JAMP-MOXIFLOXACIN TABLETS

Valsts: Kanāda

Valoda: angļu

Klimata pārmaiņas: Health Canada

Aktīvā sastāvdaļa:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Pieejams no:

JAMP PHARMA CORPORATION

ATĶ kods:

J01MA14

SNN (starptautisko nepatentēto nosaukumu):

MOXIFLOXACIN

Deva:

400MG

Zāļu forma:

TABLET

Kompozīcija:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Ievadīšanas:

ORAL

Vienības iepakojumā:

30/100

Receptes veids:

Prescription

Ārstniecības joma:

QUINOLONES

Produktu pārskats:

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

Autorizācija statuss:

APPROVED

Autorizācija datums:

2016-01-07

Produkta apraksts

_JAMP-MOXIFLOXACIN_
_Page 1 of 70_
PRODUCT MONOGRAPH
PR
JAMP-MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin
hydrochloride)
Antibacterial Agent
Manufactured by:
Date of Revision:
Jamp Pharma Corporation
July 8, 2019
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Canada
SUBMISSION CONTROL NO: 225689
_JAMP-MOXIFLOXACIN_
_Page 2 of 70_
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
..........................................................................
32
CLINICAL TR