ROPINIROLE TABLET

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

זמין מ:

SANIS HEALTH INC

קוד ATC:

N04BC04

INN (שם בינלאומי):

ROPINIROLE

כמות:

2MG

טופס פרצבטיות:

TABLET

הרכב:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

100

סוג מרשם:

Prescription

איזור תרפויטי:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

leaflet_short:

Active ingredient group (AIG) number: 0132618004; AHFS:

מצב אישור:

CANCELLED POST MARKET

תאריך אישור:

2014-08-01

מאפייני מוצר

_ _
_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
..............................