APO-CEFPROZIL TABLET
Nchi: Kanada
Lugha: Kiingereza
Chanzo: Health Canada
Tabia za bidhaa
(SPC)
03-06-2020
Hati zingine za bidhaa hii hazipatikani kwa sasa, unaweza kutuma ombi kwa huduma ya wateja wetu na tutakuarifu mara tu tutakapopata.
Tuma ombi.
Tuma ombi.
Viambatanisho vya kazi:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Inapatikana kutoka:
APOTEX INC
ATC kanuni:
J01DC10
INN (Jina la Kimataifa):
CEFPROZIL
Kipimo:
250MG
Dawa fomu:
TABLET
Tungo:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
Njia ya uendeshaji:
ORAL
Vitengo katika mfuko:
100
Dawa ya aina:
Prescription
Eneo la matibabu:
SECOND GENERATION CEPHALOSPORINS
Bidhaa muhtasari:
Active ingredient group (AIG) number: 0127613003; AHFS:
Idhini hali ya:
APPROVED
Idhini ya tarehe:
2007-03-09
Tabia za bidhaa
Page 1 of 27
PRODUCT MONOGRAPH
PR
APO-CEFPROZIL
Cefprozil Tablets
(cefprozil as cefprozil monohydrate)
250 mg and 500 mg cefprozil (on anhydrous basis)
USP
Antibiotic
APOTEX INC.
150 Signet Drive
Toronto, Ontario
DATE OF REVISION:
M9L 1T9
June 3, 2020
_Control Number: _235587
_ _
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
.........................................................................................................
8
DOSAGE AND ADMINISTRATION
.....................................................................................
8
OVERDOSAGE
........................................................................................................................
9
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 9
STORAGE AND STABILITY
...............................................................................................
11
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 11
PART II: SCIENTIFIC INFORMATION
.............................................................................
12
PHARMACEUTICAL INFORMATION
...............................................................................
12
CLINICAL TRIALS
...............................................................................................................
13
MIC
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