Expanded the indication from adults to pediatric patients 2 years and olderSafety and effectiveness for iron maintenance treatment in pediatric patients 2 years of age and older with dialysis-dependent or non-dialysis-dependent CKD receiving erythropoietin therapy were studied Safety and effectiveness for iron replacement treatment in pediatric patients with dialysis-dependent or non-dialysis-dependent CKD have not been established Venofer has not been studied in patients < 2 years The mean Cmax and AUC values were 1.42- and 1.67-fold higher than dose adjusted adult Cmax and AUC values The most common treatment-emergent adverse reactions were headache (6%), respiratory tract viral infection (4%), peritonitis (4%), vomiting (4%), pyrexia (4%), dizziness (4%), cough (4%), renal transplant (4%), nausea (3%), arteriovenous fistula thrombosis (2%), hypotension (2%), and hypertension (2.1%) Information on dosing, adverse reactions, pharmacokinetics, and clinical trial Postmarketing study
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