APO-GLICLAZIDE MR TABLET (EXTENDED-RELEASE)
Država: Kanada
Jezik: angleščina
Source: Health Canada
Lastnosti izdelka
(SPC)
27-12-2019
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Aktivna sestavina:
GLICLAZIDE
Dostopno od:
APOTEX INC
Koda artikla:
A10BB09
INN (mednarodno ime):
GLICLAZIDE
Odmerek:
30MG
Farmacevtska oblika:
TABLET (EXTENDED-RELEASE)
Sestava:
GLICLAZIDE 30MG
Pot uporabe:
ORAL
Enote v paketu:
100
Tip zastaranja:
Prescription
Terapevtsko območje:
SULFONYLUREAS
Povzetek izdelek:
Active ingredient group (AIG) number: 0119934002; AHFS:
Status dovoljenje:
APPROVED
Datum dovoljenje:
2008-06-04
Lastnosti izdelka
PRODUCT MONOGRAPH
Pr
APO-GLICLAZIDE MR
GLICLAZIDE
MODIFIED-RELEASE TABLETS
30 MG
MODIFIED-RELEASE BREAKABLE TABLETS
60 MG
Hypoglycemic sulfonylurea - Oral antidiabetic agent
APOTEX INC.
DATE OF REVISION:
150 SIGNET DRIVE
December 27, 2019
TORONTO ONTARIO
M9L 1T9
CONTROL NO: 233440
Page 2 of 43
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
............................................................................................................................
8
DRUG INTERACTIONS
..........................................................................................................................
12
DOSAGE AND ADMINISTRATION
......................................................................................................
15
OVERDOSAGE
.........................................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................................
17
STORAGE AND STABILITY
..................................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
................................................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
......................................................................
20
PART II: SCI
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