APO-PRAMIPEXOLE TABLET
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
15-03-2021
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Active ingredient:
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
Available from:
APOTEX INC
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:
100
Prescription type:
Prescription
Therapeutic area:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Product summary:
Active ingredient group (AIG) number: 0152169002; AHFS:
Authorization status:
APPROVED
Authorization date:
2007-02-23
Summary of Product characteristics
Page 1 of 57
PRODUCT MONOGRAPH
PR
APO-PRAMIPEXOLE
Pramipexole Dihydrochloride Monohydrate Tablets
Apotex Standard
0.125 mg, 0.25 mg, 0.5 mg, 0.75 mg, 1.0 mg, 1.5 mg
Antiparkinsonian Agent / Dopamine Agonist
APOTEX INC.
150 SIGNET DRIVE
TORONTO, ONTARIO
M9L 1T9
DATE OF REVISION:
March 15, 2021
SUBMISSION CONTROL NO.: 243770
Page 2 of 57
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
......................................................................................22
OVERDOSAGE
....................................................................................................................25
ACTION AND CLINICAL PHARMACOLOGY
......................................................................25
STORAGE AND STABILITY
................................................................................................29
SPECIAL HANDLING INSTRUCTIONS
................................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.........................................................29
PART II: SCIENTIFIC INFORMATION .................................................................................31
PHARMACEUTICAL INFORMATION
............................................
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