CEFEPIME FOR INJECTION POWDER FOR SOLUTION

Country: Canada

Language: English

Source: Health Canada

Active ingredient:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Available from:

APOTEX INC

ATC code:

J01DE01

INN (International Name):

CEFEPIME

Dosage:

2G

Pharmaceutical form:

POWDER FOR SOLUTION

Composition:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 2G

Administration route:

INTRAVENOUS

Units in package:

IV:10ML/IV INF.:SEE PM

Prescription type:

Prescription

Therapeutic area:

FOURTH GENERATION CEPHALOSPORINS

Product summary:

Active ingredient group (AIG) number: 0150504005; AHFS:

Authorization status:

APPROVED

Authorization date:

2009-02-16

Summary of Product characteristics

PRODUCT MONOGRAPH
Cefepime for Injection
(cefepime hydrochloride)
1 g and 2 g cefepime per vial
Orchid Standard
Antibiotic
_Manufactured by: _
ORCHID HEALTHCARE
(A Division of Orchid Chemicals & Pharmaceuticals Ltd.)
Plot No: B3-B6 & B11-B14, SIPCOT Industrial Park,
Irungattukottai- 602 105, Sriperumbudur P.O.,
Kancheepuram District, INDIA.
_Manufactured for: _
APOTEX INC.
150 Signet Drive
Weston, ON, M9L 1T9
DATE OF PREPARATION
April 20, 2020
Control #: 234594
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
...................................................................................
10
OVERDOSAGE
.....................................................................................................................
15
ACTION AND CLINICAL PHARMACOLOGY
................................................................. 15
STORAGE AND STABILITY
..............................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................. 19
PART II: SCIENTIFIC INFORMATION
.........................................................