BARACLUDE TABLET

Country: Կանադա

language: անգլերեն

source: Health Canada

active_ingredient:

ENTECAVIR

MAH:

BRISTOL-MYERS SQUIBB CANADA

ATC_code:

J05AF10

INN:

ENTECAVIR

dosage:

0.5MG

pharmaceutical_form:

TABLET

composition:

ENTECAVIR 0.5MG

administration_route:

ORAL

units_in_package:

30

prescription_type:

Prescription

therapeutic_area:

NUCLEOSIDES AND NUCLEOTIDES

leaflet_short:

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

authorization_status:

APPROVED

authorization_date:

2006-06-16

SPC

1
PRODUCT MONOGRAPH
Pr
BARACLUDE*
(entecavir)
Tablets 0.5 mg
Antiviral
Bristol-Myers Squibb Canada
Date of Preparation:
Montreal, Canada
June 16, 2006
*
TM of Bristol-Myers Squibb Company used under license by
Bristol-Myers Squibb Canada
Date of revision:
23 September 2020
Control No. 233293
2
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
...........................................................................................................
6
DRUG INTERACTIONS
.........................................................................................................
10
DOSAGE AND ADMINISTRATION
.....................................................................................
11
OVERDOSAGE
........................................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
12
STORAGE AND STABILITY
.................................................................................................
19
DOSAGE FORMS, COMPOSITION AND
PACKAGING..................................................... 19
PART II: SCIENTIFIC INFORMATION
...............................................................................
21
PHARMACEUTICAL INFORMATION
.................................................................................
21
CLINICAL TRIALS
...........................................................................................