Država: Kanada
Jezik: engleski
Izvor: Health Canada
ESCITALOPRAM (ESCITALOPRAM OXALATE)
SANDOZ CANADA INCORPORATED
N06AB10
ESCITALOPRAM
10MG
TABLET
ESCITALOPRAM (ESCITALOPRAM OXALATE) 10MG
ORAL
30/100
Prescription
SELECTIVE-SEROTONIN REUPTAKE INHIBITORS
Active ingredient group (AIG) number: 0150435002; AHFS:
APPROVED
2014-09-10
_ _ _Sandoz Escitalopram _ _Page 1 of 61_ PRODUCT MONOGRAPH PR SANDOZ ESCITALOPRAM Escitalopram Oxalate Tablets 10, 20 mg as escitalopram ANTIDEPRESSANT / ANXIOLYTIC / ANTIOBSESSIONAL Sandoz Canada Inc. Date of Revision: October 6, 2020 110 Rue de Lauzon Boucherville, QC J4B 1E6 Submission Control No: 240809 _ _ _Sandoz Escitalopram _ _Page 2 of 61_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ......................................................... 3 SUMMARY PRODUCT INFORMATION ................................................................................ 3 INDICATIONS AND CLINICAL USE ..................................................................................... 3 CONTRAINDICATIONS .......................................................................................................... 4 WARNINGS AND PRECAUTIONS ......................................................................................... 5 ADVERSE REACTIONS ......................................................................................................... 11 DRUG INTERACTIONS ......................................................................................................... 27 DOSAGE AND ADMINISTRATION ..................................................................................... 33 OVERDOSAGE ....................................................................................................................... 35 ACTION AND CLINICAL PHARMACOLOGY .................................................................... 36 STORAGE AND STABILITY ................................................................................................. 38 DOSAGE FORMS, COMPOSITION AND PACKAGING ..................................................... 38 PART II: SCIENTIFIC INFORMATION ............................................................................... 40 PHARMACEUTICAL INFORMATION ................................................................................. 40 CLINICAL TRIALS ................................... Pročitajte cijeli dokument