ALPHAGAN SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

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Parsisiųsti Prekės savybės (SPC)
29-09-2022

Veiklioji medžiaga:

BRIMONIDINE TARTRATE

Prieinama:

ABBVIE CORPORATION

ATC kodas:

S01EA05

INN (Tarptautinis Pavadinimas):

BRIMONIDINE

Dozė:

0.2%

Vaisto forma:

SOLUTION

Sudėtis:

BRIMONIDINE TARTRATE 0.2%

Vartojimo būdas:

OPHTHALMIC

Vienetai pakuotėje:

15G/50G

Recepto tipas:

Prescription

Gydymo sritis:

ALPHA-ADRENERGIC AGONISTS

Produkto santrauka:

Active ingredient group (AIG) number: 0131859001; AHFS:

Autorizacija statusas:

APPROVED

Leidimo data:

1997-11-24

Prekės savybės

                                _ALPHAGAN (brimonidine tartrate) _
_Page 1 of 26 _
_ _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
ALPHAGAN®
brimonidine tartrate ophthalmic solution
Solution, 0.2% 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: 267088
Date of Initial Authorization:
NOV 24, 1997
Date of Revision:
SEP
29, 2022
_ALPHAGAN (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
.........................................................................................................
4
4.5
Missed Dose
..
                                
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