FrancophonIA/ELRC3.0 huggingface dataset:
English: Strong CYP3A4 inhibitors must not be co-administered with Ketek in patients with severe renal/or hepatic dysfunction (see section 4.3).
Danish: Stærke CYP 3A4-hæmmere må ikke tages samtidigt med Ketek hos patienter med alvorlig nyre- og
English: These changes in pharmacokinetics do not necessitate dosage adjustment.
Danish: Disse ændringer i farmakokinetikken førte
English: Mean steady-state trough plasma concentrations of between 0.04 and 0.07 mg/l are reached within 3 to 4 days with once-daily dosing of telithromycin 800 mg. At steady-state AUC is approximately 1.5 fold increased compared to the single dose.
Danish: Gennemsnitlig minimum plasmakoncentration ved steady state på 0,04 og 0,07 mg/l nås indenfor 3-4 dage ved dosering én gang daglig af 800 mg telithromycin.
English: (See sections 4.3 and 4.5).
Danish: 4.3 og 4.5).
English: -Renal impairment
Danish: -Nedsat nyrefunktion
English: If you notice any of the following, stop taking Ketek and tell your doctor immediately: - Allergic or skin reactions such as face swelling, general allergic reactions including allergic shock, or serious skin conditions associated with red spots, blisters (frequency not known).
Danish: - Overfølsomheds- og hudreaktioner som f.eks. ansigtshævelse, generelle allergiske reaktioner, inklusive anafylaktisk shock eller alvorlige hudsygdomme ledsaget af røde pletter og blærer
English: Immune system disorders
Danish: Nervesystemet søvnløshed
English: Available as packs of 10, 14, 20 and 100 tablets.
Danish: Pakninger: 10, 14, 20 og 100 tabletter Uigennemsigtig PVC/aluminiumsblisterpakning.
English: The tablets may be taken Consideration may be given to taking Ketek at bedtime, to reduce the potential impact of visual disturbances and loss of consciousness (see section 4.4).
Danish: Tabletterne kan indtages med eller uden Det bør overvejes at administrere Ketek inden sengetid med henblik på at reducere den potentielle påvirkning i form af visuel forstyrrelse og tab af bevidsthed (se pkt.
English: Telithromycin is a semisynthetic derivative of erythromycin A belonging to the ketolides, a class of antibacterial agents related to macrolides.
Danish: Farmakoterapeutisk klassifikation: antibakterielle midler til systemisk brug, makrolider, lincosamider Telithromycin er et semisyntetisk derivat af erythromycin A og tilhører gruppen af ketolider, en ny gruppe af antibakterielle midler beslægtet med makrolider.
English: Tell your doctor or pharmacist if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription, as some of them could affect or be
Danish: Fortæl altid til lægen eller på apoteket, hvis du bruger anden medicin eller har gjort det for nylig.
English: - phenobarbital or St John's wort (herbal medicine used to treat mild depression) - medicines like tacrolimus, cyclosporin and sirolimus (for organ transplantation)
Danish: Det er vigtigt du fortæller det til din læge, hvis du anvender: - medicin indeholdende phenytoin og carbamazepin (mod epilepsi) - rifampicin (antibiotikum) - phenobarbital eller perikon (sidstnævnte er naturmedicin til behandling af let depression) - medicin som tacrolimus, ciclosporin samt sirolimus (i forbindelse med organtransplantation) - metropolol (mod hjertesygdomme)
English: Concomitant administration with ergot alkaloid derivatives (such as ergotamine and
Danish: Samtidig administration af sekalealkaloider (såsom ergotamin og dihydroergotamin) (se pkt.
English: Hepatitis
Danish: Fertilitet
English: To reduce the potential impact of visual disturbances take the tablets before going to bed (see also
Danish: Tag tabletterne før sengetid for at reducere virkningen af de potentielle synsforstyrrelser (se også
English: Very rare side effects (may affect up to 1 in 10,000 people)
Danish: Meget sjældne bivirkninger (forekommer hos færre end 1 ud af 10.000 patienter) - Forstyrrelser i lugtesansen, muskelkramper
English: Theophylline
Danish: Colchicin
English: Metoprolol
Danish: Acinetobacter
English: - if you experience fainting (transient loss of consciousness) Talk to your doctor, pharmacist or nurse if you experience irregular heartbeat.
Danish: Tal med din læge, apotekspersonalet eller sundhedspersonalet, hvis du oplever
English: -Hepatic impairment
Danish: Psykiske forstyrrelser
English: pain, flatulence constipation
Danish: Forvirring, hallucinationer
English: • saquinavir (anti-HIV treatment)
Danish: • medicin, som kaldes en proteasehæmmer (mod hiv)
English: - Community-acquired pneumonia: 800 mg once a day for 7 to 10 days, - Acute exacerbation of chronic bronchitis: 800 mg once a day for 5 days, - Acute sinusitis: 800 mg once a day for 5 days, - Tonsillitis/pharyngitis caused by Streptococcus pyogenes: 800 mg once a day for 5 days.
Danish: Akutte eksacerbationer af kronisk bronkitis: 800 mg én gang daglig i 5 dage.
English: Antibacterial spectrum
Danish: Arveligt betingede resistente organismer Aerobe Gram-negative bakterier
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: Ciclosporin, tacrolimus eller sirolimus-niveauerne skal derfor overvåges nøje og dosis nedjusteres om nødvendigt når patienter, som allerede er i behandling med et immunsupprimerende stof, opstartes på telithromycin.
English: Ketek may be taken with or without food.
Danish: Brug af Ketek sammen med mad, drikke og alkohol
English: Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.
Danish: Du kan finde yderligere information om Ketek på Det Europæiske Lægemiddelagenturs hjemmeside
English: Avastin has been authorised in the EU since 12 January 2005.
Danish: Avastin har været godkendt i EU siden den 12. januar 2005.
English: In addition, there was no benefit in terms of overall survival.
Danish: Desuden var der ingen fordel i form af total overlevelse.
English: The full European Public Assessment Report for Avastin can be found on the Agency's website ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
Danish: Den fuldstændige europæiske offentlige vurderingsrapport for Avastin findes på agenturets websted: ema.europa.eu/Find medicine/Human medicines/European Public Assessment Reports.
English: What is Avastin?
Danish: Hvad er Avastin?
English: Although there was an improvement in progression-free survival, it could not be considered clinically relevant because of limitations in the methods available to measure the size of brain tumours.
Danish: Skønt der var bedring i progressionsfri overlevelse, kunne dette ikke anses for at have klinisk betydning på grund af begrænsninger i de tilgængelige metoder til måling af hjernesvulsters størrelse.
English: If you are in a clinical trial and need more information about your treatment, contact the doctor who is giving it to you.
Danish: Hvis du deltager i en klinisk undersøgelse med Avastin og har behov for mere information om din behandling, kan du kontakte den læge, der giver dig behandlingen.
English: The main measures of effectiveness were overall survival (how long the patients lived) and progression-free survival (how long the patients lived without their disease getting worse).
Danish: Virkningen af behandlingen blev hovedsagelig bedømt på, hvor længe patienterne overlevede (total overlevelse), og hvor længe de levede, uden at sygdommen blev værre (progressionsfri overlevelse).
English: What is happening with Avastin for treatment of other cancers?
Danish: Hvad vil der ske med brugen af Avastin til behandling af andre kræftformer?
English: EMA/577647/2014
Danish: Den 26. september 2014 EMA/577647/2014
English: What was Avastin expected to be used for?
Danish: Hvad forventedes Avastin anvendt til?
English: Refusal of a change to the marketing authorisation for Avastin (bevacizumab) EMA/577647/2014
Danish: Afslag på ansøgningen om ændring af markedsføringstilladelsen for Avastin (bevacizumab) EMA/577647/2014
English: There are no consequences on the use of Avastin in its authorised indications.
Danish: Afgørelsen vil ikke få konsekvenser for brugen af Avastin til de godkendte indikationer.
English: The company presented the results from one main study with Avastin involving 921 patients with newly diagnosed glioblastoma.
Danish: Virksomheden fremlagde resultaterne af én hovedundersøgelse med Avastin, hvori der deltog 921 patienter med nydiagnosticeret glioblastom.
English: Refusal of a change to the marketing authorisation for Avastin (bevacizumab)
Danish: Afslag på ansøgningen om ændring af markedsføringstilladelsen for Avastin (bevacizumab)
English: It is used, in combination with other chemotherapy medicines (medicines to treat cancer), to treat certain types of the following cancers: cancer of the colon or rectum (large intestine); breast cancer; lung cancer; kidney cancer; cancer of the ovary; cancer of the fallopian tube or the peritoneum (the membrane lining the abdomen).
Danish: Det anvendes i kombination med andre kræftmidler (kemoterapi) til behandling af følgende kræfttyper: kræft i tyktarmen (kolon eller rektum), brystkræft, lungekræft, nyrekræft, æggestokkræft, kræft i æggelederne eller bughinden (peritoneum).
English: Avastin is a cancer medicine that contains the active substance bevacizumab.
Danish: Avastin er et lægemiddel mod kræft og indeholder det aktive stof bevacizumab.
English: The company informed the CHMP that there are no consequences for patients with glioblastoma receiving Avastin in clinical trials: patients will continue to receive Avastin in the on-going and future clinical trials.
Danish: Virksomheden har til CHMP oplyst, at beslutningen ikke vil få konsekvenser for patienter med glioblastom, der på nuværende tidspunkt deltager i kliniske undersøgelser med Avastin: Patienterne vil fortsat få Avastin i de igangværende og kommende kliniske undersøgelser.
English: How is Avastin expected to work?
Danish: Hvordan forventes Avastin at virke?
English: The change concerned an extension of indication to add treatment of glioblastoma (an aggressive type of brain cancer).
Danish: Ændringen vedrører en udvidelse af anvendelsen med behandling af en aggressiv form for kræft i hjernen (glioblastom).
English: On 22 May 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a negative opinion, recommending the refusal of a change to the marketing authorisation for the medicinal product Avastin.
Danish: Den 22. maj 2014 vedtog Udvalget for Lægemidler til Mennesker (CHMP) en negativ udtalelse, der anbefalede afslag på ansøgningen om ændring af markedsføringstilladelsen for lægemidlet Avastin.
English: Therefore, at that point in time, the CHMP was of the opinion that the benefits of Avastin in the treatment of newly diagnosed glioblastoma did not outweigh its risks.
Danish: På daværende tidspunkt var CHMP derfor af den opfattelse, at fordelene ved Avastin til behandling af nydiagnosticeret glioblastom ikke var større end risiciene.
English: At the time of the initial recommendation the CHMP noted that the effectiveness of Avastin in combination with radiotherapy and temozolomide had not been sufficiently demonstrated.
Danish: På tidspunktet for den oprindelige anbefaling bemærkede CHMP, at virkningen af Avastin kombineret med strålebehandling og temozolomid ikke var tilfredsstillende påvist.
English: It is available as a concentrate that is made up into a solution for infusion (drip into a vein).
Danish: Det leveres som et koncentrat, der efter opløsning indgives med drop i en vene (infusion).
English: The active substance in Avastin, bevacizumab, is a monoclonal antibody (a type of protein), that has been designed to recognise and attach to vascular endothelial growth factor (VEGF), a protein that
Danish: Det aktive stof i Avastin, bevacizumab, er et protein af typen monoklonalt antistof, der er udformet, så det genkender og bindes til proteinet vaskulær endotelial vækstfaktor (VEGF), der cirkulerer i blodet og får blodkar til at vokse.
English: During the re-examination, the CHMP looked again at the data from the company and confirmed its opinion that the benefits of Avastin had not been sufficiently demonstrated in newly diagnosed glioblastoma.
Danish: Under den fornyede overvejelse gennemgik CHMP på ny oplysningerne fra virksomheden, men fastholdt, at fordelene ved Avastin ved nydiagnosticeret glioblastom ikke var tilfredsstillende påvist.
English: In the study, patients received Avastin or placebo (a dummy treatment) in addition to treatment with radiotherapy and temozolomide.
Danish: I undersøgelsen fik patienterne Avastin eller virkningsløs behandling (placebo) som tillæg til strålebehandling og temozolomid.
English: After considering the grounds for this request, the CHMP re-examined the initial opinion, and confirmed the refusal of the marketing authorisation on 22 September 2014.
Danish: CHMP gennemgik begrundelsen for anmodningen og foretog en fornyet overvejelse af den oprindelige udtalelse, men bekræftede den 22. september 2014 afslaget på ansøgningen om markedsføringstilladelse.
English: Therefore, the CHMP maintained its previous recommendation that the change to the marketing authorisation be refused.
Danish: CHMP fastholdt derfor sin tidligere anbefaling om afslag på ansøgningen om ændring af markedsføringstilladelsen.
English: Avastin was also expected to be used to treat adult patients with newly diagnosed glioblastoma in combination with radiotherapy (treatment with radiation) and temozolomide (another cancer medicine).
Danish: Avastin forventedes anvendt sammen med strålebehandling og et andet kræftmiddel (temozolomid) til behandling af nydiagnosticeret glioblastom hos voksne patienter.
English: Hence, the CHMP recommended that the change to the marketing authorisation be refused.
Danish: CHMP anbefalede derfor afslag på ansøgningen om ændring af markedsføringstilladelsen.
English: By attaching to VEGF, Avastin stops cancer cells from developing their own blood supply and starves them of oxygen and nutrients, helping to slow down the growth of the cancer.
Danish: Ved at bindes til VEGF forhindrer Avastin kræftcellerne i at udvikle deres
English: circulates in the blood and makes blood vessels grow.
Danish: Dette nedsætter kræftens vækst.
English: --1 Porcine circovirus type 2 ORF2 subunit antigen ≥4.5 log2 ELISA units* * Antibody titre obtained according to the in vivo potency test in chickens
Danish: --1 Porcint circovirus type 2 ORF2 subunit-antigen; mindst 4,5 log2 ELISA-enheder* * Antistoftiter opnået ved in vivo potency-test i kyllinger.
English: MA (EU) number
Danish: EU Nummer
English: Target species
Danish: Dyrearter
English: “Recent” here means between 12 hours and 10 days.
Danish: “Nylig” betyder her mellem 12 timer og 10 dage.
English: The average accumulation factor is about 1.7.
Danish: Den gennemsnitlige akkumuleringsfaktor er ca. 1,7.
English: These cases occurred in a population who had significant comorbidities.
Danish: Disse tilfælde forekom i en population, som havde betydelig comorbiditet.
English: In addition:
Danish: Derudover:
English: The final dose depends on what you as an individual patient can tolerate.
Danish: Den endelige dosis afhænger af, hvad du som patient kan tåle.
English: o In the pharmacovigilance plan:
Danish: o I lægemiddelovervågningsplanen:
English: Doses higher than those listed have not been studied and are therefore not recommended.
Danish: Højere doser end dem, der er anført, er ikke undersøgt og anbefales derfor ikke.
English: Method of administration Diovan may be taken independently of a meal and should be administered with water.
Danish: Administrationsmetode Diovan kan tages uafhængigt af måltider og bør tages sammen med vand.
English: The mean duration of follow-up was nearly two years.
Danish: Den gennemsnitlige varighed af opfølgning var næsten 2 år.
English: Additional information on special populations
Danish: Yderligere informationer vedrørende særlige populationer
English: Consequently, a clinical relevance in children <1 year of age cannot be excluded, while preclinical data do not indicate a safety concern for children older than 1 year.
Danish: Som konsekvens heraf kan en klinisk relevant effekt hos børn <1 år ikke udelukkes, hvorimod prækliniske data ikke indikerer sikkerhedsproblemer for børn over 1 år.
English: The mean treatment duration was two years.
Danish: Den gennemsnitlige behandlingsvarighed var 2 år.
English: • if you are more than 3 months pregnant (it is also better to avoid Diovan in early pregnancy - see pregnancy section).
Danish: • hvis du er mere end 3 måneder henne i en graviditet (det er også bedre at undgå Diovan tidligt i graviditeten) - se afsnittet Graviditet.
English: Targeted checklists for follow up of adverse events listed above as potential risks in the paediatric population
Danish: Målrettede tjeklister for opfølgning på de utilsigtede hændelser, der er nævnt ovenfor som potentielle risici hos den pædiatriske population.
English: Like all medicines, Diovan can cause side effects, although not everybody gets them.
Danish: Diovan kan som al anden medicin give bivirkninger, men ikke alle får bivirkninger.
English: This applies particularly when valsartan is given in the presence of other conditions (fever, dehydration) likely to impair renal function.
Danish: Dette gælder særligt, når valsartan gives ved tilstedeværelse af andre tilstande (feber, dehydrering), som kan forringe nyrefunktionen.
English: The rats in the juvenile valsartan study were dosed up to day 70, and effects on renal maturation (postnatal 4-6 weeks) cannot be excluded.
Danish: Rotterne i det juvenile valsartan-forsøg blev doseret op til dag 70, og virkning på nyreudviklingen (4-6 uger postnatalt) kan ikke udelukkes.
English: This period coincides with 36 weeks of gestation in humans, which could occasionally extend up to 44 weeks after conception in humans.
Danish: Denne periode er sammenfaldende med 36 ugers gestationsalder hos mennesker, hvor svangerskabet en gang imellem kan forlænges op til 44 uger efter undfangelse.
English: Age does not affect the apparent clearance in heart failure patients.
Danish: Alder påvirker ikke den tilsyneladende clearance hos patienter med hjertesvigt.
English: Combining valsartan with captopril did not add further benefit over captopril alone.
Danish: Kombinationen af valsartan og captopril gav ikke yderligere fordele i forhold til captopril alene.
English: The primary endpoint was time to all-cause mortality.
Danish: Det primære endepunkt var tid til mortalitet uanset årsag.
English: Overall, the dosedependent antihypertensive effect of valsartan was consistent across all the demographic subgroups.
Danish: Samlet var den dosisafhængige antihypertensive virkning af valsartan konstant på tværs af alle demografiske undergrupper.
English: • if you have lost a lot of fluid (dehydration) caused by diarrhoea, vomiting, or high doses of water tablets (diuretics).
Danish: • hvis du har mistet meget væske (er dehydreret) på grund af diarré, opkastninger eller høje doser af vanddrivende medicin (diuretika).
English: This medicinal product is authorised in the Member States of the EEA under the following names: [To be completed nationally]
Danish: Denne indlægsseddel blev senest godkendt Dette lægemiddel er godkendt i EEAs medlemslande under følgende navne: [Udfyldes nationalt]
English: • if you are below 18 years of age and you take Diovan in combination with other medicines that inhibit the renin angiotensin aldosterone system (medicines that lower blood pressure), your doctor may check your kidney function and the amount of potassium in your blood at regular intervals.
Danish: • hvis du er under 18 år og tager Diovan i kombination med anden medicin, som hæmmer reninangiotensin-aldosteron-systemet (medicin, der sænker blodtrykket), vil din læge tjekke din nyrefunktion og indholdet af kalium i dit blod med jævne mellemrum.
English: The maximum daily dose administered in clinical trials is 320 mg in divided doses.
Danish: Højeste daglige dosis administreret i kliniske forsøg er 320 mg i delte doser.
English: The purpose of the study was to determine the optimal dose of valsartan for reducing UAE in hypertensive patients with type 2 diabetes.
Danish: Formålet med undersøgelsen var at bestemme den optimale valsartandosis til reduktion af UAE hos hypertensive patienter med type 2-diabetes.
English: Patients were randomized to one of 3 doses of valsartan (160, 320 and 640 mg/od) and treated for 30 weeks.
Danish: Patienterne blev randomiseret til en af 3 valsartandoser (160, 320 og 640 mg/od) og behandledes i 30 uger.
English: Recent myocardial infarction
Danish: Nyligt myokardieinfarkt
English: - Post-myocardial infarction and/or heart failure (studied in adult patients only)
Danish: - Post-myokardieinfarkt og/eller hjertesvigt (kun undersøgt hos voksne patienter)
English: If you have accidentally taken too many tablets, contact your doctor, pharmacist, or hospital.
Danish: Hvis du er kommet til at tage for mange tabletter, skal du kontakte lægen, skadestuen eller apoteket.
English: Patients were re-randomized to either continue receiving the same dose of valsartan or were switched to placebo.
Danish: Patienterne blev derefter randomiseret til enten at fortsætte med at få den samme dosis af valsartan eller blev skiftet til placebo.
English: The dose should be adjusted based on blood pressure response.
Danish: Dosis bør justeres i henhold til virkningen på blodtrykket.
English: There was no difference between valsartan and captopril in all-cause mortality based on age, gender, race, baseline therapies or underlying disease.
Danish: Der var ingen forskel mellem valsartan og captopril med hensyn til totalmortalitet, baseret på alder, køn, race, baseline-behandlinger eller tilgrundliggende sygdom.
English: In heart failure patients:
Danish: Patienter med hjertesvigt:
English: Maximum dose studied in clinical trials
Danish: Maksimaldosis undersøgt i kliniske forsøg
English: At the end of 2 weeks, valsartan reduced both systolic and diastolic blood pressure in a dose-dependent manner.
Danish: Ved slutningen af 2 uger reducerede valsartan både systolisk og diastolisk blodtryk på en dosisafhængig måde.
English: Renal and urinary disorders, and obesity were the most common underlying medical conditions potentially contributing to hypertension in the children enrolled in these studies.
Danish: Nyre- og urinvejslidelser og fedme var de mest almindelige underliggende sygdomstilstande, som kunne bidrage til hypertension hos børnene inkluderet i disse forsøg.
English: Valsartan was as effective as captopril in reducing all-cause mortality after myocardial infarction.
Danish: Valsartan var lige så effektivt som captopril til reduktion af totalmortalitet efter myokardieinfarkt.
English: In the first study, the efficacy of valsartan was confirmed compared to placebo but a dose-response could not be demonstrated.
Danish: I det første forsøg blev virkningen af valsartan bekræftet sammenlignet med placebo, men der kunne ikke vises et dosisrespons.
English: However safety and efficacy of Diovan in children aged 1 to 6 years have not been established.
Danish: Sikkerhed og virkning er imidlertid ikke fastsat for børn i aldersgruppen 1 til 6 år.
English: If symptomatic hypotension or renal dysfunction occur, consideration should be given to a dose reduction.
Danish: Hvis der opstår symptomatisk hypotension, eller nyreinsufficiens, skal dosisreduktion overvejes.
English: It was concluded that 160-320 mg of valsartan produced clinically relevant reductions in UAE in hypertensive patients with type 2 diabetes.
Danish: Heraf udledtes, at 160-320 mg valsartan gav klinisk relevante reduktioner af UAE hos hypertensive patienter med type 2-diabetes.
English: • if you are treated after a heart attack or for heart failure, your doctor may check your kidney function.
Danish: • hvis du er i behandling efter et hjerteanfald eller hjertesvigt, vil din læge måske undersøge din nyrefunktion.