FrancophonIA/ELRC3.0 huggingface dataset:
English: Zirabev must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Danish: Zirabev skal administreres under supervision af en læge med erfaring i anvendelse af antineoplastiske lægemidler.
English: Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Danish: Tabel 7 Nøgletal for virkningsresultater af superioritets-analysen (ITT Population, studie NO16966)
English: Zirabev is a biosimilar medicinal product.
Danish: Zirabev er et biosimilært lægemiddel.
English: For further information as to human epidermal growth factor receptor 2 (HER2) status, please refer to section 5.1.
Danish: 5.1 for yderligere oplysninger om human epidermal vækstfaktorreceptor 2 (HER2)-status.
English: Zirabev therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Danish: Zirabev bør seponeres hos patienter, der udvikler nekrotiserende fasciitis og relevant behandling straks påbegyndes.
English: ● If you have or have had an aneurysm (enlargement and weakening of a blood vessel wall) or a tear in a blood vessel wall.
Danish: ● Hvis du har eller har haft et aneurisme (udvidelse og svækkelse af en blodårevæg) eller en rift i en blodårevæg.
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 sygdomsprogression.
English: Bevacizumab is not approved for use in patients under the age of 18 years.
Danish: Bevacizumab er ikke godkendt til anvendelse hos patienter under 18 år.
English: I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Danish: Ibevacizumab tyder på, at dets metaboliske profil svarer til, hvad der kan forventes af et nativt IgGmolekyle, som ikke binder VEGF.
English: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01X C07
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, antineoplastiske midler, andre antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01X C07
English: These were most commonly NCI-CTCAE v.3 Grade 1 epistaxis that lasted less than 5 minutes, resolved without medical intervention and did not require any changes in the bevacizumab treatment regimen.
Danish: Det drejede sig for det meste om NCI-CTCAE v.3 grad 1 næseblod, som varede mindre end 5 minutter og ophørte uden behandling, og som ikke krævede ændringer i bevacizumabbehandlingen.
English: The addition of bevacizumab to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Danish: Tillæg af bevacizumab til IFL resulterede i en statistisk signifikant stigning i den samlede overlevelse (overall survival) (OS), progressionsfri overlevelse (PFS) og samlet responsrate (se tabel 4).
English: Bevacizumab addition to multimodal standard of care treatment seemed to be tolerated in this paediatric population.
Danish: Bevacizumab som tillæg til kombinationsstandardbehandlingen blev tolereret hos denne pædiatriske population.
English: Patients should be monitored for signs and symptoms of CNS bleeding, and Zirabev treatment discontinued in cases of intracranial bleeding.
Danish: Patienter skal overvåges for tegn og symptomer på CNS-blødning, og behandling med Zirabev skal seponeres i tilfælde af intrakranial blødning.
English: However, sleepiness and fainting have been reported with bevacizumab use.
Danish: Alligevel er der rapporteret søvnighed og besvimelse ved anvendelse af bevacizumab.
English: ● This medicine can increase the risk of bleeding or increase the risk of problems with wound healing after surgery.
Danish: ● Denne medicin kan øge risikoen for blødning eller problemer med sårhelingen efter operation.
English: After correcting for body weight, male patients had a higher bevacizumab clearance (+ 17%) than females.
Danish: Efter korrektion for legemsvægt havde mandlige patienter en højere bevacizumab-clearance (+ 17 %) i forhold til kvindelige patienter.
English: Intravitreal use Zirabev is not formulated for intravitreal use.
Danish: Zirabev er ikke formuleret til intravitreal anvendelse.
English: Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Danish: Vaskulære sygdomme Renal trombotisk mikroangiopati, som kan manifestere sig som proteinuri (ikke kendt) med eller uden samtidig anvendelse af sunitinib.
English: Oxaliplatin Capecitabine
Danish: Oxaliplatin Capecitabin
English: It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
Danish: Hypertension resulterede sjældent i afbrydelse af bevacizumabbehandlingen eller hospitalsindlæggelse.
English: ● Zirabev may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Danish: ● Zirabev kan øge risikoen for, at der dannes abnorme forbindelser eller passager mellem to organer eller blodårer.
English: Necrotising fasciitis c
Danish: Nekrotiserende fasciitis c
English: GI-vaginal fistulae in study GOG-0240
Danish: Gastrointestinale-vaginale fistler i studie GOG-0240
English: XELOX or XELOX + bevacizumab
Danish: XELOX eller XELOX + bevacizumab
English: ● if you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Danish: ● hvis du er allergisk (overfølsom) over for produkter fremstillet i ovarieceller (CHO) fra kinesisk hamster eller andre rekombinante humane eller humaniserede antistoffer.
English: Table 11 Efficacy results for trial E4599
Danish: Tabel 11 Virkningsresultater i studie E4599
English: • decreased number of cells in the blood, including white cells that help to fight against infections (this may be accompanied by fever), and cells that help the blood to clot,
Danish: • nedsat antal af celler i blodet, inklusive hvide blodlegemer som hjælper med at bekæmpe infektioner i kroppen (kan være ledsaget af feber) og celler, der hjælper blodet med at størkne,
English: The efficacy data from trials AVF0780g and AVF2192g investigating bevacizumab in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
Danish: Effektdata fra studierne AVF0780g og AVF2192g, som undersøgte bevacizumab i kombination med 5-FU/FA-kemoterapi, er sammenfattet i tabel 5.
English: Progression-free survival and objective response rate were inferior in the bevacizumab monotherapy arm compared to the FOLFOX-4 arm.
Danish: Progressionsfri overlevelse og objektiv responsrate var inferior i bevacizumab monoterapi-armen i forhold til FOLFOX-4-armen.
English: Table 8 Efficacy results for trial E3200
Danish: Tabel 8 Resultater for virkning i studie E3200
English: Asthenia, Fatigue,
Danish: Asteni, Træthed,
English: Zirabev is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Danish: Zirabev administreres i kombination med et af følgende kemoterapiregimer: paclitaxel og cisplatin eller paclitaxel og topotecan.
English: The only variables that showed statistically significant correlations with bleeding were bevacizumab therapy and squamous cell histology.
Danish: De eneste faktorer, som viste statistisk signifikant sammenhæng med blødning, var bevacizumabbehandling og planocellulær histologi.
English: Cases of Osteonecrosis of the Jaw (ONJ) have been reported in patients treated with bevacizumab, most of which occurred in patients who had identified risk factors for ONJ, in particular exposure to intravenous bisphosphonates and/or a history of dental disease requiring invasive dental procedures (see also section 4.4)
Danish: Tilfælde af osteonekrose af kæben (ONJ) er blevet rapporteret hos patienter behandlet med bevacizumab, hvoraf de fleste tilfælde forekom hos patienter, der havde kendte risikofaktorer for ONJ, navnlig eksponering for intravenøse bisfosfonater og/eller en anamnese med tandsygdomme, som krævede invasive tandprocedurer (se også pkt.
English: The analysis of the primary endpoint showed no difference between the bevacizumab + Placebo arm and the bevacizumab + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Danish: Analysen af primært endepunkt viste ingen forskel mellem bevacizumab + placeboarmen og bevacizumab + erlotinib-armen (median progressionsfri overlevelse 8,5 vs. 9,9 måneder).
English: 2D barcode carrying the unique identifier included.
Danish: < Der er anført en 2D-stregkode, som indeholder en entydig identifikator.>
English: In the majority of the occasions the necessary amount of Zirabev can be diluted with 0.9% sodium chloride solution for injection to a total volume of 100 mL.
Danish: I fleste tilfælde kan den nødvendige mængde Zirabev blive fortyndet med 0,9 % natriumchlorid opløsning til injektion op til 100 ml (totalvolumen).
English: Do not use Zirabev if you notice any particulate matter or discolouration prior to administration.
Danish: Brug ikke Zirabev, hvis du opdager partikler eller misfarvning før indgift.
English: Within each frequency category, adverse reactions are presented in the order of decreasing seriousness.
Danish: Inden for hver frekvensgruppe er bivirkningerne anført efter aftagende alvorlighed.
English: ● if you have problems with wound healing following surgery,
Danish: ● hvis du har problemer med sårheling efter en operation,
English: This condition is usually secondary to wound healing complications, gastrointestinal perforation or fistula formation.
Danish: Dette har som regel været sekundært til sårhelingskomplikationer, gastrointestinal perforation eller fisteldannelse.
English: You must not breast-feed your baby during treatment with Zirabev and for at least 6 months after the last dose of Zirabev, as this medicine may interfere with the growth and development of your baby.
Danish: Du må ikke amme under behandling med Zirabev og i mindst 6 måneder efter sidste dosis Zirabev, da Zirabev kan påvirke væksten og udviklingen af dit barn.
English: The clinical presentation of PRES is often nonspecific, and therefore the diagnosis of PRES requires confirmation by brain imaging, preferably MRI.
Danish: Det kliniske billede af PRES er ofte uspecifikt, og diagnosticeringen kræver derfor en bekræftelse ved en hjernescanning, helst magnetisk resonans (MR) scanning.
English: This was a randomised phase II trial conducted to compare the efficacy and safety of bevacizumab versus placebo.
Danish: Dette var et randomiseret fase II-studie, der blev udført for at sammenligne effekt og sikkerhed af bevacizumab vs. placebo.
English: A reduction of circulating VEGF concentration has been demonstrated following intravitreal anti-VEGF therapy.
Danish: Der er påvist nedsat koncentration af cirkulerende vaskulær endotelial vækstfaktor (VEGF) efter intravitreal anti-VEGF-behandling.
English: An interim analysis showed there was a significant prolongation of the time to progression of disease in the 10 mg/kg group as compared with the placebo group (hazard ratio, 2.55; p < 0.001).
Danish: En interimanalyse viste, at der var signifikant forlængelse af tid til progression af sygdom for 10 mg/kg gruppen i forhold til placebogruppen (hazard ratio, 2,55; p < 0,001).
English: In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that bevacizumab in combination with FOLFOX-4 or XELOX chemotherapy was superior to chemotherapy alone.
Danish: Der var to primære formål med studiet: At vise at XELOX var non-inferior i forhold til FOLFOX-4 og at vise at bevacizumab i kombination med FOLFOX-4 eller XELOX kemoterapi var bedre i forhold til kemoterapi alene.
English: ● Zirabev can increase the incidence of high blood pressure.
Danish: ● Zirabev kan øge hyppigheden af forhøjet blodtryk.
English: Pulmonary hypertension a,
Danish: Pulmonal hypertension a,
English: The clinical benefit, as measured by overall survival, was seen in all pre-specified patient subgroups, including those defined by age, sex, performance status, location of primary tumour, number of organs involved and duration of metastatic disease.
Danish: Den kliniske fordel, bedømt efter samlet overlevelse, blev set i alle forudspecificerede patientundergrupper, inklusive grupper defineret i henhold til alder, køn, performancestatus, lokalisering af primær tumor, antal involverede organer og varighed af metastatisk sygdom.
English: Marketing Authorisation Holder Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgium
Danish: Indehaver af markedsføringstilladelsen og fremstiller Pfizer Europe MA EEIG, Boulevard de la Plaine 17, 1050 Bruxelles, Belgien
English: Table 3 Adverse reactions reported in post-marketing setting
Danish: Tabel 3 Bivirkninger rapporteret efter markedsføring
English: A total of 116 patients were randomised to receive bevacizumab 3 mg/kg every 2 weeks (n=39), 10 mg/kg every 2 weeks; (n=37), or placebo (n=40).
Danish: Et samlet antal på 116 patienter blev randomiseret til at få bevacizumab 3 mg/kg hver 2. uge (n=39); 10 mg/kg hver 2. uge (n=37) eller placebo (n=40).
English: Efficacy results for study ML18147 (ITT population)
Danish: Tabel 9 Virkningsresultater i studie ML18147 (ITT-population)
English: This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) plus bevacizumab to R-CHOP without bevacizumab.
Danish: Dette kliniske fase III-studie sammenlignede rituximab/cyclophosphamid/doxorubicin/vincristin/prednison (R-CHOP) plus bevacizumab med RCHOP uden bevacizumab.
English: These therapies in combination with Zirabev may increase the risk of severe side effects.
Danish: Kombination af Zirabev og disse behandlinger kan øge risikoen for alvorlige bivirkninger.
English: (p-value
Danish: (p-værdi
English: Sepsis, Cellulitis, Abscess a,b
Danish: Sepsis, Cellulitis, Absces a,b
English: The concentrate is a clear to slightly opalescent, colourless to pale brown liquid in a glass vial with a rubber stopper.
Danish: Koncentratet er en klar til let opaliserende, farveløs til lysebrun væske i et hætteglas af glas med gummiprop.
English: Therefore fertility preservation strategies should be discussed with women of child-bearing potential prior to starting treatment with Zirabev.
Danish: Fertilitetsbevarende strategier bør derfor drøftes med kvinder i den fertile alder før igangsættelse af behandling med Zirabev.
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: 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 fremskreden og/eller metastatisk renalcellekarcinom (BO17705)
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 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 ved hjælp af en populationsfarmakokinetisk model.
English: Very rare Frequency not known
Danish: Frekvens ikke kendt
English: An increased incidence of hypertension was observed in bevacizumab-treated patients.
Danish: Der er observeret øget forekomst af hypertension hos bevacizumabbehandlede patienter.
English: Combinations of Zirabev with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Danish: Kombination af Zirabev med en anden medicin, sunitinibmalat (ordineret for kræft i nyrerne eller mave- tarmkanalen) kan forårsage alvorlige bivirkninger.
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 bevacizumabbehandling hos patienter, som har fået kumulative doxorubicindoser større end 300 mg/m
English: b For additional information refer below within section “Further information on selected serious adverse reactions”
Danish: For yderligere information henvises til nedenstående afsnit "Yderligere information om visse alvorlige bivirkninger".
English: Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the bevacizumab arm reduced the dose of IFN alfa-2a from 9 MIU to either 6 or 3 MIU three times a week as pre-specified in the protocol.
Danish: Syvoghalvfems (97) patienter i IFN alfa-2a-armen og 131 patienter i bevacizumab-armen reducerede dosis af IFN alfa-2a fra 9 MIE tre gange ugentligt til enten 6 eller 3 MIE tre gange ugentligt som præspecificeret i protokollen.
English: ● if you have or have had 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 tell your doctor and dentist immediately.
Danish: ● hvis du har eller har haft smerter i munden, tænderne og/eller kæben, hævelse eller sår inde i munden, følelsesløshed eller en følelse af tyngde i kæben, eller får en løs tand, skal du straks fortælle det til din læge og tandlæge.
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: Supraventricular tachycardia
Danish: Supraventrikulær takykardi
English: In most clinical trials urine protein levels of ≥ 2 g/24 hrs led to the holding of bevacizumab until recovery to < 2 g/24 hrs.
Danish: I de fleste kliniske studier medførte proteinkoncentrationer på ≥ 2 g/24 timer i urinen til seponering af bevacizumabbehandlingen, indtil der var nået et niveau på < 2 g/24 timer.
English: Each pack of Zirabev contains one vial.
Danish: Hver pakning med Zirabev indeholder et hætteglas.
English: Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline 95% CI for one sample binomial using Pearson-Clopper method Approximate 95% CI for difference of two rates using Hauck-Anderson method log-rank test (stratified) Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis
Danish: Kaplan-Meier-estimater Patienter og procentdel af patienter med det bedste objektive respons bekræftet komplet respons eller partielt respons; procent beregnet på grundlag af patienter med målbar sygdom ved baseline 95 % konfidensinterval for one sample binomial ved brug af Pearson-Clopper-metoden Ca. 95 % konfidensinterval for forskel mellem to rater ved brug af Hauck-Anderson-metoden log-rank-test (stratificeret) Primær-analyse blev udført ved data cut-off 12. december 2012 og betragtes som den endelige analyse Followup-analyse blev udført ved data cut-off 7. marts 2014 p-værdi er kun vist for oplysende formål
English: In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the bevacizumab containing arms compared with up to 14% in the control arms.
Danish: I kliniske studier, med undtagelse af studie JO25567, var den totale hyppighed af hypertension (alle grader) på op til 42,1 % i bevacizumab-armene sammenlignet med en hyppighed på op til 14 % i kontrolarmene.
English: In clinical trials of metastatic carcinoma of the colon or rectum, there was no increased risk of post-operative bleeding or wound healing complications observed in patients who underwent major surgery 28-60 days prior to starting bevacizumab.
Danish: I kliniske studier for metastatisk kolorektalkræft var der ingen forøget risiko for postoperativ blødning eller sårhelingskomplikationer hos patienter, der fik foretaget større kirurgiske indgreb mellem 28 og 60 dage før påbegyndelsen af behandlingen med bevacizumab.
English: The side effects listed below were seen when bevacizumab was given together with chemotherapy.
Danish: De bivirkninger, der er vist nedenfor, blev observeret, når bevacizumab blev givet sammen med kemoterapi.
English: Administration of bevacizumab or its parental murine antibody to xenotransplant models of cancer in nude mice resulted in extensive anti-tumour activity in human cancers, including colon, breast,
Danish: Administration af bevacizumab eller dets parenterale, murine antistof til nøgne mus i xenotransplantationsmodeller af kræft medførte omfattende anti-tumor aktivitet ved humane kræftformer, inklusive colon, mamma-, pancreas- og prostatakræft.
English: ● presence of protein in your urine accompanied by swelling of your body,
Danish: ● protein i urinen, efterfulgt af hævelser på kroppen,
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) scanning.
English: Table 12 Efficacy results for trial BO17704
Danish: Tabel 12 Virkningsresultater i studie BO17704
English: Bevacizumab is contraindicated in pregnancy (see section 4.3).
Danish: Bevacizumab er kontraindiceret under graviditet (se pkt.
English: The administration of Zirabev should be temporarily discontinued
Danish: Behandlingen med Zirabev skal midlertidigt afbrydes
English: If a dose of Zirabev is missed
Danish: Hvis en dosis Zirabev glemmes
English: Adjustment for these baseline factors resulted in a treatment hazard ratio of 0.78 (95% CI [0.63; 0.96], p=0.0219), indicating a 22% reduction in the risk of death for patients in the bevacizumab + IFN alfa-2a arm compared to IFN alfa-2a arm.
Danish: Tages der højde for disse baseline-faktorer, blev hazard ratio for behandlingen 0,78 (95 % konfidensinterval [0,63 - 0,96], p = 0,0219), indikerende en 22 % risikoreduktion for død for patienter i bevacizumab + IFN alfa-2a-armen i forhold til IFN alfa-2a-armen.
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 velkarakteriseret med den pædiatriske populationsfarmakokinetiske model med data fra 70 patienter i studie BO20924 (1,4 til 17,6 år; 11,6 til 77,5 kg) og 59 patienter i studie BO25041 (1 til 17 år; 11,2 til 82,3 kg).
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 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.