DOM-FAMCICLOVIR TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FAMCICLOVIR

Dostupno od:

DOMINION PHARMACAL

ATC koda:

J05AB09

INN (International ime):

FAMCICLOVIR

Doziranje:

500MG

Farmaceutski oblik:

TABLET

Sastav:

FAMCICLOVIR 500MG

Administracija rute:

ORAL

Jedinice u paketu:

100

Tip recepta:

Prescription

Područje terapije:

NUCLEOSIDES AND NUCLEOTIDES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2009-02-09

Svojstava lijeka

_ _
_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