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1 INDICATIONS AND USAGE BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. BRIVIACT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. ( 1 )
ucb, inc.
OVAL GREEN U100
U100 OVAL GREEN
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied BRIVIACT Tablets 10 mg are white to off-white, round, film-coated, and debossed with "u10" on one side. They are supplied as follows: Bottles of 60 tablets NDC 50474-370-66 25 mg are grey, oval, film-coated, and debossed with "u25" on one side. They are supplied as follows: Bottles of 60 tablets NDC 50474-470-66 Unit dose cartons of 100 tablets NDC 50474-470-09 50 mg are yellow, oval, film-coated, and debossed with "u50" on one side. They are supplied as follows: Bottles of 60 tablets NDC 50474-570-66 Unit dose cartons of 100 tablets NDC 50474-570-09 75 mg are purple, oval, film-coated, and debossed with "u75" on one side. They are supplied as follows: Bottles of 60 tablets NDC 50474-670-66 100 mg are green-grey, oval, film-coated, and debossed with "u100" on one side. They are supplied as follows: Bottles of 60 tablets NDC 50474-770-66 Unit dose cartons of 100 tablets NDC 50474-770-09 BRIVIACT Oral Solution 10 mg/mL is a slightly viscous, clear, colorless to yellowish, raspberry-flavored liquid. It is supplied in amber glass bottles: 300 mL bottles NDC 50474-870-15 BRIVIACT Injection 50 mg/5 mL is a clear, colorless, sterile solution supplied in colorless single-dose glass vials. Carton of 10 vials NDC 50474-970-75 16.2 Storage and Handling Store at 25°C (77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). See USP Controlled Room Temperature. Do not freeze BRIVIACT injection or oral solution. Discard any unused BRIVIACT oral solution remaining after 5 months of first opening the bottle. BRIVIACT injection vials are single-dose only [see Dosage and Administration (2.3) ] .
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