TEVA-PERINDOPRIL/INDAPAMIDE TABLET

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

PERINDOPRIL ERBUMINE; INDAPAMIDE

Tilgjengelig fra:

TEVA CANADA LIMITED

ATC-kode:

C09BA04

INN (International Name):

PERINDOPRIL AND DIURETICS

Dosering :

8MG; 2.5MG

Legemiddelform:

TABLET

Sammensetning:

PERINDOPRIL ERBUMINE 8MG; INDAPAMIDE 2.5MG

Administreringsrute:

ORAL

Enheter i pakken:

30/100

Resept typen:

Prescription

Terapeutisk område:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produkt oppsummering:

Active ingredient group (AIG) number: 0248401003; AHFS:

Autorisasjon status:

APPROVED

Autorisasjon dato:

2018-03-07

Preparatomtale

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_Teva-Perindopril/Indapamide Page 1 of 73 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
TEVA-PERINDOPRIL/INDAPAMIDE
Perindopril Erbumine and Indapamide Tablets
Tablets, 2 mg/0.625 mg, 4 mg/1.25 mg and 8 mg/2.5 mg, Oral
Angiotensin converting enzyme inhibitor / Diuretic
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
Canada M1B 2K9
Date of Initial Authorization:
MAR 07, 2018
Date of Revision:
MAY 02, 2023
www.tevacanada.com
Submission Control Number:
270126
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_Teva-Perindopril/Indapamide Page 2 of 73 _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
05/2023
7 WARNING AND PRECAUTIONS
05/2023
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 (<18 years of age)
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4
1.2 Geriatrics (> 65 years of age)
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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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6
4.1 Dosing Considerations
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