Innovair/Innovair NEXThaler Dosage/Direction for Use

INNOVAIR/INNOVAIR NEXTHALER is for inhalation use.
ASTHMA: The dosage of Innovair/Innovair Nexthaler is individual and should be adjusted to the severity of the disease. This should be considered not only when treatment with combination products is initiated but also when the dose is adjusted. If an individual patient should require a combination of doses other than those available in the combination inhaler, appropriate doses of beta₂-agonists and/or corticosteroids by individual inhalers should be prescribed.
Because of its extrafine particle size distribution, dose adjustment is required when patients are transferred to Innovair/Innovair Nexthaler inhalation powder from a formulation with a non-extrafine particle size distribution. When switching patients from previous treatments, it should be considered that the recommended total daily dose of beclometasone dipropionate for Innovair/Innovair Nexthaler is lower than that for current beclometasone dipropionate-containing non-extrafine products and should be adjusted to the needs of the individual patient. However, patients who are transferred to Innovair/Innovair Nexthaler inhalation powder from Innovair/Innovair Nexthaler pressurised inhalation solution do not need dose adjustment.
Dose recommendations for adults 18 years and above: One or two inhalations twice daily.
The maximum daily dose is 4 inhalations daily.
Dose recommendations for children and adolescents under 18 years: The safety and efficacy of Innovair/Innovair Nexthaler in children and adolescents under 18 years of age have not been established yet. No data are available with Innovair/Innovair Nexthaler in children under 12 years of age. Only limited data are available in adolescents between 12 and 18 years of age. Therefore Innovair/Innovair Nexthaler is not recommended for children and adolescent under 18 years until further data become available.
Patients should be regularly reassessed by a doctor, so that the dosage of Innovair/Innovair Nexthaler remains optimal and is only changed on medical advice. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained. When control of symptoms is maintained with the lowest recommended dosage, then the next step-down could include the inhaled corticosteroid alone. Patients should be advised to take Innovair/Innovair Nexthaler every day even when asymptomatic.
Special patient groups: There is no need to adjust the dose in elderly patients.
There are no data available for use of Innovair/Innovair Nexthaler in patients with hepatic or renal impairment (see Pharmacology: Pharmacokinetics under Actions).
Innovair NEXThaler: COPD: Dose recommendations for adults 18 years and above: Two inhalations twice daily.
Method of administration: Innovair: To ensure proper administration of the drug, the patient should be shown how to use the inhaler correctly by a physician or other health professional. Correct use of the pressurised metered dose inhaler is essential in order that treatment is successful. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use.
Before using the inhaler for the 1st time or if the patient have not used the inhaler for ≥14 days, release 1 puff into the air to make sure the inhaler is working properly. Whenever possible, stand or sit in an upright position when inhaling.
Innovair NEXThaler: Nexthaler is a breath-operated inhaler. Moderate and severe asthmatic patients and COPD patients were shown to be able to produce sufficient inspiratory flow to trigger dose release from Nexthaler (see Pharmacology: Pharmacodynamics under Actions). The delivery of Innovair Nexthaler is flow-independent in the range of inspiratory flow that this patient population can achieve through the inhaler.
Correct use of the Nexthaler inhaler is essential in order for the treatment to be successful. The patient should be advised to read the Patient Information Leaflet carefully and follow the instructions for use as given in the leaflet. For the convenience of the prescriber these instructions are provided in Special precautions for disposing and other handling under Cautions for Usage.
Whenever possible patients should stand or sit in an upright position when inhaling from their inhaler.
With Nexthaler, a dose is made available for inhalation only when the cover is fully opened. Opening the cover, inhaling and closing the cover in sequence drive the dose counter mechanism. The patient should be instructed to close the cover full, at all times. The number of doses shown in the window on the shell does not decrease on closing the cover if the patient has not inhaled through the inhaler.
The patient should be instructed to only open the inhaler's cover when needed. In the event that the patient has opened the inhaler but not inhaled, and the cover is closed, the dose is moved back to the powder reservoir within the inhaler; the following dose can be safely inhaled.
Optimal lung delivery is obtained if the patient inhales by breathing in quickly and deeply through the inhaler. A breath holding period of 5-10 seconds (or as long as comfortable for the patient) is suggested before breathing out.
The patient must be made aware that exhaling through the Nexthaler, before or after inhalation of the dose, must be avoided as this would affect its performance.
Patients should rinse their mouth or gargle with water or brush their teeth after inhaling (see Precautions).