SYNTHETIC MEDICINAL AIR SOLGROUP 21.75% V/V COMPRESSED MEDICAL GAS

2. What you need to know before you start using Medicinal Synthetic Air Solgroup

Do not use Medicinal Synthetic Air Solgroup

There are no known situations in which this medicine should not be used.

Warnings and Precautions

Consult your doctor or pharmacist before you start using this medicine.

• Before treatment with the medicinal air, ensure that it is administered at atmospheric pressure.
• Administration of medicinal air under pressure can cause decompression sickness and oxygen toxicity. Decompression sickness is a disease that occurs during the transition between high pressure and normal pressure and causes headache, nausea, and confusion, and sometimes paralysis and loss of consciousness (which can even lead to death).
• If the medicinal air is mixed with other inhalation gases, the gas mixture must contain sufficient oxygen (at least 21% v/v). Therefore, mixtures of medicinal air with other gases must always include additional oxygen from other sources.
• If you administer medicinal air at high flow rates, the air may feel cold to the touch.
• Medicinal air should not be used in cases where higher oxygen concentrations (>21%) than atmospheric concentration have been prescribed.
• Absolute compliance with the specified safety measures is required both before and during administration of the medicinal air.
• The synthetic medicinal air is administered through specific equipment. If the equipment does not have a valve to control the pressure, there is a risk of suffering injuries from changes in air pressure, known as barotrauma.

Safety Precautions

• It is necessary to specify that air is not flammable by itself, but oxygen can activate its combustion when there are combustible substances, such as fats (oils, lubricants) and organic substances (fibers, wood, paper, plastic materials, etc.), due to an igniter (sparks, flames, ignition sources) or during a sudden reduction in gas pressure. Therefore:
• do not use greasy creams or lip balms;
• do not smoke;
• do not bring the gas cylinder close to flames;
• do not use any electrical equipment that may emit sparks near patients receiving treatment with medicinal air;
• do not use oils or greases in connections, taps, valves, and any material that comes into contact with oxygen;
• never introduce air into a device that may contain combustible materials, especially greasy materials;
• do not manipulate the connections of the gas cylinders, supply devices, and related accessories or components in any way;
• do not use pliers or other tools to open or close the valve of the gas cylinder to avoid the risk of damage;
• avoid any contact with oils or greases;
• do not handle devices or components with hands or with clothing or face stained with greases, oils, creams, and various ointments.

The gas cylinders should not be used if they have visible damage or if they are suspected to have been damaged or exposed to extreme temperatures.

In case of a leak, the valve of the cylinder should be closed immediately, as long as it is safe to do so. If the valve cannot be closed, the gas cylinder should be taken to a safer outdoor location to allow the air to escape.

The valves of empty gas cylinders should be kept closed.

Pediatric Population

No additional warnings or precautions are required beyond those mentioned above. However, caution should be exercised when administering this medicine to children.

Other Medicines and Medicinal Synthetic Air Solgroup

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.

No interactions have been reported between this medicine and other medicines.

Medicinal Synthetic Air with Food and Alcohol

No interactions have been observed with alcohol, tobacco, and food.

Pregnancy, Breast-feeding, and Fertility

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

You can use this medicine if you are pregnant or breast-feeding.

Driving and Using Machines

This medicine does not affect your ability to drive or use machines.

3. How to Use Medicinal Synthetic Air Solgroup

Dosage

The dosage depends on the clinical situation and should be adjusted to the needs of the patient.

If in doubt, ask your doctor or pharmacist.

How to Use Medicinal Synthetic Air Solgroup

To use the medicinal air, the high pressure contained in the cylinder must be reduced to the necessary pressure using a pressure-reducing device.

If you need to use the medicinal air for a prolonged period, it is recommended to humidify the medicinal air.

Your healthcare professional will ensure that your medicinal air supply is suitable for you and that the equipment is correctly configured so that you receive the correct amount of air.

This medicine is an inhalation gas and is administered with inhaled air through a special device, such as a nasopharyngeal catheter, a face mask, with a mask that fits around the head, or through a tube supplying the trachea (tracheotomy). The device should be used according to the manufacturer's instructions.

Any excess air will leave your body through exhalation and mix with the surrounding air.

If you are unable to breathe on your own, you may need to receive artificial pulmonary ventilation.

If You Use More Medicinal Synthetic Air Solgroup Than You Should

It is highly unlikely that you will take more medicinal synthetic air than you should because your doctor or nurse will monitor you during treatment.

There is no risk of overdose with medicinal synthetic air. However, it is essential to be aware of the risk of sudden changes in atmospheric pressure (barotrauma), especially if the medicinal synthetic air is administered through equipment that does not have a pressure-reducing valve.

If You Forget to Use Medicinal Synthetic Air Solgroup

Do not take a double dose to make up for a forgotten dose. Continue treatment with the prescribed dose.

If You Stop Using Medicinal Synthetic Air Solgroup

The disease for which you are being treated with compressed medicinal air may worsen.

If you have any further questions on the use of this medicine, ask your doctor or pharmacist.

4. Possible Side Effects

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

No side effects are known.

However, the following side effects may occur:

decompression sickness* frequency unknown

oxygen toxicity* frequency unknown

*if administered under pressure (see also "Warnings and Precautions")

Reporting of Side Effects

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

You can also report side effects directly to the Spanish Medicines Monitoring System: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Synthetic Air Solgroup

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 gas cylinder after the statement "Best before end of ... " or "EXP.". The expiry date is the last day of the month stated.

The following safety precautions should be followed for the storage of gas cylinders:

• Store between –20 °C and +65 °C.
• Keep in a vertical position. In the case of cylinders with a round base, store in a horizontal position or in a box.
• Protect the cylinders from falls and other impacts by taking adequate precautions, such as securing the cylinders or placing them in a box.
• Protect from sunlight. Store in a well-ventilated area used exclusively for storing medicinal gases.
• Keep away from flammable products.
• Cylinders containing a different type of gas or composition should be stored separately.
• Full and empty gas cylinders should be stored separately.
• Gas cylinders should not be stored near heat sources.
• Store the cylinders under cover and well protected from adverse weather conditions.
• Close the valves of the gas cylinders after use.
• Return the cylinders to the supplier when they are empty.

6. Contents of the Pack and Further Information

Composition of Medicinal Synthetic Air Solgroup

• The active substance is oxygen 21.75% v/v
• The other component is nitrogen.

Appearance of Medicinal Synthetic Air Solgroup and Contents of the Pack

• Medicinal Synthetic Air Solgroup is an inhalation gas. The gas is colorless, odorless, and tasteless.
• Medicinal Synthetic Air Solgroup is stored under pressure of 200 bar (at 15 °C) in gas cylinders.
• The cylinders are made of steel or aluminum. The valves are made of brass, steel, or aluminum.
• The shoulder part of the cylinder has a black band on a white background. The body of the cylinder is white.
• The gas cylinders, valves, and valve outlets comply with the relevant EU regulations.
• The gas cylinders with a capacity of (x) liters provide (y) liters of air at 15 °C and 1 bar, as indicated below:

Some pack sizes may not be marketed.

Marketing Authorization Holder

SOL FRANCE SUCURSAL EN ESPAÑA

Calle Yeso, num. 2

28500 Arganda del Rey - (Madrid)

Spain

Manufacturer

SOL Nederland B.V.

Swaardvenstraat 11

5048 AV Tilburg

Netherlands

SOL B S.r.l.

Zoning Ouest 15

7860 Lessines

Belgium

SOL HELLAS S.A.

Thesi Stefani,

ASPROPYRGOS ATTIKI,

GR-193 00,

Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Belgium: Lucht synthetisch medicinaal SOL

Germany: Künstliche Luft zur medizinischen Anwendung SOL

Greece: Φαρμακευτικ?ς Συνθετικ?ς Α?ρας SOL

Ireland: Medicinal air synthetic SOL

Luxembourg: Air synthétique médicinal SOL

Netherlands: Lucht synthetisch medicinaal SOL

Spain: Aire medicinal sintético Solgroup

Czech Republic: Vzduch medicinální syntetický SOL

United Kingdom: Medicinal air synthetic

Date of Last Revision of this Leaflet: August 2025