AG-DULOXETINE CAPSULE (DELAYED RELEASE)

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

DULOXETINE (DULOXETINE HYDROCHLORIDE)

Dostupné z:

ANGITA PHARMA INC.

ATC kód:

N06AX21

INN (Medzinárodný Name):

DULOXETINE

Dávkovanie:

60MG

Forma lieku:

CAPSULE (DELAYED RELEASE)

Zloženie:

DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG

Spôsob podávania:

ORAL

Počet v balení:

100

Typ predpisu:

Prescription

Terapeutické oblasti:

SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS

Prehľad produktov:

Active ingredient group (AIG) number: 0152350002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2018-05-04

Súhrn charakteristických

______________________________________________________________________
AG-Duloxetine Product Monograph
Page 1 of 82
PRODUCT MONOGRAPH
Pr
AG-Duloxetine
Duloxetine Delayed-Release Capsules
Duloxetine (as duloxetine hydrochloride)
30 mg and 60 mg
Manufacturer’s standard
Analgesic/Antidepressant/Anxiolytic
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control No: 257576
Date of Revision: November 22, 2021
______________________________________________________________________
AG-Duloxetine Product Monograph
Page 2 of 82
Table of Contents
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
.......................................................................
3
INDICATIONS AND CLINICAL USE
.............................................................................
3
CONTRAINDICATIONS
........................................................................................................
5
WARNINGS AND PRECAUTIONS
.................................................................................
6
ADVERSE REACTIONS
..................................................................................................
18
DRUG INTERACTIONS
.................................................................................................
37
DOSAGE AND ADMINISTRATION
..............................................................................
40
OVERDOSAGE
......................................................................................................................
43
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 44
STORAGE AND STABILITY
..........................................................................................
47
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 47
PART II: SCIENTIFIC INFORMATION
................................................................................
49
PHARMACEUTICAL INFORMATION
..