AURO-CEFIXIME POWDER FOR SUSPENSION
Country: Kanada
Tungumál: enska
Heimild: Health Canada
Vara einkenni
(SPC)
05-11-2020
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:
CEFIXIME
Fáanlegur frá:
AURO PHARMA INC
ATC númer:
J01DD08
INN (Alþjóðlegt nafn):
CEFIXIME
Skammtar:
100MG
Lyfjaform:
POWDER FOR SUSPENSION
Samsetning:
CEFIXIME 100MG
Stjórnsýsluleið:
ORAL
Einingar í pakka:
50ML/100ML
Gerð lyfseðils:
Prescription
Lækningarsvæði:
THIRD GENERATION CEPHALOSPORINS
Vörulýsing:
Active ingredient group (AIG) number: 0122105001; AHFS:
Leyfisstaða:
APPROVED
Leyfisdagur:
2017-10-11
Vara einkenni
Page 1 of 33
PRODUCT MONOGRAPH
INCLUDING PATIENT MEDICATION INFORMATION
PR
AURO-CEFIXIME
CEFIXIME FOR ORAL SUSPENSION, HOUSE STANDARD
100 MG / 5 ML, WHEN RECONSTITUTED
(as cefixime trihydrate)
ANTIBIOTIC
AURO PHARMA INC.
3700 Steeles Avenue West, Suite # 402
Woodbridge, Ontario, L4L 8K8,
Canada.
Date of Revision
:
November 5, 2020.
Submission Control No: 239750
Page 2 of 33
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
............................................................................................................8
DRUG INTERACTIONS
..........................................................................................................10
DOSAGE AND ADMINISTRATION
......................................................................................11
OVERDOSAGE
.........................................................................................................................13
ACTION AND CLINICAL PHARMACOLOGY
.....................................................................13
STORAGE AND STABILITY
..................................................................................................15
SPECIAL HANDLING INSTRUCTIONS
................................................................................16
DOSAGE FORMS, COMPOSITION AND PACKAGING
.....................................................16
PART II: SCIENTIFIC INFORMATION
................................................................................17
PHARMACEUTICAL INFORMATI
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