Country: Canada
Language: English
Source: Health Canada
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
APOTEX INC
N04BC05
PRAMIPEXOLE
1.5MG
TABLET
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 1.5MG
ORAL
100
Prescription
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0152169004; AHFS:
APPROVED
2007-02-23
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 ............................................ Read the complete document