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:

OPHTHALMIC

Vienetai pakuotėje:

5ML/11ML

Recepto tipas:

Prescription

Gydymo sritis:

PROSTAGLANDIN ANALOGS

Produkto santrauka:

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

Autorizacija statusas:

APPROVED

Leidimo data:

2013-11-21

Prekės savybės

_Page 1 of 30_
_ _
PRODUCT MONOGRAPH
PR
APO-BIMATOPROST
Bimatoprost Ophthalmic Solution
0.03% w/v
Elevated Intraocular Pressure Therapy
Prostamide Analogue
APOTEX INC.
150 Signet Drive
Toronto, Ontario
M9L 1T9
Date of Preparation:
November 21, 2013
Date of Revision:
June 20, 2022
Submission Control Number: 260048
_Page 2 of 30_
_ _
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.....................................................................
3
SUMMARY PRODUCT
INFORMATION..................................................................................
3
INDICATIONS AND CLINICAL USE
........................................................................................
3
CONTRAINDICATIONS.........................................................................................................
3
DOSAGE AND
ADMINISTRATION.........................................................................................
3
OVERDOSAGE
....................................................................................................................
4
WARNINGS AND PRECAUTIONS
..........................................................................................
4
ADVERSE REACTIONS
.........................................................................................................
7
DRUG INTERACTIONS
........................................................................................................10
ACTION AND CLINICAL PHARMACOLOGY
...........................................................................10
STORAGE AND
STABILITY...................................................................................................12
DOSAGE FORMS, COMPOSITION AND
PACKAGING.............................................................12
PART II: SCIENTIFIC INFORMATION
.......................................................................................13
PHARMACEUTICAL
INFORMATION.....................................................................................13
CLINICAL TRIALS
......................