FrancophonIA/ELRC3.0 huggingface dataset:
English: In a second study of 955 patients who had migraines 8 days a month on average, those treated with Aimovig had on average 3 to 4 fewer days with migraines per month compared with around 2 fewer days for patients on placebo.
Danish: I et andet studie med 955 patienter, der led af migræne i gennemsnitligt otte dage om måneden, havde de patienter, der fik Aimovig, i gennemsnit tre-fire færre dage med migræne om måneden sammenholdt med ca. to færre dage hos de patienter, der fik placebo.
English: Aimovig (erenumab) EMA/CHMP/249688/2019
Danish: Aimovig (erenumab) EMA/191978/2019
English: For the full list of side effects and restrictions of Aimovig, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Aimovig fremgår af indlægssedlen.
English: How is Aimovig used?
Danish: Hvordan anvendes Aimovig?
English: Aimovig is effective at reducing the number of days patients suffer migraines.
Danish: Aimovig er effektivt til at reducere antallet af dage med migræne hos patienterne.
English: Aimovig was shown to be effective at reducing the number of days patients have migraines.
Danish: Det er påvist, at Aimovig er effektivt til at reducere antallet af dage med migræne hos patienterne.
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Aimovig have been included in the summary of product characteristics and the package leaflet.
Danish: Der er anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Aimovig.
English: A chemical messenger called CGRP has been shown to be involved in the development of migraine.
Danish: Det er påvist, at udvikling af migræne er forbundet med det kemiske signalstof CGRP.
English: What benefits of Aimovig have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Aimovig?
English: How does Aimovig work?
Danish: Hvordan virker Aimovig?
English: Each cycle lasts 21 days.
Danish: Hver serie varer 21 dage.
English: • you are due to have a vaccine or you know you may need to have one in the near future
Danish: • du skal have en vaccination, eller du ved, at du muligvis skal have en i den nærmeste fremtid
English: These may be new symptoms or a change in your current symptoms.
Danish: Det kan være nye symptomer eller en ændring i dine nuværende symptomer.
English: Reactivation of latent infections has been reported.
Danish: Der er rapporteret reaktivering af latente infektioner.
English: Polivy can cause IRRs , including severe cases.
Danish: Polivy kan forårsage IRR, inklusiv svære tilfælde.
English: Give supportive treatment.
Danish: Giv understøttende behandling.
English: 80% of patients had refractory disease.
Danish: 80% af patienterne havde refraktær sygdom.
English: PET-CT PR required meeting both PET-CT criteria and CT criteria.
Danish: PET-CT PR krævede at såvel PET-CT-kriterier og CT-kriterier var opfyldt.
English: Contraception (women and men)
Danish: Prævention (kvinder og mænd)
English: • feel tired
Danish: • føler dig træt
English: The safety and efficacy in children and adolescents less than 18 years have not been established.
Danish: Sikkerhed og virkning hos børn og unge i alderen under 18 år er ikke klarlagt.
English: Polivy has not been evaluated in patients with HIV.
Danish: Polivy er ikke blevet evalueret hos patienter med HIV.
English: Studies have not been conducted in patients who recently received live vaccines.
Danish: Der er ikke gennemført studier hos patienter, der nyligt har fået levende vacciner.
English: For the treatment to be fully effective, it is very important not to miss a dose.
Danish: For at behandlingen kan være effektiv, er det vigtigt ikke at springe en dosis over.
English: Very common (may affect more than 1 in 10 people)
Danish: Meget almindelig (set hos mere end 1 ud af 10 patienter)
English: In order to improve traceability of biological medicinal products, the trade name and the batch number of the administered product should be clearly recorded.
Danish: For at forbedre sporbarheden af biologiske lægemidler, bør handelsnavn og batchnummer for det administrerede produkt registreres tydeligt.
English: Polivy will be stored by the healthcare professionals at the hospital or clinic.
Danish: Polivy opbevares af sundhedspersonalet på hospitalet eller klinikken.
English: The following side effects have been reported with this medicine:
Danish: Følgende bivirkninger er indberettet for dette lægemiddel:
English: • you think you have an infection or have had long-lasting or repeated infections such as herpes (see “Infections” in section 4).
Danish: • du tror, at du har en infektion eller, at du tidligere har haft langvarige eller gentagne infektioner såsom herpes (se under “Infektioner” i afsnit 4).
English: 5% Glucose
Danish: 5% glukose
English: Human Immunodeficiency Virus (HIV)
Danish: Human Immundefekt Virus (HIV)
English: Do not stop treatment with Polivy unless you have discussed this with your doctor.
Danish: Stop ikke behandling med Polivy uden at have diskuteret det med lægen.
English: Stop Polivy infusion immediately.
Danish: Stop Polivy infusion øjeblikkeligt.
English: Sodium chloride 9 mg/mL (0.9%)
Danish: Natriumchlorid 9 mg/ml (0,9%)
English: This being a conditional marketing authorisation and pursuant to Article 14-a(4) of Regulation (EC) No 726/2004, the MAH shall complete, within the stated timeframe, the following measures:
Danish: Dette er en betinget markedsføringstilladelse, og i henhold til artikel 14-a, stk. 4, i forordning (EF) nr. 726/2004 skal indehaveren af markedsføringstilladelsen inden for den fastsatte tidsramme gennemføre følgende foranstaltninger:
English: There is no experience with overdose in human clinical trials.
Danish: Der er ingen erfaring med overdosering i kliniske humanstudier.
English: Very common pruritis
Danish: Meget almindelig pruritis
English: The dose of this medicine depends on your body weight.
Danish: Dosis af Polivy afhænger af din kropsvægt.
English: Polivy should not be administered in the presence of an active severe infection.
Danish: Polivy bør ikke administreres ved tilstedeværelsen af en aktiv alvorlig infektion.
English: If you get any serious reaction, your doctor may stop treatment with Polivy.
Danish: Hvis du får en alvorlig reaktion, så vil din læge muligvis stoppe behandling med Polivy.
English: Pay attention to the following side effects
Danish: Vær opmærksom på følgende bivirkninger
English: The most common gastrointestinal toxicity events were diarrhoea and nausea.
Danish: De hyppigste gastrointestinale hændelser var diarré og kvalme.
English: Grade 2-3
Danish: Grad 2-3
English: The median age was 69 years (range: 30-86 years).
Danish: Medianalder var 69 år (30-86 år).
English: The reconstituted product contains no preservative and is intended for single-dose only.
Danish: Det rekonstituerede produkt indeholder ikke konserveringsmidler og er udelukkende beregnet til brug som enkeltdosis.
English: See section 4 for more information about side effects.
Danish: Se afsnit 4 for mere information om bivirkninger.
English: These include:
Danish: Det kan for eksempel være:
English: Infusion-related reactions, allergic or anaphylactic (more severe allergic) reactions can happen.
Danish: Infusionsrelaterede reaktioner, allergiske eller anafylaktiske (mere alvorlig allergi) reaktioner, kan ske.
English: Your doctor or nurse will check for side effects during your infusion and for 30 to 90 minutes afterwards.
Danish: Din læge eller sygeplejerske vil se efter bivirkninger under din infusion og i 30-90 minutter efter.
English: Prophylactic granulocyte colony stimulating factor (G-CSF) administration was required in the clinical development and should be considered.
Danish: Profylaktisk administration af human granulocytkolonistimulerende faktor (G-CSF) var nødvendig i den kliniske udviklingsfase og bør overvejes.
English: Delayed IRRs as late as 24 hours after receiving Polivy have occurred.
Danish: Forsinkede IRR er forekommet så sent som 24 timer efter administration af Polivy.
English: The majority of patients (98%) had DLBCL not otherwise specified (NOS).
Danish: Størstedelen af patienterne (98%) havde ikke yderligere specificeret DLBCL.
English: This patient had three prior lines of therapy that included anti-CD20 antibodies.
Danish: Denne patient havde 3 tidligere behandlingsregimer, der inkluderede anti-CD20antistoffer.
English: Proper aseptic technique throughout the handling of this medicinal product should be followed.
Danish: Korrekt aseptisk teknik bør anvendes under hele håndteringen af dette lægemiddel.
English: The storage details are as follows
Danish: Opbevaringsbetingelserne er som følger:
English: Interrupt POLIVY infusion and give supportive treatment.
Danish: Afbryd Polivy infusion og giv understøttende behandling.
English: Bendamustine + rituximab N = 40 Median observation time 22 months
Danish: Bendamustin + rituximab N = 40 Median for observationstid 22 måneder
English: Withhold Polivy dosing until improvement to ≤ Grade 1.
Danish: Afbryd Polivy-behandling indtil bedring til ≤grad 1.
English: Lonzastrasse CH-3930 Visp Switzerland
Danish: Lonzastrasse CH-3930 Visp Schweiz
English: There are no data in pregnant women using Polivy.
Danish: Der foreligger ingen data for gravide kvinder behandlet med Polivy.
English: • memory loss, trouble speaking, difficulty walking or problems with your eyesight
Danish: • hukommelsestab, problemer med at tale, besvær med at gå eller synsforstyrrelser
English: Among 173 patients treated with Polivy in Study GO29365, 95 (55%) were ≥65 years of age.
Danish: Af de 173 patienter, behandlet med Polivy i studiet GO29365, var 95 (55%) ≥ 65 år.
English: Determine the volume of 20 mg/mL reconstituted solution needed based on the required dose (see below):
Danish: Bestem volumen af den 20 mg/ml rekonstituerede opløsning baseret på den ønskede dosis (se nedenfor):
English: If no infusionrelated reaction occurs, subsequent infusions may be administered over 30 minutes.
Danish: Hvis ingen infusionsrelaterede reaktioner opstår kan efterfølgende infusioner administreres over 30 minutter.
English: Clinical studies of Polivy did not include sufficient numbers of patients aged ≥65 to determine whether they respond differently from younger patients.
Danish: Kliniske studier med Polivy havde ikke inkluderet et stort nok antal af patienter ≥ 65 år til at bestemme om disse reagerer anderledes fra yngre patienter.
English: MMAE does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, or CYP2D6.
Danish: MMAE hæmmer ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19 eller CYP2D6.
English: Pregnant women should be advised regarding risk to the foetus.
Danish: Gravide kvinder bør rådgives i forhold til risikoen for fostret.
English: Patients with pre-existing PN may experience worsening of this condition.
Danish: Patienter med allerede eksisterende PN kan opleve forværring af tilstanden.
English: If a planned dose of Polivy is missed, it should be administered as soon as possible and the schedule of administration should be adjusted to maintain a 21-day interval between doses.
Danish: Hvis en planlagt dosis glemmes, bør denne administreres så hurtigt som muligt, og doseringsskemaet justeres således, at der opretholdes et 21-dages interval mellem doserne.
English: • The usual starting dose is 1.8 mg for each kilogram of your body weight.
Danish: • Den sædvanlige startdosis er 1,8 mg pr. kg. kropsvægt.
English: • discomfort or weakness.
Danish: • ubehag eller svaghed
English: If primary cause is due to lymphoma, the dose of bendamustine may not need to be reduced.
Danish: 1Hvis den primære årsag er lymfom, behøver bendamustindosis muligvis ikke reduceres.
English: Overall survival (OS) was an exploratory endpoint which was not type 1 error controlled.
Danish: Samlet overlevelse (OS) var et eksplorativt endepunkt, som ikke var type 1-fejl kontrolleret.
English: Liver enzymes and bilirubin level should be monitored.
Danish: Leverenzymer og bilirubin værdier bør monitoreres.
English: Do not breast-feed while receiving Polivy because small amount of Polivy may pass into your breast milk.
Danish: Du må ikke amme, mens du er i behandling med Polivy fordi en lille mængde Polivy kan passere over i modermælken.
English: The levels of MMAE metabolites have not been measured in human plasma.
Danish: Niveauet af MMAE-metabolitter er ikke målt i humant plasma.
English: If you have symptoms of peripheral neuropathy, your doctor may lower your dose.
Danish: Hvis du har symptomer på perifer neuropati, kan lægen vælge at sætte din dosis ned.
English: Patients should be monitored closely for new or worsening neurological, cognitive, or behavioural changes suggestive of PML.
Danish: Patienter bør monitoreres tæt for nye eller forværrede neurologiske, kognitive eller adfærdsrelaterede forandringer tydende på PML.
English: • you have ever had liver problems
Danish: • du har eller har haft leverproblemer
English: Avoid transportation of the prepared solution for infusion as agitation stress can result in aggregation.
Danish: Undgå transport af den tilberedte opløsning til infusion, da rystelser kan forårsage aggregation.
English: When accounting for the influence of baseline covariates the OS HR was adjusted to 0.59.
Danish: Når der tages højde for påvirkningen af baseline-kovariater, blev OS-HR justeret til 0,59.
English: In vitro, MMAE is moderately bound (71%-77%) to human plasma proteins.
Danish: In vitro bindes MMAE moderat (71%-77%) til humane plasmaproteiner.
English: The reconstituted solution and solution for infusion should not be frozen or exposed to direct sunlight.
Danish: Den rekonstituerede opløsning og opløsning til infusion må ikke fryses eller udsættes for direkte sollys.
English: Severity of IRR on Day 1 of any cycle
Danish: Sværhedsgrad af IRR på dag 1 i en given serie
English: Your doctor will do blood tests to check your blood cell count.
Danish: Din læge vil tage blodprøver for at kontrollere dine blodcelletal.
English: • if you are allergic to polatuzumab vedotin or any of the other ingredients of this medicine (listed in section 6).
Danish: • hvis du er allergisk over for polatuzumab vedotin eller et af de øvrige indholdsstoffer i Polivy (angivet i afsnit 6).
English: Once attached to B cells, the medicine releases MMAE into the B cells and kills them.
Danish: Når lægemidlet har bundet sig til B-cellerne, vil lægemidlet frigive MMAE ind i B-cellerne og dræbe dem.
English: Patients who experience overdose should have immediate interruption of their infusion and be closely monitored.
Danish: Patienter, der får en overdosis, bør straks have afbrudt infusionen og monitoreres tæt.
English: Patients with high tumour burden and rapidly proliferative tumour may be at increased risk of TLS.
Danish: Patienter med stor tumorbyrde og hurtigt prolifererende tumor kan have øget risiko for tumorlyse syndrom (TLS).
English: Primary reasons patients were not candidates for HSCT included age (40%), insufficient response to salvage therapy (26%) and prior transplant failure (20%).
Danish: De primære årsager til, at patienterne ikke var kandidater til HSCT inkluderede alder (40%), utilstrækkeligt respons på lindrende behandling (26%) og tidligere mislykket transplantation (20%).
English: If an IRR occurs, the infusion should be interrupted and appropriate medical management should be instituted (see section 4.2).
Danish: Hvis en IRR forekommer, afbryd infusionen og administrer passende medicinsk behandling (se pkt.
English: If the prior infusion was well tolerated, the subsequent dose of Polivy may be administered as a 30-minute infusion and patients should be monitored during the infusion and for at least 30 minutes after completion of the infusion.
Danish: Hvis den forudgående infusion var veltolereret, kan den efterfølgende dosis af Polivy administreres som en 30 minutters infusion, og patienter skal monitoreres under infusionen og i mindst 30 minutter efter infusionens afslutning.
English: Procedures for proper handling and disposal of antineoplastic and cytotoxic medicines should be used.
Danish: Procedurer for korrekt håndtering og bortskaffelse af antineoplastiske og cytotoksiske lægemidler skal anvendes.
English: Grade 3-4 Thrombocytopenia
Danish: Grad 3-4 trombocytopeni
English: Grade 4 IRR
Danish: Grad 4 IRR
English: • yellowing of skin or whites of your eyes
Danish: • gulfarvning af huden eller det hvide i øjnene
English: For these reasons, comparison of incidence of antibodies to polatuzumab vedotin with the incidence of antibodies to other products may be misleading.
Danish: Derfor kan en sammenligning af incidensen af antistoffer mod polatuzumab vedotin med incidensen af antistoffer mod andre lægemidler være misvisende.
English: Overall, 48% of patients had activated B-cell (ABC) DLBCL and 40% had germinal center B-cell like (GCB) DLBCL.
Danish: I alt havde 48% af patienterne aktiveret B-celle-DLBCL, og 40% havde germinal center B-celle-lignende DLBCL.
English: This mechanism is consistent with the pharmacological effect of MMAE as a microtubule disrupting agent.
Danish: Denne mekanisme er i overensstemmelse med MMAEs farmakologiske virkning som mikrotubulus-disruptivt stof.
English: • Do not use this medicine after the expiry date which is stated on the carton and the vial after
Danish: • Brug ikke lægemidlet efter den udløbsdato, der står på pakningen og hætteglasset efter EXP.
English: Grade 1-3 IRR
Danish: Grad 1-3 IRR
English: You should not use this medicine if you are pregnant unless you and your doctor decide that the benefit to you outweighs possible risk to the unborn baby.
Danish: Du må ikke bruge dette lægemiddel, hvis du er gravid, med mindre du og lægen beslutter, at dine fordele ved behandlingen opvejer risikoen for barnet.
English: Due to the limited number of anti-polatuzumab vedotin antibody positive patients, no conclusions can be drawn concerning a potential effect of immunogenicity on efficacy or safety.
Danish: På grund af det begrænsede antal anti-polatuzumab vedotin-antistofpositive patienter, kan der ikke konkluderes vedrørende potentiel effekt i forhold til immunogenicitet på virkning eller sikkerhed.
English: Plasma exposures of unconjugated MMAE are < 3% of acMMAE exposures.
Danish: Plasmaeksponering af ukonjugeret MMAE er <3% af acMMAEoptaget.
English: Administer premedication for all cycles.
Danish: Administrér præmedicinering ved alle serier.
English: The initial dose of Polivy should be administered as a 90-minute intravenous infusion.
Danish: Den initiale dosis af Polivy bør administreres som en 90-minutters intravenøs infusion.
English: Investigator-assessed progression free survival (PFS) was an exploratory endpoint which was not type 1 error controlled.
Danish: Investigator-vurderet progressionsfri overlevelse var et eksplorativt endepunkt, som ikke var type 1fejl kontrolleret.
English: The population estimate of central volume of distribution for acMMAE was 3.15 L, which approximated plasma volume.
Danish: Populationsestimatet for central fordeling af acMMAE er 3,15 l, ca. svarende til plasmavolumen.
English: Appropriate measures/prophylaxis in accordance with local guidelines should be taken prior to treatment with Polivy.
Danish: Der bør iværksættes relevante tiltag/ profylaktisk behandling i overensstemmelse med lokale retningslinjer inden behandling med Polivy påbegyndes.
English: Tell your doctor or nurse straight away if you notice any of the following serious side effects - you may need urgent medical treatment.
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du oplever én eller flere af følgende alvorlige bivirkninger - du kan have behov for akut medicinsk behandling.
English: Patients should be monitored closely for TLS during treatment with Polivy.
Danish: Patienter bør monitoreres tæt for TLS under behandling med Polivy.
English: No significant difference was observed in the pharmacokinetics of acMMAE and unconjugated MMAE among patients < 65 years of age (n = 187) and patients ≥ 65 years of age (n = 273).
Danish: Der blev ikke set nogen signifikant forskel i farmakokinetikken for acMMAE og ukonjugeret MMAE blandt patienter <65 år (n = 187) og patienter ≥65 år (n = 273).
English: It is important to tell your doctor before and during treatment if you are pregnant, think you may be pregnant, or are planning to get pregnant.
Danish: Før du får behandlingen og under hele behandlingen er det vigtigt at informere lægen, hvis du er gravid, tror du kan være gravid eller planlægger at blive gravid.
English: This is because stopping treatment may make your condition worse.
Danish: Hvis du stopper behandlingen, kan det forværre tilstanden.
English: The active substance in Polivy is made up of a monoclonal antibody linked to MMAE, a substance that can kill cancer cells.
Danish: Det aktive indholdsstof i Polivy består af et monoklonalt antistof, bundet til MMAE, et stof der kan dræbe kræftceller.
English: This is because Polivy can affect your baby's health.
Danish: Det er vigtigt fordi Polivy kan skade barnet.
English: Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
Danish: Læger og sundhedspersoner anmodes om at indberette alle formodede bivirkninger via det nationale rapporteringssystem anført i Appendiks V.
English: Among the 80 patients who were randomized to receive Polivy plus BR (n=40) or BR alone (n = 40) the majority were white (71%) and male (66%).
Danish: Blandt de 80 patienter, der blev randomiseret til behandling med Polivy plus BR (n=40) eller BR alene (n = 40) var størstedelen hvide (71%) og mænd (66%).
English: For the next cycle, infuse Polivy over 90 minutes.
Danish: Ved næste serie gives Polivy infusion over 90 minutter.
English: Covariates included primary refractory status, number of prior lines of therapy, IPI, and prior stem cell transplant.
Danish: Kovariater inkluderede primær refraktær status, antal tidligere behandlingslinjer, IPI, og forudgående stamcelletransplatation.
English: • have unusual bleeding, bruising under the skin, bleeding longer than usual after your blood has been drawn, or bleeding from your gums.
Danish: • får usædvanlig blødning, blå mærker på huden, bløder længere end sædvanligt efter blodprøver eller bløder fra tandkødet.
English: Patients were stratified by duration of response to last prior treatment of ≤ 12 months or > 12 months.
Danish: Patienterne var stratificeret efter varighed af respons under sidste behandling, ≤12 måneder eller >12 måneder.
English: Patients should be monitored for IRRs/hypersensitivity reactions during the infusion and for at least 90 minutes following completion of the initial dose.
Danish: Patienter bør monitoreres for infusionsrelaterede reaktioner (IRR)/overfølsomhedsreaktioner under infusionen og i mindst 90 minutter efter afslutning af den initiale dosis.
English: Live or live-attenuated vaccines should not be given concurrently with the treatment.
Danish: Der bør ikke gives levende eller levende, svækkede vacciner samtidig med behandlingen.
English: MMAE does not significantly partition into human red blood cells in vitro; the blood to plasma ratio is 0.79 to 0.98.
Danish: In vitro fordeler MMAE sig ikke i betydelig grad til humane røde blodlegemer; blod-/plasma-forholdet er 0,79 til 0,98.
English: See section “Polivy contains sodium”.
Danish: Se afsnit 2 ”Polivy indeholder natrium”.
English: Each pack of Polivy consists of one vial.
Danish: Hver pakning med Polivy indeholder ét hætteglas.
English: It is given into a vein, as a drip over 90 minutes.
Danish: Det gives i en blodåre, som et drop, over 90 minutter.
English: Polivy can cause some serious side effects that you need to tell your doctor or nurse about straight away.
Danish: Polivy kan give alvorlige bivirkninger, som det er vigtigt du straks fortæller lægen eller sundhedspersonalet om.
English: The unadjusted estimate for OS HR was 0.42.
Danish: Det ikke-justerede estimat for OS HR var 0,42.
English: • a burning sensation
Danish: • en brændende fornemmelse