natgillin/translations-raw huggingface dataset:
I kliniske undersøgelser af voksne resulterede uforsætlig administration af op til 3 g på en dag ikke i utilsigtede reaktioner af klinisk betydning.
In clinical studies in adults inadvertent administration of up to 3 g in a day did not result in clinically important adverse reactions.
I pædiatriske kliniske undersøgelser resulterede en enkelt IV- dosis på 40 mg/ kg op til maksimalt 2 g ikke i toksicitet.
In paediatric clinical studies, a single IV dose of 40 mg/ kg up to a maximum of 2 g did not result in toxicity.
Ertapenem kan i nogen udstrækning fjernes ved hæmodialyse (se afsnit 5. 2); der er dog ingen information vedrørende brug af hæmodialyse til behandling af overdosering.
Ertapenem can be removed to some extent by haemodialysis (see section 5.2); however, no information is available on the use of haemodialysis to treat overdose.
Carbapenem, ATC- kode:
Pharmacotherapeutic group: carbapenems, ATC code:
Virkningsmåde Ertapenem hæmmer bakteriecellevægssyntesen efter binding til penicillinbindende proteiner (PBP’ er).
Mode of action Ertapenem inhibits bacterial cell wall synthesis following attachment to penicillin binding proteins (PBPs).
7 Det farmakokinetiske/ farmakodynamiske (PK/ PD) forhold I lighed med andre beta- lactam antimikrobielle stoffer har tiden som ertapenems plasmakoncentration overstiger den inficerende organismes MIC vist sig bedst at korrelere med effekten i prækliniske PK/ PD undersøgelser.
Pharmacokinetic/ Pharmacodynamic (PK/ PD) relationship Similar to other beta-lactam antimicrobial agents, the time that the plasma concentration of ertapenem exceeds the MIC of the infecting organism has been shown to best correlate with efficacy in pre- clinical PK/ PD studies.
Resistensmekanisme For arter, der betragtes som modtagelige for ertapenem, var resistens usædvanlig i kontrolundersøgelser i Europa.
Mechanism of Resistance For species considered susceptible to ertapenem, resistance was uncommon in surveillance studies in Europe.
Ertapenem er effektivt stabilt over for hydrolyse af de fleste beta- lactamaseklasser, inklusiv penicillinaser, cefalosporinaser og udvidede spektrum beta - lactamaser, men ikke metallo- beta- lactamaser.
Ertapenem is effectively stable to hydrolysis by most classes of beta- lactamases, including penicillinases, cephalosporinases and extended spectrum beta-lactamases, but not metallo-beta-lactamases.
Methicillin- resistente stafylokokker og enterokokker er resistente over for ertapenem på grund af PBP målcelle- ufølsomhed; P. aeruginosa og andre ikke - gærende bakterier er generelt resistente, sandsynligvis på grund af begrænset penetration og aktiv udstrømning.
Methicillin-resistant staphylococci and enterococci are resistant to ertapenem, owing to PBP target insensitivity; P. aeruginosa and other non-fermentative bacteria are generally resistant, probably owing to limited penetration and to active efflux.
Resistens er usædvanlig hos Enterobacteriaceae, og stoffet er generelt aktivt over for dem med udvidet spektrum beta- lactamaser (ESBL).
Resistance is uncommon in Enterobacteriaceae and the drug is generally active against those with extended-spectrum beta-lactamases (ESBLs).
Resistens kan imidlertid observeres, når ESBL eller andre potente beta- lactamaser (f. eks.
Resistance can however be observed when ESBLs or other potent beta-lactamases (e. g.
Resistens kan også opstå via tilegnelse af beta- lactamaser med signifikant carbapenem- hydrolyserende aktivitet (f. eks.
Resistance can also arise via the acquisition of betalactamases with significant carbapenem-hydrolysing activity (e. g.
IMP og VIM metallo- beta- lactamaser eller KPC typer), skønt disse er sjældne.
IMP and VIM metallo-beta-lactamases or KPC types), though these are rare.
Ertapenems virkningsmekanisme er forskellig fra andre antibiotikaklassers, så som quinoloner, aminoglykosider, makrolider og tetracykliner.
The mechanism of action of ertapenem differs from that of other classes of antibiotics, such as quinolones, aminoglycosides, macrolides and tetracyclines.
Mikroorganismer kan dog udvise resistens over for mere end en klasse af antibakterielle stoffer, når mekanismen er, eller omfatter, uigennemtrængelighed for nogle sammensætninger og/ eller en udstrømningspumpe.
However, micro-organisms may exhibit resistance to more than one class of antibacterial agents when the mechanism is, or includes, impermeability to some compounds and/ or an efflux pump.
S ≤ 0, 5 mg/ l og R > 1 mg/ l • Streptococcus A, B, C, G:
S≤ 0.5 mg/ l and R > 1 mg/ l • Streptococcus A, B, C, G:
S ≤ 0, 5 mg/ l og R > 0, 5 mg/ l • Streptococcus pneumoniae:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • Streptococcus pneumoniae:
S≤ 0, 5 mg/ l og R > 0, 5 mg/ l • Haemophilus influenzae:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • Haemophilus influenzae:
S ≤ 0, 5 mg/ l og R > 0, 5 mg/ l • M. catarrhalis:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • M. catarrhalis:
S ≤ 0, 5 mg/ l og R > 0, 5 mg/ l • Gram negative anaerober:
S ≤ 0.5 mg/ l and R > 0.5 mg/ l • Gram negative anaerobes:
S ≤ 1 mg/ l og R > 1 mg/ l • Non species relaterede grænseværdier:
S ≤ 1mg/ l and R > 1 mg/ l • Non species related breakpoints:
S ≤ 0, 5 mg/ l og R > 1 mg/ l (NB:
S≤ 0.5 mg/ l and R > 1 mg/ l (NB:
Staphylococci følsomheden overfor ertapenem udledes fra methicillinfølsomheden).
Susceptibility of staphylococci to ertapenem is inferred from the methicillin susceptibility)
Mikrobiologisk følsomhed
8 Microbiological Susceptibility
Der er i den Europæiske Union rapporteret om lokaliserede infektionsklynger grundet carbapenem- resistente organismer.
Localized clusters of infections due to carbapenem-resistant organisms have been reported in the European Union.
8 Almindeligvis følsomme arter:
9 Commonly susceptible species:
Gram- positive aerober:
Gram-positive aerobes:
Methicillin- følsomme stafylokokker herunder Staphylococcus aureus * Streptococcus agalactiae * Streptococcus pneumoniae * † Streptococcus pyogenes Gram- negative aerober:
Methicillin-susceptible-staphylococci (including Staphylococcus aureus)* Streptococcus agalactiae* Streptococcus pneumoniae*† Streptococcus pyogenes Gram-negative aerobes:
Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli * Haemophilus influenzae * Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae * Moraxella catarrhalis * Morganella morganii Proteus mirabilis * Proteus vulgaris Serratia marcescens Anaerober:
Citrobacter freundii Enterobacter aerogenes Enterobacter cloacae Escherichia coli* Haemophilus influenzae* Haemophilus parainfluenzae Klebsiella oxytoca Klebsiella pneumoniae* Moraxella catarrhalis* Morganella morganii Proteus mirabilis* Proteus vulgaris Serratia marcescens Anaerobes:
Bacteroides fragilis og arter i B. fragilis- gruppen * Clodistrium arter (eksklusiv C. difficile) * Eubacterium arter * Fusobacterium arter Peptostreptococcus arter * Porphyromonas asaccharolytica * Prevotella arter * Arter for hvilke erhvervet resistens kan blive et problem:
Bacteroides fragilis and species in the B. fragilis Group* Clostridium species (excluding C. difficile)* Eubacterium species* Fusobacterium species* Peptostreptococcus species* Porphyromonas asaccharolytica* Prevotella species* Species for which acquired resistance may be a problem:
Methicillin- resistente stafylokokker + # Naturligt resistente organismer:
Methicillin-resistant staphylococci +# Inherently resistant organisms:
Corynebacterium jeikeium Enterococci inklusiv Enterococcus faecalis og Enterococcus faecium Gram- negative aerober:
Corynebacterium jeikeium Enterococci including Enterococcus faecalis and Enterococcus faecium Gram-negative aerobes:
Aeromonas arter Acinetobacter arter Burkholderia cepacia Pseudomonas aeruginosa Stenotrophomonas maltophilia Anaerober:
Aeromonas species Acinetobacter species Burkholderia cepacia Pseudomonas aeruginosa Stenotrophomonas maltophilia Anaerobes:
Lactobacillus arter Andre:
Lactobacillus species Others:
Klamydiaarter Mycoplasmaarter Rickettsiaarter Legionellaarter * Aktivitet er tilfredsstillende påvist i kliniske undersøgelser. † Der er ikke påvist effekt af INVANZ i behandling af non- nosocomiel pneumoni grundet penicillin resistent Streptococcus pneumoniae. + frekvens for erhvervet resistens > 50% i nogle medlemslande # Methicillin- resistente stafylokokker (inklusiv MRSA) er altid resistente over for betalaktamer.
Chlamydia species Mycoplasma species Rickettsia species Legionella species * Activity has been satisfactorily demonstrated in clinical studies. † The efficacy of INVANZ in the treatment of community acquired pneumonia due to penicillin- resistant Streptococcus pneumoniae has not been established. + frequency of acquired resistance > 50% in some Member States # Methicillin-resistant staphylococci (including MRSA) are always resistant to betalactams.
9 Information fra kliniske undersøgelser
10 Information from clinical studies
Effekt i pædiatriske undersøgelser Ertapenem blev primært evalueret med henblik på pædiatrisk sikkerhed og sekundært med henblik på effekt i randomiserede, komparative multicenterundersøgelser med patienter i alderen 3 måneder til 17 år.
Efficacy in Pediatric Studies Ertapenem was evaluated primarily for pediatric safety and secondarily for efficacy in randomized comparative, multicenter studies in patients 3 months to 17 years of age.
Fordelingen af patienter med favorabel klinisk responsvurdering ved kontrolbesøg efter afslutning af behandling i den kliniske MITT (modified intention to treat) population ses nedenfor:
The proportion of patients with a favorable clinical response assessment at posttreatment visit in the clinical MITT population is shown below:
stratum †
Disease Stratum †
Non -
Community Acquired Pneumonia (CAP)
88. 6
88.6
2 - 12 år
2 to 12 years 13 to 17 years
96. 5
96.5 100.0
100, 0 3/ 3
94.1 100.0
Ticarcillin/ clavulanat
Ticarcillin/ clavulanate
stratum
Disease Stratum
%
% n/ m
n/ m%
n/ m% n/ m
Intra - abdominale infektioner
Intraabdominal Infections (IAI)
2 - 12 år 13 - 17 år
2 to 12 years
28/ 34 15/ 16
28/ 34
82, 4 93, 8
82.4
7/ 9 4/ 6
7/ 9
77, 8 66, 7
13 to 17 years
Akutte bækkeninfek - tioner †
Acute Pelvic Infections (API) †
Dette omfatter 9 patienter i ertapenem- gruppen (7 med non- nosokomiel pneumoni og 2 med intra- abdominale infektioner), 2 patienter i ceftriaxon- gruppen (2 med non- nosokomiel pneumoni) og 1 patient med intra- abdominale infektioner i ticarcillin/ clavulanat- gruppen med sekundær bakteriæmi ved inklusion i undersøgelsen.
This includes 9 patients in the ertapenem group (7 CAP and 2 IAI), 2 patients in the ceftriaxone group (2 CAP), and 1 patient with IAI in the ticarcillin/ clavulanate group with secondary bacteremia at entry into the study.
Plasmakoncentrationer Gennemsnitlige plasmakoncentrationer af ertapenem efter enkelt, 30 minutters, intravenøs infusion af en 1 g dosis til raske, unge voksne (25 - 45 år) var 155 mikrogram/ ml (Cmax) ved 0, 5 time efter dosering (ved afslutning på infusion), 9 mikrogram/ ml ved 12 timer efter dosering, og 1 mikrogram/ ml ved 24 timer efter dosering.
Plasma concentrations Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in healthy young adults (25 to 45 years of age) were 155 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 9 micrograms/ ml at 12 hour postdose, and 1 microgram/ ml at 24 hour postdose.
Arealet under plasmakoncentrationskurven (AUC) af ertapenem hos voksne øges næsten dosisproportionelt inden for dosisspændet 0, 5 - 2 g.
Area under the plasma concentration curve (AUC) of ertapenem in adults increases nearly dose- proportionally over the 0.5 to 2 g dose range.
Ertapenem akkumuleres ikke hos voksne efter gentagne intravenøse doser fra 0, 5 - 2 g daglig.
There is no accumulation of ertapenem in adults following multiple intravenous doses ranging from 0.5 to 2 g daily.
Gennemsnitlige plasmakoncentrationer af ertapenem efter enkelt 30 minutters intravenøs infusion af en 15 mg/ kg dosis (op til maksimal dosis på 1 g) til patienter i alderen 3 - 23 måneder var 103, 8 mikrogram/ ml (Cmax) ved 0, 5 time efter dosering (ved afslutning på infusion), 13, 5 mikrogram/ ml ved 6 timer efter dosering og 2, 5 mikrogram/ ml ved 12 timer efter dosering.
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 15 mg/ kg (up to a maximum dose of 1 g) dose in patients 3 to 23 months of age were 103.8 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 13.5 micrograms/ ml at 6 hour postdose, and 2.5 micrograms/ ml at 12 hour postdose.
Gennemsnitlige plasmakoncentrationer af ertapenem efter enkelt 30 minutters intravenøs infusion af en 15 mg/ kg dosis (op til maksimal dosis på 1 g) til patienter i alderen 2 – 12 år var 113, 2 mikrogram/ ml (Cmax) ved 0, 5 time efter dosering (ved afslutning på infusion), 12, 8 mikrogram/ ml ved 6 timer efter dosering og 3, 0 mikrogram/ ml ved 12 timer efter dosering.
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 15 mg/ kg (up to a maximum dose of 1 g) dose in patients 2 to 12 years of age were 113.2 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 12.8 micrograms/ ml at 6 hour postdose, and 3.0 micrograms/ ml at 12 hour postdose.
Gennemsnitlige plasmakoncentrationer af ertapenem efter enkelt 30 minutters intravenøs infusion af en 20 mg/ kg dosis (op til maksimal dosis på 1 g) til patienter i alderen 13 - 17 år var 170, 4 mikrogram/ ml (Cmax) ved 0, 5 time efter dosering (ved afslutning på infusion), 7, 0 mikrogram/ ml ved 12 timer efter dosering og 1, 1 mikrogram/ ml ved 24 timer efter dosering.
Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 20 mg/ kg (up to a maximum dose of 1 g) dose in patients 13 to 17 years of age were 170.4 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), 7.0 micrograms/ ml at 12 hour postdose, and 1.1 microgram/ ml at 24 hour postdose.
10 Gennemsnitlige plasmakoncentrationer af ertapenem efter en enkelt 30 minutters intravenøs infusion af en 1 g dosis til 3 patienter i alderen 13 - 17 år var 155, 9 mikrogram/ ml (Cmax) ved 0, 5 time efter dosering (ved afslutning på infusion) og 6, 2 mikrogram/ ml ved 12 timer efter dosering.
11 Average plasma concentrations of ertapenem following a single 30 minute intravenous infusion of a 1 g dose in three patients 13 to 17 years of age were 155.9 micrograms/ ml (Cmax) at 0.5 hour postdose (end of infusion), and 6.2 micrograms/ ml at 12 hour postdose.
Distribution Ertapenem bindes i udstrakt grad til humane plasmaproteiner.
Distribution Ertapenem is highly bound to human plasma proteins.
92% binding ved en ca. plasmakoncentration på 155 mikrogram/ ml (gennemsnitlig koncentration nået ved afslutning af infusion af 1 g intravenøst).
In healthy young adults (25 to 45 years of age), the protein binding of ertapenem decreases, as plasma concentrations increase, from approximately 95% bound at an approximate plasma concentration of < 50 micrograms/ ml to approximately 92% bound at an approximate plasma concentration of 155 micrograms/ ml (average concentration achieved at the end of infusion following 1 g intravenously).
0, 16 liter/ kg hos børn i alderen 13 - 17 år.
The volume of distribution (Vdss) of ertapenem in adults is approximately 8 litres (0.11 liter/ kg) and approximately 0.2 liter/ kg in paediatric patients 3 months to 12 years of age and approximately 0.16 liter/ kg in paediatric patients 13 to 17 years of age.
Koncentrationer af ertapenem hos voksne fundet i væske i vabler efter 3 dages intravenøs behandling med 1 g, 1 gang daglig viste en AUC- ratio i hudvabelvæske/ plasma på 0, 61.
AUC in plasma of 0.61.
In- vitro undersøgelser viser at ertapenem havde en lille effekt på plasmaproteinbinding hos meget proteinbundne lægemidler (warfarin, ethinyl estradiol og norethindron).
In-vitro studies indicate that the effect of ertapenem on the plasma protein binding of highly protein bound medicinal products (warfarin, ethinyl estradiol, and norethindrone) was small.
Ændring i bindingen var < 12% ved peak plasma ertapenem koncentration efter en dosis på 1 g.
The change in binding was < 12% at peak plasma ertapenem concentration following a 1 g dose.
87%.
In vivo, probenecid (500 mg every 6 hours) decreased the bound fraction of ertapenem in plasma at the end of infusion in subjects administered a single 1 g intravenous dose from approximately 91% to approximately 87%.
En klinisk signifikant interaktion på grund af at ertapenem displacerer et andet lægemiddel, eller at et andet lægemiddel displacerer ertapenem er usandsynlig.
A clinically significant interaction due to ertapenem displacing another medicinal product or another medicinal product displacing ertapenem is unlikely.
In- vitro undersøgelser viser, at ertapenem ikke hæmmer P- glycoprotein- medieret transport af digoxin eller vinblastin og, at ertapenem ikke er et substrat for P- glycoprotein- medieret transport.
In-vitro studies indicate that ertapenem does not inhibit P-glycoprotein-mediated transport of digoxin or vinblastine and that ertapenem is not a substrate for P-glycoprotein-mediated transport.
Metabolisme Efter intravenøs infusion af radiomærket ertapenem 1 g til raske, unge voksne (23 - 49 år), består plasmaradioaktiviteten primært (94%) af ertapenem.
Metabolism In healthy young adults (23 to 49 years of age), after intravenous infusion of radiolabelled 1 g ertapenem, the plasma radioactivity consists predominantly (94%) of ertapenem.
Ertapenems hovedmetabolit dannes ved en dihydropeptidase- I- medieret hydrolytisk åbning af beta- lactamringen.
The major metabolite of ertapenem is the ring-opened derivative formed by dehydropeptidase-I-mediated hydrolysis of the beta-lactam ring.
In- vitro undersøgelser i humane levermikrosomer viser at ertapenem ikke hæmmer metabolismen medieret af de 6 primære CYP- isoformer:
In-vitro studies in human liver microsomes indicate that ertapenem does not inhibit metabolism mediated by any of the six major CYP isoforms:
1A2, 2C9, 2C19, 2D6, 2E1 og 3A4.
1A2, 2C9, 2C19, 2D6, 2E1 and 3A4.
80% i urinen og 10% i fæces.
Elimination Following administration of a 1 g radiolabelled intravenous dose of ertapenem to healthy young adults (23 to 49 years of age), approximately 80% is recovered in urine and 10% in faeces.
37% i hydrolyseret form.
Of the 80% recovered in urine, approximately 38% is excreted as unchanged ertapenem and approximately 37% as the ring-opened metabolite.
4 timer.
In healthy young adults (18 to 49 years of age) and patients 13 to 17 years of age given a 1 g intravenous dose, the mean plasma half-life is approximately 4 hours.
2, 5 time.
The mean plasma half-life in children 3 months to 12 years of age is approximately 2.5 hours.
Gennemsnitlige koncentrationer af ertapenem i urinen er højere end 984 mikrogram/ ml i perioden 0 - 2 timer efter administration og højere end 52 mikrogram/ ml i perioden 12 - 24 timer efter administration.
Average concentrations of ertapenem in urine exceed 984 micrograms/ ml during the period 0 to 2 hours postdose and exceed 52 micrograms/ ml during the period 12 to 24 hours post-administration.
39% og 22%) hos raske, ældre patienter (≥ 65 år) end hos unge voksne (< 65 år).
12 Elderly Plasma concentrations following a 1 g and 2 g intravenous dose of ertapenem are slightly higher (approximately 39% and 22%, respectively) in healthy elderly adults (≥ 65 years) relative to young adults (< 65 years).
Det er ikke nødvendigt at justere dosis til ældre patienter, hvis der ikke er fremskreden nyreinsufficiens.
In the absence of advanced renal insufficiency, no dosage adjustment is necessary in elderly patients.
11 Børn Ertapenem plasmakoncentrationer er sammenlignelige hos børn i alderen 13 - 17 år og voksne efter en daglig intravenøs dosis på 1 g.
Paediatric Patients Plasma concentrations of ertapenem are comparable in paediatric patients 13 to 17 years of age and adults following a 1 g once daily intravenous dose.
Efter 20 mg/ kg dosen (op til maksimal dosis på 1 g) var de farmakokinetiske parameterværdier hos patienter i alderen 13 - 17 år generelt sammenlignelige med dem hos raske unge voksne.
Following the 20 mg/ kg dose (up to a maximum dose of 1 g), the pharmacokinetic parameter values in patients 13 to 17 years of age were generally comparable to those in healthy young adults..
En sammenligning af resultater viste, at ved en dosis ertapenem på 1 g daglig opnås en farmakokinetisk profil hos patienter i alderen 13 - 17 år, der er sammenlignelig med voksnes.
A comparison of results show that a 1 g once daily dose of ertapenem achieves a pharmacokinetic profile in patients 13 to 17 years of age comparable to that of adults.
Ratio for AUC (13 - 17 år/ voksne), koncentrationen ved afslutning på infusion og koncentrationen ved midtpunktet af doseringsintervallet var henholdsvis 0, 99, 1, 20 og 0, 84.
The ratios (13 to 17 years/ Adults) for AUC, the end of infusion concentration and the concentration at the midpoint of the dosing interval were 0.99, 1.20, and 0.84, respectively.
Plasmakoncentrationerne ved midtpunktet af doseringsintervallet efter en enkelt intravenøs dosis ertapenem på 15 mg/ kg hos patienter i alderen 3 måneder - 12 år er sammenlignelig med plasmakoncentrationerne ved midtpunktet af doseringsintervallet efter en daglig intravenøs dosis på 1 g hos voksne (se Plasmakoncentrationer).
Plasma concentrations at the midpoint of the dosing interval following a single 15 mg/ kg intravenous dose of ertapenem in patients 3 months to 12 years of age are comparable to plasma concentrations at the midpoint of the dosing interval following a 1 g once daily intravenous dose in adults (see Plasma concentrations).
2 gange højere end hos voksne.
The plasma clearance (ml/ min/ kg) of ertapenem in patients 3 months to 12 years of age is approximately 2-fold higher as compared to that in adults.
Ved dosis på 15 mg/ kg var AUC - værdien og plasmakoncentrationerne ved midtpunktet af doseringsintervallet hos patienter i alderen 3 måneder - 12 år sammenlignelig med værdierne hos unge raske voksne, der fik 1 g ertapenem intravenøst.
At the 15 mg/ kg dose, the AUC value and plasma concentrations at the midpoint of the dosing interval in patients 3 months to 12 years of age were comparable to those in young healthy adults receiving a 1 g intravenous dose of ertapenem.
Leverinsufficiens Ertapenems farmakokinetik er ikke undersøgt hos patienter med leverinsufficiens.
Hepatic Insufficiency The pharmacokinetics of ertapenem in patients with hepatic insufficiency have not been established.
Nyreinsufficiens Efter enkelt, intravenøs dosis af ertapenem 1 g hos voksne, er AUC af ertapenem totalt (bundet og ubundet) og af ubundet ertapenem, ens hos patienter med mild nyreinsufficiens (Clcr 60 - 90 ml/ min/ 1, 73 m2) og hos raske frivillige (25 - 82 år).
Renal Insufficiency Following a single 1 g intravenous dose of ertapenem in adults, AUCs of total ertapenem (bound and unbound) and of unbound ertapenem are similar in patients with mild renal insufficiency (Clcr 60 to 90 ml/ min/ 1.73 m2) compared with healthy subjects (ages 25 to 82 years).
AUC af totalt ertapenem og af ubundet ertapenem øges hos patienter med moderat nyreinsufficiens (Clcr 31 til 59 ml/ min/ 1, 73 m2) med ca.
AUCs of total ertapenem and of unbound ertapenem are increased in patients with moderate renal insufficiency (Clcr 31 to 59 ml/ min/ 1.73 m2) approximately 1.5-fold and 1.8-fold, respectively, compared with healthy subjects.
Hos patienter med svær nyreinsufficiens (Clcr 5 til 30 ml/ min/ 1, 73 m2) øges AUC af totalt ertapenem og af ubundet ertapenem med ca.
AUCs of total ertapenem and of unbound ertapenem are increased in patients with advanced renal insufficiency (Clcr 5 to 30 ml/ min/ 1.73 m2) approximately 2.6-fold and 3.4-fold, respectively, compared with healthy subjects.
Hos patienter med nyreinsufficiens, som er hæmodialysekrævende, øges AUC af totalt ertapenem og af ubundet ertapenem med ca.
AUCs of total ertapenem and of unbound ertapenem are increased in patients who require haemodialysis approximately 2.9-fold and 6.0-fold, respectively, between dialysis sessions, compared with healthy subjects.