Source: European Medicines Agency (EU) Revision Year: 2022 Publisher: GlaxoSmithKline (Ireland) Limited, 12 Riverwalk, Citywest Business Campus, Dublin 24, Ireland
Avamys is indicated in adults, adolescents and children (6 years and over).
Avamys is indicated for the treatment of the symptoms of allergic rhinitis.
The recommended starting dose is two spray actuations (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 110 micrograms).
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril (total daily dose 55 micrograms) may be effective for maintenance. The dose should be titrated to the lowest dose at which effective control of symptoms is maintained.
The recommended starting dose is one spray actuation (27.5 micrograms of fluticasone furoate per spray actuation) in each nostril once daily (total daily dose, 55 micrograms).
Patients not adequately responding to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) may use two spray actuations in each nostril once daily (total daily dose, 110 micrograms).
Once adequate control of symptoms is achieved, dose reduction to one spray actuation in each nostril once daily (total daily dose, 55 micrograms) is recommended.
For full therapeutic benefit regular, scheduled usage is recommended. Onset of action has been observed as early as 8 hours after initial administration. However, it may take several days of treatment to achieve maximum benefit, and the patient should be informed that their symptoms will improve with continuous regular use (see section 5.1). The duration of treatment should be restricted to the period that corresponds to allergenic exposure.
The safety and efficacy of Avamys in children under the age of 6 years has not been established. Currently available data are described in section 5.1 and 5.2 but no recommendation on a posology can be made.
No dose adjustment is required in this population (see section 5.2).
No dose adjustment is required in this population (see section 5.2).
No dose adjustment is required in patients with hepatic impairment (see section 5.2).
Avamys nasal spray is for administration by the intranasal route only.
The intranasal device should be shaken before use. The device is primed by pressing the mist release button for at least six spray actuations (until a fine mist is seen), whilst holding the device upright. Re-priming (approximately 6 sprays until a fine mist is seen) is only necessary if the cap is left off for 5 days or the intranasal device has not been used for 30 days or more.
The device should be cleaned after each use and the cap replaced.
In a bioavailability study, intranasal doses of up to 2640 micrograms per day were administered over three days with no adverse systemic reactions observed (see section 5.2).
Acute overdose is unlikely to require any therapy other than observation.
3 years.
In-use shelf life: 2 months.
Do not refrigerate or freeze.
Store upright.
Always keep the cap on.
14.2 ml Type I or Type III amber bottle (glass) fitted with a metering spray pump.
The medicinal product is available in three pack sizes: 1 bottle of 30, 60 or 120 sprays.
Not all pack sizes may be marketed.
No special requirements for disposal.
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