natgillin/translations-raw huggingface dataset:
Temybric Ellipta bør anvendes med forsigtighed til patienter med moderat til svært nedsat leverfunktion (se pkt. 
Temybric Ellipta should be used with caution in patients with moderate to severe hepatic impairment (see sections 4.4 and 5.2).
Det skal du vide, før du begynder at bruge Temybric Ellipta 
What you need to know before you use Temybric Ellipta
Æsken med Temybric Ellipta-inhalatoren indeholder 
Your Temybric Ellipta inhaler carton contains
LÆGEMIDLETS NAVN Temybric Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol 
NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92/55/22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Indlægsseddel: Information til patienten Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol 
Package leaflet: Information for the patient Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Tel: + 39 050 971011 
Laboratori Guidotti S.p.A. Tel: + 39 050 971011
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. 
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.
Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt fluticasonfuroat/umeclidinium/vilanterol 
Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed fluticasone furoate/umeclidinium/vilanterol
Temybric Ellipta 92 mikrogram/55 mikrogram/22 mikrogram inhalationspulver, afdelt 
NAME OF THE MEDICINAL PRODUCT Temybric Ellipta 92 micrograms/55 micrograms/22 micrograms inhalation powder, pre-dispensed
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. 
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).
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. 
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).
LÆGEMIDLETS NAVN, STYRKE OG/ELLER ADMINISTRATIONSVEJ(E) Temybric Ellipta 92/55/22 µg inhalationspulver fluticasone furoate/umeclidinium/vilanterol 
NAME OF THE MEDICINAL PRODUCT AND ROUTE(S) OF ADMINISTRATION Temybric Ellipta 92 /55 /22 mcg inhalation powder fluticasone furoate/umeclidinium/vilanterol
Sådan skal du bruge Temybric Ellipta 
How to use Temybric Ellipta
Hvis du har brugt for meget Temybric Ellipta 
If you stop using Temybric Ellipta
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. 
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).
(n = 4.151) 
Temybric Ellipta (N = 4,151
Det skal du vide, før du begynder at bruge Temybric Ellipta Sådan skal du bruge Temybric Ellipta Bivirkninger 
What you need to know before you use Temybric Ellipta 3.
Ellipta 
Elderly
Sammenligning Temybric ift. 
How to use Temybric Ellipta 4.
UMEC/VI 
Comparison Temybric vs. UMEC/VI
• Risiko for reaktivering af latent tuberkulose og information om screening for tuberkulose ifølge den lokale vejledning; 
• Risk of reactivation of latent tuberculosis and information about the screening for tuberculosis according to the local guidance;
• Lokal vejledning i tuberkulose-screening; 
• Local Guidance for tuberculosis screening;
• Egnede teknikker til selvadministration af Stelara, inklusive brug af den fyldte injektionssprøjte. 
• Appropriate techniques for self administration of Stelara, including use of the prefilled syringes.
Medlemsstaterne skal sikre sig, at alle betingelser eller begrænsninger med hensyn til en sikker og effektiv anvendelse af lægemidlet beskrevet nedenfor implementeres: 
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:
• Uddannelsepakke til sundhedspersonale • Informationspakke til patienter 
Healthcare Professional educational pack • Patient information pack
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: 
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:
• Risiko for maligniteter. 
• Risk of malignancies.
Hovedbudskaberne og de vigtigste komponenter inkluderet i uddannelsepakken til sundhedspersonale er defineret som følger: 
The key messages and components included in the Healthcare Professional educational pack are defined as follows:
• Mulig risiko for maligniteter 
• Potential risk of malignancies;
Hovedbudskaberne i informationspakken til patienter er defiveret som følger: 
The key messages in the patient information pack are defined as follows:
• Indlægsseddel 
• Patient Information Leaflet
N: antal patienter i en behandlingsgruppe. 
N: number of patients in a treatment group.
Performance-status og BMI 
Performance status and BMI
(Del af den ydre karton) 
(Part of the Outer Carton)
Tid (dage) til hændelse 
Time (days) to event
Børn og teenagere Removab må ikke anvendes til børn og teenagere under 18 år. 
Children and adolescents Removab should not be used in children and adolescents under 18 years of age.
Den samlede behandlingsperiode må ikke overstige 20 dage. 
The overall treatment period should not exceed 20 days.
Desuden skal der bruges følgende materialer: 
In addition the following is required:
• Begrundelse for en ekstra fornyelse 
• Grounds for one additional renewal
Estimeret sandsynlighed for at være punkturfri (%) 
Estimated Probability of Being Puncture-free (%)
Det kan fjernes dagen efter den sidste infusion. 
It can be removed the day after the last infusion.
Patienter af ikke-kaukasisk oprindelse har ikke været inkluderet i disse kliniske studier. 
Patients of nonCaucasian origin have not been included in these clinical studies.
Nødvendige materialer og udstyr 
Material and equipment required
Nogle af disse bivirkninger kan kræve lægebehandling. 
Some of these side effects may require medical treatment.
Slutvolumen til administration 
Final volume for administration
• 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. 
• 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.
Derefter kan kateteret fjernes. 
Subsequently, the catheter can be removed.
Kun i tilfælde af klinisk relevant eller vedvarende forhøjelse bør yderligere diagnostik eller behandling overvejes. 
Only in case of clinically relevant or persisting increase further diagnostics or therapy should be considered.
Plasmaniveauet havde tendens til at falde efter at have nået et maksimum efter hver dosis. 
Plasma levels tended to decline after achieving a maximum after each dose.
Særlige populationer Der er ikke foretaget nogen studier. 
Special populations No studies have been conducted.
Ved den første af de fire doser kan en infusionstid på 6 timer overvejes, afhængigt af patientens sundhedstilstand. 
For the first of the four doses an infusion time of 6 hours may be considered depending on the patient's health condition.
Disse reaktioner svandt under symptomatisk behandling. 
These reactions resolved under symptomatic treatment.
Administration af prednisolon som præmedicinering medførte ingen reduktion af disse bivirkninger. 
Administration of prednisolone as premedication did not result in a reduction of these adverse reactions.
Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Tyskland 
Trion Pharma GmbH Frankfurter Ring 193a DE-80807 Munich Germany
Det er ukendt, om catumaxomab/metabolitter udskilles i human mælk. 
It is unknown whether catumaxomab/metabolites are excreted in human milk.
Efter studiets afslutning blev patienterne yderligere observeret indtil deres død for at bedømme den samlede overlevelse (Tabel 4). 
After completion of the study, patients were further observed until the end of their lifetime to assess overall survival (Table 4).
Bivirkningerne er afledt af en integreret sikkerhedsanalyse, der omfattede 12 kliniske studier. 
Adverse reactions are derived from an integrated safety analysis including 12 clinical studies.
82166 Graefelfing Tyskland 
82166 Graefelfing
Intervallet mellem infusionsdagene kan forlænges i tilfælde af relevante bivirkninger. 
The interval between the infusion days can be prolonged in case of relevant adverse reactions.
Disse symptomer reflekterer catumaxomabs virkningsmekanisme og er generelt fuldt reversible. 
These symptoms reflect the mechanism of action of catumaxomab and are in general fully reversible.
Der er ingen eller utilstrækkelige data fra anvendelse af catumaxomab til gravide kvinder. 
There are no or limited amount of data from the use of catumaxomab in pregnant women.
Under og efter infusionen med Removab vil mere end 1 ud af 10 patienter (meget almindelig) sandsynligvis opleve infusionsrelaterede bivirkninger. 
During and after infusion with Removab more than 1 in 10 patients (very common) will probably experience infusion-related side effects.
Resume over sikkerhedsprofil 
Summary of the safety profile
Patientpopulationen svarede til den fra det pivotale studie. 
The patient population was comparable to the pivotal study.
Figur 3: Skematisk illustration af infusionssystemet 
Figure 3 Schematic illustration of the infusion system
Hvis disse symptomer opstår, skal De straks kontakte lægen, da disse bivirkninger kræver omgående undersøgelse og behandling. 
If such symptoms occur, speak to a doctor immediately, as these side effects require immediate attention and treatment.
Følgende komponenter skal bruges til opløsning og administration af Removab, da Removab kun er kompatibel med: 
The following components must be used for the dilution and administration of Removab as Removab is only compatible with:
I pivotal-studiet IP-REM-AC01 var 98,1 % af patienterne indlagt i gennemsnitligt 11 dage. 
In the pivotal study IP-REM-AC-01 98.1% of patients were hospitalised for a median of 11 days.
Endometrie *= lobulær brystcancer 
Endometrial *= lobular breast cancer
I kliniske studier blev infusionstider på 3 timer og 6 timer undersøgt. 
In clinical studies infusion times of 3 hours and 6 hours were investigated.
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). 
Frequency groupings are defined as follows: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100).
Instruktioner til fortynding før administration 
Instructions for dilution prior to administration
Procentdel af EpCAMpositive effusioner 
Percentage of EpCAM positive effusions
Dyspnø og hypo-/hypertension ses hyppigt. 
Dyspnoea and hypo-/ hypertension are commonly observed.
I det pivotale studie blev patienterne monitoreret i 24 timer efter hver infusion. 
In the pivotal study patients were monitored for 24 h after each infusion.
Meget almindelige alvorlige bivirkninger (disse kan påvirke flere end 1 ud af 10 personer): - Træthed 
Very common serious side effects (may affect more than 1 in 10 people): - Tiredness
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: 
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:
• Hold kateteret lukket indtil næste infusion. 
• The catheter is kept closed until the next infusion.
I alt krydsede 45 ud af 88 (51 %) af patienterne i kontrolarmen over til at få aktiv behandling med catumaxomab. 
Altogether 45 out of 88 (51%) patients in the control arm crossed-over to achieve active treatment with catumaxomab.
Akutte infektioner 
Acute infections
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. 
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.
Til trods for præeksisterende ADA-værdier fik alle patienter alle 4 catumaxomab-infusioner. 
Despite pre-existing ADA values all patients received all 4 catumaxomab infusions.
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. 
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.
Dato for første markedsføringstilladelse: 20 april 2009 Dato for seneste fornyelse: 18 december 2013 
Date of latest renewal: 18 December 2013
Tilstrækkelig overvågning af patienten anbefales efter endt infusion med Removab. 
Adequate monitoring of the patient after end of Removab infusion is recommended.
Der skal være mindst to infusionsfrie kalenderdage mellem infusionsdagene. 
An interval of at least two infusion free calendar days must elapse between infusion days.
Disse fund er imidlertid af begrænset værdi på grund af catumaxomabs høje artsspecificitet. 
However, these findings are of limited value due to the high species-specificity of catumaxomab.
Infektion. 
Infection.
Hvis disse symptomer opstår, skal De kontakte lægen så hurtigt som muligt. 
If such symptoms occur, please inform your doctor as soon as possible.
Følgende information er tiltænkt læger og sundhedspersonale. 
The following information is intended for healthcare professionals only:
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. 
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.
Samlet population (N=219) 
Pooled population (N=219)
Der blev ikke observeret nogen overfølsomhedsreaktioner. 
No hypersensitivity reactions were observed.
• Dagen efter sidste infusion foretages en drænage af ascites, til den spontane strøm ophører. 
• The day after the last infusion a drainage of ascites until stop of spontaneous flow is performed.
Generelt var ændringerne i laboratorieparametrene ikke kliniske relevante, og de vendte som regel tilbage til baseline-værdier efter behandlingsophør. 
In general, the changes in laboratory parameters were not clinically relevant and mostly returned to baseline after end of treatment.
Bortskaffelse Ingen særlige forholdsregler. 
Disposal No special requirements.
Angst, søvnløshed. 
Anxiety, insomnia.
Patienter, som oplever infusionsrelaterede symptomer, skal rådes til ikke at føre motorkøretøj eller betjene maskiner, før symptomerne aftager. 
Patients experiencing infusion-related symptoms should be advised not to drive and use machines until symptoms abate.
Fertilitet Der foreligger ingen data for catumaxomabs virkning på fertilitet. 
Fertility No data on the effect of catumaxomab on fertility are available.
Koncentrationerne øgedes hos de fleste patienter i takt med antallet af infusioner og de anvendte doser. 
The concentrations increased with the number of infusions and the doses applied in most patients.
EpCAM-antigenet er overudtrykt i de fleste karcinomer (tabel 2). 
The EpCAM antigen is overexpressed on most carcinomas (Table 2).
I Tabel 1 er bivirkningerne opstillet efter organklasse. 
In Table 1, adverse reactions are listed by organ class.
Patienterne forblev ADApositive under behandlingsfasen og opfølgningen. 
The patients remained ADA positive during treatment phase and follow-up.
Administration af catumaxomab i dyremodeller viste ingen tegn på unormal eller lægemiddelrelateret akut toksicitet eller tegn på lokal intolerans på injektions-/infusionsstedet. 
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.
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. 
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.
Det anbefales, at kateteret forbliver i bughulen under hele behandlingsperioden. 
It is recommended that the catheter remains in the abdominal cavity during the entire treatment period.
Effekten af catumaxomab blev påvist ved to fase-III- kliniske studier. 
The efficacy of catumaxomab was demonstrated in two phase III clinical studies.
728 patienter fik catumaxomab intraperitonealt, 293 patienter som 6 timers infusion og 435 patienter som 3 timers infusion. 
728 patients received catumaxomab intraperitoneally, 293 patients as 6 hour - and 435 patients as 3 hour infusions.
Et sekundært effektendepunkt for den samlede overlevelse (Tabel 6) blev evalueret. 
As secondary efficacy endpoint overall survival (Table 6) was assessed.
Catumaxomab blev givet til patienter, hvor standardbehandling ikke var tilgængelig eller ikke længere mulig, og som havde en Karnofsky-performance-status på mindst 60. 
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.
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 
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
Overfølsomhed over for murine (rotte- og/eller muse-) proteiner. 
Hypersensitivity to murine (rat and / or mouse) proteins.
De vil få andre lægemidler til at reducere feber, smerter eller betændelse forårsaget af Removab (se punkt 3). 
You will be given other medicines to reduce fever, pain or inflammation caused by Removab (see section 3).
Behandling af disse patienter med Removab bør kun overvejes efter en grundig vurdering af fordele og risici. 
Treatment of these patients with Removab should only be considered after a thorough evaluation of benefit / risk.
Til trods for denne præmedicinering oplevede patienterne de ovenfor beskrevne bivirkninger med en intensitet på op til grad 3 ifølge Common Terminology Criteria for Adverse Events (CTCAE) fra US National Cancer Institute, version 3.0. 
Despite this premedication, patients experienced the adverse reactions described above with an intensity of up to grade 3, according to the Common Terminology Criteria for Adverse Events (CTCAE) of the US National Cancer Institute, version 3.0.
Infusionsrelaterede bivirkninger og mavesmerter er meget almindelige (se punkt 4). 
Infusion-related side effects and abdominal pain are very common (see section 4).
For at kunne evaluere indvirkningen af præmedicinering med prednisolon på sikkerhed og virkning blev det primære endepunkt for sikkerhed “sammensat sikkerhedsscore“ og det co-primære endepunkt for virkning “punkturfri overlevelse” undersøgt. 
In order to assess the impact of prednisolone premedication on safety and efficacy the primary safety endpoint “composite safety score” and the co-primary efficacy endpoint “puncture-free survival” were investigated.
Den samlede sikkerhedsprofil for Removab karakteriseres af symptomer relateret til cytokinfrigivelse og gastrointestinale reaktioner. 
The overall safety profile of Removab is characterised by cytokine-release related symptoms and gastrointestinal reactions.
Dette skal som minimum omfatte ascites-drænage indtil ophør af spontan udtømning eller symptomlindring og, hvis det er relevant, understøttende substitutionsbehandling med krystalloider og/eller kolloider. 
This must at least include ascites drainage until stop of spontaneous flow or symptom relief, and, if appropriate, supportive replacement therapy with crystalloids and / or colloids.
Dette medfører, at tumorcellerne destrueres. 
This results in destruction of tumour cells.
Hvis der forekommer faktorer, som påvirker immunsystemet, især akutte infektioner, frarådes aministration af Removab. 
In presence of factors interfering with the immune system, in particular acute infections, the administration of Removab is not recommended.
Denne forbigående bivirkning betragtes delvist som en følge af den intraperitoneale indgivelsesvej. 
This transient effect is considered partially a consequence of the intraperitoneal route of administration.
Den klargjorte infusionsvæske skal anvendes straks. 
The prepared infusion solution should be used immediately.
CD3 findes på modne T-celler som en komponent af T-cellereceptoren. 
CD3 is expressed on mature T-cells as a component of the T-cell receptor.
Der forekom HAMA'er hos 94 % af patienterne en måned efter den sidste infusion med catumaxomab. 
HAMAs were present in 94% of patients one month after the last catumaxomab infusion.
Kontakt lægen eller sundhedspersonalet, før De bruger Removab. 
Talk to your doctor or nurse before using Removab.
Der bliver placeret et kateter i Deres bughule (intraperiotenealt) i hele behandlingsperioden indtil dagen for den sidste infusion. 
A catheter will be placed in your abdominal space (intraperitoneal) for the whole treatment period, until the day after your last infusion.
Den ydre overflade af den fyldte injektionssprøjte er ikke steril. 
The outer surface of the pre-filled syringe is not sterile.
Doseringsplanen for Removab består af følgende fire intraperitoneale infusioner: 1. dosis 
Removab dosing schedule comprises the following four intraperitoneal infusions: 1st dose
Proteinuri. 
Proteinuria.
Hvis De ønsker yderligere oplysninger om dette lægemiddel, skal De henvende Dem til indehaveren af markedsføringstilladelsen. 
For any information about this medicine, please contact the Marketing Authorisation Holder.
Hvis De er gravid eller ammer, har mistanke om, at De er gravid, eller planlægger at blive gravid, skal De spørge Deres læge til råds, før De bruger dette lægemiddel. 
If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor for advice before taking this medicine.You should not use Removab if you are pregnant unless clearly necessary.
6 Kateter 
6 Catheter