PERINDOPRIL ERBUMINE/ INDAPAMIDE HD TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Viambatanisho vya kazi:

INDAPAMIDE; PERINDOPRIL ERBUMINE

Inapatikana kutoka:

SIVEM PHARMACEUTICALS ULC

ATC kanuni:

C09BA04

INN (Jina la Kimataifa):

PERINDOPRIL AND DIURETICS

Kipimo:

2.5MG; 8MG

Dawa fomu:

TABLET

Tungo:

INDAPAMIDE 2.5MG; PERINDOPRIL ERBUMINE 8MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30

Dawa ya aina:

Prescription

Eneo la matibabu:

ANGIOTENSIN-CONVERTING ENZYME INHIBITORS

Bidhaa muhtasari:

Active ingredient group (AIG) number: 0248401003; AHFS:

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2018-08-10

Tabia za bidhaa

_ _
_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
...............................