TRIMBOW PRESSURISED INHALATION SOLUTION 100/6/12.5 μG PER ACTUATION [SIN15924P]

Product Info

TRIMBOW PRESSURISED INHALATION SOLUTION 100/6/12.5 μG PER ACTUATION

[SIN15924P]

4.1 Therapeutic indications

Maintenance treatment in adult patients with chronic obstructive pulmonary disease (COPD) who are not adequately treated by a combination of an inhaled corticosteroid and a long-acting beta2-agonist (for effects on symptoms control and prevention of exacerbations see section 5.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

4.2 Posology and method of administration

Posology

Adults
The recommended dose is two inhalations of Trimbow twice daily.
The maximum dose is two inhalations of Trimbow twice daily.

Special populations

Elderly
No dosage adjustment is required in elderly patients (65 years of age and older).

Renal impairment
Trimbow can be used at the recommended dose in patients with mild to moderate renal impairment. Use of Trimbow in patients with severe renal impairment or end-stage renal disease requiring dialysis, especially if associated with significant body weight reduction, should be considered only if the expected benefit outweighs the potential risk (see section 4.4 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Hepatic impairment
There are no relevant data on the use of Trimbow in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see section 4.4 and section 5.2 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

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

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. The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the leaflet.

After inhaling, patients should rinse their mouth or gargle with water without swallowing it or brush their teeth (see section 4.4 and section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information).

Trimbow is provided with a dose counter or dose indicator on the back of the inhaler, which shows how many actuations are left. For the 60 and 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.
For the 180 actuation pressurised container, each time the patient presses the pressurised container a puff of the solution is released and the counter rotates by a small amount; the number of puffs remaining is displayed in intervals of 20.
Patients should be advised not to drop the inhaler as this may cause the counter to count down.

For instructions for use, see section 6.6 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.

4.3 Contraindications

Hypersensitivity to the active substances or to any of the excipients listed in section 6.1 – please refer to the Product Insert/Patient Information Leaflet published on HSA for the full drug information.