COMBIGAN SOLUTION

Страна: Канада

мова: англійська

Джерело: Health Canada

Активний інгредієнт:

BRIMONIDINE TARTRATE; TIMOLOL (TIMOLOL MALEATE)

Доступна з:

ABBVIE CORPORATION

Код атс:

S01ED51

ІПН (Міжнародна Ім'я):

TIMOLOL, COMBINATIONS

Дозування:

0.2%; 0.5%

Фармацевтична форма:

SOLUTION

Склад:

BRIMONIDINE TARTRATE 0.2%; TIMOLOL (TIMOLOL MALEATE) 0.5%

Адміністрація маршрут:

OPHTHALMIC

Одиниць в упаковці:

2.5/5/10ML

Тип рецепту:

Prescription

Терапевтична области:

ALPHA-ADRENERGIC AGONISTS

Огляд продуктів:

Active ingredient group (AIG) number: 0249643001; AHFS:

Статус Авторизація:

APPROVED

Дата Авторизація:

2022-10-06

Характеристики продукта

_COMBIGAN (brimonidine tartrate and timolol) _
_Page 1 of 31 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
COMBIGAN®
brimonidine tartrate / timolol ophthalmic solution
Solution, brimonidine tartrate 0.2% w/v and timolol 0.5% w/v (as
timolol maleate), for ophthalmic use
Relatively Selective α2-adrenoceptor Agonist and β-adrenergic
Blocking Agent
(ATC Code: S01ED51)
Submission Control Number: 267372
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Date of Initial Authorization:
DEC
09, 2003
Date of Revision:
OCT
3,
2022
_COMBIGAN (brimonidine tartrate and timolol) _
_Page 2 of 31 _
_ _
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
........................................................ 5
4.3
Administrati