FrancophonIA/ELRC3.0 huggingface dataset:
English: The prevalence of 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 resistens kan variere geografiskt og over tid for udvalgte arter, og lokal information om resistensudviklingen er ønskelig, specielt ved behandling af alvorlige infektioner.
English: Medicines should not be disposed of via wastewater or household waste.
Danish: Medicinen må ikke tilføres spildevand eller husholdnigsaffald.
English: Furthermore, telithromycin is able to block the formation of the 50S and 30S ribosomal subunits.
Danish: Desuden er telithromycin i stand til at blokere dannelsen af de 50S og 30S ribosomale subunits.
English: The other side effects listed below are given with an estimation of the frequency with which they may occur.
Danish: For de øvrige bivirkninger, som er anført nedenfor, er angivet en forventet hyppighed med hvilken de forventes at forekomme.
English: The tablets should be swallowed whole with a sufficient amount of water.
Danish: Tabletterne bør synkes hele smmen tilstrækkelig vandmængde.
English: Cerivastatin should be used with caution and patients should be carefully monitored for signs and symptoms of myopathy.
Danish: Cerivastatin bør anvendes med forsigtighed og patienterne skal monitoreres omhyggeligt for tegn og symptomer på myopati.
English: BATCH NUMBER Batch {number}
Danish: BATCHNUMMER Lot{nummer}
English: No special precautions for storage.
Danish: Ingen særlige forholdsregler vedrørende opbevaringen.
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: Hvis nødvendigt, bør der søges ekspert bistand hvis lokal prævalens af resistens er af en sådan karakter, at anvendelse af stoffet i det mindste for nogle typer af infektioner er diskutabel.
English: Most events were mild to moderate; however, severe cases have been reported.
Danish: De fleste hændelser var milde til moderate; imidlertid har alvorlige tilfælde været rapporteret (se pkt.
English: During post-marketing experience, liver failure has been reported (frequency unknown).
Danish: Gennem erfaringer efter markedsføring er leversvigt blevet rapporteret (ukendt frekvens).
English: 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.
Danish: De fleste er milde og forbigående men meget sjældne tilfælde af alvorlige leverreaktioner og leversvigt, inklusive dødelige tilfælde, har været rapporteret.
English: Refer also to section “Do not take Levviax”.
Danish: Se også afsnittet “De bør ikke anvende Levviax”.
English: The above serious side effects are uncommon (1 out of 1000 to less than 1 out of 100), rare (1 out of 10,000 to less than 1 out of 1000 patients) or very rare (less than 1/10,000 patients including isolated report), but may require urgent medical attention.
Danish: Ovennævnte alvorlige bivirkninger er usædvanlige (fra 1 ud af 1.000 til mindre end 1 ud af 100), sjældne (fra 1 ud af 10.000 til mindre end 1 ud af 1.000 patienter) eller meget sjældne (mindre end 1 ud af 10.000 patienter inklusive isolerede rapporter), men kan kræve omgående lægehjælp.
English: In children:
Danish: Børn:
English: For any information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder.
Danish: For yderligere oplysninger om dette lægemiddel bedes henvendelse rettet til den lokale repræsentant for indehaveren af markedsføringstilladelsen:
English: If pseudomembranous colitis is suspected, the treatment must be stopped immediately and patients should be treated with supportive measures and/or specific therapy.
Danish: Hvis pseudomembranøs colitis mistænkes, skal behandling med Levviax skal stoppes omgående og patienten skal i understøttende og/eller specifik behandling.
English: Refer also to sections “Do not take Levviax”, “Taking other medicines” and “Driving and using machines”.
Danish: Se også afsnittene: ”De bør ikke tage Levviax,” ”Indtagelse af anden medicin” samt ”Bilkørsel og betjening af maskiner”.
English: Development of in vitro resistance to telithromycin due to spontaneous mutation is rare.
Danish: Udvikling af in vitro resistens over for telithromycin på grund af spontan mutation er sjælden.
English: - while taking other medicines containing any of the following active substances:
Danish: - hvis De tager anden medicin indeholdende et af de følgende indholdsstoffer:
English: The significance of these findings for humans is unknown.
Danish: Disse observationers betydning for mennesker er ukendt.
English: If you stop taking the tablets too soon you may also create a bacterial resistance to the medicine.
Danish: Hvis De stopper med at tage tabletterne for tidligt, kan De også være med til at gøre bakterierne resistente over for medicinen.
English: Other metabolites were detected in plasma, urine and faeces and represent less or equal than 3 % of plasma AUC.
Danish: Andre metaboliter blev påvist i plasma, urin og fæces og udgør mindre end eller er lig med 3 % af plasma AUC.
English: • Effect of other medicinal products on Levviax
Danish: • Andre lægemidlers virkning på Levviax:
English: Take the complete course of tablets prescribed by your doctor, even if you begin to feel better before you have finished them all.
Danish: De skal tage hele tabletkuren, sådan som lægen har ordineret det., Det gælder også selv om De får det bedre, inden De er færdig med at tage alle tabletterne.
English: • terfenadine or astemizole (allergic problems)
Danish: • terfenadin eller astemizol (allergi problemer)
English: - Levviax tablets are not recommended for use in children and adolescents less than 12 years old.
Danish: - Levviax tabletter anbefales ikke til børn og unge under 12 år.
English: In 2461 patients treated by Levviax in phase III clinical trials, the following undesirable effects possibly or probably related to telithromycin have been reported.
Danish: Hos 2461 patienter behandlet med telithromycin i fase III kliniske forsøg, blev følgende bivirkninger, der muligvis eller sandsynligvis kunne relateres til telithromycin rapporteret.
English: What Levviax contains
Danish: Hvad Levviax indeholder
English: If possible, take your tablets or the box with you to show the doctor or pharmacist.
Danish: Om muligt, skal De medbringe tabletterne eller æsken og vise denne til lægen.
English: METHOD AND, ROUTE(S) OF ADMINISTRATION Read the package leaflet before use Oral use
Danish: ANVENDELSESMÅDE OG INDGIVELSESVEJ(E) Læs indlægssedlen inden brug Oral anvendelse
English: In vivo interaction studies with other statins have not been performed, but Levviax may produce a similar interaction with lovastatin and atorvastatin, a lesser interaction with cerivastatin and little or no interaction with pravastatin and fluvastatin.
Danish: In-vivo interaktionsforsøg med andre statiner er ikke udført, men Levviax kunne bevirke en lignende interaktion med lovastatin og atorvastatin, en mindre interaktion med cerivastatin og lille eller ingen interaktion med pravastatin og fluvastatin.
English: INFORMATION IN BRAILLE Levviax
Danish: INFORMATION I BRAILLE-SKRIFT Levviax
English: Hypokalaemia and quinidine had additive/supra-additive effects in vitro while potentiation was evident with sotalol.
Danish: Hypokaliæmi og kinidin havde additiv / supraadditiv virkninger in-vitro mens forstærkningen var åbenbar med sotalol.
English: In both studies, higher renal elimination was observed in the hepatically impaired patients.
Danish: I begge forsøg blev observeret højere nyre elimination hos patienter med nedsat leverfunktion.
English: Effects were evident at plasma levels of free drug 8 to 13 times the expected clinical level.
Danish: Virkningerne var åbenbare ved plasmakoncentrationer af det frie lægemiddel på 8 til 13 gange det forventede kliniske niveau..
English: Intravenous dosage of midazolam should be adjusted as necessary and monitoring of the patient be undertaken.
Danish: Intravenøs dosis af midazolam justeres efter behov og patieneten skal monitoreres.
English: 10 film-coated tablets 14 film-coated tablets 20 film-coated tablets 100 film-coated tablets 5 x 2 film-coated tablets
Danish: 10 filmovertrukne tabletter 14 filmovertrukne tabletter 20 filmovertrukne tabletter 100 filmovertrukne tabletter 5 x 2 filmovertrukne tabletter
English: Levviax is not recommended for use in children below 12 years of age due to lack of data on safety and efficacy (see section 5.2).
Danish: Anvendelse af Levviax anbefales ikke til børn under 12 år på grund af mangel på data om sikkerhed og effekt (se pkt.
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 ekspositionen.
English: The increase exposure to metoprolol may be of clinical importance in patients with heart failure treated with metoprolol.
Danish: Den forhøjede eksposition af metoprolol kan være af klinisk betydning for patienter med hjertefejl, som behandles med metoprolol.
English: • ergotamine or dihydroergotamine (tablets or inhaler for migraine)
Danish: • Ergotamin eller dihydroergotamin (tabletter eller inhalator til migræne)
English: At high doses embryotoxicity was apparent and an increase in incomplete ossification and in skeletal anomalies was seen.
Danish: Ved høje doser var embryotoksiciteten åbenbar og en stigning i ufuldstændig ossifikaton og skeletale anomalier sås.
English: Levviax has been shown to increase the plasma concentrations of digoxin.
Danish: Levviax øger plasmakoncentrationen af digoxin.
English: Following oral administration, telithromycin is fairly rapidly absorbed.
Danish: Efter peroral administration absorberes telithromycin ganske hurtigt.
English: In clinical trials the effect on QTc was small (mean of approximately 1 msec).
Danish: I kliniske forsøg var effekten på QTc ringe (gennemsnitlig ca 1 msec).
English: • ketoconazole (anti fungal treatment)
Danish: • Ketoconazol (behandling mod svamp)
English: Limit driving or other hazardous activities while taking Levviax.
Danish: Begrænset kørsel eller andre risikobetonede aktiviteter under behandling med Levviax.
English: - if you develop severe or prolonged or bloody diarrhoea during or after taking Levviax tablets, consult your doctor immediately since it may be necessary to interrupt the treatment.
Danish: - Hvis De får alvorlig eller længerevarende og/eller blodig diarré medens eller efter at De har taget Levviax tabletter, skal De straks kontakte lægen, da de kan være nødvendigt at afbryde behandlingen.
English: Nevertheless, monitoring of serum digoxin level should be considered during concomitant administration of digoxin and Levviax.
Danish: Alligevel bør kontrol af se-digoxinniveauet overvejes ved samtidig anvendelse af digoxin og Levviax
English: For Streptococcus pneumoniae, there is no cross- or co-resistance between telithromycin and other antibacterial classes including erythromycin A and/or penicillin resistance.
Danish: For Streptococcus pneumoniae er der ikke kryds- eller co-resistens mellem telithromycin og andre antibakterielle klasser inklusive erythromycin A og/eller penicillinresistens.
English: In the event of acute overdose the stomach should be emptied.
Danish: I tilfælde af akut overdosering skal mavens indhold tømmes .
English: Although Levviax 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 Levviax har ingen klinisk relevant farmakokineteisk eller farmkodynamisk interaktion med warfarin efter enkeltdosis administartion, hyppigere monitorering af protrombintid/INR (International Normalised Ratio) værdier bør overvejes under samtidig behandling.
English: Levviax belongs to one of a group of medicines called ketolides, a new class of antibiotics related to macrolides.
Danish: Levviax tilhører den gruppe af lægemidler, der kaldes ketolider, en ny klasse af antibiotika beslægtet med makrolider.
English: Vertigo somnolence, nervousness, insomnia,
Danish: Vertigo, somnolens, nervøsitet, søvnløshed
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: The same precautions should also apply to the other benzodiazepins which are metabolized 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: Visual disturbances (<1%) associated with the use of Levviax, including blurred vision, difficulty focusing and diplopia, were mostly mild to moderate.
Danish: Synsforstyrrelser (< 1%) i forbindelse med brug af Levviax, inklusive sløret syn, svært ved at fokusere og diplopi, var mest milde til moderate.
English: Repeated dose toxicity studies of 1, 3 and 6 months 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: Gentagen dosis toksicitetsforsøg af 1, 3 og 6 måneders varighed med telithromycin udført på rotter, hund og aber viste at leveren var primær målet for toksicitet med stigninger i leverenzymer, og histologiske tegn på skader.
English: PARTICULARS TO APPEAR ON THE OUTER PACKAGING Carton
Danish: OPLYSNINGER, DER SKAL ANFØRES PÅ DEN YDRE EMBALLAGE Karton
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: If you are pregnant do not take Levviax tablets as the safety of Levviax in pregnancy is insufficiently established.
Danish: Hvis De er gravid skal De ikke tage Levviax tabletter, da Levviax tabletters sikkerhed ikke er tilstrækkelig klarlagt.
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 Kvl.5 kanaler.
English: Levviax must not be used in patients with previous history of hepatitis and/or jaundice associated with the use of telithromycin.
Danish: Levviax må ikke anvendes til patienter med tidligere hepatitis og/eller gulsot forbundet med anvendelse af telithromycin.
English: Levviax is contraindicated in patients with a 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: Levviax er kontraindiceret hos patienter med medfødt eller familieanamnetisk forlænget QT syndrom (hvis ikke udelukket ved EKG) og hos patienter med erkendt forlænget QT interval.
English: This may be a sign of bowel inflammation (pseudomembranous colitis) which can occur following treatment with antibiotics.
Danish: Dette kan være tegn på en maveinfektion (pseudomembranøs colitis), som kan opstå i forbindelse med antibiotika.
English: In these patients, co-administration of Levviax and metoprolol, a CYP2D6 substrate, should be considered with caution.
Danish: Hos disse patienter bør samtidig administration af Levviax og metoprolol, et CYP2D6 substrat, ske med forsigtighed.
English: No dosage adjustment is necessary in patients with mild, moderate, or severe hepatic impairment, unless renal function is severely impaired, however the experience in patients with impaired hepatic function is limited.
Danish: Dosisjustering til patienter med mild, moderat eller alvorlig nedsat leverfunktion er ikke nødvendig, medmindre nyrefunktionen er alvorligt nedsat, der er dog begrænsede erfaringer hos patienter med nedsat leverfunktion.
English: Oral contraceptives
Danish: Perorale kontraceptiva
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 macrolider bevirkede telithromycin en QTc interval forlængelse hos hunde og på aktionspotentialets varighed hos kanin Purkinje fibre in-vitro.
English: $ natural intermediate susceptibility +Among MRSA the rate of MLSBc resistant strains is more than 80%, telithromycin is not active against MLSBc.
Danish: $ Naturlig intermediate følsomhed +**Blandt MRSA er raten af MLSB resistente stammer mere end 80%, telithromycin er ikke aktiv overfor MLSBc.
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, telithromycin indbefattet.
English: The majority of MRSA are resistant to erythromycin A by a constitutive MLSB mechanism.
Danish: Hovedparten af MRSA er resistente overfor erythromycinA ved en konstitutiv MLSB mekanisme.
English: The pharmacokinetics of telithromycin in paediatric population less than 12 years old have not yet been studied.
Danish: Telithromycins farmakokinetik hos børn under 12 år er endnu ikke undersøgt.
English: However, in contrast to clarithromycin, no resistant strains of alpha streptococci emerged in saliva on treatment with telithromycin.
Danish: I modsætning til clarithromycin opstod imidlertid ingen resistente stammer af alfa-streptokokker i saliva ved behandling med telithromycin.
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: Due to its CYP3A4 inhibitory potential, telithromycin can increase blood concentrations of these CYP34A4 substrates.
Danish: På grund af dets CYP3A4 hæmningspotentiale, kan telithromycin øge blodkoncentrationerne af disse CYP3A4 substrater.
English: After oral administration, two-thirds of the dose is eliminated as metabolites and one-third unchanged.
Danish: Efter peroral administration udskilles 2/3 af en dosis som metabolitter og 1/3 uomdannet.
English: As with nearly all antibacterial agents, diarrhoea, particularly if severe, persistent and /or bloody, during or after treatment with Levviax may be caused by pseudomembranous colitis.
Danish: Som ved næsten alle antibiotika kan diarré, især hvis den er alvorlig, vedvarende og/eller blodig, under og efter behandling med telithromycin, være forårsaget af pseudomembranøs colitis.
English: They are available in packs of 10, 5x2, 14, 20 and 100 tablets.
Danish: De får i pakninger med 10, 5x2, 14, 20 og 100 tabletter.
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 ekspositionen forbliver indenfor et veltolerret interval.
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 samt 7 til 10 dage til lungebetændelse.
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 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 forsøg, blev lignende virkninger som observeret under clarithromycin set på en on-terapi ΔQTc> 30 msec hos henholdsvis 7,6% og 7% af tilfældene.
English: Telithromycin is excreted in the milk of lactating animals, at concentrations about 5 times those of maternal plasma.
Danish: Telithromycin udskilles i modermælk hos dyr, i koncentrationer på ca. 5 gange af maternel plasmakoncentration.
English: Treatment with these agents should be interrupted during Levviax treatment.
Danish: Behandling med disse midler skal afbrydes under Levviax behandling.
English: You should not use Levviax if you are taking certain medicinal products to control the blood level of cholesterol or other lipids, like simvastatin.
Danish: De bør ikke anvende Levviax, hvis De tager visse lægemidler til at kontrollere niveauet af kolesterol eller andre lipider i blodet, såsom simvastatin.
English: Approximately one-third of telithromycin was eliminated unchanged; 20 % in faeces and 12 % in urine.
Danish: Ca. 1/3 af telithromycin udskilles uomdannet, 20 % i fæces og 12 % i urin.
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 følsomhedsmøstret for telithromycin og andre antibiotika i betragtning.
English: Ranitidine (taken 1 hour before Levviax) and antacid containing aluminium and magnesium hydroxide has no clinically relevant influence on telithromycin pharmacokinetics.
Danish: Ranitidin (indtaget 1 time før Levviax) og antacida indeholdende aluminium og magnesiumhydroksid har ingen klinisk relevant påvirkning af telithromycins farmakokinetik
English: Taking Levviax with food and drink Levviax may be taken with or without food.
Danish: Hvordan man tager Levviax sammen med mad og drikkevarer De kan både tage Levviax med og uden mad..
English: if you have had a hepatitis and/or jaundice while taking Levviax in the past.
Danish: - Hvis De tidligere har haft hepatitis og/eller gulsot samtidig med anvendelse af Levviax.
English: - Worsening of a condition called myasthenia gravis, a rare disease which causes muscle weakness.
Danish: - Forværring af en tilstand kaldet myastenia gravis, en sjælden sygdom som giver muskelsvaghed.
English: • cisapride (digestive problems)
Danish: • cisaprid (fordøjelsesproblemer)
English: Light orange, oblong, biconvex tablet, imprinted with H3647 on one side and 400 on the other.
Danish: Lys orange, aflang, bikonveks tablet præget med H3647 på den ene side og 400 på den anden.
English: These changes in pharmacokinetics do not necessitate dosage adjustment.
Danish: Disse ændringer i farmakokinetikken førte ikke til dosisjustering.
English: When midazolam was coadministered with Levviax, 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 Levviax steg midazolam AUC 2,2 gange efter intravenøs administration af midazolam og 6,1 gang efter oral administration.