CEFPROZIL POWDER FOR ORAL SUSPENSION POWDER FOR SUSPENSION
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
09-10-2019
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Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Inapatikana kutoka:
RANBAXY PHARMACEUTICALS CANADA INC.
ATC kanuni:
J01DC10
INN (Jina la Kimataifa):
CEFPROZIL
Kipimo:
250MG
Dawa fomu:
POWDER FOR SUSPENSION
Tungo:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
50/75/100ML
Dawa ya aina:
Prescription
Eneo la matibabu:
SECOND GENERATION CEPHALOSPORINS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0127613004; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2009-08-20
Tabia za bidhaa
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
...................
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