MINT-LOSARTAN TABLET

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

LOSARTAN POTASSIUM

Tersedia dari:

MINT PHARMACEUTICALS INC

Kode ATC:

C09CA01

INN (Nama Internasional):

LOSARTAN

Dosis:

100MG

Bentuk farmasi:

TABLET

Komposisi:

LOSARTAN POTASSIUM 100MG

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: 0127971002; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2015-03-03

Karakteristik produk

MINT-LOSARTAN
_MINT-LOSARTAN(losartan _
_potassium) _
_Page 1 of 44_
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
MINT-LOSARTAN
Losartan Potassium Tablets
Tablets, 25 mg, 50 mg and 100 mg, Oral
House Standard
Angiotensin II Receptor Antagonist
MINT PHARMACEUTICALS INC.
6575 Davand Drive
Mississauga, ON Canada L5T 2M3
Date of Initial Authorization:
May 9, 2013
Date of Revision:
April 18, 2023
Submission Control Number: 269236
_MINT-LOSARTAN_
_ _
_(losartan potassium) _
_Page 2 of 44_
_ _
RECENT MAJOR LABEL CHANGES
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
..............................................................................................................................
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
................