ACT MOXIFLOXACIN SOLUTION

Nazione: Canada

Lingua: inglese

Fonte: Health Canada

Principio attivo:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Commercializzato da:

TEVA CANADA LIMITED

Codice ATC:

S01AE07

INN (Nome Internazionale):

MOXIFLOXACIN

Dosaggio:

0.5%

Forma farmaceutica:

SOLUTION

Composizione:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 0.5%

Via di somministrazione:

OPHTHALMIC

Confezione:

3ML

Tipo di ricetta:

Prescription

Area terapeutica:

ANTIBACTERIALS

Dettagli prodotto:

Active ingredient group (AIG) number: 0142242003; AHFS:

Stato dell'autorizzazione:

CANCELLED POST MARKET

Data dell'autorizzazione:

2022-05-27

Scheda tecnica

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ACT_ _MOXIFLOXACIN_ _
_Page 1 of 26_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
ACT MOXIFLOXACIN
Moxifloxacin Ophthalmic Solution
0.5% w/v moxifloxacin (as moxifloxacin hydrochloride)
USP
Antibacterial (ophthalmic)
Teva Canada Limited
30 Novopharm Court
Toronto, Ontario
M1B 2K9
Date of Revision:
May 15, 2020
Submission Control Number: 238161
_ _
ACT_ _MOXIFLOXACIN_ _
_Page 2 of 26_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION ...... ERROR! BOOKMARK NOT
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SUMMARY
PRODUCT
INFORMATION ..................................... E
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INDICATIONS
AND
CLINICAL
USE........................................... E
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WARNINGS
AND
PRECAUTIONS .............................................. E
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ADVERSE
REACTIONS
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DRUG
INTERACTIONS
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DOSAGE
AND
ADMINISTRATION ............................................ E
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OVERDOSAGE
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ACTION
AND
CLINICAL
PHARMACOLOGY ........................... E
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STORAGE
AND
STABILITY ........................................................ E
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DOSAGE
FORMS,
COMPOSITION
AND
PACKAGING ............ E
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PART II: SCIENTIFIC INFORMATION ............................. ERROR!
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DETAILED
PHARMACOLOGY ................................................... E
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MICROBIOLOGY
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TOXICOLOGY
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