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:

OPHTHALMIC

Jednotky v balení:

5ML/11ML

Druh předpisu:

Prescription

Terapeutické oblasti:

PROSTAGLANDIN ANALOGS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2013-11-21

Charakteristika produktu

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