TORRENT-LEVETIRACETAM TABLET

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

LEVETIRACETAM

Disponible depuis:

TORRENT PHARMACEUTICALS LIMITED

Code ATC:

N03AX14

DCI (Dénomination commune internationale):

LEVETIRACETAM

Dosage:

750MG

forme pharmaceutique:

TABLET

Composition:

LEVETIRACETAM 750MG

Mode d'administration:

ORAL

Unités en paquet:

100/120

Type d'ordonnance:

Prescription

Domaine thérapeutique:

MISCELLANEOUS ANTICONVULSANTS

Descriptif du produit:

Active ingredient group (AIG) number: 0148843003; AHFS:

Statut de autorisation:

CANCELLED (UNRETURNED ANNUAL)

Date de l'autorisation:

2021-12-20

Résumé des caractéristiques du produit

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_Page 1 of 32_
PRODUCT MONOGRAPH
PR
TORRENT-LEVETIRACETAM
Levetiracetam Tablets USP
250 mg, 500 mg and 750 mg
Antiepileptic Agent
Torrent Pharmaceuticals Ltd.
Indrad – 382 721,
Dist. Mehsana
India
Control # 181391
Date of Revision:
January 26, 2015
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_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
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................13
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................18
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................18
PART II: SCIENTIFIC INFORMATION
...............................................................................19
PHARMACEUTICAL INFORMATION
..........................................................................19
CLINICAL TRIALS
..........................................................................................................20
DETAILED PHARMACOLOGY
..........................................................................