FrancophonIA/ELRC3.0 huggingface dataset:
English: The concentration of the final bevacizumab solution should be kept within the range of 1.4 mg/mL to 16.5 mg/mL.
Danish: Koncentrationen af den endelige bevacizumab-opløsning skal ligge inden for følgende grænser: 1,4 mg/ml-16,5 mg/ml.
English: Do not use MVASI if you notice any particulate matter or discolouration prior to administration.
Danish: Brug ikke MVASI, hvis du opdager partikler eller misfarvning før indgift.
English: The efficacy results of bevacizumab in combination with IFL-chemotherapy are displayed in table 4.
Danish: Resultaterne for effekt af bevacizumab i kombination med IFL-kemoterapi fremgår af tabel 4.
English: Tumour assessments and response evaluations were determined by the investigators using the GOG RECIST criteria (Revised RECIST guideline (version 1.1).
Danish: Tumorvurdering og responsevaluering var bestemt af investigatorerne udfra GOG RECIST kriterier (revideret RECIST guideline (version 1.1) Eur J Cancer.
English: Peripheral sensory neuropathya
Danish: Perifer sensorisk neuropatia
English: Follow-up analysis was performed with a data cut-off date of 07 March 2014; all p-values are displayed for descriptive purpose only.
Danish: Followup-analyse blev udført ved data cut-off 7. marts 2014; p-værdier er kun vist for oplysende formål.
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with bevacizumab.
Danish: Den observerede stigning i serum-kreatinin var ikke forbundet med højere forekomst af kliniske manifestationer af nedsat nyrefunktion hos patienter, som var behandlet med bevacizumab.
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 FOLFOX4armen.
English: There is no information on the effect of bevacizumab in patients with uncontrolled hypertension at the time of initiating therapy.
Danish: Der foreligger ingen information om effekten af bevacizumab hos patienter, der har ukontrolleret hypertension ved behandlingens påbegyndelse.
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: Pharmacotherapeutic group: antineoplastic and immunomodulating agents, antineoplastic agents, other antineoplastic agents, monoclonal antibodies, ATC code: L01XC07.
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske og immunmodulerende midler, antineoplastiske midler, andre antineoplastiske midler, monoklonale antistoffer, ATC-kode: L01XC07.
English: In most clinical trials of bevacizumab, patients with pre-existing CHF of NYHA (New York Heart Association) II-IV were excluded, therefore, no information is available on the risk of CHF in this population.
Danish: I de fleste af de kliniske studier med bevacizumab blev patienter med præ-eksisterende CHF af NYHA (New York Heart Association) klasse II-IV ekskluderet, og derfor findes der ingen data for risikoen for
English: Each pack of MVASI contains one vial.
Danish: Hver pakning med MVASI indeholder et hætteglas.
English: • if you have problems with wound healing following surgery,
Danish: • hvis du har problemer med sårheling efter en operation,
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 (progression free survival) (PFS) og samlet responsrate (se tabel 4).
English: It rarely resulted in discontinuation of bevacizumab treatment or hospitalisation.
Danish: Hypertension resulterede sjældent i afbrydelse af behandlingen med bevacizumab eller hospitalsindlæggelse.
English: • you are allergic (hypersensitive) to bevacizumab or to any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for bevacizumab eller et af de øvrige indholdsstoffer i MVASI (angivet i punkt 6).
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 behandlingen med bevacizumab.
English: With gross residual disease.
Danish: Med makroskopisk residualsygdom.
English: Alternatively, a 1.25 mg/m2 dose could be administered over 30 minutes on days 1-5 every 3 weeks.
Danish: • Alternativt kan en dosis på 1,25 mg/m2 administreres over 30 minutter på dag 1-5 hver 3. uge.
English: Investigator assessed GOG protocol-specified PFS analysis (neither censored for CA-125 progressions nor censored for NPT prior to disease progression) with data cut-off date of 25 February, 2010.
Danish: Investigatorvurderet GOG-protokolspecificeret PFS-analyse (hverken censureret for CA-125-progressioner eller censureret for NPT før sygdomsprogression) med data-cut-off den 25. februar 2010.
English: In the majority of the occasions the necessary amount of MVASI 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 MVASI blive fortyndet med 0,9 % natriumchlorid opløsning til injektion op til 100 ml (total volumen).
English: EGFR mutation testing should be performed prior to initiation of treatment with the combination of MVASI and erlotinib.
Danish: Der skal udføres EGFR-mutationstest før igangsættelse af kombinationsbehandling med MVASI og erlotinib.
English: Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of bevacizumab compounded from vials approved for intravenous administration in cancer patients.
Danish: Individuelle tilfælde og samling af tilfælde med alvorlige okulære bivirkninger er blevet rapporteret efter ikke-godkendt intravitreal anvendelse af bevacizumab i hætteglas godkendt til intravenøs administration til kræftpatienter.
English: Overall approximately 34% of patients were FIGO stage III optimally debulked with gross residual disease, 40% stage III suboptimally debulked, and 26% were stage IV patients.
Danish: Samlet set var ca. 34 % af patienterne FIGO stadie III optimalt tumorreducerede med makroskopisk residualsygdom, 40 % stadie III sub-optimalt tumorreducerede, og 26 % var stadie IVpatienter.
English: The concentrate is a clear to slightly opalescent, colourless to slightly yellow liquid in a glass vial with a rubber stopper.
Danish: Koncentratet er en klar til let opaliserende, farveløs til let gul væske i et hætteglas af glas med gummilukke.
English: A. MANUFACTURER OF THE BIOLOGICAL ACTIVE SUBSTANCE AND MANUFACTURERS RESPONSIBLE FOR BATCH RELEASE
Danish: A. FREMSTILLERE AF DET BIOLOGISK AKTIVE STOF OG FREMSTILLERE ANSVARLIGE FOR BATCHFRIGIVELSE
English: An increased incidence of hypertension was observed in bevacizumab-treated patients.
Danish: Der er observeret øget forekomst af hypertension hos bevacizumab-behandlede patienter.
English: If patients are experiencing symptoms that affect their vision or concentration, or their ability to react, they should be advised not to drive and use machines until symptoms abate.
Danish: Hvis patienter oplever symptomer, som påvirker deres syn eller koncentration eller deres reaktionsevne, bør de frarådes at køre bil eller betjene maskiner, indtil symptomerne aftager.
English: Combinations of MVASI with another medicine called sunitinib malate (prescribed for renal and gastrointestinal cancer) may cause severe side effects.
Danish: Kombination af MVASI med en anden medicin, sunitinibmalat (ordineret for kræft i nyrerne eller mavetarmkanalen) kan forårsage alvorlige bivirkninger.
English: Chemical and physical in-use stability has been demonstrated for 48 hours at 2°C to 30°C in sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Der er dokumenteret kemisk og fysisk holdbarhed før anvendelsen i 48 timer ved 2 °C til 30 °C i natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion.
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 behandling med bevacizumab og planocellulær histologi.
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with MVASI.
Danish: Tandundersøgelse og passende forebyggende tandbehandling bør overvejes før behandling med MVASI.
English: For additional information refer below within section “Description of selected serious adverse reactions”.
Danish: For yderligere information henvises til nedenstående afsnit ”Beskrivelse af udvalgte alvorlige bivirkninger”.
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 R-CHOP uden bevacizumab.
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: In situations where early discontinuation of chemotherapy was required, treatment with bevacizumab as a single agent continued until disease progression.
Danish: I situationer, hvor tidlig afbrydelse af kemoterapi var påkrævet, fortsatte behandlingen med bevacizumab som enkeltstof indtil sygdomsprogression.
English: 5.8% of the overall randomised patient population had stage IIIB disease.
Danish: 5,8 % af den samlede randomiserede patientpopulation havde stadium III B sygdom.
English: The corresponding frequencies in the control group receiving chemotherapy alone were 1.1% vs. 0.8%, respectively.
Danish: Den tilsvarende forekomst hos kontrolgruppen, som blev behandlet med kemoterapi alene, var henholdsvis 1,1 % og 0,8 %.
English: Final analysis
Danish: Endelig analyse.
English: • MVASI increases the risk of having protein in your urine especially if you already have high blood pressure.
Danish: • MVASI kan øge risikoen for at få protein i urinen, især hvis du har forhøjet blodtryk.
English: No significant difference was observed in the duration of overall survival between patients who received bevacizumab monotherapy compared to patients treated with FOLFOX-4.
Danish: Der blev ikke observeret nogen signifikant forskel i varighed af overlevelse hos patienter, der modtog bevacizumab monoterapi i forhold til patienter, som blev behandlet med FOLFOX-4.
English: Common (may affect up to 1 in 10 people) side effects, which were not severe, include: • voice changes and hoarseness.
Danish: Almindelige bivirkninger (kan påvirke op til 1 patient ud af 10), som ikke er alvorlige, omfatter: • ændringer i stemmen og hæshed.
English: Bevacizumab vs. No bevacizumab
Danish: Bevacizumab vs ingen bevacizumab
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: Most patients in both the CP arm (80.4%) and the CPB arm (78.9%) were white.
Danish: De fleste af patienterne i både CP-armen (80,4 %) og CPB-armen (78,9 %) var kaukasiere.
English: Investigator assessment
Danish: Investigators vurdering
English: Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with bevacizumab through:
Danish: Tabel 1 viser frekvensen af alle bivirkninger, hvor der er fastslået årsagssammenhæng med bevacizumab gennem:
English: Bevacizumab clearance was approximately 30% faster in patients with low levels of serum albumin and 7% faster in subjects with higher tumour burden when compared with a typical patient with median values of albumin and tumour burden.
Danish: Clearance af bevacizumab var ca. 30 % hurtigere hos patienter med lave niveauer af serumalbumin og 7 % hurtigere hos patienter med høj tumorbyrde i forhold til en typisk patient med mediane niveauer af serumalbumin og tumorbyrde.
English: Renal thrombotic microangiopathy, which may be clinically manifested as proteinuria (not known) with or without concomitant sunitinib use.
Danish: 4.4) Vaskulære sygdomme Renal trombotisk mikroangiopati, som kan manifestere sig som proteinuri (ikke kendt) med eller uden samtidig anvendelse af sunitinib.
English: Patients with non-small cell lung cancer treated with bevacizumab may be at risk of serious, and in some cases fatal, pulmonary haemorrhage/haemoptysis.
Danish: Patienter med ikke små-cellet lungekræft, som behandles med bevacizumab, kan have risiko for svære og i visse tilfælde dødelige pulmonale blødninger/hæmoptyse.
English: • MVASI can increase the incidence of high blood pressure.
Danish: • MVASI kan øge hyppigheden af forhøjet blodtryk.
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: A reduction of circulating VEGF concentration has been demonstrated following intravitreal antiVEGF therapy.
Danish: Der er påvist nedsat koncentration af cirkulerende vaskulær endotelial vækstfaktor (VEGF) efter intravitreal anti-VEGF-behandling.
English: Progression-free survival*
Danish: Progressionsfri overlevelse*
English: The clinical benefit, as measured by overall survival, was seen in all prespecified 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 gevinst, 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: The addition of bevacizumab to fluoropyrimidine-based chemotherapy resulted in a statistically significant prolongation of survival in patients with mCRC who have progressed on a first-line bevacizumab-containing regimen (ITT = 819) (see table 9).
Danish: Tilføjelse af bevacizumab til fluoropyrimidin-baseret kemoterapi resulterede i statistisk signifikant forlænget overlevelse hos patienter med metastatisk kolorektalkræft, som progredierede på 1.linje bevacizumab-indeholdende regime (ITT = 819) (se tabel 9).
English: 3.7% of the overall randomised patient population had stage IIIB disease.
Danish: 3,7 % af den samlede randomiserede patientpopulation havde stadium III B-sygdom.
English: Clear to slightly opalescent, colourless to slightly yellow liquid.
Danish: Klar til let opaliserende, farveløs til let gul væske.
English: In addition, hypertension (including hypertensive crisis), elevated creatinine, and neurological symptoms were observed in some of these patients.
Danish: Derudover blev der hos nogle af disse patienter observeret hypertension (inklusive hypertensive kriser), forhøjet kreatinin og neurologiske symptomer.
English: The necessary amount of bevacizumab should be withdrawn and diluted to the required administration volume with sodium chloride 9 mg/mL (0.9%) solution for injection.
Danish: Den nødvendige mængde bevacizumab skal udtages og fortyndes til det ønskede administrationsvolumen med natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion.
English: These include a decreased number of white cells in the blood, in particular neutrophils (one type of white blood cell which helps protect against infections) in the blood; presence of protein in the urine; decreased blood potassium, sodium or phosphorous (a mineral); increased blood sugar; increased blood alkaline phosphatase (an enzyme); increased serum creatinine (a protein measured by a blood test to see how well your kidneys are working); decreased haemoglobin (found in red blood cells, which carry oxygen), which may be severe.
Danish: Disse inkluderer: Nedsat antal hvide blodceller, specielt neutrofile (en type hvide blodceller, som hjælper mod infektioner), protein i urinen, nedsat kalium, nedsat natrium eller nedsat fosfor (mineral) i blodet, øget sukker i blodet, øget basisk fosfatase (et enzym) i blodet, forhøjet serum-kreatinin (et protein, som måles ved en blodprøve og bruges til at vurdere din nyrefunktion), nedsat hæmoglobin (findes i røde blodceller, og som transporterer ilt), som kan være alvorlig.
English: The primary endpoint of this trial was progression-free survival (PFS), based on trial investigators' assessment of disease progression.
Danish: Det primære endepunkt for dette studie var progressionsfri overlevelse (PFS), baseret på studieinvestigatorernes vurdering af sygdomsprogression.
English: There have been rare reports of bevacizumab-treated patients developing signs and symptoms that are consistent with PRES, a rare neurologic disorder, which can present with the following signs and symptoms among others: seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Danish: Der har været sjældne tilfælde af bevacizumab-behandlede patienter, som har udviklet symptomer, der stemmer overens med PRES, en sjælden neurologisk forstyrrelse, som kan optræde med blandt andre følgende tegn og symptomer: kramper, hovedpine, forandret mental status, visuelle forstyrrelser eller kortikal blindhed, med eller uden tilknyttet hypertension.
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 5FU/FA-kemoterapi, er sammenfattet i tabel 5.
English: If too much MVASI is given
Danish: Hvis du har fået for meget MVASI
English: In the bevacizumab-containing arms, patients could receive bevacizumab as a single agent every 3 weeks until disease progression or unacceptable toxicity.
Danish: I bevacizumab-armen kunne patienter få bevacizumab som enkeltstofbehandling hver 3. uge indtil sygdomsprogression eller indtil uacceptabel toksicitet.
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: 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)- skanning.
English: • symptoms that suggest changes in normal brain function (headaches, vision changes, confusion, or seizures), and high blood pressure,
Danish: • symptomer, som tyder på ændringer i den normale hjernefunktion (hovedpine, synsforstyrrelser, forvirring eller kramper) og højt blodtryk,
English: • presence of protein in your urine accompanied by swelling of your body,
Danish: • protein i urinen, efterfulgt af hævelser på kroppen,
English: In published literature reports, cases of non-mandibular osteonecrosis have been observed in patients under the age of 18 years treated with bevacizumab.
Danish: I publicerede rapporter har tilfælde af ikke-mandibulær osteonekrose været observeret hos patienter under 18 år behandlet med bevacizumab.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/17/1246/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (NUMRE) EU/1/17/1246/001
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: MVASI has been developed and made to treat cancer by injecting it into the bloodstream.
Danish: MVASI er blevet udviklet og fremstillet til behandling af kræft efter injektion i blodbanen.
English: Pre-existing hypertension should be adequately controlled before starting MVASI treatment.
Danish: Allerede eksisterende hypertension skal være tilstrækkelig kontrolleret, inden MVASI-behandling påbegyndes.
English: In clinical trials with bevacizumab, congestive heart failure (CHF) was observed in all cancer indications studied to date, but occurred predominantly in patients with metastatic breast cancer.
Danish: I kliniske studier med bevacizumab blev kongestiv hjerteinsufficiens (CHF) observeret ved alle de kræftindikationer, som er undersøgt indtil videre, men forekom primært hos patienter med metastatisk brystkræft.
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 postoperative 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: MVASI is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Danish: MVASI administreres i kombination med et af følgende kemoterapiregimer: paclitaxel og cisplatin eller paclitaxel og topotecan.
English: Treatment of platinum-resistant recurrent disease: MVASI is administered in combination with one of the following agents - paclitaxel, topotecan (given weekly) or pegylated liposomal doxorubicin.
Danish: Behandling af platinresistent recidiverende sygdom: MVASI administreres i kombination med et af følgende stoffer - paclitaxel, topotecan (givet ugentligt) eller pegyleret liposomal doxorubicin.
English: In most clinical trials urine protein levels of ≥ 2g/24 hrs led to stopping treatment with bevacizumab until recovery to < 2g/24 hrs.
Danish: I de fleste kliniske studier medførte proteinkoncentrationer på ≥ 2 g/24 timer i urinen til seponering af behandlingen med bevacizumab, indtil der var nået et niveau på < 2 g/24 timer.