COMBIGAN SOLUTION

Ülke: Kanada

Dil: İngilizce

Kaynak: Health Canada

Aktif bileşen:

BRIMONIDINE TARTRATE; TIMOLOL (TIMOLOL MALEATE)

Mevcut itibaren:

ABBVIE CORPORATION

ATC kodu:

S01ED51

INN (International Adı):

TIMOLOL, COMBINATIONS

Doz:

0.2%; 0.5%

Farmasötik formu:

SOLUTION

Kompozisyon:

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

Uygulama yolu:

OPHTHALMIC

Paketteki üniteler:

2.5/5/10ML

Reçete türü:

Prescription

Terapötik alanı:

ALPHA-ADRENERGIC AGONISTS

Ürün özeti:

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

Yetkilendirme durumu:

APPROVED

Yetkilendirme tarihi:

2022-10-06

Ürün özellikleri

_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