APO-DARIFENACIN TABLET (EXTENDED-RELEASE)

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

DARIFENACIN (DARIFENACIN HYDROBROMIDE)

Dostopno od:

APOTEX INC

Koda artikla:

G04BD10

INN (mednarodno ime):

DARIFENACIN

Odmerek:

7.5MG

Farmacevtska oblika:

TABLET (EXTENDED-RELEASE)

Sestava:

DARIFENACIN (DARIFENACIN HYDROBROMIDE) 7.5MG

Pot uporabe:

ORAL

Enote v paketu:

30/100

Tip zastaranja:

Prescription

Terapevtsko območje:

Antimuscarinics

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-08-23

Lastnosti izdelka

_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
.......