SANDOZ FENOFIBRATE E TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

FENOFIBRATE

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

C10AB05

INN (Διεθνής Όνομα):

FENOFIBRATE

Δοσολογία:

145.0MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

FENOFIBRATE 145.0MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

FRIBIC ACID DERIVATIVES

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0118895006; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2012-08-02

Αρχείο Π.Χ.Π.

_Sandoz Fenofibrate E Page 1 of 43_
PRODUCT MONOGRAPH
PR
SANDOZ FENOFIBRATE E
Fenofibrate tablets
48 mg and 145 mg
Manufacturer’s standard
Lipid Metabolism Regulator
Sandoz Canada Inc. Date of Revision: November 17, 2017
145 Jules-Léger
Boucherville, QC, Canada
J4B 7K8
Submission Control No: 204109
_ _
_Sandoz Fenofibrate E Page 2 of 43_
TABLE OF CONTENTS
PART 1: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................9
DRUG INTERACTIONS
..................................................................................................13
DOSAGE AND ADMINISTRATION
..............................................................................17
OVERDOSAGE
................................................................................................................18
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................20
PART II: SCIENTIFIC INFORMATION
................................................................................22
PHARMACEUTICAL INFORMATION
..........................................................................22
CLINICAL TRIALS
..........................................................................................................23
DETAILED PHARMACOLOGY
............