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1 Indications & 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 Month 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. 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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