FrancophonIA/ELRC3.0 huggingface dataset:
English: MVASI is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR).
Danish: MVASI bruges også hos voksne til behandling af fremskreden ikke-småcellet lungekræft, når kræftcellerne har bestemte mutationer i et protein, der kaldes epidermal vækstfaktor-receptor (EGFR).
English: • you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Danish: • hvis du er allergisk over for celleprodukter fra kinesisk hamsterovarie (CHO) eller overfor andre rekombinante humane eller humaniserede antistoffer.
English: Overall survival - Primary analysis6 Median (months)1
Danish: Samlet overlevelse (primær analyse)6 Median (måneder)1
English: • It is possible that MVASI may increase the risk of developing holes in the gut wall.
Danish: • Det er muligt, at MVASI kan øge risikoen for, at der dannes huller i tarmvæggen.
English: PFS1 results by disease stage and debulking status from study GOG-0218
Danish: PFS1-resultater efter sygdomsstadie og tumorreduktionsstatus fra studie GOG-0218
English: The risk of bevacizumab-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Danish: Risikoen for bevacizumab-associeret hypertension korrelerede ikke med patienternes baselinekarakteristika, med den underliggende sygdom eller med anden samtidig behandling.
English: • The active substance is bevacizumab.
Danish: • Aktivt stof: bevacizumab.
English: • MVASI may cause bleeding, especially tumour-related bleeding.
Danish: • MVASI kan forårsage blødning, især tumor-relateret blødning.
English: Patients may be at increased risk for the development of fistulae when treated with bevacizumab.
Danish: Patienter kan have en øget risiko for udvikling af fistler, når de behandles med bevacizumab.
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections).
Danish: • en udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner).
English: There is no information on the safety profile of bevacizumab in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting bevacizumab treatment, as such patients were excluded from clinical trials.
Danish: Der findes ingen informationer om sikkerhedsprofilen af bevacizumab hos patienter med kongenit hæmoragisk diatese, erhvervet koagulationsdefekt eller hos patienter, som får fuld dosis af antikoagulantia for behandling af tromboemboli, før behandlingen med bevacizumab påbegyndes, da sådanne patienter ikke indgik i de kliniske studier.
English: During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of bevacizumab and 21.1% (89/422) of patients received 13 or more administrations of bevacizumab.
Danish: Af de patienter, der i løbet af studiet modtog studiebehandling, modtog 32,2 % (136/422) af patienterne 7-12 administrationer af bevacizumab, og 21,1 % (89/422) af patienterne modtog 13 eller flere administrationer af bevacizumab.
English: The pharmacokinetics of bevacizumab were evaluated in 152 children, adolescents and young adults (7 months to 21 years, 5.9 to 125 kg) across 4 clinical studies in paediatrics using a population pharmacokinetic model.
Danish: Bevacizumabs farmakokinetik blev evalueret hos 152 børn, unge og unge voksne (7 måneder til 21 år; 5,9 kg til 125 kg) på tværs af 4 kliniske studier af pædiatriske patienter ved hjælp af en populationsfarmakokinetisk model.
English: Decreased neutrophil count, decreased white blood cell count and presence of urine protein may be associated with MVASI treatment.
Danish: Nedsat neutrofiltal, nedsat leukocyttal og tilstedeværelse af proteiner i urinen kan være relateret til behandling med MVASI.
English: Increased rates of severe neutropenia, febrile neutropenia, or infection with or without severe neutropenia (including some fatalities) have been observed mainly in patients treated with platinumor taxane-based therapies in the treatment of NSCLC and mBC.
Danish: Øget hyppighed af alvorlig neutropeni, febril neutropeni eller infektion med eller uden alvorlig neutropeni (herunder nogle dødsfald) er hovedsagelig blevet observeret hos patienter behandlet med platin- eller taxanbaserede terapier i behandlingen af NSCLC og mBC.
English: A diagnosis of PRES requires confirmation by brain imaging, preferably magnetic resonance imaging (MRI).
Danish: PRES-diagnosen kræver bekræftelse ved en hjernescanning, fortrinsvist magnetisk resonans (MR)- skanning.
English: FOLFOX-4 or XELOX + placebo (n = 701)
Danish: FOLFOX-4 eller XELOX + placebo (n = 701)
English: The primary outcome measure was overall survival defined as the time from randomisation until death from any cause.
Danish: Det primære effektmål var samlet overlevelse, defineret som tiden fra randomisering indtil død, uanset årsag.
English: The trial contained two parts: an initial unblinded 2-arm part (Part I) in which patients were randomised to two different treatment groups (XELOX and FOLFOX-4) and a subsequent 2 x 2 factorial 4-arm part (Part II) in which patients were randomised to four treatment groups (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, FOLFOX-4 + bevacizumab).
Danish: Studiet bestod af to dele: en initial, ublindet 2-armet del (del 1), hvor patienterne blev randomiseret til to forskellige behandlingsarme (XELOX og FOLFOX-4), og en efterfølgende 2 x 2 faktor 4-armet del (del 2), hvor patienterne blev randomiseret til fire behandlingsarme (XELOX + placebo, FOLFOX-4 + placebo, XELOX + bevacizumab, FOLFOX-4 + bevacizumab).
English: • an abnormal tube-like connection or passage between the windpipe and the gullet, between internal organs and skin, between the vagina and any parts of the gut or between other tissues that are not normally connected (fistula), and are judged by your doctor to be severe,
Danish: • en abnorm, rørformet forbindelse eller passage mellem luftrøret og spiserøret, mellem indre organer og huden, mellem skeden og et eller andet sted på tarmen eller mellem andre væv, som ikke normalt er forbundet (fistel), og som lægen vurderer er alvorlig,
English: * Primary analysis was performed with a data cut-off date of 14 November 2011.
Danish: * Skæringsdato for den primære analyse var 14. november 2011.
English: An increased incidence of post-operative bleeding or wound healing complication occurring within 60 days of major surgery was observed if the patient was being treated with bevacizumab at the time of surgery.
Danish: Der blev observeret en forøget hyppighed af postoperativ blødning eller sårhelingskomplikationer ved større kirurgiske indgreb i op til 60 dage efter indgrebet, hvis patienten var i behandling med bevacizumab på tidspunktet for operationen.
English: The pharmacokinetics of bevacizumab was well characterised by the paediatric population PK model for 70 paediatric patients in study BO20924 (1.4 to 17.6 years; 11.6 to 77.5 kg) and 59 patients in study BO25041 (1 to 17 years; 11.2 to 82.3 kg).
Danish: Bevacizumabs farmakokinetik er vel karakteriseret med den pædiatriske populationsfarmakokinetiske model med data fra 70 pædiatriske patienter i studie BO20924 (1,4-17,6 år; 11,6-77,5 kg) og 59 patienter i studie BO25041(1-17 år; 11,2-82,3 kg).
English: • It is possible that MVASI can increase the risk of bleeding in your lungs, including coughing or spitting blood.
Danish: • Det er muligt, at MVASI kan øge risikoen for blødning i lungerne, herunder blodig hoste eller spyt.
English: In study BO20924, bevacizumab exposure was generally lower compared to a typical adult patient at the same dose.
Danish: I studie BO20924 var eksponeringen af bevacizumab generelt lavere sammenlignet med eksponeringen hos en typisk voksen patient ved samme dosis.
English: Bevacizumab in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Danish: Bevacizumab i kombination med interferon alfa-2a til 1.-linjebehandling af patienter med fremskreden og/eller metastatisk renalcellekarcinom (BO17705)
English: A doctor or nurse will give you this diluted MVASI solution by intravenous infusion (a drip into your vein).
Danish: Du vil få den fortyndede opløsning med MVASI af en læge eller sygeplejerske ved intravenøs infusion (et drop i din vene).
English: The occurrence of those events varied in type and severity, ranging from free air seen on the plain abdominal X-ray, which resolved without treatment, to intestinal perforation with abdominal abscess and fatal outcome.
Danish: Forekomsten af disse bivirkninger varierede i type og intensitet fra fri luft set på et almindeligt røntgenbillede af abdomen, og som normaliseredes uden behandling, til perforation af colon med abdominal absces og dødeligt udfald.
English: Analyses of the clinical safety data suggest that the occurrence of hypertension and proteinuria with bevacizumab therapy are likely to be dose-dependent.
Danish: Analyser af de kliniske sikkerhedsdata tyder på, at forekomst af hypertension og proteinuri efter behandling med bevacizumab sandsynligvis er dosisafhængig.
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 behandlingen med bevacizumab er forbundet med midlertidige stigninger i serum-kreatinin (i intervallet 1,5-1,9 gange baseline-niveau), både med og uden proteinuri.
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: PFS subgroup analyses depending on recurrence since last platinum therapy are summarised in table 20.
Danish: PFS undergruppeanalyser, som er afhængige af tiden til recidiv siden den sidste platinbehandling, er opsummeret i tabel 20.
English: The most frequently observed adverse reactions across clinical trials in patients receiving bevacizumab were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.
Danish: De hyppigst observerede bivirkninger i alle kliniske studier hos patienter, som fik bevacizumab, var hypertension, træthed eller asteni, diarré og abdominalsmerter.
English: Severe reactions are defined as adverse events 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: 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 progession af symptomer (HR = 1,172; p = 0,5076).
English: You may be advised to have a dental check-up before you start treatment with MVASI.
Danish: Du kan blive rådet til at få foretaget et tandeftersyn, før du starter i behandling med MVASI.
English: • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Danish: • Overfølsomhed over for det aktive stof eller et eller flere af indholdsstofferne anført i pkt.
English: • MVASI can also increase the risk of developing blood clots in your veins (a type of blood vessel).
Danish: • MVASI kan også øge risikoen for at udvikle blodpropper i venerne (en type blodkar),
English: Bevacizumab 10 mg/kg was given every 2 weeks until disease progression.
Danish: Der blev givet bevacizumab 10 mg/kg hver 2. uge indtil sygdomsprogession.
English: The median age was 60.0 years in the CP arm and 59.0 years in the CPB arm.
Danish: Medianalderen var 60 år i CP-armen og 59 år i CPB-armen.
English: In one clinical trial, the incidence of hypertension of grade ≥ 3 was two fold higher in patients aged > 65 years than in the younger age group (< 65 years).
Danish: I et klinisk studie var hypertension af grad ≥ 3 dobbelt så hyppig hos patienter ˃ 65 år som hos patienter < 65 år.
English: There were neither statistically significant nor clinically relevant differences in bevacizumab clearance in patients receiving bevacizumab monotherapy compared to patients receiving bevacizumab in combination with interferon alfa-2a, erlotinib or chemotherapies (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabine, doxorubicin or cisplatin/gemcitabine).
Danish: Der var hverken statistisk signifikante eller klinisk relevante forskelle på bevacizumabs clearance hos patienter, som fik bevacizumab monoterapi, i forhold til patienter, som fik bevacizumab i kombination med interferon alfa-2a, erlotinib eller kemoterapiregimer (IFL, 5-FU/LV, carboplatin/paclitaxel, capecitabin, doxorubicin eller cisplatin/gemcitabin).
English: Adverse reactions reported in post-marketing setting
Danish: Bivirkninger rapporteret post-marketing
English: • MVASI 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: • MVASI 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: Bevacizumab has no or negligible influence on the ability to drive and use machines.
Danish: Bevacizumab påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
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 i gruppen behandlet med 3 mg/kg i forhold til placebogruppen (hazard ratio, 1,26; p = 0,053).
English: Efficacy results for trials AVF0780g and AVF2192g
Danish: Resultater for effekt i studierne AVF0780g og AVF2192g AVF0780g
English: QUALITATIVE AND QUANTITATIVE COMPOSITION Each mL of concentrate contains 25 mg of bevacizumab*.
Danish: KVALITATIV OG KVANTITATIV SAMMENSÆTNING 1 ml koncentrat indeholder 25 mg bevacizumab*.
English: FOLFOX-4 or
Danish: FOLFOX-4 eller
English: Efficacy results1,2 from study GOG-0213
Danish: Effektresultater1,2 fra studie GOG-0213
English: Trehalose dihydrate, sodium phosphate, polysorbate 20, water for injections.
Danish: LISTE OVER HJÆLPESTOFFER Trehalosedihydrat, natriumphosphat, polysorbat 20, vand til injektionsvæsker.
English: MVASI is a concentrate for solution for infusion.
Danish: MVASI er et koncentrat til opløsning til infusion.
English: In NSABP C-08, a phase III trial of bevacizumab in adjuvant treatment of patients with colon cancer, the incidence of new cases of ovarian failure, defined as amenorrhoea lasting 3 or more months, FSH level ≥ 30 mIU/mL and a negative serum β-HCG pregnancy test, has been evaluated in 295 premenopausal women.
Danish: I NSABP C-08, et fase III-studie af bevacizumab som adjuverende behandling hos patienter med coloncancer, er hyppigheden af nye tilfælde af ovariesvigt, defineret som amenoré af 3 måneders varighed eller mere, FSH-koncentration ≥ 30 mIE/ml og en negativ serum-β-HCG-graviditetstest, blevet vurderet hos 295 præmenopausale kvinder.
English: In bevacizumab clinical trials, gastrointestinal fistulae (all grade) have been reported with an incidence of up to 2% in patients with metastatic colorectal cancer and ovarian cancer, but were also reported less commonly in patients with other types of cancer.
Danish: I kliniske studier med bevacizumab er gastrointestinale fistler (alle grader) blevet rapporteret hos op til 2 % af patienterne med metastatisk kolorektalkræft og ovariecancer, men blev også rapporteret mindre hyppigt hos patienter med andre cancertyper.
English: Gastrointestinal perforations have been reported in clinical trials with an incidence of less than 1% in patients with non-squamous non-small cell lung cancer, up to 1.3% in patients with metastatic breast cancer, up to 2.0% in patients with metastatic renal cell cancer or in patients with ovarian cancer, and up to 2.7% (including gastrointestinal fistula and abscess) in patients with metastatic colorectal cancer.
Danish: Gastrointestinal perforation er blevet rapporteret i kliniske studier med en hyppighed på mindre end 1 % hos patienter med ikke-småcellet lungekræft, op til 1,3 % hos patienter med metastatisk brystkræft, op til 2,0 % hos patienter med metastatisk renalcellekarcinom eller hos patienter med ovariecancer og op til 2,7 % (herunder gastrointestinale fistler og abscesser) hos patienter med metastatisk kolorektalkræft.
English: The overall safety profile of bevacizumab is based on data from over 5,700 patients with various malignancies, predominantly treated with bevacizumab in combination with chemotherapy in clinical trials.
Danish: Sikkerhedsprofilen for bevacizumab er baseret på data fra kliniske studier med over 5.700 patienter med forskellige maligne sygdomme, som primært blev behandlet med bevacizumab i kombination med kemoterapi.
English: In two clinical trials of metastatic renal cell carcinoma, microangiopathic haemolytic anaemia (MAHA) was reported in 7 of 19 patients treated with bevacizumab (10 mg/kg every two weeks) and sunitinib malate (50 mg daily) combination.
Danish: I to kliniske studier omhandlende metastatisk renalcellekarcinom, blev mikroangiopatisk hæmolytisk anæmi (MAHA) rapporteret hos 7 ud af 19 patienter behandlet med bevacizumab (10 mg/kg hver 2. uge) og sunitinibmaleat (50 mg daglig) i kombination.
English: 5 mg/kg IV 30-90 min Day 1, prior to FOLFOX-4, every 2 weeks
Danish: 30-90 min Dag 1 før FOLFOX-4, hver 2. uge
English: Posterior reversible encephalopath y syndromea,b,c, Hypertensive encephalopath yc
Danish: Posteriort reversibelt encefalopati syndroma,b,c Hypertensiv encefalopatic
English: Therapy should be permanently discontinued in patients who develop nephrotic syndrome (NCI-CTCAE v.3).
Danish: Behandlingen skal seponeres permanent hos patienter, som udvikler nefrotisk syndrom (NCI-CTCAE v. 3).
English: The 131 patients in the bevacizumab + IFN alfa-2a arm who reduced and maintained the IFN alfa-2a dose at 6 or 3 MIU during the trial, exhibited at 6, 12 and 18 months PFS event free rates of 73, 52 and 21% respectively, as compared to 61, 43 and 17% in the total population of patients receiving bevacizumab + IFN alfa-2a.
Danish: De 131 patienter i bevacizumab + IFN alfa-2a-armen, som reducerede og fastholdt IFN alfa-2a dosis på 6 eller 3 MIE under studiet, viste at antal hændelser i tidsrummet for progressionsfri overlevelse ved 6, 12 og 18 måneder var henholdsvis 73, 52 og 21 % i forhold til 61, 43 og 17 % i den totale population af patienter, som fik bevacizumab + IFN alfa-2a.
English: • Topotecan 4 mg/m2 as a 30-minute IV infusion on days 1, 8, and 15 every 4 weeks.
Danish: • Topotecan 4 mg/m2 som 30-minutters i.v.-infusion på dag 1, 8 og 15 hver 4. uge.
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: Stopping your treatment with MVASI may stop the effect on tumour growth.
Danish: Hvis behandlingen med MVASI stoppes, kan virkningen på tumorvæksten ophøre.
English: Relative to control arm. NR = Not Reached.
Danish: NR = ikke nået.
English: In patients in AVF3694g who received treatment with anthracyclines and who had not received anthracyclines before, no increased incidence of all grade CHF was observed in the anthracycline + bevacizumab group compared to the treatment with anthracyclines only.
Danish: Hos patienter i AVF3694g, som blev behandlet med antracykliner, og som ikke havde været behandlet med antracykliner tidligere, blev der ikke observeret øget hyppighed af CHF (alle grader) i gruppen, som blev behandlet med antracyklin + bevacizumab, sammenlignet med gruppen, som blev behandlet med antracykliner alene.
English: Most patients had EOC (82% in CPP and CPB15, 85% in CPB15+) followed by PPC (16% in CPP, 15% in CPB15, 13% in CPB15+) and FTC (1% in CPP, 3% in CPB15, 2% in CPB15+).
Danish: De fleste patienterhavde epitelialt ovariekarcinom (82 % i CPP og CPB15, 85 % i CPB15+), efterfulgt af primært peritonealt karcinom (16 % i CPP, 15 % i CPB15, 13 % i CPB15+) og tubakarcinom (1 % i CPP, 3 % i CPB15, 2 % i CPB15+).
English: The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and adult patients when normalised by body weight, with exposure trending lower as body weight decreased.
Danish: Resultaterne viser, at bevacizumabs clearance og distributionsvolumen er sammenlignelige hos børn og voksne, når der bliver justeret for legemsvægt med en tendens til lavere eksponering ved lavere legemsvægt.
English: Overall survival - Follow-up analysis7 Median (months)1
Danish: Samlet overlevelse (followup-analyse)7 Median (måneder)
English: Hypersensitivity reactions/infusion reactions (see section 4.8)
Danish: Overfølsomhedsreaktioner/infusionsreaktioner (se pkt.
English: In study BO25041, bevacizumab exposure was similar compared to a typical adult at the same dose.
Danish: I studie BO25041 var eksponeringen af bevacizumab sammenlignelig med eksponeringen hos en typisk voksen ved samme dosis.
English: • bleeding from the lower part of the large bowel,
Danish: • blødning fra den nedre del af tyktarmen,
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: Efficacy results for trial E4599
Danish: Effektresultater fra studie E4599
English: Other medicines and MVASI
Danish: Brug af anden medicin sammen med MVASI
English: After completion of six cycles of carboplatin-paclitaxel chemotherapy or upon premature discontinuation of chemotherapy, patients on the bevacizumab + carboplatin-paclitaxel arm continued to receive bevacizumab as a single agent every 3 weeks until disease progression.
Danish: Efter afslutning af 6 serier kemoterapi med carboplatin-paclitaxel eller efter for tidlig seponering af kemoterapi, fortsatte patienter, der fik bevacizumab + carpoplatin-paclitaxel, med at få bevacizumab som enkeltstofbehandling hver 3. uge indtil sygdomsprogression.
English: A total of 1,528 patients were randomised in equal proportions to the following two arms:
Danish: Sammenlagt blev 1.528 patienter randomiseret til to lige store arme:
English: Proteinuriaa,b
Danish: Proteinuria,b
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: The rates of discontinuation due to adverse events in the subgroup of patients > 65 years old were 8.8% in the CT arm and 50.0% in the CT + BV arm.
Danish: Seponeringsfrekvensen på grund af bivirkninger i undergruppen af patienter > 65 år var 8,8 % i kemoterapi-armen og 50,0 % i kemoterapi + bevacizumab-armen.