APO-FAMCICLOVIR TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
30-05-2017
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Werkstoffen:
FAMCICLOVIR
Beschikbaar vanaf:
APOTEX INC
ATC-code:
J05AB09
INN (Algemene Internationale Benaming):
FAMCICLOVIR
Dosering:
250MG
farmaceutische vorm:
TABLET
Samenstelling:
FAMCICLOVIR 250MG
Toedieningsweg:
ORAL
Eenheden in pakket:
30
Prescription-type:
Prescription
Therapeutisch gebied:
NUCLEOSIDES AND NUCLEOTIDES
Product samenvatting:
Active ingredient group (AIG) number: 0127885001; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2007-02-19
Productkenmerken
PRODUCT MONOGRAPH
APO-FAMCICLOVIR
FAMCICLOVIR TABLETS
125 MG, 250 MG AND 500 MG
ANTIVIRAL AGENT
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
MAY 24, 2017
WESTON, ONTARIO
M9L 1T9
_Control No. 204192_
_ _
Page 2 of 30
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
OVERDOSAGE
................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
............................................................ 11
STORAGE AND STABILITY
.........................................................................................
14
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................. 14
PART II: SCIENTIFIC INFORMATION
.............................................................................
15
PHARMACEUTICAL INFORMATION
.........................................................................
15
CLINICAL TRIALS
.........................................................................................................
16
TOXICOLOGY
.................................................................................................................
21
REFERENCES
...............
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