Medicinal synthetic air Solgroup 21.75% v/v compressed medicinal gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Solgroup Synthetic Medicinal Air 21.75% v/v compressed medicinal gas

Oxygen

Read the 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you must not give it 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 adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Solgroup Synthetic Medicinal Air is and what it is used for
2. What you need to know before using Solgroup Synthetic Medicinal Air
3. How to use Solgroup Synthetic Medicinal Air
4. Possible side effects
5. How to store Solgroup Synthetic Medicinal Air
6. Contents of the pack and other information

1. What Aire Medicinal Sintético Solgroup is and what it is used for

Aire Medicinal Sintético Solgroup is an inhalation gas and belongs to the group of medicinal gases.

This medicine is used to prevent oxygen deficiency in cases where treatment with atmospheric air is indicated.

2. What you need to know before using Aire medicinal sintético Solgroup

Do not use Aire medicinal sintético Solgroup

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

Warnings and precautions

Consult your doctor or pharmacist before starting to use this medicine.

• Before treatment with medicinal air, ensure that it is administered at atmospheric pressure.
• Administration of medicinal air under pressure may cause decompression sickness and oxygen toxicity. Decompression sickness is a condition that occurs during the transition from high pressure to normal pressure and may cause headache, nausea, and confusion, and sometimes paralysis and loss of consciousness (which may even lead to death).
• If medicinal air is mixed with other gases for inhalation, 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 medicinal air is administered at high flow rates, the air may feel cold to the touch.
• Medicinal air should not be used in cases where oxygen concentrations higher than atmospheric concentration (>21%) have been prescribed.
• Strict adherence to the safety measures specified below is required both before and during the administration of medicinal air.
• Medicinal synthetic air is administered using specific equipment. If the equipment does not have a pressure control valve, there is a risk of injury due to changes in air pressure, known as barotrauma.

Safety precautions

• It must be clearly understood that air itself is not flammable, but oxygen can promote combustion in the presence of combustible substances such as greases (oils, lubricants) and organic materials (fibers, wood, paper, plastic materials, etc.), especially when exposed to an ignition source (sparks, flames, ignition sources) or during a sudden reduction in gas pressure. Therefore:
• do not use greasy creams or lipsticks;
• do not smoke;
• do not bring the gas cylinder near flames;
• do not use any electrical equipment that may emit sparks near patients receiving treatment with medicinal air;
• do not use oils or greases on connections, taps, valves, or any material in contact with oxygen;
• never introduce air into a device that may contain combustible materials, especially greasy substances;
• do not tamper in any way with cylinder connections, supply devices, or related accessories or components;
• do not use pliers or other tools to open or close the cylinder valve to avoid the risk of damage;
• avoid all contact with oils or greases;
• do not handle devices or components with hands, clothing, or face contaminated with greases, oils, creams, or various ointments.

Gas cylinders must not be used if they show visible damage or if damage or exposure to extreme temperatures is suspected.

In case of leakage, the cylinder valve must be closed immediately, provided this can be done safely. If the valve cannot be closed, the gas cylinder must be moved to a safer outdoor location to allow it to empty safely.

Valves on empty gas cylinders must remain closed.

Paediatric population

No additional warnings or precautionary measures other than those mentioned above are required. However, caution should be exercised when administering this medicine to children.

Other medicines and Aire medicinal sintético Solgroup

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

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

Medicinal air with food and alcohol

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

Pregnancy, breastfeeding and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.

You may use this medicine if you are pregnant or breastfeeding.

Driving and using machines

This medicine does not affect the ability to drive or operate machinery.

3. How to use Synthetic Medicinal Air Solgroup

Posology

The dosage depends on the clinical condition and must be adjusted according to the patient's needs.

If in doubt, consult your doctor or pharmacist.

How to use Synthetic Medicinal Air Solgroup

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

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

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

This medicine is a gas for inhalation and is administered with inhaled air by means of a special device, such as a nasopharyngeal catheter, a face mask, a mask that fits around the head, or via a tracheal supply tube (tracheostomy). The device must be used in accordance with 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 require artificial pulmonary ventilation.

If you use more Synthetic Medicinal Air Solgroup than you should

It is highly unlikely that you will receive more synthetic medicinal air than required, as your doctor or nurse will monitor you during treatment.

There is no risk of overdose with synthetic medicinal air. However, be aware of the risk of sudden changes in atmospheric pressure (barotrauma), especially if synthetic medicinal air is administered using equipment lacking a pressure-reducing valve.

If you forget to use Synthetic Medicinal Air Solgroup

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

If you stop using Synthetic Medicinal Air

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

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

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

No adverse effects are known.

However, the following adverse effects may occur:

decompression illness* frequency unknown

oxygen toxicity* frequency unknown

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet.

You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es.

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

5. Storage of Medicinal Synthetic Air Solgroup

Keep this medicinal product out of sight and reach of children.

Do not use this medicine after the expiry date stated on the gas cylinder following the indication "Use preferably before the end of ..." or "EXP.". The expiry date refers to the last day of the month indicated.

The following safety precautions must be observed for the storage of gas cylinders:

• Store between –20 °C and +65 °C.
• Keep in an upright position. For cylinders with a rounded base, store horizontally or in a box.
• Protect cylinders from falls and other impacts by taking appropriate precautions, such as securing the cylinders or placing them in a box.
• Protect from direct sunlight. Store in a well-ventilated area used exclusively for storing medicinal gases.
• Keep away from flammable materials.
• Gas cylinders containing different types of gas or gas compositions must be stored separately.
• Full and empty gas cylinders must be stored separately.
• Gas cylinders must not be stored near sources of heat.
• Store cylinders under cover and well protected from adverse weather conditions.
• Close the valves of gas cylinders after use.
• Return empty cylinders to the supplier.

6. Contents of the container and other information

Composition of Aire medicinal sintético Solgroup

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

Appearance of Aire medicinal sintético Solgroup and contents of the container

• Aire medicinal sintético Solgroup is a gas for inhalation. The gas is colorless, odorless, and tasteless.
• Aire medicinal sintético Solgroup is stored under a 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 portion 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 applicable EU regulations.
• Gas cylinders with a capacity of (x) liters provide (y) liters of air at 15 °C and 1 bar, as indicated below:

Some package 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
The 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 medicinal product is authorized in the European Economic Area member states under the following names:

Belgium: Lucht synthetisch medicinaal SOL
Germany: Künstliche Luft zur medizinischen Anwendung SOL
Greece: Φαρμακευτικός Συνθετικός Αέρας SOL
Ireland: Medicinal air synthetic SOL
Luxembourg: Air synthétique médicinal SOL
The Netherlands: Lucht synthetisch medicinaal SOL
Spain: Aire medicinal sintético Solgroup
Czech Republic: Vzduch medicinální syntetický SOL
United Kingdom: Medicinal air synthetic

Date of the most recent review of this leaflet: August 2025