MIRAPEX TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-01-2018
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Active ingredient:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Available from:
BOEHRINGER INGELHEIM (CANADA) LTD LTEE
ATC code:
N04BC05
INN (International Name):
PRAMIPEXOLE
Dosage:
0.5MG
Pharmaceutical form:
TABLET
Composition:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.5MG
Administration route:
ORAL
Units in package:
90
Prescription type:
Prescription
Therapeutic area:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Product summary:
Active ingredient group (AIG) number: 0152169002; AHFS:
Authorization status:
CANCELLED POST MARKET
Authorization date:
2018-06-18
Summary of Product characteristics
_ _
_MIRAPEX Product Monograph _
_Page 1 of 53 _
PRODUCT MONOGRAPH
PR
MIRAPEX
®
PRAMIPEXOLE DIHYDROCHLORIDE TABLETS
Tablets 0.125 mg, 0.25 mg, 0.5 mg, 1.0 mg, 1.5 mg
pramipexole dihydrochloride monohydrate
Antiparkinsonian agent / Dopamine Agonist
Boehringer Ingelheim (Canada) Ltd.
5180 South Service Road
Burlington, ON L7L 5H4
BICL CCDS #0186-18
Date of Revision:
January 15, 2018
Submission Control No: 210942
_ _
_MIRAPEX Product Monograph _
_Page 2 of 53 _
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
..................................................................................................19
DOSAGE AND ADMINISTRATION
..............................................................................21
OVERDOSAGE
................................................................................................................24
ACTION AND CLINICAL PHARMACOLOGY
............................................................25
STORAGE AND STABILITY
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................29
PART II: SCIENTIFIC INFORMATION
................................................................................30
PHARMACEUTICAL INFORMATION
...........
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