APO-DARIFENACIN TABLET (EXTENDED-RELEASE)

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

DARIFENACIN (DARIFENACIN HYDROBROMIDE)

Commercializzato da:

APOTEX INC

Codice ATC:

G04BD10

INN (Nome Internazionale):

DARIFENACIN

Dosaggio:

15MG

Forma farmaceutica:

TABLET (EXTENDED-RELEASE)

Composizione:

DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15MG

Via di somministrazione:

ORAL

Confezione:

30/100

Tipo di ricetta:

Prescription

Area terapeutica:

Antimuscarinics

Dettagli prodotto:

Active ingredient group (AIG) number: 0151554002; AHFS:

Stato dell'autorizzazione:

APPROVED

Data dell'autorizzazione:

2016-08-23

Scheda tecnica

_APO-DARIFENACIN Product Monograph_
Page 1 of 26
PRODUCT MONOGRAPH
PR
APO-DARIFENACIN
DARIFENACIN EXTENDED RELEASE TABLETS
7.5 MG AND 15 MG DARIFENACIN (AS DARIFENACIN HYDROBROMIDE)
Muscarinic M3 selective receptor antagonist
APOTEX INC. DATE OF PREPARATION:
150 SIGNET DRIVE FEBRUARY 23, 2016
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 170837
_APO-DARIFENACIN Product Monograph_
Page 2 of 26
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
......................................................................................................
5
DRUG INTERACTIONS
.......................................................................................................
8
DOSAGE AND ADMINISTRATION
......................................................................................
9
OVERDOSAGE
...................................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
......................................................................10
STORAGE AND
STABILITY................................................................................................13
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................13
PART II: SCIENTIFIC INFORMATION
....................................................................................14
PHARMACEUTICAL INFORMATION
..................................................................................14
CLINICAL TRIALS
.......