DOM-DIVALPROEX TABLET (ENTERIC-COATED)

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
21-06-2017

Viambatanisho vya kazi:

VALPROIC ACID (DIVALPROEX SODIUM)

Inapatikana kutoka:

DOMINION PHARMACAL

ATC kanuni:

N03AG01

INN (Jina la Kimataifa):

VALPROIC ACID

Kipimo:

125MG

Dawa fomu:

TABLET (ENTERIC-COATED)

Tungo:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

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: 0112996004; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2002-04-10

Tabia za bidhaa

                                PRODUCT MONOGRAPH
PR
DOM-DIVALPROEX
Divalproex Sodium Delayed-Release Tablets, USP
125 mg, 250 mg, 500 mg
ANTIEPILEPTIC
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
June 20, 2017
Submission Control No: 206234
_Dom-DIVALPROEX Product Monograph _
_Page 2 of 60_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................22
DRUG INTERACTIONS
..................................................................................................29
DOSAGE AND ADMINISTRATION
..............................................................................36
OVERDOSAGE
................................................................................................................39
ACTION AND CLINICAL PHARMACOLOGY
............................................................40
STORAGE AND STABILITY
..........................................................................................43
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................43
PART II: SCIENTIFIC INFORMATION
...............................................................................45
PHARMACEUTICAL INFORMATION
..........................................................................45
CLINICAL TRIALS
..........................................................................................................46
DETAILED PHARMACOLOGY
................................................
                                
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