JAMP-MOXIFLOXACIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostopno od:

JAMP PHARMA CORPORATION

Koda artikla:

J01MA14

INN (mednarodno ime):

MOXIFLOXACIN

Odmerek:

400MG

Farmacevtska oblika:

TABLET

Sestava:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Pot uporabe:

ORAL

Enote v paketu:

30

Tip zastaranja:

Prescription

Terapevtsko območje:

QUINOLONES

Povzetek izdelek:

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

Status dovoljenje:

APPROVED

Datum dovoljenje:

2015-11-04

Lastnosti izdelka

_JAMP-MOXIFLOXACIN_
_Page 1 of 71_
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_
_Page 2 of 71_
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
....................................................................