ZOVIRAX SUSPENSION
Land: Kanada
Språk: engelska
Källa: Health Canada
Produktens egenskaper
(SPC)
31-05-2016
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Aktiva substanser:
ACYCLOVIR
Tillgänglig från:
GLAXOSMITHKLINE INC
ATC-kod:
J05AB01
INN (International namn):
ACYCLOVIR
Dos:
200MG
Läkemedelsform:
SUSPENSION
Sammansättning:
ACYCLOVIR 200MG
Administreringssätt:
ORAL
Enheter i paketet:
125ML
Receptbelagda typ:
Prescription
Terapiområde:
NUCLEOSIDES AND NUCLEOTIDES
Produktsammanfattning:
Active ingredient group (AIG) number: 0115506003; AHFS:
Bemyndigande status:
APPROVED
Tillstånd datum:
2001-08-07
Produktens egenskaper
_Page 1 of 39_
PRODUCT MONOGRAPH
PR
ZOVIRAX
®
Acyclovir Oral Suspension USP, 200 mg /5 mL
Antiviral Agent
GlaxoSmithKline Inc.
7333 Mississauga Road
Mississauga, Ontario
L5N 6L4
Date of Revision:
May 30, 2016
Submission Control No: 191703
_©_
_2016 GlaxoSmithKline Inc. All Rights Reserved _
_ZOVIRAX is a registered trademark of GlaxoSmithKline Inc. _
_Page 2 of 39_
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
..........................................................................15
CLINICAL TRIALS
..........................................................................................................15
DETALIL
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