BRIMONIDINE P SOLUTION

Pays: Canada

Langue: anglais

Source: Health Canada

Ingrédients actifs:

BRIMONIDINE TARTRATE

Disponible depuis:

AA PHARMA INC

Code ATC:

S01EA05

DCI (Dénomination commune internationale):

BRIMONIDINE

Dosage:

0.15%

forme pharmaceutique:

SOLUTION

Composition:

BRIMONIDINE TARTRATE 0.15%

Mode d'administration:

OPHTHALMIC

Unités en paquet:

5ML/10ML

Type d'ordonnance:

Prescription

Domaine thérapeutique:

ALPHA-ADRENERGIC AGONISTS

Descriptif du produit:

Active ingredient group (AIG) number: 0131859003; AHFS:

Statut de autorisation:

APPROVED

Date de l'autorisation:

2008-07-15

Résumé des caractéristiques du produit

_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) _
_Page 2 of 30 _
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
4.4 Administration
...................................