CLONAPAM TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
01-09-2021

有效成分:

CLONAZEPAM

可用日期:

BAUSCH HEALTH, CANADA INC.

ATC代码:

N03AE01

INN(国际名称):

CLONAZEPAM

剂量:

2MG

药物剂型:

TABLET

组成:

CLONAZEPAM 2MG

给药途径:

ORAL

每包单位数:

100/500

处方类型:

Targeted (CDSA IV)

治疗领域:

BENZODIAZEPINES

產品總結:

Active ingredient group (AIG) number: 0111558002; AHFS:

授权状态:

APPROVED

授权日期:

2021-03-10

产品特点

                                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
...................................................
                                
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