IOPIDINE SOLUTION

Negara: Kanada

Bahasa: Inggris

Sumber: Health Canada

Bahan aktif:

APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE)

Tersedia dari:

ESSENTIAL PHARMA SWITZERLAND GMBH

Kode ATC:

S01EA03

INN (Nama Internasional):

APRACLONIDINE

Dosis:

1%

Bentuk farmasi:

SOLUTION

Komposisi:

APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE) 1%

Rute administrasi :

OPHTHALMIC

Unit dalam paket:

15G/50G

Jenis Resep:

Prescription

Area terapi:

EENT DRUGS, MISCELLANEOUS

Ringkasan produk:

Active ingredient group (AIG) number: 0122471001; AHFS:

Status otorisasi:

APPROVED

Tanggal Otorisasi:

2023-05-19

Karakteristik produk

_IOPIDINE Product Monograph _
_Page 1 of 29_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
IOPIDINE
®
Apraclonidine Ophthalmic Solution, USP
0.5% w/v and 1% w/v (as apraclonidine hydrochloride)
S01EA03 Ophthalmologicals: Antiglaucoma Preparations and Miotics
Essential Pharma Switzerland GmbH
Landis + Gyr-Strasse 1 c/o LacMont AG,
6300 Zug, Switzerland
www.essentialpharmagroup.com
Date of Preparation:
MAY 19, 2023
Imported / Distributed by:
McKesson Specialized Distribution Inc.
8449 Lawson Road, Unit 102
Milton, ON
L9T 9L1
Canada
Submission Control No.: 273954
IOPIDINE is a registered trademark
_ _
_IOPIDINE Product Monograph _
_Page 2 of 29_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
.........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................4
WARNINGS AND PRECAUTIONS
..................................................................................4
ADVERSE REACTIONS
....................................................................................................6
DRUG INTERACTIONS
..................................................................................................10
DRUG INTERACTIONS
..................................................................................................10
DOSAGE AND ADMINISTRATION
..............................................................................11
OVERDOSAGE
................................................................................................................12
ACTION AND CLINICAL PHARMACOLOGY
............................................................12
STORAGE AND STABILITY
..........................................................................................13
DOSAGE FORMS, COMPOSIT