Pays: Canada
Langue: anglais
Source: Health Canada
DULOXETINE (DULOXETINE HYDROCHLORIDE)
SANDOZ CANADA INCORPORATED
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:
APPROVED
2016-05-02
______________________________________________________________________________ _Sandoz Duloxetine Product Monograph_ _ Page 1 of 84_ PRODUCT MONOGRAPH PR SANDOZ DULOXETINE Duloxetine Delayed-Release Capsules 30 mg and 60 mg duloxetine (as duloxetine hydrochloride) Manufacturer’s standard ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, Quebec J4B 1E6 Submission Control No: 259736 DATE OF REVISION: June 3, 2022 ______________________________________________________________________________ _Sandoz Duloxetine Product Monograph_ _ Page 2 of 84_ 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 ................................................................................................ 39 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 .......... Lire le document complet