Levetiracetam 100 mg/mL Injection, 5 mL Vial, 25 Vials/Pack

Levetiracetam — 500MG, Injection, carton of 25 × 5 mL vials

Levetiracetam is a injection for intravenous use. Levetiracetam Injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older ( 1.1 ) Levetiracetam Injection is indicated for adjunctive therapy for the treatment of: Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy ( 1.2 ) Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy ( 1.3 ) Levetiracetam Injection is for intravenous use only as an alternative for patients when oral administration is temporarily not feasible ( 1.4 ) 1.1 Partial-Onset Seizures Levetiracetam Injection is indicated for the treatment of partial-onset seizures in patients 1 month of age and older. 1.2 Myoclonic Seizures in Patients with Juvenile Myoclonic Epilepsy Levetiracetam Injection is indicated as adjunctive therapy for the treatment of myoclonic seizures in patients 1

• Active ingredient or product type: LEVETIRACETAM
• Strength/concentration: 500MG
• Dosage form and route: Injection, Intravenous
• Exact package presentation: carton of 25 × 5 mL vials
• NDC/item number: 0143-9673-25
• Manufacturer: HIKMA PHARMACEUTICALS USA INC
• Storage/handling: Store at controlled room temperature according to the current product labeling.
• Status: Rx only

Important safety information: Behavioral abnormalities including psychotic symptoms, suicidal ideation, irritability, and aggressive behavior have been observed; monitor patients for psychiatric signs and symptoms ( 5.1 ) Monitor for somnolence and fatigue; advise patients not to drive or operate machinery until they have sufficient experience on Levetiracetam Injection ( 5.2 ) Serious Dermatological Reactions: Discontinue Levetiracetam Injection at the first sign of rash unless clearly not drug related ( 5.4 ) Drug Reaction

Refer to the current product labeling for complete indications, preparation or administration instructions, contraindications, warnings, precautions, and storage requirements.