FrancophonIA/ELRC3.0 huggingface dataset:
English: Meropenem alone is not known to interact with active transport systems.
Danish: Meropenem alene vides ikke at interagere med aktive transportsystemer.
English: This medicine can affect your liver.
Danish: Dette lægemiddel kan påvirke din lever.
English: Meropenem is mostly eliminated unchanged.
Danish: Meropenem elimineres hovedsagelig uændret.
English: It can kill many types of bacteria by preventing them from building the protective walls that surround their cells.
Danish: Det kan dræbe mange slags bakterier ved at forhindre dem i at bygge de beskyttende vægge, der omgiver deres celler.
English: Your doctor will decide how many days of treatment are needed, depending on the type of infection.
Danish: Lægen vil beslutte hvor mange dages behandling, du har brug for, afhængigt af infektionstypen.
English: Small amounts of this medicine may pass into the breast milk and it may affect the baby.
Danish: Små mængder af dette lægemiddel kan passere over i modermælken, og det kan påvirke barnet.
English: About 25% of the administered dose is eliminated as the inactive open ring form.
Danish: Cirka 25 % af den administrerede dosis elimineres som den inaktive, åbne ring.
English: Recommended Dosage Regimen2
Danish: Anbefalet doseringsregimen2
English: The concentration time profiles are similar for ELF and plasma.
Danish: Koncentration-tid-profilerne er de samme for ELF og plasma.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/18/1334/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/18/1334/001
English: It is also used to treat infections
Danish: Det bruges desuden til behandling af infektioner
English: You must not be given Vaborem if
Danish: Du må ikke få Vaborem, hvis
English: How you will be given Vaborem 4.
Danish: Sådan vil du få Vaborem 4.
English: Vaborem should not be used in children or adolescents under 18 years of age.
Danish: Vaborem må ikke anvendes til børn og unge under 18 år.
English: Direct and indirect Coombs test positive
Danish: Positiv direkte og indirekte Coombs' test
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Man bør være opmærksom på den officielle vejledning til passende brug af antibakterielle midler.
English: • caused by bacteria that other antibiotics may not be able to kill
Danish: • der skyldes bakterier, som andre antibiotika muligvis ikke kan dræbe
English: From a microbiological point of view, the medicinal product should be used immediately upon reconstitution and dilution.
Danish: Fra et mikrobiologisk synspunkt bør lægemidlet anvendes straks efter rekonstitution og fortynding.
English: Your doctor will monitor you closely for any new infections and give you another treatment if necessary.
Danish: Lægen vil kontrollere dig nøje for eventuelle nye infektioner og om nødvendigt give dig en anden behandling.
English: Less than 10
Danish: Under 10
English: Children or adolescents
Danish: Børn og unge
English: If you are pregnant, think you may be pregnant or are planning to have a baby, ask your doctor for advice before receiving this medicine.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds, før du får dette lægemiddel.
English: 20 to 39
Danish: 20 til 39
English: There is no experience with overdose of Vaborem.
Danish: Der er ingen erfaring med overdosering af Vaborem.
English: Frequency Infusion time Duration of treatment
Danish: Hyppighed Infusionstid Behandlingsvarighed
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Danish: Omslagspunkterne for mindste inhibitoriske koncentration (MIC), der er fastlagt af EUCAST (European Committee on Antimicrobial Susceptibility Testing), er som følger:
English: It may be due to bacteria called Clostridium difficile.
Danish: Det kan skyldes en bakterie, der kaldes for Clostridium difficile.
English: • of the blood associated with any of the infections mentioned above
Danish: • i blodet i forbindelse med en af ovenstående infektioner
English: • Swelling of the tongue, face, lips or throat
Danish: • Hævelse på tungen, ansigtet, læberne eller i halsen
English: • you have ever developed severe diarrhoea during or after antibiotic treatment
Danish: • du nogensinde har fået svær diarré under eller efter behandling med et antibiotikum
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 20 November 2018
Danish: Dato for første tilladelse: 20. november 2018
English: • medicines that weaken your body's immune system, such as tacrolimus, everolimus and cyclosporine
Danish: • medicin, som svækker kroppens immunsystem, for eksempel tacrolimus, everolimus og cyclosporin
English: Every 12 hours
Danish: Hver 12. time
English: There are no or limited amount of data (less than 300 pregnancy outcomes) from the use of meropenem/vaborbactam in pregnant women.
Danish: Der er ingen eller utilstrækkelige data (mindre end 300 graviditetsudfald) fra anvendelse af meropenem/vaborbactam til gravide kvinder.
English: This is because you may get an abnormal result with something called a “Coombs test”.
Danish: Det skyldes, at du kan få et unormalt resultat af en prøve, der kaldes for “Coombs' test”.
English: Alternative or additional antibacterial agents should be used when these pathogens are known or suspected to be contributing to the infectious process.
Danish: Der bør anvendes alternative eller yderligere antibakterielle midler, hvis disse patogener vides eller formodes at bidrage til infektionsprocessen.
English: Adverse reactions are classified according to frequency and System Organ Class.
Danish: Bivirkningerne er inddelt efter hyppighed og systemorganklasse.
English: Vaborem is not chemically compatible with glucose-containing solutions.
Danish: Vaborem er ikke kemisk kompatibelt med glucoseholdige opløsninger.
English: Vaborem will be given to you by a doctor or a nurse, so it is unlikely you will be given the wrong dose.
Danish: Vaborem vil blive givet af en læge eller sundhedspersonale, og det er derfor usandsynligt, at du vil få den forkerte dosis.
English: The reconstituted solution is not for direct injection.
Danish: Den rekonstituerede opløsning er ikke beregnet til direkte injektion.
English: Discontinuation of therapy with Vaborem and the administration of specific treatment for Clostridium difficile should be considered.
Danish: Seponering af behandlingen med Vaborem og administration af en specifik behandling mod Clostridium difficile bør overvejes.
English: Vaborem may decrease their effect
Danish: Vaborem kan reducere medicinens virkning
English: Vaborem is administered by intravenous infusion over 3 hours.
Danish: Vaborem administreres som en intravenøs infusion over 3 timer.
English: The risk may vary with the underlying infection, age and general status of the patient so that the contribution of the antibacterial agent to the increase in international normalised ratio (INR) is difficult to assess.
Danish: Risikoen kan variere alt efter den underliggende infektion, patientens alder og generelle status, og det er derfor vanskeligt at vurdere det antibakterielle middels bidrag til stigningen i INR (international normalised ratio).
English: This helps meropenem kill some bacteria that it cannot kill on its own.
Danish: Dette bidrager til, at meropenem dræber nogle bakterier, det ellers ikke ville kunne dræbe selv.
English: Minimum Inhibitory Concentrations (mg/l) Susceptible
Danish: Mindste inhibitoriske koncentrationer (mg/l) Følsom
English: • Peptostreptococcus species (including P. micros, P anaerobius, P. magnus)
Danish: • Peptostreptococcus species (inklusive P. micros, P. anaerobius, P. magnus)
English: How you will be given Vaborem
Danish: Sådan vil du få Vaborem
English: Therefore, caution should be exercised when driving or using machines.
Danish: Der skal derfor udvises forsigtighed i forbindelse med bilkørsel eller betjening af maskiner.
English: It is particularly important to tell your doctor if you are taking any of the following medicines:
Danish: Det er særlig vigtigt at fortælle det til lægen, hvis du bruger følgende medicin:
English: Pharmacotherapeutic group: antibacterials for systemic use, carbapenems, ATC code: J01DH52
Danish: Farmakoterapeutisk klassifikation: antibakterielle midler til systemisk anvendelse, carbapenemer, ATC-kode: J01DH52
English: 3 hours
Danish: 3 timer
English: The use of meropenem/vaborbactam may result in the overgrowth of non-susceptible organisms, which may require interruption of treatment or other appropriate measures.
Danish: Anvendelse af meropenem/vaborbactam kan medføre overvækst af ikke-følsomme organismer, som kan nødvendiggøre afbrydelse af behandlingen eller andre relevante foranstaltninger.
English: Non-clinical data reveal no special hazard for humans based on conventional studies of safety pharmacology, reproduction toxicity or genotoxicity.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra konventionelle studier af sikkerhedsfarmakologi, reproduktionstoksicitet samt genotoksicitet.
English: Non-susceptible organisms
Danish: Ikke-følsomme organismer
English: • Sudden and serious allergic reaction that needs urgent medical treatment and may include itching,
Danish: • Pludselig og alvorlig allergisk reaktion, der nødvendiggør akut behandling og kan omfatte kløe,
English: It is recommended that the INR should be monitored frequently during and shortly after co-administration of Vaborem with an oral anticoagulant.
Danish: Det anbefales, at INR monitoreres hyppigt under og umiddelbart efter samtidig administration af Vaborem og et oralt antikoagulans.
English: Unknown: (frequency cannot be estimated from the available data)
Danish: Ikke kendt (hyppigheden kan ikke estimeres ud fra de forhåndenværende data):
English: • oral anticoagulant medicines, such as warfarin (used to treat or prevent blood clots)
Danish: • orale antikoagulante lægemidler, for eksempel warfarin (bruges til behandling eller forebyggelse af blodpropper)
English: It blocks the action of an enzyme that allows some bacteria to resist the action of meropenem.
Danish: Det blokerer for virkningen af et enzym, der tillader nogle bakterier at modstå meropenems virkning.
English: Approximately 75 to 95% of vaborbactam is excreted unchanged in the urine over a 24 - 48 hour period.
Danish: Cirka 75 til 95 % af vaborbactam udskilles uændret i urin i et tidsrum på 24-48 timer.
English: Medicinal products that inhibit peristalsis should not be given.
Danish: Der bør ikke gives lægemidler, som hæmmer peristaltikken.
English: It is unknown whether a potential interaction would result in increased or decreased plasma concentrations, and thus patients should be monitored both for signs of toxicity and lack of efficacy of the narrow therapeutic index drug.
Danish: Det vides ikke, om en potentiel interaktion vil medføre forhøjede eller reducerede plasmakoncentrationer, og patienterne bør derfor monitoreres for tegn på toksicitet og manglende effekt af præparatet med det smalle terapeutiske indeks.
English: Tell your doctor that you are taking Vaborem if you are going to have any blood tests.
Danish: Fortæl det til lægen, at du får Vaborem, hvis du skal have taget blodprøver.
English: This should be taken into consideration if you are on a controlled sodium diet.
Danish: Dette skal du tage højde for, hvis du er på en kontrolleret natriumdiæt.
English: The most common adverse reactions that occurred among 322 patients from the pooled Phase 3 trials were headache (8.1%), diarrhoea (4.7%), infusion site phlebitis (2.2%) and nausea (2.2%).
Danish: De mest almindelige bivirkninger, der opstod hos 322 patienter fra de poolede fase 3-forsøg, var hovedpine (8,1 %), diarré (4,7 %), flebitis på infusionsstedet (2,2 %) og nausea (2,2 %).
English: Although Vaborem can fight certain bacteria, there is a possibility that you may get a different infection caused by another organism during or after your treatment.
Danish: Selvom Vaborem kan bekæmpe visse bakterier, er der mulighed for, at du under eller efter din behandling kan få en anden infektion, der skyldes en anden organisme.
English: In vitro data suggest that vaborbactam may inhibit CYP2D6, and a risk for increased plasma concentrations of sensitive CYP2D6 substrates in vivo cannot be excluded.
Danish: In vitro-data tyder på, at vaborbactam kan hæmme CYP2D6, og en risiko for forhøjede plasmakoncentrationer af følsomme CYP2D6-substrater in vivo kan ikke udelukkes.
English: Antiglobulin test (Coombs test) seroconversion
Danish: Antiglobulintest (Coombs' test), serokonversion
English: The safety and efficacy of meropenem/vaborbactam in children and adolescents younger than 18 years of age have not yet been established.
Danish: Meropenems/vaborbactams sikkerhed og virkning hos børn og unge under 18 år er endnu ikke klarlagt.
English: It is unknown whether vaborbactam is excreted in human milk or animal milk.
Danish: Det er ukendt, om vaborbactam udskilles i human mælk eller mælk hos dyr.
English: • you are allergic to meropenem, vaborbactam or the other ingredients of this medicine (listed in section 6).
Danish: • du er allergisk over for meropenem, vaborbactam eller et af de øvrige indholdsstoffer i dette lægemiddel (angivet i afsnit 6)
English: Approximately 40-60% of a meropenem dose is excreted unchanged within 24 - 48 hours with a further 25% recovered as the microbiologically inactive hydrolysis product.
Danish: Cirka 40-60 % af en meropenem-dosis udskilles uændret inden for 24-48 timer, og yderligere 25 % udskilles som det mikrobiologisk inaktive hydrolyseprodukt.
English: • Meropenem belongs to group of antibiotics called “carbapenems”.
Danish: • Meropenem tilhøre en gruppe antibiotika, der kaldes for “carbapenemer”.
English: Meropenem is a substrate of OAT1 and OAT3 and as such, probenecid competes with meropenem for active tubular secretion and thus inhibits the renal excretion of meropenem.
Danish: Meropenem er et substrat af OAT1 og OAT3, og som sådan konkurrerer probenecid med meropenem om den aktive tubulære sekretion og hæmmer således udskillelsen af meropenem via nyrerne.
English: • A positive result from a test called“Coombs”used to identify haemolytic anemia (see above) or reaction of your immune system to Vaborem
Danish: • Et positivt resultat af en prøve, der kaldes for ”Coombs's test”, der bruges til at påvise hæmolytisk anæmi (se ovenfor) eller immunsystemets reaktion på Vaborem
English: This may affect your ability to drive, use tools or machines.
Danish: Dette kan påvirke evnen til at føre motorkøretøj, bruge værktøj eller betjene maskiner.
English: The diluted solution should be inspected visually for particulate matter.
Danish: Den fortyndede opløsning skal kontrolleres visuelt for partikler.
English: Talk to your doctor or nurse if you suffer from diarrhoea during your treatment.
Danish: Kontakt lægen eller sundhedspersonalet, hvis du får diarré under din behandling.
English: • Swollen and red and irritated veins
Danish: • Hævede, røde og irriterede blodårer
English: 10 to 19
Danish: 10 til 19
English: Tell your doctor straight away if you notice any of the following serious side effects - you may need urgent medical treatment:
Danish: Fortæl det straks til din læge, hvis du bemærker en eller flere af følgende alvorlige bivirkninger, da du muligvis vil have behov for akut behandling:
English: Infections due to aerobic Gram-negative organisms in patients with limited treatment options
Danish: Infektioner, der skyldes aerobe gramnegative organismer hos patienter med begrænsede behandlingsmuligheder
English: Do not use this medicine after the expiry date which is stated on the container.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter 'EXP'.
English: The reconstituted vial should be further diluted immediately.
Danish: Det rekonstituerede hætteglas skal straks fortyndes yderligere.
English: The terminal half-life (t½) is 2.30 hours and 2.25 hours for meropenem and vaborbactam, respectively.
Danish: Den terminale halveringstid (t½) er 2,30 og 2,25 timer for henholdsvis meropenem og vaborbactam.
English: • Complicated intra-abdominal infection (cIAI)
Danish: • Kompliceret intraabdominal infektion (cIAI)
English: Vaborem is used in adults to treat certain serious bacterial infections:
Danish: Vaborem anvendes til voksne til behandling af visse alvorlige bakterieinfektioner
English: White to light yellow powder.
Danish: Hvidt til lysegult pulver.
English: Controlled sodium diet
Danish: Kontrolleret natriumdiæt
English: • Difficulty to control the bladder
Danish: • Problemer med at styre blæren
English: This should be taken into consideration while treating patients on a controlled sodium diet.
Danish: Dette skal tages i betragtning i behandlingen af patienter, der er på en kontrolleret natriumdiæt.
English: The following adverse reactions have been reported with meropenem alone and/or identified during the Phase 3 trials with Vaborem.
Danish: Nedenstående bivirkninger er indberettet for meropenem alene og/eller identificeret under fase 3forsøgene med Vaborem.
English: Dose of Vaborem (meropenem/ vaborbactam)2
Danish: Dosis Vaborem (meropenem/ vaborbactam)2
English: This test looks for the presence of antibodies that can destroy red blood cells or may be affected by the response of your immune system to Vaborem.
Danish: Denne prøve bruges til at undersøge, om der findes antistoffer, der kan ødelægge røde blodlegemer, og testen kan blive påvirket af dit immunsystems reaktion på Vaborem.
English: Anaerobic micro-organisms:
Danish: Anaerobe mikroorganismer:
English: Patients taking CYP2D6 substrates with narrow therapeutic index (e.g. dextromethorphan, desipramine, venlafaxine, and metoprolol) should be monitored for signs of toxicity.
Danish: Patienter, der tager CYP2D6-substrater med et smalt terapeutisk indeks (fx dextromethorphan, desipramin, venlafaxin og metoprolol), bør monitoreres for tegn på toksicitet.
English: Insomnia Hallucination
Danish: Insomni Hallucinationer
English: New infection
Danish: Ny infektion
English: What you need to know before you are given Vaborem 3.
Danish: Det skal du vide, før du får Vaborem 3.
English: Patients who develop focal tremors, myoclonus, or seizures should be evaluated neurologically and placed on anticonvulsant therapy if not already instituted.
Danish: Patienter, som udvikler fokal tremor, myoklonus eller krampeanfald bør undersøges neurologisk og sættes i behandling med antikonvulsiva, hvis dette ikke allerede er sket.
English: Drug reaction with eosinophilia and systemic symptoms (DRESS syndrome)
Danish: Lægemiddelreaktion med eosinofili og systemiske symptomer (DRESSsyndrom)
English: As a precautionary measure, it is preferable to avoid the use of Vaborem during pregnancy.
Danish: For en sikkerheds skyld bør Vaborem undgås under graviditeten.
English: The reconstituted solution must be diluted before intravenous infusion.
Danish: Den rekonstituerede opløsning skal fortyndes inden intravenøs infusion.
English: It acts by forming a covalent adduct with beta-lactamases and is stable to beta-lactamase-mediated hydrolysis.
Danish: Det virker ved at danne en kovalent addukt med betalactamaser og er stabil over for beta-lactamase-medieret hydrolyse.
English: In repeat dose toxicity studies in dogs, minimal hepatic inflammation was observed after 14 days and 28 days of exposure to vaborbactam alone or combined meropenem/vaborbactam.
Danish: I studier på hunde af toksiciteten efter gentagne doser blev der observeret minimal leverinflammation efter 14 dages og 28 dages eksponering for vaborbactam alene eller meropenem/vaborbactam kombineret.
English: The mean non-renal clearance for meropenem was 4.8 L/h, which comprises both fecal elimination (~2% of the dose) and degradation due to hydrolysis.
Danish: Den gennemsnitlige ikke-renale clearance af meropenem var 4,8 l/t, hvilket består af både elimination i fæces (~2 % af dosen) og nedbrydning som følge af hydrolyse.
English: The medicinal product is supplied in packs of 6 vials.
Danish: Lægemidlet leveres i pakninger med 6 hætteglas.
English: There is no accumulation of meropenem or vaborbactam following multiple intravenous infusions administered every 8 hours for 7 days in subjects with normal renal function.
Danish: Der er ingen akkumulering af meropenem eller vaborbactam efter flere intravenøse infusioner, der gives hver 8. time i 7 dage til patienter med normal nyrefunktion.
English: In individuals with normal renal function, rapid renal elimination will occur.
Danish: Hos personer med normal nyrefunktion vil der forekomme hurtig eliminering via nyrerne.
English: Within each System Organ Class, undesirable effects are presented in order of decreasing seriousness.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter, hvor alvorlige de er.
English: In vitro studies demonstrated no antagonism between meropenem/vaborbactam and levofloxacin, tigecycline, polymyxin, amikacin, vancomycin, azithromycin, daptomycin or linezolid.
Danish: Studier in vitro har ikke vist nogen antagonisme mellem meropenem/vaborbactam og levofloxacin, tigecyclin, polymyxin, amikacin, vancomycin, azithromycin, daptomycin eller linezolid.
English: The number of vials used for a single dose will depend on the creatinine clearance (CrCl) of the patient.
Danish: Det antal hætteglas, der skal bruges til en enkelt dosis, afhænger af patientens kreatininclearance (CrCl).
English: In one additional patient, a serious adverse reaction of infusion related reaction was reported (0.3%).
Danish: Der blev indberettet en alvorlig bivirkning i form af en infusionsrelateret reaktion hos yderligere en patient (0,3 %).
English: Vaborbactam has no antibacterial activity.
Danish: Vaborbactam har ingen antibakterielaktivitet.
English: What Vaborem is Vaborem is an antibiotic medicine that contains two active substances: meropenem and vaborbactam.
Danish: Vaborem er et antibiotisk lægemiddel, der indeholder to aktive stoffer: meropenem og vaborbactam.
English: There have been many reports of increases in the anticoagulant effects of orally administered anticoagulants, including warfarin in patients, who are concomitantly receiving antibacterial agents.
Danish: Der har været mange rapporter om stigninger i de antikoagulante virkningerne af oralt administrerede antikoagulantia, herunder warfarin, hos patienter, der samtidigt får antibakterielle midler.
English: Meropenem does not have activity against methicillin-resistant Staphylococcus aureus (MRSA) and Staphylococcus epidermidis (MRSE) or vancomycin-resistant Enterococci (VRE).
Danish: Meropenem har ingen aktivitet mod methicillin-resistent Staphylococcus aureus (MRSA) og Staphylococcus epidermidis (MRSE) eller vancomycin-resistent Enterococci (VRE).
English: Your doctor may also want to do some blood tests to see how well your kidneys are working.
Danish: Desuden vil lægen eventuelt tage nogle blodprøver for at se, hvor godt dine nyrer fungerer.
English: The chemical and physical in-use stability has been demonstrated for up to 4 hours at 25 °C or within 22 hours at 2 - 8 °C.
Danish: Den kemiske og fysiske stabilitet efter åbning er påvist i op til 4 timer ved 25 °C eller inden for 22 timer ved 2 - 8 °C.
English: Your doctor may take some blood to check how well your liver is working while taking the medicine.
Danish: Lægen vil eventuelt tage blodprøver for at kontrollere, hvor godt din lever fungerer, mens du får lægemidlet.
English: • a medicine used to treat seizures or given prior to a surgery or certain examinations inside your body such as a colonoscopy, called midazolam
Danish: • medicin, der bruges til behandling af krampeanfald eller gives inden en operation eller visse undersøgelser inde i kroppen (for eksempel kolonoskopi), og som hedder midazolam
English: Severe adverse reactions were observed in two patients (0.6 %), one infusion related reaction and one blood alkaline phosphatase increased respectively.
Danish: Der blev observeret kraftige bivirkninger hos to patienter (0,6 %); henholdsvis en infusionsrelateret reaktion og et tilfælde af forhøjet alkalisk phosphatase i blodet.