí 141-143

08174 San Cugat del Vallès (Barcelona)

Ó

OXIGEN SALUD, S. A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos)

This prospectus was approved in November 2022

The detailed and updated information on this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/