STEGLATRO TABLET

国家: 加拿大

语言: 英文

来源: Health Canada

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产品特点 产品特点 (SPC)
08-05-2018

有效成分:

ERTUGLIFLOZIN

可用日期:

MERCK CANADA INC

ATC代码:

A10BK04

INN(国际名称):

ERTUGLIFLOZIN

剂量:

5MG

药物剂型:

TABLET

组成:

ERTUGLIFLOZIN 5MG

给药途径:

ORAL

每包单位数:

7/14/30

处方类型:

Prescription

治疗领域:

Sodium-Glucose Cotransporter 2 (SGLT2) Inhibitors

產品總結:

Active ingredient group (AIG) number: 0160211001; AHFS:

授权状态:

CANCELLED POST MARKET

授权日期:

2021-02-03

产品特点

                                _STEGLATRO_™_ (ertugliflozin tablets) _
_Page 1 of 39 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
STEGLATRO™
ertugliflozin tablets
5 mg and 15 mg ertugliflozin, tablets, oral
ATC Code: A10BK04
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Date of Preparation:
May 8, 2018
Submission Control No: 204724
_STEGLATRO_™_ (ertugliflozin tablets) _
_Page 2 of 39 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................4
1
INDICATIONS
...................................................................................................................4
1.1
Pediatrics
.................................................................................................................
4
1.2
Geriatrics
.................................................................................................................
4
2
CONTRAINDICATIONS
.................................................................................................4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
...................................................5
4
DOSAGE AND ADMINISTRATION
..............................................................................5
4.1
Dosing Considerations
............................................................................................
5
4.2
Recommended Dose and Dosage Adjustment
........................................................ 5
4.3
Administration
.........................................................................................................
6
4.4
Reconstitution
..........................................................................................................
6
4.5
Missed Dose
............................................................................................................
6
5
OVERDOSAGE
.................................................................................................................7
6
DOSAGE FOR
                                
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