Posology : מינונים

4.2      Posology and method of administration

Treatment must be initiated and supervised by physicians experienced in the treatment of asthma and COPD.

Posology
Asthma

Patients should be made aware that Trelegy Ellipta must be used regularly, even when asymptomatic.

If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be taken for immediate relief.

Patients should be regularly reassessed by a healthcare professional so that the strength of Trelegy Ellipta they are receiving remains optimal and is only changed on medical advice.

Adults

The recommended dose is one inhalation of Trelegy Ellipta 92/55/22 mcg once daily or one inhalation of Trelegy Ellipta 184/55/22 mcg once daily.

Trelegy Ellipta 92/55/22 mcg should be considered for patients who require a low to mid dose of ICS in combination with a LAMA and a LABA.

Trelegy Ellipta 184/55/22 mcg should be considered for patients who require a higher dose of ICS in combination with a LAMA and a LABA.

If patients are inadequately controlled on Trelegy Ellipta 92/55/22 mcg, consider increasing the dose to 184/55/22 mcg, which may provide additional improvement in asthma control.

Paediatric population
The safety and efficacy of Trelegy Ellipta have not been established in children or adolescents less than 18 years of age.

COPD

Adults
The recommended and maximum dose is one inhalation of Trelegy Ellipta 92/55/22 micrograms once daily, at the same time each day.

If a dose is missed the next dose should be inhaled at the usual time the next day.

Paediatric population
There is no relevant use of Trelegy Ellipta 92/55/22 mcg in the paediatric population (under 18 years of age) 
for the indication of COPD.

Asthma and COPD

Special populations

Elderly patients
No dose adjustment is required in patients over 65 years (see section 5.2 Pharmacokinetic properties).

Renal impairment

No dose adjustment is required in patients with renal impairment (see section 5.2 Pharmacokinetic properties).

Hepatic impairment

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 Trelegy Ellipta 92/55/22 mcg (see section 4.4 Special warnings and precautions for use and section 5.2 Pharmacokinetic properties).


Method of administration
Trelegy Ellipta is for inhalation use only. Trelegy Ellipta should be administered once daily, either morning or evening, but at the same time each day.

Instructions for use:

The following instructions for the 30 dose (30 day supply) Ellipta inhaler also apply to the 14 dose (14 day supply) Ellipta inhaler.

 a)     Prepare a dose
Open the cover when ready to inhale a dose. The inhaler should not be shaken.

Slide the cover down fully 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.
 b)     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 the lips and the lips should then be closed firmly around it. The air vents should not be blocked with fingers during use.

• Inhale with one long, steady, deep breath in. This breath should be held in 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.
c)    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.

For further instructions on handling the device, see section 6.6.