देश: कनाडा
भाषा: अंग्रेज़ी
स्रोत: Health Canada
ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
SANIS HEALTH INC
N04BC04
ROPINIROLE
2MG
TABLET
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG
ORAL
100
Prescription
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Active ingredient group (AIG) number: 0132618004; AHFS:
CANCELLED POST MARKET
2014-08-01
_ _ _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 SANIS HEALTH INC. 333 Champlain Street, Suite 102 Dieppe, New Brunswick E1A 1P2 www.sanis.com Date of Revision: May 04, 2015 Submission Control No: 183842 _ _ _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 .............................. पूरा दस्तावेज़ पढ़ें