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1 Indications And Usage Valganciclovir Tablets, Usp Are A Cytomegalovirus (Cmv) Nucleoside Analogue Dna Polymerase Inhibitor Indicated For: Adult Patients ( 1.1 ) Treatment Of Cmv Retinitis In Patients With Acquired Immunodeficiency Syndrome (Aids). Prevention Of Cmv Disease In Kidney, Heart, And Kidney-Pancreas Transplant Patients At High Risk. Pediatric Patients ( 1.2 ) Prevention Of Cmv Disease In Heart Transplant Patients At High Risk. 1.1 Adult Patients Treatment Of Cytomegalovirus (Cmv) Retinitis: Valganciclovir Tablets, Usp Are Indicated For The Treatment Of Cmv Retinitis In Patients With Acquired Immunodeficiency Syndrome (Aids) [See Clinical Studies (14.1) ] . Prevention Of Cmv Disease: Valganciclovir Tablets, Usp Are Indicated For The Prevention Of Cmv Disease In Kidney, Heart, And Kidney-Pancreas Transplant Patients At High Risk (Donor Cmv Seropositive/recipient Cmv Seronegative [D+/r-]) [See Clinical Studies (14.1) ] . 1.2 Pediatric Patients Prevention Of Cmv Disease: Valganciclovir Tablets, Usp Are Indicated For The Prevention Of Cmv Disease In Heart Transplant Patients (4 Months To 16 Years Of Age) At High Risk [See Clinical Studies (14.2) ] . Pediatric Use Information For Pediatric Kidney Transplant Patients Ages 4 Months To 16 Years And For Pediatric Heart Transplant Patients Ages 1 To Less Than 4 Months Is Approved For Roche Palo Alto Llc’s Valcyte (Valganciclovir Hydrochloride) Tablets And Oral Solution. However, Due To Roche Palo Alto Llc’s Marketing Exclusivity Rights, This Drug Product Is Not Labeled With That Pediatric Information.
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