FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Danish: 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.
English: Localised clusters of infections due to carbapenem-resistant organisms have been reported in the European Union.
Danish: Der er i den Europæiske Union rapporteret om lokaliserede infektionsklynger grundet carbapenem-resistente organismer.
English: Efficacy in Paediatric Studies
Danish: Effekt i pædiatriske studier
English: Do not use solvents or infusion fluids containing dextrose for reconstitution or administration of ertapenem.
Danish: Brug ikke solvenser eller infusionsvæsker indeholdende glucose til rekonstitution eller administration af ertapenem.
English: 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.
Danish: In-vitro studier 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.
English: It is particularly important that your doctor knows if you have kidney disease and whether you undergo dialysis treatment.
Danish: Det er særlig vigtigt, at Deres læge ved, om De har nyresygdom, og om De er i dialysebehandling.
English: Prevention
Danish: Forebyggelse
English: Rare: Scleral disorder
Danish: Sjælden: Sklerale forstyrrelser
English: • Hypersensitivity to any other carbapenem antibacterial agent
Danish: • Overfølsomhed over for andre carbapenem antibakterielle lægemidler
English: The mechanism of action of ertapenem differs from that of other classes of antibiotics, such as quinolones, aminoglycosides, macrolides and tetracyclines.
Danish: Ertapenems virkningsmekanisme er forskellig fra andre antibiotikaklassers, såsom quinoloner, aminoglykosider, makrolider og tetracykliner.
English: There is relatively little experience with ertapenem in children less than two years of age.
Danish: Der er relativt ringe erfaring med ertapenem til børn under 2 år.
English: Decreased neutrophil counts, however, occurred in rats that received high doses of ertapenem, which was not considered a significant safety issue.
Danish: Der sås imidlertid fald i neutrofiltal hos rotter der fik høje doser ertapenem; dette blev ikke betragtet som havende betydning for sikkerhedsprofilen.
English: Discontinuation of therapy with INVANZ and the administration of specific treatment for Clostridium difficile should be considered.
Danish: Det bør overvejes at seponere behandlingen med INVANZ samt den specifikke behandling for Clostridum difficile.
English: • abnormal movements
Danish: • Unormale bevægelser
English: In clinical studies in adults inadvertent administration of up to 3 g in a day did not result in clinically important adverse reactions.
Danish: I kliniske studier af voksne resulterede uforsætlig administration af op til 3 g på en dag ikke i utilsigtede reaktioner af klinisk betydning.
English: In paediatric clinical studies, a single intravenous (IV) dose of 40 mg/kg up to a maximum of 2 g did not result in toxicity.
Danish: I pædiatriske kliniske studier resulterede en enkelt intravenøs (IV) dosis på 40 mg/kg op til maksimalt 2 g ikke i toksicitet.
English: Ertapenem is highly bound to human plasma proteins.
Danish: Ertapenem bindes i udstrakt grad til humane plasmaproteiner.
English: Uncommon: Headache Not known: Hallucinations
Danish: Ikke almindelig: Hovedpine Ikke kendt: Hallucinationer
English: During treatment, if you experience an allergic reaction (such as swelling of the face, tongue or throat, difficulty in breathing or swallowing, skin rash), tell your doctor straight away as you may need urgent medical treatment.
Danish: Hvis De får en allergisk reaktion under behandlingen (såsom hævelse af ansigt, tunge eller svælg, besvær med at trække vejret eller synke, hududslæt), skal De straks kontakte lægen, da De kan have brug for øjeblikkelig lægehjælp.
English: Warnings and precautions Talk to your doctor, nurse or pharmacist before taking INVANZ.
Danish: Advarsler og forsigtighedsregler Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før De tager INVANZ.
English: F-63963 Clermont-Ferrand Cedex 9, France.
Danish: F-63963 Clermont-Ferrand Cedex 9, Frankrig.
English: Intravenous administration of ertapenem at a 3 g daily dose for 8 days to healthy adult volunteers did not result in significant toxicity.
Danish: Intravenøs administration af ertapenem 3 g dagligt i 8 dage til raske voksne frivillige resulterede ikke i signifikant toksicitet.
English: 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.
Danish: 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.
English: 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 bacteraemia at entry into the study.
Danish: Dette omfatter 9 patienter i ertapenem-gruppen (7 med samfundserhvervet pneumoni og 2 med intraabdominale infektioner), 2 patienter i ceftriaxon-gruppen (2 med samfundserhvervet pneumoni) og 1 patient med intra-abdominale infektioner i ticarcillin/clavulanat-gruppen med sekundær bakteriæmi ved inklusion i studiet.
English: • Low blood pressure, slow heart rate
Danish: • Lavt blodtryk, langsom hjerterytme
English: Women who are receiving INVANZ should not breast-feed, because it has been found in human milk and the breast-fed baby may therefore be affected.
Danish: Kvinder, som får INVANZ, bør ikke amme, da INVANZ udskilles i modermælken, og det ammede barn kan derfor påvirkes.
English: The prescribers are informed that local MIC breakpoints, if available, should be consulted.
Danish: Lægen, der udskriver medicinen, informeres om, at der bør bruges lokale MIC grænseværdier, hvis de findes.
English: Do not freeze the reconstituted solutions.
Danish: Rekonstituerede opløsninger må ikke fryses.
English: 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.
Danish: Det farmakokinetiske/farmakodynamiske (PK/PD) forhold I lighed med andre beta-laktam antimikrobielle stoffer har tiden som ertapenems plasmakoncentration overstiger den inficerende organismes MIC vist sig bedst at korrelere med effekten i prækliniske PK/PD studier.
English: Of the 80 % recovered in urine, approximately 38 % is excreted as unchanged ertapenem and approximately 37 % as the ring-opened metabolite.
Danish: Af de 80% genfundet i urinen, er ca. 38% udskilt uomdannet og ca. 37% i hydrolyseret form.
English: Interactions caused by inhibition of P-glycoprotein-mediated clearance or CYP-mediated clearance of medicinal products are unlikely (see section 5.2).
Danish: Interaktioner forårsaget af hæmning af P-glykoproteinmedieret eller CYP-medieret clearance af lægemidler er ikke sandsynlige (se pkt.
English: However, ertapenem should not be used during pregnancy unless the potential benefit outweighs the possible risk to the foetus.
Danish: Ertapenem bør dog ikke anvendes under graviditet med mindre den potentielle fordel opvejer mulige risici for fostret.
English: Resistance can however be observed when ESBLs or other potent beta-lactamases (e.g. AmpC types) are present in conjunction with reduced permeability, arising by the loss of one or more outer membrane porins, or with up-regulated efflux.
Danish: Resistens kan imidlertid observeres, når ESBL eller andre potente beta-laktamaser (f.eks. AmpC typer) er til stede i forbindelse med reduceret permeabilitet, der opstår ved tab af en eller flere ydre membranporiner, eller med opreguleret udstrømning.
English: 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.
Danish: In-vitro studier viser, at ertapenem havde en lille effekt på plasmaproteinbinding hos meget proteinbundne lægemidler (warfarin, ethinyl estradiol og norethindron).
English: The lowered valproic acid levels can lead to inadequate seizure control; therefore, concomitant use of ertapenem and valproic acid/sodium valproate is not recommended and alternative antibacterial or anti-convulsant therapies should be considered.
Danish: Den lavere koncentration af valproinsyre kan føre til utilstrækkelig anfaldskontrol; derfor bør ertapenem ikke gives samtidig med valproinsyre/natriumvalproat, og alternativ antibakteriel eller antikonvulsiv behandling bør overvejes.
English: It is important that you tell your doctor if you are pregnant or are planning to become pregnant before receiving INVANZ.
Danish: Det er vigtigt, at De fortæller lægen, om De er gravid eller planlægger at blive gravid, før De får INVANZ.
English: Methicillin-resistant staphylococci (including MRSA) are always resistant to beta-lactams.
Danish: Methicillin-resistente stafylokokker (inklusive MRSA) er altid resistente over for beta-laktamer.
English: Rare: Genital bleeding
Danish: Sjælden: Genital blødning
English: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products except those mentioned in section 6.6.
Danish: Da der ikke foreligger studier over eventuelle uforligeligheder, må dette lægemiddel ikke blandes med andre lægemidler end dem, der er anført under pkt.
English: Resistance can also arise via the acquisition of beta-lactamases with significant carbapenem-hydrolysing activity (e.g. IMP and VIM metallo-beta-lactamases or KPC types), though these are rare.
Danish: Resistens kan også opstå via tilegnelse af beta-laktamaser med signifikant carbapenem-hydrolyserende aktivitet (f.eks. IMP og VIM metallo-beta-laktamaser eller KPC typer), skønt disse er sjældne.
English: Seizures occurred most commonly in elderly patients and those with pre-existing central nervous system (CNS) disorders (e.g. brain lesions or history of seizures) and/or compromised renal function.
Danish: Kramper forekom mest almindeligt hos ældre patienter og hos patienter med eksisterende sygdomme i centralnervesystemet (CNS) (f.eks. hjernelæsion eller kramper i anamnesen) og/eller kompromitteret nyrefunktion.
English: What you need to know before you are given INVANZ
Danish: Det skal De vide, før De får INVANZ
English: • Problems with the vein into which the medicine is given (including inflammation, formation of a lump, swelling at the injection site, or leaking of fluid into the tissue and skin around the injection site)
Danish: • Problemer i venen, hvor medicinen indgives (inklusive betændelse, knudedannelse, hævelse på injektionsstedet eller væskeudsivning i vævet og huden omkring injektionsstedet)
English: The safety and efficacy of INVANZ in children below 3 months of age have not yet been established.
Danish: INVANZ' sikkerhed og virkning hos børn under 3 måneder er endnu ikke klarlagt.
English: • Intra-abdominal infections
Danish: • Intra-abdominale infektioner
English: Solutions of INVANZ range from colourless to pale yellow.
Danish: Opløsninger af INVANZ kan variere fra farveløs til lys gul.
English: Preclinical studies do not indicate direct or indirect harmful effects with respect to fertility (see section 5.3).
Danish: Prækliniske studier viser ingen direkte eller indirekte skadelige virkninger med hensyn til fertilitet (se pkt.
English: There have also been reports of changes in some laboratory blood tests.
Danish: Der er også set ændringer i laboratorieresultater af blodprøver.
English: Do not use this medicine after the expiry date which is stated on the container.
Danish: Brug ikke INVANZ efter den udløbsdato, der står på pakningen efter EXP.
English: Rare: Neutropenia, thrombocytopenia
Danish: Sjælden: Neutropeni, trombocytopeni
English: If you experience raised or fluid-filled skin spots over a large area of your body, tell your doctor or nurse straight away.
Danish: Hvis De oplever hævede eller væskefyldte hudpletter på en stor del af kroppen, skal De straks kontakte lægen eller sygeplejersken.
English: INVANZ may influence patients' ability to drive and use machines.
Danish: INVANZ kan påvirke patientens evne til at føre motorkøretøj og/eller betjene maskiner.
English: Area under the plasma concentration curve (AUC) of ertapenem in adults increases nearly doseproportionally over the 0.5 to 2 g dose range.
Danish: Arealet under plasmakoncentrationskurven (AUC) af ertapenem hos voksne øges næsten dosisproportionelt inden for dosisspændet 0,5 - 2 g.
English: Overdosing of ertapenem is unlikely.
Danish: Overdosering med ertapenem er ikke sandsynlig.
English: INVANZ is indicated in paediatric patients (3 months to 17 years of age) and in adults for the 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 sections 4.4 and 5.1):
Danish: INVANZ er indiceret til pædiatriske patienter (i alderen 3 måneder til 17 år) og til voksne til behandling af følgende infektioner forårsaget af bakterier, der vides at være eller sandsynligvis er følsomme over for ertapenem, når parenteral behandling er nødvendig (se pkt.
English: Ertapenem is effectively stable to hydrolysis by most classes of betalactamases, including penicillinases, cephalosporinases and extended spectrum beta-lactamases, but not metallo-beta-lactamases.
Danish: Ertapenem er effektivt stabilt over for hydrolyse af de fleste betalaktamaseklasser, inklusive penicillinaser, cefalosporinaser og udvidede spektrum beta-laktamaser, men ikke metallo-beta-laktamaser.
English: Each vial contains: 1.0 g ertapenem (as sodium).
Danish: Hvert hætteglas indeholder: 1,0 g ertapenem (som natrium).
English: Antibiotic-associated colitis and pseudomembranous colitis have been reported with ertapenem and may range in severity from mild to life-threatening.
Danish: Der er rapporteret antibiotika-associeret colitis og pseudomembranøs colitis med ertapenem, i sværhedsgrad varierende fra mild til livstruende.
English: Therefore, ertapenem should not be used in these patients (see section 5.2.).
Danish: Derfor bør ertapenem ikke anvendes til disse patienter (se pkt.
English: Resistance is uncommon in Enterobacteriaceae and ertapenem is generally active against those with extended-spectrum beta-lactamases (ESBLs).
Danish: Resistens er usædvanlig hos Enterobacteriaceae, og ertapenem er generelt aktivt over for dem med udvidet spektrum beta-laktamaser (ESBL).
English: EU/1/02/216/001 1 vial EU/1/02/216/002 10 vials
Danish: EU/1/02/216/001 1 hætteglas EU/1/02/216/002 10 hætteglas
English: 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.
Danish: Bivirkninger (dvs. af investigator anset for at være muligvis, sandsynligvis eller afgjort lægemiddelrelateret) blev rapporteret hos ca. 20,8 % af de patienter, der blev behandlet med ertapenem.
English: 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.
Danish: 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.
English: It is important that you tell your doctor if you have diarrhoea before, during or after your treatment with INVANZ.
Danish: Det er vigtigt, at De fortæller det til lægen, hvis De får diarré før, under eller efter behandling med INVANZ.
English: The proportion of patients with a favourable clinical response assessment at posttreatment visit in the clinical MITT population is shown below:
Danish: Fordelingen af patienter med favorabel klinisk responsvurdering ved kontrolbesøg efter afslutning af behandling i den kliniske MITT (modified intention to treat) population ses nedenfor:
English: 2 to 12 years 13 to 17 years
Danish: 2 - 12 år 13 - 17 år
English: Since the drug has been marketed, severe allergic reactions (anaphylaxis), hypersensitivity syndromes (allergic reactions including rash, fever, abnormal blood tests) have been reported.
Danish: Efter lægemidlet er markedsført, er der set alvorlige allergiske reaktioner (anafylaksi), overfølsomhedssymptomer (allergiske reaktioner som udslæt, feber, unormale blodprøver).
English: 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.
Danish: 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.
English: Fusobacterium species*
Danish: Fusobacterium arter
English: INVANZ contains ertapenem which is an antibiotic of the beta-lactam group.
Danish: INVANZ indeholder ertapenem, som er et antibiotikum (tilhørende beta-laktamgruppen).
English: There is no accumulation of ertapenem in adults following multiple intravenous doses ranging from 0.5 to 2 g daily.
Danish: Ertapenem akkumuleres ikke hos voksne efter gentagne intravenøse doser fra 0,5 -2 g dagligt.
English: 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.
Danish: I et klinisk studie fik yderligere 476 patienter ertapenem som en enkelt 1 g dosis før operation som profylakse for infektioner på operationssted efter kolorektal operation.
English: Not known: Altered mental status (including aggression)
Danish: Ikke kendt: Ændret mental status (inklusive aggression)
English: Detailed information on this medicinal product is available on the website of the European Medicines Agency http://www.ema.europa.eu.
Danish: Yderligere oplysninger om INVANZ findes på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: • Decrease in white blood cells, decrease in blood platelet count
Danish: • Fald i hvide blodlegemer, fald i blodpladetal
English: There are no data in children and adolescents with renal impairment.
Danish: Der er ingen data for børn og unge med nedsat nyrefunktion.
English: Species for which acquired resistance may be a problem:
Danish: Arter for hvilke erhvervet resistens kan blive et problem: Gram-positive aerober:
English: • Changes in liver function tests
Danish: • Ændringer i leverfunktionstests
English: 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.
Danish: En sammenligning af resultater viste, at ved en dosis ertapenem på 1 g dagligt opnås en farmakokinetisk profil hos patienter i alderen 13 - 17 år, der er sammenlignelig med voksnes.
English: How to use INVANZ
Danish: Sådan skal INVANZ anvendes
English: General properties
Danish: Generelle egenskaber
English: Not known: Anaphylaxis including anaphylactoid reactions
Danish: Ikke kendt: Anafylaksi inklusive anafylaktiske reaktioner
English: • Irregular heart rate, increased blood pressure, bleeding, fast heart rate
Danish: • Forstyrrelser i hjerterytmen, forhøjet blodtryk, blødning, hurtig hjerterytme
English: Methicillin-susceptible-staphylococci (including Staphylococcus aureus)* Streptococcus agalactiae*
Danish: Methicillin-følsomme stafylokokker herunder Staphylococcus aureus* Streptococcus agalactiae*
English: • Acute gynaecological infections
Danish: • Akutte gynækologiske infektioner
English: The other ingredients are: sodium bicarbonate (E500) and sodium hydroxide (E524).
Danish: Øvrige indholdsstoffer: Natriumhydrogencarbonat (E500) og natriumhydroxid (E524).
English: • altered mental status (including aggression, delirium, disorientation, mental status changes)
Danish: • Ændret mental tilstand (herunder aggressivitet, delirium, desorientering, ændringer i den mentale tilstand)
English: Tell your doctor, nurse or pharmacist if you are taking medicines called valproic acid or sodium valproate (used to treat epilepsy, bipolar disorder, migraines, or schizophrenia).
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis De tager medicin, der indeholder valproinsyre eller natriumvalproat (til behandling af epilepsi, maniodepressiv psykose, migræne eller skizofreni).
English: Compatibility of INVANZ with intravenous solutions containing heparin sodium and potassium chloride has been demonstrated.
Danish: Der er vist forligelighed mellem INVANZ og intravenøse solvenser indeholdende heparinnatrium og kaliumchlorid.
English: The active ingredient of INVANZ is ertapenem 1 g.
Danish: Aktivt stof: Ertapenem 1 g.
English: The mean plasma half-life in children 3 months to 12 years of age is approximately 2.5 hours.
Danish: Den gennemsnitlige halveringstid hos børn i alderen 3 måneder - 12 år er ca. 2,5 time.
English: INVANZ is indicated in adults for the prophylaxis of surgical site infection following elective colorectal surgery (see section 4.4).
Danish: INVANZ er indiceret til voksne til profylakse mod infektion på operationssted efter elektiv kolorektal operation (se pkt.
English: 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.
Danish: I et klinisk studie med akutte gynækologiske infektioner hos voksne, havde 26% af de evaluerbare patienter behandlet med ertapenem svær sygdom (defineret som temperatur ≥39°C og/eller bakteriæmi); ti patienter havde bakteriæmi.
English: Following a single 1 g intravenous dose given immediately prior to a haemodialysis session, approximately 30 % of the dose is recovered in the dialysate.
Danish: Efter en enkelt intravenøs dosis på 1 g, administreret umiddelbart inden hæmodialyse, kan ca. 30% af dosis genfindes i dialysatet.
English: • Altered mental status (including aggression)
Danish: • Ændret mental tilstand (herunder aggressivitet)
English: Enterococci including Enterococcus faecalis and Enterococcus faecium Gram-negative aerobes:
Danish: Enterococci inklusive Enterococcus faecalis og Enterococcus faecium
English: Common: Infused vein complication, phlebitis/thrombophlebitis Uncommon: Hypotension Rare: Haemorrhage, increased blood pressure
Danish: Almindelig: Infusionsvenekomplikationer, flebitis/tromboflebitis Ikke almindelig: Hypotension Sjælden: Blødning, forhøjet blodtryk
English: 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).
Danish: I kliniske studier af behandling af samfundserhvervet pneumoni hos voksne, havde 25% af de evaluerbare patienter behandlet med ertapenem svær sygdom (defineret som pneumoni-sværhedsindex >III).
English: If you get any side effects, talk to your doctor, nurse or pharmacist.
Danish: Hvis De oplever bivirkninger, bør De tale med Deres læge, sygeplejerske eller apoteket.
English: Patients should be informed that dizziness and somnolence have been reported with INVANZ (see section 4.8).
Danish: Patienter bør informeres om, at der er rapporteret om svimmelhed og søvnighed i forbindelse med brug af INVANZ (se pkt.