APO-BIMATOPROST SOLUTION

Šalis: Kanada

kalba: anglų

Šaltinis: Health Canada

Veiklioji medžiaga:

BIMATOPROST

Prieinama:

APOTEX INC

ATC kodas:

S01EE03

INN (Tarptautinis Pavadinimas):

BIMATOPROST

Dozė:

0.03%

Vaisto forma:

SOLUTION

Sudėtis:

BIMATOPROST 0.03%

Vartojimo būdas:

TOPICAL

Vienetai pakuotėje:

100

Recepto tipas:

Prescription

Gydymo sritis:

PROSTAGLANDIN ANALOGS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2013-09-10

Prekės savybės

_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...........................................................................................