FrancophonIA/ELRC3.0 huggingface dataset:
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine.
Danish: Hvert 4 ml hætteglas indeholder 400 mikrogram dexmedetomidin.
English: Dexdor 100 micrograms/ml concentrate for solution for infusion Dexmedetomidine
Danish: Dexdor 100 mikrogram/ml koncentrat til infusionsvæske, opløsning Dexmedetomidin
English: Hepatic impairment
Danish: Vågen bedøvelse
English: Breastfeeding
Danish: Beholdere
English: Each 2 ml ampoule contains 200 micrograms of dexmedetomidine (as hydrochloride).
Danish: Hver 2 ml ampul indeholder 200 mikrogram dexmedetomidin (som hydrochlorid).
English: NAME OF THE MEDICINAL PRODUCT Dexdor 100 micrograms/ml concentrate for solution for infusion
Danish: LÆGEMIDLETS NAVN Dexdor 100 mikrogram/ml, koncentrat til infusionsvæske, opløsning
English: Respiratory, thoracic and mediastinal disorders Very common: Respiratory depression2,3
Danish: Respirationsdepression2,3
English: Although dexmedetomidine is administered to effect, it may be necessary to consider initial/maintenance dose reduction in patients with hepatic impairment depending on the degree of impairment and the response.
Danish: Selvom dexmedetomidin administreres til virkning, kan det blive nødvendigt at overveje en reduktion af initial.
English: The adverse drug reaction (ADR) of hyperthermia is already highlighted in the Summary of Product Characteristics (SmPCs) therefore is subject to routine pharmacovigilance and routine risk minimisation, however the current warning in section 4.4 of the SmPC does not mention the lack of effect of cooling through other measures.
Danish: Derfor er den underkastet rutinemæssig lægemiddelovervågning og rutinemæssig risikominimering, men den nuværende advarsel i pkt.
English: Each 4 ml vial contains 400 micrograms of dexmedetomidine (as hydrochloride).
Danish: Hvert 4 ml hætteglas indeholder 400 mikrogram dexmedetomidin (som hydrochlorid).
English: Volume of Dexdor 100 micrograms/ml concentrate for solution for infusion
Danish: Volumen af Dexdor 100 mikrogram/ml koncentrat til infusionsvæske, opløsning
English: Procedural sedation/awake sedation
Danish: Initiering af vågen sedation
English: The concentrate is a clear, colourless solution.
Danish: Udseende og pakningsstørrelser Koncentrat til infusionsvæske, opløsning Koncentratet er en klar, farveløs opløsning.
English: Dexdor 100 micrograms/ml concentrate for solution for infusion
Danish: Dexdor 100 mikrogram/ml, koncentrat til infusionsvæske, opløsning
English: METHOD OF ADMINISTRATION
Danish: Anvendelsesmåde
English: - If you get any side effects, talk to your doctor.
Danish: - Kontakt lægen, hvis du får bivirkninger, herunder bivirkninger, som ikke er nævnt her.
English: (midazolam or propofol) and opioids during sedation for up to 24 hours.
Danish: μg/kg/time og det akkumulerer ikke i behandlinger, der varer op til 14 dage.
English: In approximately 50% of cases, positive dechallenges were reported.
Danish: I ca. 50% af tilfældene forsvandt bivirkningen efter seponering af dexmedetomidin.
English: Gastrointestinal disorders
Danish: Tilberedning af infusionsvæske
English: Renal impairment
Danish: Abdominal distension
English: ● At the request of the European Medicines Agency.
Danish: ● på anmodning fra Det Europæiske Lægemiddelagentur.
English: The interaction had a fast onset.
Danish: Interaktionen havde et hurtigt onset.
English: Date of first authorisation: 25 July 2008
Danish: Dato for første markedsføringstilladelse: 25. juli 2008
English: Infusion time a, b
Danish: Infusionstid a,b
English: The clinical consequences of such an increase in exposure are unknown.
Danish: De kliniske konsekvenser af en sådan øget eksponering er ukendte.
English: The first two numbers indicate the month.
Danish: De første to cifre angiver måneden.
English: - The treatment course usually lasts 5 to 14 days.
Danish: - Behandlingsforløbet varer normalt 5-14 dage.
English: The next four numbers indicate the year.
Danish: De næste fire cifre angiver årstallet.
English: Patients should be carefully monitored during therapy.
Danish: Patienter bør monitoreres nøje under behandlingen.
English: Each dose is given over a period of one or four
Danish: Hver dosis gives over en periode på 1 eller
English: Elderly patients ( 65 years of age)
Danish: Ældre (≥65 år)
English: These changes were mainly attributed to age-related changes in renal function.
Danish: Disse forskelle blev hovedsagelig tillagt aldersrelaterede forandringer i nyrefunktionen.
English: Your doctor will monitor you for overgrowth and treat you if necessary.
Danish: Lægen vil kontrollere dig for superinfektion og behandle dig, hvis det er nødvendigt.
English: Inspect the suspension visually for foreign matter.
Danish: Inspicer suspensionen visuelt for fremmedlegemer.
English: Note: the suspension is not for direct infusion.
Danish: Bemærk: Suspensionen er ikke beregnet til direkte infusion.
English: Of these, 51% had generalised peritonitis at baseline.
Danish: Af disse havde 51 % generaliseret peritonitis ved baseline.
English: (see section 5.1).
Danish: (se pkt 5.1).
English: Do not use this medicine if any of the above applies to you.
Danish: Brug ikke dette lægemiddel, hvis et eller flere af ovenstående gælder for dig.
English: Therefore, alternative antibacterial or supplemental anticonvulsant therapies should be considered.
Danish: Derfor bør alternativ antibakteriel eller supplerende antikonvulsiv behandling overvejes.
English: The study was stopped early based on the recommendation of an independent data monitoring committee.
Danish: Studiet blev afsluttet i utide på anbefaling af en uafhængig komité til datamonitorering.
English: Solution stored in a refrigerator (2C-8C)
Danish: Opløsning opbevaret i køleskab (2-8 C)
English: Storage of reconstituted solutions
Danish: Opbevaring af rekonstituerede opløsninger
English: This dosing regimen should also be considered in particularly severe
Danish: Dette doseringsregime bør også overvejes ved særligt alvorlige infektioner.
English: Mean renal clearance is 10.3 l/hour.
Danish: Gennemsnitlig renal clearance er 10,3 l/time.
English: Small amounts of this medicine may pass into breast milk and it may affect the baby.
Danish: Små mængder af dette lægemiddel kan udskilles i modermælken og dermed påvirke barnet.
English: The average binding of doripenem to plasma proteins was approximately 8.1% and is independent of plasma concentrations.
Danish: Den gennemsnitlige binding af doripenem til plasmaproteiner var ca. 8,1 % og er uafhængig af plasmakoncentrationerne.
English: This is called overgrowth.
Danish: Dette kaldes superinfektion.
English: Minimum inhibitory concentration (MIC) breakpoints established by the European Committee on Antimicrobial Susceptibility Testing (EUCAST) are as follows:
Danish: Følsomhedsgrænserne for minimal inhibitorisk koncentration (MIC) fastsat af Den Europæiske Referencekomité EUCAST (European Committee on Antimicrobial Susceptibility Testing) er følgende:
English: These may be signs of a severe allergic reaction (anaphylaxis) and may be life-threatening.
Danish: Det kan være tegn på en alvorlig allergisk reaktion (anafylaksi), som kan være livstruende.
English: No reproductive toxicity was observed in studies performed in rats and rabbits.
Danish: Der blev ikke observeret reproduktionstoksicitet i studier udført med rotter og kaniner.
English: However, these studies are of limited relevance because studies were performed with single daily dosing resulting in less than one tenth of daily doripenem exposure duration in animals.
Danish: Relevansen af disse studier er dog begrænset, fordi studierne blev udført med dosering én gang daglig, hvilket er mindre end en tiendedel af varigheden af den daglige doripenemeksponering i dyr.
English: Hypersensitivity to the active substance
Danish: Overfølsomhed over for det aktive stof
English: This medicine is an antibiotic which works by killing different types of bacteria (germs) that cause infections in various parts of the body.
Danish: Dette lægemiddel er et antibiotikum, der virker ved at dræbe forskellige former for bakterier, der forårsager infektion forskellige steder i kroppen.
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 infektionsophobninger grundet carbapenemresistente organismer.
English: The safety and efficacy of Doribax in children aged less than 18 years have not yet been established.
Danish: Doribax' sikkerhed og virkning hos børn under 18 år er endnu ikke klarlagt.
English: Variations in colour within this range do not affect the potency of the product.
Danish: Farvevariationer inden for dette område har ingen indflydelse på produktets virkning.
English: It is important that you receive treatment with Doribax as long as your doctor feels it is necessary.
Danish: Det er vigtigt, at du får behandling med Doribax så længe, som lægen mener, at du har behov for det.
English: - Your doctor will decide how much Doribax you need and for how long.
Danish: - Lægen beslutter, hvor meget Doribax du har brug for og i hvor lang tid.
English: Doripenem is primarily eliminated unchanged by the kidneys.
Danish: Doripenem elimineres hovedsagelig uændret gennem nyrerne.
English: Therefore, doripenem should not be administered by this route.
Danish: Doripenem bør derfor ikke administreres på denne måde.
English: Doribax should be used with caution in patients with such a history.
Danish: Doribax bør anvendes med forsigtighed til patienter med en sådan anamnese.
English: ● Whenever the risk management system is modified, especially as the result of new information being received that may lead to a significant change to the benefit/risk profile or as the result of an important (pharmacovigilance or risk minimisation) milestone being
Danish: ● når risikostyringssystemet ændres, særlig som følge af at der er modtaget nye oplysninger, der kan medføre en væsentlig ændring i risk/benefit-forholdet, eller som følge af at der er nået en vigtig minepæl (lægemiddelovervågning eller risikominimering).
English: Do not take any medicine to treat diarrhoea without first checking with your doctor.
Danish: Du må ikke tage nogen form for medicin mod diaré uden at tale med lægen først.
English: Not known: toxic epidermal necrolysis, Stevens-Johnson syndrome
Danish: Ikke kendt: toksisk epidermal nekrolyse, Stevens-Johnsons syndrom
English: 72 hours*
Danish: 72 timer*
English: In vitro studies have determined that doripenem does not inhibit or induce the activities of CYP isoforms 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 or 3A4.
Danish: Det er i in vitro-studier vist, at doripenem ikke inhiberer eller inducerer aktivitet i CYPisoformerne 1A2, 2A6, 2C9, 2C19, 2D6, 2E1 eller 3A4.
English: The prevalence of acquired resistance may vary geographically and with time for selected species and local information on resistance is desirable, particularly when treating severe infections.
Danish: Prævalensen af erhvervet resistens kan variere geografisk og med tid for udvalgte arter, og lokal information om resistens anbefales, især ved behandling af alvorlige infektioner.
English: Adults (including people over 65 years of age) - The usual dose is 500 mg every eight hours.
Danish: Voksne (herunder personer over 65 år) - Den sædvanlige dosis er 500 mg hver 8. time.
English: Doribax should not be given to children or adolescents (under 18 years of age) as there is not enough information to be sure that Doribax can be used safely in children or adolescents.
Danish: Doribax bør ikke anvendes til børn og teenagere under 18 år, da der ikke er tilstrækkelig viden til, at man er sikker på, at Doribax kan anvendes til børn og unge uden risiko.
English: Doripenem-M-1 had a slow elimination in the patient group and the half-life (and AUC) has not been satisfactorily determined.
Danish: Doripenem-M-1 blev elimineret langsomt i patientgruppen, og halveringstiden (og AUC) er ikke fastlagt tilfredsstillende.
English: Frequency categories are defined as follows: Very common (≥ 1/10); Common (≥ 1/100 to < 1/10); Uncommon (≥ 1/1,000 to < 1/100); Not known (cannot be
Danish: Frekvenskategorierne er defineret som følger: meget almindelig (≥ 1/10), almindelig (≥ 1/100 til < 1/10), ikke almindelig (≥ 1/1.000 til < 1/100), ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: It is unknown whether doripenem is excreted in human breast milk.
Danish: Det er ukendt, om doripenem udskilles i human mælk.
English: Tell your doctor straight away if you get any of these side effects as you may need urgent medical treatment: - Sudden swelling of your lips, face, throat or tongue, a rash, swallowing or breathing problems.
Danish: Kontakt straks din læge, hvis du får en af disse bivirkninger - du kan have behov for akut lægehjælp: - Pludselige hævelser i læber, ansigt, hals eller tunge, udslæt, besvær med at synke eller trække vejret.
English: No significant difference in mean doripenem clearance was observed across race groups and therefore, no dose adjustment is recommended for race.
Danish: Der blev ikke observeret nogen signifikant forskel i gennemsnitlig doripenemclearance på tværs af racegrupper, og der kræves derfor ingen dosisjustering på baggrund af race.
English: An interaction with other medicinal products eliminated by renal tubular secretion cannot be excluded.
Danish: Det kan ikke udelukkes, at der kan være interaktion med andre lægemidler, der elimineres ved renal tubulær sekretion.
English: In vitro doripenem showed little potential to antagonise or be antagonised by other antibacterial agents.
Danish: In vitro viste doripenem ringe potentiale for at antagonisere eller blive antagoniseret af andre antibiotika.
English: Symptoms of overdose may include rash.
Danish: Symptomerne på overdosering kan omfatte udslæt.
English: The marketing authorisation holder shall submit periodic safety update reports for this product in accordance with the requirements set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and published on the European medicines web-portal.
Danish: ● Periodiske, opdaterede sikkerhedsindberetninger (PSUR) Indehaveren af markedsføringstilladelsen skal fremsende periodiske, opdaterede sikkerhedsindberetninger (PSUR) for dette lægemiddel i overensstemmelse med kravene på listen over EUreferencedatoer (EURD list) som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF og offentliggjort på den europæiske webportal for lægemidler.
English: Doribax was discontinued because of adverse drug reactions in 0.1% of patients overall.
Danish: Doribax blev seponeret på grund af bivirkninger hos i alt 0,1 % af patienterne.
English: In the event of overdose, Doribax should be discontinued and general supportive treatment given until renal elimination takes place.
Danish: I tilfælde af overdosering skal Doribax seponeres og generel understøttende behandling gives, indtil renal elimination finder sted.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: De officielle retningslinjer for korrekt brug af antibiotika bør følges.
English: - Diarrhoea.
Danish: - Diaré.
English: In addition, the patients were allowed to receive specified adjunctive therapies.
Danish: Patienterne kunne desuden få en nærmere angivet adjuverende behandling.
English: As necessary, expert advice should be sought when the local prevalence of resistance is such that the utility of the agent in at least some types of infections is questionable.
Danish: Fornøden ekspertrådgivning bør søges, når den lokale resistensprævalens er af en sådan karakter, at stoffets nytte ved mindst nogle af infektionstyperne er tvivlsom.
English: Probenecid competes with doripenem for renal tubular secretion and reduces the renal clearance of doripenem.
Danish: Probenecid konkurrerer med doripenem om renal tubulær sekretion og reducerer den renale clearance af doripenem.
English: Patients with chronic renal impairment on CRRT can be treated with either a 1 or 4-hour infusion time.
Danish: Patienter med kronisk nedsat nyrefunktion i CRRT kan behandles med infusion over enten 1 eller 4 timer.
English: A decision on whether to continue/discontinue breast-feeding or to continue/discontinue therapy with Doribax should be made taking into account the benefit of breast-feeding to the child and the benefit of Doribax therapy to the woman.
Danish: Beslutningen om, hvorvidt amning skal fortsættes/afbrydes, eller om behandling med Doribax skal fortsættes/afbrydes, bør foretages under hensyntagen til fordelen ved amning for barnet og fordelen ved Doribax-behandling for kvinden.
English: The lowered valproic acid levels can lead to inadequate seizure control.
Danish: Det sænkede niveau af valproinsyre kan medføre utilstrækkelig anfaldskontrol.
English: Animal studies are insufficient with respect to pregnancy, embryonal/foetal development, parturition or postnatal development (see section 5.3).
Danish: Data fra dyrestudier er utilstrækkelige hvad angår virkningerne på graviditeten, den embryonale/føtale udvikling, fødslen eller den postnatale udvikling (se pkt.
English: * species against which activity has been demonstrated in clinical studies species that show natural intermediate susceptibility species with > 50% acquired resistance in one or more Member State ^ all methicillin-resistant staphylococci should be regarded as resistant to doripenem
Danish: * Arter mod hvilke aktivitet er påvist i kliniske studier Arter med naturlig middelfølsomhed Arter med > 50 % erhvervet resistens i én eller flere medlemsstater ^ Alle methicillinresistente staphylococci bør betragtes som værende resistente over for doripenem
English: Therefore, no CYP450-related drug interactions are to be expected (see section 5.2).
Danish: Der kan derfor ikke forventes nogen CYP450-relaterede lægemiddelinteraktioner (se pkt.
English: Chemical and physical in-use stability has been demonstrated for the times and solutions shown in the
Danish: Kemisk og fysisk holdbarhed under brug er påvist for de tidsperioder og opløsninger, der er anført i ovenstående tabel.
English: other than S. pneumoniae
Danish: bortset fra S. pneumoniae S. pneumoniae
English: Other sources of infection included colon perforation (20%), complicated cholecystitis (5%) and infections at other sites (14%).
Danish: Andre infektionskilder omfattede colonperforation (20 %), kompliceret cholecystitis (5 %) og infektioner andre steder (14 %).
English: A study in rats has shown that doripenem and its metabolite are transferred to milk.
Danish: Et studie med rotter har vist, at doripenem og dets metabolit udskilles i mælk.
English: The usual treatment duration of doripenem therapy ranges from 5-14 days and should be guided by the severity, site of the infection, infecting pathogen and the patient's clinical response.
Danish: Den sædvanlige behandlingsvarighed med doripenem er mellem 5 og 14 dage og bør baseres på sværhedsgrad, infektionssted, det inficerende patogen og patientens kliniske respons.
English: While antibiotics including Doribax kill certain bacteria, other bacteria and fungi may continue to grow more than normal.
Danish: Selv om antibiotika som Doribax dræber visse bakterier, er der andre bakterier og svampe, som kan vokse mere end normalt.
English: Your doctor may need to lower your dose of Doribax.
Danish: Lægen vil muligvis reducere din dosis af Doribax.
English: 500 mg every 8 hours
Danish: 500 mg hver 8. time 1 time
English: Eleven percent had an APACHE II score of > 10, 9.5% had post-operative infections, 27% had single or multiple intra-abdominal abscesses and 4% had concurrent bacteraemia at baseline.
Danish: 11 % havde en APACHE II-score på > 10, 9,5 % havde postoperative infektioner, 27 % havde en enkelt eller flere intraabdominale abscesser, og 4 % havde samtidig bakteriæmi ved baseline.
English: Mean plasma terminal elimination half-life of doripenem in healthy young adults is approximately 1 hour and plasma clearance is approximately 15.9 l/hour.
Danish: Doripenems gennemsnitlige terminale plasmaeliminationshalveringstid hos raske unge voksne er ca. 1 time, og plasmaclearance er ca. 15,9 l/time.
English: Doribax is reconstituted and then further diluted prior to infusion.
Danish: Doribax skal rekonstitueres og dernæst fortyndes yderligere før infusion.
English: Based on in vitro studies it is not expected that doripenem will inhibit or induce the activities of CYP450.
Danish: På baggrund af in vitro-studier forventes det ikke, at doripenem inhiberer eller inducerer aktiviteterne af CYP450.
English: Do not use this medicine after the expiry date which is stated on the carton and vial.
Danish: Brug ikke dette lægemiddel efter den udløbsdato, der står på æsken og hætteglasset (efter Exp).
English: Doripenem AUC increased 49% in elderly adults relative to young adults.
Danish: Doripenems AUC var 49 % højere hos ældre end hos unge voksne.
English: The magnitude of this value, coupled with the significant decrease in the elimination of doripenem seen with concomitant probenecid administration, suggests that doripenem undergoes glomerular filtration, tubular secretion and re-absorption.
Danish: Størrelsen af denne værdi sammen med det signifikante fald i eliminationen af doripenem, som ses ved samtidig indgift af probenecid, tyder på, at doripenem gennemgår glomerulær filtration, tubulær sekretion og reabsorption.
English: Seizures have been reported during treatment with Doribax and antibiotics that work in a similar way to Doribax.
Danish: Der er indberettet krampeanfald under behandling med Doribax og antibiotika, der virker på samme måde som Doribax.
English: * 1 g every 8 hours as a 4-hour infusion may be considered in patients with augmented renal clearance (particularly those with creatinine clearance (CrCl) ≥ 150 ml/min) and/or in infections due to non-fermenting gram-negative pathogens (such as Pseudomonas spp.
Danish: * 1 g hver 8. time som 4 timers infusion kan overvejes hos patienter med forhøjet renal clearance (især patienter med kreatininclearance (CrCl) > 150 ml/min) og/eller ved infektioner, der skyldes non-fermenterende gramnegative patogener (såsom Pseudomonas spp.
English: - If you have kidney problems, your doctor may lower your dose of Doribax to 250 mg given over one or four hours every eight or 12 hours.
Danish: - Hvis du har nyreproblemer, kan det være, at din læge nedsætter din Doribax-dosis til 250 mg givet i løbet af 1 eller 4 timer hver 8. eller 12. time.
English: - You are breast-feeding or if you plan to breast-feed.
Danish: - du ammer eller planlægger at amme.
English: The in vivo consequences of the increased exposures to the metabolite are unknown as data on pharmacological activity, except for antimicrobiological activity, are lacking (see section 4.4).
Danish: Konsekvenserne in vivo af den øgede eksponering for metabolitten er ukendte, da der ikke foreligger data for farmakologisk aktivitet med undtagelse af antimikrobiel aktivitet (se pkt.
English: The most common adverse reactions were headache (10%), diarrhoea (9%) and nausea (8%).
Danish: De mest almindelige bivirkninger var hovedpine (10 %), diaré (9 %) og kvalme (8 %).
English: Remove 55 ml of this solution from the infusion bag and discard.
Danish: Fjern 55 ml af denne opløsning fra infusionsposen og kassér dette.
English: Doribax is supplied in packs of 10 vials.
Danish: Doribax leveres i æsker med 10 hætteglas.
English: It is important that you tell your doctor if you have bloody diarrhoea before, during or after your treatment with Doribax.
Danish: Det er vigtigt, at du fortæller det til lægen, hvis du har blodig diaré før, under eller efter behandlingen med Doribax.
English: Pseudomembranous colitis due to Clostridium difficile has been reported with Doribax and may range in severity from mild to life-threatening.
Danish: Pseudomembranøs colitis forårsaget af Clostridium difficile er rapporteret med Doribax og kan variere i sværhedsgrad fra let til livstruende.