APO-DARIFENACIN TABLET (EXTENDED-RELEASE)

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

DARIFENACIN (DARIFENACIN HYDROBROMIDE)

Disponibbli minn:

APOTEX INC

Kodiċi ATC:

G04BD10

INN (Isem Internazzjonali):

DARIFENACIN

Dożaġġ:

15MG

Għamla farmaċewtika:

TABLET (EXTENDED-RELEASE)

Kompożizzjoni:

DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

30/100

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

Antimuscarinics

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2016-08-23

Karatteristiċi tal-prodott

_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
.......