CLONAPAM TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

CLONAZEPAM

Mevcut itibaren:

BAUSCH HEALTH, CANADA INC.

ATC kodu:

N03AE01

INN (International Adı):

CLONAZEPAM

Doz:

2MG

Farmasötik formu:

TABLET

Kompozisyon:

CLONAZEPAM 2MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100/500

Reçete türü:

Targeted (CDSA IV)

Terapötik alanı:

BENZODIAZEPINES

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2021-03-10

Ürün özellikleri

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