DOM-VALPROIC ACID E.C. CAPSULE (ENTERIC-COATED)

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

VALPROIC ACID

제공처:

DOMINION PHARMACAL

ATC 코드:

N03AG01

INN (International Name):

VALPROIC ACID

복용량:

500MG

약제 형태:

CAPSULE (ENTERIC-COATED)

구성:

VALPROIC ACID 500MG

관리 경로:

ORAL

패키지 단위:

150

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTICONVULSANTS

제품 요약:

Active ingredient group (AIG) number: 0112996003; AHFS:

승인 상태:

APPROVED

승인 날짜:

1997-04-24

제품 특성 요약

PRODUCT MONOGRAPH
PR
DOM-VALPROIC ACID
Valproic Acid Capsules, USP
250 mg
PR
DOM-VALPROIC ACID E.C.
Valproic Acid Enteric Coated Capsules
500 mg
PR
DOM-VALPROIC ACID
Valproic Acid Oral Solution, USP
250 mg /5 mL
ANTIEPILEPTIC
DOMINION PHARMACAL DATE OF REVISION:
6111 Royalmount Avenue, suite 100 May 12, 2017
Montréal, Quebec
H4P 2T4
SUBMISSION CONTROL NO.: 204664
_ _
_Monographie de produit Dom-VALPROIC ACID & Dom-VALPROIC ACID E.C. _
_Page 2 de 61 _
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
.................................................................................................
26
DOSAGE AND ADMINISTRATION
.............................................................................
34
OVERDOSAGE
................................................................................................................
36
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 37
STORAGE AND STABILITY
.........................................................................................
39
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 40
PART II: SCIENTIFIC INFORMATION
.............................................................................
41
PHARMACEUTICAL INFORMATION
.........................................................................
41
CLINICAL TRIALS
............................