TEVA-MOXIFLOXACIN TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
02-12-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)
Fáanlegur frá:
TEVA CANADA LIMITED
ATC númer:
J01MA14
INN (Alþjóðlegt nafn):
MOXIFLOXACIN
Skammtar:
400MG
Lyfjaform:
TABLET
Samsetning:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
QUINOLONES
Vörulýsing:
Active ingredient group (AIG) number: 0142242001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2015-11-04
Vara einkenni
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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