natgillin/translations-raw huggingface dataset:
Europa- Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for INVANZ til Merck Sharp & Dohme Limited den 18. april 2002.
The European Commission granted a marketing authorisation valid throughout the European Union for INVANZ to Merck Sharp & Dohme Limited on 18 April 2002.
Den europæiske offentlige vurderingsrapport (EPAR) for INVANZ kan ses i sin helhed her.
The full EPAR for INVANZ can be found here.
Dette sammendrag blev sidst ajourført i marts 2006.
This summary was last updated in 03-2006.
Hætteglas (glas)
vial (glass) 1g
Hætteglas (glas) 1g
vial (glass) 1g
INVANZ 1 g pulver til koncentrat til infusionsvæske.
INVANZ 1 g powder for concentrate for solution for infusion.
Hvert hætteglas indeholder 1, 0 g ertapenem svarende til 1, 046 g ertapenemnatrium.
Each vial contains 1.0 g ertapenem equivalent to 1.046 g ertapenem sodium.
137 mg).
Excipients: each 1.0 g dose contains approximately 6.0 mEq of sodium (approximately 137 mg).
En liste over alle hjælpestoffer er anført under afsnit 6. 1
For a full list of excipients, see section 6.1.
Hvidt/ brækket hvidt tørstof.
White to off-white powder.
Behandling af følgende infektioner, forårsaget af bakterier der vides at være, eller sandsynligvis at være, følsomme over for ertapenem, samt når parenteral behandling er nødvendig (se afsnit 4. 4 og afsnit 5. 1):
Treatment of the following infections when caused by bacteria known or very likely to be susceptible to ertapenem and when parenteral therapy is required (see section 4.4 and section 5.1):
• Intra- abdominale infektioner • Non- nosocomiel pneumoni • Akutte gynækologiske infektioner • Diabetiske fodinfektioner i hud og bløddele (se afsnit 4. 4).
• Intra-abdominal infections • Community acquired pneumonia • Acute gynaecological infections • Diabetic foot infections of the skin and soft tissue (see section 4.4)
INVANZ er indiceret til voksne til profylakse af infektion på operationssted efter elektiv kolorektal operation.
INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery.
Officielle retningslinier for brug af passende antibakterielle stoffer bør iagttages.
Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Voksne og unge (13 – 17 år):
Adults and adolescents (13 to 17 years of age):
Dosis af INVANZ er 1 gram (g) givet 1 gang daglig ved intravenøs administration (se afsnit 6. 6).
The dose of INVANZ is 1 gram (g) given once a day by the intravenous route (see section 6.6).
Profylakse af infektion på operationssted efter elektiv kolorektal operation hos voksne:
Prophylaxis of surgical site infection following elective colorectal surgery in adults:
Til forebyggelse af infektioner på operationssted er den anbefalede dosis 1 g indgivet som en enkelt intravenøs dosis, der skal være afsluttet 1 time før indgrebet.
To prevent surgical site infections, the recommended dosage is 1 g administered as a single intravenous dose to be completed within 1 hour prior to the surgical incision.
Til spædbørn og børn (3 måneder til 12 år): Dosis af INVANZ er 15 mg/ kg givet 2 gange daglig (må ikke overstige 1 g/ dag) ved intravenøs administration (se afsnit 6. 6).
The dose of INVANZ is 15 mg/ kg given twice daily (not to exceed 1 g/ day) by the intravenous route (see section 6.6).
INVANZ bør ikke anvendes til børn under 3 måneder p. g. a. manglende dokumentation for sikkerhed og virkning (se afsnit 4. 4; 5. 1 og 5. 2).
INVANZ is not recommended for use in children below 3 months of age due to a lack of data on safety and efficacy (see sections 4.4; 5.1 and section 5.2).
Intravenøs administration:
Intravenous administration:
INVANZ skal infunderes over en periode på 30 minutter.
INVANZ should be infused over a period of 30 minutes.
2 Sædvanlig varighed af behandling med INVANZ er 3 - 14 dage, men kan variere afhængig af type og sværhedsgrad af infektionen og af kausale patogener.
2 The usual duration of therapy with INVANZ is 3 to 14 days but may vary depending on the type and severity of infection and causative pathogen(s).
Hvis der er klinisk indikation herfor, kan skift til passende oral antibakteriel behandling initieres såfremt klinisk forbedring er observeret.
When clinically indicated, a switch to an appropriate oral antibacterial agent may be implemented if clinical improvement has been observed.
INVANZ kan anvendes til behandling af infektioner hos voksne patienter med nyreinsufficiens.
INVANZ may be used for the treatment of infections in adult patients with renal insufficiency.
Dosisjustering er ikke nødvendig hos patienter med creatininclearance > 30 ml/ min/ 1, 73 m2.
In patients whose creatinine clearance is > 30 ml/ min/ 1.73 m2, no dosage adjustment is necessary.
Der foreligger ikke tilstrækkelig data om ertapenems sikkerhed og effekt hos patienter med fremskreden nyreinsufficiens, der kan understøtte en dosisrekommandation.
There are inadequate data on the safety and efficacy of ertapenem in patients with advanced renal insufficiency to support a dose recommendation.
Derfor bør ertapenem ikke anvendes til disse patienter (se afsnit 5. 2).
Therefore, ertapenem should not be used in these patients.
Der er ingen data for børn og unge med nyreinsufficiens.
(See section 5.2.) There are no data in children and adolescents with renal insufficiency.
Patienter i hæmodialyse:
Patients on haemodialysis:
Der foreligger ikke tilstrækkelig data om ertapenems sikkerhed og effekt hos patienter i hæmodialyse, der kan understøtte en dosisrekommandation.
There are inadequate data on the safety and efficacy of ertapenem in patients on haemodialysis to support a dose recommendation.
Der anbefales ikke dosisjustering til patienter med leverinsufficiens (se afsnit 5. 2).
No dosage adjustment is recommended in patients with impaired hepatic function (see section 5.2).
Der bør administreres anbefalet dosis af INVANZ, bortset fra i tilfælde af fremskreden nyreinsufficiens (se Nyreinsufficiens).
The recommended dose of INVANZ should be administered, except in cases of advanced renal insufficiency (see Renal insufficiency).
• Overfølsomhed over for det aktive stof eller et eller flere af hjælpestofferne • Overfølsomhed over for andre carbapenem antibakterielle lægemidler • Svær overfølsomhed (f. eks. anafylaktisk reaktion, svær hudreaktion) ved andre beta- lactam antibakterielle lægemidler (f. eks. penicilliner eller cefalosporiner).
• Hypersensitivity to the active substance or to any of the excipients • Hypersensitivity to any other carbapenem antibacterial agent • Severe hypersensitivity (e. g., anaphylactic reaction, severe skin reaction) to any other type of beta-lactam antibacterial agent (e. g., penicillins or cephalosporins).
Der er rapporteret alvorlige, og ind i mellem fatale, overfølsomhedsreaktioner (anafylaktiske reaktioner) hos patienter i behandling med beta- lactamer.
Serious and occasionally fatal hypersensitivity (anaphylactic) reactions have been reported in patients receiving therapy with beta-lactams.
Inden påbegyndelse med behandling med ertapenem, bør patienten nøje udspørges vedrørende tidligere overfølsomhedsreaktioner i forbindelse med penicillin, cefalosporiner, andre beta- lactamer samt andre allergener (se afsnit 4. 3).
Before initiating therapy with ertapenem, careful inquiry should be made concerning previous hypersensitivity reactions to penicillins, cephalosporins, other beta-lactams and other allergens (see section 4.3).
Hvis der opstår overfølsomhedsreaktion på ertapenem, skal behandlingen straks seponeres.
If an allergic reaction to ertapenem occurs, discontinue the therapy immediately.
Som ved brug af andre antibiotika, kan længerevarende brug af ertapenem resultere i overvækst af ikke- følsomme organismer.
As with other antibiotics, prolonged use of ertapenem may result in overgrowth of non-susceptible organisms.
Hvis der opstår anden infektion under behandlingen, skal der tages relevante forholdsregler.
If superinfection occurs during therapy, appropriate measures should be taken.
Der er rapporteret antibiotika- associeret colitis og pseudomembranøs colitis med næsten alle antibakterielle stoffer, inklusiv ertapenem, i sværhedsgrad varierende fra mild til livstruende.
Antibiotic-associated colitis and pseudomembranous colitis have been reported with nearly all antibacterial agents, including ertapenem, and may range in severity from mild to life-threatening.
Under klinisk undersøgelse er der rapporteret om kramper hos voksne i behandling med ertapenem natrium (1 g en gang daglig) eller i 14- dages opfølgningsperioden.
Seizures have been reported during clinical investigation in adult patients treated with ertapenem sodium (1g once a day) during therapy or in the 14-day follow-up period.
Kramper forekom mest almindeligt hos ældre patienter og hos patienter med eksisterende CNS sygdomme (f. eks. hjernelæsion eller kramper i anamnesen) og/ eller kompromitteret nyrefunktion.
Seizures occurred most commonly in elderly patients and those with pre-existing CNS disorders (e. g., brain lesions or history of seizures) and/ or compromised renal function.
Der er gjort lignende observationer efter markedsføring.
Similar observations have been made in the post- marketing environment.
Effekt af INVANZ til behandling af non- nosocomiel pneumoni på grund af penicillinresistent Streptococcus pneumoniae er ikke undersøgt.
3 The efficacy of INVANZ in the treatment of community acquired pneumonia due to penicillin- resistant Streptococcus pneumoniae has not been established.
Der er relativt ringe erfaring med ertapenem til børn
There is relatively little experience with ertapenem in children less than two years of age.
I kliniske undersøgelser af behandling af non- nosocomiel pneumoni, hos voksne, havde 25% af de evaluerbare patienter behandlet med ertapenem svær sygdom (defineret som pneumoni sværhedsindex - > III).
In clinical studies for the treatment of community-acquired pneumonia, in adults, 25% of evaluable patients treated with ertapenem had severe disease (defined as pneumonia severity index > III).
I en klinisk undersøgelse af akutte gynækologiske infektioner, hos voksne, havde 26% af de evaluerbare patienter behandlet med ertapenem svær sygdom (defineret som temperatur ≥ 39°C og/ eller bacteriæmi) ti patienter havde bacteriæmi.
In a clinical study for the treatment of acute gynaecologic infections, in adults, 26% of evaluable patients treated with ertapenem had severe disease (defined as temperature ≥ 39°C and/ or bacteraemia); ten patients had bacteraemia.
Evaluerbare patienter behandlet med ertapenem i en klinisk undersøgelse af behandling af intra- abdominale infektioner, hos voksne, havde 30% af disse generaliseret peritonitis og 39% havde infektioner, der involverede andre positioner end appendiks, inkluderende mave, duodenum, tyndtarm, colon og galdeblære; der var et begrænset antal evaluerbare patienter med APACHE II scores ≥ 15, og effekt hos disse patienter er ikke påvist.
Of evaluable patients treated with ertapenem in a clinical study for the treatment of intra- abdominal infections, in adults, 30% had generalized peritonitis and 39% had infections involving sites other than the appendix including the stomach, duodenum, small bowel, colon, and gallbladder; there were limited numbers of evaluable patients who were enrolled with APACHE II scores ≥ 15 and efficacy in these patients has not been established.
Effekt af ertapenem i behandlingen af diabetiske fodinfektioner med ledsagende osteomyelitis er ikke påvist.
Efficacy of ertapenem in the treatment of diabetic foot infections with concurrent osteomyelitis has not been established.
På basis af de tilgængelige data kan det ikke udelukkes, at patienter kan blive udsat for sub- optimale ertapenem koncentrationer og dermed risikoen for potentiel mislykket behandling i de få tilfælde af kirurgiske indgreb på over 4 timer.
Based on the data available it cannot be excluded that in the few cases of surgical interventions exceeding 4 hours, patients could be exposed to sub-optimal Ertapenem concentrations and consequently to a risk of potential treatment failure.
137 mg) natrium per 1, 0 g dosis, hvilket bør tages med i overvejelserne hos patienter på kontrolleret natriumdiæt.
This medicinal product contains approximately 6.0 mEq (approximately 137 mg) of sodium per 1.0 g dose which should be taken into consideration by patients on a controlled sodium diet.
Interaktioner forårsaget af hæmning af P- glycoproteinmedieret clearance eller CYP- medieret clearance af lægemidler er ikke sandsynlig (se afsnit 5. 2).
Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2).
De antibakterielle stoffer penem og carbapenem kan reducere serumniveauer af valproinsyre.
Penem and carbapenem antibacterial agents may decrease the serum levels of valproic acid.
Monitorering af valproinsyre bør overvejes hvis ertapenem skal administreres samtidig med valproinsyre.
Monitoring of serum levels of valproic acid should be considered if ertapenem is to be co- administered with valproic acid.
Der er ikke udført tilstrækkelige og velkontrollerede undersøgelser med gravide kvinder.
Adequate and well-controlled studies have not been performed in pregnant women.
Dyreundersøgelser har ikke vist direkte eller indirekte skadelige virkninger med hensyn til graviditet, embryoføtal udvikling, fødselsforløb eller postnatal udvikling.
Animal studies do not indicate direct or indirect harmful effects with respect to pregnancy, embryo-foetal development, parturition or post-natal development.
INVANZ kan påvirke patientens evne til at føre motorkøretøj og/ eller betjene maskiner.
INVANZ may influence patients' ability to drive and use machines.
Patienter bør informeres om, at der er rapporteret om svimmelhed og søvnighed i forbindelse med brug af INVANZ (se afsnit 4. 8).
Patients should be informed that dizziness and somnolence have been reported with INVANZ (see section 4.8).
Voksne (18 år og ældre):
Adults 18 years of age and older:
Det totale antal patienter behandlet med ertapenem i kliniske undersøgelser er over 2. 200, ud af disse modtog mere end 2. 150 en dosis på 1 g ertapenem.
4 The total number of patients treated with ertapenem in clinical studies was over 2,200 of which over 2,150 received a 1 g dose of ertapenem.
20% af patienterne behandlet med ertapenem.
Adverse reactions (i. e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20% of patients treated with ertapenem.
Behandling blev seponeret på grund af utilsigtede reaktioner hos 1, 3% af patienterne.
Treatment was discontinued due to adverse reactions in 1.3% of patients.
I en klinisk undersøgelse fik yderligere 476 patienter ertapenem som en enkelt 1 g dosis før operation som profylakse for infektioner på operationssted efter kolorektal operation.
An additional 476 patients received ertapenem as a single 1 g dose prior to surgery in a clinical study for the prophylaxis of surgical site infections following colorectal surgery.
Hos patienter der udelukkende fik INVANZ, var de hyppigst rapporterede utilsigtede hændelser i løbet af behandling plus en 14 dages follow- up efter behandlingen blev seponeret: diarré (4, 8%), infusionsvenekomplikationer (4, 5%) og kvalme (2, 8%).
For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (4.8%), infused vein complication (4.5%) and nausea (2.8%).
Øgning i ALAT (4, 6%), ASAT (4, 6%), alkalisk phosphatase (3, 8%) og thrombocyttal (3, 0%).
For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: elevations in ALT (4.6%), AST (4.6%), alkaline phosphatase (3.8%) and platelet count (3.0%).
Børn og unge (3 måneder til 17 år):
Children and adolescents (3 months to 17 years of age):
Det totale antal patienter behandlet med ertapenem i kliniske undersøgelser var 384.
The total number of patients treated with ertapenem in clinical studies was 384.
20, 8% af de patienter, der blev behandlet med ertapenem.
Adverse reactions (i. e., considered by the investigator to be possibly, probably, or definitely related to the medicinal product) were reported in approximately 20.8% of patients treated with ertapenem.
Behandlingen blev seponeret hos 0, 5% af patienterne pga. bivirkninger.
Treatment was discontinued due to adverse reactions in 0.5% of patients.
Hos patienter, der kun fik INVANZ, var de mest almindelige bivirkninger under behandling samt 14 dages follow- up efter behandlingen seponeredes: diarré (5, 2%) og smerte ved infusionsstedet (6, 1%).
For patients who received only INVANZ, the most common adverse reactions reported during therapy plus follow-up for 14 days after treatment was stopped were: diarrhoea (5.2%) and infusion site pain (6.1%).
Nedsat neutrofiltal (3, 0%) og øgning i ALAT (2, 9%) og ASAT (2, 8%).
For patients who received only INVANZ, the most frequently reported laboratory abnormalities and their respective incidence rates during therapy plus follow-up for 14 days after treatment was stopped were: decreases in neutrophil count (3.0%), and elevations in ALT (2.9%) and AST (2.8%).
Hos patienter der udelukkende fik INVANZ, blev følgende utilsigtede relaterede reaktioner rapporteret i løbet af den behandling plus en 14 dages follow- up efter behandlingen blev seponeret:
For patients who received only INVANZ, the following adverse reactions were reported during therapy plus follow-up for 14 days after treatment was stopped:
Almindelig (≥1/ 100 til < 1/ 10); ikke almindelig (≥ 1/ 1. 000 til < 1/ 100); sjælden (≥1/ 10. 000 til < 1/ 1. 000); meget sjælden (< 1/ 10. 000)
Common (≥ 1/ 100 to < 1/ 10); Uncommon (≥ 1/ 1000 to < 1/ 100); Rare (≥ 1/ 10,000 to < 1/ 1000); Very rare (< 1/ 10,000)
Voksne (18 år og ældre)
Adults 18 years of age and older
Børn og unge (3 måneder til 17 år)
Children and adolescents (3 months to 17 years of age)
Infektioner og parasitære sygdomme Blod og lymfesystem
Blood and lymphatic disorders:
Oral candidiasis Sjælden:
Oral candidiasis Rare:
Ikke almindelig:
Neutropenia, thrombocytopenia Uncommon:
Anorexi Sjælden:
Anorexia Rare:
Hovedpine Ikke almindelig:
Headache Uncommon:
Svimmelhed, søvnighed, søvnløshed, konfusion, kramper (se afsnit 4. 4) Sjælden:
Dizziness, somnolence, insomnia, confusion, seizure (see section 4.4) Rare:
Agitation, angst, depression, skælven
Agitation, anxiety, depression, tremor
Hjerte
Cardiac Disorders:
Sinusbradukardi Sjælden:
Sinus bradycardia Rare:
Arytmi, takykardi
Arrhythmia, tachycardia
Vaskulære sygdomme
Vascular Disorders:
Phlebitis/ thrombophlebitis
Phlebitis/ thrombophlebitis Uncommon:
Hedeture, hypertension, petekkier
Hot flush, hypertension, petechiae
Hypotension Sjælden:
Respiratory, thoracic and mediastinal disorders:
Dyspnø, pharyngeale gener Sjælden:
Dyspnoea, pharyngeal discomfort Rare:
Tilstoppet næse, hoste, epistaxi, pneumoni, rales/ rhonchi, hvæsen
Nasal congestion, cough, epistaxis, pneumonia, rales/ rhonchi, wheezing
Mave- tarmkanalen
Gastrointestinal disorders:
Diarré, kvalme, opkastning Ikke almindelig:
Diarrhoea, nausea, vomiting Uncommon:
Obstipation, pseudomembranøs enterocolitis, syreregurgitation, tør mund, dyspepsi Sjælden:
Constipation, pseudomembranous enterocolitis, acid regurgitation, dry mouth, dyspepsia Rare:
Dysphagi, fækal inkontinens
Dysphagia, faecal incontinence
Diarré Ikke almindelig:
Diarrhoea Uncommon:
Misfarvet faeces, melaena
Faeces discoloured, melaena
Cholecystitis, icterus, leverforstyrrelser
Cholecystitis, jaundice, liver disorder
Udslæt, pruritus Ikke almindelig:
Rash, pruritus Uncommon:
Erythem, urticaria Sjælden:
Erythema, urticaria Rare:
Dermatitis, dermatomykose, afskalning, postoperativ sårinfektion
Dermatitis, dermatomycosis, desquamation, postoperative wound infection
Bledermatitis Ikke almindelig:
Diaper dermatitis Uncommon:
Erythema, udslæt
Erythema, rash
Knogler, led, muskler og bindevæv Nyrer og urinveje
Musculoskeletaland connective tissue disorders:
Muskelkramper, skuldersmerter Sjælden:
Muscle cramp, shoulder pain Rare:
Urinvejsinfektion, nyreinsufficiens, akut nyreinsufficiens
Urinary tract infection, renal insufficiency, acute renal insufficiency
Vaginitis Sjælden:
Vaginitis Rare:
Abort, genital blødning
Abortion, genital bleeding
Almene symptomer og reaktioner på administrationsstedet Laboratorieresultater:
Laboratory test findings:
Infusionsvenekomplikationer Ikke almindelig:
Infused vein complication Uncommon:
Ekstravasation, abdominalsmerter, candidiasis, asteni/ træthed, svampeinfektion, feber, ødem/ hævelser, brystsmerter, smagsforstyrrelser Sjælden:
Extravasation, abdominal pain, candidiasis, asthenia/ fatigue, fungal infection, fever, oedema/ swelling, chest pain, taste perversion Rare:
Allergi, induration på injektionsstedet, utilpashed, pelviopritonitis, sclerale forstyrrelser, synkope
Allergy, injection-site induration, malaise, pelvic peritonitis, scleral disorder, syncope
Smerte ved infusionsstedet Ikke almindelig:
Infusion site pain Uncommon:
Brændende fornemmelse ved infusionsstedet, kløe ved infusionsstedet, erythema ved infusionsstedet, erythema ved injektionsstedet, varme ved infusionsstedet
Infusion site burning, infusion site pruritus, infusion site erythema, injection site erythema, infusion site warmth
Kemi
Chemistry:
Forhøjet ALAT, ASAT, alkalisk phosphatase Ikke almindelig:
Elevations in ALT, AST, alkaline phosphatase Uncommon:
Forhøjet total serumbilirubin, direkte serumbilirubin og indirekte serumbilirubin; serumcreatinin; serumcarbamid, serumglucose Sjælden:
Increases in total serum bilirubin, direct serum bilirubin, indirect serum bilirubin, serum creatinine, serum urea, serum glucose Rare:
Fald i serumbicarbonat, serumcreatinin og serumkalium; øget serum LDH, serumfosfat og serumkalium
Decreases in serum bicarbonate, serum creatinine, and serum potassium; increases in serum LDH, serum phosphorus, serum potassium
Forhøjelser af ALAT og ASAT
Elevations in ALT and AST
Hæmatologi
Haematology:
Forhøjet thrombocyttal
Elevation in platelet 6
Øgning af
Decreases in
Ikke almindelig:
count Uncommon:
leukocytter, fald i thrombocyttal og segmenterede neutrofiler, fald i hæmoglobin og hæmatocrit; forhøjede eosinophiltal, øget APPT, øget protrombintid, øget segmenterede neutrofiler og hvide blodlegemer Sjælden:
Decreases in white blood cells, platelet count, segmented neutrophils, haemoglobin and haematocrit; increases in eosinophils, activated partial thromboplastin time, prothrombin time, segmented neutrophils, and white blood cells Rare:
Fald i lymfocytter; stigning i båndneutrofiler, lymfocytter, metamyelocytter, monocytter og myelocytter; atypiske lymfocytter
Decrease in lymphocytes; increases in band neutrophils, lymphocytes, metamyelocytes, monocytes, myelocytes; atypical lymphocytes
prothrombintid, fald i hæmoglobin
neutrophil count Uncommon:
Urinanalyse
Urinalysis:
Stigning i urinbakterier, hvide blodlegemer i urinen, urine epithelceller og røde blodlegemer i urinen; gærceller til stede i urinen Sjælden:
Increases in urine bacteria, urine white blood cells, urine epithelial cells, and urine red blood cells; urine yeast present Rare:
Stigning i urobilinogen
Increase in urobilinogen
Diverse Erfaring efter markedsføring:
Post Marketing Experience:
Positiv Clostridium difficile toksin
Positive Clostridium difficile toxin
Anafylaksi inklusive anafylaktiske reaktioner
Anaphylaxis including anaphylactoid reactions
Psykiske forstyrrelser Nervesystemet:
Nervous system disorders:
Ændret mental tilstand Hallucinationer
Altered mental status Hallucinations
Intravenøs administration af ertapenem 3 g daglig i 8 dage til raske voksne frivillige resulterede ikke i signifikant toksicitet.
Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity.