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:

2MG

Lääkemuoto:

TABLET

Koostumus:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG

Antoreitti:

ORAL

Kpl paketissa:

100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

CANCELLED POST MARKET

Valtuutus päivämäärä:

2014-08-01

Valmisteyhteenveto

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