DOM-FAMCICLOVIR TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FAMCICLOVIR

Verfügbar ab:

DOMINION PHARMACAL

ATC-Code:

J05AB09

INN (Internationale Bezeichnung):

FAMCICLOVIR

Dosierung:

500MG

Darreichungsform:

TABLET

Zusammensetzung:

FAMCICLOVIR 500MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

NUCLEOSIDES AND NUCLEOTIDES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0127885002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2009-02-09

Fachinformation

_ _
_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