BRIMONIDINE P SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
29-08-2023
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Active ingredient:
BRIMONIDINE TARTRATE
Available from:
AA PHARMA INC
ATC code:
S01EA05
INN (International Name):
BRIMONIDINE
Dosage:
0.15%
Pharmaceutical form:
SOLUTION
Composition:
BRIMONIDINE TARTRATE 0.15%
Administration route:
OPHTHALMIC
Units in package:
5ML/10ML
Prescription type:
Prescription
Therapeutic area:
ALPHA-ADRENERGIC AGONISTS
Product summary:
Active ingredient group (AIG) number: 0131859003; AHFS:
Authorization status:
APPROVED
Authorization date:
2008-07-15
Summary of Product characteristics
_BRIMONIDINE P (Brimonidine Tartrate ophthalmic solution) _
_Page 1 of 30 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
BRIMONIDINE P
Brimonidine Tartrate ophthalmic solution
Sterile Solution, 0.15% w/v, for ophthalmic use
Relatively Selective α
2
-Adrenoceptor Agonist
ATC code: S01EA05
AA PHARMA INC
1165 Creditstone Road, Unit #1
Vaughan, Ontario
L4K 4N7
Date of Initial Authorization:
July 15, 2008
Date of Revision:
August 29, 2023
Submission Control Number: 273876
_BRIMONIDINE P (Brimonidine Tartrate ophthalmic solution) _
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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
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2
PART I: HEALTH PROFESSIONAL INFORMATION
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4
1
INDICATIONS
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4
1.1
Pediatrics
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4
1.2
Geriatrics
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4
2
CONTRAINDICATIONS
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4
4
DOSAGE AND ADMINISTRATION
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4
4.1 Dosing Considerations
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4
4.2 Recommended Dose and Dosage Adjustment
................................................................. 5
4.4 Administration
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