Country: Կանադա
language: անգլերեն
source: Health Canada
ENTECAVIR
SANDOZ CANADA INCORPORATED
J05AF10
ENTECAVIR
0.5MG
TABLET
ENTECAVIR 0.5MG
ORAL
30/1000
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0151648001; AHFS:
CANCELLED PRE MARKET
2021-04-21
_Sandoz Entecavir _ _Page 1 of 40_ PRODUCT MONOGRAPH PR SANDOZ ENTECAVIR Entecavir Tablets 0.5 mg Antiviral Sandoz Canada Inc. 110 Rue de Lauzon Boucherville, QC J4B 1E6 Date of Revision: October 24, 2018 Submission Control No: 220844 _Sandoz Entecavir _ _Page 2 of 40_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ........................................................ 3 SUMMARY PRODUCT INFORMATION ........................................................................ 3 INDICATIONS AND CLINICAL USE ............................................................................. 3 CONTRAINDICATIONS ................................................................................................... 3 WARNINGS AND PRECAUTIONS ................................................................................. 4 ADVERSE REACTIONS ................................................................................................... 6 DRUG INTERACTIONS ................................................................................................... 9 DOSAGE AND ADMINISTRATION ............................................................................. 10 OVERDOSAGE ................................................................................................................ 11 ACTION AND CLINICAL PHARMACOLOGY ............................................................ 11 STORAGE AND STABILITY ......................................................................................... 18 DOSAGE FORMS, COMPOSITION AND PACKAGING ............................................. 18 PART II: SCIENTIFIC INFORMATION .............................................................................. 19 PHARMACEUTICAL INFORMATION ......................................................................... 19 CLINICAL TRIALS ......................................................................................................... 20 DETAILED PHARMACOLOGY ................................................................................ read_full_document