ACT FAMCICLOVIR TABLET
Land: Canada
Taal: Engels
Bron: Health Canada
Productkenmerken
(SPC)
05-08-2020
Sommige documenten voor dit product zijn momenteel niet beschikbaar, u kunt een verzoek sturen naar onze klantenservice en we zullen u hiervan op de hoogte stellen zodra we ze kunnen verkrijgen.
Verzend verzoek.
Verzend verzoek.
Werkstoffen:
FAMCICLOVIR
Beschikbaar vanaf:
TEVA CANADA LIMITED
ATC-code:
J05AB09
INN (Algemene Internationale Benaming):
FAMCICLOVIR
Dosering:
125MG
farmaceutische vorm:
TABLET
Samenstelling:
FAMCICLOVIR 125MG
Toedieningsweg:
ORAL
Eenheden in pakket:
10/30/100/500
Prescription-type:
Prescription
Therapeutisch gebied:
NUCLEOSIDES AND NUCLEOTIDES
Product samenvatting:
Active ingredient group (AIG) number: 0127885003; AHFS:
Autorisatie-status:
APPROVED
Autorisatie datum:
2014-11-05
Productkenmerken
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
...................................................................................................
Lees het volledige document
