A Study of the Safety and Efficacy of Tobramycin for Inhalation in Young Children With Cystic Fibrosis

Exclusion Criteria

• •History of adverse reaction to anesthesia or sedation.
• •History of aminoglycoside hypersensitivity.
• •History of unresolved anemia (hematocrit \< 30%) or thrombocytopenia (platelet count \< 100,000/mm3).
• •History of hemoptysis with 30 days prior to screening.
• •History of abnormal renal function (serum creatinine \> 1.5 times the upper limit of normal for age).
• •History of clinically documented chronic hearing loss.
• •Administration of any investigational drug within 30 days prior to screening.