valganciclovir hydrochloride 450 mg
1 INDICATIONS AND USAGE Valganciclovir tablets are a deoxynucleoside analogue cytomegalovirus (CMV) 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 kidney and heart transplant patients at high risk. 1.1 Adult Patients Treatment of Cytomegalovirus (CMV) Retinitis: Valganciclovir tablets 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 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 are indicated for the prevention of CMV disease in kidney transplant patients (4 months to 16 years of age) and heart transplant patients (1 month to 16 years of age) at high risk [see Clinical Studies (14.2) ] .
Aurobindo Pharma Limited
OVAL PINK H 96
H 96 OVAL PINK
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valganciclovir hydrochloride 450 mg
Aurobindo Pharma Limited
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16 HOW SUPPLIED/STORAGE AND HANDLING Valganciclovir Tablets USP, 450 mg are pink colored, oval shaped, biconvex, film-coated tablets, debossed with ‘H’ on one side and ‘96’ on other side. Bottles of 60 NDC 65862-753-60 Bottles of 100 NDC 65862-753-01 Bottles of 180 NDC 65862-753-18 Bottles of 500 NDC 65862-753-05 Bottles of 1,000 NDC 65862-753-99 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].
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