CLONAPAM TABLET

국가: 캐나다

언어: 영어

출처: Health Canada

유효 성분:

CLONAZEPAM

제공처:

BAUSCH HEALTH, CANADA INC.

ATC 코드:

N03AE01

INN (국제 이름):

CLONAZEPAM

복용량:

1MG

약제 형태:

TABLET

구성:

CLONAZEPAM 1MG

관리 경로:

ORAL

패키지 단위:

100/500

처방전 유형:

Targeted (CDSA IV)

치료 영역:

BENZODIAZEPINES

제품 요약:

Active ingredient group (AIG) number: 0111558004; AHFS:

승인 상태:

APPROVED

승인 날짜:

2021-03-10

제품 특성 요약

PRODUCT MONOGRAPH
CLONAPAM
®
Clonazepam Tablets, USP
0.5 mg. 1 mg, and 2 mg
ANTICONVULSANT
BAUSCH HEALTH, CANADA INC.
DATE OF REVISION:
2150 St-Elzear Blvd. West
September 1, 2021
Laval, Quebec
H7L 4A8
Control #: 253836
_T/C_
_CLONAPAM_
_®_
_ Product Monograph Page 2 of 34_
_ _
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.....................................................................................................12
DRUG INTERACTIONS
.....................................................................................................14
DOSAGE AND ADMINISTRATION
..................................................................................16
OVERDOSAGE
..................................................................................................................17
ACTION AND CLINICAL
PHARMACOLOGY..................................................................19
STORAGE AND STABILITY
.............................................................................................20
SPECIAL HANDLING INSTRUCTIONS
............................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................21
PART II: SCIENTIFIC
INFORMATION...............................................................................
22
PHARMACEUTICAL INFORMATION
..............................................................................22
CLINICAL TRIALS
...................................................