APO-BIMATOPROST SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

BIMATOPROST

Dostupné s:

APOTEX INC

ATC kód:

S01EE03

INN (Mezinárodní Name):

BIMATOPROST

Dávkování:

0.03%

Léková forma:

SOLUTION

Složení:

BIMATOPROST 0.03%

Podání:

TOPICAL

Jednotky v balení:

100

Druh předpisu:

Prescription

Terapeutické oblasti:

PROSTAGLANDIN ANALOGS

Přehled produktů:

Active ingredient group (AIG) number: 0147303001; AHFS:

Stav Autorizace:

APPROVED

Datum autorizace:

2013-09-10

Charakteristika produktu

_APO-BIMATOPROST (Bimatoprost topical solution) _
_ _
_Page 1 of 28 _
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
APO-BIMATOPROST
Bimatoprost Topical Solution
Solution, 0.03% w/v, Topical
Prostamide Analogue
Submission Control Number.: 263284
APOTEX INC.
150 Signet Drive
Toronto Ontario
M9L 1T9
Date of Initial Authorization:
SEP 10, 2013
Date of Revision:
OCT 13, 2022
_APO-BIMATOPROST (Bimatoprost topical solution) _
_ _
_Page 2 of 28 _
RECENT MAJOR LABEL CHANGES
N/A
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
4.3
Reconstitution
.......................................................................................................
5
4.4
Administration...........................................................................................