Страна: Канада
Язык: английский
Источник: Health Canada
DULOXETINE (DULOXETINE HYDROCHLORIDE)
JAMP PHARMA CORPORATION
N06AX21
DULOXETINE
30MG
CAPSULE (DELAYED RELEASE)
DULOXETINE (DULOXETINE HYDROCHLORIDE) 30MG
ORAL
15G/50G
Prescription
SELECTIVE SEROTONIN AND NOREPINEPHRINE-REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0152350001; AHFS:
APPROVED
2016-05-02
______________________________________________________________________________ _JAMP-Duloxetine Product Monograph _ _ _ _ _ _ Page 1 of 81 _ PRODUCT MONOGRAPH PR JAMP-DULOXETINE Duloxetine Delayed-Release Capsules Duloxetine (as duloxetine hydrochloride) 30 mg and 60 mg Manufacturer’s standard ANALGESIC/ANTIDEPRESSANT/ANXIOLYTIC Submission Control No: 256492 DATE OF REVISION: September 28, 2021 JAMP Pharma Corporation 1310 rue Nobel Boucherville, Québec J4B 5H3, Canada ______________________________________________________________________________ _JAMP-Duloxetine Product Monograph _ _ _ _ _ _ Page 2 of 81 _ 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 PHARMA Прочитать полный документ