ROPINIROLE TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Dostupné z:

SANIS HEALTH INC

ATC kód:

N04BC04

INN (Medzinárodný Name):

ROPINIROLE

Dávkovanie:

0.25MG

Forma lieku:

TABLET

Zloženie:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Prehľad produktov:

Active ingredient group (AIG) number: 0132618001; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2010-06-18

Súhrn charakteristických

_ _
_ROPINIROLE 0.25 mg, 1 mg, Tablets _
_Page 1 of 53_
PRODUCT MONOGRAPH
Pr
ROPINIROLE
Ropinirole Tablets, USP
0.25 mg and 1 mg ropinirole (as ropinirole hydrochloride)
Antiparkinsonian Agent / Dopamine Agonist
Sanis Health Inc.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
February 10, 2021
Submission Control No.: 244016
_ _
_ROPINIROLE 0.25 mg, 1 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
.........................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
...............................................................................