PMS-ROPINIROLE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Dostupno od:

PHARMASCIENCE INC

ATC koda:

N04BC04

INN (International ime):

ROPINIROLE

Doziranje:

2MG

Farmaceutski oblik:

TABLET

Sastav:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG

Administracija rute:

ORAL

Jedinice u paketu:

10/100

Tip recepta:

Prescription

Područje terapije:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2009-07-22

Svojstava lijeka

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
......................................................................