PMS-ROPINIROLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
21-06-2017
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Active ingredient:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
Available from:
PHARMASCIENCE INC
ATC code:
N04BC04
INN (International Name):
ROPINIROLE
Dosage:
2MG
Pharmaceutical form:
TABLET
Composition:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG
Administration route:
ORAL
Units in package:
10/100
Prescription type:
Prescription
Therapeutic area:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Product summary:
Active ingredient group (AIG) number: 0132618004; AHFS:
Authorization status:
APPROVED
Authorization date:
2009-07-22
Summary of Product characteristics
PRODUCT MONOGRAPH
PR
PMS-ROPINIROLE
Ropinirole Hydrochloride Tablets, House
0.25 mg, 0.5 mg 1.0 mg, 2.0 mg, 5.0 mg ropinirole
(as ropinirole hydrochloride)
ANTIPARKINSONIAN AGENT / DOPAMINE AGONIST
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Ave. Royalmount, Suite 100
June 12, 2017
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 206310
_pms-ROPINIROLE Product Monograph Page 2 of 52 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
4
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
21
DOSAGE AND ADMINISTRATION
..............................................................................
23
OVERDOSAGE
................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 25
STORAGE AND STABILITY
.........................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 28
PART II: SCIENTIFIC INFORMATION
................................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
......................................................................
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