Country: Ирска
Језик: Енглески
Извор: HPRA (Health Products Regulatory Authority)
Tobramycin
Novartis Ireland Limited
J01GB; J01GB01
Tobramycin
300 mg/5ml
Nebuliser solution
Product subject to prescription which may not be renewed (A)
Other aminoglycosides; tobramycin
2000-09-15
SUMMARY OF PRODUCT CHARACTERISTICS 1 NAME OF THE MEDICINAL PRODUCT TOBI 300 mg/5 mL Nebuliser Solution Tobramycin 300 mg/5 ml Nebuliser Solution 2 QUALITATIVE AND QUANTITATIVE COMPOSITION One ampoule of 5mL contains tobramycin 300mg as a single dose. For the full list of excipients, see section 6.1. 3 PHARMACEUTICAL FORM Nebuliser solution. Clear, slightly yellow solution. 4 CLINICAL PARTICULARS 4.1 THERAPEUTIC INDICATIONS TOBI is indicated in cystic fibrosis (CF) patients aged 6 years and older for long-term management of chronic pulmonary infection due to_ Pseudomonas aeruginosa_. Consideration should be given to official guidance on the appropriate use of antibacterial agents. 4.2 POSOLOGY AND METHOD OF ADMINISTRATION TOBI is supplied for use via inhalation and is not for parenteral use. POSOLOGY The recommended dose for adults and children is one ampoule twice daily for 28 days. The dose interval should be as close as possible to 12 hours and not less than 6 hours. After 28 days of therapy, patients should stop TOBI therapy for the next 28 days. A cycle of 28 days of active therapy and 28 days of rest from treatment should be maintained. Dosage is not adjusted for weight. All patients should receive one ampoule of TOBI (300 mg of tobramycin) twice daily. Controlled clinical studies, conducted for a period of 6 months using the following TOBI dosage regimen, have shown that improvement in lung function was maintained above baseline during the 28 day rest periods. TOBI Dosing Regimen in Controlled Clinical Studies Safety and efficacy for long-term management of chronic pulmonary infection due to_ Pseudomonas aeruginosa_ have been assessed in controlled and open label studies for up to 96 weeks (12 cycles), but have not been studied in patients Cycle 1 Cycle 2 Cycle 3 28 Days 28 Days 28 Days 28 Days 28 Days 28 Days TOBI 300 mg twice daily plus standard care standard care TOBI 300 mg twice daily plus standard care standard care TOBI 300 mg twice daily plus standard care standard care H E A L T H P R O D U C T S R Прочитајте комплетан документ