PMS-PRAMIPEXOLE TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE

Boleh didapati daripada:

PHARMASCIENCE INC

Kod ATC:

N04BC05

INN (Nama Antarabangsa):

PRAMIPEXOLE

Dos:

0.25MG

Borang farmaseutikal:

TABLET

Komposisi:

PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0152169001; AHFS:

Status kebenaran:

CANCELLED POST MARKET

Tarikh kebenaran:

2019-05-01

Ciri produk

PRODUCT MONOGRAPH
PR
PMS-PRAMIPEXOLE
Pramipexole Dihydrochloride Monohydrate Tablets
0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg
ANTIPARKINSONIAN AGENT / DOPAMINE AGONIST
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Royalmount Ave., Suite 100
October 10, 2018
Montreal, Quebec
H4P 2T4
www.pharmascience.com
Submission Control No: 220196
_ _
_pms-PRAMIPEXOLE Product Monograph_
_Page 2 of 48 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................15
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................20
ACTION AND CLINICAL PHARMACOLOGY
............................................................20
STORAGE AND STABILITY
..........................................................................................24
SPECIAL HANDLING INSTRUCTIONS
.......................................................................24
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................24
PART II: SCIENTIFIC INFORMATION
................................................................................26
PHARMACEUTICAL INFORMATION
..........................................................................26
CLINICAL TRIALS
....