ACT FAMCICLOVIR TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FAMCICLOVIR

Dostupno od:

TEVA CANADA LIMITED

ATC koda:

J05AB09

INN (International ime):

FAMCICLOVIR

Doziranje:

500MG

Farmaceutski oblik:

TABLET

Sastav:

FAMCICLOVIR 500MG

Administracija rute:

ORAL

Jedinice u paketu:

21/30/100/500

Tip recepta:

Prescription

Područje terapije:

NUCLEOSIDES AND NUCLEOTIDES

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2014-11-05

Svojstava lijeka

Page 1 of 31
PRODUCT MONOGRAPH
Pr
ACT FAMCICLOVIR
Famciclovir
125 mg, 250 mg and 500 mg Tablets
ANTIVIRAL AGENT
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario,
Canada, M1B 2K9
Submission Control Number: 241023
Date of Revision:
August 5, 2020
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
...................................................................................................
5
DRUG INTERACTIONS
...................................................................................................
9
DOSAGE AND ADMINISTRATION
.............................................................................
10
OVERDOSAGE
...............................................................................................................
12
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 12
STORAGE AND STABILITY
.........................................................................................
15
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
...............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................................................................................................
17
TOXICOLOGY
...................................................................................................