Posology : מינונים

4.2   Posology and method of administration

The patient’s initiation dose of Bronchitol (400 mg) must be used under the supervision and monitoring of an experienced physician or another health care professional appropriately trained and equipped to perform spirometry, monitor oxygen saturation (SpO 2 ), and manage acute bronchospasm (see sections 4.4 and 4.8) including appropriate use of resuscitation equipment.

Posology

Initiation dose assessment
Before commencing treatment with Bronchitol, all patients should be assessed for bronchial hyperresponsiveness to inhaled mannitol during administration of their initiation dose (see sections 4.4 and 5.1).

The patient should be pre-medicated with a bronchodilator 5-15 minutes prior to the initiation dose but after the baseline FEV 1 and SpO 2 (Oxygen saturation in the blood) measurement. All FEV 1 measurements and SpO 2 monitoring should be performed 60 seconds after dose inhalation.

Training the patient to practice correct inhaler technique during the initiation dose assessment is important.

The initiation dose assessment must be performed according to the following steps: 
Step 1: Patients baseline FEV 1 and SpO 2 is measured prior to the initiation dose Step 2: Patient inhales 40 mg (1x40 mg capsules) and SpO 2 is monitored Step 3: Patient inhales 80 mg (2x40 mg capsules) and SpO 2 is monitored Step 4: Patient inhales 120 mg (3x40 mg capsules), FEV 1 is measured and SpO 2 is monitored 1
Step 5: Patient inhales 160 mg (4x40 mg capsules), FEV 1 is measured and SpO 2 is monitored Step 6: Patients FEV 1 is measured 15 minutes post initiation dose.

Patients with asthma may experience reversible temporary mild bronchospasm after passing the initiation dose assessment and therefore all patients should be monitored until their FEV 1 has returned to baseline levels.

Therapeutic dose regimen
The therapeutic dose regimen should not be prescribed until the initiation dose assessment has been performed.

For patients receiving several respiratory therapies, the recommended order is: 
1. Bronchodilator
2. Bronchitol
3. Physiotherapy/exercise
4. Dornase alfa (if applicable)
5. Inhaled antibiotics (if applicable)

A bronchodilator must be administered 5-15 minutes before each dose of Bronchitol.
The recommended dose of Bronchitol is 400 mg twice a day. This requires the inhalation of the contents of ten capsules via the inhaler device twice a day.

Special populations

Renal or hepatic impairment
Bronchitol has not specifically been studied in patients with impaired renal and hepatic function.
Available data from studies DPM-CF-301 and 302 suggest that no dose adjustments are required for these patient populations.

Elderly patients (≥65 years)
There are insufficient data in this population to support a recommendation for or against dose adjustment.

Paediatric population
The safety and efficacy of Bronchitol in children and adolescents aged 6 to 18 years has not yet been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.

The safety and efficacy of Bronchitol in children aged less than 6 years has not been established. No data are available.

Method of administration
Bronchitol is administered by the oral inhalation route using the inhaler provided in the pack. It must not be administered by any other route or using any other inhaler. The capsules must not be swallowed.

The doses should be taken morning and night with the evening dose taken 2-3 hours before bedtime.

Each of the capsules is loaded into the device separately. The contents of the capsules are inhaled via the inhaler device with one or two breaths. After inhalation, each empty capsule is discarded before inserting the next capsule into the inhaler device with as little delay as possible between capsules.

The inhaler device is to be replaced after one week of use. If the inhaler does require cleaning, ensure the device is empty then wash in warm water and before re-use, allow the inhaler to thoroughly air dry.

Detailed instructions on how to use the inhaler can2 be found in the patient information leaflet. Patients should be advised to carefully read them.