PHL-FAMCICLOVIR TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

FAMCICLOVIR

Verfügbar ab:

PHARMEL INC

ATC-Code:

J05AB09

INN (Internationale Bezeichnung):

FAMCICLOVIR

Dosierung:

125MG

Darreichungsform:

TABLET

Zusammensetzung:

FAMCICLOVIR 125MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

100

Verschreibungstyp:

Prescription

Therapiebereich:

NUCLEOSIDES AND NUCLEOTIDES

Produktbesonderheiten:

Active ingredient group (AIG) number: 0127885003; AHFS:

Berechtigungsstatus:

CANCELLED PRE MARKET

Berechtigungsdatum:

2017-09-13

Fachinformation

_ _
PRODUCT MONOGRAPH
Pr
PHL-FAMCICLOVIR
Famciclovir
125 mg, 250 mg and 500 mg Film-Coated Tablets
Antiviral Agent
PHARMEL INC.
6111 Royalmount Avenue, Suite #100
Montréal, Québec H4P 2T4
Date of Revision:
January 11, 2013
Submission Control No: 161288
_ _
_phl-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
OVERDOSAGE
...........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
11
STORAGE AND STABILITY
....................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 13
PART II: SCIENTIFIC INFORMATION
...................................................................................
15
PHARMACEUTICAL INFORMATION
..................................................................................
15
CLINICAL TRIALS
.........................................