ENTECAVIR TABLETS

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

Saatavilla:

STRIDES PHARMA CANADA INC

ATC-koodi:

J05AF10

INN (Kansainvälinen yleisnimi):

ENTECAVIR

Annos:

0.5MG

Lääkemuoto:

TABLET

Koostumus:

ENTECAVIR (ENTECAVIR MONOHYDRATE) 0.5MG

Antoreitti:

ORAL

Kpl paketissa:

30

Prescription tyyppi:

Prescription

Terapeuttinen alue:

NUCLEOSIDES AND NUCLEOTIDES

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2016-04-13

Valmisteyhteenveto

PRODUCT MONOGRAPH
Pr
ENTECAVIR TABLETS
Entecavir Tablets
0.5 mg
Antiviral
Strides Pharma Canada Inc.
Date of Revision:
1565, Boul. Lionel-Boulet
August 22, 2022
Varennes, QC
J3X 1P7
Submission Control No.: 266151
_2_
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
.......................................................................................................................8
DRUG INTERACTIONS
....................................................................................................................
12
DOSAGE AND
ADMINISTRATION......................................................................................................
13
OVERDOSAGE
...............................................................................................................................
14
ACTION AND CLINICAL PHARMACOLOGY
..........................................................................................
14
STORAGE AND
STABILITY................................................................................................................
24
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................................................
24
PART II: SCIENTIFIC INFORMATION
.................................................................................................
25
PHARMACEUTICAL
INFORMATION...................................................................