Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
COBALT PHARMACEUTICALS COMPANY
N04BC04
ROPINIROLE
0.25MG
TABLET
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25MG
ORAL
21/100/500
Prescription
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0132618001; AHFS:
CANCELLED PRE MARKET
2017-09-01
_ _ _ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _ _Page 1 of 52_ PRODUCT MONOGRAPH Pr ROPINIROLE Ropinirole Tablets, USP 0.25 mg, 1 mg, 2 mg & 5 mg ropinirole (as ropinirole hydrochloride) Antiparkinsonian Agent / Dopamine Agonist Cobalt Pharmaceuticals Company 6733 Mississauga Road Mississauga, Ontario L5N 6J5 Date of Revision: September 4, 2014 Submission Control No: 177073 _ _ _ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _ _Page 2 of 52_ 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 ................................................................................................... 8 DRUG INTERACTIONS ................................................................................................. 20 DOSAGE AND ADMINISTRATION ............................................................................. 22 OVERDOSAGE ............................................................................................................... 23 ACTION AND CLINICAL PHARMACOLOGY ........................................................... 24 STORAGE AND STABILITY ......................................................................................... 27 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................ 28 PART II: SCIENTIFIC INFORMATION .............................................................................. 29 PHARMACEUTICAL INFORMATION ......................................................................... 29 CLINICAL TRIALS ..................................... Prečítajte si celý dokument