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

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

Do not use MEDICINAL SYNTHETIC OXYGEN AIR HEALTH

No situations are known in which the medicinal air should not be used.

Warnings and precautions

• Before starting treatment with medicinal air, 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 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 mixture of gases should always contain sufficient oxygen (at least 22% 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 (high speed in the flow), you may feel cold to the touch.

Interaction of MEDICINAL SYNTHETIC OXYGEN AIR HEALTH with other medications:

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

No interaction is expected between medicinal air and other medications.

MEDICINAL SYNTHETIC OXYGEN AIR HEALTH with food and beverages

MEDICINAL SYNTHETIC OXYGEN AIR HEALTH 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.

MEDICINAL SYNTHETIC OXYGEN AIR HEALTH can be used during pregnancy and breastfeeding.

Driving and using machines

MEDICINAL SYNTHETIC OXYGEN AIR HEALTH does not affect the ability to drive or use machines.

3. How to use MEDICINAL SYNTHETIC OXYGEN AIR HEALTH

Follow the administration instructions for MEDICINAL SYNTHETIC OXYGEN AIR HEALTH exactly as indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

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 to do it.

If you need to use MEDICINAL SYNTHETIC OXYGEN AIR HEALTH for a prolonged period, it is recommended that the medicinal air be humidified (with humidity); the healthcare staff will do it or indicate how to do it.

MEDICINAL SYNTHETIC OXYGEN AIR HEALTH is an inhalation gas that is administered through special equipment (such as a nasal catheter or facial mask), with a mask that fits around the head or with a tube in the trachea (tracheotomy). The device should be used as described by the manufacturer. The excess oxygen leaves the body through exhalation and mixes with the ambient air. During anesthesia, a special device with re-inspiration or recycling systems is used 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 bottle 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 bottle should be used.
• To avoid the risk of damage, pliers or other tools should not be used to open or close the bottle valve.
• The container shape should not be modified.
• In case of a leak, the bottle valve should be closed immediately, as long as it is safe to do so. If the valve cannot be closed, the bottle should be moved to a safe outdoor location to discharge the oxygen.
• The valves of empty gas bottles should be closed.
• The connections for tubes, valves, etc. should be clean and dry, and when they are dirty, they 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 bottle is not allowed.

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

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).

If you forget to use MEDICINAL SYNTHETIC OXYGEN AIR HEALTH

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

4. Possible side effects

No known side effects.

If you experience side effects, consult your doctor or pharmacist.

5. Storage of MEDICINAL SYNTHETIC OXYGEN AIR HEALTH

Keep out of the reach and sight of children.

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

Do not store at a temperature above 50°C.

During the storage of gas bottles, the following safety rules should be followed:

• Keep the containers in a vertical 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 should be stored separately.
• Full and empty gas bottles should be stored separately.
• Store under cover and well-protected from adverse atmospheric conditions.
• Close the valves of the bottles.
• Return the bottle to the provider when it is empty.

6. Package contents and additional information

Composition of MEDICINAL SYNTHETIC OXYGEN AIR HEALTH

• The active principle of MEDICINAL SYNTHETIC OXYGEN AIR HEALTH, compressed medicinal gas in a gas cylinder, is oxygen 22% v/v.
• The other component is nitrogen.

MEDICINAL SYNTHETIC OXYGEN AIR HEALTHis an inhalation gas that is packaged in gas cylinders at 200 bar pressure at 15°C.

The synthetic medicinal air is presented in gas cylinders with defined colors according to current legislation. As of this revision, the gas cylinders have a white and black quartered tip.

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,

BLOCK OF BOTTLES 600L (12x50 L)

BLOCK OF BOTTLES 900L (18x50 L)

Only some package 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 San 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 updated information on this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/