FrancophonIA/ELRC3.0 huggingface dataset:
English: During the blinded treatment phase, patients received chemotherapy and medicinal product (Avastin or placebo) every 3 weeks until disease progression, treatment-limiting toxicity, or death.
Danish: Under den blindede behandlingsfase fik patienterne kemoterapi og lægemiddel (Avastin eller placebo) hver 3. uge indtil sygdomsprogression, behandlingsbegrænsende toksicitet eller død.
English: An increased incidence of hypertension was observed in Avastin-treated patients.
Danish: Der er observeret øget forekomst af hypertension hos Avastinbehandlede patienter.
English: OTHER SPECIAL WARNING(S), IF NECESSARY This medicinal product does not contain any preservative
Danish: EVENTUELLE ANDRE SÆRLIGE ADVARSLER Dette lægemiddel indeholder ikke konserveringsmiddel
English: Bevacizumab binds selectively to a protein called human vascular endothelial growth factor (VEGF), which is found on the lining of blood and lymph vessels in the body.
Danish: Bevacizumab bindes selektivt til et protein, som kaldes human vaskulær endotelial vækstfaktor (VEGF), som findes på indersiden af blod- og lymfekar i kroppen.
English: The findings ranged from asymptomatic declines in left ventricular ejection fraction to symptomatic CHF, requiring treatment or hospitalisation.
Danish: Fundene spændte fra asymptomatisk fald i venstre ventrikels uddrivningsfraktion til symptomatisk CHF, der krævede behandling eller indlæggelse.
English: Please let your doctor, pharmacist or nurse know if you have previously experienced problems after injections, such as dizziness/feeling of fainting, breathlessness, swelling or skin rash.
Danish: Fortæl lægen, apotekspersonalet eller sundhedspersonalet, hvis du tidligere har oplevet problemer efter injektioner, såsom svimmelhed/fornemmelse af at besvime, kortåndethed, hævelse eller hududslæt.
English: The analysis of the primary endpoint showed no difference between the Avastin + Placebo arm and the Avastin + Erlotinib arm (median PFS 8.5 versus 9.9 months).
Danish: Analysen af primært endepunkt viste ingen forskel mellem Avastin + placeboarmen og Avastin + erlotinib-armen (median progressionsfri overlevelse 8,5 vs 9,9 måneder).
English: Reactions consistent with CHF were reported in clinical trials.
Danish: Bivirkninger, som er forenelige med CHF, er rapporteret i kliniske studier.
English: 15.5% had received prior radiotherapy and 28.4% prior chemotherapy.
Danish: 15,5 % havde tidligere fået strålebehandling, og 28,4 % havde tidligere fået kemoterapi.
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: Terms represent a group of events that describe a medical concept rather than a single condition or MedDRA (Medical Dictionary for Regulatory Activities) preferred term.
Danish: Termerne repræsenterer grupperede bivirkninger, der beskriver et medicinsk koncept frem for en enkelttilstand eller MedDRA (Medical Dictionary for Regulatory Activities) foretrukne term.
English: The observed increase in serum creatinine was not associated with a higher incidence of clinical manifestations of renal impairment in patients treated with Avastin.
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 Avastin.
English: Avastin is contraindicated in pregnancy (see section 4.3).
Danish: Avastin er kontraindiceret under graviditet (se pkt.
English: The majority of patients had serous adenocarcinoma histologic type (85% in CPP and CPB15, 86% in CPB15+).
Danish: Størstedelen af patienterne havde serøs histologisk type af adenokarcinom (85 % i CPP og CPB15, 86 % i CPB15+).
English: The addition of Avastin to IFL resulted in statistically significant increases in overall survival, progression-free survival and overall response rate (see Table 4).
Danish: Tillæg af Avastin 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: Advanced and/or metastatic renal cell cancer (mRCC)
Danish: Fremskreden og/eller metastatisk renalcellekarcinom (mRCC)
English: Therefore fertility preservation strategies should be discussed with women of child-bearing potential prior to starting treatment with Avastin.
Danish: Fertilitetsbevarende strategier bør derfor drøftes med kvinder i den fertile alder før igangsættelse af Avastinbehandling.
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: 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: Statistical analyses were performed independently for 1) patients who received capecitabine in combination with Avastin or placebo; 2) patients who received taxane-based or anthracycline-based chemotherapy in combination with Avastin or placebo.
Danish: Statistiske analyser blev udført uafhængigt for 1) patienter, som fik capecitabin i kombination med Avastin eller placebo; 2) patienter, som fik taxanbaseret eller antracyklinbaseret kemoterapi i kombination med Avastin eller placebo.
English: Please discuss this with your doctor if you have metastatic cancer affecting your brain.
Danish: Tal med din læge, hvis du har kræftspredning, som påvirker hjernen.
English: Avastin has no or negligible influence on the ability to drive and use machines.
Danish: Avastin påvirker ikke eller kun i ubetydelig grad evnen til at føre motorkøretøj og betjene maskiner.
English: ● any severe bleeding.
Danish: • svær blødning.
English: All treatments were continued until disease progression.
Danish: Alle behandlinger fortsatte indtil sygdomsprogression.
English: The highest dose tested in humans (20 mg/kg of body weight, intravenous every 2 weeks) was associated with severe migraine in several patients.
Danish: Den højeste dosis, som blev afprøvet på mennesker (20 mg/kg legemsvægt, intravenøst hver 14. dag), var forbundet med svær migræne hos flere patienter.
English: Neutralising the biological activity of VEGF regresses the vascularisation of tumours, normalises remaining tumour vasculature, and inhibits the formation of new tumour vasculature, thereby inhibiting tumour growth.
Danish: Neutralisering af VEGF's biologiske aktivitet hæmmer vaskulariseringen af tumorer, normaliserer den tilbageblevne tumorvaskulatur, hæmmer dannelsen af ny tumorvaskulatur og hæmmer derved tumorvæksten.
English: EGFR mutation testing should be performed prior to initiation of treatment with the combination of Avastin and erlotinib.
Danish: Der skal udføres EGFR-mutationstest før igangsættelse af kombinationsbehandling med Avastin og erlotinib.
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: • feeling weak and having no energy,
Danish: • svaghedsfølelse og mangel på energi,
English: Presentation may include seizures, headache, altered mental status, visual disturbance, or cortical blindness, with or without associated hypertension.
Danish: Symptomerne kan inkludere kramper, hovedpine, forandret mental status, visuelle forstyrrelser eller kortikal blindhed, med eller uden tilknyttet hypertension.
English: Monitoring of blood pressure is generally recommended during therapy.
Danish: Det anbefales at kontrollere blodtrykket under behandlingen.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/04/300/001 - 100 mg/4 ml vial EU/1/04/300/002 - 400 mg/16 ml vial
Danish: MARKEDSFØRINGSTILLADELSESNUMRE EU/1/04/300/001 - 100 mg/4 ml hætteglas EU/1/04/300/002 - 400 mg/16 ml hætteglas
English: Store in a refrigerator (2°C-8°C).
Danish: Opbevares i køleskab (2 ºC - 8 °C).
English: In this trial, there were two primary objectives: to show that XELOX was non-inferior to FOLFOX-4 and to show that Avastin 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 Avastin i kombination med FOLFOX-4 eller XELOX kemoterapi var bedre i forhold til kemoterapi alene.
English: Bevacizumab binds to vascular endothelial growth factor (VEGF), the key driver of vasculogenesis and angiogenesis, and thereby inhibits the binding of VEGF to its receptors, Flt-1 (VEGFR-1) and KDR (VEGFR-2), on the surface of endothelial cells.
Danish: Bevacizumab binder til vaskulær endotelial vækst faktor (VEGF), som er den primære faktor i vaskulogenesen og angiogenesen og hæmmer derved bindingen af VEGF til dets receptorer, Flt-1 (VEGFR-1) og KDR (VEGFR-2), på overfladen af endotelceller.
English: The only variables that showed statistically significant correlations with bleeding were Avastin therapy and squamous cell histology.
Danish: De eneste faktorer, som viste statistisk signifikant sammenhæng med blødning, var Avastinbehandling og planocellulær histologi.
English: The side effects listed below were seen when Avastin was given together with chemotherapy.
Danish: De bivirkninger, der er vist nedenfor, blev observeret, når Avastin blev givet sammen med kemoterapi.
English: No significant difference was observed in the duration of overall survival between patients who received Avastin monotherapy compared to patients treated with FOLFOX-4.
Danish: Der blev ikke observeret nogen signifikant forskel i varighed af overlevelse hos patienter, der modtog Avastin monoterapi i forhold til patienter, som blev behandlet med FOLFOX-4.
English: Parenteral medicinal products should be inspected visually for particulate matter and discolouration prior to administration.
Danish: Parenterale lægemidler bør inspiceres visuelt for partikler og misfarvning før anvendelse.
English: If you experience symptoms that affect your vision or concentration, or your ability to react, do not drive and use machines until symptoms disappear.
Danish: Hvis du oplever symptomer, som påvirker dit syn eller din koncentrationsevne eller din reaktionsevne, skal du lade være med at køre bil og betjene maskiner, før symptomerne er forsvundet.
English: When used for patients with kidney cancer, it will be administered with another type of medicine called interferon.
Danish: Når det anvendes til patienter med nyrekræft, bliver det givet sammen med en anden type medicin, som kaldes interferon.
English: Ovarian failure/fertility
Danish: Ovariesvigt/fertilitet
English: Prior anthracyclines exposure and/or prior radiation to the chest wall may be possible risk factors for the development of CHF.
Danish: Tidligere eksponering for antracykliner og/eller strålebehandling af brystvæggen kan være mulige risikofaktorer for udvikling af CHF.
English: Four patients had objective (partial) response, and all of these had received the 10 mg/kg dose bevacizumab; the ORR for the 10 mg/kg dose was 10%.
Danish: Fire patienter viste objektiv (partiel) respons og alle de patienter modtog 10 mg/kg bevacizumab; samlet responsrate for 10 mg/kg var 10 %.
English: • diarrhoea,
Danish: • diarré,
English: The risk of Avastin-associated hypertension did not correlate with the patients' baseline characteristics, underlying disease or concomitant therapy.
Danish: Risikoen for Avastinassocieret hypertension korrelerede ikke med patienternes baseline-karakteristika, med den underliggende sygdom eller med anden samtidig behandling.
English: You should seek help immediately if you suffer from any of the below mentioned side effects.
Danish: Du skal omgående søge hjælp, hvis du får en af de nedenfor anførte bivirkninger.
English: • blood clot in the arteries which can lead to a stroke or a heart attack,
Danish: • blodprop i arterierne, som kan resultere i slagtilfælde eller hjertetilfælde,
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 vækstfaktor receptor 2- (HER2) status.
English: However, sleepiness and fainting have been reported with Avastin use.
Danish: Alligevel er der rapporteret søvnighed og besvimelse ved anvendelse af Avastin.
English: You may be advised to have a dental check-up before you start treatment with Avastin.
Danish: Du kan blive rådet til at få foretaget et tandeftersyn, før du starter i behandling med Avastin.
English: The concentrate is a clear, colourless to pale brown liquid in a glass vial with a rubber stopper.
Danish: Koncentratet er en klar, farveløs til lysebrun væske i et hætteglas af glas med gummilukke.
English: Patients should be monitored for signs and symptoms of CNS bleeding, and Avastin treatment discontinued in cases of intracranial bleeding.
Danish: Patienter skal overvåges for tegn og symptomer på CNS-blødning, og behandling med Avastin skal seponeres i tilfælde af intrakranial blødning.
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: In the majority of the occasions the necessary amount of Avastin 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 Avastin blive fortyndet med 0,9 % natriumchlorid opløsning til injektion op til 100 ml (total volume).
English: Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Danish: Der er ikke foretaget studier for at evaluere Avastins carcinogene og mutagene potentiale.
English: was initiated prior to documented progression; data from those patients were censored at the last tumour assessment prior to starting NPT.
Danish: Data fra disse patienter blev censored ved sidste tumorvurdering inden start af NPT.
English: An unstratified analysis of PFS (investigator assessed) was performed that did not censor for nonprotocol therapy prior to disease progression.
Danish: Der blev udført en ustratificeret analyse af PFS (vurderet af investigator), som ikke var censored for non-protokolleret terapi inden sygdomsprogression.
English: ● Avastin can increase the incidence of high blood pressure.
Danish: • Avastin kan øge hyppigheden af forhøjet blodtryk.
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, pancreas and prostate.
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: • Seeing flashes of light with floaters, progressing to a loss of some of your vision,
Danish: • lysglimt, som bevæger sig som ”flyvende fluer”, og som udvikler sig til tab af noget af synet,
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 interim analyse 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: Individual cases and clusters of serious ocular adverse reactions have been reported following unapproved intravitreal use of Avastin 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 Avastin i hætteglas godkendt til intravenøs administration til kræftpatienter.
English: • shortness of breath or low levels of oxygen in the blood,
Danish: • kortåndethed eller lavt indhold af ilt i blodet,
English: The efficacy results of Avastin in combination with IFL-chemotherapy are displayed in Table 4.
Danish: Resultaterne for effekt af Avastin i kombination med IFL-kemoterapi fremgår af tabel 4.
English: Table 7 Key efficacy results for the superiority analysis (ITT population, trial NO16966) Endpoint (months)
Danish: Nøgletal for effektresultater af superioritets-analysen (ITT Population, studie NO16966)
English: In this trial arterial thromboembolic reactions were observed in 11% (11/100) of patients compared to 5.8% (6/104) in the chemotherapy control group.
Danish: I dette studie blev der observeret arterielle tromboemboliske bivirkninger hos 11 % (11/100) af patienterne i forhold til 5,8 % (6/104) i kemoterapikontrolgruppen.
English: Objective Response Rate**
Danish: Objektiv responsrate**
English: Avastin has not been shown to reduce your ability to drive or to use any tools or machines.
Danish: Det er ikke påvist, at Avastin nedsætter din evne til at køre bil eller betjene maskiner.
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: L01XC07
English: During the trial, of the patients who received trial treatment, 32.2% (136/422) of patients received 7-12 administrations of Avastin and 21.1% (89/422) of patients received 13 or more administrations of Avastin.
Danish: Af de patienter, der i løbet af studiet modtog studiebehandling, modtog 32,2 % (136/422) af patienterne 7-12 administrationer af Avastin, og 21,1 % (89/422) af patienterne modtog 13 eller flere administrationer af Avastin.
English: ● Periodic Safety Update Reports
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR´er)
English: These therapies in combination with Avastin may increase the risk of severe side effects.
Danish: Kombination af Avastin og disse behandlinger kan øge risikoen for alvorlige bivirkninger.
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 Avastin 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 Avastinbehandlingen.
English: Secondary endpoints included overall survival, response rate, disease control rate, duration of response, and safety.
Danish: De sekundære endepunkter inkluderede samlet overlevelse, responsrate, sygdomskontrolrate, responsvarighed og sikkerhed.
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 Avastin (angivet i punkt 6).
English: Conclusions on the impact of bevacizumab on gemcitabine pharmacokinetics cannot be drawn.
Danish: Der kan ikke drages konklusion vedrørende bevacizumabs påvirkning af gemcitabins farmakokinetik.
English: The signs may include: difficulty in breathing or chest pain.
Danish: Symptomerne kan inkludere vejrtrækningsbesvær eller brystsmerter.
English: In a phase III trial in the adjuvant treatment of patients with colon cancer, a substudy with premenopausal women has shown a higher incidence of new cases of ovarian failure in the bevacizumab group compared to the control group.
Danish: I et fase III-studie med adjuverende behandling hos patienter med coloncancer har et substudie med præmenopausale kvinder vist en højere hyppighed af nye tilfælde af ovariesvigt i bevacizumab-gruppen sammenlignet med kontrolgruppen.
English: In both studies, bevacizumb exposure trended lower as body weight decreased.
Danish: I begge studier var der en tendens til, at eksponeringen var lavere ved lavere legemsvægt.
English: This has mainly been seen in combination with platinum- or taxane-based therapies in the treatment of NSCLC, mBC, and in combination with paclitaxel and topotecan in persistent, recurrent, or metastatic cervical cancer.
Danish: Dette er hovedsageligt blevet observeret i kombination med platin- eller taxanbaserede terapier i behandlingen af NSCLC, mBC og i kombination med paclitaxel og topotecan i behandlingen af persisterende, recidiverende eller metastatisk cervixcancer.
English: The median age of patients was 61.0 (range: 25−84) years.
Danish: Patienternes medianalder var 61,0 år (spændevidde 25-84).
English: ● if you have problems with wound healing following surgery,
Danish: • hvis du har problemer med sårheling efter en operation,
English: The safety of reinitiating Avastin therapy in patients previously experiencing PRES is not known.
Danish: Sikkerheden ved at genoptage behandlingen med Avastin hos patienter, der tidligere har udviklet PRES, er ikke kendt.
English: At baseline, most patients in both treatment arms had a GOG PS of 0 (CP: 82.4%: CPB; 80.7%) or 1 (CP: 16.7%: CPB; 18.1%).
Danish: Ved baseline havde de fleste patienter i begge behandlingsarme en GOG PS på 0 (CP: 82,4 %; CPB: 80,7 %) eller 1 (CP: 16,7 %; CPB: 18,1 %).
English: METHOD OF ADMINISTRATION For intravenous use after dilution
Danish: ADMINISTRATIONSMETODE Til intravenøs anvendelse efter fortynding
English: Overall approximately 50% of patients had a GOG PS of 0 at baseline, 43% a GOG PS score of 1, and 7% a GOG PS score of 2.
Danish: Samlet set havde ca. 50 % af patienterne en GOGperformancestatus (PS)-score på 0 ved baseline, 43 % en GOG PS-score 1 og 7 % en GOG PS score på 2.
English: Additional endpoints included objective response, duration of response, overall survival and safety.
Danish: Yderligere endepunkter inkluderede objektivt respons, responsvarighed, samlet overlevelse og sikkerhed.
English: IRF assessment
Danish: IRF vurdering
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: For instructions on dilution of the medicinal product before administration, see section 6.6.
Danish: For instruktion i fortynding af lægemidlet før administration, se pkt.
English: Day 1, prior to XELOX, q 3 weeks
Danish: Dag 1, før XELOX, hver 3. uge
English: Due date the MAH should discuss any further outcome data on the combination of bevacizumab + erlotinib in this indication (e.g. data from the ongoing ACCRU study, NCT number NCT01532089) (due date: Q2 2019)
Danish: Indehaveren af markedsføringstilladelsen skal diskutere andre resultater for kombinationen bevacizumab + erlotinib for denne indikation (f.eks. data fra det igangværerende ACCRU-studie, NCT-nummer NCT01532089)
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: 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: A doctor or nurse will give you this diluted Avastin solution by intravenous infusion (a drip into your vein).
Danish: Du vil få den fortyndede Avastinopløsning af en læge eller sygeplejerske ved intravenøs infusion (et drop i din vene).