AG-MOXIFLOXACIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostopno od:

ANGITA PHARMA INC.

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:

2018-06-28

Lastnosti izdelka

_AG-_
_MOXIFLOXACIN _
_Page 1 of 70 _
PRODUCT MONOGRAPH
PR
AG
-
MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
Antibacterial Agent
Date
of
Revision:
August 03, 2022
Manufactured
by:
Angita
Pharma
Inc.
1310 rue Nobel
Boucherville,Québec
J4B
5H3
Canada
SUBMISSION
CONTROL
NO:
265857
_AG-_
_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 TRIALS
...