FrancophonIA/ELRC3.0 huggingface dataset:
English: Before initiating MVASI, this risk should be carefully considered in patients with risk factors such as hypertension or history of aneurysm.
Danish: Inden indledning af behandling med MVASI bør denne risiko overvejes nøje for patienter med risikofaktorer såsom hypertension eller tidligere aneurisme.
English: There are no clinical trial data on the use of bevacizumab in pregnant women.
Danish: Der er ingen data fra kliniske studier om anvendelse af bevacizumab til gravide kvinder.
English: 95% CI for one sample binomial using Pearson-Clopper method.
Danish: 95 % konfidensinterval for one sample binomial ved brug af Pearson-Clopper metoden.
English: The population pharmacokinetics were analysed in adult and paediatric patients to evaluate the effects of demographic characteristics.
Danish: Populationsfarmakokinetiske data hos voksne og pædiatriske patienter blev analyseret for at evaluere virkningen af demografiske karakteristika.
English: Low albumin and high tumour burden are generally indicative of disease severity.
Danish: Generelt er lav albumin og høj tumorbyrde indikativ for sygdommens sværhedsgrad.
English: High-grade glioma
Danish: Høj-grads-gliom
English: Patients may be at risk of developing infusion/hypersensitivity reactions.
Danish: Der er risiko for, at patienterne udvikler infusions-/overfølsomhedsreaktioner.
English: A total of 484 patients with measurable disease were randomised 1:1 to either:
Danish: I alt 484 patienter med målbar sygdom blev randomiseret 1:1 til enten:
English: It is recommended that the treatment with MVASI in addition to erlotinib is continued until disease progression.
Danish: Det anbefales, at behandling med MVASI i tillæg til erlotinib fortsættes indtil sygdomsprogression.
English: Patients with recent pulmonary haemorrhage/haemoptysis (> 2.5 mL of red blood) should not be treated with bevacizumab.
Danish: Patienter med nylig pulmonal blødning/hæmoptyse (> 2,5 ml rødt blod) bør ikke behandles med bevacizumab.
English: However two of the randomised patients discontinued the study before receiving any study treatment.
Danish: To af de randomiserede patienter forlod i studiet før de fik studiemedicin.
English: Primary analysis was performed with a data cut-off date of 12 December 2012 and is considered the final analysis.
Danish: Primær-analyse blev udført ved data cut-off 12. december 2012 og betragtes som den endelige analyse.
English: If you are going to have an operation, if you have had major surgery within the last 28 days or if you still have an unhealed wound following surgery, you should not receive this medicine.
Danish: Hvis du skal opereres, hvis du har fået foretaget en større operation indenfor de sidste 28 dage, eller hvis du har et sår efter en operation, som ikke er helet, må du ikke få MVASI.
English: In order to improve the traceability of this medicine, your doctor or pharmacist should record the tradename and the lot number of the product you have been given in your patient file.
Danish: For at forbedre sporbarheden af denne medicin skal din læge eller apotekspersonalet registrere handelsnavn og lotnummer på det produkt, du har fået, i din journal.
English: • MVASI can increase the risk of developing a weak heart.
Danish: • MVASI kan øge risikoen for at udvikle et svagt hjerte.
English: One-sided log-rank p-value.
Danish: Ensidig log-rank p-værdi.
English: Summarised below are PFS results:
Danish: Resultaterne for PFS er opsummeret nedenfor:
English: Your doctor will prescribe a dose of MVASI that is right for you.
Danish: Din læge vil ordinere den MVASI-dosis, som passer til dig.
English: However, sleepiness and fainting have been reported with MVASI use.
Danish: Alligevel er der rapporteret søvnighed og besvimelse ved anvendelse af MVASI.
English: After cycle 1, the medicinal product could be delivered as a 1-hour infusion.
Danish: Efter første behandlingsserie kan lægemidlet gives som en 1-times infusion.
English: Among the 110 patients randomised to Arm 3 (5-FU/FA + bevacizumab) prior to discontinuation of this arm, the median overall survival was 18.3 months and the median progression-free survival was 8.8 months.
Danish: Blandt de 110 patienter randomiseret til arm 3 (5-FU/FA + bevacizumab) inden lukning af denne arm, var den mediane samlede overlevelse 18,3 måneder og den mediane progressionsfri overlevelse var 8,8 måneder.
English: MVASI infusions should not be administered or mixed with glucose solutions.
Danish: Infusionsvæsker med MVASI bør ikke administreres eller blandes med glucoseopløsninger.
English: Approximate 95% CI for difference of two rates using Hauck-Anderson method.
Danish: Ca. 95 % konfidensinterval for forskel mellem to rater ved brug af Hauck-Anderson metoden.
English: The side effects listed below were seen when MVASI was given together with chemotherapy.
Danish: De bivirkninger, der er vist nedenfor, blev observeret, når MVASI blev givet sammen med kemoterapi.
English: XELOX or
Danish: XELOX eller
English: Most patients were FIGO stage IIIC or stage IV.
Danish: De fleste patienter var i FIGO-stadie IIIC eller IV.
English: In the chemotherapy arms, the FOLFOX-4 regimen used the same doses and schedule as shown in table 6 for trial NO16966.
Danish: I kemoterapiarmene anvendtes et FOLFOX-4 regime med samme dosering og frekvens som vist i tabel 6 for studie NO16966.
English: Enrolment in Arm 3 was discontinued, as pre-specified, once safety of bevacizumab with the IFL regimen was established and considered acceptable.
Danish: Som forud planlagt blev inklusionen i arm 3 standset, så snart sikkerheden af bevacizumab med IFLregimet var dokumenteret og blev anset for acceptabel.
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: In addition, an independent review of the primary endpoint was also conducted.
Danish: Der blev også udført en uafhængig vurdering af det primære endepunkt.
English: MVASI must be administered under the supervision of a physician experienced in the use of antineoplastic medicinal products.
Danish: MVASI skal administreres under supervision af en læge med erfaring i anvendelse af antineoplastiske lægemidler.
English: If a dose of MVASI is missed
Danish: Hvis en dosis MVASI glemmes
English: Do not use MVASI if:
Danish: Brug ikke MVASI:
English: MVASI therapy should be discontinued in patients who develop necrotising fasciitis, and appropriate treatment should be promptly initiated.
Danish: MVASI bør seponeres hos patienter, der udvikler nekrotiserende fasciitis, og relevant behandling straks påbegyndes.
English: Depending on the dose prescribed for you, some or all of the contents of the MVASI 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 hætteglasset med MVASI eller hele indholdet blive fortyndet med natriumchloridopløsning (saltvandsopløsning) før anvendelsen.
English: MVASI will be administered in combination with erlotinib.
Danish: MVASI vil blive givet sammen med erlotinib.
English: Efficacy results from study MO22224 Primary endpoint
Danish: Effektresultater fra Studie MO22224 Primært endepunkt
English: The incidence of adverse events, including grade ≥ 3 adverse events and serious adverse events, was similar between the two treatment arms.
Danish: Forekomst af bivirkninger, herunder grad ≥ 3 bivirkninger og alvorlige bivirkninger var sammenlignelige mellem de to behandlingsarme.
English: • severe high blood pressure which cannot be controlled by blood pressure medicines; or a sudden severe rise in blood pressure,
Danish: • svært forhøjet blodtryk, som ikke kan kontrolleres med blodtrykssænkende medicin, eller hvis blodtrykket pludseligt stiger alvorligt,
English: In an exploratory analysis, the extent of bevacizumab 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 bevacizumab på den samlede overlevelse mindre udtalt i undergruppen af patienter, som ikke havde adenokarcinom-histologi.
English: Limited information is available on the continued use of bevacizumab in patients with other fistulae.
Danish: Der er kun begrænset information om fortsat brug af bevacizumab hos patienter med andre fistler.
English: Detailed information about these post-marketing reactions are provided in table 3.
Danish: Detaljeret information om disse postmarketing-bivirkninger er givet i tabel 3.
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 MVASI eller har planer om at blive gravid.
English: No incompatibilities between MVASI and polyvinyl chloride or polyolefin bags or infusion sets have been observed.
Danish: Der er ikke observeret uforligeligheder mellem MVASI og polyvinylchlorid- eller polyolefinposer.
English: MVASI 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: MVASI 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: Objective response rate**
Danish: Objektiv responsrate**
English: The overall mean age was 59.4 years; 56.6% of patients had an ECOG performance status of 0, 43% had a value of 1 and 0.4% had a value of 2.
Danish: Den samlede gennemsnitsalder var 59,4 år, 56,6 % af patienterne havde en ECOGperformancestatus på 0, 43 % havde en status på 1 og 0,4 % havde en status på 2.
English: Your doctor should advise you about using contraception during treatment with MVASI and for at least 6 months after the last dose of MVASI.
Danish: Din læge bør vejlede dig om anvendelsen af prævention under behandlingen med MVASI og i mindst 6 måneder efter sidste MVASI-dosis.
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 DNA teknologi i ovarieceller fra kinesiske hamstere.
English: IgGs are known to cross the placenta, and bevacizumab is anticipated to inhibit angiogenesis in the foetus, and thus is suspected to cause serious birth defects when administered during pregnancy.
Danish: Det vides, at IgG passerer placentabarrieren, og bevacizumab forventes at hæmme angiogenesen hos fostret og er dermed under mistanke for at kunne forårsage alvorlige medfødte misdannelser ved indgivelse under graviditet.
English: A GOG PS of 2 at baseline was reported in 0.9% of patients in the CP arm and in 1.2% of patients in the CPB arm.
Danish: En GOG PS på 2 ved baseline var rapporteret hos 0,9 % af patienterne i CP-armen og 1,2 % af patienterne i CPB-armen.
English: The safety and efficacy of bevacizumab in children less than 18 years old have not been established.
Danish: Sikkerheden og effekten af bevacizumab hos børn under 18 år er ikke klarlagt.
English: MVASI 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 MVASI til børn og unge under 18 år, da sikkerheden og fordelene ved MVASI ikke er fastlagt hos denne patientgruppe.
English: Progression-free survival by time from last platinum therapy to recurrence
Danish: Progressionsfri overlevelse efter tid fra sidste platinbehandling indtil recidiv
English: UNIQUE IDENTIFIER - HUMAN READABLE DATA PC
Danish: ENTYDIG IDENTIFIKATOR - MENNESKELIGT LÆSBARE DATA
English: MVASI is contraindicated in pregnancy (see section 4.3).
Danish: MVASI er kontraindiceret under graviditet (se pkt.
English: There is evidence suggesting that all grade (US National Cancer Institute-Common 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 Institute Common Terminology Criteria for Adverse Event [NCI-CTCAE v. 3]) kan være relateret til dosis.
English: In addition, a pre-specified 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: Talk to your doctor, pharmacist or nurse before using MVASI
Danish: Kontakt lægen, apotekspersonalet eller sundhedspersonalet, før du bruger MVASI
English: Fatal outcome was reported in approximately a third of serious cases of gastrointestinal perforations, which represents between 0.2%-1% of all bevacizumab-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 bevacizumab-behandlede patienter.
English: MVASI 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: MVASI 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: 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: 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: 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: • It is possible that MVASI may cause bleeding in and around your brain.
Danish: • Det er muligt, at MVASI kan forårsage blødning i og omkring hjernen.
English: Bevacizumab was combined with two chemotherapy regimens:
Danish: Bevacizumab blev kombineret med to kemoterapiregimer:
English: MVASI has not been shown to reduce your ability to drive or to use any tools or machines.
Danish: Det er ikke påvist, at MVASI nedsætter din evne til at køre bil eller betjene maskiner.
English: • if you need to undergo an invasive dental treatment or dental surgery, tell your dentist that you are being treated with MVASI (bevacizumab), 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 MVASI (bevacizumab), især hvis du også bliver eller er blevet behandlet med bisfosfonater, som injektion i blodet.
English: Proteinuriab,d
Danish: Proteinurib,d
English: Patients and percentage of patients with best overall response of confirmed CR or PR; percentage calculated on patients with measurable disease at baseline.
Danish: Patienter og procentdel af patienter med det bedste objektive respons bekræftet komplet respons eller partielt respons; procent beregnet på grundlag af patienter med målbar sygdom ved baseline.
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: 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: • MVASI may cause infections and a decreased number of your neutrophils (a type of blood cell important for your protection against bacteria).
Danish: • MVASI kan forårsage infektioner og nedsætte antallet af neutrofiler (en type blodceller, som er vigtige for at beskytte dig mod bakterier).
English: You must not breast-feed your baby during treatment with MVASI and for at least 6 months after the last dose of MVASI, as this medicine may interfere with the growth and development of your baby.
Danish: Du må ikke amme under behandling med MVASI og i mindst 6 måneder efter sidste MVASI-dosis, da MVASI kan påvirke væksten og udviklingen af dit barn.
English: All analyses presented in this table are stratified analyses.
Danish: Alle analyser i tabellen er stratificerede.
English: A high proportion of patients (approximately 62%) went on to receive a variety of non-protocol specified anti-cancer 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: Precautions to be taken before handling or administering the medicinal product For instructions on dilution of the medicinal product before administration, see section 6.6.
Danish: Sikkerhedsforanstaltninger som skal tages før håndtering og administration af lægemidlet For instruktion i fortynding af lægemidlet før administration, se pkt.
English: The safety of reinitiating bevacizumab therapy in patients previously experiencing PRES is not known.
Danish: Sikkerheden ved at genoptage behandlingen med bevacizumab hos patienter, der tidligere har udviklet PRES, er ikke kendt.
English: MVASI should be prepared by a healthcare professional using aseptic technique to ensure the sterility of the prepared solution.
Danish: MVASI bør klargøres af en sundhedsfaglig person under anvendelse af aseptisk teknik for at sikre steriliteten af den klargjorte opløsning.
English: Endpoint (months)
Danish: Endepunkt (måneder)
English: Long term effects of the treatment with bevacizumab on fertility are unknown.
Danish: Langtidsvirkningerne af bevacizumabbehandling på fertiliteten er ukendt.
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 bevacizumab 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 bevacizumab 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: These therapies in combination with MVASI may increase the risk of severe side effects.
Danish: Kombination af MVASI og disse behandlinger kan øge risikoen for alvorlige bivirkninger.
English: b stratified by the duration of treatment free-interval prior to enrolling onto this study per the registration form, and secondary surgical debulking status Yes/No.
Danish: Stratificeret efter varighed af behandlingsfri periode før inklusion i studiet per registreringsform og sekundær kirurgisk tumorreduktionsstatus Ja/Nej.
English: Tables 1 and 2 list adverse reactions associated with the use of bevacizumab in combination with different chemotherapy regimens in multiple indications.
Danish: Tabel 1 og 2 opsummerer de bivirkninger, som er associeret til brugen af bevacizumab i kombination med forskellige kemoterapiregimer til flere forskellige indikationer.
English: Pharmacodynamic effects
Danish: Farmakodynamisk virkninger
English: In both studies, bevacizumab exposure trended lower as body weight decreased.
Danish: I begge studier var der en tendens til, at eksponeringen var lavere ved lavere legemsvægt.
English: Bevacizumab has been associated with serious cases of gastrointestinal perforation.
Danish: Bevacizumab er blevet forbundet med alvorlige tilfælde af gastrointestinal perforation.
English: • MVASI may increase the risk of developing an abnormal connection or passageway between two organs or vessels.
Danish: • MVASI kan øge risikoen for, at der dannes abnorme forbindelser eller passager mellem to organer eller blodårer.
English: Patients should be monitored for signs and symptoms of CNS bleeding, and MVASI treatment discontinued in cases of intracranial bleeding.
Danish: Patienter skal overvåges for tegn og symptomer på CNS-blødning, og behandling med MVASI skal seponeres i tilfælde af intrakranial blødning.
English: Eight hundred and twenty-nine patients were randomised (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 and 244 bevacizumab monotherapy).
Danish: 829 patienter blev randomiseret (292 FOLFOX-4, 293 bevacizumab + FOLFOX-4 og 244 bevacizumab monoterapi).
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: • any severe bleeding.
Danish: • svær blødning.
English: Dose reduction of IFN alfa-2a did not appear to affect the efficacy of the combination of bevacizumab and IFN alfa-2a based on PFS event free rates over time, as shown by a subgroup analysis.
Danish: Dosisreduktion af IFN alfa-2a syntes ikke at påvirke effekten af kombinationen af bevacizumab og IFN alfa-2a, baseret på antal hændelser i tidsrummet for progressionsfri overlevelse, som er vist ved en undergruppeanalyse.
English: Studies to evaluate the mutagenic and carcinogenic potential of bevacizumab have not been performed.
Danish: Der er ikke foretaget studier for at evaluere bevacizumabs carcinogene og mutagene potentiale.
English: METHOD AND ROUTE(S) OF ADMINISTRATION For intravenous use after dilution.
Danish: ANVENDELSESMÅDE OG ADMINISTRATIONSVEJ(E) Til intravenøs anvendelse efter fortynding.
English: The median age of patients was 61.0 (range: 25-84) years.
Danish: Patienternes medianalder var 61,0 år (spændevidde 25-84).
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 2. uge), var forbundet med svær migræne hos flere patienter.
English: The safety and efficacy of concomitant administration of radiotherapy and bevacizumab has not been established.
Danish: Sikkerheden og effekten af samtidigt administreret strålebehandling og bevacizumab er ikke fastlagt.
English: • a hole in the stomach or intestines,
Danish: • hul i maven eller tarmen,
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 administration of MVASI should be temporarily discontinued
Danish: Behandlingen med MVASI skal midlertidigt afbrydes