Posology : מינונים

4.2   Posology and method of administration

Posology
Asthma

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.

Adults and adolescents aged 12 years and over

A starting dose of one inhalation of Relvar Ellipta 92/22 micrograms once daily 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.

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 used for immediate relief.

The maximum recommended dose is Relvar Ellipta 184/22 micrograms once daily.

Children aged under 12 years
The safety and efficacy of Relvar Ellipta in children under 12 years of age have not been established in the indication for asthma.
Relvar Ellipta should not be used in children under 12 years of age. Currently available data are described in sections 5.1 and 5.2.

COPD

Adults aged 18 years and over
One inhalation of Relvar Ellipta 92/22 micrograms once daily.

Relvar Ellipta 184/22 micrograms is not indicated for patients with COPD. There is no additional benefit of the 184/22 micrograms dose compared to the 92/22 micrograms dose and there is a potential increased risk of pneumonia and systemic corticosteroid-related adverse reactions (see sections 4.4 and 4.8).

Patients usually experience an improvement in lung function within 16-17 minutes of inhaling Relvar Ellipta.

Paediatric population
There is no relevant use of Relvar Ellipta in the paediatric population (under 18 years of age) for the indication of COPD.

Special populations

Elderly
No dose adjustment is required in patients 65 years of age or older (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 oral inhalation 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.

After inhalation, patients should rinse their mouth with water without swallowing.
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.

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. The desiccant sachet should be thrown away and it should not be opened, eaten or inhaled.

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 and carton in the space provided. The “Discard by” date is 6 weeks from the date of opening the tray, but not later than the expiry date. 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 (30 day supply) also apply to the 14-dose Ellipta inhaler (14 day supply).

Instructions for use

1.      Read this before you start

If the inhaler cover is opened and closed without inhaling the medicinal product, the dose will be lost. The lost dose will be securely held inside the inhaler, but it will no longer be available to be inhaled.
It is not possible to accidentally take extra medicinal product or a double dose in one inhalation.



2.    Prepare a dose

Open the cover when ready to inhale a dose. The inhaler should not be shaken.
Slide the cover down until a ‘click’ is heard. The medicinal product is now ready to be inhaled.

The dose counter counts down by 1 to confirm. If the dose counter does not count down as the ‘click’ is heard, the inhaler will not deliver a dose and should be taken back to a pharmacist for advice.



3.    How to inhale the medicinal product

The inhaler should be held away from the mouth breathing out as far as is comfortable, but not breathing out into the inhaler.

The mouthpiece should be placed between lips and the lips should be then closed firmly around it.

The air vents should not be blocked with fingers during use.

• Inhale with one long, steady, deep breath in. The breath should be held for as long as possible (at least 3-4 seconds).
• Remove the inhaler from the mouth.
• Breathe out slowly and gently.



The medicinal product may not be tasted or felt, even when using the inhaler correctly.

The mouthpiece of the inhaler may be cleaned using a dry tissue before closing the cover.
4.      Close the inhaler and rinse your mouth

Slide the cover upwards as far as it will go to cover the mouthpiece.

Rinse your mouth with water after you have used the inhaler, do not swallow.
This will make it less likely to develop a sore mouth or throat as side effects.