TORRENT-LEVETIRACETAM TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

LEVETIRACETAM

Pieejams no:

TORRENT PHARMACEUTICALS LIMITED

ATĶ kods:

N03AX14

SNN (starptautisko nepatentēto nosaukumu):

LEVETIRACETAM

Deva:

750MG

Zāļu forma:

TABLET

Kompozīcija:

LEVETIRACETAM 750MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

100/120

Receptes veids:

Prescription

Ārstniecības joma:

MISCELLANEOUS ANTICONVULSANTS

Produktu pārskats:

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

Autorizācija statuss:

CANCELLED (UNRETURNED ANNUAL)

Autorizācija datums:

2021-12-20

Produkta apraksts

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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
..........................................................................