TORRENT-LEVETIRACETAM TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

LEVETIRACETAM

Mevcut itibaren:

TORRENT PHARMACEUTICALS LIMITED

ATC kodu:

N03AX14

INN (International Adı):

LEVETIRACETAM

Doz:

750MG

Farmasötik formu:

TABLET

Kompozisyon:

LEVETIRACETAM 750MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/120

Reçete türü:

Prescription

Terapötik alanı:

MISCELLANEOUS ANTICONVULSANTS

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED (UNRETURNED ANNUAL)

Yetkilendirme tarihi:

2021-12-20

Ürün özellikleri

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