INVANZ

Țară: Indonezia

Limbă: indoneziană

Sursă: Badan Pengawas Obat dan Makanan RI - Indonesian Food and Drug Supervisory Agency

Ingredient activ:

ERTAPENEM SODIUM

Disponibil de la:

ORGANON PHARMA INDONESIA TBK - Indonesia

INN (nume internaţional):

ERTAPENEM SODIUM

Dozare:

1213.00 MG

Forma farmaceutică:

SERBUK INJEKSI

Unități în pachet:

KARTON, MAKSIMUM @ 260 UNIT (BULK)

Produs de:

FAREVA MIRABEL - France

Data de autorizare:

2021-09-11

Caracteristicilor produsului

_ _
INVANZ
(Ertapenem for Injection)
THERAPEUTIC CLASS
INVANZ
(Ertapenem for Injection) is a sterile, synthetic, long-acting,
parenteral, 1-β methyl-
carbapenem
that
is
structurally
related
to
beta-lactam
antibiotics,
such
as
penicillins
and
cephalosporins, with activity against a wide range of gram-positive
and gram-negative aerobic and
anaerobic bacteria.
MICROBIOLOGY
Ertapenem has
in vitro
activity against a wide range of gram-positive and gram-negative
aerobic
and anaerobic bacteria. The bactericidal activity of ertapenem results
from the inhibition of cell wall
synthesis and is mediated through ertapenem binding to penicillin
binding proteins (PBPs). In
Escherichia coli
, it has strong affinity toward PBPs 1a, 1b, 2, 3, 4 and 5 with
preference for PBPs
2 and 3. Ertapenem has significant stability to hydrolysis by most
classes of beta-lactamases,
including penicillinases, and cephalosporinases and extended spectrum
beta-lactamases, but not
metallo-beta-lactamases.
INVANZ has been shown to be active against most strains of the
following microorganisms
in vitro
and in clinical infections (see INDICATIONS):
AEROBIC
AND
FACULTATIVE
ANAEROBIC
GRAM-POSITIVE
MICROORGANISMS:
Staphylococcus aureus
(including penicillinase-producing strains)
Streptococcus agalactiae
Streptococcus pneumoniae
Streptococcus pyogenes
Note: Methicillin-resistant staphylococci are resistant to INVANZ.
Many strains of
Enterococcus
faecalis
and most strains of
Enterococcus faecium
are resistant.
AEROBIC AND FACULTATIVE ANAEROBIC GRAM-NEGATIVE MICROORGANISMS:
DISETUJUI OLEH BPOM : 02/08/2021
ID : EREG100373VR12100079
EREG100373VR12100080
_ _
Escherichia coli
Haemophilus influenzae
(including beta-lactamase producing strains)
Klebsiella pneumoniae
Moraxella catarrhalis
Proteus mirabilis
ANAEROBIC MICROORGANISMS:
Bacteroides fragilis
and other species in the
B. fragilis
Group
Clostridium
species (excluding
C. difficile
)
Eubacterium
species
Peptostreptococcus
species
Porphyromonas asaccharolytica
Prevotella
species.
The following
in vitro
data a