ALPHAGAN P SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

BRIMONIDINE TARTRATE

Tersedia dari:

ABBVIE CORPORATION

Kode ATC:

S01EA05

INN (Nama Internasional):

BRIMONIDINE

Dosis:

0.15%

Bentuk farmasi:

SOLUTION

Komposisi:

BRIMONIDINE TARTRATE 0.15%

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

3/5/10ML

Jenis Resep:

Prescription

Area terapi:

ALPHA-ADRENERGIC AGONISTS

Ringkasan produk:

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

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2003-11-04

Karakteristik produk

_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
...