BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION

Држава: Канада

Језик: Енглески

Извор: Health Canada

Активни састојак:

BRIMONIDINE TARTRATE

Доступно од:

HIKMA CANADA LIMITED

АТЦ код:

S01EA05

INN (Међународно име):

BRIMONIDINE

Дозирање:

0.2%

Фармацеутски облик:

SOLUTION

Састав:

BRIMONIDINE TARTRATE 0.2%

Пут администрације:

OPHTHALMIC

Јединице у пакету:

15G/50G

Тип рецептора:

Prescription

Терапеутска област:

ALPHA-ADRENERGIC AGONISTS

Резиме производа:

Active ingredient group (AIG) number: 0131859001; AHFS:

Статус ауторизације:

APPROVED

Датум одобрења:

2022-05-25

Карактеристике производа

_Page 1 of 27_
_ _
_ Brimonidine Tartrate Ophthalmic Solution, 0.2% w/_v
Confidential
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
BRIMONIDINE TARTRATE OPHTHALMIC SOLUTION
0.2% w/v, for ophthalmic use
Relatively Selective α
2
-Adrenoceptor Agonist
ATC Code: S01EA05
Hikma Canada Limited
5995 Avebury Road, Suite 804
Mississauga, ON L5R 3P9
Date of Initial Authorization:
MAY 25, 2022
Date of Revision:
MAY 24, 2023
Submission Control Number: 274896
_Page 2 of 27_
_ _
_ Brimonidine Tartrate Ophthalmic Solution, 0.2% w/_v
Confidential
RECENT MAJOR LABEL CHANGES
None at the time of the most recent authorization.
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
4
DOSAGE AND ADMINISTRATION
.............................................................................................
4
4.1
Dosing Considerations
...........................................................................................................
4
4.2
Recommended Dose and Dosage Adjustment
........................................