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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:  03/14/2019
 
Trade Name:  Avycaz
 
Generic Name or Proper Name (*):  ceftazidime/ avibactam
 
Indications Studied:  Treatment of complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI) to include patients 3 months to less than 18 years
 
Label Changes Summary:  *Safety and effectiveness in the treatment of cUTI and cIAI have been established in pediatric patients 3 months to less than 18 years. Use in these age groups is supported by evidence from adequate and well-controlled studies of Avycaz in adults with cUTI and cIAI and additional pharmacokinetic and safety data from pediatric trials. *Safety and effectiveness in pediatric patients below the age of 3 months with cUTI or cIAI have not been established. *Safety and effectiveness in pediatric patients less than 18 years of age with hospital-acquired bacterial pneumonia and ventilator-associated bacterial pneumonia have not been established. *Dosage adjustment is required in pediatric patients with cIAI or cUTI and renal impairment from 2 years to < 18 years with eGFR 50 mL/min/1.73 m2 or less. There is insufficient information to recommend a dosing regimen for pediatric patients younger than 2 years of age with cIAI or cUTI and renal impairment. * Safety in patients ages 3 months to less than 18 years was similar to that observed in adults. *Information on recommended dosing, dosing in renal impairment patients, PK parameters and clinical trials in patients ages 3 months to less than 18 years. *Postmarketing study.
 
Product Labeling:  [INVALID]  Opens a new window
 
PREA(P):  P
 
Sponsor:  Allergan
 
NNPS:  FALSE
 
Therapeutic Category:  Antibiotic
 
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