JAMP-MOXIFLOXACIN TABLET

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Διαθέσιμο από:

JAMP PHARMA CORPORATION

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.

_JAMP-MOXIFLOXACIN_
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PRODUCT MONOGRAPH
PR
JAMP-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
Antibacterial Agent
Manufactured by:
Date of Revision:
Jamp Pharma Corporation
September 18, 2020
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Canada
SUBMISSION CONTROL NO: 239203
_JAMP-MOXIFLOXACIN_
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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
......................................................................................
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
...........................................................................
30
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 31
PART II: SCIENTIFIC INFORMATION
.................................................................................
32
PHARMACEUTICAL INFORMATION
....................................................................