Prospecto: information for the user

Solgroup 21.75% v/v synthetic medicinal compressed gas

Oxygen

Read this prospectus carefully before starting to use this medication, as it contains important information for you.

• Keep this prospectus, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed only to you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. See section 4.

Synthetic Medical Air Solgroup is a gas for inhalation and belongs to the group of medicinal gases.

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

No use Aire medicinal sintético Solgroup

No existen situaciones conocidas en las que no se deba usar este medicamento.

Advertencias y precauciones

Consulte a su médico o farmacéutico antes de empezar a usar este medicamento.

• Antes del tratamiento con el aire medicinal, asegúrese de que se administra a presión atmosférica.
• La administración de aire medicinal bajo presión puede provocar enfermedad por descompresión y toxicidad del oxígeno. La enfermedad por descompresión es una enfermedad que se produce durante la transición entre una presión alta y una presión normal y provoca dolor de cabeza, náuseas y confusión y, en ocasiones, parálisis y pérdida del conocimiento (pudiendo llegar incluso a la muerte).
• Si el aire medicinal se mezcla con otros gases para inhalación, la mezcla de gas debe contener suficiente oxígeno (al menos 21% v/v). Por lo tanto, las mezclas de aire medicinal con otros gases siempre deben incluir oxígeno adicional a partir de otras fuentes.
• Si administra aire medicinal con tasas de flujo elevadas, el aire puede notarse frío al tacto.
• El aire medicinal no debería usarse en casos en los que se hayan prescrito concentraciones de oxígeno (>21%) superiores a la concentración atmosférica.
• Se requiere un absoluto cumplimiento de las medidas de seguridad especificadas a continuación tanto antes como durante la administración del aire medicinal.

Precauciones de seguridad

• Es necesario especificar que el aire no es inflamable por sí solo, pero el oxígeno puede activar su combustión cuando hay sustancias combustibles, como grasas (aceites, lubricantes) y sustancias orgánicas (fibras, madera, papel, materiales plásticos, etc.), debido a un detonante (chispas, llamas, fuentes de ignición) o durante una reducción repentina en la presión del gas. Por lo tanto:
• no utilice cremas grasas o labiales;
• no fume;
• no acerque la bala de gas a llamas;
• no utilice ningún equipo eléctrico que pueda emitir chispas cerca de pacientes que reciben tratamiento con aire medicinal;
• no utilice aceites ni grasas en conexiones, grifos, válvulas y cualquier material que esté en contacto con el oxígeno;
• no introduzca nunca aire en un dispositivo que pueda contener materiales combustibles, especialmente materiales grasos;
• no manipule de ninguna manera las conexiones de las balas de gas, los dispositivos de suministro y los accesorios o componentes relacionados;
• no debe utilizar tenazas ni otras herramientas para abrir o cerrar la válvula de la bala de gas para evitar el riesgo de que se produzcan daños;
• evite todo contacto con aceites o grasas;
• no maneje dispositivos o componentes con las manos o con la ropa o la cara manchada de grasas, aceites, cremas y pomadas variadas.

No se deben usar las balas de gas si estas presentan daños visibles o si se sospecha que han sido dañadas o expuestas a temperaturas extremas.

En caso de fuga, deberá cerrarse inmediatamente la válvula de la bala, siempre que esto sea posible de forma segura. Si no se puede cerrar la válvula, deberá llevarse la bala de gas a un lugar exterior más seguro para dejar que se vacíe de aire.

Las válvulas de las balas de gas vacías deben mantenerse cerradas.

Población pediátrica

No se deben tomar advertencias o medidas de precaución adicionales a las mencionadas anteriormente. Sin embargo, se debe tener precaución a la hora de administrar este medicamento a niños.

Uso de Aire medicinal sintético Solgroup con otros medicamentos

Informe a su médico o farmacéutico si está tomando, ha tomado recientemente o pudiera tener que tomar cualquier otro medicamento.

No se han comunicado interacciones entre este medicamento y otros medicamentos.

Aire medicinal sintético con alimentos y alcohol

No se han observado interacciones con alcohol, tabaco y alimentos.

Embarazo, lactancia y fertilidad

Si está embarazada o en periodo de lactancia, cree que podría estar embarazada o tiene intención de quedarse embarazada, consulte a su médico o farmacéutico antes de utilizar este medicamento.

Puede usar este medicamento si está embarazada o en período de lactancia.

Conducción y uso de máquinas

Este medicamento no afecta a la capacidad para conducir y manipular máquinas.

Dosage

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

In case of doubt, ask your doctor or pharmacist.

How to use Solgroup Medical Synthetic Air

To use the medical air, the high pressure contained in the bottle must be reduced to the necessary pressure using a reducing device.

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

Your healthcare professional will ensure that your medical air supply is adequate for you and that the equipment is correctly set up so that you receive the correct amount of air.

This medication is a gas for inhalation and is administered with inhaled air through a special device, such as a nasopharyngeal catheter, a facial mask, with a mask that fits around the head or through a tracheal tube (tracheotomy). The device must be used according to the manufacturer's instructions.

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

If you cannot breathe on your own, you may need to receive artificial pulmonary ventilation.

If you use more Solgroup Medical Synthetic Airthan you should

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

If you forgot to use Solgroup Medical Synthetic Air

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

If you stop usingSolgroup Medical Synthetic Air

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

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

Like all medications, this medication may produce adverse effects, although not all people may experience them.

No adverse effects are known.

However, the following adverse effects may occur:

decompression sickness* unknown frequency

oxygen toxicity* unknown frequency

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

Reporting Adverse Effects

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

You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es.

By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the gas bottle after the indication «Consume preferably before the end of ...» or «CAD.». The expiration date is the last day of the month indicated.

The following safety precautions must be followed for the conservation of the gas cartridges:

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

Composition of Solgroup Medical Synthetic Air

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

Appearance of Solgroup Medical Synthetic Air and packaging contents

• Solgroup Medical Synthetic Air is an inhalation gas. The gas is colorless, odorless, and tasteless.
• Solgroup Medical Synthetic Air 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 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:

Only some sizes of packaging may be commercially available.

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 medicinal product is authorized in the member states of the European Economic Area with 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

Last review date of this leaflet: May 2019