FrancophonIA/ELRC3.0 huggingface dataset:
English: • fistula: abnormal tube-like connection between internal organs and skin or other tissues that are not normally connected, including connections between vagina and the gut in patients with cervical cancer.
Danish: • fistel: abnorm, rørformet forbindelse mellem indre organer og hud eller andre væv, som normalt ikke er forbundet, inklusive forbindelse mellem skeden og tarmen hos patienter med livmoderhalskræft.
English: After discontinuation of bevacizumab treatment, ovarian function recovered in 86.2% of these evaluable women.
Danish: Ovariefunktionen blev genoprettet hos 86,2 % af disse evaluerbare kvinder efter seponering af bevacizumab.
English: Vial (unopened)
Danish: Hætteglas (uåbnet)
English: In situations where early discontinuation of chemotherapy was required, treatment with Avastin as a single agent continued until disease progression.
Danish: I situationer, hvor tidlig afbrydelse af kemoterapi var påkrævet, fortsatte behandlingen med Avastin som enkeltstof indtil sygdomsprogression.
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 løsnen af en tand.
English: fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy fluoropyrimidine/irinotecan or fluoropyrimidine/oxaliplatin based chemotherapy + Avastina
Danish: fluoropyrimidin/irinotecaneller fluoropyrimidin/oxaliplatinbaseret kemoterapi fluoropyrimidin/irinotecaneller fluoropyrimidin/oxaliplatinbaseret kemoterapi + Avastina
English: • reduction in the number of white cells in the blood, and cells that help the blood clot,
Danish: • reduktion i antallet af hvide blodceller i blodet og i antallet af celler, der hjælper blodet med at størkne,
English: ● Avastin can also increase the risk of developing blood clots in your veins (a type of blood vessel).
Danish: • Avastin kan også øge risikoen for at udvikle blodpropper i venerne (en type blodkar),
English: 5-fluorouracil IV bolus/infusion, each on days 1 and 2
Danish: bolus/infusion på dag 1 og 2
English: In patients developing PRES, early recognition of symptoms with prompt treatment of specific symptoms including control of hypertension (if associated with severe uncontrolled hypertension) is recommended in addition to discontinuation of bevacizumab therapy.
Danish: For patienter, der udvikler PRES, anbefales tidlig opdagelse af symptomerne sammen med hurtig behandling af specifikke symptomer, herunder kontrol af hypertension (hvis der er tilknyttet en alvorlig ukontrolleret hypertension) samtidig med, at bevacizumabbehandlingen afbrydes.
English: Table 24: Exploratory PFS and OS analyses by chemotherapy cohort CT
Danish: Tabel 24: Eksploratoriske PFS- og OS-analyser af kemoterapi-kohorten Kemoterapi
English: The metabolism and elimination of bevacizumab is similar to endogenous IgG i.e. primarily via proteolytic catabolism throughout the body, including endothelial cells, and does not rely primarily on elimination through the kidneys and liver.
Danish: Metabolismen og eliminationen af bevacizumab er lignende den for endogent IgG, dvs. primært via proteolytisk katabolisme i hele kroppen inklusive endotelceller.
English: The most frequently observed adverse reactions across clinical trials in patients receiving Avastin were hypertension, fatigue or asthenia, diarrhoea and abdominal pain.
Danish: De hyppigst observerede bivirkninger i alle kliniske studier hos patienter, som fik Avastin, var hypertension, træthed eller asteni, diarré og abdominalsmerter.
English: Table 5 Efficacy results for trials AVF0780g and AVF2192g AVF0780g
Danish: Resultater for effekt i studierne AVF0780g og AVF2192g AVF0780g
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: • a hole in the stomach or intestines,
Danish: • hul i maven eller tarmen
English: 19% of the patients had received prior chemotherapy and 14% prior radiotherapy.
Danish: 19 % af patienterne havde tidligere fået kemoterapi og 14 % havde tidligere fået strålebehandling.
English: The incidence of these reactions in some clinical trials of Avastin is common (up to 5% in bevacizumabtreated patients).
Danish: I nogle kliniske studier med Avastin er forekomsten af disse reaktioner almindelig (op til 5 % af bevacizumabbehandlede patienter).
English: Necrotising fasciitis, usually secondary to wound healing complications, gastrointestinal perforation or fistula formation (rare) (see also section 4.4)
Danish: Nekrotiserende fasciitis, som regel sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse (sjælden) (se også pkt.
English: A concentration dependent degradation profile of bevacizumab was observed when diluted with glucose solutions (5%).
Danish: Der blev set en koncentrationsafhængig nedbrydningsprofil for bevacizumab efter fortynding med glucoseopløsninger (5 %).
English: PFS subgroup analyses depending on recurrence since last platinum therapy are summarised in Table 21.
Danish: PFS undergruppeanalyser, som er afhængige af tiden til recidiv siden den sidste platinbehandling, er opsummeret i tabel 21.
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 bevacizumab-armen.
English: However, somnolence and syncope have been reported with Avastin use (see table 1 in section 4.8).
Danish: Alligevel er søvnighed og synkope blevet rapporteret ved anvendelse af Avastin (se tabel 1, pkt.
English: In rabbits, bevacizumab was shown to inhibit wound healing at doses below the proposed clinical dose.
Danish: Hos kaniner er det vist, at bevacizumab hæmmer sårheling i doser under den foreslåede kliniske dosis.
English: When events were noted as both all grade and grade 3-5 adverse drug reactions in clinical trials, the highest frequency observed in patients has been reported.
Danish: Hvis bivirkningerne i kliniske studier er registreret som både bivirkning af alle grader og bivirkning af grad 3-5, er den højeste frekvens, som er observeret hos patienter, rapporteret.
English: These results suggest that close clinical observation with appropriate cardiac assessments should be considered for patients exposed to cumulative doxorubicin doses greater than 300 mg/m2 when combined with bevacizumab.
Danish: Disse resultater antyder, at tæt observation med passende kardielle vurderinger bør overvejes ved bevacizumab-behandling hos patienter, som har fået kumulative doxorubicindoser større end 300 mg/m2.
English: In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with Avastin.
Danish: I publicerede rapporter har tilfælde af ikke-mandibulær osteonekrose været observeret hos patienter under 18 år behandlet med Avastin.
English: Combinations of Avastin with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Danish: Kombination af Avastin med en anden medicin, sunitinibmalat (ordineret for kræft i nyrerne eller mave- tarmkanalen) kan forårsage alvorlige bivirkninger.
English: The overall safety profile of Avastin is based on data from over 5,700 patients with various malignancies, predominantly treated with Avastin in combination with chemotherapy in clinical trials.
Danish: Sikkerhedsprofilen for Avastin er baseret på data fra kliniske studier med over 5.700 patienter med forskellige maligne sygdomme, som primært blev behandlet med Avastin i kombination med kemoterapi.
English: Investigator assessed PFS analysis with data cut-off date of 30 November 2010.
Danish: Investigatorvurderet PFS-analyse med data cut-off den 30. november 2010.
English: 95% CI
Danish: 95 % konfidensinterval
English: An exploratory multivariate Cox regression model using backward selection indicated that the following baseline prognostic factors were strongly associated with survival independent of treatment: gender, white blood cell count, platelets, body weight loss in the 6 months prior to trial entry, number of metastatic sites, sum of longest diameter of target lesions, Motzer score.
Danish: En eksplorativ, multivariant, baglæns trinvis (backward stepwise) Cox-regressionsanalyse indikerede, at følgende prognostiske faktorer ved baseline var stærkt relateret til overlevelse uafhængigt af behandling: Køn, antal hvide blodlegemer, antal blodplader, vægttab i de 6 måneder inden indtræden i studiet, antal metastaser, summen af den længste diameter af targetlæsioner, Motzer-score.
English: Serious wound healing complications, including anastomotic complications, have been reported, some of which had a fatal outcome.
Danish: Der har været rapporteret alvorlige sårhelingskomplikationer, herunder anastomotiske komplikationer, hvoraf nogle havde dødelig udgang.
English: Keep the vial in the outer carton
Danish: Opbevar hætteglasset i den ydre karton
English: Most of the patients who experienced CHF had metastatic breast cancer and had received previous treatment with anthracyclines, prior radiotherapy to the left chest wall or other risk factors for CHF were present.
Danish: De fleste patienter, som fik CHF, havde metastatisk brystkræft og var tidligere behandlet med antracykliner, havde fået strålebehandling af venstre brystvæg eller havde andre risikofaktorer for CHF.
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: Treatment of platinum-resistant recurrent disease: Avastin is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin.
Danish: Behandling af platinresistent recidiverende sygdom: Avastin administreres i kombination med et af følgende stoffer - paclitaxel, topotecan (givet ugentligt) eller pegyleret liposomal doxorubicin.
English: Progression-Free Survival*
Danish: Progressionsfri overlevelse*
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 incidence of CNS bleeding in patients with untreated CNS metastases receiving bevacizumab has not been prospectively evaluated in randomised clinical trials.
Danish: Forekomsten af CNS-blødning hos patienter med ubehandlede CNS-metastaser, som fik bevacizumab, er ikke blevet prospektivt undersøgt i randomiserede kliniske studier.
English: • Increased eye pressure,
Danish: • forhøjet tryk i øjet,
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: Table 22 Efficacy results1,2 from study GOG-0213 Primary Endpoint
Danish: Tabel 22 Effektresultater1,2 fra studie GOG-0213 Primært endepunkt
English: • The active substance is bevacizumab.
Danish: • Aktivt stof; bevacizumab.
English: The pharmacokinetics of bevacizumab was well characterized by the paediatric population PK model for 70 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 patienter i studie BO20294 (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: The majority of patients had EOC (87.7%) followed by PPC (6.9%) and FTC (3.7%) or a mixture of the three origins (1.7%).
Danish: Størstedelen af patienterne havde epitelialt ovariekarcinom (87,7 %), efterfulgt af primært peritonealt karcinom (6,9 %) og tubakarcinom (3,7 %) eller en blanding af de tre oprindelser (1,7 %).
English: The typical value for peripheral volume (Vp) was 1.69 L and 2.35 L for female and male patients respectively, when bevacizumab is co-administered with anti-neoplastic agents.
Danish: Den typiske værdi for det perifere volumen (Vp) var 1,69 l og 2,35 l for henholdsvis kvindelige og mandlige patienter, når bevacizumab administreres sammen med antineoplastiske lægemidler.
English: Tumour-associated haemorrhage was also seen rarely in other tumour types and locations, including cases of central nervous system (CNS) bleeding in patients with CNS metastases (see section 4.4).
Danish: I sjældne tilfælde blev der også set tumorassocieret blødning ved andre tumortyper og lokalitet, inklusive tilfælde af blødning i centralnervesystemet (CNS) hos patienter med CNS-metastaser (se pkt.
English: Serious wound healing complications, including anastomotic complications, with a fatal outcome have been reported.
Danish: Der har været rapporteret alvorlige sårhelingskomplikationer, herunder anastomotiske komplikationer, med dødelig udgang.
English: What you need to know before you use Avastin
Danish: Det skal du vide, før du begynder at bruge Avastin
English: Systemic adverse reactions including non-ocular haemorrhages and arterial thromboembolic reactions have been reported following intravitreal injection of VEGF inhibitors.
Danish: Systemiske bivirkninger, herunder ikke-okulære blødninger og arterielle tromboemboliske bivirkninger, er blevet rapporteret efter intravitreal injektion af VEGFhæmmere.
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 ubetydelige 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: There is no relevant use of bevacizumab in the paediatric population in the indications for treatment of cancers of the colon, rectum, breast, lung, ovarian, fallopian tube, peritoneum, cervix and kidney.
Danish: Det er ikke relevant at anvende bevacizumab i den pædiatriske population for indikationerne behandling af cancer i kolon, rektum, bryst, lunge, ovarie, æggeleder, peritoneum, cervix og nyre.
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: In Avastin 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 Avastin 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: The 131 patients in the Avastin + 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 Avastin + IFN alfa-2a.
Danish: De 131 patienter i Avastin + 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 Avastin + IFN alfa-2a.
English: Venous thromboembolic reactions include deep venous thrombosis, pulmonary embolism and thrombophlebitis.
Danish: Venøse tromboemboliske bivirkninger omfatter dyb venetrombose, lungeemboli og tromboflebitis.
English: If a dose of Avastin is missed
Danish: Hvis en Avastindosis glemmes
English: The primary endpoint was duration of survival.
Danish: Det primære endepunkt var varigheden af overlevelse.
English: Description of selected serious adverse reactions
Danish: Beskrivelse af udvalgte alvorlige bivirkninger
English: Dose reduction for adverse reactions is not recommended.
Danish: Det anbefales ikke at nedsætte dosis på grund af bivirkninger.
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: Therapy should not be initiated for at least 28 days following major surgery or until the surgical wound is fully healed.
Danish: Behandlingen bør tidligst påbegyndes 28 dage efter større operationer, eller efter såret er fuldstændig helet.
English: In NSABP C-08, a phase III trial of Avastin 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 Avastin 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: Patients with NSCLC of known squamous cell histology or mixed cell type with predominant squamous cell histology were excluded from subsequent phase III trials, while patients with unknown tumour histology were included.
Danish: Patienter med NSCLC med kendt planocellulær histologi eller blandet celletype med dominerende planocellulær histologi blev ekskluderet fra de efterfølgende fase III-studier, mens patienter med ukendt tumorhistologi blev inkluderet.
English: The primary efficacy parameter of the trial was overall survival, defined as the time from randomisation to death from any cause.
Danish: Den primære effektparameter for studiet var samlet overlevelse, defineret som tid fra randomisering til død, uanset årsag.
English: Objective response rate (%) in Patients with measurable disease
Danish: Objektiv responsrate (%) for patienter med målelig sygdom
English: Effect of antineoplastic agents on bevacizumab pharmacokinetics No clinically relevant interaction of co-administered chemotherapy on bevacizumab pharmacokinetics was observed based on the results of population pharmacokinetic analyses.
Danish: Effekt af antineoplastiske lægemidler på bevacizumabs farmakokinetik Der er ikke observeret klinisk relevante interaktioner på bevacizumabs farmakokinetik af samtidigt administreret kemoterapi,baseret på resultaterne fra populationsfarmakokinetiske analyser.
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 (f.eks. epistaxis) kan være dosisafhængig.
English: A third group of 110 patients received bolus 5-FU/FA + Avastin (Arm 3).
Danish: En tredje gruppe på 110 patienter fik en bolus af 5-FU/FA + Avastin (arm 3).
English: IFN alfa-2a was given up to 52 weeks or until disease progression at a recommended starting dose of 9 MIU three times a week, allowing a dose reduction to 3 MIU three times a week in 2 steps.
Danish: IFN alfa-2a blev givet i op til 52 uger eller indtil sygdomsprogression startende med den anbefalede initialdosis på 9 MIE tre gange ugentligt.
English: Cervical Cancer
Danish: Cervixcancer
English: The incidence of AEs, including Grade ≥ 3 AEs and SAEs, was similar between the two treatment arms.
Danish: Forekomst af bivirkninger, herunder grad ≥ 3 bivirkninger og alvorlige bivirkninger var sammenlignelige mellem de to behandlingsarme.
English: The safety and efficacy of bevacizumab in children less than 18 years old have not been established.
Danish: Bevacizumabs sikkerhed og virkning hos børn under 18 år er ikke klarlagt.
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: Hazard ratio Best overall response ratea
Danish: Hazard ratio Bedste objektive responsrate a
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/300/001
English: The pharmacokinetic results show that the clearance and volume of distribution of bevacizumab were comparable between paediatric and young 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 unge voksne, når der bliver justeret for legemsvægt med en tendens til lavere eksponering ved lavere legemsvægt.
English: All of these findings were reversible upon discontinuation of bevacizumab and sunitinib malate (see Hypertension, Proteinuria, PRES in section 4.4).
Danish: Alle symptomerne var reversible efter afbrydelse af behandling med bevacizumab og sunitinibmaleat (se Hypertension, Proteinuria, PRES i pkt.
English: No Avastin
Danish: Ingen Avastin
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: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/002
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/04/300/002
English: In these studies, bevacizumab was administered at the following dosing regimens in combination with FOLFOX-4 (5-FU/LV/oxaliplatin), XELOX (capecitabine/oxaliplatin), and fluoropyrimidine/irinotecan and fluoropyrimidine/oxaliplatin:
Danish: I disse studier blev bevacizumab administreret i følgende doser i kombination med FOLFOX-4 (5FU/LV/oxaliplatin), XELOX (capecitabin/oxaliplatin) og fluoropyrimidin/irinotecan og fluoropyrimidin/oxaliplatin:
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/T-behandlingsarmen sammenlignet med RT/T-behandlingsarmen alene.