TEVA-FEBUXOSTAT TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE)

Pieejams no:

TEVA CANADA LIMITED

ATĶ kods:

M04AA03

SNN (starptautisko nepatentēto nosaukumu):

FEBUXOSTAT

Deva:

80MG

Zāļu forma:

TABLET

Kompozīcija:

FEBUXOSTAT (FEBUXOSTAT HEMIHYDRATE) 80MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100

Receptes veids:

Prescription

Ārstniecības joma:

ANTIGOUT AGENTS

Produktu pārskats:

Active ingredient group (AIG) number: 0152809001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2019-04-23

Produkta apraksts

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_TEVA-FEBUXOSTAT _
_Page 1 of 32 _
PRODUCT MONOGRAPH
PR
TEVA-FEBUXOSTAT
Febuxostat Tablets
80 mg febuxostat (as febuxostat hemihydrate)
Preparations Inhibiting Uric Acid Production
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada, M1B 2K9
Date of Revision:
January 27, 2020
Submission Control No: 234067
_ _
_TEVA-FEBUXOSTAT _
_Page 2 of 32 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................3
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................7
DRUG INTERACTIONS
..................................................................................................11
DOSAGE AND ADMINISTRATION
..............................................................................14
OVERDOSAGE
................................................................................................................14
ACTION AND CLINICAL PHARMACOLOGY
............................................................15
STORAGE AND STABILITY
..........................................................................................17
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................17
PART II: SCIENTIFIC INFORMATION
................................................................................18
PHARMACEUTICAL INFORMATION
..........................................................................18
CLINICAL TRIALS
..........................................................................................................19
DETAILED PHARMA