PERINDOPRIL ERBUMINE/ INDAPAMIDE TABLET

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

INDAPAMIDE; PERINDOPRIL ERBUMINE

Pieejams no:

SIVEM PHARMACEUTICALS ULC

ATĶ kods:

C09BA04

SNN (starptautisko nepatentēto nosaukumu):

PERINDOPRIL AND DIURETICS

Deva:

1.25MG; 4MG

Zāļu forma:

TABLET

Kompozīcija:

INDAPAMIDE 1.25MG; PERINDOPRIL ERBUMINE 4MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100

Receptes veids:

Prescription

Ārstniecības joma:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2018-08-10

Produkta apraksts

_ _
_Product Monograph_: _PERINDOPRIL ERBUMINE / INDAPAMIDE and
PERINDOPRIL ERBUMINE / INDAPAMIDE HD_
_ _
_Page 1 of 64_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
PERINDOPRIL ERBUMINE / INDAPAMIDE
Tablets, 4 mg / 1.25 mg Oral
Pr
PERINDOPRIL ERBUMINE / INDAPAMIDE HD
Tablets, 8 mg / 2.5 mg Oral
perindopril erbumine / indapamide
Angiotensin Converting Enzyme Inhibitor / Diuretic
Sivem Pharmaceuticals ULC
4705 Dobrin Street
Saint-Laurent, Quebec, Canada
H4R 2P7
www.sivem.ca
DATE OF INITIAL AUTHORIZATION:
August 10, 2018
DATE OF REVISION:
August 11, 2023
Submission Control Number: 272698
_ _
_Product Monograph_: _PERINDOPRIL ERBUMINE / INDAPAMIDE and
PERINDOPRIL ERBUMINE / INDAPAMIDE HD_
_ _
_Page 2 of 64_
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
08/2023
7 WARNING AND PRECAUTIONS
08/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED
.
RECENT MAJOR LABEL CHANGES
..........................................................................................
2
TABLE OF CONTENTS
............................................................................................................
2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1
INDICATIONS
.............................................................................................................
4
1.1
Pediatrics (< 18 years of age)
...................................................................................
4
1.2
Geriatrics (> 65 years of age)
...................................................................................
4
2
CONTRAINDICATIONS
................................................................................................
4
3
SERIOUS WARNINGS AND PRECAUTIONS BOX
........................................................... 5
4
DOSAGE AND ADMINISTRATION
................................................................................
5
4.1
Dosing Considerations
...............................