AG-DULOXETINE CAPSULE (DELAYED RELEASE)
Țară: Canada
Limbă: engleză
Sursă: Health Canada
Caracteristicilor produsului
(SPC)
22-11-2021
Unele documente pentru acest produs nu sunt disponibile în prezent, puteți trimite o solicitare la serviciul nostru pentru clienți și vă vom anunța de îndată ce vom putea să le obținem.
Trimite cerere.
Trimite cerere.
Ingredient activ:
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Disponibil de la:
ANGITA PHARMA INC.
Codul ATC:
N06AX21
INN (nume internaţional):
DULOXETINE
Dozare:
60MG
Forma farmaceutică:
CAPSULE (DELAYED RELEASE)
Compoziție:
DULOXETINE (DULOXETINE HYDROCHLORIDE) 60MG
Calea de administrare:
ORAL
Unități în pachet:
100
Tip de prescriptie medicala:
Prescription
Zonă Terapeutică:
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Rezumat produs:
Active ingredient group (AIG) number: 0152350002; AHFS:
Statutul autorizaţiei:
APPROVED
Data de autorizare:
2018-05-04
Caracteristicilor produsului
______________________________________________________________________
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
..
Citiți documentul complet
