ZOVIRAX 400 TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

ACYCLOVIR

Διαθέσιμο από:

GLAXOSMITHKLINE INC

Φαρμακολογική κατηγορία (ATC):

J05AB01

INN (Διεθνής Όνομα):

ACYCLOVIR

Δοσολογία:

400MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

ACYCLOVIR 400MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

56

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

NUCLEOSIDES AND NUCLEOTIDES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0115506004; AHFS:

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2014-02-20

Αρχείο Π.Χ.Π.

_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..........................