MOXIFLOXACIN TABLET

Land: Canada

Sprog: engelsk

Kilde: Health Canada

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Hent Produktets egenskaber (SPC)
21-09-2021

Aktiv bestanddel:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Tilgængelig fra:

SANIS HEALTH INC

ATC-kode:

J01MA14

INN (International Name):

MOXIFLOXACIN

Dosering:

400MG

Lægemiddelform:

TABLET

Sammensætning:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Indgivelsesvej:

ORAL

Enheder i pakken:

15G/50G

Recept type:

Prescription

Terapeutisk område:

QUINOLONES

Produkt oversigt:

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

Autorisation status:

APPROVED

Autorisation dato:

2021-09-23

Produktets egenskaber

                                Page 1 of 66
PRODUCT MONOGRAPH
PR
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg Moxifloxacin
(as moxifloxacin
hydrochloride)
House Standard
Antibacterial Agent
SANIS HEALTH INC.
1 President’s Choice Circle
Brampton, Ontario
L6Y 5S5
Date of Revision:
September 21, 2021
SUBMISSION CONTROL NO:
249928
Page 2 of 66
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
..................................................... 3
SUMMARY PRODUCT INFORMATION
................................................................... 3
INDICATIONS AND CLINICAL USE
........................................................................
3
CONTRAINDICATIONS
............................................................................................
5
WARNINGS AND PRECAUTIONS
............................................................................
6
ADVERSE
REACTIONS............................................................................................14
DRUG INTERACTIONS
............................................................................................18
DOSAGE AND ADMINISTRATION
.........................................................................20
OVERDOSAGE
.........................................................................................................21
ACTION AND CLINICAL
PHARMACOLOGY.........................................................22
STORAGE AND STABILITY
....................................................................................29
SPECIAL HANDLING INSTRUCTIONS
...................................................................29
DOSAGE FORMS, COMPOSITION AND PACKAGING
..........................................29
PART II: SCIENTIFIC INFORMATION
..........................................................................
30
PHARMACEUTICAL INFORMATION
.....................................................................30
CLINICAL TRIALS
...................................................................................................31
DETAILED
PHARMACOLOGY..........................
                                
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