AURO-CEFPROZIL TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
22-09-2020
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
Fáanlegur frá:
AURO PHARMA INC
ATC númer:
J01DC10
INN (Alþjóðlegt nafn):
CEFPROZIL
Skammtar:
250MG
Lyfjaform:
TABLET
Samsetning:
CEFPROZIL 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:
2010-04-09
Vara einkenni
Page 1 of 28
PRODUCT MONOGRAPH
PR
AURO-CEFPROZIL
(Cefprozil)
Tablets 250 mg & 500 mg
USP
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision:
September 22, 2020
Submission control No.: 243286
Page 2 of 28
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
MICROBIOLOGY
............
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