SANDOZ FENOFIBRATE E TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
17-11-2017
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
FENOFIBRATE
Fáanlegur frá:
SANDOZ CANADA INCORPORATED
ATC númer:
C10AB05
INN (Alþjóðlegt nafn):
FENOFIBRATE
Skammtar:
48.0MG
Lyfjaform:
TABLET
Samsetning:
FENOFIBRATE 48.0MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30
Gerð lyfseðils:
Prescription
Lækningarsvæði:
FRIBIC ACID DERIVATIVES
Vörulýsing:
Active ingredient group (AIG) number: 0118895005; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2012-08-02
Vara einkenni
_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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