CEFEPIME FOR INJECTION POWDER FOR SOLUTION

Țară: Canada

Limbă: engleză

Sursă: Health Canada

Ingredient activ:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Disponibil de la:

APOTEX INC

Codul ATC:

J01DE01

INN (nume internaţional):

CEFEPIME

Dozare:

1G

Forma farmaceutică:

POWDER FOR SOLUTION

Compoziție:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G

Calea de administrare:

INTRAMUSCULAR

Unități în pachet:

IM:2.4ML/ IV:10ML/ IV INF:SEE PM.

Tip de prescriptie medicala:

Prescription

Zonă Terapeutică:

FOURTH GENERATION CEPHALOSPORINS

Rezumat produs:

Active ingredient group (AIG) number: 0150504004; AHFS:

Statutul autorizaţiei:

APPROVED

Data de autorizare:

2009-02-16

Caracteristicilor produsului

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
.........................................................