* Safety and effectiveness have been established in pediatric patients 1 month to less than 1 year of age. * Use in this population is supported by adequate and well-controlled studies in adults and safety, pharmacokinetic, and pharmacodynamic studies performed in pediatric patients. * Safety and efficacy have not been establish in patients less than 1 month of age for any indication. *Adverse reactions frequently reported in the 1 month to <1 year age group include respiratory adverse reactions (42%), and otitis media (22%). Information on dosing, PK, adverse reactions. *Postmarketing study
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