ALPHAGAN P SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

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Fachinformation Fachinformation (SPC)
25-08-2022

Wirkstoff:

BRIMONIDINE TARTRATE

Verfügbar ab:

ABBVIE CORPORATION

ATC-Code:

S01EA05

INN (Internationale Bezeichnung):

BRIMONIDINE

Dosierung:

0.15%

Darreichungsform:

SOLUTION

Zusammensetzung:

BRIMONIDINE TARTRATE 0.15%

Verabreichungsweg:

OPHTHALMIC

Einheiten im Paket:

3/5/10ML

Verschreibungstyp:

Prescription

Therapiebereich:

ALPHA-ADRENERGIC AGONISTS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2003-11-04

Fachinformation

                                _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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