MAXIPIME FOR INJECTION-PWS IV 2GM POWDER FOR SOLUTION

Χώρα: Καναδάς

Γλώσσα: Αγγλικά

Πηγή: Health Canada

Δραστική ουσία:

CEFEPIME (CEFEPIME HYDROCHLORIDE)

Διαθέσιμο από:

BRISTOL-MYERS SQUIBB CANADA

Φαρμακολογική κατηγορία (ATC):

J01DE01

INN (Διεθνής Όνομα):

CEFEPIME

Δοσολογία:

2G

Φαρμακοτεχνική μορφή:

POWDER FOR SOLUTION

Σύνθεση:

CEFEPIME (CEFEPIME HYDROCHLORIDE) 2G

Οδός χορήγησης:

INTRAVENOUS

Μονάδες σε πακέτο:

2.0G

Τρόπος διάθεσης:

Prescription

Θεραπευτική περιοχή:

FOURTH GENERATION CEPHALOSPORINS

Περίληψη προϊόντος:

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

Καθεστώς αδειοδότησης:

CANCELLED POST MARKET

Ημερομηνία της άδειας:

2015-01-28

Αρχείο Π.Χ.Π.

PRODUCT MONOGRAPH
PR MAXIPIME
*
(CEFEPIME HYDROCHLORIDE)
FOR INJECTION 500 MG, 1 G AND 2 G CEFEPIME
ANTIBIOTIC
Bristol-Myers Squibb Canada
Date of Preparation:
Montréal, Canada
May 23, 1995
Date of Revision:
September 23
rd
, 2008
*
TM of Bristol-Myers Squibb Company
used under licence by Bristol-Myers Squibb Canada
Control no.:122780
L4 version 1.1 dated: 11 November 2013
1
PRODUCT MONOGRAPH
MAXIPIME
(CEFEPIME HYDROCHLORIDE)
for Injection 500 mg, 1 g and 2 g Cefepime
THERAPEUTIC CLASSIFICATION
Antibiotic
ACTIONS AND CLINICAL PHARMACOLOGY
MAXIPIME
(cefepime
hydrochloride)
is
a
semi-synthetic
broad
spectrum
cephalosporin
antibiotic intended for intramuscular or intravenous administration.
Cefepime is a bactericidal
agent that acts by inhibition of bacterial cell wall synthesis. It has
a broad spectrum of activity
against a wide range of Gram-positive and Gram-negative bacteria.
PHARMACOKINETICS
The average plasma concentrations of cefepime in normal adult males at
various times following
single 30-minute infusions and single intramuscular injections of 500
mg, 1 g and 2 g are
summarized below.
MEAN PLASMA CONCENTRATIONS OF CEFEPIME (ΜG/ML)
CEFEPIME
DOSE
0.5 HR
1.0 HR
2.0 HR
4.0 HR
8.0 HR
12.0 HR
IV
500 mg
38.2
21.6
11.6
5.0
1.4
0.2
1 g
78.7
44.5
24.3
10.5
2.4
0.6
2 g
163.1
85.8
44.8
19.2
3.9
1.1
IM
500 mg
8.2
12.5
12.0
6.9
1.9
0.7
1 g
14.8
25.9
26.3
16.0
4.5
1.4
2 g
36.1
49.9
51.3
31.5
8.7
2.3
2
MEAN PLASMA CONCENTRATION - TIME PROFILES AFTER SINGLE INTRAVENOUS
INFUSIONS
COMPARED TO MIC
90 OF TARGET PATHOGENS
MEAN PLASMA CONCENTRATION - TIME PROFILES
AFTER SINGLE INTRAMUSCULAR INJECTIONS COMPARED TO MIC
90 OF TARGET PATHOGENS
3
See MICROBIOLOGY for susceptibility break points.
Average elimination half-life of cefepime is approximately 2 hours,
and does not vary with
respect to dose over the range of 250 mg to 2 g. There was no
accumulation in healthy subjects
receiving doses up to 2 g intravenously every 8 hours for a period of
9 days. Total body
clearance averages 120 mL/min. Average renal clearance of cefepime