FAMVIR TABLET

Pajjiż: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

FAMCICLOVIR

Disponibbli minn:

ATNAHS PHARMA UK LIMITED

Kodiċi ATC:

J05AB09

INN (Isem Internazzjonali):

FAMCICLOVIR

Dożaġġ:

500MG

Għamla farmaċewtika:

TABLET

Kompożizzjoni:

FAMCICLOVIR 500MG

Rotta amministrattiva:

ORAL

Unitajiet fil-pakkett:

21

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

NUCLEOSIDES AND NUCLEOTIDES

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2001-01-18

Karatteristiċi tal-prodott

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
.................................................