everolimus 2 mg tablet for suspension
1 INDICATIONS AND USAGE Everolimus tablets for oral suspension are a kinase inhibitor indicated for the treatment of adult and pediatric patients aged 1 year and older with TSC who have subependymal giant cell astrocytoma (SEGA) that requires therapeutic intervention but cannot be curatively resected. ( 1.5 ) Everolimus tablets for oral suspension are a kinase inhibitor indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures. ( 1.6 ) 1.5 Tuberous Sclerosis Complex (TSC)-Associated Subependymal Giant Cell Astrocytoma (SEGA) Everolimus tablets for oral suspension are indicated in adult and pediatric patients aged 1 year and older with TSC for the treatment of SEGA that requires therapeutic intervention but cannot be curatively resected. 1.6 Tuberous Sclerosis Complex (TSC)-Associated Partial-Onset Seizures Everolimus tablets for oral suspension are indicated for the adjunctive treatment of adult and pediatric patients aged 2 years and older with TSC-associated partial-onset seizures.
mylan pharmaceuticals inc.
ROUND WHITE M EVD 2
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mylan pharmaceuticals inc.
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16 HOW SUPPLIED/STORAGE AND HANDLING
EVEROLIMUS Tablets for Oral Suspension are available containing 2 mg, 3 mg, or 5 mg of
EVEROLIMUS. The 2 mg tablets are white to slightly yellow, round, unscored tablets debossed with M on one side of the tablet and EVD over 2 on the other side. They are available as follows: NDC 0378-0005-85 cartons of 28 tablets The 3 mg tablets are white to slightly yellow, round, unscored tablets debossed with M on one side of the tablet and EVD over 3 on the other side. They are available as follows: NDC 0378-0006-85 cartons of 28 tablets The 5 mg tablets are white to slightly yellow, round, unscored tablets debossed with M on one side of the tablet and EVD over 5 on the other side. They are available as follows: NDC 0378-0007-85 cartons of 28 tablets Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Store in the original container, protect from light and moisture. Follow special handling and disposal procedures for anti-cancer pharmaceuticals. 1
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