Publication of Result-Resulted Information on Paediatric Studies Submitted Under Article

Publication of result-resulted information on paediatric studies submitted under Article 45 of the Regulation (EC) No 1901/2006 (‘Paediatric Regulation’).

Response to the European Medicine Agency request dated 20 May 2011

Chromium [51Cr] EDTA Injection

List of published articles related to paediatric studies for the above mentioned product have been provided below. Copies of each of the articles listed have been provided as individual pdf documents.

Publication author(s) and date / Journal / Publication Title / File name /
Ismaili K et al 2006 / 10.1016/j.jpeds.2005.09.037 / PRIMARY VESICOURETERAL REFLUX DETECTED IN NEONATES WITH A
HISTORY OF FETAL RENAL PELVIS DILATATION: A PROSPECTIVE CLINICAL
AND IMAGING STUDY
PDF Supplied / Ismaili K et al 2006.pdf /
Ismaili K et al 2005 / 10.1016/j.jpeds.2005.03.048 / EVOLUTION OF INDIVIDUAL RENAL FUNCTION IN CHILDREN
WITH UNILATERAL COMPLEX RENAL DUPLICATION
PDF Supplied / Ismaili K et al 2005.pdf /
Piepsz A et al 2005a / Pediatr Nephrol (2005) 20: 1593-1598 / At what level of unilateral renal impaiment
does contralateral functional compensation occur? /
Piepsz A et al 2005b / European Urology 47 (2005) 686–690 / How to Interpret a Deterioration of Split Function?
PDF Supplied / Piepsz A et al 2005b.pdf /
Piepsz A 2002 / European Journal of Radiology 43 (2002) 146–153 / Radionuclide studies in paediatric nephro-urology
PDF Supplied / Piepsz A 2002.pdf /
Benitez Segura A et al 2002 / Rev. Esp. hfed Nuclear 21, 1 (12-161, 2002 / Estudio isotdpico renal en la nefropatia diab6tica
PDF Supplied / Benitez Segura A et al 2002.pdf /
Benitez Segura A et al 2002 eng / Rev. Esp. hfed Nuclear 21, 1 (12-161, 2002 / Isotopic renal study within diabetic nephropathy
PDF Supplied / Benitez Segura A et al 2002 eng.pdf /
Otto AC et al 1995 / Vobrnle 85 hlo. 8 Angtrst 1995 SAMJ / Determination of glomerular filtration rate with radionuclide renography and direct urinary activity quantitation /
Boudreau RJ et al 1994 / CLlNlCAL NUCLEAR MEDICINE.
Volume 19 November 6 pp 493-498 / A Comparison of Single Blood Sample and Multiple Blood Sample Methods to Measure G FR in a Pediatric Population /
Wang SJ et al 1992 / Chin Med J (Taipei) 1992; 49: 29-33 / Intestinal Permeability Test in Systemic Lupus Erythematosus /
Long SE et al 1984 / unspecified / Tc-99m Glucoheptonate Estimation of Glomerular Filtration Rate
Correlation with Endogenous Creatinine Clearance /
Grebe SF et al 1981 / Radiologe (1981) 21 : 553-561 / Vergleich konventioneller Nierenclearancewerte
mit verschiedenen Auswerteergebnissen der Radioisotopennephrographie /
Grebe SF et al 1981 eng / Radiologe (1981) 21 : 553-561 / Comparison of conventional renal clearance values with
differently evaluated results of radioisotope nephrography /
Columbo JP et al 1980 / Clin. Biochem 13 (1) 6-11 (1980) / Comparison of Plasma Creatinine Determined with the Greiner Selective Analyser GSA 11 and the
Glomerular Filtration Rate
PDF Supplied / Columbo JP et al 1980.pdf /
Senf L et al 1978 / unspecified / Zur simultanen Bestimmutlg rler lZ5J-Hippuran- lind 51Cr-EDTA-Clearance
bci Kin[lcrn / Senf L et al 1978.pdf /
Senf L et al 1978 eng / unspecified / Simultaneous determination of I 125-Hippuran and Cr 51-EDTA clearance
in children / Senf L et al 1978 eng.pdf /

Response to the European Medicine Agency Page 2 of 2

Sept 2011