ZOVIRAX SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

ACYCLOVIR

זמין מ:

GLAXOSMITHKLINE INC

קוד ATC:

J05AB01

INN (שם בינלאומי):

ACYCLOVIR

כמות:

200MG

טופס פרצבטיות:

SUSPENSION

הרכב:

ACYCLOVIR 200MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

125ML

סוג מרשם:

Prescription

איזור תרפויטי:

NUCLEOSIDES AND NUCLEOTIDES

leaflet_short:

Active ingredient group (AIG) number: 0115506003; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2001-08-07

מאפייני מוצר

_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