APO-DARIFENACIN TABLET (EXTENDED-RELEASE)

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

DARIFENACIN (DARIFENACIN HYDROBROMIDE)

Dostępny od:

APOTEX INC

Kod ATC:

G04BD10

INN (International Nazwa):

DARIFENACIN

Dawkowanie:

15MG

Forma farmaceutyczna:

TABLET (EXTENDED-RELEASE)

Skład:

DARIFENACIN (DARIFENACIN HYDROBROMIDE) 15MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

Antimuscarinics

Podsumowanie produktu:

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

Status autoryzacji:

APPROVED

Data autoryzacji:

2016-08-23

Charakterystyka produktu

_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
.......