ROPINIROLE TABLET

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Beszerezhető a:

SANIS HEALTH INC

ATC-kód:

N04BC04

INN (nemzetközi neve):

ROPINIROLE

Adagolás:

0.25MG

Gyógyszerészeti forma:

TABLET

Összetétel:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 0.25MG

Az alkalmazás módja:

ORAL

db csomag:

100

Recept típusa:

Prescription

Terápiás terület:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2010-06-18

Termékjellemzők

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