NORFLOXACIN TABLET
Land: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
03-03-2010
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:
NORFLOXACIN
Fáanlegur frá:
COBALT PHARMACEUTICALS COMPANY
ATC númer:
J01MA06
INN (Alþjóðlegt nafn):
NORFLOXACIN
Skammtar:
400MG
Lyfjaform:
TABLET
Samsetning:
NORFLOXACIN 400MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
100
Gerð lyfseðils:
Prescription
Lækningarsvæði:
QUINOLONES
Vörulýsing:
Active ingredient group (AIG) number: 0116961001; AHFS:
Leyfisstaða:
CANCELLED PRE MARKET
Leyfisdagur:
2017-09-01
Vara einkenni
PRODUCT MONOGRAPH
PR
NORFLOXACIN
Norfloxacin Tablets USP
400 mg
Antibacterial Agent
Manufactured by:
Cobalt Pharmaceuticals Inc.
6500 Kitimat Road
Mississauga, ON
Canada L5N 2B8
Date of Preparation:
February 25, 2010
Control#: 136534
-2-
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 . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . 9
OVERDOSAGE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 10
ACTION AND CLINICAL PHARMACOLOGY . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . 11
STORAGE AND STABILITY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 12
DOSAGE FORMS, COMPOSITION AND PACKAGING . . . . . . . . . . . . . . .
. . . . . . . 13
PART II: SCIENTIFIC INFORMATION . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . 14
PHARMACEUTICAL INFORMATION . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . 14
CLINICAL TRIALS . . . . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . . . . . . . . 15
DETAILED PHARMACOLOGY . . . . . . . . . . . . . . . . . . . . . . . .
. . . . . . . . . . . . . . . . . . 15
MICROBIOLOGY . . . . . . . . . . . . . . . . . . . . .
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