DIVALPROEX TABLET (ENTERIC-COATED)

国: カナダ

言語: 英語

ソース: Health Canada

即購入

製品の特徴 製品の特徴 (SPC)
16-06-2014

有効成分:

VALPROIC ACID (DIVALPROEX SODIUM)

から入手可能:

SANIS HEALTH INC

ATCコード:

N03AG01

INN(国際名):

VALPROIC ACID

投薬量:

125MG

医薬品形態:

TABLET (ENTERIC-COATED)

構図:

VALPROIC ACID (DIVALPROEX SODIUM) 125MG

投与経路:

ORAL

パッケージ内のユニット:

100

処方タイプ:

Prescription

治療領域:

MISCELLANEOUS ANTICONVULSANTS

製品概要:

Active ingredient group (AIG) number: 0112996004; AHFS:

認証ステータス:

APPROVED

承認日:

2013-02-11

製品の特徴

                                Page 1 of 49
PRODUCT MONOGRAPH
Pr
DIVALPROEX
DIVALPROEX SODIUM ENTERIC-COATED TABLETS
125 MG, 250 MG AND 500 MG VALPROIC ACID (AS DIVALPROEX SODIUM)
HOUSE STANDARD
ANTIEPILEPTIC
SANIS HEALTH INC.
DATE OF REVISION:
333 CHAMPLAIN ST. SUITE 102
DIEPPE, NEW BRUNSWICK
JUNE 16, 2014
E1A 1P2
CONTROL NUMBER: 174536
Page 2 of 49
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
.....................................................................................................................
23
DOSAGE AND
ADMINISTRATION
..............................................................................................
29
OVERDOSAGE
...................................................................................................................................
31
ACTION AND CLINICAL PHARMACOLOGY
...............................................................................
32
STORAGE AND STABILITY
.............................................................................................................
35
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................................ 35
PART II: SCIENTIFIC INFORMATION
...........................................................................................
36
PHARMACEUTICAL INFORMATION
....................
                                
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