IRBESARTAN TABLET

Country: Kanada

Bahasa: Inggeris

Sumber: Health Canada

Bahan aktif:

IRBESARTAN

Boleh didapati daripada:

JUBILANT GENERICS LIMITED

Kod ATC:

C09CA04

INN (Nama Antarabangsa):

IRBESARTAN

Dos:

75MG

Borang farmaseutikal:

TABLET

Komposisi:

IRBESARTAN 75MG

Laluan pentadbiran:

ORAL

Unit dalam pakej:

100

Jenis preskripsi:

Prescription

Kawasan terapeutik:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0131700001; AHFS:

Status kebenaran:

APPROVED

Tarikh kebenaran:

2012-10-25

Ciri produk

IMPORTANT: PLEASE READ
P r
Irbesartan
Page 1 of 34
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION
INFORMATION
PR
IRBESARTAN
Irbesartan Tablets
Tablets 75 mg, 150 mg and 300 mg, Oral
Manufacturer’s Standard
Angiotensin II AT
1
Receptor Blocker
Manufacturer:
Jubilant Generics Limited
1-A, Sector -16A, Institutional Area,
Noida -201301, Uttar Pradesh, India
Distributor:
Strides Pharma Canada Inc.1565 Boul. Lionel-
Boulet Varennes QC J3X 1P7
Submission Control Number: 259692
Date of Initial Authorization:
October 31, 2012
Date of Revision:
July 14, 2022
IMPORTANT: PLEASE READ
P r
Irbesartan
Page 2 of 34
RECENT MAJOR LABEL CHANGES
1 Indications, 1.1 Pediatrics
07/2022
1 Indications, 1.2 Geriatrics
07/2022
7 Warnings and Precautions
07/2022
8 Adverse Reactions, 8.2 Clinical Trial Adverse Reactions
07/2022
8 Adverse Reactions, 8.5 Post-Market Adverse Reactions
07/2022
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
3
1.
INDICATIONS………………………………………………………………...
3
1.1
PEDIATRICS_………...………………………………………………………_
3
1.2
GERIATRICS_………..………………………………………………………_
3
2.
CONTRAINDICATIONS
……………………………………………………
3
3.
SERIOUS WARNINGS AND PRECAUTIONS BOX…………………...
3
4.
DOSAGE AND
ADMINISTRATION……………………………………….
4
4.1 DOSING
CONSIDERATIONS……………………………………………….
4
4.2 RECOMMENDED DOSE AND DOSAGE ADJUSTMENT…………………...
4
4.4
ADMINISTRATION………………………………………………………….
5
4.5 MISSED
DOSE……………………………………………………………
5
5.
OVERDOSAG