TEVA-MOXIFLOXACIN TABLET

Država: Kanada

Jezik: angleščina

Source: Health Canada

Aktivna sestavina:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Dostopno od:

TEVA CANADA LIMITED

Koda artikla:

J01MA14

INN (mednarodno ime):

MOXIFLOXACIN

Odmerek:

400MG

Farmacevtska oblika:

TABLET

Sestava:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Pot uporabe:

ORAL

Enote v paketu:

30/100

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

1
PRODUCT MONOGRAPH
PR
TEVA-MOXIFLOXACIN
Moxifloxacin tablets
400 mg moxifloxacin (as moxifloxacin hydrochloride)
Antibacterial Agent
Teva Canada Limited
Date of Revision:
30 Novopharm Court
Dec 02, 2020
Toronto, Ontario
M1B 2K9
Submission Control No: 241009
2
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
.....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
.........................................................................................
5
ADVERSE REACTIONS
.........................................................................................................
14
DRUG INTERACTIONS
.........................................................................................................
18
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
22
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 23
STORAGE AND STABILITY
.................................................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II: SCIENTIFIC INFORMATION
...............................................................................
31
PHARMACEUTICAL INFORMATION
.................................................................................
31
CLINICAL TRIALS
.................................................................................................................
32
DETAILED PHA