COMBIGAN SOLUTION

Country: Kanada

Lingwa: Ingliż

Sors: Health Canada

Ingredjent attiv:

BRIMONIDINE TARTRATE; TIMOLOL (TIMOLOL MALEATE)

Disponibbli minn:

ABBVIE CORPORATION

Kodiċi ATC:

S01ED51

INN (Isem Internazzjonali):

TIMOLOL, COMBINATIONS

Dożaġġ:

0.2%; 0.5%

Għamla farmaċewtika:

SOLUTION

Kompożizzjoni:

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

Rotta amministrattiva:

OPHTHALMIC

Unitajiet fil-pakkett:

2.5/5/10ML

Tip ta 'preskrizzjoni:

Prescription

Żona terapewtika:

ALPHA-ADRENERGIC AGONISTS

Sommarju tal-prodott:

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

L-istatus ta 'awtorizzazzjoni:

APPROVED

Data ta 'l-awtorizzazzjoni:

2022-10-06

Karatteristiċi tal-prodott

_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