AURO-TELMISARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

TELMISARTAN

Tersedia dari:

AURO PHARMA INC

Kode ATC:

C09CA07

INN (Nama Internasional):

TELMISARTAN

Dosis:

40MG

Bentuk farmasi:

TABLET

Komposisi:

TELMISARTAN 40MG

Rute administrasi :

ORAL

Unit dalam paket:

30/100/500

Jenis Resep:

Prescription

Area terapi:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Ringkasan produk:

Active ingredient group (AIG) number: 0138223001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2016-04-04

Karakteristik produk

AURO-TELMISARTAN Product Monograph
Page 1 of 39
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
AURO-TELMISARTAN
Telmisartan Tablets, USP
Tablets, 40 mg and 80 mg, Oral
Angiotensin II AT1 Receptor Blocker
Auro Pharma Inc.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Initial Authorization:
April 04, 2016
Date of Revision:
June 02, 2023
Submission Control Number: 270620
AURO-TELMISARTAN Product Monograph
Page 2 of 39
RECENT MAJOR LABEL CHANGES
2 CONTRAINDICATIONS
06/2023
7 WARNINGS AND PRECAUTIONS
06/2023
TABLE OF CONTENTS
SECTIONS OR SUBSECTIONS THAT ARE NOT APPLICABLE AT THE TIME OF
AUTHORIZATION ARE NOT LISTED.
TABLE OF
CONTENTS…………………………………………………………………………………………..…………………2
PART I: HEALTH PROFESSIONAL INFORMATION
.................................................................... 4
1 INDICATIONS
.....................................................................................................................
4
1.1
Pediatrics.......................................................................................................................
4
1.2 Geriatrics
.......................................................................................................................
4
2 CONTRAINDICATIONS
........................................................................................................
4
3 SERIOUS WARNINGS AND PRECAUTIONS BOX
................................................................... 5
4 DOSAGE AND ADMINISTRATION
........................................................................................
5
4.1 Dosing Considerations
...................................................................................................
5
4.2 Recommended Dose and Dosage Adjustment
.............................................................. 5
4.4 Administration
.......................................................................................................