SANDOZ ENTECAVIR TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

ENTECAVIR

Boleh didapati daripada:

SANDOZ CANADA INCORPORATED

Kod ATC:

J05AF10

INN (Nama Antarabangsa):

ENTECAVIR

Dos:

0.5MG

Borang farmaseutikal:

TABLET

Komposisi:

ENTECAVIR 0.5MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

30/1000

Jenis preskripsi:

Prescription

Kawasan terapeutik:

NUCLEOSIDES AND NUCLEOTIDES

Ringkasan produk:

Active ingredient group (AIG) number: 0151648001; AHFS:

Status kebenaran:

CANCELLED PRE MARKET

Tarikh kebenaran:

2021-04-21

Ciri produk

_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
................................................................................