Country: Kanada
Lingwa: Ingliż
Sors: Health Canada
ACYCLOVIR
GLAXOSMITHKLINE INC
J05AB01
ACYCLOVIR
800MG
TABLET
ACYCLOVIR 800MG
ORAL
50
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0115506005; AHFS:
CANCELLED POST MARKET
2011-08-03
_2008-09-10/131-prisitne-english-zovirax.doc _ _ _ _Page 1 of 39_ PRODUCT MONOGRAPH PR ZOVIRAX ® Acyclovir Oral Suspension USP, 200 mg /5 mL Acyclovir Tablets USP, 200, 400, and 800 mg Antiviral Agent GlaxoSmithKline Inc. 7333 Mississauga Road Mississauga, Ontario L5N 6L4 Date of Revision: September 10, 2008 SUBMISSION CONTROL NUMBER: 123012 _©_ _ 2008 GlaxoSmithKline Inc. All Rights Reserved _ _®_ _ ZOVIRAX, WELLSTAT PAC and ZOSTAB PAC are registered trademarks, GlaxoSmithKline Inc. _ _2008-09-10/131-prisitne-english-zovirax.doc _ _ _ _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 ...............................................................................16 PHARMACEUTICAL INFORMATION.......................... Aqra d-dokument sħiħ