LIPIDIL SUPRA TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

FENOFIBRATE

Pieejams no:

BGP PHARMA ULC

ATĶ kods:

C10AB05

SNN (starptautisko nepatentēto nosaukumu):

FENOFIBRATE

Deva:

160MG

Zāļu forma:

TABLET

Kompozīcija:

FENOFIBRATE 160MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30

Receptes veids:

Prescription

Ārstniecības joma:

FRIBIC ACID DERIVATIVES

Produktu pārskats:

Active ingredient group (AIG) number: 0118895004; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2000-03-02

Produkta apraksts

_Lipidil Supra_
®
_ Product Monograph _
_Page 1 of 40 _
_Date of Revision: January 13, 2017 and Control No. 198973 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
LIPIDIL SUPRA
®
fenofibrate, microcoated formulation
film-coated tablets (160 mg)
LIPID METABOLISM REGULATOR
BGP Pharma ULC
85 Advance Road
Etobicoke, Ontario
M8Z 2S6
Date of Revision:
January 13, 2017
Submission Control No.: 198973
® Lipidil Supra: Registered Trademark Fournier Industrie et Santé,
Suresnes, France; Licensed use by BGP Pharma ULC, Etobicoke, Ontario,
M8Z 2S6
_Lipidil Supra_
®
_ Product Monograph _
_Page 2 of 40 _
_Date of Revision: January 13, 2017 and Control No. 198973 _
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
...................................................................................................
9
DRUG INTERACTIONS
.................................................................................................
13
DOSAGE AND ADMINISTRATION
.............................................................................
18
OVERDOSAGE
...............................................................................................................
19
ACTION AND CLINICAL PHARMACOLOGY
........................................................... 19
STORAGE AND STABILITY
.........................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
............................................ 20
PART II: SCIENTIFIC INFORMATION
.........