MINT-OLOPATADINE 0.2% SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE)

Dostupné z:

MINT PHARMACEUTICALS INC

ATC kód:

S01GX09

INN (Medzinárodný Name):

OLOPATADINE

Dávkovanie:

0.2%

Forma lieku:

SOLUTION

Zloženie:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.2%

Spôsob podávania:

OPHTHALMIC

Počet v balení:

15G/50G

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTIALLERGIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0132394002; AHFS:

Stav Autorizácia:

APPROVED

Dátum Autorizácia:

2021-03-04

Súhrn charakteristických

_ MINT-OLOPATADINE 0.2% (_
Olopatadine Hydrochloride Ophthalmic Solution
_) _
Page 1 of 23
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
MINT-OLOPATADINE 0.2%
Olopatadine Hydrochloride Ophthalmic Solution
0.2% w/v olopatadine (as olopatadine hydrochloride), topical
USP
Anti-allergy Agent
Mint Pharmaceuticals Inc.
6575 Davand Drive
Mississauga, Ontario L5T 2M3
Canada
Date of Initial Authorization:
NOV 23, 2020
Date of Revision:
NOV 14, 2023
Submission Control Number: 278540
_ _
_MINT-OLOPATADINE 0.2% (_
Olopatadine Hydrochloride Ophthalmic Solution
_) _
_Page 2 of 23_
RECENT MAJOR LABEL CHANGES
None at the time of authorization
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
4.5
Missed Dose
.............................................................