ALPHAGAN SOLUTION

País: Canadá

Língua: inglês

Origem: Health Canada

Ingredientes ativos:

BRIMONIDINE TARTRATE

Disponível em:

ABBVIE CORPORATION

Código ATC:

S01EA05

DCI (Denominação Comum Internacional):

BRIMONIDINE

Dosagem:

0.2%

Forma farmacêutica:

SOLUTION

Composição:

BRIMONIDINE TARTRATE 0.2%

Via de administração:

OPHTHALMIC

Unidades em pacote:

15G/50G

Tipo de prescrição:

Prescription

Área terapêutica:

ALPHA-ADRENERGIC AGONISTS

Resumo do produto:

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

Status de autorização:

APPROVED

Data de autorização:

1997-11-24

Características técnicas

_ALPHAGAN (brimonidine tartrate) _
_Page 1 of 26 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALPHAGAN®
brimonidine tartrate ophthalmic solution
Solution, 0.2% w/v, for ophthalmic use
Relatively Selective α
2
-Adrenoceptor Agonist
ATC Code: S01EA05
AbbVie Corporation
8401 Trans-Canada Highway
St-Laurent, Quebec
H4S 1Z1
Submission Control Number: 267088
Date of Initial Authorization:
NOV 24, 1997
Date of Revision:
SEP
29, 2022
_ALPHAGAN (brimonidine tartrate) _
_Page 2 of 26 _
_ _
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
........................................................ 4
4.4
Administration
.........................................................................................................
4
4.5
Missed Dose
..