FAMCICLOVIR TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
29-07-2016
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Werkstoffen:
FAMCICLOVIR
Beschikbaar vanaf:
PRO DOC LIMITEE
ATC-code:
J05AB09
INN (Algemene Internationale Benaming):
FAMCICLOVIR
Dosering:
125MG
farmaceutische vorm:
TABLET
Samenstelling:
FAMCICLOVIR 125MG
Toedieningsweg:
ORAL
Eenheden in pakket:
10
Prescription-type:
Prescription
Therapeutisch gebied:
NUCLEOSIDES AND NUCLEOTIDES
Product samenvatting:
Active ingredient group (AIG) number: 0127885003; AHFS:
Autorisatie-status:
CANCELLED POST MARKET
Autorisatie datum:
2018-04-13
Productkenmerken
_ _
_FAMCICLOVIR Product Monograph_
_Page 1 of 28 _
PRODUCT MONOGRAPH
Pr
FAMCICLOVIR
Famciclovir Film-Coated Tablets
125 mg, 250 mg and 500 mg
ANTIVIRAL AGENT
PRO DOC LTÉE
2925, Boul. Industriel
Laval, Quebec
H7L 3W9
DATE OF REVISION:
July 28, 2016
SUBMISSION CONTROL NO: 196566
_ _
_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: SCIENTIFIC INFORMATION
........
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