SANDOZ FAMCICLOVIR TABLET

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

FAMCICLOVIR

Dostupno od:

SANDOZ CANADA INCORPORATED

ATC koda:

J05AB09

INN (International ime):

FAMCICLOVIR

Doziranje:

125MG

Farmaceutski oblik:

TABLET

Sastav:

FAMCICLOVIR 125MG

Administracija rute:

ORAL

Jedinice u paketu:

10

Tip recepta:

Prescription

Područje terapije:

NUCLEOSIDES AND NUCLEOTIDES

Proizvod sažetak:

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

Status autorizacije:

CANCELLED POST MARKET

Datum autorizacije:

2023-11-02

Svojstava lijeka

_Sandoz Famcilovir _
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_Page 1 of 29 _
PRODUCT MONOGRAPH
PR SANDOZ FAMCICLOVIR
(famciclovir)
125mg, 250 mg and 500 mg film-coated Tablets
ANTIVIRAL AGENT
Sandoz Canada Inc.
145 Jules-Léger
Boucherville, Quebec
J4B 7K8
Date of Revision:
December 19, 2016
Submission Control No: 200396
_Sandoz Famcilovir _
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_Page 2 of 29 _
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
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 15
PART II: SCIENTIFIC INFORMATION
..............................................................................
16
PHARMACEUTICAL INFORMATION
.........................................................................
16
CLINICAL TRIALS
.........................................................................................................
17
TOXICOLOGY
......................................