PHL-FAMCICLOVIR TABLET
Land: Canada
Sprog: engelsk
Kilde: Health Canada
Produktets egenskaber
(SPC)
11-01-2013
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Aktiv bestanddel:
FAMCICLOVIR
Tilgængelig fra:
PHARMEL INC
ATC-kode:
J05AB09
INN (International Name):
FAMCICLOVIR
Dosering:
500MG
Lægemiddelform:
TABLET
Sammensætning:
FAMCICLOVIR 500MG
Indgivelsesvej:
ORAL
Enheder i pakken:
100
Recept type:
Prescription
Terapeutisk område:
NUCLEOSIDES AND NUCLEOTIDES
Produkt oversigt:
Active ingredient group (AIG) number: 0127885002; AHFS:
Autorisation status:
CANCELLED PRE MARKET
Autorisation dato:
2017-09-13
Produktets egenskaber
_ _
PRODUCT MONOGRAPH
Pr
PHL-FAMCICLOVIR
Famciclovir
125 mg, 250 mg and 500 mg Film-Coated Tablets
Antiviral Agent
PHARMEL INC.
6111 Royalmount Avenue, Suite #100
Montréal, Québec H4P 2T4
Date of Revision:
January 11, 2013
Submission Control No: 161288
_ _
_phl-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
OVERDOSAGE
...........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
11
STORAGE AND STABILITY
....................................................................................................
13
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 13
PART II: SCIENTIFIC INFORMATION
...................................................................................
15
PHARMACEUTICAL INFORMATION
..................................................................................
15
CLINICAL TRIALS
.........................................
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