DOM-FAMCICLOVIR TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
16-05-2016
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Aktiv bestanddel:
FAMCICLOVIR
Tilgængelig fra:
DOMINION PHARMACAL
ATC-kode:
J05AB09
INN (International Name):
FAMCICLOVIR
Dosering:
125MG
Lægemiddelform:
TABLET
Sammensætning:
FAMCICLOVIR 125MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
NUCLEOSIDES AND NUCLEOTIDES
Produkt oversigt:
Active ingredient group (AIG) number: 0127885003; AHFS:
Autorisation status:
APPROVED
Autorisation dato:
2009-02-09
Produktets egenskaber
_ _
_Dom-FAMCICLOVIR Product Monograph_
_Page 1 of 28 _
PRODUCT MONOGRAPH
Pr
DOM-FAMCICLOVIR
Famciclovir Film-Coated Tablets
125 mg, 250 mg and 500 mg
ANTIVIRAL AGENT
DOMINION PHARMACAL
6111 Royalmount Ave., Suite 100
Montréal, Québec
H4P 2T4
DATE OF REVISION:
May 13, 2016
SUBMISSION CONTROL NO: 194100
_ _
_Dom-FAMCICLOVIR Product Monograph_
_Page 2 of 28 _
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
..............................................................................................................................................
5
DRUG INTERACTIONS
...............................................................................................................................................
8
DOSAGE AND ADMINISTRATION
...........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
.......................................................................................................
11
STORAGE AND STABILITY
....................................................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
........................................................................................
14
PART II: S
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