AURO-DAPAGLIFLOZIN TABLET

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

DAPAGLIFLOZIN

Prieinama:

AURO PHARMA INC

ATC kodas:

A10BK01

INN (Tarptautinis Pavadinimas):

DAPAGLIFLOZIN

Dozė:

10MG

Vaisto forma:

TABLET

Sudėtis:

DAPAGLIFLOZIN 10MG

Vartojimo būdas:

ORAL

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Produkto santrauka:

Active ingredient group (AIG) number: 0156370002; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

2023-05-16

Prekės savybės

AURO-DAPAGLIFLOZIN
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PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-DAPAGLIFLOZIN
Dapagliflozin Tablets
Tablets, 5 mg and 10 mg, Oral
Sodium-glucose co-transporter 2 (SGLT2) inhibitors
ATC Code: A10BK01
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
September 26, 2022
Submission Control Number: 260267
AURO-DAPAGLIFLOZIN
Page 2 of 71
RECENT MAJOR LABEL CHANGES
NA
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
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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
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5
3. SERIOUS WARNINGS AND PRECAUTIONS BOX
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5
4. DOSAGE AND ADMINISTRATION
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5
4.1 Dosing Considerations
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5
4.2 Recommended Dose and Dosage Adjustment
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