SANDOZ VALPROIC CAPSULE

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

VALPROIC ACID

제공처:

SANDOZ CANADA INCORPORATED

ATC 코드:

N03AG01

INN (국제 이름):

VALPROIC ACID

복용량:

250MG

약제 형태:

CAPSULE

구성:

VALPROIC ACID 250MG

관리 경로:

ORAL

패키지 단위:

100

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTICONVULSANTS

제품 요약:

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

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2019-08-01

제품 특성 요약

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_Page 1 of 48 _
PRODUCT MONOGRAPH
PR
SANDOZ VALPROIC
Valproic Acid
250 mg Capsules
Mfr. Std.
Antiepileptic
Sandoz Canada Inc.
Date of Revision: December 18, 2018
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Submission Control No: 222665
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_Page 2 of 48 _
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
.........................................................................................................
19
DRUG INTERACTIONS
.........................................................................................................
23
DOSAGE AND ADMINISTRATION
.....................................................................................
31
OVERDOSAGE
........................................................................................................................
33
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
34
STORAGE AND STABILITY
.................................................................................................
36
DOSAGE FORMS, COMPOSITION AND PACKAGING
..................................................... 36
PART II: SCIENTIFIC INFORMATION
................................................................................
37
PHARMACEUTICAL INFORMATION
.................................................................................
37
CLINICAL TRIALS
............................................................................................................