JAMP-MOXIFLOXACIN SOLUTION

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE)

متاح من:

JAMP PHARMA CORPORATION

ATC رمز:

S01AE07

INN (الاسم الدولي):

MOXIFLOXACIN

جرعة:

0.5%

الشكل الصيدلاني:

SOLUTION

تركيب:

MOXIFLOXACIN (MOXIFLOXACIN HYDROCHLORIDE) 0.5%

طريقة التعاطي:

OPHTHALMIC

الوحدات في الحزمة:

3ML

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

ANTIBACTERIALS

ملخص المنتج:

Active ingredient group (AIG) number: 0142242003; AHFS:

الوضع إذن:

APPROVED

تاريخ الترخيص:

2018-04-24

خصائص المنتج

_Jamp-Moxifloxacin Product Monograph_
_Page 1 of 27_
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
Pr
JAMP-MOXIFLOXACIN
Moxifloxacin Ophthalmic Solution USP
0.5% w/v moxifloxacin (as hydrochloride)
sterile
Antibacterial (ophthalmic)
JAMP Pharma Corporation
1310 rue Nobel
Boucherville, Québec
J4B 5H3
Date of Preparation:
January 18, 2018
Submission Control No.: 203089
_Jamp-Moxifloxacin Product Monograph_
_Page 2 of 27_
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
......................................................... 3
SUMMARY PRODUCT INFORMATION
...........................................................................
3
INDICATIONS AND CLINICAL USE
..............................................................................
3
CONTRAINDICATIONS
....................................................................................................
4
WARNINGS AND PRECAUTIONS
..................................................................................
4
ADVERSE REACTIONS
....................................................................................................
6
DRUG INTERACTIONS
....................................................................................................
7
DOSAGE AND ADMINISTRATION
................................................................................
8
OVERDOSAGE
...................................................................................................................
8
ACTION AND CLINICAL PHARMACOLOGY
............................................................... 8
STORAGE AND STABILITY
............................................................................................
9
DOSAGE FORMS, COMPOSITION AND PACKAGING
.............................................. 10
PART II: SCIENTIFIC INFORMATION
.................................................................................
11
PHARMACEUTICAL INFORMATION
..........................................................................
11
CLINICAL TRIALS
......................