Страна: Канада
Язык: английский
Источник: Health Canada
ENTECAVIR
APOTEX INC
J05AF10
ENTECAVIR
0.5MG
TABLET
ENTECAVIR 0.5MG
ORAL
30
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0151648001; AHFS:
APPROVED
2012-11-23
_APO-ENTECAVIR (Entecavir Tablets) _ _ _ _ _ _ _ _ _ _ _ _Page 1 of 52_ PRODUCT MONOGRAPH PR APO-ENTECAVIR Entecavir Tablets Tablets 0.5 mg USP Antiviral APOTEX INC. 150 Signet Drive Toronto, Ontario M9L 1T9 Date of Preparation: November 23, 2012 Date of Revision: January 11, 2023 Submission Control Number: 271047 _APO-ENTECAVIR (Entecavir Tablets) _ _ _ _ _ _ _ _ _ _ _ _Page 2 of 52_ TABLE OF CONTENTS PART I: HEALTH PROFESSIONAL INFORMATION ..................................................................... 3 SUMMARY PRODUCT INFORMATION ......................................................................................... 3 INDICATIONS AND CLINICAL USE ................................................................................................ 3 CONTRAINDICATIONS.................................................................................................................. 3 WARNINGS AND PRECAUTIONS .................................................................................................. 3 ADVERSE REACTIONS .................................................................................................................. 7 DRUG INTERACTIONS ................................................................................................................ 11 DOSAGE AND ADMINISTRATION ............................................................................................... 12 OVERDOSAGE ............................................................................................................................ 13 ACTION AND CLINICAL PHARMACOLOGY ................................................................................. 13 STORAGE AND STABILITY .......................................................................................................... 20 DOSAGE FORMS, COMPOSITION AND PACKAGING .................................................................. 20 PART II: SCIENTIFIC INFORMATION ...................................................................................... 22 PHARMAC Прочитать полный документ