OLMESARTAN TABLET

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

OLMESARTAN MEDOXOMIL

Доступно од:

JUBILANT GENERICS LIMITED

АТЦ код:

C09CA08

INN (Међународно име):

OLMESARTAN MEDOXOMIL

Дозирање:

40MG

Фармацеутски облик:

TABLET

Састав:

OLMESARTAN MEDOXOMIL 40MG

Пут администрације:

ORAL

Јединице у пакету:

30/100/1000

Тип рецептора:

Prescription

Терапеутска област:

ANGIOTENSIN II RECEPTOR ANTAGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0152496003; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2017-05-01

Карактеристике производа

_PR_
_ OLMESARTAN_
Page 1 of 27
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
OLMESARTAN
Olmesartan Medoxomil
Tablets
Tablets, 20 mg and 40 mg Oral
Angiotensin II AT
1
Receptor Blocker
MANUFACTURER:
Jubilant Generics Limited
1-A, Sector -16A, Institutional Area,
Noida -201301, Uttar Pradesh, India
DISTRIBUTOR:
JAMP Pharma Corporation,
1310 rue Nobel, Boucherville,
QC, Canada, J4B 5H3
SUBMISSION CONTROL NO: 254847
DATE OF INITIAL AUTHORIZATION:
May 01, 2017
DATE OF REVISION
December 13, 2021
_PR_
_ OLMESARTAN_
Page 2 of 27
RECENT MAJOR LABEL CHANGES
2 Contraindications, Pregnancy and Breastfeeding
12/2021
7 Warnings and Precautions, 7.1 Special Populations, Pregnant women
12/2021
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 4
1.
INDICATIONS
..........................................................................................................
4
Pediatrics......................................................................................................................
4
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
........................................................... 6
4.3
Reconstitution..........................................................................................................
6
4.4
Administration
.........................................................................................................
6
4.5
Missed Dose
.......................................