AG-PERINDOPRIL ERBUMINE TABLET

Maa: Kanada

Kieli: englanti

Lähde: Health Canada

Aktiivinen ainesosa:

PERINDOPRIL ERBUMINE

Saatavilla:

ANGITA PHARMA INC.

ATC-koodi:

C09AA04

INN (Kansainvälinen yleisnimi):

PERINDOPRIL

Annos:

4MG

Lääkemuoto:

TABLET

Koostumus:

PERINDOPRIL ERBUMINE 4MG

Antoreitti:

ORAL

Kpl paketissa:

15G/50G

Prescription tyyppi:

Prescription

Tuoteyhteenveto:

Active ingredient group (AIG) number: 0127178002; AHFS:

Valtuutuksen tilan:

APPROVED

Valtuutus päivämäärä:

2022-07-27

Valmisteyhteenveto

_AG-Perindopril Erbumine (Perindopril Erbumine Tablets USP) Product
Monograph Page 1 of 74 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AG-PERINDOPRIL ERBUMINE
Perindopril Erbumine Tablets
Tablets, 2 mg, 4 mg and 8 mg, Oral
USP
Angiotensin Converting Enzyme Inhibitor
Angita Pharma Inc.
1310 rue Nobel
Boucherville, Quebec
J4B 5H3, Canada
Submission Control Number: 278379
Date of Initial Authorization:
JUL
27,
2022
Date of Revision:
SEP 22, 2023
_AG-Perindopril Erbumine (Perindopril Erbumine Tablets USP) Product
Monograph Page 2 of 74 _
_ _
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
09/2023
7 WARNING AND PRECAUTIONS
09/2023
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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5
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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6
4.2 Recommended Dose and Dosage Adjustment
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