Posology : מינונים

4.2    Posology and method of administration

Posology
The dose of TOBI Podhaler is the same for all patients within the approved age range, regardless of age or weight. The recommended dose is 112 mg tobramycin (4 x 28 mg capsules), administered twice daily for 28 days. TOBI Podhaler is taken in alternating cycles of 28 days on treatment followed by 28 days off-treatment. The two doses (of 4 capsules each) should be inhaled as close as possible to 12 hours apart and not less than 6 hours apart.
Missed doses
In case of missed dose with at least 6 hours until the next dose, the patient should take the dose as soon as possible. Otherwise, the patient should wait for the next dose and not inhale more capsules to make up for the missed dose.
Duration of treatment
Treatment with TOBI Podhaler should be continued on a cyclical basis for as long as the physician considers the patient is gaining clinical benefit from the treatment with TOBI Podhaler taking into account that long-term safety data are not available for TOBI Podhaler. If clinical deterioration of pulmonary status is evident, additional or alternative anti-pseudomonal therapy should be considered. See also information on clinical benefit and tolerability in sections 4.4, 4.8 and 5.1.
Safety and efficacy have not been demonstrated in patients under the age of 6 years, patients with FEV1 (Forced Expiratory Volume in 1 second) <25% or >75% predicted, or patients colonized with Burkholderia cepacia.

Special populations
Elderly patients (≥ 65 years)
There are insufficient data in this population to support a recommendation for or against dose adjustment. Renal function in elderly patients should be taken into account while using TOBI Podhaler (see section 4.8).
Renal impairment
Tobramycin is primarily excreted unchanged in the urine and renal function is expected to affect the exposure to tobramycin. Patients with serum creatinine 2 mg/dL or more and blood urea nitrogen (BUN) 40 mg/dL or more have not been included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI Podhaler. Caution should be exercised when prescribing TOBI Podhaler to patients with known or suspected renal dysfunction.
Please also refer to nephrotoxicity information in section 4.4.
Hepatic impairment
No studies have been performed on patients with hepatic impairment. As tobramycin is not metabolized, an effect of hepatic impairment on the exposure to tobramycin is not expected.
Patients after organ transplantation
Adequate data do not exist for the use of TOBI Podhaler in patients after organ transplantation.
Paediatric population
The safety and efficacy of TOBI Podhaler in children aged under 6 years have not been established.
No data are available.
Method of administration
Inhalation use.
TOBI Podhaler is administered by inhalation using the Podhaler device (see section 6.6 for detailed instructions for use). It must not be administered by any other route or using any other inhaler.
Caregivers should provide assistance to children starting TOBI Podhaler treatment, particularly those aged 10 years or younger, and should continue to supervise them until they are able to use the Podhaler device properly without help.
TOBI Podhaler capsules must not be swallowed. Each TOBI Podhaler capsule should be inhaled with two breath-hold manoeuvres and checked to ensure it is empty.
Where patients are receiving several different inhaled medicinal products and chest physiotherapy, it is recommended that TOBI Podhaler is taken last.