SANDOZ PERINDOPRIL ERBUMINE/ INDAPAMIDE LD TABLET

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

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24-05-2023

Wirkstoff:

PERINDOPRIL ERBUMINE; INDAPAMIDE

Verfügbar ab:

SANDOZ CANADA INCORPORATED

ATC-Code:

C09BA04

INN (Internationale Bezeichnung):

PERINDOPRIL AND DIURETICS

Dosierung:

2MG; 0.625MG

Darreichungsform:

TABLET

Zusammensetzung:

PERINDOPRIL ERBUMINE 2MG; INDAPAMIDE 0.625MG

Verabreichungsweg:

ORAL

Einheiten im Paket:

30

Verschreibungstyp:

Prescription

Therapiebereich:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produktbesonderheiten:

Active ingredient group (AIG) number: 0248401002; AHFS:

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-12-12

Fachinformation

                                PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
SANDOZ
® PERINDOPRIL ERBUMINE / INDAPAMIDE LD
2 mg / 0.625 mg tablets
Pr
SANDOZ
® PERINDOPRIL ERBUMINE / INDAPAMIDE
4 mg / 1.25 mg tablets
Pr
SANDOZ
® PERINDOPRIL ERBUMINE / INDAPAMIDE HD
8 mg / 2.5 mg tablets
(perindopril erbumine / indapamide)
Angiotensin Converting Enzyme Inhibitor / Diuretic
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC, Canada
J4B 1E6
Date of Initial
Authorization:
December 12, 2017
Date of Revision:
May 24, 2023
Submission Control No.: 270365
_ _
_Sandoz Perindopril Erbumine / Indapamide LD, _
_Sandoz Perindopril Erbumine / Indapamide and Sandoz Perindopril
Erbumine / Indapamide HD _
_Page 2 of 76_
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
.............................................................................................
2
TABLE OF CONTENTS
................................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.......................................................................
3
1
INDICATIONS
................................................................................................................
4
1.1
Pediatrics (<18 years of age
.....................................................................................
4
1.2
Geriatrics (>65 years of age)
....................................................................................
4
2
CONTRAINDICATIONS
...................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
.............................................................. 5
4
DOSAGE AND ADMINISTRATION
..................................................................................
6
4.1
Dosing considerations
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