[Product Monograph Template - Standard]

KEPPRA (levetiracetam) Page 1 of 32 product Monograph Pr KEPPRA Levetiracetam Tablets of 250 mg, 500 mg, and 750 mg Antiepileptic Agent UCB Canada Inc. Oakville, ON L6H 5R7 Date of Revision: August 17, 2017 Control Number: 205152 KEPPRA is a registered trademark of the UCB Group of companies KEPPRA (levetiracetam) Page 2 of 32 Table of Contents PART I: HEALTH PROFESSIONAL INFORMATION ..3 SUMMARY product INFORMATION ..3 INDICATIONS AND CLINICAL USE ..3 CONTRAINDICATIONS ..4 WARNINGS AND PRECAUTIONS ..4 ADVERSE REACTIONS ..8 DRUG INTERACTIONS ..12 DOSAGE AND ADMINISTRATION ..14 OVERDOSAGE ..16 ACTION AND CLINICAL PHARMACOLOGY ..16 STORAGE AND STABILITY ..19 DOSAGE FORMS, COMPOSITION AND PACKAGING ..19 PART II: SCIENTIFIC INFORMATION ..20 PHARMACEUTICAL INFORMATION ..20 CLINICAL TRIALS ..21 DETAILED PHARMACOLOGY ..24 TOXICOLOGY ..25 REFERENCES ..27 PART III: CONSUMER KEPPRA (levetiracetam) Page 3 of 32 Pr KEPPRA levetiracetam PART I: HEALTH PROFESSIONAL INFORMATION SUMMARY product INFORMATION Route of Administration Dosage Form / Strength Nonmedicinal Ingredients oral tablet 250 mg, 500 mg, and 750 mg colloidal anhydrous silica, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol, sodium croscarmellose, talc, titanium dioxide, and coloring agents.

oral : tablet 250 mg, 500 mg, and 750 mg . colloidal anhydrous silica, magnesium stearate, polyethylene glycol 3350, polyethylene glycol 6000, polyvinyl alcohol,

Loading..

Tags:

  Product, Standards, Monographs, Template, Product monograph template standard

Information

Related search queries