FrancophonIA/ELRC3.0 huggingface dataset:
English: Overall approximately 34% of patients were FIGO Stage III optimally debulked with gross residual disease, 40% Stage III sub-optimally 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 IV-patienter.
English: Necrotising fasciitisc
Danish: Nekrotiserende fasciitisc
English: • changes in speech,
Danish: • taleforstyrrelser,
English: The safety and efficacy of concomitant administration of radiotherapy and Avastin has not been established.
Danish: Strålebehandling Sikkerheden og effekten af samtidigt administreret strålebehandling og Avastin er ikke fastlagt.
English: If too much Avastin is given
Danish: Hvis du har fået for meget Avastin
English: • lesions in the gums with an exposed jaw bone that does not heal and may be associated with pain and inflammation of the surrounding tissue (see the paragraphs below the list of side effects for further recommendations),
Danish: • skader i tandkødet med en blotlagt kæbeknogle, der ikke heler; kan være forbundet med smerter og inflammation (betændelseslignende tilstand) i det omgivende væv (for yderligere anbefalinger se nedenfor efter bivirkningslisten),
English: a Hazard ratio was estimated from Cox proportional hazards models stratified by the duration of platinum free-interval prior to enrolling onto this study per eCRF (electronic case report form) and secondary surgical debulking status Yes/No
Danish: aHazard ratio blev estimeret ud fra Cox proportionelle hazard modeller stratificeret efter varighed af platinfri periode før inklusion i studiet per eCRF (electronic case report form) og sekundær kirurgisk tumorreduktionsstatus Ja/Nej.
English: Major or massive pulmonary haemorrhage/haemoptysis has been observed primarily in trials in patients with non-small cell lung cancer (NSCLC).
Danish: Alvorlig eller massiv pulmonal blødning/hæmoptyse er observeret fortrinsvis i studier med patienter med ikke-småcellet lungekræft (NSCLC).
English: Grade 3 proteinuria was reported in up to 10.9% of treated patients.
Danish: Der blev rapporteret grad 3 proteinuri hos op til 10,9 % af de behandlede patienter.
English: In clinical trials with Avastin, 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 Avastin blev kongestiv hjerteinsufficiens (CHF) observeret ved alle de kræftindikationer, som er undersøgt indtil videre, men forekom primært hos patienter med metastatisk brystkræft.
English: Patients with non-small cell lung cancer treated with Avastin may be at risk of serious, and in some cases fatal, pulmonary haemorrhage/haemoptysis.
Danish: Patienter med ikke små-cellet lungekræft, som behandles med Avastin, kan have risiko for svære og i visse tilfælde dødelige pulmonale blødninger/hæmoptyse.
English: Cases of Osteonecrosis of the Jaw (ONJ) have been reported in patients treated with Avastin, 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 Avastin, 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 percentage of patients who received Avastin in the open-label phase was 62.1% in the capecitabine + placebo arm and 49.9% in the capecitabine + Avastin arm.
Danish: Procentdelen af patienter, der fik åben behandling med Avastin, var 62,1 % i capecitabin + placebo-armen og 49,9 % i capecitabin + Avastin-armen.
English: Schedule
Danish: Tidsfrist
English: • decreased number of red cells in the blood,
Danish: • nedsat antal røde blodlegemer i blodet,
English: In order to improve the traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
Danish: Handelsnavnet og batchnummeret på det anvendte præparat skal registreres (eller anføres) tydeligt i patientens journal for at sikre sporbarheden af biologiske lægemidler.
English: Age was not associated with the pharmacokinetics of bevacizumab when body weight was taken into account.
Danish: Alder havde ingen indvirkning på bevacizumabs farmakokinetik, når der blev taget hensyn til legemsvægt.
English: Repeat dose toxicity studies in animals have shown that bevacizumab may have an adverse effect on female fertility (see section 5.3).
Danish: Toksicitetsstudier på dyr med gentagne doser har vist, at bevacizumab kan have en ugunstig virkning på hunners fertilitet (se pkt.
English: Patients were treated until disease progression.
Danish: Patienterne blev behandlet indtil progression af sygdommen.
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: In clinical trials, with the exception of study JO25567, the overall incidence of hypertension (all grades) ranged up to 42.1% in the Avastin 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 Avastin-armene sammenlignet med en hyppighed på op til 14 % i kontrolarmene.
English: Studies in animals have shown reproductive toxicity including malformations (see section 5.3).
Danish: Dyrestudier har vist reproduktionstoksicitet, inklusive malformationer (se pkt.
English: Do not use Avastin if you notice any particulate matter or discolouration prior to administration.
Danish: Brug ikke Avastin, hvis du opdager partikler eller misfarvning før indgift.
English: Secondary endpoints
Danish: Sekundære endepunkter
English: • a hole in the cartilage wall separating the nostrils of the nose,
Danish: • hul i skillevæggen mellem de to næsebor,
English: Response rates (for patients with measurable disease)
Danish: Responsrater (for patienter med målbar sygdom)
English: Toxicity and adverse reactions included arterial hypertension and fatigue as well as CNS ischaemia with acute neurological deficit.
Danish: Toksicitet og bivirkninger inkluderede arteriel hypertension og træthed samt CNS-iskæmi med akutte neurologiske udfald.
English: Intra-abdominal inflammatory process may be a risk factor for gastrointestinal perforations in patients with metastatic carcinoma of the colon or rectum, therefore, caution should be exercised when treating these patients.
Danish: En intra-abdominal inflammatorisk proces kan være en risikofaktor for gastrointestinal perforation hos patienter med metastatisk kolorektalkræft, og der skal derfor iagttages forsigtighed, når disse patienter behandles.
English: Avastin 10 mg/kg was given every 2 weeks until disease progression.
Danish: Der blev givet Avastin 10 mg/kg hver 2. uge indtil sygdomsprogession.
English: Trehalose dihydrate Sodium phosphate Polysorbate 20
Danish: Trehalosedihydrat Natriumphosphat Polysorbat 20
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: 1, the drug could be delivered as a 1-hour infusion.
Danish: Efter første behandlingsserie kan lægemidlet gives som en 1-times infusion.
English: • abnormal urine test (protein in the urine),
Danish: • unormal urintest (protein i blodet),
English: The efficacy data from trials AVF0780g and AVF2192g investigating Avastin in combination with 5-FU/FA-chemotherapy are summarised in Table 5.
Danish: Effektdata fra studierne AVF0780g og AVF2192g, som undersøgte Avastin i kombination med 5-FU/FA-kemoterapi, er sammenfattet i tabel 5.
English: FOLFOX-4 or XELOX + bevacizumab (n=699)
Danish: FOLFOX-4 eller XELOX + bevacizumab (n=699)
English: Avastin is also used for the treatment of adult patients with advanced non-small cell lung cancer when cancer cells have specific mutations of a protein called epidermal growth factor receptor (EGFR).
Danish: Avastin bruges også hos voksne til behandling af fremskreden ikke-småcellet lungekræft, når kræftcellerne har bestemte mutationer i et protein, der kaldes epidermal vækstfaktor-receptor (EGFR).
English: The trial met its primary objective of PFS improvement.
Danish: Studiet mødte sit primære mål for forbedring af PFS.
English: Once bevacizumab is bound to VEGF, tumour growth is prevented by blocking the growth of the blood vessels which provide the nutrients and oxygen to the tumour.
Danish: Når bevacizumab først er bundet til VEGF, forhindres tumoren i at vokse, idet væksten af de blodkar, som forsyner tumoren med næringsstoffer og ilt, blokeres.
English: The primary endpoint was progression-free survival based on investigator assessment using modified RECIST 1.0.
Danish: Det primære endepunkt var progressionfri overlevelse vurderet af investigator ved brug af modificeret RECIST 1.0.
English: The pharmacokinetics of bevacizumab was linear at doses ranging from 1 to 10 mg/kg.
Danish: Bevacizumabs farmakokinetik var lineær i dosisområdet 1 til 10 mg/kg.
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: 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 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: Congestive heart failure (CHF)
Danish: Kongestiv hjerteinsufficiens (CHF)
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 farmakokinetikblev 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: 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: Patients who have received taxane and anthracyclinecontaining regimens in the adjuvant setting within the last 12 months should be excluded from treatment with Avastin in combination with capecitabine.
Danish: Patienter, som har fået adjuverende behandling indeholdende taxan eller antracyklin inden for de sidste 12 måneder, bør udelukkes fra behandling med Avastin i kombination med capecitabin.
English: What Avastin contains
Danish: Avastin indeholder:
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 ºC til 30 ºC i natriumchlorid 9 mg/ml (0,9 %) opløsning til injektion.
English: ● It is possible that Avastin may increase the risk of developing holes in the gut wall.
Danish: • Det er muligt, at Avastin kan øge risikoen for, at der dannes huller i tarmvæggen.
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),
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: ● It is possible that Avastin can increase the risk of bleeding in your lungs, including coughing or spitting blood.
Danish: • Det er muligt, at Avastin kan øge risikoen for blødning i lungerne, herunder blodig hoste eller spyt.
English: Ninety seven (97) patients in the IFN alfa-2a arm and 131 patients in the Avastin 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 Avastin-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: Bevacizumab has been shown to be embryotoxic and teratogenic when administered to rabbits.
Danish: Det er vist, at bevacizumab er embryotoksisk og teratogent, når det gives til kaniner.
English: Front-line treatment of ovarian cancer
Danish: Frontlinjebehandling af ovariecancer
English: CT + BV arm. Information on race exists for 29.3% of patients and nearly all patients were white.
Danish: Der foreligger information om race for 29,3 % af patienterne, og næsten alle var kaukasiere.
English: Avastin in combination with interferon alfa-2a for the first-line treatment of advanced and/ or metastatic renal cell cancer (BO17705)
Danish: Avastin i kombination med interferon alfa-2a til 1.-linjebehandling af patienter med fremskreden og/eller metastatisk renalcellekarcinom (BO17705)
English: The 649 randomised patients (641 treated) had Karnofsky Performance Status (KPS) of ≥ 70%,
Danish: De 649 randomiserede patienter (641 behandlede) havde Karnofsky performancestatus (KPS) på ≥ 70 %, ingen CNS-metastaser og tilstrækkelig organfunktion.
English: Recurrence of cancer within the field of prior radiation is an additional important risk factor for the development of GI-vaginal fistulae.
Danish: Recidiv af kræft indenfor strålefeltet af den tidligere strålebehandling er yderligere en risikofaktor for udvikling af gastrointestinale-vaginale fistler.
English: Most patients who developed CHF during mBC trials showed improved symptoms and/or left ventricular function following appropriate medical therapy.
Danish: De fleste patienter, som udviklede CHF under studier af metastatisk brystkræft, udviste symptombedring og/eller forbedring af venstre ventrikels funktion efter passende medicinsk behandling.
English: There is no information on the safety profile of Avastin in patients with congenital bleeding diathesis, acquired coagulopathy or in patients receiving full dose of anticoagulants for the treatment of thromboembolism prior to starting Avastin treatment, as such patients were excluded from clinical trials.
Danish: Der findes ingen informationer om sikkerhedsprofilen af Avastin hos patienter med kongenit hæmoragisk diatese, erhvervet koagulationsdefekt eller hos patienter, som får fuld dosis af antikoagulantia for behandling af tromboemboli, før behandlingen med Avastin påbegyndes, da sådanne patienter ikke indgik i de kliniske studier.
English: Avastin is a concentrate for solution for infusion.
Danish: Avastin er et koncentrat til opløsning til infusion.
English: Overall response rate Rate (%)
Danish: Samlet responsrate Rate (procent)
English: Avastin has been developed and made to treat cancer by injecting it into the bloodstream.
Danish: Avastin er blevet udviklet og fremstillet til behandling af kræft efter injektion i blodbanen.
English: Response rate (for patients with measurable disease)b
Danish: Responsrate (for patienter med målbar sygdom)b
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 + Avastin, FOLFOX-4 + Avastin).
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 + Avastin, FOLFOX-4 + Avastin).
English: Detailed information on this medicine is available on the European Medicines Agency (EMA) web site: http://www.ema.europa.eu
Danish: Du kan finde yderligere oplysninger om Avastin på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu/.
English: Therapy should be permanently discontinued in patients who develop gastrointestinal perforation.
Danish: Behandlingen skal seponeres permanent hos patienter, som udvikler gastrointestinal perforation.
English: Table 1 provides all adverse reactions by frequency that were determined to have a causal relationship with Avastin through:
Danish: Tabel 1 viser frekvensen af alle bivirkninger, hvor der er fastslået årsagssammenhæng med Avastin gennem
English: ● you are allergic (hypersensitive) to Chinese hamster ovary (CHO) cell products or to other recombinant human or humanised antibodies.
Danish: • hvis du er allergisk over for celleprodukter fra kinesisk hamsterovarie (CHO) eller overfor andre rekombinante humane eller humaniserede antistoffer.
English: ● 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: FOLFOX-4 or XELOX + placebo (n=701)
Danish: FOLFOX-4 eller XELOX + placebo (n=701)
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 Avastin.
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 Avastin.
English: Clinical trials have shown that transient increases in serum creatinine (ranging between 1.5-1.9 times baseline level), both with and without proteinuria, are associated with the use of Avastin.
Danish: Kliniske studier har vist, at Avastinbehandlingen er forbundet med midlertidige stigninger i serumkreatinin (i intervallet 1,5-1,9 gange baseline-niveau), både med og uden proteinuri.
English: Tell your doctor if you are using platinum- or taxane-based therapies for lung or metastatic breast cancer.
Danish: Fortæl din læge, hvis du får en platin- eller taxan-baseret behandling til lungekræft eller til brystkræft, som har spredt sig.
English: 3 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: Biotransformation Assessment of bevacizumab metabolism in rabbits following a single IV dose of 125I-bevacizumab indicated that its metabolic profile was similar to that expected for a native IgG molecule which does not bind VEGF.
Danish: Vurdering af bevacizumabs metabolisme hos kaniner efter en intravenøs enkeltdosis af 125I-bevacizumab tyder på, at dets metaboliske profil svarer til, hvad der kan forventes af et nativt IgG-molekyle, som ikke binder VEGF.
English: Trial results show that 94% (277 / 296) of eligible patients went on to receive single agent bevacizumab at cycle 7.
Danish: Studieresultaterne viser, at 94 % (277/296) af de kvalificerede patienter kom i enkeltstofbehandling med bevacizumab ved serie 7.
English: Patients may be at increased risk for the development of fistulae when treated with Avastin.
Danish: Patienter kan have en øget risiko for udvikling af fistler, når de behandles med Avastin.
English: Avastin is administered in combination with one of the following chemotherapy regimens: paclitaxel and cisplatin or paclitaxel and topotecan.
Danish: Avastin administreres i kombination med et af følgende kemoterapiregimer: paclitaxel og cisplatin eller paclitaxel og topotecan.
English: Objective Response Rate 1
Danish: Objektiv responsrate 1
English: Therefore, the risk of CNS haemorrhage in such patients has not been prospectively evaluated in randomised clinical trials (see section 4.8).
Danish: Derfor er risikoen for CNS-blødning hos disse patienter ikke blevet undersøgt prospektivt i randomiserede kliniske studier (se pkt.
English: If you have headache, vision changes, confusion or seizure with or without high blood pressure, please contact your doctor.
Danish: Hvis du får hovedpine, synsforstyrrelser, bliver omtåget eller får kramper med eller uden forhøjet blodtryk, skal du kontakte lægen.
English: MAHA is a haemolytic disorder which can present with red cell fragmentation, anaemia, and thrombocytopenia.
Danish: MAHA er en hæmolytisk lidelse, som kan optræde med fragmentering af røde blodlegemer, anæmi og thrombocytopeni.
English: The primary efficacy parameter of the trial was the duration of progression-free survival.
Danish: Den primære effektparameter for studiet var varigheden af progressionsfri overlevelse.
English: Neutropenia and infections (see section 4.8)
Danish: Neutropeni og infektioner (se pkt.
English: • redness, peeling, tenderness, pain, or blistering on the fingers or feet,
Danish: • rødme, afskalning, ømhed, smerter eller blisterdannelse på fingre eller fødder,
English: Clinical safety data suggest that the incidence of hypertension is likely to be dose-dependent.
Danish: Kliniske sikkerhedsdata tyder på, at hyppigheden af hypertension sandsynligvis er dosisafhængig.
English: This phase III clinical trial compared rituximab/cyclophosphamide/doxorubicin/vincristine/prednisone (R-CHOP) plus bevacizumab to RCHOP without bevacizumab.
Danish: Dette kliniske fase III-studie sammenlignede rituximab/cyclophosphamid/doxorubicin/vincristin/prednison (R-CHOP) plus bevacizumab med RCHOP uden bevacizumab.
English: • an enlargement and weakening of a blood vessel wall or a tear in a blood vessel wall (aneurysms and artery dissections),
Danish: • en udvidelse og svækkelse af en blodårevæg eller en rift i en blodårevæg (aneurismer og arterielle dissektioner),
English: ● presence of protein in your urine accompanied by swelling of your body,
Danish: • protein i urinen, efterfulgt af hævelser på kroppen,
English: GI-vaginal Fistulae in study GOG-0240
Danish: Gastrointestinale-vaginale fistler i studie GOG-0240