FrancophonIA/ELRC3.0 huggingface dataset:
English: The usual duration of treatment is 5 days for infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and 7 to 10 days for pneumonia.
Danish: Den sædvanlige varighed af behandlingen er 5 dage til infektioner i halsen, infektioner i bihulerne, infektioner i brystet hos patienter med længerevarende åndedrætsbesvær og 7 til 10 dage til lungebetændelse.
English: Diarrhoea, nausea and dizziness were the most commonly reported adverse reactions in phase III clinical trials.
Danish: Diarré, kvalme og svimmelhed var de hyppigst rapporterede bivirkninger i fase III kliniske studier.
English: The exposure of pravastatin, rosuvastatin and to a lesser extent fluvastatin, may be increased due to possible involvement of transporters proteins, but this increase is expected to be lesser than interactions involving CYP3A4 inhibition.
Danish: Eksponeringen for pravastatin, rosuvastatin og i mindre udstrækning fluvastatin kan blive forhøjet på grund af mulig involvering af transportproteiner, men denne forhøjelse forventes at blive mindre end interaktioner involverende CYP3A4 hæmning.
English: No dosage adjustment is required in elderly patients based on age alone.
Danish: Dosisjustering til ældre baseret på alder alene er ikke nødvendig.
English: Visual disturbances (<1%) associated with the use of Ketek, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate, but severe reactions have also been reported.
Danish: Synsforstyrrelser (< 1%) i forbindelse med brug af Ketek, inklusiv sløret syn, svært ved at fokusere og diplopi, var mest lette til moderate, men alvorlige reaktioner har også været rapporteret.
English: Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma
Danish: Andre metabolitter blev påvist i plasma, urin og fæces og udgør mindre end eller er lig med 3 % af plasma AUC.
English: Limit driving or other hazardous activities while taking Ketek.
Danish: Begræns kørsel eller andre risikobetonede aktiviteter under behandling med Ketek.
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the
Danish: Du eller dine pårørende kan også indberette bivirkninger direkte til Sundhedsstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information
English: The same precautions should also apply to the other benzodiazepines which are metabolised by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).
Danish: De samme forsigtighedsregler skal også iagttages for andre benzodiazepiner, der metaboliseres af CYP3A4 (specielt triazolam men også i mindre udstrækning alprazolam).
English: If you develop severe or prolonged or bloody diarrhoea during or after taking Ketek tablets, consult your doctor immediately since it may be necessary to interrupt the treatment.
Danish: Hvis du får alvorlig, længerevarende eller blodig diarré mens eller efter at du har taget Ketek tabletter, skal du straks kontakte lægen, da det kan være nødvendigt at afbryde behandlingen.
English: Adequate hydration should be maintained.
Danish: Tilstrækkelig væskebalance bør opretholdes.
English: Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using
Danish: Se også afsnittene: ”Tag ikke Ketek”, ”Brug af anden medicin sammen med Ketek” samt ”Trafik- og
English: Ketek is not recommended in this population.
Danish: Ketek anbefales ikke til denne aldersgruppe.
English: If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures
Danish: Hvis pseudomembranøs colitis mistænkes, skal behandling med Ketek stoppes omgående og patienten skal i understøttende og/eller
English: ∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications.
Danish: * Klinisk effekt er blevet vist ved følsomme isolater til godkendte indikationer.
English: Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Danish: Øget antikoagulationsaktivitet er set hos patienter, der behandles samtidigt med antikoagulantia og antibiotika, herunder telithromycin.
English: If you stop taking the tablets too soon, the infection may return, or your
Danish: Hvis du stopper med at tage tabletterne for tidligt, kan infektionen komme tilbage eller din tilstand kan forværres.
English: 4.3 and 4.4).
Danish: 4.3 og 4.4).
English: Parosmia Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections
Danish: Tilfælde af hurtig forværring af myasthenia gravis er rapporteret (se pkt.
English: In these patients, co-administration of Ketek and metoprolol, a CYP2D6 substrate, should be considered with caution.
Danish: Hos disse patienter, skal samtidig administration af Ketek og metoprolol, et CYP2D6 substrat, påtænkes med forsigtighed.
English: Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient should be undertaken.
Danish: Intravenøs dosis af midazolam justeres efter behov og patienten skal monitoreres.
English: - if you or someone in your family are known to have an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
Danish: - hvis det er kendt, at du eller nogen i din familie har en sjælden abnormitet i elektrokardiogrammet (ekg), kaldet medfødt langt QT-syndrom.
English: - other medicines that can prolong the QT interval of the electrocardiogram (ECG), such as:
Danish: - andre lægemidler, der kan forlænge QT-intervallet på et elektrokardiogram (ekg), såsom:
English: Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Danish: Den primære cirkulerende metabolit repræsenterer ca. 13% af telithromycin AUC, og har ringe antimikrobiel virkning sammenlignet med modersubstansen.
English: This leaflet was last revised in <MM/YYYY> <month YYYY>.
Danish: Denne indlægsseddel blev senest ændret <MM/YYYY>.
English: Patients should be informed that these adverse reactions may occur as early as after the first dose of medicinal product.
Danish: Patienterne bør informeres om, at disse bivirkninger kan forekomme allerede ved den første dosis af lægemidlet.
English: This may be a sign of bowel inflammation which can occur following treatment with antibiotics.
Danish: Dette kan være tegn på en maveinfektion, som kan opstå i forbindelse med antibiotika.
English: Telithromycin inhibits protein synthesis by interacting with domains II and V of the 23S ribosomal RNA of the 50S ribosome subunit.
Danish: Telithromycin hæmmer proteinsyntesen ved at interagere med domænerne II og V på det 23S ribosomale RNA af den 50S ribosomale subunit.
English: These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well tolerated range.
Danish: Disse ændringer i telithromycins farmakokinetik nødvendiggør ikke dosisjustering, da telithromycin-eksponeringen forbliver indenfor et veltolereret interval.
English: The effect of ritonavir on telithromycin has not been studied and could lead to larger increase in telithromycin exposure.
Danish: Ritonavirs virkning på telithromycin er ikke undersøgt og kunne medføre en større stigning i telithromycin-eksponringen.
English: Although Ketek has no clinically relevant pharmacokinetic or pharmacodynamic interaction with warfarin after single dose administration, more frequent monitoring of prothrombin time/INR (International Normalised Ratio) values should be considered during concomitant treatment.
Danish: Selv om Ketek ikke har klinisk relevant farmakokinetisk eller farmakodynamisk interaktion med warfarin efter enkeltdosisadministration, bør hyppigere monitorering af protrombintid/INR (International Normalised Ratio) overvejes ved samtidig behandling.
English: L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
Danish: L. pneumophila er meget følsom overfor telithromycin in vitro, imidlertid er den kliniske erfaring med behandling af pneumoni forårsaget af legionella begrænset.
English: In areas with a high incidence of erythromycin A resistance, it is especially important to take into consideration the evolution of the pattern of susceptibility to telithromycin and other antibiotics.
Danish: Det er specielt vigtigt i områder med høj incidens af erythromycin A resistens at tage evolutionen af følsomhedsmønstret for telithromycin og andre antibiotika i betragtning.
English: History of congenital or a family history of long QT syndrome (if not excluded by ECG) and in patients with known acquired QT interval prolongation.
Danish: Medfødt eller familieanamnetisk forlænget QT-syndrom (hvis ikke udelukket ved ekg) og hos patienter med erkendt forlænget QT-interval.
English: Corresponding data for humans is not available.
Danish: Der findes ingen tilgængelige oplysninger for mennesker.
English: Visual disturbances included blurred vision, difficulty focusing, and diplopia.
Danish: Synsforstyrrelser, inklusive sløret syn, vanskelighed ved at fokusere samt diplopia.
English: Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Danish: Ranitidin (indtaget 1 time før Ketek) og antacida indeholdende aluminium og magnesiumhydroxid har ingen klinisk relevant påvirkning af telithromycins farmakokinetik
English: Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
Danish: Telithromycin, men ikke dets humane hovedmetabolitter, havde inhibitorisk aktivitet på HERG- og Kv1.5-kanaler.
English: - if you are allergic to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of this medicine (listed in section 6).
Danish: - hvis du er allergisk over for telithromycin, et af de øvrige makrolidantibiotika eller et af de øvrige indholdsstoffer i Ketek (angivet i punkt 6).
English: - if you are taking other medicines that can prolong the QT interval of the electrocardiogram
Danish: - hvis du tager andre lægemidler, som kan forlænge QT-intervallet i elektrokardiogrammet
English: - Severe, persistent or bloody diarrhoea associated with abdominal pain or fever, which can be a sign of serious bowel inflammation which may occur following treatment with antibiotics (very
Danish: - Alvorlig, vedvarende eller blodig diarré ledsaget af mavesmerter eller feber, som kan være tegn på alvorlig maveinfektion som kan opstå i forbindelse med antibiotikabehandling (meget
English: In similarity to some macrolides, telithromycin caused a prolongation of QTc interval in dogs and on action potential duration in rabbit Purkinje fibers in vitro.
Danish: I lighed med nogle makrolider forlængede telithromycin QTc-intervallet hos hunde og aktionspotentialets varighed hos kanin-Purkinje-fibre in vitro.
English: Diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Ketek may be caused by pseudomembranous colitis (see section 4.8).
Danish: Diarré, især hvis den er alvorlig, vedvarende og/eller blodig, under og efter behandling med telithromycin, være forårsaget af pseudomembranøs colitis (se 4.8).
English: Pharmacokinetic/Pharmacodynamic (PK/PD) relationship: The AUC/MIC ratio has been shown to be the PK/PD parameter that correlates best with the efficacy
Danish: Farmakokinetisk/farmakodynamisk (PK/PD) sammenhæng AUC/MIC forholdet er vist at være den PK/PD-parameter, der korrelerer bedst med virkningen af
English: After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Danish: Efter oral administration af radiomærket telithromycin genfindes 76 % af radioaktiviteten i fæces, og 17 % i urinen.
English: If telithromycin treatment is deemed necessary, these patients may be treated with alternating daily doses of 800 mg and 400 mg, starting with the 800 mg
Danish: Hvis behandling med telithromycin er nødvendig, kan disse patienter behandles med alternative daglige doseringer på 800 mg og 400 mg, begyndende med
English: Blood and the lymphatic system disorders
Danish: Blod og lymfesystem Immunsystemet
English: - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Danish: Tonsilitis/Pharyngitis forårsaget af Streptococcus pyogenes: 800 mg én gang daglig i 5 dage.
English: Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9,
Danish: Telithromycin er en CYP3A4- og CYP2D6-hæmmer, men har ingen eller begrænset effekt på CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 og
English: If any of these apply to you, or if you are not sure, tell your doctor before taking Ketek.
Danish: Hvis nogle af ovenstående punkter gælder for dig, eller hvis du er usikker, så tal med lægen før du
English: Telithromycin is metabolised primarily by the liver.
Danish: Telithromycin metaboliseres primært af leveren.
English: If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on,
Danish: Hvis nogle af disse bivirkninger er generende, alvorlige eller ikke aftager i løbet af behandlingen,
English: Additional side effects (frequency not known - frequency cannot be estimated from available data)
Danish: Andre bivirkninger (hyppighed ikke kendt - kan ikke estimeres ud fra forhåndværende data), som kan
English: B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Danish: B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Rumænien
English: Rapid distribution of telithromycin into tissues results in significantly higher telithromycin concentrations in most target tissues than in plasma.
Danish: Hurtig fordeling af telithromycin i vævet resulterer i signifikant højere telithromycinkoncentrationer i de fleste mål-væv end i plasma.
English: Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Danish: Baseret på observerede data er en daglig dosis på 600 mg nogenlunde ækvivalent med den påvirkning som var målet observeret hos de raske frivillige.
English: Furthermore, telithromycin is able to block the formation of the
Danish: Desuden kan telithromycin blokere dannelsen af 50S
English: Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Danish: Telithromycin udskilles i mælken hos dyr, i koncentrationer på ca. 5 gange af maternel plasmakoncentration.
English: Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
Danish: Telithromycin og dets humane hovedmetabolitter var negative i studier på genotoksisk potentiale in vivo og in vitro.
English: In the event of acute overdose the stomach should be emptied.
Danish: I tilfælde af akut overdosering skal mavens indhold tømmes.
English: When midazolam was coadministered with Ketek, midazolam AUC was increased 2.2-fold after intravenous administration of midazolam and 6.1-fold after oral administration.
Danish: Ved samtidig administration af midazolam med Ketek steg midazolam AUC 2,2 gange efter intravenøs administration af midazolam og 6,1 gang efter oral administration.
English: Experience of treatment of infections caused by penicillin/or erythromycin resistant S. pneumoniae is limited, but so far, clinical efficacy and eradication rates have been similar compared with the treatment of susceptible S. pneumoniae.
Danish: Erfaringen for behandling af infektioner forårsaget af penicillin/eller erythromycin resistente S. pneumoniae er begrænset, men indtil nu har klinisk effekt og eradikationsrate være ens sammenlignet med behandling af følsomme S pneumoniae.
English: During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
Danish: Under samtidig administration af rifampicin og telithromycin i gentagne doser, var Cmax og AUC for telithromycin i gennemsnit nedsat med henholdsvis 79% og 86%.
English: Plasma exposures based on free fraction of active substance, at the no observed adverse effect levels ranged from 1.6 to 13 times the expected clinical exposure.
Danish: Plasma-ekspositioner baseret på frie fraktioner af det aktive stof, ved koncentrationer med ingen observerede bivirkninger, nås i interval på 1,6 til 13 gange den forventede kliniske eksposition.
English: In subjects over 65 (median 75 years), the maximum plasma concentration and AUC of telithromycin were increased approximately 2-fold compared with those achieved in young healthy adults.
Danish: Hos forsøgspersoner over 65 (median 75 år) var den maksimale plasmakoncentration og AUC for telithromycin øget 2 gange i forhold til unge raske voksne.
English: Interaction studies with itraconazole and ketoconazole, two CYP3A4 inhibitors, showed that maximum plasma concentrations of telithromycin were increased respectively by 1.22 and 1.51 fold and AUC by respectively 1.54 fold and 2.0 fold.
Danish: Interaktionsstudier med itraconazol og ketoconazol, to CYP3A4-inhibitorer, viste, at maksimumplasmakoncentrationerne af telithromycin steg henholdsvis 1,22 og 1,51 gange og AUC henholdsvis 1,54 og 2,0 gange.
English: Concomitant administration with simvastatin, atorvastatin, and lovastatin.
Danish: Samtidig administration af simvastatin, atovastatin og lovastatin.
English: In comparative trials, similar effects to those observed with clarithromycin were seen with an on-therapy ΔQTc >30 msec in 7.6% and 7.0% of cases, respectively.
Danish: I sammenlignende kliniske studier blev lignende virkninger, som observeret under clarithromycin, set på en on-terapi ΔQTc> 30 msek hos henholdsvis 7,6% og 7% af tilfældene.
English: Talk to your doctor, pharmacist or nurse if you experience visual disturbances (blurred vision, difficulty focusing, double vision).
Danish: Tal med din læge, apotekspersonalet eller sundhedspersonalet hvis du oplever synsforstyrrelser (sløret syn, besvær med at se skarpt, dobbeltsyn).
English: Concomitant treatment with these medicinal products is likely to result in subtherapeutic levels of telithromycin and therefore encompass a risk of treatment failure (see section 4.5).
Danish: Samtidig behandling med disse lægemidler vil sandsynligvis resultere i subterapeutiske koncentrationer af telithromycin og udgør derfor en risiko for behandlingssvigt (se pkt.
English: The rate and extent of absorption is unaffected by food intake, and thus Ketek tablets can be given without regard to food.
Danish: Absorptionsraten og -udbredelsen påvirkes ikke af fødeindtagelse, hvorfor Ketek tabletter kan gives
English: In clinical trials the effect on QTc was small (mean of approximately 1 msec).
Danish: I kliniske studier var effekten på QTc ringe (gennemsnitlig ca. 1 msek.).
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2 of the Marketing Authorisation and any agreed
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RMP, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: These effects showed a tendency to regress after cessation of treatment.
Danish: Disse virkninger viste en tendens til regression efter behandlingsophør.
English: In patients of 12 to 18 years old, the treatment regimen will be:
Danish: For patienter på 12-18 år er behandlingen som følger
English: The combination is contraindicated (see section 4.3).
Danish: Kombinationen er kontraindiceret (se pkt.
English: The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
Danish: Minimumsværdierne i plasma, Cmax, AUC og renal clearance steg med henholdsvis 20%, 73%, 37% og 27% hos raske forsøgspersoner.
English: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY France
Danish: Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY Frankrig
English: • Tonsillitis/pharyngitis caused by Streptococcus pyogenes, as an alternative when beta lactam antibiotics are not appropriate in countries/regions with a significant prevalence of macrolide resistant S. pyogenes, when mediated by ermTR or mefA (see sections 4.4 and 5.1).
Danish: • Tonsilitis/pharyngitis, forårsaget af Streptococcus pyogenes som alternativ når beta-laktam antibiotika ikke er egnet i lande/regioner med en signifikant prævalens af makrolidresistent S. pyogenes, medieret via ermTR eller mefA (se pkt.
English: Very common
Danish: Meget almindelig >
English: There was evidence of reversibility upon cessation of treatment.
Danish: Der var evidens for reversibilitet efter afbrydelse af behandlingen.
English: S.C. Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Danish: S.C. Zentiva S.A. B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Rumænien
English: Repeated dose toxicity studies of 1, 3 and 6 month duration with telithromycin conducted in rat, dog and monkey showed that the liver was the principal target for toxicity with elevations of liver enzymes, and histological evidence of damage.
Danish: Toksicitetsstudier af 1, 3 og 6 måneders varighed udført på rotte, hund og abe med gentagne doser telithromycin viste, at leveren var det primære mål for toksicitet med stigninger i leverenzymer og histologiske tegn på skader.
English: What you need to know before you take Ketek
Danish: Det skal du vide, før du begynder at tage Ketek
English: Caution is warranted when Ketek is administered to patients taking other medicinal products with the potential to prolong the QT interval (see section 4.4).
Danish: Forsigtighed anbefales, når Ketek anvendes til patienter, der får anden medicin med potentiale til at forlænge QT-intervallet (se pkt.
English: The mean maximum white blood cell concentration of telithromycin was 83±25 mg/l.
Danish: Den gennemsnitlig maksimumtelithromycin-koncentration i hvide blodlegemer var 83 ± 25 mg/l.
English: Reports have included death and life threatening acute respiratory failure with rapid onset (see section 4.8).
Danish: Rapporter har omfattet død og livstruende akut hurtigt indtrædende respirationssvigt (se pkt.
English: Colchicine intoxication, including fatal cases, has been reported in patients treated with colchicine and strong CYP 3A4 inhibitors.
Danish: Colchicin-forgiftning, inklusive dødelige tilfælde, er set hos patienter behandlet med colchicin og stærke CYP3A4-inhibitorer.
English: If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Danish: Hvis du stopper med at tage tabletterne for tidligt, kan dette også være med til at gøre bakterierne
English: - if you have had a liver disease (hepatitis and/or jaundice) while taking Ketek in the past.
Danish: - hvis du tidligere har haft en leversygdom (hepatitis og/eller gulsot) i forbindelse med, at du tog
English: Ketek tablets are presented in blister packs.
Danish: Ketek sælges i blisterpakninger.
English: • When treating infections caused by known or suspected beta-lactam and/or macrolide resistant strains (according to history of patients or national and/or regional resistance data) covered by the antibacterial spectrum of telithromycin (see sections 4.4 and 5.1):
Danish: • Ved behandling af infektioner forårsaget af kendte eller suspekte beta-laktam- og/eller makrolidresistente stammer (i henhold til tidligere patientforløb eller nationale og/eller regionale resistensdata) dækket af det antibakterielle spektrum af telithromycin (se pkt.