ZOVIRAX TAB 200MG TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

ACYCLOVIR

Tersedia dari:

GLAXOSMITHKLINE INC

Kode ATC:

J05AB01

INN (Nama Internasional):

ACYCLOVIR

Dosis:

200MG

Bentuk farmasi:

TABLET

Komposisi:

ACYCLOVIR 200MG

Rute administrasi :

ORAL

Unit dalam paket:

100

Jenis Resep:

Prescription

Area terapi:

NUCLEOSIDES AND NUCLEOTIDES

Ringkasan produk:

Active ingredient group (AIG) number: 0115506002; AHFS:

Status otorisasi:

CANCELLED POST MARKET

Tanggal Otorisasi:

2016-01-11

Karakteristik produk

_2014-11-10/131-pristine-pm-zovirax.doc _
_ _
_ _
_ _
_ _
_Page 1 of 38_
PRODUCT MONOGRAPH
PR
ZOVIRAX
®
Acyclovir Oral Suspension USP, 200 mg /5 mL
Acyclovir Tablets USP, 200 mg
Antiviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
November 10, 2014
Submission Control No: 177766
_©_
_2014 GlaxoSmithKline Inc. All Rights Reserved _
_ZOVIRAX is a registered trademark of GlaxoSmithKline Inc. _
_2014-11-10/131-pristine-pm-zovirax.doc _
_ _
_ _
_ _
_ _
_Page 2 of 38_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
....................................................................................................9
DOSAGE AND ADMINISTRATION
..............................................................................10
OVERDOSAGE
................................................................................................................11
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................14
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................14
PART II: SCIENTIFIC INFORMATION
...............................................................................15
PHARMACEUTICAL INFORMATION
..........................................................