RATIO-VALPROIC 50MG/ML SYRUP

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

VALPROIC ACID (SODIUM VALPROATE)

제공처:

RATIOPHARM INC DIVISION OF TEVA CANADA LIMITED

ATC 코드:

N03AG01

INN (International Name):

VALPROIC ACID

복용량:

50MG

약제 형태:

SYRUP

구성:

VALPROIC ACID (SODIUM VALPROATE) 50MG

관리 경로:

ORAL

패키지 단위:

450 ML

처방전 유형:

Prescription

치료 영역:

MISCELLANEOUS ANTICONVULSANTS

제품 요약:

Active ingredient group (AIG) number: 0112996002; AHFS:

승인 상태:

CANCELLED POST MARKET

승인 날짜:

2015-10-26

제품 특성 요약

PRODUCT MONOGRAPH
PR
RATIO-VALPROIC
Capsules and Oral Solution
Capsules (250 mg)
Oral solution (250 mg / 5 mL)
USP
Antiepileptic
Ratiopharm Inc.
Date of Revision:
17 800 Lapointe
February 2, 2012
Mirabel, Quebec
Canada J7J 1P3
Control No.: 152606
2
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
..............................................................................................
19
DOSAGE AND
ADMINISTRATION..........................................................................
26
OVERDOSAGE
............................................................................................................
28
ACTION AND CLINICAL PHARMACOLOGY
........................................................ 29
STORAGE AND
STABILITY......................................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................... 32
PART II: SCIENTIFIC
INFORMATION...............................................................................
33
PHARMACEUTICAL
INFORMATION......................................................................
33
DETAILED
PHARMACOLOGY.................................................................................
34
TOXICOLOGY
.............................................................................................................
34
REFERENCES
........................................................