Država: Kanada
Jezik: engleski
Izvor: Health Canada
ACYCLOVIR
GLAXOSMITHKLINE INC
J05AB01
ACYCLOVIR
200MG
SUSPENSION
ACYCLOVIR 200MG
ORAL
125ML
Prescription
NUCLEOSIDES AND NUCLEOTIDES
Active ingredient group (AIG) number: 0115506003; AHFS:
APPROVED
2001-08-07
_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 Pročitajte cijeli dokument