Pajjiż: Kanada
Lingwa: Ingliż
Sors: Health Canada
ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
TEVA CANADA LIMITED
N04BC04
ROPINIROLE
5MG
TABLET
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5MG
ORAL
15G/50G
Prescription
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0132618005; AHFS:
APPROVED
2019-12-02
_ _ _TEVA-ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _ _Page 1 of 53_ PRODUCT MONOGRAPH Pr TEVA-ROPINIROLE Ropinirole Tablets, USP 0.25 mg, 1 mg, 2 mg & 5 mg ropinirole (as ropinirole hydrochloride) Antiparkinsonian Agent / Dopamine Agonist Teva Canada Limited 30 Novopharm Court Toronto, Ontario, M1B 2K9 Date of Revision: May 19, 2020 Submission Control No: 236456 _ _ _TEVA- ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _ _Page 2 of 53_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ....................................................................... 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS .................................................................................................. 4 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 9 DRUG INTERACTIONS ................................................................................................. 21 DOSAGE AND ADMINISTRATION ............................................................................. 23 OVERDOSAGE ............................................................................................................... 24 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 25 STORAGE AND STABILITY ......................................................................................... 28 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 29 PART II: SCIENTIFIC INFORMATION .............................................................................. 30 PHARMACEUTICAL INFORMATION ......................................................................... 30 CLINICAL TRIALS ........................................... Aqra d-dokument sħiħ