FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with central nervous system metastases, including previously treated or resected brain lesions, were excluded.
Danish: Patienter med metastaser til centralnervesystemet, herunder tidligere behandlede eller resekterede hjernelæsioner, blev ekskluderet.
English: The patient characteristics were similar across the trial arms.
Danish: Patientkarakteristika var sammenlignelige på tværs af armene i studiet.
English: Observed effects included decreases in maternal and foetal body weights, an increased number of foetal resorptions and an increased incidence of specific gross and skeletal foetal malformations.
Danish: De observerede virkninger omfatter fald i maternel og føtal vægt, et øget antal af føtale resorptioner og en øget hyppighed af specifikke grove og skeletale misdannelser hos fostret.
English: Close observation of the patient during and following the administration of bevacizumab is recommended as expected for any infusion of a therapeutic humanised monoclonal antibody.
Danish: Omhyggelig monitorering af patienten anbefales under og efter administration af bevacizumab, som det forventes ved enhver infusion af et terapeutisk humaniseret monoklonalt antistof.
English: In addition, a prespecified analysis of the data censoring for CA-125 progression events was conducted, as well as an independent review of PFS as determined by radiological scans.
Danish: Yderligere blev en præspecificeret analyse med datacensurering for CA-125-progressioner udført såvel som en uafhængig vurdering af PFS fastlagt ved radiologiske scanninger.
English: Efficacy results for study JO25567
Danish: Effektresultater for studie JO25567
English: Metastatic breast cancer (mBC)
Danish: Metastatisk brystkræft (mBC)
English: Avastin contains the active substance bevacizumab, which is a humanised monoclonal antibody (a type of protein that is normally made by the immune system to help defend the body from infection and cancer).
Danish: Avastin indeholder det aktive stof bevacizumab, som er et humaniseret monoklonalt antistof (et type protein, som normalt laves af immunsystemet, og som hjælper med at beskytte kroppen mod infektioner og kræft).
English: ● It is possible that Avastin may cause bleeding in and around your brain.
Danish: • Det er muligt, at Avastin kan forårsage blødning i og omkring hjernen.
English: Avastin must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Danish: Avastin skal administreres under supervision af en læge med erfaring i anvendelse af antineoplastiske lægemidler.
English: The rate of infusion was based on tolerability, with an initial infusion duration of 90 minutes.
Danish: Infusionshastigheden afhang af tolerabiliteten, med en initial infusionsvarighed på 90 minutter.
English: No incompatibilities between Avastin and polyvinyl chloride or polyolefine bags or infusion sets have been observed.
Danish: Der er ikke observeret uforligeligheder mellem Avastin og polyvinylchlorid- eller polyolefinposer.
English: Tell your doctor straightaway if you are pregnant, become pregnant during treatment with this medicine, or plan to become pregnant in the near future.
Danish: Fortæl straks din læge, hvis du er gravid, bliver gravid under behandling med Avastin eller har planer at blive gravid.
English: Your doctor will prescribe a dose of Avastin that is right for you.
Danish: Din læge vil ordinere den Avastindosis, som passer til dig.
English: Median PFS (on treatment)**
Danish: Median PFS (i behandling)**
English: Table 2 provides the frequency of severe adverse reactions.
Danish: Tabel 2 viser frekvensen af alvorlige bivirkninger.
English: • increase in heart rate (pulse),
Danish: • forøgelse af hjerterytmen (pulsen),
English: Caution should be taken when treating these patients with Avastin.
Danish: Der skal iagttages forsigtighed, når disse patienter behandles med Avastin.
English: Adverse foetal outcomes were observed at all tested doses, of which the lowest dose resulted in average serum concentrations approximately 3 times larger than in humans receiving 5 mg/kg every 2 weeks.
Danish: Der blev observeret skadelige virkninger på fostret ved alle afprøvede doser, af hvilke den laveste dosis medførte middel-serumkoncentrationer, som var ca. 3 gange større end hos mennesker, som fik 5 mg/kg hver 2. uge.
English: In adults, the results showed no significant difference in the pharmacokinetics of bevacizumab in relation to age.
Danish: Hos voksne viste resultaterne ingen signifikante forskelle i bevacizumabs farmakokinetik i relation til alder.
English: Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 Avastin + FOLFOX-4 and 244 Avastin monotherapy).
Danish: 829 patienter blev randomiseret (292 FOLFOX-4, 293 Avastin + FOLFOX-4 og 244 Avastin monoterapi).
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all Avastin treated patients.
Danish: Der blev rapporteret dødelig udgang i ca. en tredjedel af de alvorlige tilfælde af gastrointestinal perforation, hvilket svarer til 0,2-1 % af alle Avastinbehandlede patienter.
English: These could be signs and symptoms of bone damage in the jaw (osteonecrosis).
Danish: Dette kan være tegn og symptomer på knogleskade i kæben (osteonekrose).
English: Vascular disorders 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: In an exploratory analysis, the extent of Avastin benefit on overall survival was less pronounced in the subgroup of patients who did not have adenocarcinoma histology.
Danish: I en eksplorativ analyse var omfanget af fordelene ved Avastin på den samlede overlevelse mindre udtalt i undergruppen af patienter, som ikke havde adenokarcinom-histologi.
English: • reduced blood supply to the brain or stroke,
Danish: • nedsat blodtilførsel til hjernen eller slagtilfælde,
English: 878 patients were randomised to the two arms.
Danish: 878 patienter blev randomiseret i de to arme.
English: Please tell your doctor if you have recently received, or are receiving, radiotherapy.
Danish: Fortæl det til din læge, hvis du får eller for nylig har fået strålebehandling.
English: • bleeding, including bleeding in the lungs in patients with non-small cell lung cancer,
Danish: • blødning, herunder blødning i lungerne hos patienter med ikke-småcellet lungekræft,
English: An independent review of the primary endpoint was also conducted.
Danish: En uafhængig gennemgang af det primære endepunkt blev også udført.
English: Pre-menopausal women (women who have a menstrual cycle) may notice that their periods become irregular or are missed and may experience impaired fertility.
Danish: Kvinder, som ikke er kommet i overgangsalderen (kvinder, som har en menstruationscyklus) kan opleve, at deres menstruation bliver uregelmæssig eller udebliver, og at deres frugtbarhed bliver nedsat.
English: A cross-trial comparison of the efficacy and safety data is limited by differences between these studies, most notably in patient populations, previous bevacizumab exposure and chemotherapy regimens.
Danish: Sammenligning af virknings- og sikkerhedsdata på tværs af studierne er begrænset af forskellene i studierne, især forskellene i patientpopulation, tidligere bevacizumab-eksponering og kemoterapi-regimer.
English: (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000); not known (cannot be estimated from the available data).
Danish: (≥ 1/10.000 til < 1/1.000), meget sjælden (< 1/10.000), ikke kendt (kan ikke estimeres ud fra tilgængelige data).
English: There is evidence suggesting that all Grade (US National Cancer InstituteCommon Terminology Criteria for Adverse Events [NCI-CTCAE v.3]) proteinuria may be related to the dose.
Danish: Der er evidens for, at alle grader af proteinuri (US National Cancer InstituteCommon Terminology Criteria for Adverse Event [NCI-CTCAE v.3]) kan være relateret til dosis.
English: Avastin is not approved for use in patients under the age of 18 years.
Danish: Avastin er ikke godkendt til anvendelse hos patienter under 18 år.
English: On documented disease progression, patients who entered the optional open-label phase could receive open-label Avastin together with a wide-range of second line therapies.
Danish: Ved dokumenteret sygdomsprogression kunne patienterne, som indgik i den valgfrie åbne fase, få åben behandling med Avastin sammen med en række forskellige 2. linjebehandlinger.
English: These efficacy data are consistent with the results from trial AVF2107g.
Danish: Disse effektdata er konsistente med resultaterne fra studie AVF2107g.
English: Please consult your doctor, even if these above statements were only applicable to you in the past.
Danish: Kontakt din læge, også selvom du kun tidligere har oplevet de ovennævnte tilstande.
English: *Bevacizumab is a recombinant humanised monoclonal antibody produced by DNA technology in Chinese Hamster Ovary cells.
Danish: *Bevacizumab er et rekombinant humaniseret monoklonalt antistof, som fremstilles ved DNAteknologi i ovarieceller fra kinesiske hamster.
English: In terms of safety, there was a higher overall incidence of Grade 3-5 AEs in study E3200 relative to study ML18147.
Danish: Med hensyn til sikkerheden var der overordnet en højere forekomst af grad 3-5 bivirkninger i E3200-studiet sammenlignet med ML18147-studiet.
English: Relative to the control arm; stratified hazard ratio.
Danish: I forhold til kontrolarmen; stratificeret hazard ratio.
English: Statistically significant improvements in progression-free survival and objective response rate were also observed (see Table 8).
Danish: Statistisk signifikante forbedringer i den progressionsfrie overlevelse og objektive responsrate sås også (se tabel 8).
English: Use of irinotecan- or oxaliplatin-containing regimen was switched depending on first-line usage of either oxaliplatin or irinotecan.
Danish: Anvendelse af irinotecan- eller oxaliplatin-indeholdende regime blev ændret afhængigt af 1.-linje-anvendelse af enten oxaliplatin eller irinotecan.
English: Depending on the dose prescribed for you, some or all of the contents of the Avastin vial will be diluted with sodium chloride solution before use.
Danish: Afhængig af den dosis, som er foreskrevet til dig, vil en del af indholdet i Avastinhætteglasset eller hele indholdet blive fortyndet med natriumchloridopløsning (saltvandsopløsning) før anvendelsen.
English: Avastin will be administered in combination with erlotinib.
Danish: Avastin vil blive givet sammen med erlotinib.
English: NR 25-75 percentile (months) 5.5 − NR 6.1 − NR 3.8 - 7.8 5.59 - 9.17 5.88 - 13.01
Danish: 5,5-NR 6,1-NR 3,8-7,8 5,59-9,17 5,88-13,01
English: F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Switzerland
Danish: F. Hoffmann-La Roche Ltd Grenzacherstrasse 124 CH-4070 Basel Schweiz
English: There is no information on the effect of Avastin in patients with uncontrolled hypertension at the time of initiating therapy.
Danish: Der foreligger ingen information om effekten af Avastin hos patienter, der har ukontrolleret hypertension ved behandlingens påbegyndelse.
English: Most patients were FIGO Stage III (both 68%) followed by FIGO Stage IV (13% and 14%), FIGO Stage II (10% and 11%) and FIGO Stage I (9% and 7%).
Danish: De fleste patienter var FIGO stadie III (68 % i begge), efterfulgt af FIGO stadie IV (13 % og 14 %), FIGO stadie II (10 % og 11 %) og FIGO stadie I (9 % og 7 %).
English: As Avastin may adversely impact wound healing, patients who had major surgery within the last 28 days were excluded from participation in phase III clinical trials.
Danish: Da Avastin kan påvirke sårheling negativt, blev patienter som havde fået foretaget større operationer indenfor de sidste 28 dage, ekskluderet fra deltagelse i kliniske studier i fase III.
English: An adverse effect on female fertility can however be expected as repeat dose toxicity studies in animals have shown inhibition of the maturation of ovarian follicles and a decrease/absence of corpora lutea and associated decrease in ovarian and uterus weight as well as a decrease in the number of menstrual cycles.
Danish: Der kan dog forventes en skadelig effekt på fertiliteten hos kvinder, da toksicitetsstudier på dyr med gentagne doser har vist hæmning af modningen af ovariefollikler og et fald/fravær af corpora lutea og ledsagende reduktion i vægten af ovarier og uterus samt et fald i antallet af menstruationscykler.
English: Table 2 also includes adverse reactions which are considered by the MAH to be clinically significant or severe.
Danish: Tabel 2 inkluderer også bivirkninger, som markedsføringsindehaver har vurderet som klinisk signifikante eller alvorlige.
English: A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anticancer therapies, which may have impacted the analysis of overall survival.
Danish: En stor del af patienterne (omkring 62 %) fik derefter forskellige anticancerbehandlinger uden for protokollen, hvilket kan have haft indflydelse på den samlede overlevelse.
English: Avastin use is not recommended in children and adolescents under the age of 18 years because the safety and benefit have not been established in these patient populations.
Danish: Det frarådes at anvende Avastin til børn og unge under 18 år, da sikkerheden og fordelene ved Avastin ikke er fastlagt hos denne patientgruppe.
English: Tables 1 and 2 list adverse reactions associated with the use of Avastin in combination with different chemotherapy regimens in multiple indications.
Danish: Tabel 1 og 2 opsummerer de bivirkninger, som er associeret til brugen af Avastin i kombination med forskellige kemoterapiregimer til flere forskellige indikationer.
English: Table 11 Efficacy results for study AVF3694g: - Capecitabinea and Avastin/Placebo (Cap + Avastin/Pl)
Danish: Effektresultater fra studie AVF3694g - Capecitabina og Avastin/placebo (Cap + Avastin/pl)
English: Do not use Avastin if:
Danish: Brug ikke Avastin:
English: Avastin should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Danish: Avastin bør fremstilles af en sundhedsfaglig person under anvendelse af aseptisk teknik for at sikre steriliteten af den fremstillede opløsning.
English: ● Avastin may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Danish: • Avastin kan øge risikoen for, at der dannes abnorme forbindelser eller passager mellem to organer eller blodårer.
English: Final overall survival analysis performed when 46.7% of the patients had died with data cut-off date of 31 March 2013.
Danish: Endelig OS-analyse udført, da 46,7 % af patienterne var døde, med data cut-off den 31. marts 2013.
English: Dose-reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of Avastin and IFN alfa-2a based on PFS event free rates over time, as shown by a sub-group analysis.
Danish: Dosisreduktion af IFN alfa-2a syntes ikke at påvirke effekten af kombinationen af Avastin og IFN alfa-2a, baseret på antal hændelser i tidsrummet for progressionsfri overlevelse, som er vist ved en undergruppeanalyse.
English: 3 One-sided log-rank p-value Subject to a p-value boundary of 0.0116.
Danish: Underlagt en p-værdigrænse på 0,0116.
English: If you have an allergic reaction, tell your doctor or a member of the medical staff straight away.
Danish: Hvis du får en allergisk reaktion, skal du med det samme fortælle det til din læge eller sundhedspersonalet.
English: Very rare cases of hypertensive encephalopathy have been reported, some of which were fatal.
Danish: Meget sjældne tilfælde af hypertensiv encefalopati er rapporteret, enkelte var dødelige.
English: A total of 452 patients were randomised to receive either:
Danish: Studiet omfattede i alt 452 patienter, der blev randomiseret til at få enten:
English: Common (affects 1 to 10 users in 100) side effects, which were not severe, include: • voice changes and hoarseness.
Danish: Almindelige bivirkninger (påvirker 1 til 10 patienter ud af 100), som ikke er alvorlige, omfatter: • ændringer i stemmen og hæshed.
English: In studies of up to 26 weeks duration in cynomolgus monkeys, physeal dysplasia was observed in young animals with open growth plates, at bevacizumab average serum concentrations below the expected human therapeutic average serum concentrations.
Danish: I studier af op til 26 ugers varighed på cynomolgus aber observeredes vækstforstyrrelser hos unge dyr med åbne vækstzoner efter bevacizumab middel-serumkoncentrationer under den forventede humane terapeutiske middel-serumkoncentration.
English: Your doctor should advise you about using contraception during treatment with Avastin and for at least 6 months after the last dose of Avastin.
Danish: Din læge bør vejlede dig om anvendelsen af prævention under behandlingen med Avastin og i mindst 6 måneder efter sidste Avastindosis.
English: Avastin therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Danish: Avastin bør seponeres hos patienter, der udvikler nekrotiserende fasciitis og relevant behandling straks påbegyndes.
English: Median (months)
Danish: Median (måneder)
English: Median PFS (months)
Danish: Median PFS (måneder)
English: Avastin should be permanently discontinued if medically significant hypertension cannot be adequately controlled with antihypertensive therapy, or if the patient develops hypertensive crisis or hypertensive encephalopathy.
Danish: Avastin skal seponeres permanent, hvis en klinisk signifikant hypertension ikke kan kontrolleres tilstrækkeligt med standard antihypertensionsbehandling, eller hvis patienten udvikler hypertensiv krise eller hypertensiv encefalopati.
English: Tell your doctor and dentist immediately if you experience any of them.
Danish: Fortæl straks din læge og tandlæge, hvis du oplever nogle af ovenstående symptomer.
English: The administration of Avastin should be temporarily discontinued
Danish: Behandlingen med Avastin skal midlertidigt afbrydes
English: The pharmacokinetic data for bevacizumab are available from ten clinical trials in patients with solid tumours.
Danish: De farmakokinetiske data for bevacizumab stammer fra 10 kliniske studier hos patienter med solide tumorer.
English: XELOX or XELOX + Avastin
Danish: XELOX eller XELOX + Avastin
English: The majority of patients (CP: 64.6%; CPB: 68.8%) were in the age category < 65 years.
Danish: Størstedelen af patienterne (CP: 64,6 %; CPV: 68,8 %) var < 65 år.
English: • dry mouth in combination with thirst and/or reduced or darkened urine,
Danish: • mundtørhed kombineret med tørst og/eller nedsat urinmængde eller mørkfarvet urin,
English: ● This medicine may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Danish: • Avastin kan forårsage infektioner og nedsætte antallet af neutrofiler (en type blodceller, som er vigtige for at beskytte dig mod bakterier).
English: Please consult your doctor if you or your family tend to suffer from bleeding problems or you are taking medicines to thin the blood for any reason.
Danish: Kontakt din læge, hvis du eller din familie har tendens til blødningsproblemer, eller hvis du tager blodfortyndende medicin.
English: Alternatively, a 1.25 mg/m2 dose could be administered over 30 minutes on Days 1-5
Danish: Alternativt kan en dosis på 1,25 mg/m2 administreres over 30 minutter på dag 1-5 hver 3. uge.
English: Pre-existing hypertension should be adequately controlled before starting Avastin treatment.
Danish: Allerede eksisterende hypertension skal være tilstrækkelig kontrolleret, inden Avastinbehandling påbegyndes.
English: You must not breast-feed your baby during treatment with Avastin and for at least 6 months after the last dose of Avastin, as this medicine may interfere with the growth and development of your baby.
Danish: Du må ikke amme under behandling med Avastin og i mindst 6 måneder efter sidste Avastindosis, da Avastin kan påvirke væksten og udviklingen af dit barn.
English: Keep the vial in the outer carton in order to protect from light.
Danish: Opbevar hætteglas i den ydre karton for at beskytte mod lys.
English: A dental examination and appropriate preventive dentistry should be considered prior to starting the treatment with Avastin.
Danish: Tandundersøgelse og passende forebyggende tandbehandling bør overvejes før behandling med Avastin.
English: ● if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with Avastin, in particular when you are also receiving or have received an injection of bisphosphonate into your blood.
Danish: • hvis du behøver invasiv tandbehandling (f.eks. tandudtrækning) eller en tandoperation, skal du fortælle din tandlæge, at du er i behandling med Avastin, især hvis du også bliver eller er blevet behandlet med bisfosfonater, som injektion i blodet.
English: Ask your doctor, pharmacist or nurse for advice before taking any medicine.
Danish: Spørg lægen, apotekspersonalet eller sundhedspersonalet til råds, før du tager nogen form for medicin.
English: Q2 2019
Danish: 2. kvartal 2019
English: Adverse reactions are added to the appropriate frequency category in the tables below according to the highest incidence seen in any indication.
Danish: I tabellerne er bivirkningerne anført under den relevante frekvenskategori i henhold til den højeste frekvens, som observeredes ved nogen indikation.
English: Time from last platinum therapy to recurrence
Danish: Tid fra sidste platinbehandling indtil recidiv
English: New cases of ovarian failure were reported in 2.6% patients in the mFOLFOX-6 group compared to 39% in the mFOLFOX-6 + bevacizumab group.
Danish: Nye tilfælde af ovariesvigt blev rapporteret hos 2,6 % af patienterne i mFOLFOX-6-gruppen sammenlignet med 39 % i mFOLFOX-6 plus bevacizumab-gruppen.
English: Progression-free survival and objective response rate were inferior in the Avastin monotherapy arm compared to the FOLFOX-4 arm.
Danish: Progressionsfri overlevelse og objektiv responsrate var inferior i Avastin monoterapi-armen i forhold til FOLFOX-4armen.
English: In all clinical trials, bevacizumab was administered as an IV infusion.
Danish: I alle kliniske studier blev bevacizumab administreret som en intravenøs infusion.
English: The typical value for central volume (Vc) was 2.73 L and 3.28 L for female and male patients respectively, which is in the range that has been described for IgGs and other monoclonal antibodies.
Danish: Den typiske værdi for centralt volumen (Vc) var 2,73 l og 3,28 l for henholdsvis kvindelige og mandlige patienter, hvilket ligger på samme niveau som beskrevet for IgG´er og andre monoklonale antistoffer.
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: Date of latest renewal: 14 January 2015
Danish: Dato for første markedsføringstilladelse: 12. januar 2005 Dato for seneste fornyelse: 14. januar 2015
English: In patients who experienced wound healing complications during therapy, treatment should be withheld until the wound is fully healed.
Danish: Hos patienter, som udvikler problemer med sårheling under behandlingen, bør behandlingen seponeres indtil såret er fuldstændig helet.
English: In most cases hypertension was controlled adequately using standard antihypertensive treatment appropriate for the individual situation of the affected patient.
Danish: I de fleste tilfælde kunne hypertensionen kontrolleres tilstrækkeligt ved anvendelse af standard antihypertensionsbehandling, der er tilpasset den individuelle situation og patient.