TEVA-ROPINIROLE TABLET
Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Charakteristika produktu
(SPC)
22-05-2020
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Aktivní složka:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE)
Dostupné s:
TEVA CANADA LIMITED
ATC kód:
N04BC04
INN (Mezinárodní Name):
ROPINIROLE
Dávkování:
1MG
Léková forma:
TABLET
Složení:
ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 1MG
Podání:
ORAL
Jednotky v balení:
15G/50G
Druh předpisu:
Prescription
Terapeutické oblasti:
NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS
Přehled produktů:
Active ingredient group (AIG) number: 0132618003; AHFS:
Stav Autorizace:
APPROVED
Datum autorizace:
2019-12-02
Charakteristika produktu
_ _
_TEVA-ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 mg Tablets _
_Page 1 of 53_
PRODUCT MONOGRAPH
Pr
TEVA-ROPINIROLE
Ropinirole Tablets, USP
0.25 mg, 1 mg, 2 mg & 5 mg ropinirole (as ropinirole hydrochloride)
Antiparkinsonian Agent / Dopamine Agonist
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario, M1B 2K9
Date of Revision:
May 19, 2020
Submission Control No: 236456
_ _
_TEVA- ROPINIROLE 0.25 mg, 1 mg, 2 mg & 5 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
.........................................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 29
PART II: SCIENTIFIC INFORMATION
..............................................................................
30
PHARMACEUTICAL INFORMATION
.........................................................................
30
CLINICAL TRIALS
...........................................
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