PMS-ROPINIROLE TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
21-06-2017
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Werkstoffen:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
Beschikbaar vanaf:
PHARMASCIENCE INC
ATC-code:
N04BC04
INN (Algemene Internationale Benaming):
ROPINIROLE
Dosering:
2MG
farmaceutische vorm:
TABLET
Samenstelling:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG
Toedieningsweg:
ORAL
Eenheden in pakket:
10/100
Prescription-type:
Prescription
Therapeutisch gebied:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Product samenvatting:
Active ingredient group (AIG) number: 0132618004; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2009-07-22
Productkenmerken
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
......................................................................
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