natgillin/translations-raw huggingface dataset:
Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du tager Ketek: - hvis du tidligere har haft visse hjerteproblemer såsom koronar hjertesygdom, ventrikulære arytmier, bradykardi (ændring i hjerterytmen eller elektrokardiogram) eller hvis du har haft visse unormale blodprøver som følge af medicinske tilstande såsom lavt niveau af kalium (hypokaliæmi) og lavt niveau af magnesium (hypomagnesiæmi). 
Talk to your doctor, pharmacist or nurse before taking Ketek: - if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias, bradycardia (changes in heart rate or electrocardiogram) or if you have had certain abnormal blood tests due to medical conditions such as low levels of potassium (hypokalaemia), low levels
Baseret på simulations data, kan et alternativ dagligt dosis regime på 800 mg og 400 mg til patienter med alvorlig nedsat nyrefunktion nærme sig AUC (0-48 t) hos raske individer, som får 800 mg en 
Based on simulation data, an alternating daily dosing regimen of 800 mg and 400 mg in patients with severe renal impairment can approximate the AUC (0-48h) in healthy subjects receiving 800 mg once daily.
Alternativt skal behandlingen med CYP3A4-substrat afbrydes under behandling med 
Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Ketek.
Ketek bør ikke anvendes under og 2 uger efter behandling med CYP3A4-inducere. 
Ketek should not be used during and 2 weeks after treatment with CYP3A4 inducers.
Forlængelse af QT-intervallet 
QT interval prolongation
Patienter i samtidig behandling med pravastatin, rosuvastatin eller fluvastatin bør monitoreres omhyggeligt for tegn og symptomer på myopati og rabdomyolyse (se pkt. 
Patients with concomitant treatment of pravastatin, rosuvastatin or fluvastatin should be carefully monitored for signs and symptoms of myopathy and rhabdomyolysis.
- Lægen har ordineret Ketek til dig personligt. 
- This medicine has been prescribed for you only.
• cisaprid (mod fordøjelsesproblemer) 
• cisapride (digestive problems)
- Hududslæt, udslæt (nældefeber), kløe, eksem - Døsighed, besvær med at falde i søvn (insomnia), nervøsitet, svimmelhed - Snurren i hænder eller fødder (paræstesi) - Synsforstyrrelser (sløret syn, besvær med at se skarpt, dobbeltsyn) (læs venligst punkt 2) - Rødmen, besvimelse (kortvarigt tab af bevidsthed) - Ændring i hjerterytmen (f.eks. langsom hjerterytme) eller unormalt elektrokardiogram (ekg) 
- rash, hives (urticaria), itching, eczema - drowsiness, difficulties in falling asleep (insomnia), nervousness, vertigo - tingling of the hands or feet (paraesthesia) - visual disturbances (blurred vision, difficulty in focusing, double vision)(please read section 2) - flushes, fainting (transient loss of consciousness) - changes in heart rate (e.g. slow beating) or abnormality of electrocardiogram (ECG)
Ved ekstrapolering fra erythromycin A og josamycin kan samtidig medicinering med Ketek og sekalealkaloidderivater føre til alvorlig vasokonstriktion (”ergotisme”) med mulig nekrose i ekstremiteterne. 
Ergot alkaloid derivatives (such as ergotamine and dihydroergotamine) By extrapolation from erythromycin A and josamycin, concomitant medication of Ketek and alkaloid derivatives could lead to severe vasoconstriction (“ergotism”) with possibly necrosis of the extremities.
Indtagelse af Ketek kan give bivirkninger, såsom synsforstyrrelser, forvirring eller hallucinationer, som kan nedsætte evnen til at udføre forskellige opgaver. 
Taking Ketek may cause side effects such as visual disturbances, confusion or hallucination which may reduce the capacity to carry out certain tasks.
Til patienter i hæmodialyse bør dosis justeres, så Ketek 800 mg gives efter hver dialysebehandling (se 
In haemodialysed patients, the posology should be adjusted so that Ketek 800 mg is given after the dialysis session (see also section 5.2).
Der er rapporteret sjældne tilfælde af besvimelse (forbigående bevidsthedstab), hvilke kan forudgås af en generel følelse af utilpashed (f.eks. kvalme, mavegener). 
Rare cases of fainting (transient loss of consciousness), which may be preceded by a general feeling of being sick (e.g. nausea, stomach upsets) have been reported.
Telithromycin er kendt for at være en stærk CYP3A4-hæmmer og er også en P-glykoprotein-hæmmer. 
Telithromycin is known to be a strong CYP3A4 inhibitor and is also a P-glycoprotein inhibitor.
Disse observationers betydning for mennesker er 
The significance of these findings for humans is unknown.
Størstedelen af methicillinresistente S.aureus (MRSA) udtrykker 
The majority of methicillin-resistant S. aureus (MRSA) express cMLSB.
Studier af reproduktionstoksicitet viste nedsat cellemodning hos rotter og påvirkning af befrugtningen. 
Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on fertilization.
• medicin, som kaldes en protease hæmmer (mod hiv) 
• a medicine called protease inhibitor (anti-HIV treatment)
Det primære CYPenzym involveret i telithromycinmetaboliseringen er CYP3A4. 
The major CYP450 enzyme involved in the metabolism of telithromycin is CYP3A4.
- nogle calciumantagonister (f.eks. verapamil, nifedipin, felodipin). 
- some calcium channel blockers (e.g. verapamil, nifedipine, felodipine) (for heart disorders).
Behandling med disse stoffer bør afbrydes under behandling med Ketek (se pkt. 
Treatment with these agents should be interrupted during Ketek treatment (see section 4.5).
Ketek kan forårsage bivirkninger så som synsforstyrrelser, forvirring eller hallucinationer, som kan nedsætte evnen til at udføre visse opgaver. 
Ketek may cause adverse reactions such as visual disturbances, confusion or hallucination which may reduce the capacity for the completion of certain tasks.
Hvis du har taget for meget Ketek 
If you take more Ketek than you should
Hvis du har synsproblemer, besvimer eller oplevelser med forvirring eller hallucinationer, mens du tager Ketek, skal du undlade at køre bil, betjene tunge maskiner eller udføre farlige aktiviteter. 
If you have vision problems, faint or experience confusion or hallucination while taking Ketek, do not drive, operate heavy machinery or
Telithromycin er en CYP3A4-hæmmer og en svag CYP2D6-hæmmer. 
Telithromycin is an inhibitor of CYP3A4 and a weak inhibitor of CYP2D6.
Ikke almindelige (forekommer hos færre end 1 ud af 100 patienter) eller sjældne bivirkninger (forekommer hos færre end 1 ud af 1.000 patienter) - Forstoppelse, appetitløshed - Betændelse i munden, svampeinfektion i munden (Candida-infektion) 
Uncommon (may affect up to 1 in 100 people) or rare side effects (may affect up to 1 in 1,000 people) - constipation, loss of appetite (anorexia) - inflammation in the mouth, fungal infection in the mouth (Candida infection)
QT-/QTcinterval forlængelse, ventrikulær arytmi (herunder ventrikulær takykardi, torsades de pointes) potentielt med dødeligt udfald (se pkt. 
QT/QTc interval prolongation, ventricular arrhythmia (including ventricular tachycardia, torsade de pointes) with potential fatal outcome (see section 4.4)
Ketek bør ikke anvendes under amning. 
Ketek should not be used by breast
På grund af risiko for forlængelse af QT-intervallet skal Ketek anvendes med forsigtighed til patienter med koronare hjertesygdomme, ventrikulære arytmier, ukorrigeret hypokaliæmi og/eller hypomagnesiæmi eller bradykardi (< 50 slag/ min), ved samtidig administration af lægemidler, der forlænger QT-intervallet, samt til patienter, der samtidig behandles med potente CYP3A4-inhibitorer såsom proteasehæmmere eller azolantimykotika (f.eks.ketoconazol, fluconazol) (se pkt. 
Due to a potential to increase the QT interval, Ketek should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and/or hypomagnesaemia, or bradycardia (<50 bpm), during concomitant administration of Ketek with QT interval prolonging agents, or in patients concomitantly treated with potent CYP 3A4 inhibitors such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole) (see sections 4.3 and 4.5).
Samtidig administration af stærke CYP3A4-hæmmere (såsom telithromycin) og calciumantagonister, der metaboliseres af CYP3A4 (f.eks. verapamil, nifedipin, felodipin), kan resultere i hypotension, bradykardi og bevidsthedstab og bør derfor undgås. 
Concomitant administration of strong CYP3A4 inhibitors (such as telithromycin) and calcium channel blockers that are metabolized by CYP3A4 (e.g. verapamil, nifedipine, felodipine) may result in hypotension, bradycardia or loss of consciousness, and should therefore be avoided.
Når metoprolol (et CYP2D6 substrat) blev administreret samtidig med Ketek, blev metropolol Cmax og AUC øget med omkring 38%. 
When metoprolol (a CYP2D6 substrate) was coadministered with Ketek, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Calciumantagonister, der metaboliseres af CYP3A4 
Calcium channel blockers that are metabolized by CYP3A4
Disse tilfælde forbindes ikke med tegn på øjenabnormalitet (se pkt. 
These events have not been associated with signs of ocular abnormality (see sections 4.4 and 4.7).
De maksimale totale vævskoncentrationer i epitelomkranset væske, alveolære makrofager, bronkial mucosa, tonsiller og sinusvæv var henholdsvis 14,9 ± 11,4 mg/l, 318,1 ± 231 mg/l, 3,88 ± 1,87 mg/kg, 3,95 ± 0,53 mg/kg og 6,96 ± 1,58 mg/kg. 
The maximum total tissue concentration in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 14.9±11.4 mg/l, 318.1±231 mg/l, 3.88±1.87 mg/kg, 3.95±0.53 mg/kg and 6.96±1.58 mg/kg, respectively.
Almindelige bivirkninger (forekommer hos færre end 1 ud af 10 patienter) - Kvalme, opkastning, mavesmerter, flatulens (luft i maven) - Svimmelhed, hovedpine, smagsforstyrrelser - Vaginal Candida-infektion (svampeinfektion forbundet med lokal kløe, brænden og hvidt udflåd) - Forhøjelse af leverenzymer (påvist ved blodprøve) 
Common side effects (may affect up to 1 in 10 people) - nausea, vomiting, abdominal pain, flatulence (excess wind) - dizziness, headaches, disturbance of taste - vaginal Candida infection (fungal infection associated with local itching, burning and white discharge) - increase in liver enzymes (detected by blood test).
Det bør overvejes at give Ketek ved sengetid for at reducere den potentielle følgevirkning synsforstyrrelser og tab af bevidsthed. 
Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness.
Hvis begge lægemidler skal anvendes samtidig, skal de indtages med 1 times interval for at undgå mulige bivirkninger fra mavetarmkanalen, f.eks. kvalme og 
However, the co-administration of both medicinal products should be separated by one hour in order to avoid possible digestive side effects such as nausea and vomiting.
• colchicin (mod urinsur gigt) 
• colchicine (for gout).
Der er endvidere rapporteret sjældne tilfælde af forbigående bevidsthedstab, hvilke kan være forudgået af vagus symptomer (se pkt. 
In addition, rare cases of transient loss of consciousness, which may be preceded by vagal symptoms, have been reported (see section 4.8).
Samtidig administration af lægemidler, der forlænger QT-intervallet, og som er CYP3A4-substrater, såsom cisaprid, pimozid, astemizol, terfenadin, dronedaron, saquinavir (se pkt. 
Concomitant administration with medicinal products that prolong the QT interval and are CYP3A4 substrates, such as cisapride, pimozide, astemizole, terfenadine, dronedarone, saquinavir (see section
Hos patienter med alvorlig nedsat nyrefunktion og/eller leverfunktion, er samtidig administration af Ketek og stærke CYP3A4-hæmmere, såsom proteasehæmmere eller azolantimykotika (f.eks. ketoconazol, fluconazol), kontraindiceret. 
In patients with severely impaired renal and/or hepatic function, concomitant administration of Ketek and strong CYP3A4 inhibitors, such as protease inhibitors or azole antifungals (e.g. ketoconazole, fluconazole), is contraindicated.
• saquinavir (mod hiv) - andre lægemidler indeholdende et af følgende aktive stoffer: 
- other medicines containing any of the following active substances:
Hvis patienterne oplever synsforstyrrelser, tab af bevidsthed, forvirring eller hallucinationer under behandling med Ketek, bør de ikke køre bil, betjene tunge maskiner eller påtage sig andre risikobetonede aktiviteter (se pkt. 
If patients experience visual disorders, loss of consciousness, confusion or hallucination while taking Ketek, patients should not drive a motor vehicle, operate heavy machinery or engage in other hazardous activities (see sections
Telithromycin er ikke aktiv mod organismer, der grundlæggende udtrykker MLSBresistensdeterminanten (cMLSB). 
Telithromycin is not active against organisms that constitutively express the MLSB resistance determinant (cMLSB).
Derfor vil samtidig administration af CYP3A4-inducere (f.eks. rifampicin, phenytoin, carbamazepin, phenobarbital, perikon) sandsynligvis resultere i subterapeutiske koncentrationer af telithromycin og tab af effekt. 
Therefore, concomitant administration of CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort) is likely to result in subtherapeutic levels of telithromycin and loss of effect.
Dette inkluderer medicin mod unormal hjerterytme (antiarytmika såsom quinidin, amiodaron), mod depression (citalopram, tricykliske antidepressiva), methadon, visse antipsykotika (phenothiaziner), visse antibiotika (fluorquinoloner såsom moxifloxacin), visse svampemidler (fluconazol, pentamidin) og visse antivirale lægemidler (telaprevir). 
These include medicines used for abnormal heart rhythm (antiarrhythmics such as quinidine, amiodarone), for depression (citalopram, tricyclic antidepressants), methadone, some antipsychotics (phenothiazines), some antibiotics (fluoroquinolones such as moxifloxacin), some antifungals (fluconazole, pentamidine), and some antiviral drugs (telaprevir).
Der har været rapporteret post-marketing bivirkninger af forbigående tab af bevidsthed inklusive nogle tilfælde associeret med vagus syndrom (se pkt. 
There have been post-marketing adverse reaction reports of transient loss of consciousness including some cases associated with vagal syndrome (see sections 4.7 and 4.8).
Inden for hver gruppe af bivirkninger med samme frekvens skal bivirkningerne opstilles efter hvor alvorlige bivirkningerne er. 
Within each frequency grouping, undesirable effects are presented in order of decreasing seriousness.
De totale vævskoncentrationerne 24 timer efter dosis i epitelomkranset væske, alveolære makrofager, bronkial mucosa, tonsiller og sinusvæv var henholdsvis 0,84 ± 0,65 mg/l, 162 ± 96 mg/l, 0,78 ± 0,39 mg/kg, 0,72 ± 0,29 mg/kg og 1,58 ± 1,68 mg/kg. 
The total tissue concentration 24 h after dose in epithelial lining fluid, alveolar macrophages, bronchial mucosa, tonsils and sinus tissue were 0.84±0.65 mg/l, 162±96 mg/l, 0.78±0.39 mg/kg, 0.72±0.29 mg/kg and 1.58±1.68 mg/kg, respectively.
- Tegn eller symptomer på leverbetændelse (hepatitis) såsom gulfarvning af hud og øjne, mørk urin, kløe, tab af appetit eller mavesmerter (ikke almindelig). 
- Signs and symptoms of liver disease (hepatitis) such as yellowing of skin and eyes, dark urine,
Du må ikke tage Ketek, hvis du ammer. 
If you are breast-feeding do not take Ketek.
Det gælder også, selv om du får det bedre, inden du er færdig med at tage alle tabletterne. 
Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
- Du bør ikke tage Ketek, hvis du har nyreproblemer (alvorlig nedsat nyrefunktion) og/eller leverproblemer (alvorlig nedsat leverfunktion), samtidig med anden medicin indeholdende et af følgende aktive stoffer: 
- if you have kidney problems (severely impaired renal function) and/or liver problems (severely impaired hepatic function), do not take Ketek while taking other medicines containing any of the following active substances:
Som følge heraf bør telithromycin anvendes med forsigtighed (se også pkt. 
Hence, telithromycin should be used with caution (see also sections 4.4 and 5.2).
Gennemsnitlige maksimum og minimum plasmakoncentrationer ved steady state hos patienter var 2,9±1,6 mg/l (interval 0,02-7,6 mg/ml) og 0,2±0,2 mg/l (interval 0,010-1,29 mg/l) under et terapeutisk 
Mean peak and trough plasma concentrations at steady state in patients were 2.9±1.6 mg/l (range 0.02-7.6 mg/l) and 0.2±0.2 mg/l (range 0.010 to 1.29 mg/l), during a therapeutic 800 mg once-daily dose regimen.
Alligevel bør kontrol af S-digoxin overvejes ved samtidig anvendelse af 
Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Ketek.
KVALITATIV OG KVANTITATIV SAMMENSÆTNING En filmovertrukken tablet består af 400 mg telithromycin. 
QUALITATIVE AND QUANTITATIVE COMPOSITION Each film-coated tablet contains 400 mg of telithromycin.
Ageusi, anosmi tremor, kramper 
Ageusia, anosmia, tremors, convulsions
Den non-renale clearance m nedsættes når dosis forøges.Total clearance er ca. 58±5 L/time efter intravenøs hvoraf den renale clearance er på 22 %. 
The total clearance (mean ±SD) is approximately 58±5 l/h after an intravenous administration with renal clearance accounting for about 22% of this.
Ketek 400 mg filmovertrukne tabletter Telithromycin 
Ketek 400 mg film-coated tablets Telithromycin
LÆGEMIDLETS NAVN Ketek 400 mg filmovertrukne tabletter 
NAME OF THE MEDICINAL PRODUCT Ketek 400 mg film-coated tablets
For Streptococcus pyogenes, der udviser højniveau-resistens over for eryhromycin A, er der krydsresistens over for telithromycin. 
Streptococcus pyogenes that show high-level resistance to erythromycin A are cross-resistant to
+**Telithromycin er ikke aktivt mod organismer, der grundlæggende udtrykker MLSBresistensdeterminanten (cMLSB). 
+ Telithromycin is not active against organisms that constitutively express the MLSB resistance determinant (cMLSB).
4.4 og - Akutte eksacerbationer af kronisk bronkitis 
- Acute exacerbation of chronic bronchitis,
Hvis du på grund af bivirkninger føler, at du er nødt til at stoppe med at tage Ketek, bør du spørge din læge til råds, inden du tager næste dosis. 
If you feel you are suffering from a side effect, tell a doctor immediately to get advice before taking
Når simvastatin blev administreret samtidig med Ketek, steg simvastatin Cmax 5,3 gange og simvastatin AUC steg 8,9 gange, Simvastatinsyre Cmax steg 15 gange og simvastatinsyre AUC steg 11 gange., Ketek kunne bevirke en lignende interaktion med lovastatin og atorvastatin, som også hovedsagelig metaboliseres via CYP3A4. 
When simvastatin was coadministered with Ketek, there was a 5.3-fold increase in simvastatin Cmax, an 8.9-fold increase in simvastatin AUC, a 15-fold increase in simvastatin acid Cmax and an 11-fold increase in simvastatin acid AUC.
Hvis du snart skal tage den næste dosis, så spring den glemte dosis over. 
However, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time.
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B. CONDITIONS OR RESTRICTIONS REGARDING SUPPLY
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Telithromycin inducerer ikke ekspression af makrolid-lincosamid-streptogramin B (MLSB)-medieret resistens in vitro hos Staphylococcus aureus, Streptococcus pneumoniae eller Streptococcus pyogenes. 
mediated resistance in vitro in Staphylococcus aureus, Streptococcus pneumoniae, or Streptococcus
Hvis det er muligt, bør du tage tabletterne umiddelbart inden sengetid for at mindske de mulige virkninger såsom synsforstyrrelser samt tab af bevidsthed. 
If possible take the tablets before going to bed, to reduce the potential impact of visual disturbances and loss of consciousness.
Du skal tage hele tabletkuren, sådan som din læge har ordineret det. 
Always take this medicine exactly as your doctor or pharmacist has told you.
Der er ikke nogen klinisk relevante farmakokinetiske interaktioner mellem Ketek og teophyllin, når dette gives som retard-formulering. 
There is no clinically relevant pharmacokinetic interaction of Ketek and theophylline administered as extended release formulation.
Brug af anden medicin sammen med Ketek 
• Effect of other medicinal products on Ketek
Studier på rotter og kaniner var inklusiv med hensyn til potentiale for teratogenicitet. 
Studies in rats and rabbits were inconclusive with respect to potential for teratogenicity; there was equivocal evidence of adverse effects on foetal development at high doses.
Eksponering for telithromycin in vitro-selekterede pneumokokmutationer med øget MIC for telithromycin. 
Exposure to telithromycin in vitro did select for pneumococcal mutants with increased MICs of telithromycin, generally resulting in MIC values of ≤1 mg/l.
Cholestatisk icterus 
Cholestatic jaundice
Hæmningsgraden af forskellige CYP3A4-substrater er vanskelig at forudsige, og Ketek bør derfor ikke anvendes under behandling med andre midler, der er CYP3A4-substrater, med mindre plasmakoncentrationerne af CYP3A4-substrat, effekten eller bivirkninger nøje kan monitoreres. 
Hence, Ketek should not be used during treatment with medicinal products that are CYP3A4 substrates, unless plasma concentrations of the CYP3A4 substrate, efficacy or adverse reactions can be closely monitored.
Dette inkluderer antiarytmika klasse IA (f.eks. quinidin, procainamid, disopyramid) og klasse III (f.eks. dofetilid, amiodaron), citalopram, tricykliske antidepressiva, methadon, visse antipsykotika (f.eks. phenothiaziner), fluorquinoloner (f.eks. moxifloxacin), visse svampemidler (f.eks. fluconazol, pentamidin) og visse antivirale lægemidler (f.eks. telaprevir). 
These include Class IA (e.g.quinidine, procainamide, disopyramide) and Class III (e.g. dofetilide, amiodarone) antiarrhythmic agents, citalopram, tricyclic antidepressants, methadone, some antipsychotics (e.g. phenothiazines), fluoroquinolones (e.g. moxifloxacin), some antifungals (e.g. fluconazole, pentamidine), and some
Systemorgankl asser 
System organ class
Blodelektrolytter (specielt kalium) skal kontrolleres og grundet risikoen for forlængelse af QT-interval og øget risiko for arytmier skal EKG-måling finde 
Due to the potential for the prolongation of the QT interval and increased risk of arrhythmia, ECG monitoring must take place.
Er du i tvivl, så spørg lægen eller på apoteket. 
If in doubt, talk to your doctor or pharmacist.
Telithromycins overvejende eliminationshalveringstid er 2- 3 timer og den terminale halveringstid er ca. 10 timer ved en dosis på 800 mg en gang daglig. 
Telithromycin displays a tri-exponential decay from plasma, with a rapid distribution half-life of 0.17 h. The main elimination half-life of telithromycin is 2-3 h and the terminal, less important, half-life is about 10 h at the dose 800 mg once daily.
Österreich sanofi-aventis GmbH Tel: +43 1 80 185 - 0 Polska sanofi-aventis Sp. z o.o. 
Österreich sanofi-aventis GmbH Tel: +43 1 80 185 - 0
Pseufomembranøs colitis (se pkt. 
Pseudomembranou s colitis (see section 4.4)
In vitro-proteinbindingen er ca. 60% til 70%.Telithromycin fordeles bredt i hele kroppen. 
The in vitro protein binding is approximately 60% to 70%.
(hulrummene i knoglerne omkring næsen), infektioner i brystet hos patienter med længerevarende åndedrætsbesvær samt lungebetændelse (pneumoni). 
- In adults, Ketek is used to treat infections of the throat, infections of the sinuses (hollow cavities in the bones around the nose) and chest infections in patients with long standing breathing difficulties and lung infection (pneumonia).
LÆGEMIDLETS NAVN Ketek 400 mg filmovertrukne tabletter telithromycin 
NAME OF THE MEDICINAL PRODUCT Ketek 400 mg film-coated tablets telithromycin
Ketek bør grundet begrænset erfaring anvendes med forsigtighed til patienter med nedsat 
Due to limited experience, Ketek should be used with caution in patients with liver impairment (see
• dronedaron (mod hjerteflimmer) 
• dronedarone (for atrial fibrillation)
- Aktivt stof: Hver tablet indeholder 400 mg telithromycin. 
Each tablet contains 400 mg of telithromycin.