TORRENT-MOXIFLOXACIN TABLET
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
19-07-2019
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:
TORRENT PHARMACEUTICALS LIMITED
ATC númer:
J01MA14
INN (Alþjóðlegt nafn):
MOXIFLOXACIN
Skammtar:
400MG
Lyfjaform:
TABLET
Samsetning:
MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
30/100/500
Gerð lyfseðils:
Prescription
Lækningarsvæði:
QUINOLONES
Vörulýsing:
Active ingredient group (AIG) number: 0142242001; AHFS:
Leyfisstaða:
CANCELLED (UNRETURNED ANNUAL)
Leyfisdagur:
2021-12-20
Vara einkenni
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PRODUCT MONOGRAPH
PR
TORRENT - MOXIFLOXACIN
Moxifloxacin Tablets
400 mg
(as moxifloxacin hydrochloride)
Antibacterial Agent
Manufactured by:
Date of Revision:
Torrent Pharmaceuticals Ltd. July 19, 2019
East Ahmedabad-Mehsana Highway
Taluka - Kadi, Dist. Mehsana
Indrad-382 721, Gujarat, India
Submission Control No: 225696
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_Page 2 of 61 _
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
........................................................................................................
13
DRUG INTERACTIONS
.........................................................................................................
17
DOSAGE AND ADMINISTRATION
.....................................................................................
20
OVERDOSAGE
.......................................................................................................................
21
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 22
STORAGE AND STABILITY
................................................................................................
29
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
29
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 29
PART II : SCIENTIFIC INFORMATION
......................................................................................
30
PHARMACEUTICAL
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