ZOVIRAX SUSPENSION
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
31-05-2016
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Aktívna zložka:
ACYCLOVIR
Dostupné z:
GLAXOSMITHKLINE INC
ATC kód:
J05AB01
INN (Medzinárodný Name):
ACYCLOVIR
Dávkovanie:
200MG
Forma lieku:
SUSPENSION
Zloženie:
ACYCLOVIR 200MG
Spôsob podávania:
ORAL
Počet v balení:
125ML
Typ predpisu:
Prescription
Terapeutické oblasti:
NUCLEOSIDES AND NUCLEOTIDES
Prehľad produktov:
Active ingredient group (AIG) number: 0115506003; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2001-08-07
Súhrn charakteristických
_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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