APO-PERINDOPRIL ARGININE TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

PERINDOPRIL ARGININE

Διαθέσιμο από:

APOTEX INC

Φαρμακολογική κατηγορία (ATC):

C09AA04

INN (Διεθνής Όνομα):

PERINDOPRIL

Δοσολογία:

5MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

PERINDOPRIL ARGININE 5MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30/100/500/1000

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Περίληψη προϊόντος:

Active ingredient group (AIG) number: 0151321002; AHFS:

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2018-03-09

Αρχείο Π.Χ.Π.

_APO-PERINDOPRIL ARGININE PRODUCT MONOGRAPH _
_Page 1 of 68_
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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_
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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