ABBOTT-LEVETIRACETAM TABLET

Riik: Kanada

keel: inglise

Allikas: Health Canada

Toimeaine:

LEVETIRACETAM

Saadav alates:

ABBOTT LABORATORIES, LIMITED

ATC kood:

N03AX14

INN (Rahvusvaheline Nimetus):

LEVETIRACETAM

Annus:

250MG

Ravimvorm:

TABLET

Koostis:

LEVETIRACETAM 250MG

Manustamisviis:

ORAL

Ühikuid pakis:

100

Retsepti tüüp:

Prescription

Terapeutiline ala:

MISCELLANEOUS ANTICONVULSANTS

Toote kokkuvõte:

Active ingredient group (AIG) number: 0148843001; AHFS:

Volitamisolek:

CANCELLED POST MARKET

Loa andmise kuupäev:

2015-12-31

Toote omadused

_ _
_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
............................................................................