ZOVIRAX TAB 200MG TABLET

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

ACYCLOVIR

Mevcut itibaren:

GLAXOSMITHKLINE INC

ATC kodu:

J05AB01

INN (International Adı):

ACYCLOVIR

Doz:

200MG

Farmasötik formu:

TABLET

Kompozisyon:

ACYCLOVIR 200MG

Uygulama yolu:

ORAL

Paketteki üniteler:

100

Reçete türü:

Prescription

Terapötik alanı:

NUCLEOSIDES AND NUCLEOTIDES

Ürün özeti:

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

Yetkilendirme durumu:

CANCELLED POST MARKET

Yetkilendirme tarihi:

2016-01-11

Ürün özellikleri

_2014-11-10/131-pristine-pm-zovirax.doc _
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_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 _
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_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
..........................................................