COMBIGAN SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

BRIMONIDINE TARTRATE; TIMOLOL (TIMOLOL MALEATE)

Dostupné z:

ABBVIE CORPORATION

ATC kód:

S01ED51

INN (Medzinárodný Name):

TIMOLOL, COMBINATIONS

Dávkovanie:

0.2%; 0.5%

Forma lieku:

SOLUTION

Zloženie:

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

Spôsob podávania:

OPHTHALMIC

Počet v balení:

2.5/5/10ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ALPHA-ADRENERGIC AGONISTS

Prehľad produktov:

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

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2022-10-06

Súhrn charakteristických

_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