DBL™ Cefepime Powder for Injection

Country: Nýja-Sjáland

Tungumál: enska

Heimild: Medsafe (Medicines Safety Authority)

Virkt innihaldsefni:

Cefepime dihydrochloride monohydrate 1 g

Fáanlegur frá:

Pfizer New Zealand Limited

INN (Alþjóðlegt nafn):

Cefepime dihydrochloride monohydrate 1 g

Skammtar:

1 g

Lyfjaform:

Powder for injection

Samsetning:

Active: Cefepime dihydrochloride monohydrate 1 g Excipient: Arginine

Einingar í pakka:

Vial, glass, single dose, Type I clear glass 20 mL vial with a grey bromobutyl rubber closure and Al flip-off green seal, 1 g

Tegund:

Prescription

Gerð lyfseðils:

Prescription

Framleitt af:

Orchid Chemicals and Pharmaceuticals Limited

Ábendingar:

Indicated for the treatment of lower respiratory tract infections, including pneumonia and bronchitis, when caused by susceptible bacteria.

Vörulýsing:

Package - Contents - Shelf Life: Vial, glass, single dose, Type I clear glass 20 mL vial with a grey bromobutyl rubber closure and Al flip-off green seal - 1 g - 24 months from date of manufacture stored at or below 25°C protect from light 24 hours reconstituted stored at 2° to 8°C (Refrigerate, do not freeze) protect from light

Leyfisdagur:

2011-08-22

Vara einkenni

Data Sheet – New Zealand
Hospira 3.0
Page 1 of 12
DBL
TM
CEFEPIME POWDER FOR INJECTION
NAME OF THE MEDICINE
Cefepime (as hydrochloride monohydrate) powder for solution for
injection
PRESENTATIONS
Cefepime hydrochloride is a semi-synthetic broad spectrum
cephalosporin antibiotic for
parenteral
administration.
The
chemical
name
is:
Pyrrolidinium,
1-[[7-[[2-amino-4-
thiazolyl)(methoxyimino)acetyl]-amino]-2-carboxy-8-oxo-5-thia-1-azabicyclo[4.2.0]oct-2-en-
3-yl]methyl]-1-methyl-,chloride, monohydrochloride, monohydrate, [6R-
[6

, 7

(Z)]].
Cefepime hydrochloride is a white to pale yellow powder. It is highly
soluble in water. It has
a pH of between 4.0 and 6.0.
DBL
TM
Cefepime Powder for Injection is a sterile lyophilised powder for
injection containing
the inactive ingredient L-arginine to control the pH of the
reconstituted solution at 4.0 to 6.0.
Following reconstitution with Water for Injection as directed in
labelling, it results in a pale
yellow to amber coloured, clear solution.
Each 20 mL vial contains either 1.914 g or 3.828 g of sterile cefepime
– L-arginine powder,
which is equivalent to 1 g or 2 g of cefepime and approximately 725 mg
of arginine per gram
of cefepime. It contains no antimicrobial preservative and is for use
in one patient only.
USES
_ACTIONS_
Cephalosporins act by interfering with bacterial cell-wall synthesis,
leading to lysis of the
infectious organism.
_PHARMACOKINETICS_
_In Adults_
Average plasma concentrations of cefepime observed in normal adult
males at various
times following single 30-minute infusions of 1 g and 2 g are
summarised in Table 1.
Following intramuscular (IM) administration, cefepime is completely
absorbed. The average
plasma concentrations of cefepime at various times following a single
IM injection are
summarised in Table 1.
TABLE 1: MEAN PLASMA CONCENTRATIONS OF CEFEPIME (MICROGRAM/ML)
CEFEPIME DOSES
0.5 HR
1 HR
2 HR
4 HR
8 HR
12 HR
1 g IV
66.9
41.8
25.3
11.0
2.8
0.8
2 g IV
127.6
81.7
45.4
20.1
4.6
1.2
1 g IM
14.8
25.9
26.3
16.0
4.5
1.4
2 g IM
36.1
49.9
5