Source: Health Products Regulatory Authority (IE) Revision Year: 2021 Publisher: Glenmark Pharmaceuticals s.r.o, Hvezdova 1716/2b, Prague 4, 140 78, Czech Republic
Ryaltris is indicated in adults and adolescents 12 years of age and older for the treatment of moderate to severe nasal symptoms associated with allergic rhinitis.
The usual recommended dose is two actuations in each nostril twice daily (morning and evening).
Ryaltris is not recommended for use in children below 12 years of age as safety and efficacy has not been established in this age group.
No dose adjustment is required in this population.
There are no data in patients with renal and hepatic impairment, however no dose adjustment is expected to be required in these populations considering the absorption, metabolism and elimination of the active substances (see section 5.2).
Ryaltris is for nasal use only.
Prior to administration of the first dose, shake container well and actuate the pump 6 times (until a uniform spray is obtained). If the pump is not used for 14 days or longer, re-prime the pump with 2 actuations until a uniform spray is observed, before next use.
Shake container for minimum 10 seconds before each use. After using the spray, wipe the nozzle carefully with a clean handkerchief or tissue and replace the cap, to avoid that the nozzle gets blocked. The bottle should be discarded after the labelled number of actuations or within 2 months of first use.
With the nasal route of administration overdose reactions are not anticipated.
No data are available in humans regarding overdose by accidental or deliberate ingestion.
Inhalation or oral administration of excessive doses of corticosteroids may lead to suppression of HPA axis function.
There is no known specific antidotes to Ryaltris active components.
In the case of overdose, appropriate monitoring and supportive management of the patient should be implemented.
3 years.
In-use shelf life (after first use): 2 months.
Do not freeze.
The nasal spray is contained in a white, high density polyethylene bottle supplied with a metered-dose, manual polypropylene spray pump actuator. The actuator is fitted with a HDPE purple cap.
Pack sizes:
1 bottle of 20 ml with 9 g suspension (56 actuations),
1 bottle of 20 ml with 18 g suspension (120 actuations)
1 bottle of 30 ml with 29 g suspension (240 actuations).
Not all pack sizes may be marketed.
Any unused medicinal product or waste material should be disposed of in accordance with local requirements.
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