IOPIDINE SOLUTION

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE)

Dostopno od:

ESSENTIAL PHARMA SWITZERLAND GMBH

Koda artikla:

S01EA03

INN (mednarodno ime):

APRACLONIDINE

Odmerek:

1%

Farmacevtska oblika:

SOLUTION

Sestava:

APRACLONIDINE (APRACLONIDINE HYDROCHLORIDE) 1%

Pot uporabe:

OPHTHALMIC

Enote v paketu:

15G/50G

Tip zastaranja:

Prescription

Terapevtsko območje:

EENT DRUGS, MISCELLANEOUS

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2023-05-19

Lastnosti izdelka

_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