PMS-ROPINIROLE TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Dostępny od:

PHARMASCIENCE INC

Kod ATC:

N04BC04

INN (International Nazwa):

ROPINIROLE

Dawkowanie:

2MG

Forma farmaceutyczna:

TABLET

Skład:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG

Droga podania:

ORAL

Sztuk w opakowaniu:

10/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2009-07-22

Charakterystyka produktu

PRODUCT MONOGRAPH
PR
PMS-ROPINIROLE
Ropinirole Hydrochloride Tablets, House
0.25 mg, 0.5 mg 1.0 mg, 2.0 mg, 5.0 mg ropinirole
(as ropinirole hydrochloride)
ANTIPARKINSONIAN AGENT / DOPAMINE AGONIST
PHARMASCIENCE INC.
DATE OF REVISION:
6111 Ave. Royalmount, Suite 100
June 12, 2017
Montreal, Quebec
H4P 2T4
www.pharmascience.com
SUBMISSION CONTROL NO: 206310
_pms-ROPINIROLE Product Monograph Page 2 of 52 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
4
CONTRAINDICATIONS
...................................................................................................
4
WARNINGS AND PRECAUTIONS
.................................................................................
5
ADVERSE REACTIONS
.................................................................................................
10
DRUG INTERACTIONS
..................................................................................................
21
DOSAGE AND ADMINISTRATION
..............................................................................
23
OVERDOSAGE
................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 25
STORAGE AND STABILITY
.........................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 28
PART II: SCIENTIFIC INFORMATION
................................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
......................................................................