País: Canadà
Idioma: anglès
Font: Health Canada
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE)
ANGITA PHARMA INC.
N06AX23
DESVENLAFAXINE
50MG
TABLET (EXTENDED-RELEASE)
DESVENLAFAXINE (DESVENLAFAXINE SUCCINATE) 50MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0152509001; AHFS:
APPROVED
2022-03-04
PRODUCT MONOGRAPH Pr AG-DESVENLAFAXINE Desvenlafaxine Extended-Release Tablets 50 and 100 mg desvenlafaxine (as desvenlafaxine succinate monohydrate) Antidepressant Angita Pharma Inc. 1310 rue Nobel Boucherville, Québec J4B 5H3 SUBMISSION CONTROL NO.: 260512 _AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph _ _Page 1 of 57_ Date of Revision: February 28, 2022 _AG-DESVENLAFAXINE (desvenlafaxine succinate) Product Monograph_ _Page 2 of 57_ _ _ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION. .............................................................. 3 SUMMARY PRODUCT INFORMATION .......................................................................... 3 INDICATIONS AND CLINICAL USE .................................................................................3 CONTRAINDICATIONS ...................................................................................................... 4 WARNINGS AND PRECAUTIONS .................................................................................... 4 ADVERSE REACTIONS .................................................................................................... 13 DRUG INTERACTIONS ....................................................................................................24 DOSAGE AND ADMINISTRATION ................................................................................28 OVERDOSAGE ................................................................................................................... 31 ACTION AND CLINICAL PHARMACOLOGY ...............................................................33 STORAGE AND STABILITY ............................................................................................37 SPECIAL HANDLING INSTRUCTIONS .......................................................................... 37 DOSAGE FORMS, COMPOSITION AND PACKAGING ................................................37 PART II: SCIENTIFIC INFORMATION .................................................................................. Llegiu el document complet