APO-CEFEPIME POWDER FOR SOLUTION
Country: Canada
Language: English
Source: Health Canada
Summary of Product characteristics
(SPC)
12-11-2019
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Active ingredient:
CEFEPIME (CEFEPIME HYDROCHLORIDE)
Available from:
APOTEX INC
ATC code:
J01DE01
INN (International Name):
CEFEPIME
Dosage:
1G
Pharmaceutical form:
POWDER FOR SOLUTION
Composition:
CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G
Administration route:
INTRAMUSCULAR
Units in package:
15G/50G
Prescription type:
Prescription
Therapeutic area:
FOURTH GENERATION CEPHALOSPORINS
Product summary:
Active ingredient group (AIG) number: 0150504004; AHFS:
Authorization status:
APPROVED
Authorization date:
2017-08-17
Summary of Product characteristics
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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