FrancophonIA/ELRC3.0 huggingface dataset:
English: Results are presented in Table 11.
Danish: Resultaterne er præsenteret i tabel 11.
English: The addition of erlotinib to bevacizumab did not result in an improvement in OS (HR = 1.764; p=0.1789), duration of objective response (6.7 vs 9.1 months) or time to symptom progression (HR = 1.172; p=0.5076).
Danish: Tillæg af erlotinib til bevacizumab resulterede ikke i forbedring af den samlede overlevelse (HR = 1,764; p = 0,1789), varighed af objektiv respons (6,7 vs. 9,1 måneder) eller tid til progression af symptomer (HR = 1,172; p = 0,5076).
English: ● Zirabev can also increase the risk of developing blood clots in your veins (a type of blood vessel).
Danish: ● Zirabev kan også øge risikoen for at udvikle blodpropper i venerne (en type blodkar).
English: While the incidence of CHF was, in both arms, above that previously observed for doxorubicin therapy, the rate was higher in the R-CHOP plus bevacizumab arm.
Danish: Hyppigheden af CHF var højere end det, som tidligere er observeret for doxorubicinbehandling, i begge arme, og hyppigheden var højst i R-CHOP plus bevacizumabarmen.
English: Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baseline level), both with and without proteinuria, are associated with the use of bevacizumab.
Danish: Kliniske studier har vist, at bevacizumabbehandlingen er forbundet med midlertidige stigninger i serumkreatinin (i intervallet 1,5-1,9 gange baseline-niveau), både med og uden proteinuri.
English: Exfoliative dermatitis, Dry skin, Skin discoloration
Danish: Eksfoliativ dermatitis, Tør hud, Misfarvet hud
English: Necrotising fasciitis, including fatal cases, has rarely been reported in patients treated with bevacizumab.
Danish: Der er i sjældne tilfælde rapporteret nekrotiserende fasciitis, inklusive dødelige tilfælde, hos patienter behandlet med bevacizumab.
English: ● Zirabev may increase the risk of developing serious infections of the skin or deeper layers under the skin, especially if you had holes in the gut wall or problems with wound healing.
Danish: ● Zirabev kan øge risikoen for udvikling af alvorlige infektioner i huden eller i de dybereliggende lag under huden, især hvis du har haft hul i tarmen eller problemer med sårheling.
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Zirabev.
Danish: Tandundersøgelse og passende forebyggende tandbehandling bør overvejes før behandling med Zirabev.
English: The results for all secondary endpoints (investigator assessed EFS, and ORR and OS) were consistent in showing no improvement associated with the addition of bevacizumab to the RT/T arm compared with the RT/T arm alone.
Danish: Resultater for alle sekundære endepunkter (investigator-vurderet hændelsesfri overlevelse, objektiv responsrate og samlet overlevelse) var konsistente og viste ingen forbedring ved tilføjelse af bevacizumab til RT/Tbehandlingsarmen sammenlignet med RT/T-behandlingsarmen alene.
English: The risk of bevacizumab-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Danish: Risikoen for bevacizumabassocieret hypertension korrelerede ikke med patienternes baselinekarakteristika, med den underliggende sygdom eller med anden samtidig behandling.
English: Thromboembolism (arterial)
Danish: Thromboemboli (arteriel)
English: The efficacy and safety of bevacizumab in combination with chemotherapy (paclitaxel and cisplatin or paclitaxel and topotecan) in the treatment for patients with persistent, recurrent or metastatic carcinoma of the cervix was evaluated in study GOG-0240, a randomised, four-arm, open label, multi- centre phase III trial.
Danish: Effekten og sikkerheden af bevacizumab i kombination med kemoterapi (paclitaxel og cisplatin eller paclitaxel og topotecan) i behandlingen af patienter med persisterende, recidiverende eller metastatisk cervixkarcinom blev evalueret i studiet GOG-0240, et randomiseret, 4-armet, ublindet fase III multicenterstudie.
English: 55% bevacizumab/IFN) received a variety of non-specified post-trial anti-cancer therapies, including antineoplastic agents, which may have impacted the analysis of overall survival.
Danish: 63 % IFN/placebo; 55 % bevacizumab/IFN) fik forskellige ikke-specificerede cancerbehandlinger efter studiets ophør, inklusive antineoplastiske lægemidler, som kan have haft indvirkning på analysen af den samlede overlevelse.
English: Table 15 Overall survival results from study GOG-0240 by trial treatment
Danish: Tabel 15 Resultater for samlet overlevelse fra studie GOG-0240 for forsøgsbehandling
English: 7.5 mg/kg intravenous 30-90 min
Danish: 7,5 mg/kg intravenøs 30-90 min
English: ● It is possible that Zirabev can increase the risk of bleeding in your lungs, including coughing or spitting blood.
Danish: ● Det er muligt, at Zirabev kan øge risikoen for blødning i lungerne, herunder blodig hoste eller spyt.
English: a 5.0 mg/kg every 2 weeks or 7.5 mg/kg every 3 weeks
Danish: 5,0 mg/kg hver 2.uge eller 7,5 mg/kg hver 3.uge
English: There was a small difference, of borderline significance, between the time to progression of disease in the 3 mg/kg group and that in the placebo group (hazard ratio, 1.26; p=0.053).
Danish: Der var en lille forskel, med ubetydelig signifikans mellem tid til progression af sygdom for 3 mg/kg gruppen i forhold til placebogruppen (hazard ratio, 1,26; p= 0,053).
English: Severe reactions are defined as adverse reactions with at least a 2% difference compared to the control arm in clinical studies for NCI-CTCAE Grade 3-5 reactions.
Danish: Alvorlige bivirkninger defineres som bivirkninger med mindst 2 % forskel i forhold til kontrolarmen i kliniske studier for NCI-CTCAE grad 3-5 bivirkninger.
English: a Interferon alfa-2a 9 MIU 3x/week b Bevacizumab 10 mg/kg q 2 wk
Danish: Interferon alfa-2a 9 MIE 3x/ugentlig Bevacizumab 10 mg/kg hver 2. uge
English: a 5 mg/kg every 2 weeks.
Danish: 5 mg/kg hver 2. uge.
English: Pain in the mouth, teeth and/or jaw, swelling or sores inside the mouth, numbness or a feeling of heaviness in the jaw, or loosening of a tooth.
Danish: Smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, følelsesløshed eller en følelse af tyngde i kæben eller en tand, der løsner sig.
English: This is consistent with results in patients in other studies of metastatic breast cancer who did not receive concurrent anthracycline treatment (NCI-CTCAE v.3) (see section 4.8).
Danish: Dette er i overensstemmelse med resultater i andre studier af metastatisk brystkræft hos patienter, som ikke fik samtidig behandling med antracykliner (NCICTCAE v. 3) (se pkt.
English: The secondary endpoint of Overall Survival (OS) was not mature.
Danish: Data for det sekundære endepunkt, den samlede overlevelse, var ikke modne.
English: Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with bevacizumab treatment.
Danish: Nedsat neutrofiltal, nedsat leukocyttal og tilstedeværelse af proteiner i urinen kan være relateret til behandling med bevacizumab.
English: Fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy
Danish: Fluoropyrimidin/irinotecan eller fluoropyrimidin/oxaliplatin baseret kemoterapi
English: The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in breast carcinoma, adenocarcinoma of the colon and rectum, lung carcinoma (small cell and non-small cell carcinoma), kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney), ovarian carcinoma (excluding rhabdomyosarcoma and germ cell tumours), fallopian tube carcinoma (excluding rhabdomyosarcoma and germ cell tumours), peritoneal carcinoma (excluding blastomas and sarcomas) and cervix and corpus uteri carcinoma.
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med bevacizumab hos alle undergrupper af den pædiatriske population ved brystkarcinom, adenokarcinom i colon og rectum, lungekarcinom (småcellet og ikke-småcellet karcinom), nyre- og nyrebækkenkarcinom (eksklusive nefroblastom, nefroblastomatose, clear-cell-sarkom, mesoblastisk nefrom, nyremarvskarcinom og rabdoid tumor i nyren), ovariekarcinom (eksklusive rabdomyosarkom og stamcelletumorer), tubakarcinom (eksklusive rabdomyosarkom og stamcelletumorer), peritonealkarcinom (eksklusive blastomer og sarkomer) samt karcinom i cervix og corpus uteri.
English: Objective response rate (%) in Patients with measurable disease N Response rate
Danish: Objektiv responsrate (%) for patienter med målelig sygdom
English: Until mature OS results and safety data are available no definitive conclusion can be drawn on the benefit/risk balance.
Danish: Der kan ikke drages nogen definitiv konklusion vedrørende benefit/risk-forholdet, førend modne resultater for den samlede overlevelse samt sikkerhedsdata er tilgængelige.
English: Pre-existing hypertension should be adequately controlled before starting Zirabev treatment.
Danish: Allerede eksisterende hypertension skal være tilstrækkelig kontrolleret, inden behandling med Zirabev påbegyndes.
English: ● It is possible that Zirabev may increase the risk of developing holes in the gut wall.
Danish: ● Det er muligt, at Zirabev kan øge risikoen for, at der dannes huller i tarmvæggen.
English: • AVF2192g: In combination with bolus 5-FU/FA for a total of 6 weeks of each 8 week-cycle (Roswell Park regimen) in patients who were not optimal candidates for first-line irinotecan treatment.
Danish: AVF2192g: I kombination med en bolus af 5-FU/FA i 6 uger i hver 8 ugers cyklus (Roswell Park-regimet) hos patienter, som ikke var optimale kandidater til 1.linjebehandling med irinotecan.
English: Examples include palmar-plantar erythrodysaesthesia syndrome with pegylated liposomal doxorubicin or capecitabine, peripheral sensory neuropathy with paclitaxel or oxaliplatin, nail disorders or alopecia with paclitaxel, and paronychia with erlotinib.
Danish: Eksempler inkluderer palmoplantar erytrodysæstesisyndrom med pegyleret liposomal doxorubicin eller capecitabin, perifer sensorisk neuropati med paclitaxel eller oxaliplatin, negleproblemer og alopeci med paclitaxel og paronykie med erlotinib.
English: 5 mg/kg intravenous 30-90 min
Danish: 5 mg/kg intravenøs 30-90 min
English: d Recto-vaginal fistulae are the most common fistulae in the GI-vaginal fistula category.
Danish: Rektovaginale fistler er de hyppigste fistler i kategorien gastrointestinale-vaginale fistler.
English: Zirabev has been developed and made to treat cancer by injecting it into the bloodstream.
Danish: Zirabev er blevet udviklet og fremstillet til behandling af kræft ved injektion i blodbanen.
English: A doctor or nurse will give you this diluted Zirabev solution by intravenous infusion (a drip into your vein).
Danish: Du vil få den fortyndede opløsning med Zirabev af en læge eller sygeplejerske ved intravenøs infusion (et drop i din vene).
English: For further information please refer to Table 3 ‘Adverse reactions reported in post-marketing setting.'
Danish: For yderligere information henvises til Tabel 3 'Bivirkninger rapporteret efter markedsføring'.
English: However, patients who developed venous thrombosis while receiving therapy did not appear to have an increased rate of Grade 3 or above bleeding when treated with a full dose of warfarin and bevacizumab concomitantly (NCI-CTCAE v.3).
Danish: Patienter, der udviklede venøs trombose under behandlingen, så dog ikke ud til at have en øget risiko for udvikling af blødning af grad 3 eller derover (NCI-CTCAE v. 3), når de blev behandlet med en fuld warfarin-dosis og bevacizumab samtidigt.
English: In study JO25567, all grade hypertension was observed in 77.3% of the patients who received bevacizumab in combination with erlotinib as first-line treatment for non-squamous NSCLC with EGFR activating mutations, compared to 14.3% of patients treated with erlotinib alone.
Danish: I studie JO25567 blev hypertension af alle grader observeret hos 77,3 % af patienterne, som fik bevacizumab i kombination med erlotinib, som 1.-linje behandling af ikke-planocellulær NSCLC med EGFR-aktiverende mutationer, sammenlignet med 14,3 % af patienterne, som blev behandlet med erlotinib alene.
English: Bevacizumab has not been shown to reduce your ability to drive or to use any tools or machines.
Danish: Det er ikke påvist, at bevacizumab nedsætter din evne til at køre bil eller betjene maskiner.
English: Arm 2 IFL + bevacizumaba
Danish: Arm 2 IFL + bevacizumab
English: 5-fluorouracil intravenous bolus/infusion, each on days 1 and 2
Danish: Leucovorin på dag 1 og 2 5-fluoruracil intravenøs bolus/infusion på dag 1 og 2
English: Dehydration, Hyponatraemia
Danish: Dehydrering, Hyponatriæmi
English: If too much Zirabev is given
Danish: Hvis du har fået for meget Zirabev
English: 95% CI for response rates
Danish: 95 % konfidensinterval for responsrater
English: Sucrose, succinic acid, disodium edetate, polysorbate 80, sodium hydroxide, water for injections.
Danish: Saccharose, succinat, dinatriumedetat, polysorbat 80, natriumhydroxid, vand til injektionsvæsker.
English: Non-mandibular osteonecrosis a,f
Danish: Ikke-mandibulær osteonekrose a,f
English: Sepsis, Abscess b,d
Danish: Sepsis, Absces b,d
English: % pts with objective response p-value
Danish: % af patienter med objektivt respons p-værdi
English: Efficacy results for trials AVF0780g and AVF2192g AVF0780g
Danish: Virkningsresultater i studie AVF0780g AVF219g
English: The active substance is bevacizumab.
Danish: • Aktivt stof: bevacizumab.
English: Response rates (for patients with measurable disease)
Danish: Responsrater (for patienter med målbar sygdom) Investigators vurdering
English: Peripheral s ensory neuropathy b,
Danish: Perifer sensorisk neuropati b,
English: Zirabev is for intravenous use.
Danish: Zirabev er til intravenøs anvendelse.
English: 0.80 (p=0.003) 95% CI (0.69; 0.93)
Danish: 0,80 (p = 0,003) 95 % konfidensinterval (0,69-0,93)
English: The safety and efficacy of the recommended dose (5 mg/kg of body weight every two weeks) in metastatic carcinoma of the colon or rectum were studied in three randomised, active-controlled clinical trials in combination with fluoropyrimidine-based first-line chemotherapy.
Danish: Sikkerhed og virkning af den anbefalede dosis (5 mg/kg legemsvægt hver 2. uge) hos patienter med metastatisk kolorektalkræft blev undersøgt i tre randomiserede, aktivt kontrollerede kliniske studier i kombination med fluoropyrimidinbaseret 1.-linjekemoterapi.
English: No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.
Danish: Der er ikke observeret klinisk relevante interaktioner på bevacizumabs farmakokinetik af samtidigt administreret kemoterapi, baseret på resultaterne fra populationsfarmakokinetiske analyser.
English: In four phase III trials (AVF2119g, E2100, BO17708 and AVF3694g) in patients with metastatic breast cancer CHF Grade 3 (NCI-CTCAE v.3) or higher was reported in up to 3.5% of patients treated with bevacizumab in combination with chemotherapy compared with up to 0.9% in the control arms.
Danish: I fire fase III-studier (AVF2119g, E2100, BO17708 og AVF3694g) hos patienter med metastatisk brystkræft blev der observeret CHF af grad 3 (NCI-CTCAE v. 3) eller højere hos op til 3,5 % af de patienter, som blev behandlet med bevacizumab i kombination med kemoterapi, sammenlignet med hos op til 0,9 % i kontrolarmene.
English: Clinical safety data suggest that the incidence of minor mucocutaneous haemorrhage (e.g. epistaxis) may be dose-dependent.
Danish: Kliniske sikkerhedsdata antyder, at forekomsten af mindre mukokutane blødninger (fx epistaxis) kan være dosisafhængig.
English: Patients receiving bevacizumab plus chemotherapy, with a history of arterial thromboembolism, diabetes or age greater than 65 years have an increased risk of developing arterial thromboembolic reactions during therapy.
Danish: Patienter, som behandles med bevacizumab samt kemoterapi, og som har en anamnese med arterielle tromboemboliske hændelser eller, diabetes eller er over 65 år, har en øget risiko for at udvikle arterielle tromboemboliske bivirkninger under behandlingen.
English: Gastrointestinal disorder, Stomatitis, Proctalgia
Danish: Gastrointestinal e forstyrrelser, Stomatitis, Proktalgi
English: Clinical benefit in NSCLC patients has been demonstrated with both 7.5 mg/kg and 15 mg/kg doses (see section 5.1).
Danish: Klinisk effekt hos patienter med NSCLC er vist ved dosering af både 7,5 mg/kg og 15 mg/kg (se pkt.
English: Responders (Response rate
Danish: Respondenter (responsrate
English: The frequency of GI-vaginal fistulae in the group treated with bevacizumab + chemotherapy was higher in patients with recurrence within the field of prior radiation (16.7%) compared with patients with no prior radiation and/ or no recurrence inside the field of prior radiation (3.6%).
Danish: Forekomsten af gastrointestinale-vaginale fistler hos patienter, som var behandlet med bevacizumab + kemoterapi, var højere hos patienter med recidiv indenfor strålefeltet af tidligere strålebehandling (16,7 %) sammenlignet med patienter, som ikke tidligere havde fået strålebehandling og/eller patienter med ingen recidiv indenfor strålefeltet af tidligere strålebehandling (3.6 %).
English: • In a retrospective single institution series, 12 consecutive (2005 to 2008) children with relapsed or progressive high-grade glioma (3 with WHO Grade IV, 9 with Grade III) were treated with bevacizumab (10 mg/kg) and irinotecan (125 mg/m²) every 2 weeks.
Danish: • I et retrospektivt studie på en enkelt institution blev 12 konsekutive børn (2005-2008) med recidiverende eller progredierende høj-grads-gliom (3 med WHO grad IV, 9 med grad III) behandlet med bevacizumab (10 mg/kg) og irinotecan (125 mg/m²) hver anden uge.
English: Permanently discontinue Zirabev in patients with tracheoesophageal (TE) fistula or any Grade 4 fistula [US National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE v.3)].
Danish: Behandling med Zirabev skal seponeres permanent hos patienter med trakeo-øsofageale (TE) fistler eller med andre fistler af grad 4 [US National Cancer Institute - Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 3].
English: In one clinical trial evaluating bevacizumab in combination with 5-fluorouracil/folinic acid, AVF2192g, patients with metastatic colorectal cancer who were not candidates for treatment with irinotecan were included.
Danish: I et klinisk studie AVF2192g, som undersøgte bevacizumab i kombination med 5fluoruracil/folininsyre, blev der inkluderet patienter med metastatisk kolorektalkræft, som ikke var kandidater til behandling med irinotecan.
English: Cerebrovascular accident, Syncope, Somnolence
Danish: Cerebrovaskulær hændelse, Synkope, Søvnighed
English: Secondary endpoints Progression-free survival - Primary analysis 6
Danish: Progressionsfri overlevelse - primær analyse
English: Possible risk factors include squamous cell histology, treatment with antirheumatic/anti-inflammatory substances, treatment with anticoagulants, prior radiotherapy, bevacizumab therapy, previous medical history of atherosclerosis, central tumour location and cavitation of tumours prior to or during therapy.
Danish: Mulige risikofaktorer inkluderer planocellulær histologi, behandling med antireumatiske/antiinflammatoriske lægemidler, behandling med antikoagulantia, tidligere strålebehandling, bevacizumabbehandling, aterosklerose i anamnesen, central placering af tumor og kavernedannelse i tumorer før eller under behandling.
English: Dysarthria, Headache, Dysguesia
Danish: Dysartri, Hovedpine, Dysgeusi
English: Three additional studies with bevacizumab have been conducted in mCRC patients: first-line (NO16966), second-line with no previous bevacizumab treatment (E3200), and second-line with previous bevacizumab treatment following disease progression in first-line (ML18147).
Danish: Yderligere tre studier med bevacizumab er blevet udført hos patienter med metastatisk kolorektalkræft: 1.-linje-behandling (NO16966), 2. linje-behandling uden tidligere bevacizumabbehandling (E3200) samt 2. linje-behandling efter sygdomsprogression efter i 1.linje-behandling med bevacizumab (ML18147).
English: The incidence of these reactions in some clinical trials of bevacizumab is common (up to 5% in bevacizumab- treated patients).
Danish: I nogle kliniske studier med bevacizumab er forekomsten af disse reaktioner almindelig (op til 5 % af bevacizumabbehandlede patienter).
English: You may be advised to have a dental check-up before you start treatment with Zirabev.
Danish: Du kan blive rådet til at få foretaget et tandeftersyn, før du starter i behandling med Zirabev.
English: This was a phase III randomised double-blind trial conducted to evaluate the efficacy and safety of bevacizumab in combination with interferon (IFN) alfa-2a versus IFN alfa-2a alone as first-line treatment in mRCC.
Danish: Dette var et fase III, randomiseret, dobbeltblindet studie, der blev udført for at undersøge effekt og sikkerhed ved bevacizumab i kombination med interferon (IFN) alfa-2a vs. IFN alfa-2a alene som 1.-linjebehandling af mRCC.
English: Patients were randomised to paclitaxel alone (90 mg/m2 intravenous over 1 hour once weekly for three out of four weeks) or in combination with bevacizumab (10 mg/kg intravenous infusion every two weeks).
Danish: Patienterne blev randomiseret til paclitaxel alene (90 mg/m2 indgivet intravenøst som 1-times infusion en gang ugentligt i tre ud af fire uger) eller i kombination med bevacizumab (10 mg/kg indgivet som intravenøs infusion hver 2. uge).
English: Gastrointestinal ulcer (not known)
Danish: Mave-tarm-kanalen Gastrointestinalt ulcus (ikke kendt)
English: In two subsequent studies in patients with treated brain metastases (which included around 800 patients), one case of Grade 2 CNS haemorrhage was reported in 83 subjects treated with bevacizumab (1.2%) at the time of interim safety analysis (NCI-CTCAE v.3).
Danish: I to efterfølgende studier hos patienter med behandlede hjernemetastaser (som inkluderede omkring 800 patienter) blev der ved sikkerheds-interimanalysen rapporteret om grad 2 CNS-blødning hos én patient ud af 83 patienter (1,2 %) behandlet med bevacizumab (NCI-CTCAE v. 3).
English: Zirabev 25 mg/ml sterile concentrate bevacizumab
Danish: Zirabev 25 mg/ml sterilt koncentrat bevacizumab i.v.
English: Progression-free survival Median (months)
Danish: Progressionsfri overlevelse Median (måneder)
English: • AVF2107g: A weekly schedule of irinotecan/bolus 5-fluorouracil/folinic acid (IFL) for a total of 4 weeks of each 6 week-cycle (Saltz regimen).
Danish: • AVF2107g: Et ugentligt regime med irinotecan/bolus af 5-fluoruracil/folininsyre (IFLregime) i 4 uger i hver 6 ugers cyklus (Saltz-regimet).
English: Zirabev is a concentrate for solution for infusion.
Danish: Zirabev er et koncentrat til opløsning til infusion.
English: Table 4 Efficacy results for trial AVF2107g
Danish: Tabel 4 Virkningsresultater i studie AVF2107g
English: The study did not meet its primary endpoint of demonstrating a significant improvement of EFS (Central Radiology Review Committee (CRRC)-assessed) when bevacizumab was added to the RT/T arm compared with RT/T alone (HR = 1.44; 95% CI: 0.90, 2.30).
Danish: Der blev ikke vist en signifikant forbedring af hændelsesfri overlevelse (vurderet af en central Radiology Review Committee), når bevacizumab var føjet til RT/T-behandlingsarmen, sammenlignet med RT/T-behandlingsarmen alene (Hazard Ratio = 1,44; 95 % konfidensinterval: 0,90; 2,30).