Tobramycin

Long-term management of chronic pulmonary infection due to Pseudomonas aeruginosa in cystic fibrosis (CF) patients aged 6 years and older. Consideration should be given to official guidance on the appropriate use of antibacterial agents.

TOBI PODHALER (Tobramycin Inhalation Powder) is indicated for: • the management of cystic fibrosis (CF) patients aged 6 years or older with chronic pulmonary Pseudomonas aeruginosa (P. aeruginosa) infections. Safety and efficacy have not been demonstrated in patients with FEV1 (Forced Expiratory Volume in 1 second) < 25% or > 80% predicted, or patients colonized with Burkholderia cepacia.

Safety and efficacy of TOBI PODHALER has been demonstrated in clinical trials over 3 cycles (6 months) of therapy. To reduce the development of drug-resistant bacteria and maintain the effectiveness of TOBI PODHALER and other antibacterial drugs, TOBI PODHALER should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Culture and susceptibility testing performed periodically will provide information on changing microbial flora and the possible emergence of bacterial resistance (see 15 MICROBIOLOGY). 1 Pediatrics Pediatrics (≥ 6 years to < 18 years of age): Based on the data submitted and reviewed by Health Canada, the safety and efficacy of TOBI PODHALER in pediatric patients 6 years of age and older has been established.

INDICATIONS AND USAGE

Tobramycin injection is indicated for the treatment of serious bacterial infections caused by susceptible strains of the designated microorganisms in the diseases listed below: Septicemia in the neonate, child, and adult caused by P.

aeruginosa , E. coli , and Klebsiella sp Lower respiratory tract infections caused by P. aeruginosa , Klebsiella sp, Enterobacter sp, Serratia sp, E. coli , and S. aureus (penicillinase- and non-penicillinase-producing strains) Serious central-nervous-system infections (meningitis) caused by susceptible organisms Intra-abdominal infections, including peritonitis, caused by E.

coli , Klebsiella sp, and Enterobacter sp. Skin, bone, and skin structure infections caused by P. aeruginosa , Proteus sp, E. coli , Klebsiella sp, Enterobacter sp and S. aureus Complicated and recurrent urinary tract infections caused by P.

TOBI

Podhaler is indicated for the suppressive therapy of chronic pulmonary infection due to Pseudomonas aeruginosa in adults and children aged 6 years and older with cystic fibrosis. 1 regarding data in different age groups. Consideration should be given to official guidance on the appropriate use of antibacterial agents.