FrancophonIA/ELRC3.0 huggingface dataset:
English: For more information about using Pelmeg, see the package leaflet or contact your doctor or pharmacist.
Danish: For mere information om brug af Pelmeg se indlægssedlen, eller kontakt lægen eller apotekspersonalet.
English: Pelmeg is given as a single dose of 6 mg injected under the skin at least 24 hours after the end of each cycle of chemotherapy (treatment with cancer medicines).
Danish: Pelmeg gives som en enkeltdosis på 6 mg, der injiceres under huden mindst 24 timer efter afslutningen af hver behandlingsserie med kemoterapi (behandling med kræftlægemidler).
English: Because Pelmeg is a biosimilar medicine, the studies on effectiveness and safety of pegfilgrastim carried out with Neulasta do not all need to be repeated for Pelmeg.
Danish: Da Pelmeg er et biosimilært lægemiddel, behøver de studier af pegfilgrastims virkning og sikkerhed, der er udført for Neulasta, ikke alle at blive gentaget for Pelmeg.
English: The active substance in Pelmeg, pegfilgrastim, is a form of filgrastim, which is very similar to a human protein called granulocyte-colony-stimulating factor (G-CSF).
Danish: Det aktive stof i Pelmeg, pegfilgrastim, er en form for filgrastim, der minder meget om det menneskelige protein granulocyt-kolonistimulerende faktor (G-CSF).
English: The safety of Pelmeg has been evaluated, and on the basis of all the studies carried out the side effects of the medicine are considered to be comparable to those of the reference medicine Neulasta.
Danish: Sikkerheden ved Pelmeg er blevet vurderet, og på grundlag af alle de gennemførte studier anses bivirkningerne ved lægemidlet for at være sammenlignelige med bivirkningerne ved referencelægemidlet Neulasta.
English: The European Medicines Agency decided that, in accordance with EU requirements for biosimilar medicines, Pelmeg has a highly similar structure, purity and biological activity to Neulasta and is distributed in the body in the same way.
Danish: Det Europæiske Lægemiddelagentur konkluderede, at det i overensstemmelse med EU's krav til biosimilære lægemidler er påvist, at Pelmeg har en struktur, renhed og biologisk aktivitet, der svarer til Neulastas, og at det fordeles i kroppen på samme måde.
English: Studies have also shown that giving Pelmeg produces similar levels of the active substance in the body to giving Neulasta.
Danish: Studier har også vist, at indgivelse af Pelmeg danner samme niveau af det aktive stof i kroppen som indgivelse af Neulasta.
English: Pelmeg is not intended for use in patients with the blood cancer chronic myeloid leukaemia or with myelodysplastic syndromes (conditions in which large numbers of abnormal blood cells are produced, which can develop into leukaemia).
Danish: Pelmeg er ikke beregnet til brug hos patienter med blodkræfttypen kronisk myeloid leukæmi eller myelodysplastisk syndromer (tilstande, hvor der produceres et stort antal blodlegemer, som kan udvikle sig til leukæmi).
English: Therefore, the Agency's view was that, as for Neulasta, the benefit of Pelmeg outweighs the identified risk and it can be authorised for use in the EU.
Danish: Agenturet var derfor af den opfattelse, at fordelene ved Pelmeg opvejer de identificerede risici som for Neulasta, og at det kan godkendes til anvendelse i EU.
English: All these data were considered sufficient to conclude that Pelmeg will behave in the same way as Neulasta in terms of effectiveness and safety in its authorised uses.
Danish: Disse oplysninger blev anset for tilstrækkelige til at konkludere, at Pelmeg vil have de samme egenskaber som Neulasta, hvad angår sikkerhed og virkning ved de godkendte anvendelser.
English: In Pelmeg, filgrastim has been ‘pegylated' (attached to a chemical called polyethylene glycol).
Danish: I Pelmeg er filgrastim blevet "pegyleret" (dvs. bundet til det kemiske stof polyethylenglykol).
English: What benefits of Pelmeg have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Pelmeg?
English: How is Pelmeg used?
Danish: Hvordan anvendes Pelmeg?
English: For the full list of side effects and restrictions with Pelmeg, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Pelmeg fremgår af indlægssedlen.
English: Laboratory studies comparing Pelmeg with Neulasta have shown that the active substance in Pelmeg is highly similar to that in Neulasta in terms of structure, purity and biological activity.
Danish: I laboratoriestudier, hvor Pelmeg blev sammenlignet med Neulasta, er det blevet påvist, at det aktive stof i Pelmeg svarer til det aktive stof i Neulasta, hvad angår struktur, renhed og biologisk aktivitet.
English: How does Pelmeg work?
Danish: Hvordan virker Pelmeg?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Pelmeg have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Pelmeg.
English: Pelmeg is a medicine used in cancer patients to help with neutropenia (low levels of neutrophils, a type of white blood cell), which is a common side effect of cancer treatment and can leave patients vulnerable to infections.
Danish: Pelmeg er et lægemiddel, der anvendes hos kræftpatienter til behandling af neutropeni (lavt antal neutrofiler, en type hvide blodlegemer).
English: Cannot be sold separately.
Danish: Må ikke sælges separat.
English: if you are currently taking steroids.
Danish: hvis du på nuværende tidspunkt tager steroider.
English: It is particularly important that you mention any of the following medicines.
Danish: Det er særlig vigtigt, at du nævner følgende medicin.
English: This is a long-term treatment, possibly lasting for months.
Danish: Dette er en langtidsbehandling, som kan vare i flere måneder.
English: They contain white to almost white powder.
Danish: De indeholder et hvidt til næsten hvidt pulver.
English: Therefore, genotoxic risk is not expected in humans.
Danish: En genotoksisk risiko forventes derfor ikke hos mennesker.
English: Includes cases reported within the clustered terms:
Danish: Inkluderer tilfælde indberettet inden for de samlede betegnelser:
English: Date of first authorisation: 06 May 2015 Date of latest renewal: 22 March 2017
Danish: Dato for første markedsføringstilladelse: 6. maj 2015 Dato for seneste fornyelse: 22. marts 2017
English: For Study X2101, OS data were not yet mature at the time of the analysis.
Danish: For studie X2101 var OS data endnu ikke modne ved tidspunktet for analysen.
English: Criteria
Danish: Kriterier
English: It may make the amount of Zykadia in your blood increase to a harmful level.
Danish: Det kan få mængden af Zykadia i dit blod til at stige til et skadeligt niveau.
English: You should not eat grapefruit or drink grapefruit juice during treatment.
Danish: Du må ikke spise grapefrugt eller drikke grapefrugtjuice under behandlingen.
English: Ammonium hydroxide 28%
Danish: Ammoniumhydroxid 28 %
English: Heart rate and blood pressure should be monitored regularly.
Danish: Hjertefrekvens og blodtryk skal monitoreres regelmæssigt.
English: Target organ effects showed partial to complete recovery.
Danish: Målorganeffekt viste partiel til komplet bedring.
English: The purpose of these tests is to check your liver function.
Danish: Formålet med disse prøver er at kontrollere din leverfunktion.
English: No. of patients still at risk
Danish: Antal patienter fortsat i risiko
English: Effects of age, gender, and race
Danish: Effekt af alder, køn og race
English: (symptomatic, may be severe and medically significant, medical intervention indicated)
Danish: (symptomatisk, kan være alvorlig og klinisk signifikant, medicinsk intervention indiceret)
English: System organ class Preferred term
Danish: Systemorganklasse Foretrukken betegnelse
English: (life-threatening consequences, urgent intervention indicated)
Danish: (livstruende konsekvenser, akut intervention indiceret)
English: Approximate diameter: 9.1 mm.
Danish: Cirka diameter: 9,1 mm.
English: Estimated using the Kaplan-Meier method.
Danish: Estimeret ved brug af Kaplan-Meier-metoden.
English: Only 1.3% of the administered oral dose is recovered in the urine.
Danish: Kun 1,3 % af den administrerede orale dosis genfindes i urinen.
English: Your doctor will tell you exactly how many tablets you need to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange tabletter du skal tage.
English: There is no reported experience with overdose in humans.
Danish: Der er ingen rapporteret erfaring med overdosering hos mennesker.
English: STOP taking Zykadia and seek medical help immediately if you experience any of the following, which may be signs of an allergic reaction:
Danish: STOP med at tage Zykadia og søg omgående læge, hvis du oplever noget af følgende, som kan være tegn på en allergisk reaktion:
English: 92.1% of patients had adenocarcinoma.
Danish: 92,1 % af patienterne havde adenocarcinom.
English: HR=hazard ratio; CI=confidence interval; BIRC=Blinded Independent Review Committee; NE=not estimable a
Danish: HR=hazard ratio; CI=konfidensinterval; BIRC=Blinded Independent Review Committee; NE=ikke estimérbar a
English: Overall survival c
Danish: Samlet overlevelse c
English: The effectiveness of concomitant administration of oral contraceptives may be reduced.
Danish: Virkningen af samtidig administration af orale kontraceptiva kan være nedsat.
English: All of the patients were treated with at least one regimen prior to enrolment into the study and 84.0% with two or more regimens.
Danish: Alle patienterne havde fået behandling med mindst et regime før inkludering i studiet og 84,0 % med to eller flere regimer.
English: Swelling of the face, lips, tongue or throat
Danish: Hævelse af ansigt, læber, tunge eller hals
English: The micronucleus test in TK6 cells was positive.
Danish: Mikronukleustesten i TK6-celler var positiv.
English: Zykadia is for oral use.
Danish: Zykadia er til oral anvendelse.
English: Your doctor will tell you exactly how many capsules you need to take.
Danish: Din læge vil fortælle dig helt nøjagtigt, hvor mange kapsler du skal tage.
English: What to do if you forget to take a dose depends on how long it is until your next dose.
Danish: Hvad du skal gøre, hvis du har glemt at tage en dosis afhænger af, hvor længe der er til den næste dosis.
English: The following medicines may reduce the effectiveness of Zykadia:
Danish: Følgende medicin kan nedsætte Zykadias virkning:
English: The median time to first dose reduction due to any reason was 8 weeks.
Danish: Median tid til første dosisreduktion var ca. 8 uger.
English: Final overall survival (OS) data are presented for Study A2201.
Danish: De endelige data for samlet overlevelse (OS) er præsenteret for studie A2201.
English: Then take the next tablets at the usual time.
Danish: Tag derefter de næste tabletter på det sædvanlige tidspunkt.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og offentliggjort alle efterfølgende opdateringer på den europæiske webportal for lægemidler.
English: A risk for induction of other PXR regulated enzymes apart from CYP3A4 cannot be completely excluded.
Danish: Risiko for induktion af andre PXR-regulerede enzymer ud over CYP3A4 kan ikke helt udelukkes.
English: If you are pregnant, think you might be pregnant or plan to become pregnant, ask your doctor for advice.
Danish: Hvis du er gravid, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge til råds.
English: a p-value b
Danish: a p-værdi b
English: Then take the next capsules at the usual time.
Danish: Tag derefter de næste kapsler på det sædvanlige tidspunkt.
English: Your doctor will monitor your condition to see that the treatment is having the desired effect.
Danish: Din læge vil holde øje med din tilstand for at se, om behandlingen virker, som den skal.
English: Do not change the dose without talking to your doctor.
Danish: Du må ikke ændre dosis uden at tale med din læge.
English: ALK testing
Danish: ALK-test
English: Few events required discontinuation of treatment.
Danish: Få af hændelserne krævede seponering af behandlingen.
English: Probability (%) of event-free
Danish: Sandsynlighed (%) for hændelsesfri
English: Your doctor will discuss with you the potential risks of taking Zykadia during pregnancy.
Danish: Din læge vil fortælle dig om de mulige risici ved at tage Zykadia under graviditeten.
English: Permanently discontinue in the event of recurrence
Danish: Seponér permanent i tilfælde af recidiv.
English: Treatment with Zykadia should be initiated and supervised by a physician experienced in the use of anti-cancer medicinal products.
Danish: Behandlingen med Zykadia bør initieres og overvåges af en læge med erfaring i anvendelse af anticancerlægemidler.
English: As these non-clinical effects were mild, variable and inconsistent, the relationship between ceritinib and thyroid gland changes in animals is unclear.
Danish: Da disse non-kliniske påvirkninger var milde, variable og inkonsistente, er sammenhængen mellem ceritinib og thyroidea-ændringer hos dyr uklar.
English: The main efficacy data for both studies are summarised in Table 6.
Danish: Hoveddata for effekt fra begge studier er opsummeret i tabel 6.
English: Treatment should continue as long as clinical benefit is observed.
Danish: Behandlingen bør fortsætte, så længe der observeres en gavnlig klinisk effekt.
English: Other factors apart from study treatment could have impacted on observed events of hepatic encephalopathy, however, the relation between study treatment and events cannot be fully ruled out.
Danish: Andre forhold ud over studiebehandlingen kan have påvirket de observerede hændelser med hepatisk encefalopati, men en sammenhæng mellem studiebehandlingen og de observerede hændelser kan ikke fuldstændig udelukkes.
English: In patients with ALK defects, an abnormal protein is produced that stimulates the growth of the cancer cells.
Danish: Hos patienter med ALK-defekter produceres et unormalt protein, som stimulerer væksten af kræftcellerne.
English: Heart rate less than 60 beats per minutes (bpm)
Danish: Hjertefrekvens under 60 slag pr. minut (bpm)
English: Within each system organ class, the ADRs are ranked by frequency, with the most frequent reactions first.
Danish: Inden for hver systemorganklasse er bivirkningerne opstillet efter hyppighed, med de hyppigste bivirkninger først.
English: These medicines should be used with care or may need to be avoided during your treatment with Zykadia.
Danish: Disse lægemidler skal anvendes med forsigtighed eller skal muligvis undgås under din behandling med Zykadia.
English: Zykadia has minor influence on the ability to drive or use machines.
Danish: Zykadia påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: Other side effects are listed below.
Danish: Andre bivirkninger er anført herunder.
English: Temporary dose interruption and/or dose reduction of Zykadia may be required based on individual safety and tolerability.
Danish: Det kan være nødvendigt med midlertidig dosisafbrydelse og/eller dosisreduktion af Zykadia på baggrund af individuel sikkerhed og tolerabilitet.
English: There is no data with concomitant use of H2 blockers or antacids.
Danish: Der findes ingen data for samtidig behandling med H2blokkere eller antacida.
English: Metabolism and nutrition disorders Decreased appetite
Danish: Metabolisme og ernæring Nedsat appetit
English: In addition, the corresponding frequency category using the following convention (CIOMS III) is also provided for each ADR: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); and not known (cannot be estimated from the available data).
Danish: Derudover er der for hver bivirkning også angivet den tilsvarende frekvenskategori som følger konventionen (CIOMS III): meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000); og ikke kendt (kan ikke estimeres ud fra forhåndenværende data).
English: Do not use this medicine after the expiry date which is stated on the carton and blister after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på pakningen efter ”EXP”.
English: Do not stop taking this medicine before talking to your doctor.
Danish: Stop ikke med at tage denne medicin, før du har talt med din læge.
English: The EQ-5D questionnaire showed a significant overall health status improvement for Zykadia in comparison to the chemotherapy.
Danish: EQ-5Dspørgeskemaet viste en signifikant forbedring af overordnet sundhedsstatus for Zykadia i sammenligning med kemoterapi.
English: All patients were treated with prior crizotinib.
Danish: Alle patienter var tidligere behandlet med crizotinib.
English: topotecan, a medicine used to treat certain types of cancer.
Danish: topotecan, der bruges til at behandle visse former for kræft.
English: There are no or limited amount of data from the use of ceritinib in pregnant women.
Danish: Der er ingen eller utilstrækkelige data fra anvendelse af ceritinib til gravide kvinder.
English: It is unknown whether ceritinib/metabolites are excreted in human milk.
Danish: Det er ukendt, om ceritinib/metabolitter udskilles i human modermælk.
English: The overall survival (OS) data was not mature with 107 deaths representing approximately 42.3% of the required events for the final OS analysis.
Danish: Data for samlet overlevelse (OS) var ikke moden med 107 dødsfald, som udgør ca. 42,3 % af de nødvendige hændelser for den endelige OS-analyse.
English: Assessment for ALK-positive NSCLC should be performed by laboratories with demonstrated proficiency in the specific technology being utilised.
Danish: Vurdering af ALK-positiv NSCLC bør udføres af laboratorier med demonstreret færdighed i den specifikke teknologi, der anvendes.
English: Addition of a thiol group to O-dealkylated ceritinib was also observed.
Danish: Tilføjelse af en thiol-gruppe til O-dealkyleret ceritinib blev også observeret.
English: Zykadia should not be used during pregnancy unless the clinical condition of the woman requires treatment with ceritinib.
Danish: Zykadia bør ikke anvendes under graviditeten, medmindre kvindens kliniske tilstand kræver behandling med ceritinib.
English: ADRs are listed according to MedDRA system organ class.
Danish: Bivirkningerne er opstillet efter MedDRA-systemorganklasse.
English: Continue taking Zykadia for as long as your doctor tells you.
Danish: Bliv ved med at tage Zykadia, så længe som lægen har sagt, at du skal.
English: Efficacy results from ASCEND-8 are summarised in Table 5 below.
Danish: Effektresultaterne fra ASCEND-8 er opsummeret i tabel 5 herunder.
English: Time (Months)
Danish: Tid (Måneder)
English: Oral absorption was estimated to be ≥25% based on metabolite percentages in the faeces.
Danish: Oral absorption blev estimeret til ≥25 % baseret på procentdelen af metabolitter i fæces.
English: The in vitro apparent passive permeability of ceritinib was determined to be low.
Danish: Ceritinibs tilsyneladende passive permeabilitet in vitro blev bestemt til at være lav.
English: A key secondary efficacy endpoint was ORR according to RECIST 1.1 as evaluated by BIRC.
Danish: Et sekundært endepunkt var effekt målt ved ORR i henhold til RECIST 1.1, evalueret via BIRC.
English: Based on the stratified log-rank test.
Danish: Baseret på den stratificerede log-rank test.
English: Nausea, diarrhoea and vomiting were among the most commonly reported gastrointestinal events.
Danish: Kvalme, diarré og opkastning var blandt de hyppigst rapporterede gastrointestinale bivirkninger.
English: The ORR, DOR and PFS (by BIRC assessment) for patients with brain metastases at baseline were in line with those reported for the overall population of these studies.
Danish: ORR, DOR og PFS (vurderet af BIRC) for patienter med hjernemetastaser ved baseline svarede til dem, der blev rapporteret for den overordnede population i disse studier.
English: Take Zykadia once a day at about the same time each day with food (for example a snack or a full meal).
Danish: Tag Zykadia én gang om dagen på omtrent samme tidspunkt hver dag sammen med mad (fx en snack eller et hovedmåltid).
English: Zykadia with food and drink
Danish: Brug af Zykadia sammen med mad og drikke
English: Swallow the capsules whole with water.
Danish: Synk kapslerne hele med vand.
English: Ask your doctor or pharmacist if you are not sure whether your medicine is one of the medicines listed above.
Danish: Spørg lægen eller apotekspersonalet, hvis du er i tvivl om din medicin er et af de ovenstående lægemidler.
English: Of these patients 81 received ceritinib.
Danish: 81 af disse patienter fik ceritinib.
English: Swallow the tablets whole with water.
Danish: Synk tabletterne hele med vand.
English: One patient (1.1%) experienced grade 3 diarrhoea.
Danish: En patient (1,1 %) oplevede grad 3 diarré.
English: Patients with symptomatic CNS (central nervous system) metastases who were neurologically unstable or had required increasing doses of steroids within the 2 weeks prior to screening to manage CNS symptoms, were excluded from the study.
Danish: Patienter med symptomatiske CNS (centralnervesystemet)metastaser, som var neurologisk ustabile, eller havde behov for forhøjede doser af steroider inden for to uger før screening for at håndtere CNS-symptomer, blev ekskluderet fra studiet.
English: if you have problems with your heart, including reduced heart rate, or if the results of an electrocardiogram (ECG) have shown that you have an abnormality of the electrical activity of your heart known as “prolonged QT interval”.
Danish: hvis du har hjerteproblemer, herunder nedsat hjertefrekvens, eller hvis resultaterne fra et elektrokardiogram (EKG, hjertediagram) har vist, at du har en unormal elektrisk aktivitet i hjertet, som kaldes ”forlænget QT-interval”.
English: In contrast with single-dose data, pre-dose concentration (Cmin) after repeated daily dosing appeared to increase in a greater than dose-proportional manner.
Danish: I modsætning til enkeltdosisdata syntes prædosiskoncentrationen (Cmin) efter gentagen daglig dosering at stige på en måde, der var større end dosisproportional.
English: It is important that Zykadia is taken with food to reach the appropriate exposure.
Danish: Det er vigtigt, at Zykadia tages sammen med mad for at opnå en passende optagelse.
English: The PFS benefit was further supported by local investigator assessment, and analysis of overall response rate (ORR) and disease control rate (DCR).
Danish: PFS-fordelen blev yderligere understøttet af lokal investigatorvurdering samt samlet responsrate (ORR)- og sygdomskontrolrate (DCR)-analyse.
English: Single arm studies X2101 and A2201
Danish: Enkeltarmsstudierne X2101 og A2201
English: If adequate glucose control cannot be achieved with optimal medical management, permanently discontinue Zykadia.
Danish: Hvis tilstrækkelig glucosekontrol ikke kan opnås med optimal medicinsk behandling, skal Zykadia seponeres permanent.
English: The majority of cases were manageable with dose interruption and/or dose reduction.
Danish: Størstedelen af tilfældene kunne håndteres med dosisafbrydelse og/eller dosisreduktion.
English: 75% or more of patients in the ceritinib and chemotherapy arms completed the LCSS questionnaires at most of the time points during the course of the study.
Danish: 75 % eller flere af patienterne i ceritinib- og kemoterapi-armene færdiggjorde LCSS-spørgeskemaerne på de fleste tidspunkter i løbet af studiet.
English: Dose optimisation Study A2112 (ASCEND-8)
Danish: Dosisoptimeringsstudie A2112 (ASCEND-8)