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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Chiesi Pharmaceuticals, Inc.
NNPS:
FALSE'
Therapeutic Category:
Antibiotic, topical
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