ZOVIRAX TAB 200MG TABLET

Land: Canada

Taal: Engels

Bron: Health Canada

Werkstoffen:

ACYCLOVIR

Beschikbaar vanaf:

GLAXOSMITHKLINE INC

ATC-code:

J05AB01

INN (Algemene Internationale Benaming):

ACYCLOVIR

Dosering:

200MG

farmaceutische vorm:

TABLET

Samenstelling:

ACYCLOVIR 200MG

Toedieningsweg:

ORAL

Eenheden in pakket:

100

Prescription-type:

Prescription

Therapeutisch gebied:

NUCLEOSIDES AND NUCLEOTIDES

Product samenvatting:

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

Autorisatie-status:

CANCELLED POST MARKET

Autorisatie datum:

2016-01-11

Productkenmerken

_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
..........................................................