PRIVA-PERINDOPRIL ERBUMINE TABLET

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

PERINDOPRIL ERBUMINE

Disponible des:

NORA PHARMA INC

Codi ATC:

C09AA04

Designació comuna internacional (DCI):

PERINDOPRIL

Dosis:

2MG

formulario farmacéutico:

TABLET

Composición:

PERINDOPRIL ERBUMINE 2MG

Vía de administración:

ORAL

Unidades en paquete:

100

tipo de receta:

Prescription

Área terapéutica:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Resumen del producto:

Active ingredient group (AIG) number: 0127178001; AHFS:

Estat d'Autorització:

CANCELLED POST MARKET

Data d'autorització:

2022-07-25

Fitxa tècnica

_Priva-PERINDOPRIL ERBUMINE _
_Page 1 of 55 _
PRODUCT MONOGRAPH
PR PRIVA-PERINDOPRIL ERBUMINE
PERINDOPRIL ERBUMINE TABLETS, USP
2 MG, 4 MG AND 8 MG ANGIOTENSIN CONVERTING ENZYME INHIBITOR
NORA PHARMA INC.
1565, Lionel-Boulet Boul.
Varennes, Québec
J3X 1P7
CONTROL NUMBER: 264075
DATE OF PREPARATION:
May 31, 2022
_Priva-PERINDOPRIL ERBUMINE _
_Page 2 of 55 _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ............................................................. 3
SUMMARY PRODUCT INFORMATION
.............................................................................
3
INDICATIONS AND CLINICAL USE
..................................................................................
3
CONTRAINDICATIONS
........................................................................................................
4
WARNINGS AND PRECAUTIONS
......................................................................................
5
ADVERSE REACTIONS
......................................................................................................
13
DRUG INTERACTIONS
......................................................................................................
20
DOSAGE AND ADMINISTRATION
..................................................................................
22
OVERDOSAGE
.....................................................................................................................
24
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 25
STORAGE AND STABILITY
..............................................................................................
28
SPECIAL HANDLING INSTRUCTIONS
............................................................................
28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 29
PART II: SCIENTIFIC INFORMATION ...................................................................................
30
PHARMACEUTICAL INFORMATION
.........................................