lacosamide 100 MG Oral Tablet Vimpat
1 INDICATIONS AND USAGE VIMPAT is indicated for: Treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older ( 1.2 ) 1.1 Partial-Onset Seizures VIMPAT is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Primary Generalized Tonic-Clonic Seizures VIMPAT is indicated as adjunctive therapy in the treatment of primary generalized tonic-clonic seizures in patients 4 years of age and older.
UCB, Inc.
OVAL YELLOW SP 100
SP 100 OVAL YELLOW
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16 HOW SUPPLIED/STORAGE AND HANDLING 16.1 How Supplied VIMPAT (
LACOSAMIDE) Tablets 50 mg are pink, oval, film-coated tablets debossed with "SP" on one side and "50" on the other. They are supplied as follows: Bottles of 60 NDC 0131-2477-35 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2477-60 100 mg are dark yellow, oval, film-coated tablets debossed with "SP" on one side and "100" on the other. They are supplied as follows: Bottles of 60 NDC 0131-2478-35 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2478-60 150 mg are salmon, oval, film-coated tablets debossed with "SP" on one side and "150" on the other. They are supplied as follows: Bottles of 60 NDC 0131-2479-35 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2479-60 200 mg are blue, oval, film-coated tablets debossed with "SP" on one side and "200" on the other. They are supplied as follows: Bottles of 60 NDC 0131-2480-35 Unit Dose Carton of 60 tablets [6 cards, each card contains 10 tablets] NDC 0131-2480-60 VIMPAT (
LACOSAMIDE) Injection 200 mg/20 mL is a clear, colorless sterile solution supplied in 20 mL colorless single-dose glass vials. 200 mg/20 mL vial in cartons of 10 vials NDC 0131-1810-67 VIMPAT (
LACOSAMIDE) Oral Solution 10 mg/mL is a clear, colorless to yellow or yellow-brown, strawberry-flavored liquid. It is supplied as follows: 200 mL in glass bottles NDC 0131-5410-72 16.2 Storage and Handling Store at 20°C to 25°C (68°F to 77°F); excursions permitted between 15°C to 30°C (59°F to 86°F). [See USP Controlled Room Temperature] Do not freeze VIMPAT injection or oral solution. Discard any unused VIMPAT oral solution remaining after six (6) months of first opening the bottle.
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