ACT OLOPATADINE 0.2% SOLUTION

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Składnik aktywny:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

S01GX09

INN (International Nazwa):

OLOPATADINE

Dawkowanie:

0.2%

Forma farmaceutyczna:

SOLUTION

Skład:

OLOPATADINE (OLOPATADINE HYDROCHLORIDE) 0.2%

Droga podania:

OPHTHALMIC

Sztuk w opakowaniu:

2.5ML,5ML

Typ recepty:

Prescription

Dziedzina terapeutyczna:

ANTIALLERGIC AGENTS

Podsumowanie produktu:

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

Status autoryzacji:

CANCELLED POST MARKET

Data autoryzacji:

2021-07-30

Charakterystyka produktu

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_ACT OLOPATADINE 0.2% _
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PRODUCT MONOGRAPH
Pr
ACT OLOPATADINE 0.2%
Olopatadine Hydrochloride Ophthalmic Solution, USP
Sterile
0.2% w/v olopatadine (as olopatadine hydrochloride)
Anti-allergy Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
June 12, 2020
Toronto, Ontario
M1B 2K9
Submission Control Number: 239276
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_ACT OLOPATADINE 0.2% _
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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…………………………………………………………………4
DRUG
INTERACTIONS…………………………………………………………………6
DOSAGE AND
ADMINISTRATION……………………………………………………6
OVERDOSAGE…………………………………………………………………………..7
ACTION AND CLNICAL
PHARMACOLOGY…………………………………………7
STORAGE AND
STABILITY……………………………………………………………8
SPECIAL HANDLING
INSTRUCTIONS……………………………………………….8
DOSAGE FORMS, COMPOSITION AND
PACKAGING……………………………...8
PART II: SCIENTIFIC
INFORMATION………………………………………………………
10
PHARMACEUTICAL
INFORMATION………………………………………………..10
CLINICAL
TRIALS……………………………………………………………………..11
DETAILED
PHARMACOLOGY……………………………………………………….14
MICROBIOLOGY………………………………………………………………………15
TOXICOLOGY……………