FrancophonIA/ELRC3.0 huggingface dataset:
English: In IMPACT, Temybric Ellipta statistically significantly reduced the mean number of nighttime awakenings due to COPD compared with FF/VI (-0.05; 95% CI: -0.08, -0.01; p=0.005) and with UMEC/VI (-0.10; 95% CI: -0.14, -0.05; p<0.001) at weeks 49 to 52.
Danish: I IMPACT medførte Temybric Ellipta en statistisk signifikant reduktion i det gennemsnitlige antal natlige opvågninger som følge af KOL sammenlignet med FF/VI (-0,05; 95 % CI: -0,08; -0,01; p = 0,005) og med UMEC/VI (-0,10; 95 % CI: -0,14; -0,05; p < 0,001) i uge 49 til 52.
English: In the subset of 430 patients treated for up to 52 weeks, the incidence of pneumonia events reported in both Temybric
Danish: I undergruppen med 430 patienter i op til 52 uger var forekomsten af indberettet pneumoni for både Temybric Ellipta- og budesonid/formoterol-gruppen 2 %.
English: In IMPACT, the proportion of patients who were CAT responders at week 52 was significantly higher (p<0.001) for patients treated with Temybric Ellipta (42%) compared with FF/VI (37%; OR 1.24; 95% CI: 1.14, 1.36) and UMEC/VI (36%; OR 1.28; 95% CI: 1.15, 1.43).
Danish: I IMPACT var andelen af patienter, der var CAT-respondenter i uge 52, signifikant højere (p < 0,001) for patienter behandlet med Temybric Ellipta (42 %) sammenlignet med FF/VI (37 %; OR 1,24; 95 % CI: 1,14; 1,36) og UMEC/VI (36 %; OR 1,28; 95 % CI: 1,15; 1,43).
English: FULFIL (CTT116853) was a 24-week study (N=1,810), with an extension up to 52 weeks in a subset of subjects (n=430), that compared Temybric Ellipta (92/55/22 micrograms) with budesonide/formoterol 400/12 micrograms (BUD/FOR) administered twice-daily.
Danish: FULFIL (CTT116853) var et 24-ugers studie (n = 1.810) med forlængelse op til 52 uger i en undergruppe af forsøgspersoner (n = 430), der sammenlignede Temybric Ellipta (92/55/22 mikrogram)
English: The first time you use Temybric Ellipta you do not need to check that the inhaler is working properly; it contains previously measured doses and is ready to use straight away.
Danish: Det er ikke nødvendigt at kontrollere, om Temybric Ellipta-inhalatoren virker korrekt, før du bruger den første gang.
English: Temybric Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Danish: Temybric Ellipta bør anvendes med forsigtighed til patienter med moderat til svært nedsat leverfunktion (se pkt.
English: What you need to know before you use Temybric Ellipta
Danish: Det skal du vide, før du begynder at bruge Temybric Ellipta
English: Your Temybric Ellipta inhaler carton contains
Danish: Æsken med Temybric Ellipta-inhalatoren indeholder
English: NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Danish: LÆGEMIDLETS NAVN Temybric Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol
English: Package leaflet: Information for the patient Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Danish: Indlægsseddel: Information til patienten Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol
English: Laboratori Guidotti S.p.A. Tel: + 39 050 971011
Danish: Tel: + 39 050 971011
English: In FULFIL, based upon data up to 24 weeks, Temybric Ellipta significantly reduced (p=0.002) the annual rate of moderate/severe exacerbations by 35% (95% CI: 14, 51) compared with BUD/FOR.
Danish: I FULFIL medførte Temybric Ellipta en signifikant reduktion (p = 0,002) i den årlige frekvens af moderate/svære eksacerbationer på 35 % (95 % CI: 14; 51) sammenlignet med BUD/FOR, baseret på data op til 24 uger.
English: Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Danish: Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol
English: NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
Danish: Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt
English: In FULFIL the proportion of responders according to TDI (defined as at least 1 unit) was significantly higher (p<0.001) for Temybric Ellipta compared with BUD/FOR (61% vs 51%; OR 1.61; 95% CI: 1.33, 1.95).
Danish: I FULFIL var andelen af respondenter ifølge TDI (defineret som mindst 1 enhed) signifikant højere (p < 0,001) for Temybric Ellipta sammenlignet med BUD/FOR (61 % ift.
English: In FULFIL, the proportion of patients who were CAT responders (defined as 2 units below baseline or lower) at week 24, was significantly higher (p<0.001) for patients treated with Temybric Ellipta compared with BUD/FOR (53% vs. 45%; OR 1.44; 95% CI: 1.19, 1.75).
Danish: I FULFIL var andelen af patienter, der var CAT-respondenter (defineret som 2 enheder under baseline eller lavere) i uge 24, signifikant højere (p < 0,001) for patienter behandlet med Temybric Ellipta sammenlignet med BUD/FOR (53 % ift.
English: NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temybric Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Danish: LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temybric Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol
English: How to use Temybric Ellipta
Danish: Sådan skal du bruge Temybric Ellipta
English: If you stop using Temybric Ellipta
Danish: Hvis du har brugt for meget Temybric Ellipta
English: In IMPACT, over 52 weeks, Temybric Ellipta significantly reduced (p<0.001) the annual rate of moderate/severe exacerbations by 15% (95% CI:10, 20) compared with FF/VI (rate; 0.91 vs 1.07 events per patient year) and by 25% (95% CI: 19, 30) compared with UMEC/VI (rate; 0.91 vs 1.21 events per patient year).
Danish: I løbet af 52 uger i IMPACT medførte Temybric Ellipta en signifikant reduktion (p < 0,001) i den årlige frekvens af moderate/svære eksacerbationer på 15 % (95 % CI: 10; 20) sammenlignet med FF/VI (frekvens; 0,91 ift.
English: Temybric Ellipta (N = 4,151
Danish: (n = 4.151)
English: What you need to know before you use Temybric Ellipta 3.
Danish: Det skal du vide, før du begynder at bruge Temybric Ellipta Sådan skal du bruge Temybric Ellipta Bivirkninger
English: Elderly
Danish: Ellipta
English: How to use Temybric Ellipta 4.
Danish: Sammenligning Temybric ift.
English: Comparison Temybric vs. UMEC/VI
Danish: UMEC/VI
English: • Risk of reactivation of latent tuberculosis and information about the screening for tuberculosis according to the local guidance;
Danish: • Risiko for reaktivering af latent tuberkulose og information om screening for tuberkulose ifølge den lokale vejledning;
English: • Local Guidance for tuberculosis screening;
Danish: • Lokal vejledning i tuberkulose-screening;
English: • Appropriate techniques for self administration of Stelara, including use of the prefilled syringes.
Danish: • Egnede teknikker til selvadministration af Stelara, inklusive brug af den fyldte injektionssprøjte.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Danish: Medlemsstaterne skal sikre sig, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet beskrevet nedenfor implementeres:
English: Healthcare Professional educational pack • Patient information pack
Danish: • Uddannelsepakke til sundhedspersonale • Informationspakke til patienter
English: The Marketing authorisation Holder (MAH) shall ensure that prior to launch of the prefilled syringe form of Stelara, all healthcare professionals who are expected to prescribe/use Stelara are provided with educational materials containing the following:
Danish: Indehaverne af markedsføringstilladelsen (MAH) skal sikre sig, at alt sundhedspersonale, som forventes at udskrive/anvende Stelara, før lanceringen af den fyldte Stelara-injektionssprøjte bliver forsynet med undervisningsmateriale, som indeholder følgende:
English: • Risk of malignancies.
Danish: • Risiko for maligniteter.
English: The key messages and components included in the Healthcare Professional educational pack are defined as follows:
Danish: Hovedbudskaberne og de vigtigste komponenter inkluderet i uddannelsepakken til sundhedspersonale er defineret som følger:
English: • Potential risk of malignancies;
Danish: • Mulig risiko for maligniteter
English: The key messages in the patient information pack are defined as follows:
Danish: Hovedbudskaberne i informationspakken til patienter er defiveret som følger:
English: • Patient Information Leaflet
Danish: • Indlægsseddel
English: N: number of patients in a treatment group.
Danish: N: antal patienter i en behandlingsgruppe.
English: Performance status and BMI
Danish: Performance-status og BMI
English: (Part of the Outer Carton)
Danish: (Del af den ydre karton)
English: Time (days) to event
Danish: Tid (dage) til hændelse
English: Children and adolescents Removab should not be used in children and adolescents under 18 years of age.
Danish: Børn og teenagere Removab må ikke anvendes til børn og teenagere under 18 år.
English: The overall treatment period should not exceed 20 days.
Danish: Den samlede behandlingsperiode må ikke overstige 20 dage.
English: In addition the following is required:
Danish: Desuden skal der bruges følgende materialer:
English: • Grounds for one additional renewal
Danish: • Begrundelse for en ekstra fornyelse
English: Estimated Probability of Being Puncture-free (%)
Danish: Estimeret sandsynlighed for at være punkturfri (%)
English: It can be removed the day after the last infusion.
Danish: Det kan fjernes dagen efter den sidste infusion.
English: Patients of nonCaucasian origin have not been included in these clinical studies.
Danish: Patienter af ikke-kaukasisk oprindelse har ikke været inkluderet i disse kliniske studier.
English: Material and equipment required
Danish: Nødvendige materialer og udstyr
English: Some of these side effects may require medical treatment.
Danish: Nogle af disse bivirkninger kan kræve lægebehandling.
English: Final volume for administration
Danish: Slutvolumen til administration
English: • Uncertainty in the knowledge about the rare unfavourable effects since the safety database is still very limited due to the low number of patients treated with Removab.
Danish: • Usikkerhed om kendskabet til de sjældne, ufavorable virkninger, da sikkerhedsdatabasen stadig er meget begrænset på grund af det lille antal patienter, der er blevet behandlet med Removab.
English: Subsequently, the catheter can be removed.
Danish: Derefter kan kateteret fjernes.
English: Only in case of clinically relevant or persisting increase further diagnostics or therapy should be considered.
Danish: Kun i tilfælde af klinisk relevant eller vedvarende forhøjelse bør yderligere diagnostik eller behandling overvejes.
English: Plasma levels tended to decline after achieving a maximum after each dose.
Danish: Plasmaniveauet havde tendens til at falde efter at have nået et maksimum efter hver dosis.
English: Special populations No studies have been conducted.
Danish: Særlige populationer Der er ikke foretaget nogen studier.
English: For the first of the four doses an infusion time of 6 hours may be considered depending on the patient's health condition.
Danish: Ved den første af de fire doser kan en infusionstid på 6 timer overvejes, afhængigt af patientens sundhedstilstand.
English: These reactions resolved under symptomatic treatment.
Danish: Disse reaktioner svandt under symptomatisk behandling.
English: Administration of prednisolone as premedication did not result in a reduction of these adverse reactions.
Danish: Administration af prednisolon som præmedicinering medførte ingen reduktion af disse bivirkninger.
English: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Germany
Danish: Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Tyskland
English: It is unknown whether catumaxomab/metabolites are excreted in human milk.
Danish: Det er ukendt, om catumaxomab/metabolitter udskilles i human mælk.
English: After completion of the study, patients were further observed until the end of their lifetime to assess overall survival (Table 4).
Danish: Efter studiets afslutning blev patienterne yderligere observeret indtil deres død for at bedømme den samlede overlevelse (Tabel 4).
English: Adverse reactions are derived from an integrated safety analysis including 12 clinical studies.
Danish: Bivirkningerne er afledt af en integreret sikkerhedsanalyse, der omfattede 12 kliniske studier.
English: 82166 Graefelfing
Danish: 82166 Graefelfing Tyskland
English: The interval between the infusion days can be prolonged in case of relevant adverse reactions.
Danish: Intervallet mellem infusionsdagene kan forlænges i tilfælde af relevante bivirkninger.
English: These symptoms reflect the mechanism of action of catumaxomab and are in general fully reversible.
Danish: Disse symptomer reflekterer catumaxomabs virkningsmekanisme og er generelt fuldt reversible.
English: There are no or limited amount of data from the use of catumaxomab in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af catumaxomab til gravide kvinder.
English: During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects.
Danish: Under og efter infusionen med Removab vil mere end 1 ud af 10 patienter (meget almindelig) sandsynligvis opleve infusionsrelaterede bivirkninger.
English: Summary of the safety profile
Danish: Resume over sikkerhedsprofil
English: The patient population was comparable to the pivotal study.
Danish: Patientpopulationen svarede til den fra det pivotale studie.
English: Figure 3 Schematic illustration of the infusion system
Danish: Figur 3: Skematisk illustration af infusionssystemet
English: If such symptoms occur, speak to a doctor immediately, as these side effects require immediate attention and treatment.
Danish: Hvis disse symptomer opstår, skal De straks kontakte lægen, da disse bivirkninger kræver omgående undersøgelse og behandling.
English: The following components must be used for the dilution and administration of Removab as Removab is only compatible with:
Danish: Følgende komponenter skal bruges til opløsning og administration af Removab, da Removab kun er kompatibel med:
English: In the pivotal study IP-REM-AC-01 98.1% of patients were hospitalised for a median of 11 days.
Danish: I pivotal-studiet IP-REM-AC01 var 98,1 % af patienterne indlagt i gennemsnitligt 11 dage.
English: Endometrial *= lobular breast cancer
Danish: Endometrie *= lobulær brystcancer
English: In clinical studies infusion times of 3 hours and 6 hours were investigated.
Danish: I kliniske studier blev infusionstider på 3 timer og 6 timer undersøgt.
English: Frequency groupings are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Danish: Gruppering i hyppigheder er defineret som følger: meget almindelig (≥1/10), almindelig (≥1/100 til <1/10), ikke almindelig (≥1/1.000 til <1/100).
English: Instructions for dilution prior to administration
Danish: Instruktioner til fortynding før administration
English: Percentage of EpCAM positive effusions
Danish: Procentdel af EpCAMpositive effusioner
English: Dyspnoea and hypo-/ hypertension are commonly observed.
Danish: Dyspnø og hypo-/hypertension ses hyppigt.
English: In the pivotal study patients were monitored for 24 h after each infusion.
Danish: I det pivotale studie blev patienterne monitoreret i 24 timer efter hver infusion.
English: Very common serious side effects (may affect more than 1 in 10 people): - Tiredness
Danish: Meget almindelige alvorlige bivirkninger (disse kan påvirke flere end 1 ud af 10 personer): - Træthed
English: Based upon the data that have become available since the granting of the initial Marketing Authorisation, the CHMP considers that the benefit-risk balance of Removab remains positive, but considers that its safety profile is to be closely monitored for the following reasons:
Danish: Baseret på data, der er blevet tilgængelige siden den første markedsføringstilladelse, anser Udvalget for Lægemidler til Mennesker (CHMP) risk/benefit-forholdet for Removab for stadig at være positivt men mener, at sikkerhedsprofilen skal overvåges nøje af de følgende årsager:
English: • The catheter is kept closed until the next infusion.
Danish: • Hold kateteret lukket indtil næste infusion.
English: Altogether 45 out of 88 (51%) patients in the control arm crossed-over to achieve active treatment with catumaxomab.
Danish: I alt krydsede 45 ud af 88 (51 %) af patienterne i kontrolarmen over til at få aktiv behandling med catumaxomab.
English: Acute infections
Danish: Akutte infektioner
English: The median puncture-free survival time was 47.5 days, median time to first therapeutic puncture 60.0 days and median overall survival 406.5 days.
Danish: Den mediane punkturfrie overlevelsestid var 47,5 dage, mediantiden indtil første terapeutiske punktur var 60,0 dage og den mediane samlede overlevelsestid var 406,5 dage.
English: Despite pre-existing ADA values all patients received all 4 catumaxomab infusions.
Danish: Til trods for præeksisterende ADA-værdier fik alle patienter alle 4 catumaxomab-infusioner.
English: Therefore, based upon the safety profile of Removab, which requires the submission of yearly PSURs, the CHMP concluded that the MAH should submit one additional renewal application in 5 years time.
Danish: Baseret på sikkerhedsprofilen af Removab, hvor der kræves indsendelse af årlige PSUR'er, konkluderede CHMP derfor, at indehaveren af markedsføringstilladelsen skal indsende yderligere en ansøgning om fornyelse om 5 år.
English: Date of latest renewal: 18 December 2013
Danish: Dato for første markedsføringstilladelse: 20 april 2009 Dato for seneste fornyelse: 18 december 2013
English: Adequate monitoring of the patient after end of Removab infusion is recommended.
Danish: Tilstrækkelig overvågning af patienten anbefales efter endt infusion med Removab.
English: An interval of at least two infusion free calendar days must elapse between infusion days.
Danish: Der skal være mindst to infusionsfrie kalenderdage mellem infusionsdagene.
English: However, these findings are of limited value due to the high species-specificity of catumaxomab.
Danish: Disse fund er imidlertid af begrænset værdi på grund af catumaxomabs høje artsspecificitet.
English: Infection.
Danish: Infektion.
English: If such symptoms occur, please inform your doctor as soon as possible.
Danish: Hvis disse symptomer opstår, skal De kontakte lægen så hurtigt som muligt.
English: The following information is intended for healthcare professionals only:
Danish: Følgende information er tiltænkt læger og sundhedspersonale.
English: Current data on catumaxomab derived from the pivotal study show that only 5.6% of patients (7/124 patients) were HAMA positive before the 4th infusion.
Danish: Aktuelle data for catumaxomab fra det pivotale studie viser, at kun 5,6 % af patienterne (7/124 patienter) var HAMA-positive før den 4. infusion.
English: Pooled population (N=219)
Danish: Samlet population (N=219)
English: No hypersensitivity reactions were observed.
Danish: Der blev ikke observeret nogen overfølsomhedsreaktioner.
English: • The day after the last infusion a drainage of ascites until stop of spontaneous flow is performed.
Danish: • Dagen efter sidste infusion foretages en drænage af ascites, til den spontane strøm ophører.
English: In general, the changes in laboratory parameters were not clinically relevant and mostly returned to baseline after end of treatment.
Danish: Generelt var ændringerne i laboratorieparametrene ikke kliniske relevante, og de vendte som regel tilbage til baseline-værdier efter behandlingsophør.
English: Disposal No special requirements.
Danish: Bortskaffelse Ingen særlige forholdsregler.
English: Anxiety, insomnia.
Danish: Angst, søvnløshed.
English: Patients experiencing infusion-related symptoms should be advised not to drive and use machines until symptoms abate.
Danish: Patienter, som oplever infusionsrelaterede symptomer, skal rådes til ikke at føre motorkøretøj eller betjene maskiner, før symptomerne aftager.
English: Fertility No data on the effect of catumaxomab on fertility are available.
Danish: Fertilitet Der foreligger ingen data for catumaxomabs virkning på fertilitet.
English: The concentrations increased with the number of infusions and the doses applied in most patients.
Danish: Koncentrationerne øgedes hos de fleste patienter i takt med antallet af infusioner og de anvendte doser.
English: The EpCAM antigen is overexpressed on most carcinomas (Table 2).
Danish: EpCAM-antigenet er overudtrykt i de fleste karcinomer (tabel 2).
English: In Table 1, adverse reactions are listed by organ class.
Danish: I Tabel 1 er bivirkningerne opstillet efter organklasse.
English: The patients remained ADA positive during treatment phase and follow-up.
Danish: Patienterne forblev ADApositive under behandlingsfasen og opfølgningen.
English: Administration of catumaxomab in animal models did not result in any signs of abnormal or drug-related acute toxicity or signs of local intolerance at the injection/infusion site.
Danish: Administration af catumaxomab i dyremodeller viste ingen tegn på unormal eller lægemiddelrelateret akut toksicitet eller tegn på lokal intolerans på injektions-/infusionsstedet.
English: In 43.7% of patients abdominal pain was reported as an adverse reaction reaching grade 3 in 8.2 % of patients, but it resolved under symptomatic treatment.
Danish: Hos 43,7% af patienterne blev abdominalsmerter rapporteret som en bivirkning, som nåede grad 3 hos 8,2 % af patienterne, men de svandt under symptomatisk behandling.
English: It is recommended that the catheter remains in the abdominal cavity during the entire treatment period.
Danish: Det anbefales, at kateteret forbliver i bughulen under hele behandlingsperioden.
English: The efficacy of catumaxomab was demonstrated in two phase III clinical studies.
Danish: Effekten af catumaxomab blev påvist ved to fase-III- kliniske studier.
English: 728 patients received catumaxomab intraperitoneally, 293 patients as 6 hour - and 435 patients as 3 hour infusions.
Danish: 728 patienter fik catumaxomab intraperitonealt, 293 patienter som 6 timers infusion og 435 patienter som 3 timers infusion.
English: As secondary efficacy endpoint overall survival (Table 6) was assessed.
Danish: Et sekundært effektendepunkt for den samlede overlevelse (Tabel 6) blev evalueret.
English: Catumaxomab was applied in patients where standard therapy was not available or no longer feasible and who had a Karnofsky performance status of at least 60.
Danish: Catumaxomab blev givet til patienter, hvor standardbehandling ikke var tilgængelig eller ikke længere mulig, og som havde en Karnofsky-performance-status på mindst 60.
English: The following definitions of CTCAE criteria of the US National Cancer Institute (version 4.0) apply: CTCAE grade 1 = mild, CTCAE grade 2 = moderate, CTCAE grade 3 = severe, CTCAE grade 4 = life-threatening
Danish: Følgende definitioner af CTCAE-kriterier fra US National Cancer Institute (version 4.0) er gældende: CTCAE grad 1 = let, CTCAE grad 2 = moderat, CTCAE grad 3 = svær, CTCAE grad 4 = livstruende
English: Hypersensitivity to murine (rat and / or mouse) proteins.
Danish: Overfølsomhed over for murine (rotte- og/eller muse-) proteiner.
English: You will be given other medicines to reduce fever, pain or inflammation caused by Removab (see section 3).
Danish: De vil få andre lægemidler til at reducere feber, smerter eller betændelse forårsaget af Removab (se punkt 3).
English: Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk.
Danish: Behandling af disse patienter med Removab bør kun overvejes efter en grundig vurdering af fordele og risici.