Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail
  • Print
  • Share
  • E-mail
-
 
Pediatric Labeling Date:  10/12/2012
 
Trade Name:  Bethkis
 
Generic Name or Proper Name (*):  tobramycin
 
Indications Studied:  Management of cystic fibrosis patients with P. aeruginosa
 
Label Changes Summary:  Safety and efficacy have been established in adults and children 6 years and older Safety and efficacy have not been studied in pediatric patients less than 6 years Use caution in patients with known or suspected auditory or vestibular dysfunction or renal dysfunction. Bronchospasm can occur with inhalation of tobramycin Information on dose, adverse reactions, and clinical trials New drug
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Chiesi Pharmaceuticals, Inc.
 
NNPS:  FALSE'
 
Therapeutic Category:  Antibiotic, topical
 
-
-