STEGLUJAN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

ERTUGLIFLOZIN; SITAGLIPTIN (SITAGLIPTIN PHOSPHATE)

Доступно од:

MERCK CANADA INC

АТЦ код:

A10BD

INN (Међународно име):

COMBINATIONS OF ORAL BLOOD GLUCOSE LOWERING DRUGS

Дозирање:

15MG; 100MG

Фармацеутски облик:

TABLET

Састав:

ERTUGLIFLOZIN 15MG; SITAGLIPTIN (SITAGLIPTIN PHOSPHATE) 100MG

Пут администрације:

ORAL

Јединице у пакету:

30

Тип рецептора:

Prescription

Терапеутска област:

DIPEPTIDYL PEPTIDASE-4 (DPP-4) INHIBITORS

Резиме производа:

Active ingredient group (AIG) number: 0260270002; AHFS:

Статус ауторизације:

CANCELLED POST MARKET

Датум одобрења:

2021-02-03

Карактеристике производа

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_STEGLUJAN_™_ (ertugliflozin and sitagliptin tablets)_
_ _
_Page 1 of 52 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
STEGLUJAN™
ertugliflozin and sitagliptin tablets
5 mg/100 mg and 15 mg/100 mg
ertugliflozin/sitagliptin (as sitagliptin phosphate), tablets, oral
ATC Code: A10BD24
Combinations of oral blood glucose lowering drugs
Merck Canada Inc.
16750 route Transcanadienne
Kirkland, QC Canada H9H 4M7
www.merck.ca
Date of Preparation:
May 22, 2018
Submission Control No: 201006
_ _
_STEGLUJAN_™_ (ertugliflozin and sitagliptin tablets)_
_ _
_Page 2 of 52 _
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
............................................................................................................
7
5
OVERDOSAGE
............