SANDOZ PERINDOPRIL ERBUMINE/ INDAPAMIDE HD TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

PERINDOPRIL ERBUMINE; INDAPAMIDE

Saatavilla:

SANDOZ CANADA INCORPORATED

ATC-koodi:

C09BA04

INN (Kansainvälinen yleisnimi):

PERINDOPRIL AND DIURETICS

Annos:

8MG; 2.5MG

Lääkemuoto:

TABLET

Koostumus:

PERINDOPRIL ERBUMINE 8MG; INDAPAMIDE 2.5MG

Antoreitti:

ORAL

Kpl paketissa:

30

Prescription tyyppi:

Prescription

Terapeuttinen alue:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Tuoteyhteenveto:

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

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2017-12-12

Valmisteyhteenveto

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
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2
TABLE OF CONTENTS
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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3
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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4
DOSAGE AND ADMINISTRATION
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6
4.1
Dosing considerations
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