CEFMEX 1G POWDER FOR INJECTION

Kraj: Malezja

Język: angielski

Źródło: NPRA (National Pharmaceutical Regulatory Agency, Bahagian Regulatori Farmasi Negara)

Składnik aktywny:

CEFEPIME HCL

Dostępny od:

DUOPHARMA (M) SDN. BHD.

INN (International Nazwa):

CEFEPIME HCL

Sztuk w opakowaniu:

10vial Vials; 25vial Vials; 100vial Vials

Wyprodukowano przez:

DUOPHARMA (M) SDN. BHD.

Charakterystyka produktu

[DUOPHARMA (M) SDN BHD]
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[Revision Date: 20.03.2023]
CEFMEX POWDER FOR INJECTION
DESCRIPTIONS:
CEFMEX 500MG AND 1G POWDER FOR INJECTION:
Before reconstitution: A white to pale yellow powder, After
reconstitution: From colorless to amber solution
COMPOSITION:
Cefmex (Cefepime Hydrochloride for injection) is a cephalosporin
antibiotic intended for intramuscular or intravenous administration.
Each Cefmex vial contains 500mg or 1g of cefepime activity in the form
of a sterile, dry mixture of cefepime hydrochloride and L-arginine.
The L-arginine, at an approximate concentration of 725 mg/g of
cefepime, is added to
control the pH of the constituted solution at 4.0-6.0.
PHARMACODYNAMICS:
Cefepime is a bactericidal agent that acts by inhibition of bacterial
cell wall synthesis. Cefepime is a bactericidal agent that has a
spectrum of activity against a range of Gram-positive and
Gram-negative bacteria.
Cefepime is highly resistant to hydrolysis by a number of
beta-lactamases, has a low affinity for chromosomally encoded
beta-lactamases, and exhibits rapid penetration into Gram-negative
bacteria cells.
Cefepime minimum bactericidal concentrations were ≤2 times the
minimum inhibitory concentration for the majority of organisms tested.
Cefepime has been shown to be active against most strains tested of
the following organisms both in vitro and in clinical infections.
GRAM-POSITIVE AEROBES:Staphylococcus aureus (including
penicillinase-producing strains but excluding methicillin-resistant
staphylo-cocci), Streptococcus agalactiae (Group B streptococci),
Streptococcus pnemoniae
(formerly Diplococcuspnemoniae), Streptococcus pyogenes (Group A
streptococci), other beta-haemolytic streptococci (Group C, G, F).
GRAM-NEGATIVE AEROBES: Acinetobacter calcoaceticus
(subsp.anitratus,lwoffi), Enterobacter spp.(including E. aerogenes, E.
agglomerans, E.cloacae, E. sakazakii), Escherichia coli, Haemophilus
influenzae, (including strains
of beta-lactamase producing H. influenzae), Haemophilus parainfluzae,
Klebsiella spp.(i