TEVA-MOXIFLOXACIN TABLET

Nchi: Kanada

Lugha: Kiingereza

Chanzo: Health Canada

Nunua Sasa

Shusha Tabia za bidhaa (SPC)
02-12-2020

Viambatanisho vya kazi:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

Inapatikana kutoka:

TEVA CANADA LIMITED

ATC kanuni:

J01MA14

INN (Jina la Kimataifa):

MOXIFLOXACIN

Kipimo:

400MG

Dawa fomu:

TABLET

Tungo:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

Njia ya uendeshaji:

ORAL

Vitengo katika mfuko:

30/100

Dawa ya aina:

Prescription

Eneo la matibabu:

QUINOLONES

Bidhaa muhtasari:

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

Idhini hali ya:

APPROVED

Idhini ya tarehe:

2015-11-04

Tabia za bidhaa

                                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
                                
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