CEFEPIME FOR INJECTION, USP POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Disponibil de la:

QILU PHARMACEUTICAL CO., LTD.

Codul ATC:

J01DE01

INN (nume internaţional):

CEFEPIME

Dozare:

2G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 2G

Calea de administrare:

INTRAVENOUS

Unități în pachet:

20ML

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

FOURTH GENERATION CEPHALOSPORINS

Rezumat produs:

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

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2017-05-17

Caracteristicilor produsului

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
......