ENTECAVIR TABLETS

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

ENTECAVIR (ENTECAVIR MONOHYDRATE)

Dostopno od:

STRIDES PHARMA CANADA INC

Koda artikla:

J05AF10

INN (mednarodno ime):

ENTECAVIR

Odmerek:

0.5MG

Farmacevtska oblika:

TABLET

Sestava:

ENTECAVIR (ENTECAVIR MONOHYDRATE) 0.5MG

Pot uporabe:

ORAL

Enote v paketu:

30

Tip zastaranja:

Prescription

Terapevtsko območje:

NUCLEOSIDES AND NUCLEOTIDES

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2016-04-13

Lastnosti izdelka

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...................................................................