TEVA-DIVALPROEX TABLET (ENTERIC-COATED)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
02-05-2017

Viambatanisho vya kazi:

VALPROIC ACID (DIVALPROEX SODIUM)

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

N03AG01

INN (Jina la Kimataifa):

VALPROIC ACID

Kipimo:

250MG

Dawa fomu:

TABLET (ENTERIC-COATED)

Tungo:

VALPROIC ACID (DIVALPROEX SODIUM) 250MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

100/500

Dawa ya aina:

Prescription

Eneo la matibabu:

MISCELLANEOUS ANTICONVULSANTS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0112996001; AHFS:

Idhini hali ya:

CANCELLED POST MARKET

Idhini ya tarehe:

2020-06-10

Tabia za bidhaa

                                PRODUCT MONOGRAPH
PR
TEVA-DIVALPROEX
(Divalproex Sodium Enteric-Coated Tablets)
125, 250, 500 mg
USP
Antiepileptic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
www.tevacanada.com
Submission Control No.: 204247
Date of Revision:
May 1, 2017
_ TEVA-DIVALPROEX_
_ _
_Product Monograph_
_Page 2 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
...................................................... 3
SUMMARY PRODUCT INFORMATION
.....................................................................
3
INDICATIONS AND CLINICAL
USE...........................................................................
3
CONTRAINDICATIONS
................................................................................................
4
WARNINGS AND PRECAUTIONS
..............................................................................
5
ADVERSE REACTIONS
..............................................................................................
21
DRUG INTERACTIONS
...............................................................................................
27
DOSAGE AND ADMINISTRATION
...........................................................................
37
OVERDOSAGE
.............................................................................................................
41
ACTION AND CLINICAL PHARMACOLOGY
......................................................... 41
STORAGE AND STABILITY
......................................................................................
44
DOSAGE FORMS, COMPOSITION AND PACKAGING
.......................................... 44
PART II: SCIENTIFIC INFORMATION
............................................................................
45
PHARMACEUTICAL INFORMATION
......................................................................
45
CLINICAL
TRIALS.......................................................................................................
45
DETAILED PHARMACOLOGY
.................................................................................
                                
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