natgillin/translations-raw huggingface dataset:
De fleste er lette og forbigående men meget sjældne tilfælde af alvorlige leverreaktioner og leversvigt, inklusiv dødelige tilfælde, har været rapporteret. 
Most of them are mild and transient, but very rare cases of serious adverse liver reactions and liver failure, including fatal cases, have been reported.
Begrænsede data fra studier hos pædiatriske patienter i alderen 13-17 år viser, at koncentrationen af telithromycin i denne aldersgruppe svarer til koncentrationerne hos patienter i alderen 18-40 år. 
Limited data, obtained in paediatric patients 13 to 17 years of age, showed that telithromycin concentrations in this age group were similar to the concentrations in patients 18 to 40 years of age.
I begge studier blev observeret højere nyre elimination hos patienter med nedsat leverfunktion. 
In both studies, higher renal elimination was observed in the hepatically impaired patients.
Atriel arytmi, hypotension, bradykardi 
Atrial arrhythmia, hypotension, bradycardia
Disse symptomer kan forekomme så tidligt som efter den første dosis af 
These symptoms may appear as early as after the first dose of Ketek.
- hvis du lider af myasthenia gravis, en sjælden sygdom, som giver muskelsvaghed. 
- if you suffer from myasthenia gravis, a rare disease which causes muscle weakness.
Ved pneumoni er der påvist effekt hos et begrænset antal patienter med risikofaktorer såsom pneumococ bacteriæmi eller alder mere end 65 år. 
In community acquired pneumonia, efficacy has been demonstrated in a limited number of patients with risk factors such as pneumococcal bacteraemia or age higher than 65 years.
Meget almindelige bivirkninger (forekommer hos flere end 1 ud af 10 patienter) - Diarré, sædvanligvis let og midlertidig. 
Very common side effects (may affect more than 1 in 10 people) - diarrhoea, usually mild and temporary.
Som for macrolider, er H. influenzae klassificeret som intermediært følsom. 
As for macrolides, H. influenzae is classified as intermediately susceptible.
Disse leverreaktioner blev observeret under eller umiddelbart efter behandling og var i de fleste tilfælde reversible efter seponering af telithromycin. 
These hepatic reactions were observed during or immediately after treatment, and in most cases were reversible after discontinuation of telithromycin.
Tidligere hepatitis og/eller gulsot forbundet med anvendelse af telithromycin. 
Previous history of hepatitis and/or jaundice associated with the use of telithromycin.
FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE Navn og adresse på fremstillerne ansvarlige for batchfrigivelse: 
A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE Name and address of the manufacturer(s) responsible for batch release:
Hos 2.461 patienter behandlet med telithromycin i fase III kliniske studier samt igennem postmarketing erfaring blev følgende bivirkninger, der muligvis eller sandsynligvis kunne relateres til telithromycin, rapporteret. 
In 2,461 patients treated by Ketek in phase III clinical trials, and during post-marketing experience, the following undesirable effects possibly or probably related to telithromycin have been reported.
Ved høje doser var embryotoksiciteten åbenbar og en stigning i ufuldstændig ossifikation og skeletale anomalier sås. 
At high doses embryotoxicity was apparent and an increase in incomplete ossification and in skeletal anomalies was seen.
For patienter på 18 år og opefter, alt efter indikation, er behandlingen som følger: 
In patients of 18 years and older, according to the indication, the treatment regimen will be:
Virkningerne var åbenbare ved plasmakoncentrationer af det frie lægemiddel på 8 til 13 gange af det forventede kliniske niveau. 
Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
De anbefalede Europæiske Referencekomité (EUCAST) MIC kliniske grænseværdier for telithromycin ses nedenfor: 
The recommended European Committee for Antimicrobial Susceptibility Testing (EUCAST) MIC clinical breakpoints are presented below:
Den øgede eksponering af metoprolol kan være klinisk vigtig for patienter med hjertefejl i behandling med metoprolol. 
The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
Ketek anvendes til behandling af infektioner forårsaget af bakterier, som lægemidlet virker imod. 
Ketek is used to treat infections due to bacteria against which the medicine is active.
Hvis du har glemt en dosis, så tag den så snart du kommer i tanke om det. 
If you forget to take a dose, take it as soon as possible.
Efter oral administration udskilles 2/3 af en dosis som metabolitter og 1/3 uomdannet. 
After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
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. 
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.
Diarré, kvalme og svimmelhed var de hyppigst rapporterede bivirkninger i fase III kliniske studier. 
Diarrhoea, nausea and dizziness were the most commonly reported adverse reactions in phase III clinical trials.
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. 
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.
Dosisjustering til ældre baseret på alder alene er ikke nødvendig. 
No dosage adjustment is required in elderly patients based on age alone.
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. 
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.
Andre metabolitter blev påvist i plasma, urin og fæces og udgør mindre end eller er lig med 3 % af plasma AUC. 
Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3% of plasma
Begræns kørsel eller andre risikobetonede aktiviteter under behandling med Ketek. 
Limit driving or other hazardous activities while taking Ketek.
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 
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
De samme forsigtighedsregler skal også iagttages for andre benzodiazepiner, der metaboliseres af CYP3A4 (specielt triazolam men også i mindre udstrækning alprazolam). 
The same precautions should also apply to the other benzodiazepines which are metabolised by CYP3A4, (especially triazolam but also to a lesser extent alprazolam).
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. 
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.
Tilstrækkelig væskebalance bør opretholdes. 
Adequate hydration should be maintained.
Se også afsnittene: ”Tag ikke Ketek”, ”Brug af anden medicin sammen med Ketek” samt ”Trafik- og 
Refer also to sections “Do not take Ketek”, “Other medicines and Ketek” and “Driving and using
Ketek anbefales ikke til denne aldersgruppe. 
Ketek is not recommended in this population.
Hvis pseudomembranøs colitis mistænkes, skal behandling med Ketek stoppes omgående og patienten skal i understøttende og/eller 
If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures
* Klinisk effekt er blevet vist ved følsomme isolater til godkendte indikationer. 
∗ Clinical efficacy has been demonstrated for susceptible isolates in the approved clinical indications.
Øget antikoagulationsaktivitet er set hos patienter, der behandles samtidigt med antikoagulantia og antibiotika, herunder telithromycin. 
Increased anticoagulant activity has been reported in patients simultaneously treated with anticoagulants and antibiotics, including telithromycin.
Hvis du stopper med at tage tabletterne for tidligt, kan infektionen komme tilbage eller din tilstand kan forværres. 
If you stop taking the tablets too soon, the infection may return, or your
4.3 og 4.4). 
4.3 and 4.4).
Tilfælde af hurtig forværring af myasthenia gravis er rapporteret (se pkt. 
Parosmia Cases of rapid onset of exacerbation of myasthenia gravis have been reported (see sections
Hos disse patienter, skal samtidig administration af Ketek og metoprolol, et CYP2D6 substrat, påtænkes med forsigtighed. 
In these patients, co-administration of Ketek and metoprolol, a CYP2D6 substrate, should be considered with caution.
Intravenøs dosis af midazolam justeres efter behov og patienten skal monitoreres. 
Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient should be undertaken.
- hvis det er kendt, at du eller nogen i din familie har en sjælden abnormitet i elektrokardiogrammet (ekg), kaldet medfødt langt QT-syndrom. 
- if you or someone in your family are known to have an abnormality of electrocardiogram (ECG) called “long QT syndrome”.
- andre lægemidler, der kan forlænge QT-intervallet på et elektrokardiogram (ekg), såsom: 
- other medicines that can prolong the QT interval of the electrocardiogram (ECG), such as:
Den primære cirkulerende metabolit repræsenterer ca. 13% af telithromycin AUC, og har ringe antimikrobiel virkning sammenlignet med modersubstansen. 
Its principal circulating metabolite represents approximately 13% of telithromycin AUC, and has little antimicrobial activity compared with the parent medicinal product.
Denne indlægsseddel blev senest ændret <MM/YYYY>. 
This leaflet was last revised in <MM/YYYY> <month YYYY>.
Patienterne bør informeres om, at disse bivirkninger kan forekomme allerede ved den første dosis af lægemidlet. 
Patients should be informed that these adverse reactions may occur as early as after the first dose of medicinal product.
Dette kan være tegn på en maveinfektion, som kan opstå i forbindelse med antibiotika. 
This may be a sign of bowel inflammation which can occur following treatment with antibiotics.
Telithromycin hæmmer proteinsyntesen ved at interagere med domænerne II og V på det 23S ribosomale RNA af den 50S ribosomale subunit. 
Telithromycin inhibits protein synthesis by interacting with domains II and V of the 23S ribosomal RNA of the 50S ribosome subunit.
Disse ændringer i telithromycins farmakokinetik nødvendiggør ikke dosisjustering, da telithromycin-eksponeringen forbliver indenfor et veltolereret interval. 
These changes in the pharmacokinetics of telithromycin do not necessitate dosage adjustment as telithromycin exposure remains within a well tolerated range.
Ritonavirs virkning på telithromycin er ikke undersøgt og kunne medføre en større stigning i telithromycin-eksponringen. 
The effect of ritonavir on telithromycin has not been studied and could lead to larger increase in telithromycin exposure.
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. 
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.
L. pneumophila er meget følsom overfor telithromycin in vitro, imidlertid er den kliniske erfaring med behandling af pneumoni forårsaget af legionella begrænset. 
L. pneumophila is highly susceptible to telithromycin in vitro, however, the clinical experience of the treatment of pneumonia caused by legionella is limited.
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. 
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.
Medfødt eller familieanamnetisk forlænget QT-syndrom (hvis ikke udelukket ved ekg) og hos patienter med erkendt forlænget QT-interval. 
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.
Der findes ingen tilgængelige oplysninger for mennesker. 
Corresponding data for humans is not available.
Synsforstyrrelser, inklusive sløret syn, vanskelighed ved at fokusere samt diplopia. 
Visual disturbances included blurred vision, difficulty focusing, and diplopia.
Ranitidin (indtaget 1 time før Ketek) og antacida indeholdende aluminium og magnesiumhydroxid har ingen klinisk relevant påvirkning af telithromycins farmakokinetik 
Ranitidine (taken 1 hour before Ketek) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Telithromycin, men ikke dets humane hovedmetabolitter, havde inhibitorisk aktivitet på HERG- og Kv1.5-kanaler. 
Telithromycin, but not its major human metabolites, had inhibitory activity on HERG and Kv1.5 channels.
- hvis du er allergisk over for telithromycin, et af de øvrige makrolidantibiotika eller et af de øvrige indholdsstoffer i Ketek (angivet i punkt 6). 
- 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).
- hvis du tager andre lægemidler, som kan forlænge QT-intervallet i elektrokardiogrammet 
- if you are taking other medicines that can prolong the QT interval of the electrocardiogram
- 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 
- 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
I lighed med nogle makrolider forlængede telithromycin QTc-intervallet hos hunde og aktionspotentialets varighed hos kanin-Purkinje-fibre in vitro. 
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.
Diarré, især hvis den er alvorlig, vedvarende og/eller blodig, under og efter behandling med telithromycin, være forårsaget af pseudomembranøs colitis (se 4.8). 
Diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Ketek may be caused by pseudomembranous colitis (see section 4.8).
Farmakokinetisk/farmakodynamisk (PK/PD) sammenhæng AUC/MIC forholdet er vist at være den PK/PD-parameter, der korrelerer bedst med virkningen af 
Pharmacokinetic/Pharmacodynamic (PK/PD) relationship: The AUC/MIC ratio has been shown to be the PK/PD parameter that correlates best with the efficacy
Efter oral administration af radiomærket telithromycin genfindes 76 % af radioaktiviteten i fæces, og 17 % i urinen. 
After oral administration of radiolabelled telithromycin, 76% of the radioactivity was recovered from faeces, and 17% from the urine.
Hvis behandling med telithromycin er nødvendig, kan disse patienter behandles med alternative daglige doseringer på 800 mg og 400 mg, begyndende med 
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
Blod og lymfesystem Immunsystemet 
Blood and the lymphatic system disorders
Tonsilitis/Pharyngitis forårsaget af Streptococcus pyogenes: 800 mg én gang daglig i 5 dage. 
- Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Telithromycin er en CYP3A4- og CYP2D6-hæmmer, men har ingen eller begrænset effekt på CYP1A, 2A6, 2B6, 2C8, 2C9, 2C19 og 
Telithromycin is an inhibitor of CYP3A4 and CYP2D6, but has no or limited effect on CYP1A, 2A6, 2B6, 2C8, 2C9,
Hvis nogle af ovenstående punkter gælder for dig, eller hvis du er usikker, så tal med lægen før du 
If any of these apply to you, or if you are not sure, tell your doctor before taking Ketek.
Telithromycin metaboliseres primært af leveren. 
Telithromycin is metabolised primarily by the liver.
Hvis nogle af disse bivirkninger er generende, alvorlige eller ikke aftager i løbet af behandlingen, 
If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on,
Andre bivirkninger (hyppighed ikke kendt - kan ikke estimeres ud fra forhåndværende data), som kan 
Additional side effects (frequency not known - frequency cannot be estimated from available data)
B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Rumænien 
B-dul Theodor Pallady nr. 50, sector 3, Bucureşti, cod 032266, Romania
Hurtig fordeling af telithromycin i vævet resulterer i signifikant højere telithromycinkoncentrationer i de fleste mål-væv end i plasma. 
Rapid distribution of telithromycin into tissues results in significantly higher telithromycin concentrations in most target tissues than in plasma.
Baseret på observerede data er en daglig dosis på 600 mg nogenlunde ækvivalent med den påvirkning som var målet observeret hos de raske frivillige. 
Based on observed data, a 600 mg daily dose is approximately equivalent with the target exposure observed in healthy subjects.
Desuden kan telithromycin blokere dannelsen af 50S 
Furthermore, telithromycin is able to block the formation of the
Telithromycin udskilles i mælken hos dyr, i koncentrationer på ca. 5 gange af maternel plasmakoncentration. 
Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Telithromycin og dets humane hovedmetabolitter var negative i studier på genotoksisk potentiale in vivo og in vitro. 
Telithromycin, and its principal human metabolites, were negative in tests on genotoxic potential in vitro and in vivo.
I tilfælde af akut overdosering skal mavens indhold tømmes. 
In the event of acute overdose the stomach should be emptied.
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. 
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.
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. 
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.
Under samtidig administration af rifampicin og telithromycin i gentagne doser, var Cmax og AUC for telithromycin i gennemsnit nedsat med henholdsvis 79% og 86%. 
During concomitant administration of rifampicin and telithromycin in repeated doses, Cmax and AUC of telithromycin were on average decreased by 79% and 86% respectively.
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. 
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.
Hos forsøgspersoner over 65 (median 75 år) var den maksimale plasmakoncentration og AUC for telithromycin øget 2 gange i forhold til unge raske voksne. 
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.
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. 
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.
Samtidig administration af simvastatin, atovastatin og lovastatin. 
Concomitant administration with simvastatin, atorvastatin, and lovastatin.
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. 
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.
Tal med din læge, apotekspersonalet eller sundhedspersonalet hvis du oplever synsforstyrrelser (sløret syn, besvær med at se skarpt, dobbeltsyn). 
Talk to your doctor, pharmacist or nurse if you experience visual disturbances (blurred vision, difficulty focusing, double vision).
Samtidig behandling med disse lægemidler vil sandsynligvis resultere i subterapeutiske koncentrationer af telithromycin og udgør derfor en risiko for behandlingssvigt (se pkt. 
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).
Absorptionsraten og -udbredelsen påvirkes ikke af fødeindtagelse, hvorfor Ketek tabletter kan gives 
The rate and extent of absorption is unaffected by food intake, and thus Ketek tablets can be given without regard to food.
I kliniske studier var effekten på QTc ringe (gennemsnitlig ca. 1 msek.). 
In clinical trials the effect on QTc was small (mean of approximately 1 msec).
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. 
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
Disse virkninger viste en tendens til regression efter behandlingsophør. 
These effects showed a tendency to regress after cessation of treatment.
For patienter på 12-18 år er behandlingen som følger 
In patients of 12 to 18 years old, the treatment regimen will be:
Kombinationen er kontraindiceret (se pkt. 
The combination is contraindicated (see section 4.3).
Minimumsværdierne i plasma, Cmax, AUC og renal clearance steg med henholdsvis 20%, 73%, 37% og 27% hos raske forsøgspersoner. 
The plasma trough levels, Cmax, AUC and renal clearance were increased by 20%, 73%, 37% and 27% respectively, in healthy volunteers.
Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY Frankrig 
Aventis Pharma S.A. 20, Avenue Raymond Aron F-92160 ANTONY France