TORRENT-LEVETIRACETAM TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Kupi sada

Preuzimanje Svojstava lijeka (SPC)
30-01-2015

Aktivni sastojci:

LEVETIRACETAM

Dostupno od:

TORRENT PHARMACEUTICALS LIMITED

ATC koda:

N03AX14

INN (International ime):

LEVETIRACETAM

Doziranje:

750MG

Farmaceutski oblik:

TABLET

Sastav:

LEVETIRACETAM 750MG

Administracija rute:

ORAL

Jedinice u paketu:

100/120

Tip recepta:

Prescription

Područje terapije:

MISCELLANEOUS ANTICONVULSANTS

Proizvod sažetak:

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

Status autorizacije:

CANCELLED (UNRETURNED ANNUAL)

Datum autorizacije:

2021-12-20

Svojstava lijeka

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