APO-CEFEPIME POWDER FOR SOLUTION

Ország: Kanada

Nyelv: angol

Forrás: Health Canada

Aktív összetevők:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Beszerezhető a:

APOTEX INC

ATC-kód:

J01DE01

INN (nemzetközi neve):

CEFEPIME

Adagolás:

1G

Gyógyszerészeti forma:

POWDER FOR SOLUTION

Összetétel:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G

Az alkalmazás módja:

INTRAMUSCULAR

db csomag:

15G/50G

Recept típusa:

Prescription

Terápiás terület:

FOURTH GENERATION CEPHALOSPORINS

Termék összefoglaló:

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

Engedélyezési státusz:

APPROVED

Engedély dátuma:

2017-08-17

Termékjellemzők

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