APO-PERINDOPRIL ARGININE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

PERINDOPRIL ARGININE

Pieejams no:

APOTEX INC

ATĶ kods:

C09AA04

SNN (starptautisko nepatentēto nosaukumu):

PERINDOPRIL

Deva:

2.5MG

Zāļu forma:

TABLET

Kompozīcija:

PERINDOPRIL ARGININE 2.5MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100/500/1000

Receptes veids:

Prescription

Ārstniecības joma:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produktu pārskats:

Active ingredient group (AIG) number: 0151321001; AHFS:

Autorizācija statuss:

APPROVED

Autorizācija datums:

2018-03-09

Produkta apraksts

_APO-PERINDOPRIL ARGININE PRODUCT MONOGRAPH _
_Page 1 of 68_
_ _
PRODUCT MONOGRAPH
PR
APO-PERINDOPRIL ARGININE
Perindopril Arginine Tablets
2.5 mg, 5 mg and 10 mg
Angiotensin Converting Enzyme Inhibitor
APOTEX INC.
DATE OF PREPARATION:
150 SIGNET DRIVE
April 24, 2019
TORONTO, ONTARIO
M9L 1T9
CONTROL NUMBER: 223805
_APO-PERINDOPRIL ARGININE PRODUCT MONOGRAPH _
_Page 2 of 68_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
...........................................................................................................
4
WARNINGS AND PRECAUTIONS
.........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
21
DOSAGE AND ADMINISTRATION
.....................................................................................
25
OVERDOSAGE
........................................................................................................................
27
ACTION AND CLINICAL PHARMACOLOGY
....................................................................
28
STORAGE AND STABILITY
.................................................................................................
32
SPECIAL HANDLING INSTRUCTIONS
...............................................................................
32
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 32
PART II: SCIENTIFIC INFORMATION
...............................................................................
34
PHARMACEUTICAL INFORM