BRIMONIDINE P SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

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Fachinformation Fachinformation (SPC)
29-08-2023

Wirkstoff:

BRIMONIDINE TARTRATE

Verfügbar ab:

AA PHARMA INC

ATC-Code:

S01EA05

INN (Internationale Bezeichnung):

BRIMONIDINE

Dosierung:

0.15%

Darreichungsform:

SOLUTION

Zusammensetzung:

BRIMONIDINE TARTRATE 0.15%

Verabreichungsweg:

OPHTHALMIC

Einheiten im Paket:

5ML/10ML

Verschreibungstyp:

Prescription

Therapiebereich:

ALPHA-ADRENERGIC AGONISTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2008-07-15

Fachinformation

                                _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
...................................
                                
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Fachinformation Fachinformation Französisch 29-08-2023

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