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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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
 
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