JAMP GLICLAZIDE-MR TABLET (EXTENDED-RELEASE)

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

GLICLAZIDE

Prieinama:

JAMP PHARMA CORPORATION

ATC kodas:

A10BB09

INN (Tarptautinis Pavadinimas):

GLICLAZIDE

Dozė:

60MG

Vaisto forma:

TABLET (EXTENDED-RELEASE)

Sudėtis:

GLICLAZIDE 60MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

100/500

Recepto tipas:

Prescription

Gydymo sritis:

SULFONYLUREAS

Produkto santrauka:

Active ingredient group (AIG) number: 0119934003; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2018-07-20

Prekės savybės

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JAMP GLICLAZIDE-MR_ _
_Page 1 of 44 _
PRODUCT MONOGRAPH
PR
_ _JAMP GLICLAZIDE-MR
GLICLAZIDE
Modified-release tablets
30 mg
Modified-release breakable tablets
60 mg
Hypoglycemic sulfonylurea - Oral antidiabetic agent
Jamp Pharma Corporation
1310 Nobel Street
Boucherville, Québec
J4B 5H3
Date of Preparation:
July 20, 2018
Submission Control No: 217140
_ _
JAMP GLICLAZIDE-MR_ _
_Page 2 of 44 _
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
....................................................................................................8
DRUG INTERACTIONS
..................................................................................................12
DOSAGE AND ADMINISTRATION
..............................................................................16
OVERDOSAGE
................................................................................................................17
ACTION AND CLINICAL PHARMACOLOGY
............................................................18
STORAGE AND STABILITY
..........................................................................................21
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................21
PART II: SCIENTIFIC INFORMATION
................................................................................23
PHARMACEUTICAL INFORMATION
..........................................................................23
CLINICAL TRIALS
......................................................................................