natgillin/translations-raw huggingface dataset:
Den fuldstændige EPAR for Zejula findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
The full EPAR for Zejula can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
De patienter, der blev behandlet med Zejula, levede gennemsnitligt i 11,3 måneder uden forværring af sygdommen, sammenholdt med 4,7 måneder for de patienter, der fik placebo (ikke-aktivt stof).
Patients treated with Zejula lived on average 11.3 months without their disease getting worse compared with 4.7 months in patients treated with placebo (a dummy treatment).
Hvis du ønsker yderligere oplysninger om behandling med Zejula, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
For more information about treatment with Zejula, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Selvom der findes lægemidler mod fremskreden æggestokkræft, der vender tilbage, kan det ikke undgås, at sygdommen kommer tilbage igen.
Although treatments for advanced, relapsed ovarian cancer are available, the disease inevitably comes back again.
Sammendraget af udtalelsen fra Udvalget for Lægemidler til Sjældne Sygdomme om Zejula findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
The summary of the opinion of the Committee for Orphan Medicinal Products for Zejula can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/Rare disease designation.
Det er påvist, at Zejula forlænger den tid, der går, inden sygdommen bliver værre igen, hos patienter, der har reageret på platinbaserede behandlinger.
Zejula has been shown to prolong the time before the disease gets worse again in patients who have responded to platinum-based therapies.
Zejula er et lægemiddel mod kræft, der anvendes hos voksne kvinder med en type fremskreden kræft i æggestokkene, der kaldes høj-grads serøs epitelial æggestokkræft, herunder kræft i æggelederne og bughinden (den hinde, der beklæder bugvæggens inderside).
Zejula is a cancer medicine used in adult women with a type of advanced cancer of the ovary called ‘high grade serous epithelial ovarian cancer', including cancer of the fallopian tubes (the tubes connecting the ovaries to the uterus) and cancer of the peritoneum (the membrane lining the abdomen).
Patienterne i undersøgelsen havde høj-grads serøs epitelial æggestokkræft, herunder kræft i æggelederne og bughinden.
Patients in the study had high grade serous epithelial ovarian cancer, including fallopian tube or peritoneal cancers.
Hvis du ønsker praktisk vejledning om anvendelsen af Zejula, kan du læse indlægssedlen eller kontakte din læge eller dit apotek.
For practical information about using Zejula, patients should read the package leaflet or contact their doctor or pharmacist.
Den fuldstændige liste over indberettede bivirkninger ved Zejula fremgår af indlægssedlen.
For the full list of all side effects reported with Zejula, see the package leaflet.
Zejula anvendes alene til vedligeholdelsesbehandling af patienter, hvis sygdom er vendt tilbage efter tidligere behandling.
Zejula is used on its own for the ‘maintenance' treatment of patients who have relapsed disease (when the cancer comes back after previous treatment).
Hvordan virker Zejula?
How does Zejula work?
Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Zejula.
Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Zejula have been included in the summary of product characteristics and the package leaflet.
Hvilke fordele viser undersøgelserne, at der er ved Zejula?
What benefits of Zejula have been shown in studies?
Hvordan anvendes Zejula?
How is Zejula used?
Det er i en hovedundersøgelse med 553 patienter påvist, at Zejula øger den tid, patienterne lever uden forværring af sygdommen.
Zejula has been shown to increase the time patients lived without their disease getting worse in one main study involving 553 patients.
Alvorlige bivirkninger omfatter lavt antal blodplader og lavt antal røde blodlegemer.
Serious side effects include thrombocytopenia and anaemia.
Individdet ikke erkendt død [n (%)] Individdet erkendt død [n (%)] OS (uger)
Summary of overall survival Subject not known to have died [n (%)] Subject observed to have died [n (%)] OS (weeks)
Hvis du skal behandles for:
If you are being treated for:
Du kan måske få brug for lægehjælp.
You may require medical attention.
NA (NA til NA)
NA (NA, NA)
Median DR og OS er endnu ikke nået.
The median DR and OS had not yet been reached.
Dato for første tilladelse: 19. juli 2006 Dato for sidste forlængelse: 9. november 2016
Date of first authorisation: 19 July 2006 Date of latest renewal: 9 November 2016
Ingen af personerne opnåede fuldstændigt respons eller delvist respons.
None of the subjects achieved complete response or partial response.
Langtidssikkerhed ved mRCC
Long-term safety in MRCC
Hyppighed ikke kendt (kan ikke estimeres fra forhåndenværende data):
Not known (frequency cannot be estimated from available data):
• Besvær med at falde i søvn.
• Difficulty in falling asleep.
Median er ikke opnået endnu, da data endnu ikke er fuldstændige.
e Median not achieved because the data were not yet mature.
Fra en 2-sidet log-rank test.
From a 2-sided log-rank test.
De fleste fund var reversible efter 2-6 uger uden behandling.
Most of these findings were reversible after 2 to 6 weeks without treatment.
Det primære effektendepunkt i dette studie var ORR.
The primary efficacy endpoint of this study was ORR.
Patienten bør tage den sædvanlige, ordinerede dosis den følgende dag.
The patient should take the usual prescribed dose on the following day.
Brug af somatostain-analoger var tilladt i studiet.
Use of somatostatin analogues was allowed in the study.
Nedsat appetit
Decreased appetitei
Der ses ingen signifikant forskel i sikkerhed eller virkning mellem yngre og ældre patienter.
No significant differences in safety or efficacy were observed between younger and older patients.
Patienterne blev behandlet indtil sygdomsprogression, eller til de udgik af studiet.
Patients were treated until disease progression or withdrawal from the study.
Tag ikke Sutent:
Do not take Sutent:
Sepsis og septisk shock
Sepsis and sepsis shock.
Andre bivirkninger ved Sutent kan være:
Other side effects with Sutent may include:
Hvis diagnosen SJS eller TEN er bliver bekræftet, må behandlingen ikke reinitieres.
If the diagnosis of SJS or TEN is confirmed, treatment must not be restarted.
Sikkerhed og tolerabilitet
Safety and tolerability
Sutent kan tages med eller uden mad.
Sutent can be taken with or without food.
Brug af Sutent sammen med mad og drikke
Sutent with food and drink
Fishers Exact test
Fisher's Exact test
• Smerter i arme og ben.
• Pain in arms and legs.
Invasiv tandbehandling er også en kendt risikofaktor.
Invasive dental procedures are also an identified risk factor.
Sekundære endepunkter omfattede TTP, varighed af respons (DR) og OS.
Secondary endpoints included TTP, duration of response (DR) and OS.
Den aktive hovedmetabolit udgør 23-37% af den totale eksponering.
The primary active metabolite comprises 23% to 37% of the total exposure.
• Nedsat blodsukkerniveau (se afsnit 2).
• Decreased blood sugar level (see section 2)..
Sutent anbefales ikke til børn under 18 år.
Sutent is not recommended for people aged under 18.
*Herunder dødelige tilfælde
* Including fatal events.
Den daglige dosis må hverken overskride 75 mg eller være lavere end 25 mg.
Daily dose should not exceed 75 mg nor be decreased below 25 mg.
- Hvis du har diabetes (sukkersyge).
- If you have diabetes.
Du skal straks kontakte din læge, hvis du får nogle af disse alvorlige bivirkninger (se også Det skal du vide før du begynder at tage Sutent):
You must immediately contact your doctor if you experience any of those serious side effects (see also What you need to know before you take Sutent):
Total oral clearance (CL/F) er 34-62 l/time.
Total oral clearance (CL/F) was 34-62 L/h.
Ingen patienter havde et QTc-interval >500 msek.
No patients had a QTc interval > 500 msec.
Der blev observeret stabil sygdom hos 6 patienter (17 %).
Stable disease was observed in 6 patients (17%).
Hvis en dosis glemmes, bør patienten ikke tage en supplerende dosis.
If a dose is missed, the patient should not be given an additional dose.
• Ekstrem træthed, manglende kræfter.
• Extreme tiredness, loss of strength.
• Unormal nedsat/øget følsomhed, især ved berøring.
• Abnormally decreased/increased sensitivity, particularly to touch.
- Hvis du skal opereres eller er blevet det for nylig.
- If you are going to have surgery or if you had an operation recently.
Sutent bruges til behandling af kræft ved at forebygge aktiviteten af en særlig gruppe af proteiner, som er kendt for at være involveret i væksten og spredningen af kræftcellerne.
It is used to treat cancer by preventing the activity of a special group of proteins which are known to be involved in the growth and spread of cancer cells.
Sutent bruges til behandling af voksne med følgende typer af kræft:
Sutent is used to treat adults with the following types of cancer:
Der var ingen grad 5 bivirkninger i nogen af grupperne.
There were no Grade 5 adverse reactions in either group.
Hyppighederne er defineret som: 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), ikke kendt (kan ikke estimeres fra forhåndenværende data).
Frequencies are defined as: 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), not known (cannot be estimated from the available data).
Disse fald i LVEF synes ikke at have været progressive og forbedredes ofte ved fortsat behandling.
These LVEF declines do not appear to have been progressive and often improved as treatment continued.
Sutent påvirker i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
Sutent has minor influence on the ability to drive and use machines.
• Unormalt farvet urin.
• Abnormally coloured urine.
I både det kliniske studie og i publikationerne var sikkerhedsprofilen i overensstemmelse med den kendte sikkerhedsprofil hos voksne.
In both the clinical study and the publications, the safety profile was consistent with the known safety profile in adults.
Vægt, performancestatus
Weight, performance status
Hos 4 ud af disse 7 GIST-patienter blev behandlingen seponeret efter første observation af DVT.
Four of these 7 GIST patients discontinued treatment following first observation of DVT.
Sutent indeholder
What Sutent contains
Nogle af disse epistaxistilfælde var alvorlige, men meget sjældent letale.
Some of the epistaxis events were severe, but very rarely fatal.
Ca. en tredjedel af patienterne i de kliniske studier som fik sunitinib, var 65 år eller derover.
Approximately one-third of the patients in clinical studies who received sunitinib were 65 years of age or over.
Hvis du har glemt at tage Sutent
If you forget to take Sutent
- Hvis du har for højt blodtryk.
- If you have high blood pressure.
• Brug ikke lægemidlet, hvis du opdager at pakningen er ødelagt eller viser tegn på forfalskning.
- Do not use this medicine if you notice that the pack is damaged or shows signs of tampering.
- Hvis du har hjerteproblemer.
- If you have heart problems.
Der bør derfor udvises forsigtighed, når Sutent og intravenøse bisfosfonater administreres samtidig eller sekventielt.
Caution should therefore be exercised when Sutent and intravenous bisphosphonates are used either simultaneously or sequentially.
Fødeindtagelse har ingen effekt på biotilgængeligheden af sunitinib.
Food has no effect on the bioavailability of sunitinib.
Hvis du er allergisk over for sunitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6).
- If you are allergic to sunitinib or any of the other ingredients of Sutent (listed in section 6).
Sunitinib (0,3, 1,0, 3,0 mg/kg/dag) blev evalueret i et præ- og postnataludviklingsstudier i drægtige rotter.
Sunitinib (0.3, 1.0, 3.0 mg/kg/day) was evaluated in a pre-and postnatal development study in pregnant rats.
Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italien
Via del Commercio - Zona Industriale 63100 Marino del Tronto (Ascoli Piceno) Italy
Efterfølgende dosisjusteringer baseres på individuel sikkerhed og tolerabilitet (se pkt.
Subsequent dose adjustments should be based on individual safety and tolerability (see section 5.2).
Patienter bør undersøges for hypertension og kontrolleres efter behov.
Patients should be screened for hypertension and controlled as appropriate.
Studiets primære effektendepunkt var TTP, defineret som tiden fra randomisering til første dokumenterede objektive tumorprogression.
The primary efficacy endpoint of the study was TTP, defined as the time from randomisation to first documentation of objective tumour progression.
Populationsfarmakokinetiske analyser af demografiske data tyder på, at dosisjustering ikke er nødvendig med hensyn til vægt eller Eastern Cooperative Oncology Group (ECOG) score.
Population PK analyses of demographic data indicate that no starting dose adjustments are necessary for weight or Eastern Cooperative Oncology Group (ECOG) performance status.
Det tilsyneladende distributionsvolumen (Vd) er stort for sunitinib - 2230 l - som tyder på distribution ind i vævene.
The apparent volume of distribution (Vd) for sunitinib was large, 2230 L, indicating distribution into the tissues.
Sutent kan få blodtrykket til at stige.
Sutent can raise blood pressure.
Demografiske data var sammenlignelige mellem sunitinib- og placebogrupperne.
Demographics were comparable between the sunitinib and placebo groups.
Ikke alle pakningsstørrelser eller pakningstyper er nødvendigvis markedsført.
Not all pack sizes may be marketed.
Der er rapporteret om tilfælde af proteinuri og sjældne tilfælde af nefrotisk syndrom.
Cases of proteinuria and rare cases of nephrotic syndrome have been reported.
Interim PFS (progressions-fri overlevelse)-tallene er blevet opdateret baseret på rekalkulering af de originale data.
c The interim PFS numbers have been updated based on a recalculation of the original data.
Sunitinibs genotoksiske potentiale er vurderet in vitro og in vivo.
The genotoxic potential of sunitinib was assessed in vitro and in vivo.
Mindre metabolitter er identificeret i urin og fæces, men er sædvanligvis ikke genfundet i plasma.
Minor metabolites were identified in urine and faeces, but generally were not found in plasma.
Den maksimale dosis, som blev givet i et fase 3 pNET-studie, var 50 mg dagligt.
The maximum dose administered in the Phase 3 pNET study was 50 mg daily.
• Væskeophobning, også omkring lungerne
• Fluid retention including around the lungs.
Rutinemæssig vurdering af denne blødningsbivirkning bør omfatte fuldstændig blodtælling og objektiv undersøgelse.
Routine assessment of bleeding events should include complete blood counts and physical examination.
Kontakt lægen før du tager Sutent:
Talk to your doctor before taking Sutent:
Figur 1 - Kaplan-Meier plot af PFS i pNET fase 3-Studiet
Kaplan-Meier plot of PFS in the pNET Phase 3 study
Sunitinib-behandling var associeret med længere overlevelse sammenlignet med IFN-α-behandling.
Sunitinib treatment was associated with longer survival compared to IFN-α.
En følsomhedsanalyse af PFS blev udført, hvor progression var baseret på investigator-rapporterede tumormålinger, og hvor alle individer, censureret efter årsager andre end afslutning af studiet, blev opgjort som PFS-hændelser.
A sensitivity analysis of PFS was conducted where progression was based upon investigator-reported tumour measurements and where all subjects censored for reasons other than study termination were treated as PFS events.
Tabel 4 - pNET effektresultater fra fase 3-studiet Effektparameter
Table 4 - pNET efficacy results from the Phase 3 study Efficacy parameter
Der er ingen specifik antidot for overdosering med Sutent, og behandling af overdosis er generelt understøttende.
There is no specific antidote for overdose with Sutent and treatment of overdose should consist of general supportive measures.
Samlet havde 7% af mRCC-populationen enten kliniske eller laboratoriemæssige tegn på behandlingsinduceret hypotyreose.
Overall, 7% of the MRCC population had either clinical or laboratory evidence of treatment-emergent hypothyroidism.
Før behandling med Sutent bør tandstatus vurderes og passende forebyggende tandbehandling bør overvejes.
Prior to treatment with Sutent, a dental examination and appropriate preventive dentistry should be considered.
- Du vil muligvis blive anbefalet at få foretaget et tandeftersyn, før du begynder behandlingen med Sutent:
- You may be advised to have a dental check-up before you start treatment with Sutent.
Under behandling med sunitinib skal der udføres rutinemæssig monitorering af thyroideafunktionen hver 3. måned.
During sunitinib treatment, routine monitoring of thyroid function should be performed every 3 months.
Analysen af primære og sekundære endepunkter i studiets åben-label fase bekræftede resultaterne fra interimanalysen, som vist i tabel 2:
The analyses of primary and secondary endpoints in the open-label phase of the study reaffirmed the results obtained at the time of the interim analysis, as shown in Table 2:
Alle studiedeltagere oplevede bivirkninger; de fleste bivirkninger var alvorlige (toksicitetsgrad ≥3) og inkluderede kardiel toksicitet.
All study participants experienced adverse drug reactions; most of these were severe (toxicity grade ≥ 3) and included cardiac toxicity.
Thyroideafunktionen blev monitoreret prospektivt i 2 studier hos patienter med brystkræft; Sutent er ikke godkendt til behandling af brystkræft.
Thyroid function was monitored prospectively in 2 studies in patients with breast cancer; Sutent is not approved for use in breast cancer.
Der var 9 dødsfald i sunitinib-grupppen og 21 dødsfald i placebo-gruppen.
There were 9 deaths in the sunitinib arm and 21 deaths in the placebo arm.
Det er uvist om patienter med disse underliggende tilstande har en større risiko for at udvikle sunitinib-relateret venstre ventrikel-dysfunktion.
It is unknown whether patients with these concomitant conditions may be at a higher risk of developing sunitinib-related left ventricular dysfunction.
Hjerteproblemer.
Heart problems.
IT-63100 Marino del Tronto (Ascoli Piceno) Italien
IT-63100 Marino del Tronto (Ascoli Piceno) Italy
Hvis Sutent anvendes under graviditet, eller patienten bliver gravid under behandling med Sutent, skal patienten underrettes om den potentielle risiko for fostret.
If Sutent is used during pregnancy or if the patient becomes pregnant while on treatment with Sutent, the patient should be apprised of the potential hazard to the foetus.
Baseline blev nulstillet ved cross-over, og effektanalyser blev baseret på investigators vurdering.
Baseline was reset at cross-over and efficacy analyses were based on investigators assessment.
Lægen vil fastsætte, hvilken dosis du skal have afhængig af den type kræft, du skal behandles for.
Your doctor will prescribe a dose that is right for you, depending on the type of cancer to be treated.
Resultaterne af dobbelblind behandling er fra ITT-populationen ved brug af radiologiske målinger, efter behov.
a Results of double-blind treatment are from the ITT population and using central radiologist measurement, as appropriate.
Individdet progredierede eller døde ikke [n (%)] Individdet progredierede eller døde [n (%)] PFS (uger)
Subject did not progress or die [n (%)] Subject observed to have progressed or died [n (%)]
Behandlingen med Sutent bør initieres af en læge med erfaring i administration af lægemidler mod cancer.
Therapy with Sutent should be initiated by a physician experienced in the administration of anticancer agents.
Visse typer medicin kan påvirke mængden af Sutent i kroppen.
Some medicines can affect the levels of Sutent in your body.
Disse data tyder på, at sunitinib øger risikoen for kardiomyopati.
These data suggest that sunitinib increases the risk of cardiomyopathy.
Hvis indiceret, kan elimination af ikke absorberet aktivt stof ske ved opkastning eller maveskylning.
If indicated, elimination of unabsorbed active substance may be achieved by emesis or gastric lavage.
Forlængelse af QT-intervallet kan føre til en øget risiko for ventrikulær arytmi herunder Torsade de pointes.
QT interval prolongation may lead to an increased risk of ventricular arrhythmias including Torsade de pointes.
Midlertidig afbrydelse af behandlingen anbefales hos patienter med svær hypertension, som ikke er kontrolleret med medicinsk behandling.
Temporary suspension is recommended in patients with severe hypertension that is not controlled with medical management.
En patient med GIST blev inkluderet med et doseringsniveau på 15 mg/m2 uden tegn på fordel.
One patient with GIST was enrolled at the 15 mg/m dose level with no evidence of benefit.
Det anbefales at udføre urinanalyse ved baseline og kontrollere patienter for udvikling eller forværring af proteinuri.
Baseline urinalysis is recommended, and patients should be monitored for the development or worsening of proteinuria.
Polyploid (numeriske kromosomafvigelser) ses i humane perifere blod-lymfocytter in vitro, både ved tilstedeværelse og fravær af metabolisk aktivering.
Polyploidy (numerical chromosome aberrations) was observed in human peripheral blood lymphocytes in vitro, both in the presence and absence of metabolic activation.
Tilgængelige data tyder på, at kvinder måske har 30% lavere tilsyneladende sunitinibclearance (CL/F) end mænd; denne forskel kræver imidlertid ingen dosisjustering.
Available data indicate that females could have about 30% lower apparent clearance (CL/F) of sunitinib than males: this difference, however, does not necessitate starting dose adjustments.
Sutent indeholder det aktive stof sunitinib, som er en proteinkinasehæmmer.
Sutent contains the active substance sunitinib, which is a protein kinase inhibitor.
En hazard ratio til fordel for sunitinib blev set i alle undergrupper af evaluerede baselinekarakteristika, inklusive en analyse af antallet af forudgående systemiske behandlinger.
A hazard ratio favouring sunitinib was observed in all subgroups of baseline characteristics evaluated, including an analysis by number of prior systemic therapies.
Effektresultater for de 99 patienter, som krydsede over fra placebo til Sutent efter afblinding.
b Efficacy results for the 99 subjects who crossed over from placebo to Sutent after unblinding.
- Hvis du skal have foretaget tandudtrækninger eller kirurgisk tandbehandling, skal du fortælle tandlægen, at du bliver behandlet med Sutent, især hvis du også bliver eller er blevet behandlet med indsprøjtninger med bisfosfonater.
- If you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Sutent in particular when you are also receiving or have received intravenous bisphosphonates.
• Infektioner.
• Infections.
• Højt blodtryk.
• High blood pressure.
Normalt bliver behandlingen med Sutent stoppet, hvis du skal opereres.
You will usually be taken off Sutent if you are having an operation.
Brug af VEGF-hæmmere hos patienter med eller uden hypertension kan fremme dannelsen af aneurismer og/eller arterielle dissektioner.
The use of vascular endothelial growth factor (VEGF) pathway inhibitors in patients with or without hypertension may promote the formation of aneurysms and/or artery dissections.
Resultater for ORR (objektive responsrate) er angivet som procent patienter med bekræftet respons med 95% CI.
Results for ORR are given as percent of subjects with confirmed response with the 95% CI.
Alle thyroidea-relaterede hændelser var grad 1-2 (se pkt.
All thyroid-related events reported were Grade 1-2 (see section 4.4).
Der er ikke rapporteret letale tilfælde i GIST-, mRCC og pNET-registreringsstudier.
No cases with fatal outcome were reported in GIST, MRCC, and pNET registrational studies.