APO-CEFEPIME POWDER FOR SOLUTION

Država: Kanada

Jezik: engleski

Izvor: Health Canada

Aktivni sastojci:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Dostupno od:

APOTEX INC

ATC koda:

J01DE01

INN (International ime):

CEFEPIME

Doziranje:

1G

Farmaceutski oblik:

POWDER FOR SOLUTION

Sastav:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G

Administracija rute:

INTRAMUSCULAR

Jedinice u paketu:

15G/50G

Tip recepta:

Prescription

Područje terapije:

FOURTH GENERATION CEPHALOSPORINS

Proizvod sažetak:

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

Status autorizacije:

APPROVED

Datum autorizacije:

2017-08-17

Svojstava lijeka

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