SANDOZ MOXIFLOXACIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Διαθέσιμο από:

SANDOZ CANADA INCORPORATED

Φαρμακολογική κατηγορία (ATC):

J01MA14

INN (Διεθνής Όνομα):

MOXIFLOXACIN

Δοσολογία:

400MG

Φαρμακοτεχνική μορφή:

TABLET

Σύνθεση:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Οδός χορήγησης:

ORAL

Μονάδες σε πακέτο:

30

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

QUINOLONES

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

APPROVED

Ημερομηνία της άδειας:

2015-11-04

Αρχείο Π.Χ.Π.

_Sandoz Moxifloxacin Page 1 of 60_
_ _
PRODUCT MONOGRAPH
PR
SANDOZ MOXIFLOXACIN
®
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
Antibacterial Agent
Sandoz Canada Inc.
110 Rue de Lauzon
Boucherville, QC
J4B 1E6
Date of Revision:
May 29, 2020
Submission Control No: 238775
_Sandoz Moxifloxacin Page 2 of 60_
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
..........................................................................................28
SPECIAL HANDLING INSTRUCTIONS
.......................................................................28
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................28
PART II: SCIENTIFIC INFORMATION
...............................................................................30
PHARMACEUTICAL INFORMATION
..........................................................................30
CLINICAL TRIALS
...............................................................