TORRENT-MOXIFLOXACIN TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

متاح من:

TORRENT PHARMACEUTICALS LIMITED

ATC رمز:

J01MA14

INN (الاسم الدولي):

MOXIFLOXACIN

جرعة:

400MG

الشكل الصيدلاني:

TABLET

تركيب:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 400MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

30/100/500

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

QUINOLONES

ملخص المنتج:

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

الوضع إذن:

CANCELLED (UNRETURNED ANNUAL)

تاريخ الترخيص:

2021-12-20

خصائص المنتج

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_Page 1 of 61 _
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