FrancophonIA/ELRC3.0 huggingface dataset:
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 dose.
Danish: Hvis behandling med telithromycin er nødvendig, kan disse patienter behandles med alternative daglige doseringer på 800 mg og 400 mg, begyndende med en dosis på 800 mg.
English: - if you have had certain heart problems such as coronary heart disease, ventricular arrhythmias, bradycardia or if you have had certain abnormal blood tests due to medical conditions such as hypokalaemia, hypomagnesaemia.
Danish: - Hvis De tidligere har haft visse hjerteproblemer såsom coronar hjertesygdom, ventrikulære arytmier, bradykardi eller hvis De har haft visse unormale blodprøver som følge af medicinske tilstande som hypokaliaemia og hypomagnesaemia.
English: MARKETING AUTORISATION NUMBER(S)
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE)
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: Medicinal products with a potential to prolong QT interval Levviax is expected to increase the plasma levels of cisapride, pimozide, astemizole and terfenadine.
Danish: Lægemidler med potentiale til at forlænge QT interval Levviax forventes at forøge plasmakoncentrationerne af cisaprid, pimozid, aztemizol og terfenadin.
English: Levviax is contraindicated in patients with myasthenia gravis (see section 4.4).
Danish: Levviax er kontraindiceret til patienter med myasthenia gravis (se pkt.
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 De eller nogen i Deres familie har en sjælden abnormitet i elektrokardiogrammet, kaldet medfødt lang QT syndrome.
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: Interaktionsforsøg med itraconzol og ketoconazol, to CYP3A4 inhibitorer, viste at maximum plasmakoncentrationerne for telithromycin steg henholdsvis 1,22 og 1,51 gange og AUC henholdsvis 1,54 og 2,0 gange.
English: However, if it is nearly time for your next dose skip the missed dose and take the next tablet at the usual time.
Danish: Hvis det er tæt på tidspunktet, hvor De skal tage Deres næste dosis, skal De springe den glemte dosis over, og tage den næste dosis til tiden.
English: The most common side effect (10 or more out of 100 patients) which may occur with Levviax is diarrhoea, usually mild and temporary.
Danish: Den hyppigst forekommende bivirkning (10 eller flere ud af 100) med Levviax er diarré, sædvanligvis let og forbigående.
English: After oral administration of radiolabelled telithromycin, 76 % of the radioactivity was recovered from faeces, and 17 % from the urine.
Danish: Efter peroral administration af radiomærket telithromycin genfindes 76 % af radioaktiviteten i fæces, og 17 % i urinen.
English: Levviax is used in adults and adolescents of 12 years and older to treat infections due to bacteria against which the medicine is active.
Danish: Levviax kan anvendes af voksne og unge på 12 år eller mere til behandling af infektioner forårsaget af bakterier, som lægemidlet virker imod.
English: The mean maximum white blood cell concentration of telithromycin was 83±25 mg/l.
Danish: Den genemsnitlig maksimum telithromycin koncentration i hvide blodlegemer var 83 ± 25 mg/l.
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: If you are breast-feeding do not take Levviax tablets.
Danish: Hvis De ammer, skal De ikke tage Levviax tabletter.
English: Concomitant administration of Levviax and any of these medicinal products is contraindicated (see section 4.3).
Danish: Samtidig administration af Levviax og nogen af disse lægemidler er kontraindiceret (se pkt.
English: For those benzodiazepins which are not metabolized by CYP3A4 (temazepam, nitrazepam, lorazepam) an interaction with Levviax is unlikely.
Danish: For de benzodiazepiner som ikke metaboliseres via CYP3A4 (temazepam, nitrazepam, lorazepam) er interaktion med telithromycin usandsynlig.
English: No carcinogenicity studies have been conducted with telithromycin.
Danish: Der er ikke udført carcinogenicitetsforsøg med telithromycin.
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: In patients of 18 years and older: • Community-acquired pneumonia, mild or moderate (see section 4.4).
Danish: Patienter på 18 år og opefter: • Pneumoni, mild eller moderat (se pkt.
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 patient forløb eller nationale og/eller regionale resistensdata) dækket af det antibakterielle spektrum af telithromycin (se pkt.
English: Because of potential visual difficulties or loss of consciousness, patients should attempt to minimize activities such as driving a motor vehicle, operating heavy machinery or engaging in other hazardous activities during treatment with Levviax.
Danish: På grund af de potentielle synsvanskeligheder eller tab af bevidsthed, bør patienterne tilstræbe at minimere aktiviteter såsom at køre bil, betjene tunge maskiner eller påtage sig andre risikobetonede aktiviteter under behandling med Levviax.
English: While exposure to telithromycin did select for pneumococcal mutants with increased MICs, the MICs remained within the proposed susceptibility range.
Danish: Mens ekspositionen af telithromycin bevirkede pneumokok mutanter med forhøjede MICværdier, forblev MICværdierne indenfor forselåede følsomhedsinterval.
English: Corresponding data for humans is not available.
Danish: Der findes ingen tilgængelige oplysninger på mennesker.
English: Blood and the lymphatic system disorders
Danish: Sygdomme i blod og lymfesystem
English: Levviax tablets are presented in blister packs.
Danish: Levviax sælges i blisterpakninger.
English: This could result in QT interval prolongation and cardiac arrhythmias including ventricular tachycardia, ventricular fibrillation and torsades de pointes.
Danish: Dette kunne resultere i QT interval forlængelse og hjertearytmier inklusiv ventriculær takycardi, ventriculær fibrillation og torsades de pointes.
English: • pimozide (psychiatric problems) - if you have severely impaired renal function and/or severely impaired hepatic function, do not take Levviax while taking other medicines containing any of the following active substances:
Danish: • pimozid (psykiske problemer) - De bør ikke tage Levviax, hvis De har alvorlig nedsat nyrefunktion og/eller alvorlig nedsat leverfunktion, samtidig med anden medicin indeholdende et af de følgende indholdsstoffer:
English: Telithromycin does not induce MLSB resistance in vitro to Staphylococcus aureus, Streptococcus pneumoniae, and Streptococcus pyogenes, an attribute related to its 3 keto function.
Danish: Telithromycin inducerer ikke in vitro MLSB resistens over for Staphylococcus aureus, Streptococcus pneumoniae og Streptococcus pyogenes, en egenskab der tilskrives 3 ketonfunktionen.
English: Levviax is an inhibitor of CYP3A4 and should only be used under specific circumstances during treatment with other medicinal products that are metabolised by CYP3A4.
Danish: Levviax er en hæmmer af CYP3A4 og bør kun anvendes under specifikke omstændigheder under behandling med andre lægemidler der metaboliseres af CYP3A4.
English: When telithromycin is discontinued, cyclosporin, tacrolimus or sirolimus levels must be again carefully monitored and their dose increased as necessary.
Danish: Når telithromycin behandlingen afsluttes skal cyclosporin, tacrolimus eller sirolimus koncentrationen igen omhyggeligt monitoreres og dosis øges efter behov.
English: Post-marketing cases of severe hepatitis and liver failure, including fatal cases (which have generally been associated with serious underlying diseases or concomitant medications), have been reported (see section 4.8).
Danish: Der er rapporteret om post-marketing tilfælde af alvorlig hepatitis og leversvigt, inklusive fatale tilfælde (som generelt er blevet associeret med underliggende alvorlige sygdomme eller anden samtidig medicinering) (se pkt.
English: - if you are allergic (hypersensitive) to telithromycin, to any of the macrolide antibiotics or to any of the other ingredients of Levviax.
Danish: - Hvis De er allergisk (overfølsom) over for telithromycin, et af de øvrige makrolidantibiotika eller et af de øvrige indholdsstoffer i Levviax.
English: Levviax is not recommended as first choice in patients with severe renal impairment (creatinine clearance <30ml/min) or patients with both severe renal impairment and co-existing hepatic impairment, as an optimal dosage format (600 mg) is not available.
Danish: Levviax anbefales ikke som første valg til patienter med alvorlig nedat nyrefunktion (kreatininclearance < 30 ml/min) eller til patienter med både alvorlig nedsat nyrefunktion og samtidig nedsat leverfunktion, da en optimal dosering (600 mg) ikke er mulig.
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 sammnelignet med behandling af følsomme S pneumoniae.
English: If you accidentally take several tablets too many, contact your doctor or pharmacist.
Danish: Hvis De ved et uheld tager adskillige tabletter for meget, skal De kontakte lægen eller søge anden lægehjælp.
English: When metoprolol (a CYP2D6 substrate) was coadministered with Levviax, metropolol Cmax and AUC were increased by approximately 38%, however, there was no effect on the elimination half-life of metoprolol.
Danish: Når metoprolol (et CYP2D6 substrat ) blev administrret samtidig med Levviax, var der en let stigning på ca 38% af Cmax og af AUC for metoprolol, der var imidlerid ingen effekt på metoprolols eliminationshalveringstid.
English: In a comparative study in healthy human volunteers, telithromycin 800 mg daily and clarithromycin 500 mg twice daily for 10 days showed a similar and reversible reduction of oral and faecal flora.
Danish: I et sammenlignende forsøg på raske forsøgspersoner viste telithromycin 800 mg daglig og clarithromycin 500 mg to gange daglig i 10 dage lignende og reversibel reduktion af oral og fækal flora.
English: Levviax 400 mg tablets are light orange, oblong, biconvex, film-coated tablet imprinted with “H3647” on one side and “400” on the other.
Danish: Levviax 400 mg tabletter er lys orange, aflange, bikonvekse filmovertrukne tabletter præget med ”H3647” på den ene side og ”400” på den anden.
English: If any of these undesirable effects are troublesome, severe, or do not wear off as treatment goes on, tell your doctor.
Danish: Hvis en af disse uønskede virkninger bliver generende, alvorlig, eller ikke forsvinder når behandlingen fortsættes, skal De kontakte Deres læge.
English: (see sections 4.7 and 4.8).
Danish: 4.7 og 4.8).
English: In vitro results have shown that telithromycin is affected by the erythromycin ermB or mefA related resistance mechanisms but to lesser extent than erythromycin.
Danish: In-vitro forsøg viste at telithromycin er påvirket af erythromycin ermB elle mefA beslægtede resistensmekanismer men i mindre udstrækning end erythromycin.
English: Levviax should not be used during and 2 weeks after treatment with CYP3A4 inducers (such as rifampicin, phenytoin, carbamazepine, phenobarbital, St John's wort).
Danish: Levviax bør ikke anvendes under og 2 uger efter behandling med CYP3A4 inducere ( såsom rifampicin, phenytoin, carbamazepin, phenobarbital, St John´s wort).
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 forsøg på genotoksisk potentiale invivo og in-vitro.
English: Levviax may cause visual disturbances particularly in slowing the ability to accommodate and the ability to release accommodation.
Danish: Levviax kan forårsage synsforstyrrelser specielt ved at nedsætte akkomodationsevnen samt evnen til at frigøre akkomodation.
English: It is particularly important for your doctor to know if you are taking medicines containing phenytoin, and carbamazepine (for epilepsy), rifampicin (antibiotic), phenobarbital or St John's wort, medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation), or metoprolol (against heart disorder) or the anti HIV medicine ritonavir.
Danish: Det er særlig vigtigt for Deres læge at vide, hvis de anvender lægemidler indeholdende phenytoin, carbamazepin (mod epilepsi), rifampicin (antibiotika), phenobarbital eller St John's urt, lægemidler som tacrolimus, cyclosporin og sirolimus (til organ transplantation), eller metoprolol (mod hjertelidelser) eller ritonavir, lægemiddel mod HIV.
English: - if you are taking certain medicinal products to control the blood level of cholesterol or other lipids.
Danish: - hvis De tager lægemidler til regulering af blodets indhold af cholesterol eller andre lipider.
English: Rash, urticaria, pruritus
Danish: Udslæt, urticaria, pruritus
English: 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.
Danish: I kliniske forsøgspopulationer omfatter farmakokinetikanalyser begrænsede data på pædiatriske patienter i alderen 13-17 år, hvilket viser at koncentrationen af telithromycin i denne aldersgruppe svarer til koncentrationer på patienter i alderen 18-40 år.
English: Telithromycin inhibits protein synthesis by acting at the ribosome level.
Danish: Telithromycin hæmmer proteinsyntesen ved at virke på ribosom-niveauet.
English: Alternatively, interruption in the treatment with the CYP3A4 substrate should be made during treatment with Levviax.
Danish: Alternativ skal behandlingen med CYP3A4 substrat afbrydes under behandling med Levviax.
English: The induction gradually decreases during 2 weeks after cessation of treatment with CYP3A4 inducers.
Danish: Induktionen aftager gradvist over 2 uger efter ophør af behandling med CYP3A4 inducere.
English: If you have vision problems or faint while taking Levviax do not drive, operate heavy machinery, or engage in dangerous activities.
Danish: Hvis De har synsproblemer eller besvimer mens De tager Levviax, undlad at køre bil, betjene tunge maskiner eller påtag Dem farlige aktiviteter.
English: The affinity of telithromycin for the 50S bacterial subunit of ribosome is 10 fold higher than that of erythromycin A when the strain is susceptible to erythromycin A. Against erythromycin A resistant strains, due to an MLSB mechanism of resistance, telithromycin shows a more than 20 fold affinity compared to erythromycin A in the 50S bacterial subunit.
Danish: Telithromycins affinitet til den bakterielle 50S ribosom subunit er 10 gange højere end for erythromycin A, hvis stammerne er følsomme over for erythromycin A. Over for erythromycin A resistente stammer udviser telithromycin på grund af en MLSB resistensmekanisme i den bakterielle 50S subunit en 20 gange så høj affinitet sammenlignet med erythromycin A. Telithromycin påvirker ribosomoversættelsen på det 23S ribosomale RNA-niveau.
English: If you stop taking Levviax
Danish: Hvis De holder op med at tage Levviax
English: In haemodialysed patients, the posology should be adjusted so that Levviax 800 mg is given after the dialysis session (see also section 5.2).
Danish: Til patienter i hæmodialyse bør dosis justeres, så Levviax 800 mg gives efter hver dialysebehandling (se også pkt.
English: In patients with severely impaired renal and/or hepatic function, concomitant administration of Levviax and strong CYP3A4 inhibitors, such as protease inhibitors or ketoconazole, is contraindicated.
Danish: Hos patienter med alvorlig nedsat nyrefunktion og/eller leverfunktion, er samtidig administration af Levviax og stærke CYP3A4 hæmmere, såsom protease hæmmere eller ketoconazol, kontraindiceret.
English: Species for which acquired resistance may be a problem Aerobic Gram-positive bacteria Staphylococcus aureus methicillin resistant (MRSA)+ Streptococcus pyogenes*
Danish: Arter, for hvilke erhvervet resistens kan udgøre et problem Aerobe Gram-positive bakterier Staphylococcus aureus methicillin følsomme (MSSA)* Streptococcus pyogenes*
English: Telithromycin is metabolized primarily by the liver.
Danish: Telithromycin udskilles primært fra leveren.
English: The recommended MIC breakpoints for telithromycin, separating susceptible organisms from intermediately susceptible organisms and intermediately susceptible organisms from resistant organisms, are: susceptible ≤0.5 mg/l, resistant >2mg/l.
Danish: Det anbefalede MIC breakpoint for telithromycin, hvor følsomme bakterier adskilles fra intermediært følsomme bakterier og intermediært følsomme bakterier fra resistente bakterier, er: Følsomme ≤ 0,5 mg/l, resistente > 2 mg/l
English: - Acute exacerbation of chronic bronchitis,
Danish: Akutte eksacerbationer af kronisk bronkitis Akut sinuitis
English: If in doubt, talk to your doctor or pharmacist.
Danish: Hvis De er i tvivl, kan De kontakte lægen eller apoteket.
English: In adolescents of 12 years and older, Levviax can be used to treat: infections of the throat.
Danish: Hos unge på 12 år eller derover kan Levviax anvendes til behandling af infektioner i halsen.
English: Reproduction toxicity studies showed reduced gamete maturation in rat and adverse effects on fertilization.
Danish: Reproduktive toksicitetsforsøg viste nedsat cellemodning hos rotter og bivirkninger på befrugtningen.
English: In vivo studies with simvastatin, midazolam and cisapride have demonstrated a potent inhibition of intestinal CYP3A4 and a moderate inhibition of hepatic CYP3A4.
Danish: In-vivo forsøg med simvastatin, midazolam og cisaporid viste poetnt hæmning af intestinal CYP3A4 og moderat hæmning af hepatisk CYP3A4.
English: For Streptococcus pyogenes, cross-resistance occurs for high-level erythromycin A resistant strains.
Danish: For Streptococcus pyogenes forekommer krydsresistens for high-level erythromycin A resistente stammer.
English: Available as packs of 10, 14, 20 and 100 tablets.
Danish: Pakninger: 10, 14, 20 og 100 tabletter
English: Levviax may cause undesirable effects such as visual disturbances which may reduce the capacity for the completion of certain tasks.
Danish: Levviax kan forårsage uønskede virkninger så som synsforstyrrelser, som kan nedsætte evnen til at udføre visse opgaver.
English: In adults, Levviax can be used to treat infections of the throat, infections of the sinuses, chest infections in patients with long standing breathing difficulties and pneumonia.
Danish: Hos voksne kan Levviax anvendes til behandling af infektioner i halsen, infektioner i bihulerne, infektioner i brystet hos patienter med længerevarende åndedrætsbesvær samt lungebetændelse.
English: -Gender The pharmacokinetics of telithromycin are similar between males and females.
Danish: -Køn Telithromycins farmakokinetik er ens for mænd og kvinder.
English: • CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND
Danish: • BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL EN SIKKER OG VIRKNINGSFULD ANVENDELSE AF LÆGEMIDLET Ikke relevant.
English: Thus, when initiating telithromycin in patients already receiving any of theses immunosuppressive agents, cyclosporin, tacrolimus or sirolimus levels must be carefully monitored and their doses decreased as necessary.
Danish: Derfor når telithromycin gives til patienter, der allerede får nogen af disse immunsupprimerende stoffer, cyclosporin, tacrolimus eller sirolimus skal koncentrationerne monitoreres omhyggeligt og deres dosis nedsættes om nødvendigt.
English: You should not use Levviax with medicines containing ergotamine or dihydroergotamine tablets or ergotamine inhalers for migraine, terfenadine or astemizole for allergic problems, cisapride for digestive problems and pimozide for psychiatric problems.
Danish: De bør ikke anvende Levviax samtidig med medicin indeholdende ergotamin eller dihydroergotamin tabletter eller ergotamin inhalatorer mod migræne, terfenadin eller astemizol mod allergi, cisaprid mod problemer med fordøjelsen og pimozid mod psykiatriske lidelser.
English: Diarrhoea Nausea, vomiting, gastrointestinal pain, flatulence
Danish: Kvalme, opkastning, gastrointestinale smerter, flatulens
English: If you have severe renal insufficiency you should take alternating daily doses of 800 mg (two tablets of 400 mg) and 400 mg (one tablet of 400 mg), starting with the 800 mg dose.
Danish: Hvis De har svært nedsat nyrefunktion, skal De tage vekslende daglige doser på 800 mg (to tabletter på 400 mg) og 400 mg (en tablet på 400 mg), begyndende med dosis på 800 mg.
English: 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.
Danish: 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 gang daglig.
English: As with macrolides, due to a potential to increase QT interval, Levviax should be used with care in patients with coronary heart disease, a history of ventricular arrhythmias, uncorrected hypokalaemia and or hypomagnesaemia, bradycardia (<50 bpm), or during concomitant administration of Levviax with QT interval prolonging agents or potent CYP 3A4 inhibitors such as protease inhibitors and ketoconazole.
Danish: Som for macrolider, grundet potentiale for øgning af QT intervallet, bør Levviax anvendes med forsigtighed til patienter med coronare hjertesygdomme, ventrikulære arytmier ukorrigeret hypokaliæmi og/eller hypomagnesiæmi, bradykardi (< 50 / min), eller under samtidig administration af Levviax med QT interval forlængende midler eller potente CYP3A4 inhibitorer såsom protease hæmmere og ketoconazol.
English: When simvastatin was coadministered with Levviax, 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 simvastatine acid AUC.
Danish: Når simvastatin blev administreret samtidig med Levviax, steg simvastatin Cmax 5,3 gange og simvastatin AUC steg 8,9 gange, Simvastatinsyre Cmax steg 15 gange og simvastatinsyre AUC steg 11 gange.
English: No dosage adjustment is necessary in patients with mild or moderate renal impairment.
Danish: Dosisjustering til patienter med mild, eller moderat nedsat nyrefunktion er ikke nødvendig.