Země: Kanada
Jazyk: angličtina
Zdroj: Health Canada
DESVENLAFAXINE
SANDOZ CANADA INCORPORATED
N06AX23
DESVENLAFAXINE
50MG
TABLET (EXTENDED-RELEASE)
DESVENLAFAXINE 50MG
ORAL
100
Prescription
Active ingredient group (AIG) number: 0152509001; AHFS:
APPROVED
2023-05-29
_ _ _Sandoz Desvenlafaxine _ _Page 1 of 53_ PRODUCT MONOGRAPH PR SANDOZ DESVENLAFAXINE Desvenlafaxine Extended-Release Tablets Tablets, 50 and 100 mg, oral Antidepressant Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, Quebec, Canada J4B 1E6 Date of Preparation: May 26, 2023 Submission Control No: 257049 _ _ _Sandoz Desvenlafaxine _ _Page 2 of 53_ 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 ................................................................................................. 12 DRUG INTERACTIONS ................................................................................................. 23 DOSAGE AND ADMINISTRATION ............................................................................. 26 OVERDOSAGE ................................................................................................................ 29 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 30 STORAGE AND STABILITY ......................................................................................... 34 SPECIAL HANDLING INSTRUCTIONS ....................................................................... 34 DOSAGE FORMS, COMPOSITION AND PACKAGING............................................. 34 PART II: SCIENTIFIC INFORMATION .............................................................................. 35 PHARMACEUTICAL INFORMATION ......................................................................... 35 CLINICAL TRIALS .......................... Přečtěte si celý dokument