TEVA-SAXAGLIPTIN TABLET
国: カナダ
言語: 英語
ソース: Health Canada
製品の特徴
(SPC)
25-01-2021
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有効成分:
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE)
から入手可能:
TEVA CANADA LIMITED
ATCコード:
A10BH03
INN（国際名）:
SAXAGLIPTIN
投薬量:
2.5MG
医薬品形態:
TABLET
構図:
SAXAGLIPTIN (SAXAGLIPTIN HYDROCHLORIDE) 2.5MG
投与経路:
ORAL
パッケージ内のユニット:
30/100
処方タイプ:
Prescription
治療領域:
DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS
製品概要:
Active ingredient group (AIG) number: 0152653002; AHFS:
認証ステータス:
CANCELLED PRE MARKET
承認日:
2021-05-04
製品の特徴
PRODUCT MONOGRAPH
PR
TEVA-SAXAGLIPTIN
saxagliptin (as saxagliptin hydrochloride)
2.5 mg and 5 mg Tablets
Oral Antihyperglycemic Agent
DPP-4 inhibitor
Incretin Enhancer
Teva Canada Limited
Date of Revision;
30 Novopharm Court
January 25, 2021
Toronto, Ontario
M1B 2K9
Control No.: 247036
2
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
...................................................................................................
16
DOSAGE AND ADMINISTRATION
................................................................................
20
OVERDOSAGE
.................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
.............................................................. 21
STORAGE AND STABILITY
...........................................................................................
24
DOSAGE FORMS, COMPOSITION AND PACKAGING
................................................ 25
PART II: SCIENTIFIC INFORMATION
PHARMACEUTICAL
INFORMATION............................................................................
26
CLINICAL TRIALS
..........................................................................................................
26
DETAILED PHARMACOLOGY
......................................................................................
37
TOXICOLOGY
......................
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