Posology : מינונים

4.2     Posology and method of administration

TOBI is for oral inhalation only and must not be administered by any other route.
The dose of TOBI is the same for all patients regardless of age or weight. The recommended dosage for adults and children 6 years of age and older is one single-use ampoule (300 mg/5 mL) administered twice daily (BID) for 28 days. TOBI is taken in alternating cycles of 28 days on drug followed by 28 days off drug. Each dose should be inhaled as close as possible to 12 hours apart and not less than six hours apart.

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 (see nephrotoxicity information in section 4.4 and excretion information in section 5.2).

Patients with 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 or blood urea nitrogen (BUN) 40 mg/dl or more were not included in clinical studies and there are no data in this population to support a recommendation for or against dose adjustment with TOBI. Please also refer to nephrotoxicity information in section 4.4 and excretion information in section 5.2.
Patients with 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 in patients after organ transplantation.

Method of administration
TOBI is supplied as single dose, ready-to-use plastic ampoules, each containing 300 mg tobramycin. Ampoules are supplied in a foil pouch.

TOBI is administered by inhalation over an approximately 15 minute period, using a hand- held PARI LC PLUS™ Reusable nebuliser with a suitable compressor. Suitable compressors are those which, when attached to a PARI LC PLUS nebuliser, deliver a flow rate of 4-6 L/min and/or a back pressure of 110-217 kPa. The manufacturers’ instructions for the care and use of the nebuliser and compressor should be followed.
The use of TOBI with nebulisers other than the PARI LC PLUS has not been adequately studied.
TOBI is inhaled while the patient is sitting or standing upright and breathing normally through the mouthpiece of the nebuliser. The use of nose clips may help the patient to breathe through the mouth.
Where patients are receiving several different respiratory therapies, it is recommended that they are taken or performed in the following order: bronchodilator, chest physiotherapy, other inhaled medications, and finally, TOBI.