FrancophonIA/ELRC3.0 huggingface dataset:
English: EUCAST Recommendations
Danish: EUCAST-rekommendationer
English: Therefore, the CHMP requested that an appropriate restriction of the indication be made.
Danish: CHMP forlangte derfor, at der blev indført en passende begrænsning i indikationen.
English: A drink of water may be taken afterwards.
Danish: Tag evt. en slurk vand bagefter.
English: Advice/medical education
Danish: Råd/medicinsk information
English: The response document included a review of clinical data (published data, medical research reports) and microbiological data.
Danish: Svardokumentet indeholdt en gennemgang af kliniske data (offentliggjorte data, medicinske forskningsrapporter) og mikrobiologiske data.
English: * Non-species-related breakpoints have been determined mainly on the basis of PK/PD data and are independent of MIC distributions of specific species.
Danish: * Ikke-artsrelaterede breakpoints er primært blevet bestemt på grundlag af PK/PD-data, og er uafhængige af fordelingerne af MIC for specifikke arter.
English: They are for use only for species that have not been given a species-specific breakpoint and not for those species where susceptibility testing is not recommended.
Danish: De skal kun bruges for arter, som ikke har fået et arts-specifikt breakpoint, og ikke for de arter, hvor testning af følsomhed ikke anbefales.
English: The CHMP initially proposed to put this information in section 4.4 under the subheading “Children and adolescents”.
Danish: CHMP foreslog først at angive denne oplysning i afsnit 4.4 under undertitlen "Børn og unge".
English: No new safety concerns arose from these data.
Danish: Disse data gav ikke anledning til nye betænkeligheder ved sikkerheden.
English: More limited experience is available in treating children between 1 and 5 years of age.
Danish: Der foreligger mere begrænsede erfaringer om behandling af børn mellem 1 og 5 år.
English: ¾ Take the normal dose as soon as possible and then continue as prescribed.
Danish: ¾ Tag den normale dosis så hurtigt som muligt og fortsæt derefter som anvist.
English: Slow infusion into a large vein will minimise patient discomfort and reduce the risk of venous irritation.
Danish: Langsom infusion i en stor vene vil minimere patienternes ubehag og nedsætte risikoen for venøs irritation.
English: If your doctor has prescribed antibiotics, you need them precisely for your current illness.
Danish: Hvis din læge har ordineret antibiotika, så behøver du dem præcist for denne sygdom.
English: Consequently, ciprofloxacin should be administered either 1-2 hours before or at least 4 hours after these preparations.
Danish: Derfor skal ciprofloxacin gives enten 1-2 timer før eller mindst 4 timer efter indtagelsen af disse præparater.
English: The following information is intended for medical or healthcare professionals only
Danish: Følgende oplysninger er kun til læger og sundhedspersonale:
English: Therapy should be continued over the entire period of neutropenia
Danish: Behandlingen bør fortsættes i hele neutropeniperioden
English: IV treatment should be followed by oral route as soon as possible.
Danish: IV-behandling skal følges op med oral behandling så hurtigt som muligt.
English: Therefore, the CHMP requested a revised proposal with specific documentation in support.
Danish: CHMP anmodede derfor om et revideret forslag med specifik dokumentation til understøttelse herfor.
English: Non-species-related breakpoints *
Danish: Ikke-artsrelaterede breakpoints*
English: In a study in children Cmax and AUC were not age-dependent (above one year of age).
Danish: I et studie med børn var Cmax og AUC ikke aldersafhængige (over 1 år).
English: Do not pour water into the suspension!
Danish: Kom ikke vand i suspensionen!
English: Animal studies do not indicate direct or indirect harmful effects with respect to reproductive toxicity.
Danish: Dyreforsøg tyder ikke på direkte eller indirekte skadelige virkninger med hensyn til reproduktionstoksicitet.
English: Shake it vigorously for about 15 seconds before each dose.
Danish: Ryst den kraftigt i ca. 15 sekunder før hver dosis.
English: Then tear the sachet open as indicated and take the contents directly.
Danish: Åbn derefter posen som angivet, og tag indholdet med det samme.
English: You might also develop resistance to the antibiotic.
Danish: Du kan også udvikle resistens over for antibiotikummet.
English: Your doctor will give you each dose by slow infusion through a vein into your bloodstream.
Danish: Lægen vil give dig hver dosis som en langsom infusion i blodet i en vene.
English: Dyspnoea (including asthmatic condition)
Danish: Dyspnø (herunder astmatisk tilstand)
English: The resort to combination therapy, however, should be envisaged according to specific factors (including severe neutropenia).
Danish: Anvendelsen som kombinationsterapi bør dog overvejes under hensyntagen til specifikke faktorer (herunder svær neutropeni).
English: For children, the infusion duration is 60 minutes.
Danish: Til børn er varigheden af infusionen 60 minutter.
English: However, if it is almost time for your next dose, do not take the missed dose and continue as usual.
Danish: Hvis det imidlertid er lige før, du skal tage næste dosis, skal du ikke tage den glemte dosis, men fortsætte som sædvanligt.
English: The CHMP agreed to simplify the wording for other indications and adapt them to the current epidemiological concerns.
Danish: Der herskede enighed i CHMP om at forenkle ordlyden for andre indikationer og tilpasse dem til de nuværende epidemiologiske betænkeligheder.
English: Such a use is supported by publications and clinical experience.
Danish: Denne anvendelse understøttes af publiceret litteratur og klinisk erfaring.
English: Serum concentrations increase proportionately with doses up to 1000 mg.
Danish: Serumkoncentrationerne stiger proportionalt op til doser på 1000 mg.
English: Bayer Limited The Atrium, Blackthorn Road, Dublin 18, Ireland
Danish: Bayer Limited The Atrium, Blackthorn Road, Dublin 18.
English: Administering the infusion slowly helps prevent immediate side effects occurring.
Danish: Langsom infusion hjælper til med at forhindre, at der kommer bivirkninger med det samme.
English: Consequently, to preserve the efficacy of this drug:
Danish: For at bevare virkningen af denne medicin skal du derfor:
English: Such a prescription should be handled by specialists in the field and local and national guidelines are available to promote the good use of ciprofloxacin in such situation.
Danish: En sådan receptudskrivning bør foretages af specialister på området, og lokale og nationale retningslinjer forefindes med henblik på at fremme god anvendelse af ciprofloxacin i sådanne situationer.
English: Take the suspension exactly as your doctor has told you.
Danish: Tag suspensionen præcis, som din læge har anvist.
English: • have a history of tendon problems during previous treatment with antibiotics such as
Danish: • hvis du har haft problemer med senerne under tidligere behandling med antibiotika som f.eks.
English: Take the tablets exactly as your doctor has told you.
Danish: Tag tabletterne præcis, som din læge har anvist.
English: Viale Certosa 130 I-20156 Milan Italy
Danish: Viale Certosa 130 I-20156 Milan Italien
English: The duration of treatment depends on the severity of the illness and on the clinical and bacteriological course.
Danish: Behandlingens varighed afhænger af sygdommens sværhedsgrad og det kliniske og bakteriologiske forløb.
English: Antibiotics are used to cure bacterial infections.
Danish: Antibiotika anvendes for at helbrede bakterielle infektioner.
English: This can lead to theophylline-induced side effects that may rarely be life threatening or fatal.
Danish: Det kan medføre teofyllininducerede bivirkninger, som i sjældne tilfælde kan være livstruende eller fatale.
English: The ready-to-use suspension is stable for 14 days when stored in a refrigerator or at ambient temperatures below 30°C.
Danish: Den brugsfærdige suspension holder sig i 14 dage, når den opbevares i køleskab eller ved en temperatur på under 30°C.
English: In summary, the CHMP considers that both indications (curative treatment and prophylaxis) were acceptable.
Danish: Samlet set er CHMP af den mening, at begge indikationer (kurativ behandling og profylakse) er acceptable.
English: • mineral supplements
Danish: • mineraltilskud
English: at least 14 days
Danish: Mindst 14 dage
English: Anti-peristaltic drugs are contraindicated in this situation.
Danish: I denne situation er antiperistaltiske lægemidler kontraindiceret.
English: Psychomotor hyperactivity / agitation
Danish: Psykomotorisk hyperaktivitet / agitation
English: 3 - Do not re-use an antibiotic without medical prescription, even if you want to treat a similar illness.
Danish: 3- Ikke anvende antibiotika igen, hvis ikke lægen har ordineret det, heller ikke hvis du ønsker at behandle en lignende sygdom
English: It has a long history of known safety and efficacy in adults, children and adolescents.
Danish: Der er lang tids erfaring med stoffets sikkerhed og virkning hos voksne, børn og unge.
English: Patients should be kept well hydrated.
Danish: Patienterne skal holdes adækvat hydrerede.
English: This phenomenon is called resistance: some antibiotic treatments become ineffective.
Danish: Dette kaldes resistens: visse behandlinger med antibiotika virker ikke.
English: It must not be used if cloudy.
Danish: Den må ikke bruges, hvis den er uklar.
English: All in-vitro mechanisms of resistance are commonly observed in clinical isolates.
Danish: Alle in vitro-mekanismer for resistens ses almindeligvis i kliniske isolater.
English: Be sure to complete your course of treatment.
Danish: Sørg for at gennemføre hele behandlingsforløbet komplet.
English: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex France
Danish: Bayer Santé 13, rue Jean Jaurès 92807 Puteaux Cedex Frankrig
English: Consequently, caution is advised when treating patients with these infections.
Danish: Der skal derfor udvises forsigtighed ved behandling af patienter med sådanne infektioner.
English: Unless compatibility with other infusion solutions/drugs has been confirmed, the infusion solution must always be administered separately.
Danish: Med mindre kompatibiliteten med andre infusionsopløsninger/lægemidler er bekræftet, skal infusionsopløsningen altid gives separat.
English: Consideration should be given to official guidance on the appropriate use of antibacterial agents.
Danish: Der skal tages hensyn til den officielle vejledning for korrekt brug af antibakterielle midler.
English: - the Summaries of Products Characteristic, labelling and package leaflet proposed by the Marketing Authorisation Holders have been assessed based on the documentation submitted and the scientific discussion within the Committee,
Danish: - De produktresuméer, den etikettering og indlægsseddel, som indehaverne af markedsføringstilladelsen har foreslået, er blevet vurderet på grundlag af den fremlagte dokumentation og den faglige drøftelse i udvalget.
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: Forekomsten af erhvervet resistens kan variere geografisk og over tid for udvalgte arter, og lokal information om resistens er ønskeligt, især ved behandling af alvorlige infektioner.
English: The incidence of arthropathy, mentioned above, is referring to data collected in studies with adults.
Danish: Hyppigheden af ovennævnte artropati refererer til data, som stammer fra studier hos voksne.
English: No notable increase in Cmax and AUC upon multiple dosing (10 mg/kg three times daily) was observed.
Danish: Der blev ikke set nogen bemærkelsesværdig stigning i Cmax og AUC efter gentagen dosering (10 mg/kg tre gange dagligt).
English: The restriction does not apply to antacids belonging to the class of H2 receptor blockers.
Danish: Denne restriktion vedrører ikke gruppen af H2-receptor-blokerende antacida.
English: United Kingdom Bayer Plc Bayer House.
Danish: Storbritannien Bayer Plc Bayer House.
English: The Applicant/MAH provided reports summarizing the results of a literature search from 2001 to 2006, including animal model and clinical articles.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen fremlagde rapporter, der sammenfattede resultaterne af en litteratursøgning fra 2001 til 2006, herunder vedrørende dyreforsøg og kliniske artikler.
English: Additional studies submitted also considered that the optimal duration of antibiotic administration may be as long as 8 to 12 weeks in view of the recalcitrant nature of the infection.
Danish: Det fremgik af data fra yderligere undersøgelser, som var blevet indsendt, at den optimale varighed af antibiotisk indgift kan være på op til 8 til 12 uger som følge af infektionens genstridige natur.
English: The rate of resistance to methicillin is around 20 to 50% among all staphylococcal species and is usually higher in nosocomial isolates.
Danish: Resistensgraden over for methicillin er fra 20 til 50% for alle stafylokokarter, og er normalt højere i nosocomiale isolater.
English: They are ineffective against viral infections.
Danish: De har ingen virkning mod virusinfektioner.
English: A blood test will be taken to check possible reduction of white blood cells (agranulocytosis).
Danish: Der vil blive taget en blodprøve for at kontrollere, om antallet af hvide blodlegemer er nedsat (agranulocytose).
English: Single mutations may not result in clinical resistance, but multiple mutations generally result in clinical resistance to many or all active substances within the class.
Danish: Enkelte mutationer resulterer dog nødvendigvis ikke i klinisk resistens, men multiple mutationer resulterer generelt i klinisk resistens over for mange eller alle aktive substanser inden for klassen.
English: Diarrhoea caused by Vibrio cholerae
Danish: Diaré forårsaget af Vibrio cholerae
English: • caffeine
Danish: • koffein
English: Cytochrome P450
Danish: Cytokrom P450
English: The combination with other antibiotics, or its use as monotherapy could be considered adequate.
Danish: Kombinationen med andre antibiotika eller stoffets anvendelse som monoterapi kunne anses for at være passende.
English: Articular tolerability:
Danish: Artikulær tolerancet:
English: Spectrum of antibacterial activity:
Danish: Antibakterielt spektrum:
English: Given the fact that several EU member states have rejected the MR tablet Marketing Authorisations due to a negative benefit/risk, and taking into consideration that only 5 countries approved this pharmaceutical formulation, no consensual recommendation on the SPC wording could be provided at a European level on the basis of this present Article 30 Referral procedure.
Danish: I betragtning af at adskillige EU-medlemslande har afvist markedsføringstilladelserne for tabletterne med modificeret udløsning på grund af et negativt benefit/risk-forhold, og i betragtning af at kun 5 lande har godkendt denne lægemiddelformulering, er det ikke muligt at fremlægge en enstemmig anbefaling vedrørende ordlyden af produktresuméet på europæisk plan på baggrund af denne henvisningsprocedure i medfør af artikel 30.
English: Tell your doctor if you take or wish to take:
Danish: Fortæl det til din læge, hvis du tager eller ønsker at tage:
English: Serum Creatinine [µmol/L]
Danish: Serumkreatinin [µmol/l]
English: In line with the data submitted, the benefit/risk in prophylaxis was regarded as favourable in patients with neutrophil count less than 1000/mm3.
Danish: I overensstemmelse med de indsendte data blev benefit/risk-forholdet ved profylakse anset for at være positivt hos patienter med et neutrofiltal på mindre end 1 000/mm3.
English: Ureaplasma urealitycum * Clinical efficacy has been demonstrated for susceptible isolates in approved clinical indications + Resistance rate ≥ 50% in one or more EU countries
Danish: Ureaplasma urealitycum * Der er dokumenteret klinisk effekt for følsomme isolater ved godkendte indikationer + Resistensgrad ≥ 50% i et eller flere EU-lande
English: Other xanthine derivatives
Danish: Andre xanthinderivativer
English: The single dose treatment of uncomplicated UTI should not be approved unless scientifically justified (comparative benefit/risk assessment with the 3 day treatment regimen is provided).
Danish: Enkeltdosisbehandling af ukompliceret urinvejsinfektion bør ikke godkendes, medmindre den er fagligt begrundet (komparativ benefit/risk-vurdering med 3-dages behandlingsregime er indsendt).
English: • have ever had kidney problems because your treatment may need to be adjusted
Danish: • hvis du nogensinde har haft problemer med nyrerne, da det så kan være nødvendigt at justere behandlingen
English: Take the prescribed amount of suspension by using the measuring spoon.
Danish: Tag den foreskrevne mængde suspension ved at bruge måleskeen.
English: Low concentrations of four metabolites have been reported, which were identified as: desethyleneciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) and formylciprofloxacin (M 4).
Danish: Der er fundet små koncentrationer af fire metabolitter, som blev identificeret som: desethylenciprofloxacin (M 1), sulphociprofloxacin (M 2), oxociprofloxacin (M 3) og formylciprofloxacin (M 4).
English: Close the bottle with the solvent and added granules, turn it on its side and shake vigorously for about 15 seconds.
Danish: Luk flasken med opløsningsmiddel og det tilsatte granulat, vend den om på siden og ryst den kraftigt i ca. 15 sekunder 4.
English: • Tell your doctor if you or a member of your family is known to have a deficiency in glucose-6phosphate dehydrogenase (G6PD), since you may experience a risk of anemia with ciprofloxacin.
Danish: • Fortæl det til din læge, hvis du eller et af dine familiemedlemmer har mangel på glucose-6phosphate dehydrogenase (G6PD), da du kan have risiko for at få blodmangel (anæmi), når du tager ciprofloxacin.
English: Glucose-6-phosphate dehydrogenase deficiency
Danish: Glucose-6-phosphat dehydrogenase-mangel
English: Considering risk of failures and taking into account epidemiological concerns due to this sub-optimal schedule, this posology could not be recommended
Danish: I betragtning af risikoen for behandlingssvigt og under hensyntagen til de epidemiologiske betænkeligheder, der skyldes dette ikke-optimale regime, kunne denne dosering ikke anbefales.
English: These may appear as local skin reactions which resolve rapidly upon completion of the infusion.
Danish: De kan vise sig som lokale hudreaktioner, som hurtigt forsvinder, når infusionen er slut.
English: In general, treatment of upper respiratory tract infections requires short courses of antibiotic therapy.
Danish: Generelt kræver behandling af infektioner i de øvre luftveje kortvarig antibiotisk terapi.
English: If in doubt, talk to your doctor.
Danish: Hvis du er i tvivl om noget, skal du spørge din læge.
English: Química Farmacéutica Bayer, S.L.
Danish: Quimica Farmacéutica Bayer, S:L.
English: Treatment of Shigellosis:
Danish: Behandling af shigellose:
English: After intravenous initiation of treatment, the treatment can be continued orally as well.
Danish: Efter intravenøs påbegyndelse af behandlingen kan den fortsættes oralt.
English: The reconstituted product is a white to slightly yellowish suspension with strawberry odour.
Danish: Det rekonstituerede præparat er en hvid til lysegul suspension med jordbærduft.
English: Only those indications already present in the current MR tablets SPC would be subsequently harmonised to the individually agreed wording of each corresponding indication as per the outcome of the Article 30 Referral.
Danish: Kun de indikationer, som allerede fandtes i det gældende produktresumé for tabletterne med modificeret udløsning, ville efterfølgende blive harmoniseret i overensstemmelse med hver enkelt aftalt ordlyd for hver indikation i henhold til udfaldet af artikel 30-indbringelsen.
English: Musculoskeletal System
Danish: Det muskuloskeletale system
English: Efficacy mainly depends on the relation between the maximum concentration in serum (Cmax) and the minimum inhibitory concentration (MIC) of ciprofloxacin for a bacterial pathogen and the relation between the area under the curve (AUC) and the MIC.
Danish: Virkningen afhænger hovedsageligt af hhv. forholdet mellem den maksimale koncentration i serum (Cmax) og den minimale hæmmende koncentration (MIC) af ciprofloxacin for et bakterielt patogen og af forholdet mellem henholdsvis arealet under kurven (AUC) og MIC.
English: {Name and Address} <{tel}> <{fax}> <{e-mail}>
Danish: {Navn og adresse} <{Tlf}> <{Fax}> <{Email}>
English: Tell your doctor if you suffer from kidney problems because your dose may need to be adjusted.
Danish: Fortæl det til din læge, hvis du har problemer med nyrerne, da det kan kræve, at dosis skal justeres.
English: A glass of water may be taken after taking the dose.
Danish: Du kan tage et glas vand efter at have taget opløsningen.
English: Increased serum tizanidine concentration is associated with a potentiated hypotensive and sedative effect.
Danish: Stigninger i serumkoncentrationerne af tizanidin er forbundet med en forstærket hypotensiv og sedativ virkning.
English: Haemophilus influenzae and Moraxella catarrhalis
Danish: Haemophilus influenzae og Moraxella catarrhalis
English: Breakpoints separate susceptible strains from strains with intermediate susceptibility and the latter from resistant strains:
Danish: Breakpoints adskiller følsomme stammer fra stammer med intermediær følsomhed og de sidste fra resistente stammer:
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: Ekspertrådgivning bør om nødvendigt søges, hvis den lokale forekomst af resistens er således, at nytten af lægemidlet ved visse infektioner er tvivlsom.
English: Clinical trials have included children and adolescents aged 1-17 years.
Danish: Kliniske studier har inkluderet børn og unge i alderen 1-17 år.
English: The applicant/MAH submitted 11 studies (8 published clinical studies and 3 medical study reports) in which treatment duration for ciprofloxacin ranged from 2 and 476 days.
Danish: Ansøgeren/indehaveren af markedsføringstilladelsen indsendte data fra 11 undersøgelser (8 publicerede kliniske undersøgelser og 3 medicinske undersøgelsesrapporter), hvori varigheden af behandling med ciprofloxacin var mellem 2 og 476 dage.
English: • have myasthenia gravis (a type of muscle weakness)
Danish: • hvis du har myasthenia gravis (en slags muskelsvaghed)
English: Importantly, the MR tablet formulation would not gain any new indications.
Danish: Det vigtige var, at tabletformuleringen med modificeret udløsning ikke ville få nogen nye indikationer.
English: Respectively, an incidence of drug-related arthropathy by 1-year follow-up was 9.0% and 5.7%.
Danish: Efter 1-års follow-up var den lægemiddelrelaterede hyppighed af artropati hhv. 9,0% og 5,7%.
English: • methotrexate (for certain types of cancer, psoriasis, rheumatoid arthritis)
Danish: • methotrexat (mod visse kræftformer, psoriasis, ledegigt (rheumatoid arthritis))
English: Increase in transaminases Increased bilirubin
Danish: Stigning i transaminaser Øget bilirubin
English: Indeed, ciprofloxacin is part of the drugs recommended in the European strategy targeted on treatments and prophylaxis when biological agents are used as weapons of bioterrorism.
Danish: Ciprofloxacin er nemlig blandt de anbefalede lægemidler i den europæiske strategi for behandling og profylakse, hvis biologiske stoffer anvendes som våben i bioterrorismen.
English: The serum elimination half-life in subjects with normal renal function is approximately 4-7 hours.
Danish: Eliminationshalveringstiden i serum for forsøgspersoner med normal nyrefunktion er ca. 4-7 timer.
English: - nausea, diarrhoea - joint pains in children
Danish: - kvalme, diaré - ledsmerter hos børn
English: Ciprofloxacin Metabolites (M1-M4)
Danish: Ciprofloxacin Metaboliter (M1-M4)
English: An overdose of 12 g has been reported to lead to mild symptoms of toxicity.
Danish: Det er indberettet, at en overdosis på 12 g har medført lette toksiske symptomer.