Country: Canada
Language: English
Source: Health Canada
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE
SIVEM PHARMACEUTICALS ULC
N04BC05
PRAMIPEXOLE
0.25MG
TABLET
PRAMIPEXOLE DIHYDROCHLORIDE MONOHYDRATE 0.25MG
ORAL
100
Prescription
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0152169001; AHFS:
APPROVED
2018-01-09
_ _ _PRAMIPEXOLE Product Monograph _ _Page 1 of 59_ PRODUCT MONOGRAPH PR PRAMIPEXOLE Pramipexole Dihydrochloride Tablets 0.25 mg, 0.5 mg, 1 mg & 1.5 mg pramipexole dihydrochloride monohydrate ANTIPARKINSONIAN AGENT / DOPAMINE AGONIST Sivem Pharmaceuticals ULC 4705 Dobrin Street Saint-Laurent, Quebec, Canada H4R 2P7 www.sivem.ca Date of Revision: November 10, 2021 Submission control No.: 257831 _ _ _PRAMIPEXOLE Product Monograph _ _Page 2 of 59_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION .................................................... 3 SUMMARY PRODUCT INFORMATION .......................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................... 3 CONTRAINDICATIONS ..................................................................................................... 4 WARNINGS AND PRECAUTIONS ................................................................................... 5 ADVERSE REACTIONS ................................................................................................... 12 DRUG INTERACTIONS.................................................................................................... 21 DOSAGE AND ADMINISTRATION ............................................................................... 23 OVERDOSAGE .................................................................................................................. 26 ACTION AND CLINICAL PHARMACOLOGY .............................................................. 27 STORAGE AND STABILITY ........................................................................................... 31 SPECIAL HANDLING INSTRUCTIONS ......................................................................... 31 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................... 31 PART II: SCIENTIFIC INFORMATION .......................................................................... 33 CLINICAL TRIALS ................. Read the complete document