CEFEPIME FOR INJECTION, USP POWDER FOR SOLUTION

Land: Kanada

Sprache: Englisch

Quelle: Health Canada

Wirkstoff:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Verfügbar ab:

QILU PHARMACEUTICAL CO., LTD.

ATC-Code:

J01DE01

INN (Internationale Bezeichnung):

CEFEPIME

Dosierung:

2G

Darreichungsform:

POWDER FOR SOLUTION

Zusammensetzung:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 2G

Verabreichungsweg:

INTRAVENOUS

Einheiten im Paket:

20ML

Verschreibungstyp:

Prescription

Therapiebereich:

FOURTH GENERATION CEPHALOSPORINS

Produktbesonderheiten:

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

Berechtigungsstatus:

APPROVED

Berechtigungsdatum:

2017-05-17

Fachinformation

Page 1 of 40
PRODUCT MONOGRAPH
Pr
Cefepime for Injection, USP
(cefepime hydrochloride for injection)
1 g and 2 g cefepime per vial (as cefepime hydrochloride)
Antibiotic
_ _
_DIN OWNER / MANUFACTURED BY:_
DATE OF PREPARATION:
Qilu Pharmaceutical Co., Ltd.
May 11, 2017
No. 243 Gong Ye Bei Road
Jinan, 250100, China
_IMPORTED BY / DISTRIBUTED BY: _DATE OF REVISION:_ _
Apotex Inc.
August 9, 2019
4100 Weston Road
Toronto, Ontario
Canada, M9L 2Y6
Control Number: 216756
Page 2 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
..........................................................................................................
9
DRUG
INTERACTIONS.........................................................................................................
10
DOSAGE AND ADMINISTRATION
....................................................................................
11
OVERDOSAGE
.......................................................................................................................
16
ACTION AND CLINICAL PHARMACOLOGY
................................................................... 16
STORAGE AND STABILITY
................................................................................................
19
SPECIAL HANDLING INSTRUCTIONS
..............................................................................
19
DOSAGE FORMS, COMPOSITION AND PACKAGING
.................................................... 20
PART II: SCIENTIFIC INFORMATION
......