FrancophonIA/ELRC3.0 huggingface dataset:
English: It is recommended that the prepared dosing solution be used immediately in order to minimize the risk of microbial contamination.
Danish: Det anbefales, at den klargjorte opløsning til dosering anvendes med det samme for at minimere risikoen for mikrobiel kontaminering.
English: The ECOG PS was 0 for 31.5 %, 1 for 59.7 %, and 2 for 9 % of patients; over 50 % had metastatic disease at more than 2 sites.
Danish: ECOG PS var 0 for 31,5 % af patienterne, 1 for 59,7 % af patienterne og 2 for 9 % af patienterne, og over 50 % havde metastatisk sygdom mere end 2 steder.
English: - Infections If you have signs of infection before start of treatment please tell your doctor.
Danish: - Infektioner Hvis du har tegn på infektion, før du starter behandlingen, skal du fortælle din læge det.
English: Median age was 62 (32-86), 83 % of patients were men; 83.5 % were Caucasian; and 91 % were smokers.
Danish: Medianalderen var 62 år (32-86), 83 % af patienterne var mænd, 83,5 % var kaukasiere, og 91 % var rygere.
English: Kaplan Meier plot of overall survival (ITT population)
Danish: Kaplan Meier kurve for samlet overlevelse (ITT population)
English: The risk of fertility impairment is unknown.
Danish: Risikoen for nedsat fertilitet kendes ikke.
English: A tumour was considered to be EGFRexpressing if at least one stained cell could be identified.
Danish: En tumor blev betragtet som EGFR-udtrykkende, hvis mindst én farvet celle kunne identificeres.
English: Talk to your doctor or nurse immediately if any of the following applies to you (or you are not sure) during or after treatment with Portrazza:
Danish: Kontakt omgående lægen eller sundhedspersonalet, hvis noget af følgende gælder for dig (eller hvis du er i tvivl) under eller efter behandlingen med Portrazza:
English: Infusion solution: After dilution and preparation, the medicine must be used immediately.
Danish: Infusionsopløsning: Efter fortynding og klargøring skal lægemidlet anvendes med det samme.
English: Portrazza infusions should not be administered or mixed with glucose solutions.
Danish: Infusioner af Portrazza bør ikke administreres eller blandes med glucoseopløsninger.
English: Most of these side effects usually disappear over time after the end of Portrazza therapy.
Danish: De fleste af disse bivirkninger forsvinder normalt med tiden, efter at behandlingen med Portrazza er afsluttet.
English: DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION Date of first authorisation: 15 February 2016
Danish: Dato for første markedsføringstilladelse: 15. februar 2016
English: Pre-emptive treatment for skin reaction was not permitted prior to the beginning of the second treatment cycle.
Danish: Forebyggende behandling mod hudreaktioner var ikke tilladt forud for starten af den anden behandlingsserie.
English: Seek medical help immediately if you experience any of the following:
Danish: Søg omgående lægehjælp, hvis du får nogen af følgende bivirkninger:
English: See section 4 for more details about infusion-related reactions which may occur during or after the infusion.
Danish: Se afsnit 4 for at få yderligere oplysninger om de infusionsrelaterede reaktioner, der kan opstå under eller efter infusionen.
English: Venous blood clots are likely to occur in approximately 8 out of 100 patients.
Danish: Venøse blodpropper kan forekomme hos ca. 8 ud af 100 patienter.
English: Management recommendations (any occurrence)
Danish: Anbefalinger til håndtering (alle forekomster)
English: Portrazza must not be administered as an intravenous bolus or push.
Danish: Portrazza må ikke administreres som en intravenøs bolus eller push.
English: The number of infusions that you receive will depend on how and for how long you respond to treatment with Portrazza.
Danish: Antallet af infusioner, som du får, vil afhænge af, hvordan og hvor længe behandlingen med Portrazza virker på dig.
English: What you need to know before you are given Portrazza 3.
Danish: Det skal du vide, før du får Portrazza 3.
English: The highest dose of necitumumab studied clinically in a human dose-escalation Phase 1 study is 1,000 mg once a week or once every other week.
Danish: Den højeste dosis af necitumumab, der er undersøgt klinisk i et fase 1-studie med dosisøgning hos mennesker, er 1.000 mg én gang om ugen eller én gang hver anden uge.
English: Prior to launch of Portrazza (necitumumab) in each Member State the MAH must agree about the content and format of the educational material, including communication media, distribution modalities, and any other aspects of the programme, with the National Competent Authority.
Danish: Inden lancering af Portrazza (necitumumab) i de enkelte medlemslande skal indehaveren af markedsføringstilladelsen (MAH) aftale indholdet og formatet af uddannelsesmaterialet, herunder kommunikationsmedier, distributionsmetode samt alle andre aspekter af programmet, med den nationale myndighed.
English: • Immediately and permanently discontinue treatment with necitumumab.
Danish: • Seponer omgående og permanent behandlingen med necitumumab.
English: The causes of these deaths and their relationship to treatment were not always known.
Danish: Dødsårsagen og sammenhængen med behandlingen var ikke klarlagt i alle tilfældene.
English: The MAH shall ensure that in each Member State where Portrazza (necitumumab) is marketed, all physicians (i.e. oncologists) are notified about the key conditions for the safe use of necitumumab.
Danish: MAH skal i hvert medlemsland, hvor Portrazza (necitumumab) markedsføres, sikre sig, at alle læger (dvs. onkologer) er informeret om hovedbetingelserne for sikker anvendelse af necitumumab.
English: Name and address of the manufacturer(s) responsible for batch release Lilly, S.A.
Danish: Navn og adresse på den fremstiller, der er ansvarlig for batchfrigivelse Lilly, S.A.
English: How you are given Portrazza 4.
Danish: Sådan bliver du behandlet med Portrazza 4.
English: No overall differences in efficacy between arms were observed in patients above 70 years of age.
Danish: Der blev ikke observeret forskel i effekt mellem behandlingsarmene hos patienter over 70 år.
English: If these levels are too low, your doctor may prescribe appropriate supplements.
Danish: Hvis koncentrationen er for lav, kan lægen ordinere passende tilskud.
English: Progressively decreasing serum magnesium levels occur frequently (81.3%) and may lead to severe Hypomagnesaemia (18.7%) (see also section 4.8).
Danish: Der forekommer hyppigt (81,3 %) en gradvist faldende serumkoncentration af magnesium, hvilket kan føre til svær hypomagnesiæmi (18,7 %) (se også pkt.
English: Summary of efficacy data (ITT population) Portrazza+GC Arm N=545
Danish: Resumé af effektdata (ITT population) Portrazza+GC arm N=545
English: Skin reactions may occur in approximately 80 out of 100 patients who take Portrazza and are usually mild to moderate.
Danish: Hudreaktioner kan forekomme hos ca. 80 ud af 100 patienter, der er i behandling med Portrazza, og de er normalt lette til moderate.
English: Portrazza may cause side effects involving the skin.
Danish: Portrazza kan give bivirkninger, der påvirker huden.
English: b The table reflects the frequency of ADRs during the chemotherapy phase of study treatment in which Portrazza+GC was directly compared with GC.
Danish: b Tabellen afspejler hyppigheden af bivirkningerne i kemoterapifasen af forsøgsbehandlingen, hvor Portrazza + GC blev direkte sammenlignet med GC.
English: Based on animal models, epidermal growth factor receptor (EGFR) is involved in prenatal development and may be essential for normal organogenesis, proliferation, and differentiation in the developing embryo.
Danish: Baseret på dyremodeller er epidermal vækstfaktorreceptor (EGFR) involveret i den prænatale udvikling og kan være afgørende for normal organogenese, proliferation og differentiering i embryoet, der er under udvikling.
English: Portrazza may also cause changes in the results of blood tests.
Danish: Portrazza kan også give ændringer i blodprøvesvar.
English: Adverse events observed included headache, vomiting and nausea and were consistent with the safety profile at the recommended dose.
Danish: De observerede bivirkninger omfattede hovedpine, opkastning og kvalme, og de var i overensstemmelse med sikkerhedsprofilen ved den anbefalede dosis.
English: If you have an infusion-related reaction during treatment, your drip will be slowed down and future doses will also be given more slowly.
Danish: Hvis du får en infusionsrelateret reaktion under behandlingen, vil droppet gives langsommere og efterfølgende infusioner vil også gives langsommere.
English: The skin effects were consistent with the known class effects of EGFR inhibitors.
Danish: Effekterne på huden var i overensstemmelse med de kendte klasseeffekter for EGFR-hæmmere.
English: Infusion-related reactions may occur during treatment with Portrazza.
Danish: Der kan opstå infusionsrelaterede reaktioner under behandlingen med Portrazza.
English: Portrazza should not be used during pregnancy or in women not using effective contraception, unless the potential benefit justifies the potential risk to the foetus.
Danish: Portrazza bør ikke anvendes under graviditet eller til kvinder, der ikke benytter sikker kontraception, medmindre den potentielle fordel opvejer den potentielle risiko for fosteret.
English: Hypomagnesaemia may reoccur at the same grade or worse after a dose delay.
Danish: Hypomagnesiæmi af samme eller højere grad kan komme igen efter en dosisudsættelse.
English: In the Portrazza+GC arm, 51 % of patients continued with single-agent Portrazza after completing chemotherapy.
Danish: I Portrazza + GC-armen fortsatte 51 % af patienterne med Portrazza som enkeltstof efter at have gennemført kemoterapien.
English: Patients and physicians should be aware of signs and symptoms of thromboembolism.
Danish: Patienter og læger skal være opmærksomme på tegn og symptomer på tromboembolisme.
English: Portrazza is administered as an intravenous infusion.
Danish: Portrazza administreres som en intravenøs infusion.
English: Activation of EGFR has been correlated with malignant progression, induction of angiogenesis and inhibition of apoptosis or cell death.
Danish: Aktivering af EGFR er blevet sat i forbindelse med malign progression, induktion af angiogenese og hæmning af apoptose eller celledød.
English: Forest plot for subgroup analysis of overall survival (ITT population)
Danish: Forestplot af subgruppeanalyse af samlet overlevelse (ITT population)
English: If a decreased infusion rate is indicated, the infusion duration should not exceed 2 hours.
Danish: Hvis der er indikation for en nedsat infusionshastighed, bør infusionens varighed ikke overstige 2 timer.
English: Necitumumab recognises and binds specifically to a protein on the surface of some cancer cells.
Danish: Necitumumab genkender og binder sig til et specifikt protein, der findes på overfladen af visse kræftceller.
English: Overall, there was a low incidence of both treatment-emergent anti-drug antibodies and neutralizing antibodies among necitumumab-treated patients, and no correlation with safety outcomes in these patients.
Danish: Samlet set var der en lav incidens af både behandlingsinducerede lægemiddelantistoffer og neutraliserende antistoffer blandt de patienter, der blev behandlet med necitumumab, og der var ingen korrelation med sikkerhedsrelaterede udfald hos disse patienter.
English: Your doctor or nurse will check for side effects during your infusion.
Danish: Lægen eller sygeplejersken vil holde øje med bivirkninger under infusionen.
English: There was no relationship between immunogenicity and IRRs or treatment emergent adverse events.
Danish: Der var ingen sammenhæng mellem immunogenicitet og IRR'er eller hændelser opstået under behandling.
English: Parenteral medicinal products should be inspected visually for particulate matter prior to administration.
Danish: Parenterale lægemidler skal kontrolleres visuelt for partikler før administration.
English: Animal studies to assess fertility directly have not been conducted (see section 5.3).
Danish: Der er ikke udført dyrestudier med henblik på at vurdere fertilitet direkte (se pkt.
English: Albumin-corrected hypocalcaemiac
Danish: Albuminkorrigeret hypocalcæmic
English: Human IgG1 is known to cross the placenta; therefore, necitumumab has the potential to be transmitted from the mother to the developing foetus.
Danish: Det er kendt, at humant IgG1 passerer placenta; derfor har necitumumab potentialet til at blive overført fra moderen til fosteret, der er under udvikling.
English: The majority of skin reactions developed during the first cycle of treatment and resolved within 17 weeks after onset (see also section 4.4).
Danish: Størstedelen af hudreaktionerne udviklede sig under den første behandlingsserie og ophørte inden for 17 uger efter opståen (se også pkt.
English: The majority of infusion-related reactions developed after the first or second administration of necitumumab.
Danish: Størstedelen af de infusionsrelaterede reaktioner udviklede sig efter den første eller anden administration af necitumumab.
English: Portrazza contains the active substance necitumumab, which belongs to a group of substances called monoclonal antibodies.
Danish: Portrazza indeholder det aktive stof necitumumab, som tilhører en gruppe af stoffer, der kaldes monoklonale antistoffer.
English: Use of post-study systemic therapy was similar in the 2 arms (47.3 % in the Portrazza+GC arm and 44.7 % in the GC arm).
Danish: Brugen af systemisk behandling efter studiet var sammenlignelig i de 2 arme (47,3 % i Portrazza + GC-armen og 44,7 % i GC-armen).
English: Your doctor will discuss with you whether you need any preventive measures or early treatment.
Danish: Lægen vil drøfte med dig, om der er behov for forebyggende tiltag eller tidlig behandling.
English: The overall survival hazard ratio [HR] was 0.83 [0.55, 1.52].
Danish: Hazard ratio [HR] for samlet overlevelse var 0,83 [0,55; 1,52].
English: An increased frequency of cardiorespiratory arrest or sudden death was observed with necitumumab.
Danish: Der blev observeret en øget hyppighed af kardiorespiratorisk stop eller pludselig død med necitumumab.
English: The skin rash commonly resembles acne and often involves the face, upper chest and back, but can affect any area of the body.
Danish: Hududslættet ligner almindeligvis akne og optræder ofte i ansigtet og på den øverste del af brystkassen og ryggen, men kan forekomme alle steder på kroppen.
English: They can lead to a blockage of a blood vessel in the leg.
Danish: De kan føre til blokering af et blodkar i benet.
English: The materials will address the risks concerning arterial / venous thromboembolic events and cardiorespiratory disorders.
Danish: Materialet skal behandle risici vedrørende arterielle/venøse tromboemboliske tilfælde og karidorespiratoriske sygdomme.
English: • Decrease infusion rate by 50 % for the duration of infusion.b
Danish: • Nedsæt infusionshastigheden med 50 % under hele infusionen.b
English: There are no data from the use of necitumumab in pregnant women.
Danish: Der er ingen data fra anvendelse af necitumumab til gravide kvinder.
English: Portrazza is given in combination with the medicines gemcitabine and cisplatin for up to 6 cycles and then it is given on its own.
Danish: Portrazza gives i kombination med lægemidlerne gemcitabin og cisplatin i op til 6 serier og gives herefter alene.
English: No dose reductions are recommended.
Danish: Der er ingen anbefalinger om dosisreduktioner.
English: How you are given Portrazza
Danish: Sådan bliver du behandlet med Portrazza
English: Prompt electrolyte repletion is recommended, as appropriate.
Danish: Det anbefales at give et hurtigt elektrolyttilskud efter behov.
English: Mean total systemic clearance (CLtot) at steady state following 800 mg on Day 1 and Day 8 of a 21-day cycle was 0.014 l/hr (CV 39 %).
Danish: Den gennemsnitlige totale systemiske clearance (CLtot) ved steady state efter 800 mg på dag 1 og dag 8 i en 21-dages-serie var 0,014 l/t (CV 39 %).
English: You must not be given Portrazza - if you have ever had a severe allergic reaction to necitumumab or any of the other ingredients of this medicine (listed in section 6).
Danish: Det skal du vide, før du får Portrazza Du må ikke få Portrazza - hvis du nogensinde har haft en alvorlig allergisk reaktion på necitumumab eller et af de øvrige indholdsstoffer i Portrazza (angivet i afsnit 6).
English: Your doctor will discuss with you whether you need any preventive measures.
Danish: Din læge vil drøfte med dig, om du måske har brug for forebyggende tiltag.
English: Portrazza is for intravenous use only.
Danish: Portrazza er kun beregnet til intravenøs anvendelse.
English: Abbreviations: GC = gemcitabine and cisplatin alone; Portrazza+GC = necitumumab plus gemcitabine and cisplatin; MedDRA = Medical Dictionary for Regulatory Activities.
Danish: Forkortelser: GC = gemcitabin og cisplatin alene, Portrazza + GC = necitumumab plus gemcitabin og cisplatin, MedDRA = Medical Dictionary for Regulatory Activities.
English: This medicine contains 76 mg sodium per dose.
Danish: Dette lægemiddel indeholder 76 mg natrium pr. dosis.
English: In approximately 4 out of 100 patients these side effects are likely to be severe.
Danish: Hos ca. 4 ud af 100 patienter kan disse bivirkninger være alvorlige.
English: The relative risk of VTE or ATE was approximately three-fold higher in patients with a reported history of VTE or ATE.
Danish: Den relative risiko for VTE eller ATE var omtrent tre gange højere hos patienter med VTE eller ATE i anamnesen.
English: Abbreviations: C = cisplatin; G = gemcitabine; ITT = intent-to-treat.
Danish: Forkortelser: C = cisplatin; G = gemcitabin; ITT = intent-to-treat.
English: Twelve of the fifteen patients died within 30 days of the last dose of necitumumab and had comorbid conditions including history of coronary artery disease (n=3), hypomagnesemia (n=4), chronic obstructive pulmonary disease (n=7), and hypertension (n=5).
Danish: Tolv af de femten patienter døde inden for 30 dage efter den sidste dosis necitumumab, og havde komorbiditeter herunder koronararteriesygdom i anamnesen (n = 3), hypomagnesiæmi (n=4), kronisk obstruktiv lungesygdom (n = 7) og hypertension (n = 5).
English: The physician educational material package should also contain: o The Summary of Product Characteristics o Patient Information Leaflet
Danish: Pakken med undervisningsmateriale til læger skal også indeholde: o Produktresuméet o Indlægssedlen
English: Portrazza contains sodium
Danish: Portrazza indeholder natrium
English: o Instruction for healthcare professionals to read the materials in conjunction with the SmPC.
Danish: o Instruktion til sundhedspersonalet om at læse materialet sammen med produktresuméet.
English: The concentrate must be diluted before use (see section 6.6).
Danish: Koncentratet skal fortyndes før brug (se pkt.
English: Breast-feeding should be discontinued during treatment with Portrazza and for at least 4 months after the last dose.
Danish: Amning bør ophøre under behandling med Portrazza og i mindst 4 måneder efter den sidste dosis.
English: Common Headache Common Dysgeusia
Danish: Almindelig Hovedpine Almindelig Dysgeusi
English: Do not breast-feed your baby during treatment with Portrazza and for at least 4 months after you receive the last dose, as this medicine may harm the growth and development of your baby.
Danish: Undgå at amme dit barn, mens du er i behandling med Portrazza, og i mindst 4 måneder efter, at du har fået den sidste dosis, da dette lægemiddel kan påvirke dit barns vækst og udvikling.
English: Abbreviations: C = cisplatin; G = gemcitabine.
Danish: Forkortelser: C = cisplatin; G = gemcitabin.
English: Population pharmacokinetic analysis suggested age, gender, and race had no effect on the pharmacokinetics of necitumumab, while CL and volume of distribution had a less than proportional positive correlation with body weight.
Danish: En populationsfarmakokinetisk analyse tydede på, at alder, køn og race ikke havde nogen effekt på necitumumabs farmakokinetik, mens CL og fordelingsvolumen havde en mindre end proportional positiv korrelation med kropsvægt.
English: Of the ITT population, 982 patients (89.8%) were evaluable for an EGFR protein expression analysis by immunohistochemistry (IHC) using Dako PharmDx Kit.
Danish: I ITT-populationen var det muligt at evaluere 982 patienter (89,8 %) i en immunohistokemisk (IHC) EGFR-proteinekspressionsanalyse ved brug af Dako PharmDx kit.
English: It is unknown whether necitumumab is excreted in human milk.
Danish: Det er ukendt, om necitumumab udskilles i human mælk.
English: • Permanently discontinue if patients experience Grade 3 skin induration/fibrosis.
Danish: • Seponer permanent behandlingen, hvis patienterne får hudinduration/-fibrose af grad 3.
English: No drug-drug interactions were observed between Portrazza and gemcitabine/cisplatin.
Danish: Der er ikke observeret interaktion mellem Portrazza og gemcitabin/cisplatin.
English: Portrazza and gemcitabine were administered on days 1 and 8 of each 3-week treatment cycle, and cisplatin was administered on day 1 of each 3-week treatment cycle.
Danish: Portrazza og gemcitabin blev administreret på dag 1 og dag 8 i hver 3-ugers-behandlingsserie, og cisplatin blev administreret på dag 1 i hver 3-ugers-behandlingsserie.
English: Patients with significant coronary artery disease, myocardial infarction within 6 months, uncontrolled hypertension, and uncontrolled congestive heart failure were not enrolled in the pivotal study.
Danish: Patienter med betydelig koronararteriesygdom, myokardieinfarkt inden for de seneste 6 måneder, ukontrolleret hypertension eller ukontrolleret hjerteinsufficiens blev ikke indrulleret i det pivotale studie.
English: In addition, necitumumab induces EGFR internalization and degradation in vitro.
Danish: Derudover inducerer necitumumab internalisering og nedbrydning af EGFR in vitro.
English: The anti-cancer medicines it is combined with are gemcitabine and cisplatin.
Danish: De kræftbehandlinger, som dette lægemiddel bruges i kombination med, er gemcitabin og cisplatin.
English: The onset of events usually occurred after the first or second administration of necitumumab.
Danish: Hændelserne debuterede normalt efter den første eller anden administration af necitumumab.
English: • If symptoms do not worsen at 600 mg for another treatment cycle, the dose may be further increased to 800 mg.
Danish: • Hvis symptomerne ikke forværres ved 600 mg i endnu en behandlingsserie, kan dosis eventuelt øges til 800 mg.
English: Severe infusion-related reactions were reported in 0.4 % of patients.
Danish: Der blev rapporteret om svære infusionsrelaterede reaktioner hos 0,4 % af patienterne.
English: The incidence of fatal VTEs was similar between arms (0.2%).
Danish: Forekomsten af dødelige VTE'er var sammenlignelig i de to arme (0,2 %).
English: Portrazza is used in combination with other anti-cancer medicines for the treatment of adults with certain type of lung cancer at an advanced stage (squamous non-small cell lung cancer), whose cancer cells have the EGFR protein on their surface.
Danish: Portrazza anvendes i kombination med andre kræftbehandlinger til behandling af voksne med en bestemt form for lungekræft i et fremskredent stadium (planocellulær ikke-småcellet lungekræft, hvis kræftceller har EGFR-proteinet på deres overflade).
English: Necitumumab therapy must be administered under the supervision of a physician qualified in the use of anti-cancer chemotherapy.
Danish: Necitumumab må kun administreres under tilsyn af en læge, som er kvalificeret i brugen af kemoterapi mod cancer.
English: Thromboprophylaxis should be considered after careful assessment of a patient's risk factors (including the increased risk of serious bleeding in patients with tumour cavitation or tumour involvement of large central blood vessels).
Danish: Tromboseprofylakse bør overvejes efter omhyggelig vurdering af patientens risikofaktorer (inklusive den øgede risiko for alvorlig blødning hos patienter med tumorkavitet eller tumorinvolvering af store centrale blodkar).
English: It is administered as an intravenous infusion over approximately 60 minutes via an infusion pump.
Danish: Lægemidlet administreres som en intravenøs infusion over ca. 60 minutter via en infusionspumpe.