Relvar Ellipta 184 micrograms 22 micrograms inhalation powder

Relvar Ellipta 184 micrograms/22 micrograms inhalation powder
Relvar Ellipta is indicated for the regular treatment of asthma in adults and adolescents aged 12 years and older where use of a combination medicinal product

Relvar Ellipta 184 micrograms/22 micrograms inhalation powder
Asthma
Adults and adolescents aged 12 years and over
One inhalation of Relvar Ellipta 184/22 micrograms once daily.
Patients usually experience an improvement in lung function within 15 minutes of inhaling Relvar Ellipta.
However, the patient should be informed that regular daily usage is necessary to maintain control of asthma symptoms and that use should be continued even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.
A starting dose of Relvar Ellipta 92/22 micrograms should be considered for adults and adolescents 12 years and over who require a low to mid dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.  If patients are inadequately controlled on Relvar Ellipta 92/22 micrograms, the dose can be increased to 184/22 micrograms, which may provide additional improvement in asthma control.
Patients should be regularly reassessed by a healthcare professional so that the strength of fluticasone furoate/vilanterol they are receiving 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.
Relvar Ellipta 184/22 micrograms should be considered for adults and adolescents 12 years and over who require a higher dose of inhaled corticosteroid in combination with a long-acting beta2-agonist.
The maximum recommended dose is Relvar Ellipta 184/22 micrograms once daily.
Patients with asthma should be given the strength of Relvar Ellipta containing the appropriate fluticasone furoate (FF) dosage for the severity of their disease.  Prescribers should be aware that in patients with asthma, fluticasone furoate (FF) 100 micrograms once daily is approximately equivalent to fluticasone propionate (FP) 250 micrograms twice daily, while FF 200 micrograms once daily is approximately equivalent to FP 500 micrograms twice daily.
Children aged under 12 years
The safety and efficacy of Relvar Ellipta in children under 12 years of age has not yet been established in the indication for asthma.
No data are available.
Special populations
Elderly patients (>65 years)
No dose adjustment is required in this population (see section 5.2).
Renal impairment
No dose adjustment is required in this population (see section 5.2).
Hepatic impairment
Studies in subjects with mild, moderate and severe hepatic impairment showed an increase in systemic exposure to fluticasone furoate (both Cmax and AUC) (see section 5.2).
Caution should be exercised when dosing patients with hepatic impairment who may be more at risk of systemic adverse reactions associated with corticosteroids.
For patients with moderate or severe hepatic impairment the maximum dose is 92/22 micrograms (see section 4.4).
Method of administration
Relvar Ellipta is for inhalation use only.
It should be administered at the same time of the day, each day.
The final decision on evening or morning dosing should be left to the discretion of the physician.
If a dose is missed the next dose should be taken at the usual time the next day.
If stored in a refrigerator, the inhaler should be allowed to return to room temperature for at least an hour before use.
After inhalation, patients should rinse their mouth with water without swallowing.
When the inhaler is used for the first time, there is no need to check that it is working properly, and to prepare it for use in any special way.  The step-by-step instructions should be followed.
The Ellipta inhaler is packaged in a tray containing a desiccant sachet, to reduce moisture.  Once opened the desiccant sachet should be discarded.
The patient should be advised to not open the tray until they are ready to inhale a dose.
When the inhaler is taken out of its tray, it will be in the 'closed' position.  The "Discard by" date should be written on the inhaler label in the space provided.  The "Discard by" date is 6 weeks from the date of opening the tray.  After this date the inhaler should no longer be used.  The tray can be discarded after first opening.
The step-by-step instructions shown below for the 30-dose Ellipta inhaler also apply to the 14-dose Ellipta inhaler.

Relvar Ellipta 184 micrograms/22 micrograms inhalation powder

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