Posology: The recommended dose is two inhalations twice daily.
The maximum dose is two inhalations twice daily.
Patients should be advised to take Trimbow every day even when asymptomatic.
If symptoms arise in the period between doses, an inhaled, short-acting beta2-agonist should be used for immediate relief.
Asthma: When choosing the starting dose strength of Trimbow (87/5/9 micrograms or 172/5/9 micrograms), the patients' disease severity, their previous asthma therapy including the inhaled corticosteroid (ICS) dose as well as the patients' current control of asthma symptoms and risk of future exacerbation should be considered.
Stepping-down treatment: Patients should be regularly reassessed by a doctor, so that their doses of beclometasone/formoterol/glycopyrronium remain optimal and are only changed on medical advice. The doses should be titrated to the lowest doses at which effective control of asthma symptoms is maintained.
Special populations: Elderly: No dose adjustment is required in elderly patients (65 years of age and older).
Renal impairment: This drug can be used at the recommended dose in patients with mild (glomerular filtration rate [GFR] ≥50 to <80 mL/min/1.73 m2) to moderate (GFR ≥30 to <50 mL/min/1.73 m2) renal impairment. Use in patients with severe (GFR <30 mL/min/1.73 m2) renal impairment or end-stage renal (GFR <15 mL/min/1.73 m2) disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: There are no relevant data on the use of this drug in patients with severe hepatic impairment (classified as having Child-Pugh class C) and the medicinal product should be used with caution in these patients (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Pediatric population: COPD: There is no relevant use of this drug in the pediatric population (under 18 years of age) for the indication of COPD.
Asthma: The safety and efficacy of Trimbow in the paediatric population (under 18 years of age) have not yet been established. No data are available.
Method of administration: For inhalation use.
To ensure proper administration of the medicinal product, the patient should be shown how to use the inhaler correctly by a physician or other healthcare professional, who should also regularly check the adequacy of the patient's inhalation technique (see "Instruction for use" under Cautions for Usage). The patient should be advised to read this package insert carefully and follow the instructions for use.
This medicinal product is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left. For the 120 actuation pressurised containers, each time the patient presses the container a puff of the solution is released and the counter counts down by one.
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