AURO-TELMISARTAN HCTZ TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

TELMISARTAN; HYDROCHLOROTHIAZIDE

Dostępny od:

AURO PHARMA INC

Kod ATC:

C09DA07

INN (International Nazwa):

TELMISARTAN AND DIURETICS

Dawkowanie:

80MG; 25MG

Forma farmaceutyczna:

TABLET

Skład:

TELMISARTAN 80MG; HYDROCHLOROTHIAZIDE 25MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100/500/1000

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Podsumowanie produktu:

Active ingredient group (AIG) number: 0244783002; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2016-07-18

Charakterystyka produktu

_Auro-Telmisartan HCTZ Product Monograph _Page 1 of 64
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-TELMISARTAN HCTZ
Telmisartan and Hydrochlorothiazide Tablets, USP
Tablet, 80 mg/12.5 mg and 80 mg/25 mg, Oral
Angiotensin II AT
1
Receptor Blocker/ Diuretic
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada
Date of initial Authorization:
July 18, 2016
Date of Revision:
January 26, 2023
Submission Control No: 267665
_Auro-Telmisartan HCTZ Product Monograph _Page 2 of 64
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
01 / 2023
7 WARNINGS AND PRECAUTIONS
01 / 2023
4 DOSAGE AND ADMINISTRATION
01 / 2023
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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4
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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