CEFPROZIL POWDER FOR ORAL SUSPENSION POWDER FOR SUSPENSION

מדינה: קנדה

שפה: אנגלית

מקור: Health Canada

מרכיב פעיל:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

זמין מ:

RANBAXY PHARMACEUTICALS CANADA INC.

קוד ATC:

J01DC10

INN (שם בינלאומי):

CEFPROZIL

כמות:

250MG

טופס פרצבטיות:

POWDER FOR SUSPENSION

הרכב:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG

מסלול נתינה (של תרופות):

ORAL

יחידות באריזה:

50/75/100ML

סוג מרשם:

Prescription

איזור תרפויטי:

SECOND GENERATION CEPHALOSPORINS

leaflet_short:

Active ingredient group (AIG) number: 0127613004; AHFS:

מצב אישור:

APPROVED

תאריך אישור:

2009-08-20

מאפייני מוצר

PRODUCT MONOGRAPH
PR
CEFPROZIL POWDER FOR ORAL SUSPENSION
CEFPROZIL POWDER FOR ORAL SUSPENSION USP
(250 MG/5 ML OF CEFPROZIL AS CEFPROZIL MONOHYDRATE, WHEN
RECONSTITUTED)
USP
ANTIBIOTIC
Ranbaxy Pharmaceuticals Canada Inc.
126 East Drive,
Brampton, Ontario
L6T 1C1
Date of Revision:
October 9, 2019
Submission Control No.: 230902
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
................................................................ 4
SUMMARY PRODUCT INFORMATION
.................................................................................
4
INDICATIONS AND CLINICAL USE
.......................................................................................
4
CONTRAINDICATIONS
............................................................................................................
5
WARNINGS AND PRECAUTIONS
...........................................................................................
5
ADVERSE REACTIONS
.............................................................................................................
7
DRUG INTERACTIONS
.............................................................................................................
9
DOSAGE AND ADMINISTRATION
.........................................................................................
9
OVERDOSAGE
.........................................................................................................................
11
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................
11
STORAGE AND STABILITY
...................................................................................................
12
STORAGE OF RECONSTITUTED SUSPENSION
................................................................. 12
DOSAGE FORMS, COMPOSITION AND PACKAGING
...................................................... 13
PART II: SCIENTIFIC INFORMATION
.....................................................................................
14
PHARMACEUTICAL INFORMATION
...................