APO-CEFPROZIL TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
03-06-2020
Sum skjöl fyrir þessa vöru eru ekki tiltæk eins og er, þú getur sent beiðni til þjónustu við viðskiptavini okkar og við munum láta þig vita um leið og við getum fengið þau.
Senda beiðni.
Senda beiðni.
Virkt innihaldsefni:
CEFPROZIL (CEFPROZIL MONOHYDRATE)
Fáanlegur frá:
APOTEX INC
ATC númer:
J01DC10
INN (Alþjóðlegt nafn):
CEFPROZIL
Skammtar:
250MG
Lyfjaform:
TABLET
Samsetning:
CEFPROZIL (CEFPROZIL MONOHYDRATE) 250MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
SECOND GENERATION CEPHALOSPORINS
Vörulýsing:
Active ingredient group (AIG) number: 0127613003; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2007-03-09
Vara einkenni
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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