MYLAN-PERINDOPRIL/INDAPAMIDE TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

INDAPAMIDE; PERINDOPRIL ERBUMINE

Tersedia dari:

MYLAN PHARMACEUTICALS ULC

Kode ATC:

C09BA04

INN (Nama Internasional):

PERINDOPRIL AND DIURETICS

Dosis:

1.25MG; 4MG

Bentuk farmasi:

TABLET

Komposisi:

INDAPAMIDE 1.25MG; PERINDOPRIL ERBUMINE 4MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Ringkasan produk:

Active ingredient group (AIG) number: 0248401001; AHFS:

Status otorisasi:

CANCELLED PRE MARKET

Tanggal Otorisasi:

2023-06-07

Karakteristik produk

_Product Monograph _
_–_
_ Mylan-Perindopril/Indapamide _
_ Page 1 of 63_
PRODUCT MONOGRAPH
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(2 mg/0.625 mg) tablets
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(4 mg/1.25 mg) tablets
Pr
MYLAN-PERINDOPRIL/INDAPAMIDE
(8 mg/2.5 mg) tablets
(perindopril erbumine/indapamide)
Angiotensin Converting Enzyme Inhibitor / Diuretic
Mylan Pharmaceuticals ULC
85 Advance Road
Etobicoke, ON
M8Z 2S6
Date of Initial Approval:
March 07, 2018
Date of Revision:
July 5, 2022
Submission Control No.: 265136
_Product Monograph _
_–_
_ Mylan-Perindopril/Indapamide _
_ Page 2 of 63_
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
...........................................................................................................
16
DRUG INTERACTIONS
...........................................................................................................
23
DOSAGE AND ADMINISTRATION
..........................................................................................
29
OVERDOSAGE
........................................................................................................................
30
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................
31
STORAGE AND STABILITY
....................................................................................................
36
SPECIAL HANDLING INSTRUCTIONS
.............................................................