ACT FAMCICLOVIR TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FAMCICLOVIR

Διαθέσιμο από:

TEVA CANADA LIMITED

Φαρμακολογική κατηγορία (ATC):

J05AB09

INN (Διεθνής Όνομα):

FAMCICLOVIR

Δοσολογία:

125MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

FAMCICLOVIR 125MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

10/30/100/500

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

NUCLEOSIDES AND NUCLEOTIDES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2014-11-05

Αρχείο Π.Χ.Π.

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
...................................................................................................