ALPHAGAN P SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
25-08-2022
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Active ingredient:
BRIMONIDINE TARTRATE
Available from:
ABBVIE CORPORATION
ATC code:
S01EA05
INN (International Name):
BRIMONIDINE
Dosage:
0.15%
Pharmaceutical form:
SOLUTION
Composition:
BRIMONIDINE TARTRATE 0.15%
Administration route:
OPHTHALMIC
Units in package:
3/5/10ML
Prescription type:
Prescription
Therapeutic area:
ALPHA-ADRENERGIC AGONISTS
Product summary:
Active ingredient group (AIG) number: 0131859003; AHFS:
Authorization status:
APPROVED
Authorization date:
2003-11-04
Summary of Product characteristics
_ALPHAGAN P (brimonidine tartrate) _
_Page 1 of 26 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALPHAGAN P®
brimonidine tartrate ophthalmic solution
Solution, 0.15% 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: 266495
Date of Initial Authorization:
NOV 04, 2003
Date of Revision:
AUG
25, 2022
_ALPHAGAN P (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
.........................................................................................................
5
4.5
Missed Dose
...
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