APO-CEFEPIME POWDER FOR SOLUTION
Land: Canada
Språk: engelsk
Kilde: Health Canada
Preparatomtale
(SPC)
12-11-2019
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Aktiv ingrediens:
CEFEPIME (CEFEPIME HYDROCHLORIDE)
Tilgjengelig fra:
APOTEX INC
ATC-kode:
J01DE01
INN (International Name):
CEFEPIME
Dosering :
1G
Legemiddelform:
POWDER FOR SOLUTION
Sammensetning:
CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G
Administreringsrute:
INTRAMUSCULAR
Enheter i pakken:
15G/50G
Resept typen:
Prescription
Terapeutisk område:
FOURTH GENERATION CEPHALOSPORINS
Produkt oppsummering:
Active ingredient group (AIG) number: 0150504004; AHFS:
Autorisasjon status:
APPROVED
Autorisasjon dato:
2017-08-17
Preparatomtale
Page 1 of 40
PRODUCT MONOGRAPH
Pr
APO-CEFEPIME
Cefepime for Injection USP
1 g and 2 g cefepime per vial (as cefepime hydrochloride)
Antibiotic
_ _
APOTEX INC.
DATE OF PREPARATION:
150 Signet Drive,
NOVEMBER 12, 2019
Toronto, Ontario
M9L 1T9
Control Number: 231676 _ _
Page 3 of 40
TABLE OF CONTENTS
PART I: HEALTH PROFESSIONAL INFORMATION
............................................................ 3
SUMMARY PRODUCT INFORMATION
...............................................................................
3
INDICATIONS AND CLINICAL USE
....................................................................................
3
CONTRAINDICATIONS
..........................................................................................................
5
WARNINGS AND PRECAUTIONS
........................................................................................
5
ADVERSE REACTIONS
..........................................................................................................
8
DRUG
INTERACTIONS.........................................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................................
11
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
................................................................................................
20
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
20
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
..................................................................................
21
PHARMACEUTICAL INFORMATION
................................................................................
21
CLINICAL TRIA
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