CEFPROZIL POWDER FOR ORAL SUSPENSION POWDER FOR SUSPENSION

Land: Canada

Språk: engelsk

Kilde: Health Canada

Aktiv ingrediens:

CEFPROZIL (CEFPROZIL MONOHYDRATE)

Tilgjengelig fra:

RANBAXY PHARMACEUTICALS CANADA INC.

ATC-kode:

J01DC10

INN (International Name):

CEFPROZIL

Dosering :

250MG

Legemiddelform:

POWDER FOR SUSPENSION

Sammensetning:

CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG

Administreringsrute:

ORAL

Enheter i pakken:

50/75/100ML

Resept typen:

Prescription

Terapeutisk område:

SECOND GENERATION CEPHALOSPORINS

Produkt oppsummering:

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

Autorisasjon status:

APPROVED

Autorisasjon dato:

2009-08-20

Preparatomtale

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
...................