APO-CEFEPIME POWDER FOR SOLUTION

Země: Kanada

Jazyk: angličtina

Zdroj: Health Canada

Aktivní složka:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Dostupné s:

APOTEX INC

ATC kód:

J01DE01

INN (Mezinárodní Name):

CEFEPIME

Dávkování:

1G

Léková forma:

POWDER FOR SOLUTION

Složení:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 1G

Podání:

INTRAMUSCULAR

Jednotky v balení:

15G/50G

Druh předpisu:

Prescription

Terapeutické oblasti:

FOURTH GENERATION CEPHALOSPORINS

Přehled produktů:

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

Stav Autorizace:

APPROVED

Datum autorizace:

2017-08-17

Charakteristika produktu

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