CLONAPAM TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

CLONAZEPAM

Tersedia dari:

BAUSCH HEALTH, CANADA INC.

Kode ATC:

N03AE01

INN (Nama Internasional):

CLONAZEPAM

Dosis:

0.5MG

Bentuk farmasi:

TABLET

Komposisi:

CLONAZEPAM 0.5MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Targeted (CDSA IV)

Area terapi:

BENZODIAZEPINES

Ringkasan produk:

Active ingredient group (AIG) number: 0111558001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2021-03-10

Karakteristik produk

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