NU-CEFPROZIL TABLET

البلد: كندا

اللغة: الإنجليزية

المصدر: Health Canada

العنصر النشط:

CEFPROZIL

متاح من:

NU-PHARM INC

ATC رمز:

J01DC10

INN (الاسم الدولي):

CEFPROZIL

جرعة:

500MG

الشكل الصيدلاني:

TABLET

تركيب:

CEFPROZIL 500MG

طريقة التعاطي:

ORAL

الوحدات في الحزمة:

100

نوع الوصفة الطبية :

Prescription

المجال العلاجي:

SECOND GENERATION CEPHALOSPORINS

ملخص المنتج:

Active ingredient group (AIG) number: 0127613002; AHFS:

الوضع إذن:

CANCELLED (UNRETURNED ANNUAL)

تاريخ الترخيص:

2018-03-28

خصائص المنتج

Page 1 of 26
PRODUCT MONOGRAPH
PR
NU-CEFPROZIL
Cefprozil Tablets
(cefprozil as cefprozil monohydrate)
250 mg and 500 mg cefprozil (on anhydrous basis)
USP
Antibiotic
NU-PHARM INC.
DATE OF PREPARATION:
50 Mural Street, Units 1 & 2
October 16, 2009
Richmond Hill, Ontario
L4B 1E4
_ _
Control#: 133361
Page 2 of 26
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
.....................................................................................
7
OVERDOSAGE........................................................................................................................
8
ACTION AND CLINICAL
PHARMACOLOGY....................................................................
8
STORAGE AND
STABILITY...............................................................................................
10
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 10
PART II: SCIENTIFIC INFORMATION
.............................................................................
11
PHARMACEUTICAL
INFORMATION...............................................................................
11
CLINICAL TRIALS
..........................................................................................................