ALPHAGAN SOLUTION

País: Canadà

Idioma: anglès

Font: Health Canada

ingredients actius:

BRIMONIDINE TARTRATE

Disponible des:

ABBVIE CORPORATION

Codi ATC:

S01EA05

Designació comuna internacional (DCI):

BRIMONIDINE

Dosis:

0.2%

formulario farmacéutico:

SOLUTION

Composición:

BRIMONIDINE TARTRATE 0.2%

Vía de administración:

OPHTHALMIC

Unidades en paquete:

15G/50G

tipo de receta:

Prescription

Área terapéutica:

ALPHA-ADRENERGIC AGONISTS

Resumen del producto:

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

Estat d'Autorització:

APPROVED

Data d'autorització:

1997-11-24

Fitxa tècnica

_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
..