ACT OLOPATADINE 0.1% SOLUTION

Krajina: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktívna zložka:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE)

Dostupné z:

TEVA CANADA LIMITED

ATC kód:

S01GX09

INN (Medzinárodný Name):

OLOPATADINE

Dávkovanie:

0.1%

Forma lieku:

SOLUTION

Zloženie:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.1%

Spôsob podávania:

OPHTHALMIC

Počet v balení:

5ML

Typ predpisu:

Prescription

Terapeutické oblasti:

ANTIALLERGIC AGENTS

Prehľad produktov:

Active ingredient group (AIG) number: 0132394001; AHFS:

Stav Autorizácia:

CANCELLED POST MARKET

Dátum Autorizácia:

2021-07-30

Súhrn charakteristických

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ACT OLOPATADINE 0.1%
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_Page 1_
PRODUCT MONOGRAPH
Pr
ACT_ _OLOPATADINE 0.1%
Olopatadine Hydrochloride Ophthalmic Solution, USP
Sterile
0.1% w/v olopatadine (as olopatadine hydrochloride)
Anti-allergy Agent
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
June 15, 2020
Submission Control Number: 239279
_ _
ACT OLOPATADINE 0.1%
_ _
_Page 2_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
3
WARNINGS AND PRECAUTIONS
.........................................................................................
3
ADVERSE REACTIONS
...........................................................................................................
5
DRUG INTERACTIONS
...........................................................................................................
5
DOSAGE AND ADMINISTRATION
.......................................................................................
6
OVERDOSAGE
.........................................................................................................................
6
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
6
STORAGE AND STABILITY
...................................................................................................
7
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 7
PART II: SCIENTIFIC INFORMATION
.................................................................................
9
PHARMACEUTICAL INFORMATION
...................................................................................
9
CLINICAL TRIALS
.