MOXIFLOXACIN INJECTION SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Disponibil de la:

FRESENIUS KABI CANADA LTD

Codul ATC:

J01MA14

INN (nume internaţional):

MOXIFLOXACIN

Dozare:

400MG

Forma farmaceutică:

SOLUTION

Compoziție:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Calea de administrare:

INTRAVENOUS

Unități în pachet:

300ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

ANTIBACTERIALS

Rezumat produs:

Active ingredient group (AIG) number: 0142242002; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2016-12-13

Caracteristicilor produsului

Moxifloxacin Injection – Product Monograph Page
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PRODUCT MONOGRAPH
PR
MOXIFLOXACIN INJECTION
400 mg / 250 mL (1.6 mg / mL)
(as moxifloxacin hydrochloride)
Antibacterial Agent
FRESENIUS KABI CANADA LTD.
165 Galaxy Blvd, Suite 100
Toronto, ON M9W 0C8
Date of Revision:
March 19, 2020 SUBMISSION CONTROL NO:
237054
Moxifloxacin Injection – Product Monograph Page
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TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..........................................................3
SUMMARY PRODUCT INFORMATION
........................................................................3
INDICATIONS AND CLINICAL USE
..............................................................................3
CONTRAINDICATIONS
...................................................................................................5
WARNINGS AND PRECAUTIONS
..................................................................................5
ADVERSE REACTIONS
..................................................................................................14
DRUG INTERACTIONS
..................................................................................................18
DOSAGE AND ADMINISTRATION
..............................................................................20
OVERDOSAGE
................................................................................................................22
ACTION AND CLINICAL PHARMACOLOGY
............................................................23
STORAGE AND STABILITY
..........................................................................................30
SPECIAL HANDLING INSTRUCTIONS
.......................................................................30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................32
PART II: SCIENTIFIC INFORMATION
................................................................................33
PHARMACEUTICAL INFORMATION
..........................................................................33
CLINICAL TRIALS
...