TEVA-ROPINIROLE TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE)

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

N04BC04

INN (International ime):

ROPINIROLE

Doziranje:

2MG

Farmaceutski oblik:

TABLET

Sastav:

ROPINIROLE (ROPINIROLE HYDROCHLORIDE) 2MG

Administracija rute:

ORAL

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

NONERGOT-DERIVATIVE DOPAMINE RECEPTOR AGONISTS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2019-12-02

Svojstava lijeka

_ _
_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
...........................................