País: Canadà
Idioma: anglès
Font: Health Canada
DULOXETINE (DULOXETINE HYDROCHLORIDE)
MYLAN PHARMACEUTICALS ULC
N06AX21
DULOXETINE
30MG
CAPSULE (DELAYED RELEASE)
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
ORAL
30/100
Prescription
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0152350001; AHFS:
CANCELLED POST MARKET
2018-05-10
_MYLAN-DULOXETINE Product Monograph_ Page 1 of 86 PRODUCT MONOGRAPH PR MYLAN-DULOXETINE Duloxetine Delayed Release Capsules, Mylan Standard Duloxetine (as duloxetine hydrochloride) 30 mg and 60 mg ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC Mylan Pharmaceuticals ULC 85 Advance Road Etobicoke, ON M8Z 2S6 Submission Control No.: 198303 Date of Revision: September 29, 2016 _MYLAN-DULOXETINE Product Monograph_ Page 2 of 86 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 ......................................................................................................... 19 DRUG INTERACTIONS ......................................................................................................... 38 DOSAGE AND ADMINISTRATION ..................................................................................... 42 OVERDOSAGE ........................................................................................................................ 45 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 46 STORAGE AND STABILITY ................................................................................................. 49 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 49 PART II: SCIENTIFIC INFORMATION ......................................................................................... 51 PHARMACEUTICAL INFORMATION ..................................................... Llegiu el document complet