Posology : מינונים

4.2   Posology and method of administration

Posology

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

Patients should be advised to take Trimbow 100/6/12.5 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 100/6/12.5 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
Trimbow 100/6/12.5 can be used at the recommended dose in patients with mild to moderate renal impairment. Use 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 sections 4.4 and 5.2).

Hepatic impairment
There are no relevant data on the use of Trimbow 100/6/12.5 in patients with severe hepatic impairment and the medicinal product should be used with caution in these patients (see sections 4.4 and 5.2).

Paediatric population
COPD
There is no relevant use of Trimbow 100/6/12.5 in the paediatric population (under 18 years of age) for the indication of COPD.

Asthma
Trimbow 100/6/12.5 is not indicated for children and adolescents under 18 years of age.

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 "Instructions for use" below). The patient should be advised to read the Package Leaflet carefully and follow the instructions for use as given in the leaflet.
This medicinal product is provided with a dose counter on the back of the inhaler, which shows how many actuations are left. For the 120 actuation pressurised container, each time the patient presses the container a puff of the solution is released and the counter counts down by one.
The patient should be advised not to drop the inhaler as this may cause the counter to count down.

Instructions for use

Priming the inhaler
Before using the inhaler for the first time, the patient should release one actuation into the air in order to ensure that the inhaler is working properly (priming). Before priming the pressurised container, the counter should read 121. After priming, the counter should read 120.

Use of the inhaler
The patient should stand or sit in an upright position when inhaling from the inhaler. The steps below should be followed.
IMPORTANT: steps 2 to 5 should not be performed too quickly:
1. The patient should remove the protective cap from the mouthpiece and check that the mouthpiece is clean and free from dust and dirt or any other foreign objects.
2. The patient should breathe out slowly and as deeply as comfortable, in order to empty the lungs.
3. The patient should hold the inhaler vertically with its body upwards and place the mouthpiece between the teeth without biting. The lips should then be placed around the mouthpiece, with the tongue flat under it.
4. At the same time, the patient should breathe in slowly and deeply through the mouth until the lungs are full of air (this should take approximately 4 – 5 seconds). Immediately after starting to breathe in, the patient should firmly press down on the top of the pressurised container to release one puff.
5. The patient should then hold the breath for as long as comfortably possible, then remove the inhaler from the mouth and breathe out slowly. The patient should not breathe out into the inhaler.
6. The patient should then check the dose counter to ensure it has moved accordingly.

To inhale the second puff, the patient should keep the inhaler in a vertical position for approximately 30 seconds and repeat steps 2 to 6.

If mist appears after the inhalation, either from the inhaler or from the sides of the mouth, the procedure should be repeated from step 2.

After use, the patient should close the inhaler with the protective mouthpiece cap and check the dose counter.

After inhaling, the patient should rinse the mouth or gargle with water without swallowing it or brush the teeth (see also section 4.4).

When to get a new inhaler
The patient should be advised to get a new inhaler when the dose counter shows the number 20. He/she should stop using the inhaler when the counter shows 0 as any puffs left in the device may not be enough to release a full actuation.

Additional instructions for specific groups of patients
For patients with weak hands it may be easier to hold the inhaler with both hands. Therefore, the index fingers should be placed on the top of the pressurised container and both thumbs on the base of the inhaler.

Patients who find it difficult to synchronise aerosol actuation with inspiration of breath may use the AeroChamber Plus spacer device, properly cleaned as described in the relevant leaflet. They should be advised by their doctor or pharmacist about the proper use and care of their inhaler and spacer and their technique checked to ensure optimum delivery of the inhaled active substance to the lungs. This may be obtained by the patients using the AeroChamber Plus by one continuous slow and deep breath through the spacer, without any delay between actuation and inhalation. Alternatively, patients may simply breathe in and out (through the mouth) after the actuation, as instructed in the spacer leaflet, to obtain the medicinal product (see sections 4.4 and 5.2).
Use with a spacer
Single dose pharmacokinetic data (see section 5.2) have demonstrated that in comparison to routine use without a spacer device, the use of Trimbow 100/6/12.5 with the AeroChamber Plus spacer device increased the total systemic exposure (AUC0-t) to glycopyrronium. However, available safety data from long-term clinical studies have not raised any significant safety concerns (see section 5.1).

Cleaning
For the regular cleaning of the inhaler, patients should remove weekly the cap from the mouthpiece and wipe the outside and inside of the mouthpiece with a dry cloth. They should not remove the pressurised container from the actuator and should not use water or other liquids to clean the mouthpiece.