《LEVETIRACETAM IN SODIUM CHLORIDE INJECTION 202543lbl-大输液》.pdf

NDA 202543/Levetiracetam in Sodium Chloride Injection FDA Approved Labeling Text dated 11/9/11 Page 1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use LEVETIRACETAM IN SODIUM CHLORIDE INJECTION safely and effectively. See full prescribing information for LEVETIRACETAM IN SODIUM CHLORIDE INJECTION. DOSAGE FORMS AND STRENGTHS Single-use 100 mL bags for injection: LEVETIRACETAM IN SODIUM CHLORIDE INJECTION, for • Levetiracetam in 0.82 % sodium chloride (500 mg/100 mL) (3) intravenous use • Levetiracetam in 0.75 % sodium chloride (1000 mg/100 mL) (3) Initial U.S. Approval: 1999 • Levetiracetam in 0.54% sodium chloride (1500 mg/100 mL) (3) INDICATIONS AND USAGE CONTRAINDICATIONS Levetiracetam in Sodium Chloride Injection is an antiepileptic drug indicated • None (4) for adults (16 years and older) with the following seizure types when oral administration is temporarily not feasible.