PHL-DIVALPROEX TABLET (ENTERIC-COATED)
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
22-02-2013
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
VALPROIC ACID (DIVALPROEX SODIUM)
Inapatikana kutoka:
PHARMEL INC
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
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:
2016-10-25
Tabia za bidhaa
PRODUCT MONOGRAPH
PR
PHL-DIVALPROEX
(Divalproex Sodium USP)
Enteric-Coated Tablets (125 mg, 250 mg, 500 mg)
Antiepileptic
PHARMEL INC.
6111 Royalmount Ave., Suite 100
Montreal, Quebec
H4P 2T4
Date of Revision:
February 22, 2013
Submission Control No: 162202
_phl-DIVALPROEX Product Monograph _
_Page 2 of 51_
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
..................................................................................................16
DRUG INTERACTIONS
..................................................................................................22
DOSAGE AND ADMINISTRATION
..............................................................................29
OVERDOSAGE
................................................................................................................32
ACTION AND CLINICAL PHARMACOLOGY
............................................................32
STORAGE AND STABILITY
..........................................................................................35
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................35
PART II: SCIENTIFIC INFORMATION
...............................................................................37
PHARMACEUTICAL INFORMATION
..........................................................................37
CLINICAL TRIALS
..........................................................................................................38
DETAILED PHARMACOLOGY
................................................
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