Land: Canada
Sprog: engelsk
Kilde: Health Canada
LEVETIRACETAM
ABBOTT LABORATORIES, LIMITED
N03AX14
LEVETIRACETAM
750MG
TABLET
LEVETIRACETAM 750MG
ORAL
100
Prescription
MISCELLANEOUS ANTICONVULSANTS
Active ingredient group (AIG) number: 0148843003; AHFS:
CANCELLED POST MARKET
2015-12-31
_ _ _Abbott-Levetiracetam Product Monograph _ _Page 1 of 33_ PRODUCT MONOGRAPH PR ABBOTT-LEVETIRACETAM Levetiracetam Tablets USP 250 mg, 500 mg and 750 mg Antiepileptic Agent Abbott Laboratories, Limited 8401 Trans-Canada Highway Saint-Laurent, Quebec H4S 1Z1 Control No.: 183151 Date of Preparation: November 1, 2013 Date of Revision: March 27, 2015 _ _ _Abbott-Levetiracetam Product Monograph _ _Page 2 of 33 _ 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 ....................................................................................................7 DRUG INTERACTIONS ................................................................................................11 DOSAGE AND ADMINISTRATION ..............................................................................13 OVERDOSAGE ................................................................................................................15 ACTION AND CLINICAL PHARMACOLOGY ............................................................15 STORAGE AND STABILITY ..........................................................................................18 DOSAGE FORMS, COMPOSITION AND PACKAGING .............................................18 PART II: SCIENTIFIC INFORMATION ...............................................................................20 PHARMACEUTICAL INFORMATION ..........................................................................20 CLINICAL TRIALS ............................................................................ Læs hele dokumentet