SANDOZ FENOFIBRATE E TABLET
Krajina: Kanada
Jazyk: angličtina
Zdroj: Health Canada
Súhrn charakteristických
(SPC)
17-11-2017
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Aktívna zložka:
FENOFIBRATE
Dostupné z:
SANDOZ CANADA INCORPORATED
ATC kód:
C10AB05
INN (Medzinárodný Name):
FENOFIBRATE
Dávkovanie:
145.0MG
Forma lieku:
TABLET
Zloženie:
FENOFIBRATE 145.0MG
Spôsob podávania:
ORAL
Počet v balení:
30
Typ predpisu:
Prescription
Terapeutické oblasti:
FRIBIC ACID DERIVATIVES
Prehľad produktov:
Active ingredient group (AIG) number: 0118895006; AHFS:
Stav Autorizácia:
APPROVED
Dátum Autorizácia:
2012-08-02
Súhrn charakteristických
_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
............
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