MINT-ENTECAVIR TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

Verfügbar ab:

MINT PHARMACEUTICALS INC

ATC-Code:

J05AF10

INN (Internationale Bezeichnung):

ENTECAVIR

Dosierung:

0.5MG

Darreichungsform:

TABLET

Zusammensetzung:

ENTECAVIR (ENTECAVIR MONOHYDRATE) 0.5MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

15G/50G

Verschreibungstyp:

Prescription

Therapiebereich:

NUCLEOSIDES AND NUCLEOTIDES

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2019-02-21

Fachinformation

PRODUCT MONOGRAPH
Pr
MINT-ENTECAVIR
Entecavir Tablets
Entecavir (as monohydrate)
0.5 mg
USP
Antiviral
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario
L5T 2M3
Control No.: 246118
Date of Revision:
March 22, 2021
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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
..........................................................................................................
10
DOSAGE AND ADMINISTRATION
.......................................................................................
10
OVERDOSAGE
........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
......................................................................
11
STORAGE AND STABILITY
..................................................................................................
18
DOSAGE FORMS, COMPOSITION AND PACKAGING
....................................................... 19
PART II: SCIENTIFIC INFORMATION
.................................................................................
20
PHARMACEUTICAL INFORMATION
...................................................................................
20
CLINICAL TRIALS
..................................................................................................................