NRA-DAPAGLIFLOZIN TABLET

Страна: Канада

Език: английски

Източник: Health Canada

Активна съставка:

DAPAGLIFLOZIN

Предлага се от:

NORA PHARMA INC

АТС код:

A10BK01

INN (Международно Name):

DAPAGLIFLOZIN

дозиране:

5MG

Лекарствена форма:

TABLET

Композиция:

DAPAGLIFLOZIN 5MG

Начин на приложение:

ORAL

Броя в опаковка:

15G/50G

Вид предписание :

Prescription

Каталог на резюме:

Active ingredient group (AIG) number: 0156370001; AHFS:

Статус Оторизация:

APPROVED

Дата Оторизация:

2023-05-24

Данни за продукта

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_NRA-DAPAGLIFLOZIN (Dapagliflozin Tablets, 5 mg and 10 mg) _
_Page 1 of 70 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
P R
NRA-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
ATC Code: A10BK01
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
Nora Pharma Inc.
1565 Lionel-Boulet Blvd.
Varennes, Québec
J3X 1P7
Date of Preparation:
May 24, 2023
Submission Control Number: 275085
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_NRA-DAPAGLIFLOZIN (Dapagliflozin Tablets, 5 mg and 10 mg) _
_Page 2 of 70 _
RECENT MAJOR LABEL CHANGES
NOT APPLICABLE.
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
RECENT MAJOR LABEL CHANGES
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................. 4
1 INDICATIONS
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4
1.1 Pediatrics
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4
1.2 Geriatrics
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4
2
CONTRAINDICATIONS...........................................................................................................
5
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................ 5
4 DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
...............................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.......................................................... 6
4.5 Missed Dose
.......................