sacubitril 24 mg valsartan 26 mg Entresto
1 INDICATIONS AND USAGE ENTRESTO is a combination of sacubitril, a neprilisin inhibitor, and valsartan, an angiotensin II receptor blocker, and is indicated: to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. ( 1.1 ) for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes. ( 1.2 ) 1.1 Adult Heart Failure ENTRESTO is indicated to reduce the risk of cardiovascular death and hospitalization for heart failure in adult patients with chronic heart failure. Benefits are most clearly evident in patients with left ventricular ejection fraction (LVEF) below normal. LVEF is a variable measure, so use clinical judgment in deciding whom to treat [see Clinical Studies (14.1)] . 1.2 Pediatric Heart Failure ENTRESTO is indicated for the treatment of symptomatic heart failure with systemic left ventricular systolic dysfunction in pediatric patients aged one year and older. ENTRESTO reduces NT-proBNP and is expected to improve cardiovascular outcomes.
novartis pharmaceuticals corporation
OVAL WHITE LZ NVR
LZ NVR OVAL WHITE
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sacubitril 24 mg valsartan 26 mg Entresto
novartis pharmaceuticals corporation
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16 HOW SUPPLIED/STORAGE AND HANDLING ENTRESTO (sacubitril/valsartan) tablets are unscored, ovaloid, biconvex, and film-coated. ENTRESTO film-coated oral pellets are round, biconvex in shape, and provided in a hard capsule. All strengths are packaged in bottles as described below. ENTRESTO Tablets Sacubitril/valsartan mg/mg Color Debossment Side 1/side 2 NDC 0078-XXXX-XX Bottle of 60 Bottle of 180 24/26 violet white NVR/LZ 0659-20 0659-67 49/51 Pale yellow NVR/L1 0777-20 0777-67 97/103 Light pink NVR/L11 0696-20 0696-67 ENTRESTO SPRINKLE Sacubitril/valsartan mg/mg Color Print NDC 0078-XXXX-XX Bottle of 60 6/6 white cap and transparent body “NVR” and both parts with arrows and “04” 1231-20 15/16 yellow cap and transparent body “NVR” and both parts with arrows and “10” 1238-20 Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Protect from moisture.
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