ROPINIROLE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Διαθέσιμο από:

COBALT PHARMACEUTICALS COMPANY

Φαρμακολογική κατηγορία (ATC):

N04BC04

INN (Διεθνής Όνομα):

ROPINIROLE

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

21/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0132618005; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED PRE MARKET

Ημερομηνία της άδειας:

2017-09-01

Αρχείο Π.Χ.Π.

_ _
_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
Cobalt Pharmaceuticals Company
6733 Mississauga Road
Mississauga, Ontario
L5N 6J5
Date of Revision:
September 4, 2014
Submission Control No: 177073
_ _
_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
.....................................