HELIOX21 (HELIUM

Posology Heliox21 is administered to patients as supplied in a 79% helium/21% oxygen ratio, but can also be administered with supplemental oxygen at the physician’s discretion according to patients’ requirements. In order to maintain the desired helium concentration and avoid room air entrainment, Heliox21 should be administered at a flow that is sufficient to meet the patients’ inspiratory flow rate and volume.

Heliox21 should be administered at a sufficient flow in order to avoid room air entrainment and maintain the desired helium concentration. As with all treatments for patients with airway obstruction, the patient’s respiratory status should be monitored during Heliox21 therapy, using clinical monitoring and evaluation of blood gas concentration/saturation, and adequate oxygenation must be maintained.

Method of administration Use in Adults and Children (all age groups) Heliox21 is administered by inhalation. The duration and circumstances of the use of Heliox21 is at the discretion of the attendant physician. Cylinder duration is dependant on the prescribed flow rate and cylinder contents gauge should be checked to ensure there is sufficient gas available.

Heliox21 should only be administered by trained personnel and patients should be monitored. The physical properties of helium/oxygen mixtures are different compared to oxygen or oxygen/air mixtures, therefore be sure to use equipment designed for administration of helium oxygen mixtures in order to ensure controlled administration.

It is critical that Heliox21 is used in combination with appropriate devices and flow rates to avoid room air entrainment and maintain the desired helium concentration. • It can be administered by mask or when appropriate through tracheal tube or tracheostomy.

• It may also be administered via nasal prongs if sufficiently high flow rate is employed to prevent air entrainment • It can be administered to spontaneously breathing patients or in combination with various forms of invasive and non-invasive ventilatory modes.

Heliox21 can be used for nebulisation therapy as the driving gas for generation of aerosol and as the carrier gas for inhalation of aerosol.

Very common (>1/10) :

High-pitched voice.

Common (>1/100<1/10):

Drying of mucus membranes in the respiratory tract. Cooling. 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.

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Medicinal gases may cause drying of mucus membranes within the respiratory tract. If use is prolonged, humidification may be required. The risk for cooling should be taken into account, especially in smaller children. When using devices not designed for helium-oxygen mixtures, set ventilator tidal volumes and measured flow rates may not be accurate due to the physical properties of helium.

Under no circumstances should oils or grease be used to lubricate any part of the Heliox21 cylinder or the associated equipment used to deliver the gas to the patient. Where moisturising preparations are required for use with a facemask or in nasal passages, oil based creams should not be used.

Check that hands are clean and free from any oils or grease.

None Applicable