APO-ENTECAVIR TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
18-01-2023
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Aktiv bestanddel:
ENTECAVIR
Tilgængelig fra:
APOTEX INC
ATC-kode:
J05AF10
INN (International Name):
ENTECAVIR
Dosering:
0.5MG
Lægemiddelform:
TABLET
Sammensætning:
ENTECAVIR 0.5MG
Indgivelsesvej:
ORAL
Enheder i pakken:
30
Recept type:
Prescription
Terapeutisk område:
NUCLEOSIDES AND NUCLEOTIDES
Produkt oversigt:
Active ingredient group (AIG) number: 0151648001; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2012-11-23
Produktets egenskaber
_APO-ENTECAVIR (Entecavir Tablets) _
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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) _
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_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
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