ROPINIROLE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Saatavilla:

SANIS HEALTH INC

ATC-koodi:

N04BC04

INN (Kansainvälinen yleisnimi):

ROPINIROLE

Annos:

1MG

Lääkemuoto:

TABLET

Koostumus:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0132618003; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2010-06-18

Valmisteyhteenveto

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