TEVA-MOXIFLOXACIN TABLET

Kraj: Kanada

Język: angielski

Źródło: Health Canada

Kup teraz

Składnik aktywny:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostępny od:

TEVA CANADA LIMITED

Kod ATC:

J01MA14

INN (International Nazwa):

MOXIFLOXACIN

Dawkowanie:

400MG

Forma farmaceutyczna:

TABLET

Skład:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Droga podania:

ORAL

Sztuk w opakowaniu:

30/100

Typ recepty:

Prescription

Dziedzina terapeutyczna:

QUINOLONES

Podsumowanie produktu:

Active ingredient group (AIG) number: 0142242001; AHFS:

Status autoryzacji:

APPROVED

Data autoryzacji:

2015-11-04

Charakterystyka produktu

                                1
PRODUCT MONOGRAPH
PR
TEVA-MOXIFLOXACIN
Moxifloxacin tablets
400 mg moxifloxacin (as moxifloxacin hydrochloride)
Antibacterial Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
Dec 02, 2020
Toronto, Ontario
M1B 2K9
Submission Control No: 241009
2
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
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
.................................................................................................................
32
DETAILED PHA
                                
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