MEDICINAL AIR SYNTHETIC

Posology The flow rate and duration of administration should be determined based on the cause of the hypoxia. Method of administration A physician, experienced in intensive care or pneumology, should see to the administration of medicinal air as inlet gas for respirators used in respiratory support.

For long-term administration, humidification is advised. Medicinal air is administered via inhaled air, preferably by means of dedicated equipment (for example, a nasal cannula, facial mask, facial tent, an oxygen tent over a crib, or flow to tracheotomy).

Such devices must be used according to the instructions of the manufacturer. Through this equipment, medicinal air is administered along with inhaled air. Upon exhaling, the exhaled gas leaves the patient together with any surplus air and mixes with the ambient air (“non-rebreathing” system).

If the patient is not able to breathe independently, artificial breathing support can be provided. , must be clean and dry. If needed, clean them according to the instructions of the supplier. Do not use solvents. Do not use oil or grease on the cylinder valve or the related equipment.

No undesirable effects are known also from post-marketing surveillance. Paediatric population No undesirable effects have been reported in children or adolescents. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

Medicinal air may only be administered to patients under atmospheric pressure or at pressure levels that are slightly positive, when ventilators are used. Administration of medicinal air under pressure could cause decompression sickness (as a result of the effects of nitrogen) and oxygen toxicity.

If medicinal air is mixed with other inhalation gases, the oxygen fraction in the inhaled mixture (Fraction of inspired oxygen – FiO2) must be kept at least at 21% v/v. Practically speaking, this means that if it is a component of a gaseous mixture, oxygen must be one of the other components.

At extremely high flow rates, such as in an incubator, medicinal air may feel cold. Medicinal air should not be used where higher than atmospheric concentrations of oxygen (>21%) would be indicated. Paediatric population Children differ from adults, in more ways than just in size: they have, for example, a different breathing pattern, tidal volume and geometry of the airways.

Caution is needed in relation to the use in children. Before and during intake of the medicine, strict compliance with the safety precautions specified below is essential. SAFETY (see also sec. ), oxygen can activate combustion when exposed to a trigger (sparks, naked flame, source of ignition), or as a result of adiabatic compression, which can occur in pressure reducing devices (reducers) during sudden reduction in gas pressure.

•Medicinal gas cylinders must be kept far from sources of heat due to the combustibility of oxygen; hence, due precautions must be taken in this regard. •Oxygen can cause a sudden fire of incandescent materials or of embers; hence, it is not allowed to either smoke or keep naked flames that are not screened near the cylinders and supplying systems.

•Do not smoke in the room where medicinal air is being administered. •Do not place the cylinders near heat sources. •Do not use any electrical equipment that can issue sparks near the patients who receive medicinal air. •It is absolutely forbidden to intervene in any way on cylinder connections, on supplying devices and on the related accessories or components.

•All contact with oil, fats or other hydrocarbons must be avoided (OIL AND FATS CAN SPONTANEOUSLY CATCH FIRE IN CONTACT WITH OXYGEN). •It is absolutely forbidden to handle devices or components with hands or clothes or face soiled with grease, oil, creams and miscellaneous ointments.

Do not use either oily creams or lipsticks. •Cylinders cannot be used, if there is any evident damage or a suspicion that they have been damaged or exposed to extreme temperatures. •Only suitable devices that are compatible for the specific model of the cylinder can be used.

•Neither pliers nor other utensils can be used to either open or close the cylinder’s valve in order to prevent the risk of damage. •In case of leakage, the cylinder’s valve must be instantly closed, if this can be done safely. If the valve cannot be closed, the cylinder must be moved to a safer outdoor location to allow the air to be freely released.

•The valves of empty cylinders must be kept closed. •Administering gas under pressure is not allowed.

There are no absolute contraindications.