Instructions for use INVANZ® (INVANZ)

Instructions for use INVANZ® (INVANZ)

A carbapenem antibiotic, 1-β methyl-carbapenem is a long-acting beta-lactam antibiotic for parenteral administration with activity against a wide range of gram-positive and gram-negative aerobic and anaerobic bacteria.

The bactericidal activity of ertapenem is due to inhibition of cell wall synthesis and is mediated by its binding to penicillin binding proteins (PBPs). In Escherichia coli, it exhibits strong affinity for PBPs 1a, 1b, 2, 3, 4 and 5, with a preference for PBPs 2 and 3. Ertapenem has significant resistance to most classes of β-lactamases (including penicillinases, cephalosporinases and β-lactamases extended spectrum, but not metallo-β-lactamase).

Invanz® is effective against most strains of the following microorganisms in vitro and in infections caused by them.

Active against
aerobic and facultative anaerobic gram-positive microorganisms:
Staphylococcus aureus (including strains that produce penicillinase /methicillin-resistant staphylococci are resistant/), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.

Many strains of Enterococcus faecalis and most strains of Enterococcus faecium are resistant.

Active against aerobic and facultative anaerobic gram-negative microorganisms:

Escherichia coli, Haemophilus influenzae (including β-lactamase producing strains), Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis.

Active against
anaerobic microorganisms:
Bacteroides fragilis and other Bacteroides spp., microorganisms of the genus Clostridium (except Clostridium difficile), microorganisms of the genus Eubacterium, microorganisms of the genus Peptostreptococcus, Porphyromonas asaccharolytica, microorganisms of the genus Prevotella.

Invanz® with MIC ≤ 2 μg/ml is active against the majority (≥ 90%) of strains of microorganisms of the genus Streptococcus,

including Streptococcus pneumoniae
,
with MIC ≤ 4 μg/ml - against the majority (≥ 90%) strains of microorganisms of the genus Haemophilus, against the majority (>90%) strains of aerobic and facultative anaerobic gram-positive microorganisms (Staphylococcus spp., coagulase-negative methicillin-sensitive / methicillin-resistant staphylococci are resistant/, Streptococcus pneumoniae, penicillin-resistant Streptococcus viridans).

Methicillin-resistant staphylococci, as well as many strains of Enterococcus faecalis and most strains of Enterococcus faecium are resistant to Invanz.

Also active against aerobic and facultative anaerobic gram-negative microorganisms:

Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli (producing extended-spectrum β-lactamases), Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae (producing extended-spectrum β-lactamases), Morganella morgani, Proteus vulgaris, Serratia marcescens.

Many strains of the microorganisms listed above that are multiresistant to other antibiotics, for example, penicillins, cephalosporins (including third generation) and aminoglycosides, are sensitive to Invanza.

Active against anaerobic microorganisms

genus Fusobacterium.

The determined MIC values ​​must be interpreted in accordance with the criteria specified in the tables.

Table 1.

Table 2.

a The current lack of data on resistant strains makes it impossible to define any category as anything other than “susceptible.” If the MIC results of a strain can be interpreted as “non-susceptible”, these strains require further investigation.

b Streptococcus pneumoniae sensitive to penicillin (MIC <0.06 µg/ml) may be considered sensitive to ertapenem. Testing of isolates with intermediate susceptibility to penicillin or penicillin-resistant isolates for susceptibility to ertapenem is not recommended because reliable interpretative criteria for ertapenem are not available.

c These zone diameter interpretation standards apply only to tests using Mueller-Hinton agar supplemented with 5% sheep blood inoculated with a suspension of pure colonies incubated in 5% CO2 at 35°C for 20-24 hours.

d Streptococcus pneumoniae isolates should be tested using a 1 μg oxacillin disk. Isolates with zone sizes ≥20 mm are susceptible to penicillin and may be considered susceptible to ertapenem.

e Streptococcus spp., which are sensitive to penicillin (MIC≤0.12 µg/ml) can be considered sensitive to ertapenem. Testing of isolates with intermediate susceptibility to penicillin or penicillin-resistant isolates for susceptibility to ertapenem is not recommended because reliable interpretative criteria for ertapenem are not available.

fStreptococcus spp. should be tested using a 10 unit penicillin disk. Isolates with zone sizes ≤28 mm are susceptible to penicillin and may be considered susceptible to ertapenem.

g These standards of interpretation apply to the broth microdilution procedure using Haemophilus Test Medium (HTM) inoculated with a pure colony suspension and incubated in air at temperature for 20-24 hours.

h These zone diameters apply to disc diffusion tests on HTM agar inoculated with a suspension of pure colonies and incubated in 5% CO2 at 35°C for 16-18 hours.

i These standards of interpretation apply only to agar dilution using Brucella agar, supplemented with hemin, vitamin K1 and 5% defibrinated or hemolyzed sheep blood inoculated with a pure colony suspension, or a 6-24 hour fresh culture in thioglycolate-enriched medium when incubated in an anaerobic environment. container or chamber at 35-37°C for 42-48 hours.

Invanz®

A carbapenem antibiotic, 1-β methyl-carbapenem is a long-acting beta-lactam antibiotic for parenteral administration with activity against a wide range of gram-positive and gram-negative aerobic and anaerobic bacteria.

The bactericidal activity of ertapenem is due to inhibition of cell wall synthesis and is mediated by its binding to penicillin binding proteins (PBPs). In Escherichia coli, it exhibits strong affinity for PBPs 1a, 1b, 2, 3, 4 and 5, with a preference for PBPs 2 and 3. Ertapenem has significant resistance to the action of most classes of β-lactamases (including penicillinases, cephalosporinases and β-lactamases extended spectrum, but not metallo-β-lactamase).

Invanz® is effective against most strains of the following microorganisms in vitro and in infections caused by them.

Active against
aerobic and facultative anaerobic gram-positive microorganisms:
Staphylococcus aureus (including strains that produce penicillinase /methicillin-resistant staphylococci are resistant/), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes.

Many strains of Enterococcus faecalis and most strains of Enterococcus faecium are resistant.

Active against aerobic and facultative anaerobic gram-negative microorganisms:

Escherichia coli, Haemophilus influenzae (including β-lactamase producing strains), Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis.

Active against
anaerobic microorganisms:
Bacteroides fragilis and other Bacteroides spp., microorganisms of the genus Clostridium (except Clostridium difficile), microorganisms of the genus Eubacterium, microorganisms of the genus Peptostreptococcus, Porphyromonas asaccharolytica, microorganisms of the genus Prevotella.

Invanz® with MIC ≤ 2 μg/ml is active against the majority (≥ 90%) of strains of microorganisms of the genus Streptococcus,

including Streptococcus pneumoniae
,
with MIC ≤ 4 μg/ml - against the majority (≥ 90%) strains of microorganisms of the genus Haemophilus, against the majority (>90%) strains of aerobic and facultative anaerobic gram-positive microorganisms (Staphylococcus spp., coagulase-negative methicillin-sensitive / methicillin-sensitive resistant staphylococci, Streptococcus pneumoniae, penicillin-resistant Streptococcus viridans). The clinical significance of these in vitro MIC data is unknown.

Methicillin-resistant staphylococci, as well as many strains of Enterococcus faecalis and most strains of Enterococcus faecium are resistant to Invanz.

Also active against aerobic and facultative anaerobic gram-negative microorganisms:

Citrobacter freundii, Enterobacter aerogenes, Enterobacter cloacae, Escherichia coli (producing extended-spectrum β-lactamases), Haemophilus parainfluenzae, Klebsiella oxytoca, Klebsiella pneumoniae (producing extended-spectrum β-lactamases), Morganella morgani, Proteus vulgaris, Serratia marcescens.

Many strains of the microorganisms listed above that are multiresistant to other antibiotics, for example, penicillins, cephalosporins (including third generation) and aminoglycosides, are sensitive to Invaz.

Active against anaerobic microorganisms

genus Fusobacterium.

The determined MIC values ​​must be interpreted in accordance with the criteria specified in the tables.

Table 1.

Table 2.

a The current lack of data on resistant strains makes it impossible to define any category as anything other than “susceptible.” If the MIC results of a strain can be interpreted as “non-susceptible”, these strains require further investigation.

b Streptococcus pneumoniae sensitive to penicillin (MIC <0.06 µg/ml) may be considered sensitive to ertapenem. Testing of isolates with intermediate susceptibility to penicillin or penicillin-resistant isolates for susceptibility to ertapenem is not recommended because reliable interpretative criteria for ertapenem are not available.

c These zone diameter interpretation standards apply only to tests using Mueller-Hinton agar supplemented with 5% sheep blood inoculated with a suspension of pure colonies incubated in 5% CO2 at 35°C for 20-24 hours.

d Streptococcus pneumoniae isolates should be tested using a 1 μg oxacillin disk. Isolates with zone sizes ≥20 mm are susceptible to penicillin and may be considered susceptible to ertapenem.

e Streptococcus spp., which are sensitive to penicillin (MIC≤0.12 µg/ml) can be considered sensitive to ertapenem. Testing of isolates with intermediate susceptibility to penicillin or penicillin-resistant isolates for susceptibility to ertapenem is not recommended because reliable interpretative criteria for ertapenem are not available.

fStreptococcus spp. should be tested using a 10 unit penicillin disk. Isolates with zone sizes ≤28 mm are susceptible to penicillin and may be considered susceptible to ertapenem.

g These standards of interpretation apply to the broth microdilution procedure using Haemophilus Test Medium (HTM) inoculated with a pure colony suspension and incubated in air at temperature for 20-24 hours.

h These zone diameters apply to disc diffusion tests on HTM agar inoculated with a suspension of pure colonies and incubated in 5% CO2 at 35°C for 16-18 hours.

i These standards of interpretation apply only to agar dilution using Brucella agar, supplemented with hemin, vitamin K1 and 5% defibrinated or hemolyzed sheep blood inoculated with a pure colony suspension, or a 6-24 hour fresh culture in thioglycolate-enriched medium when incubated in an anaerobic environment. container or chamber at 35-37°C for 42-48 hours.

Invanz

A beta-lactam antibiotic whose bactericidal activity is due to the inhibition of cell wall synthesis and is mediated by its binding to penicillin-binding proteins (PBPs). In Escherichia coli, it exhibits a strong affinity for PBPs 1 alpha, 1 beta, 2, 3, 4 and 5, with a preference for PBPs 2 and 3. Ertapenem has significant resistance to hydrolysis by most classes of beta-lactamases, including penicillinases, cephalosporinases and beta-lactamases. extended spectrum lactamases, but not metallo-beta-lactamases.

Active against most strains of the following microorganisms: aerobic and facultative anaerobic gram-positive microorganisms: Staphylococcus aureus (including strains producing penicillinase; methicillin-resistant staphylococci are resistant), Streptococcus agalactiae, Streptococcus pneumoniae, Streptococcus pyogenes;

aerobic and facultative anaerobic gram-negative microorganisms: Escherichia coli, Haemophilus influenzae (including strains producing beta-lactamase), Klebsiella pneumoniae, Moraxella catarrhalis, Proteus mirabilis;

anaerobic microorganisms: Bacteroides fragilis and other species of the Bacteroides group, Clostridium spp. (except Clostridium difficile), Eubacter spp., Peptostreptococcus spp., Porphyromonas asaccharolytica, Prevotella spp.

The clinical significance of the following data on MIC values ​​obtained in vitro is unknown: with an MIC of less than 2 μg/ml, it is active against the majority (more than 90%) of strains of microorganisms of the genus Streptococcus, including Streptococcus pneumoniae; at a concentration of less than 4 μg/ml, it is active against the majority (more than 90%) strains of Haemophilus spp. and at a concentration of less than 4 μg/ml - against the majority (more than 90%) of aerobic and facultative anaerobic gram-positive microorganisms: Staphylococcus spp., coagulase-negative sensitive to methicillin (methicillin-resistant staphylococci are resistant), Streptococcus pneumoniae (penicillin-resistant), Streptococci viridans.

Many strains of microorganisms that are multi-resistant to other antibiotics, such as penicillins, cephalosporins (including third generation) and aminoglycosides, are sensitive to the drug: aerobic and facultative anaerobic gram-negative microorganisms; anaerobic microorganisms - Fusobacterium spp.

Many strains of Enterococcus faecalis and most strains of Enterococcus faecium, methicillin-resistant staphylococci, are resistant.