FAMVIR TABLET

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

FAMCICLOVIR

Dostupné z:

ATNAHS PHARMA UK LIMITED

ATC kód:

J05AB09

INN (Medzinárodný Name):

FAMCICLOVIR

Dávkovanie:

500MG

Forma lieku:

TABLET

Zloženie:

FAMCICLOVIR 500MG

Spôsob podávania:

ORAL

Počet v balení:

21

Typ predpisu:

Prescription

Terapeutické oblasti:

NUCLEOSIDES AND NUCLEOTIDES

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2001-01-18

Súhrn charakteristických

PRODUCT MONOGRAPH
PR
FAMVIR
®
(famciclovir)
125mg, 250 mg and 500 mg film-coated Tablets
ANTIVIRAL AGENT
Atnahs Pharma UK Limited
Sovereign House, Miles Gray Road
Basildon, Essex
United Kingdom, SS14 3FR
DATE OF REVISION:
February 21, 2020
SUBMISSION CONTROL NO.: 234680
FAMVIR is a registered trademark
Page 2 of 31
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
.................................................................................................
10
DOSAGE AND ADMINISTRATION
.............................................................................
11
OVERDOSAGE
...............................................................................................................
13
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 13
STORAGE AND STABILITY
.........................................................................................
16
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 16
PART II: SCIENTIFIC INFORMATION
..............................................................................
17
PHARMACEUTICAL INFORMATION
.........................................................................
17
CLINICAL TRIALS
.........................................................................................................
18
TOXICOLOGY
.................................................