APO-DARIFENACIN TABLET (EXTENDED-RELEASE)

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

DARIFENACIN (DARIFENACIN HYDROBROMIDE)

Saatavilla:

APOTEX INC

ATC-koodi:

G04BD10

INN (Kansainvälinen yleisnimi):

DARIFENACIN

Annos:

7.5MG

Lääkemuoto:

TABLET (EXTENDED-RELEASE)

Koostumus:

DARIFENACIN (DARIFENACIN HYDROBROMIDE) 7.5MG

Antoreitti:

ORAL

Kpl paketissa:

30/100

Prescription tyyppi:

Prescription

Terapeuttinen alue:

Antimuscarinics

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0151554001; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2016-08-23

Valmisteyhteenveto

_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
.......