Country: Canada
Language: English
Source: Health Canada
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
BOEHRINGER INGELHEIM (CANADA) LTD LTEE
N04BC05
PRAMIPEXOLE
1MG
TABLET
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1MG
ORAL
90
Prescription
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0152169003; AHFS:
MARKETED
1998-02-26
_ _ _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 ........... Read the complete document