FrancophonIA/ELRC3.0 huggingface dataset:
English: Some people may develop unusual levels of some substances (such as potassium and uric acid) in the blood caused by the fast breakdown of cancer cells during treatment.
Danish: Nogle patienter kan udvikle unormale niveauer af visse stoffer i blodet (for eksempel kalium og urinsyre) på grund af den hurtige nedbrydning af kræftceller under behandlingen.
English: Serious and severe neutropenia and febrile neutropenia have been reported in patients treated with Polivy as early as the first cycle of treatment.
Danish: Der er rapporteret alvorlig og svær neutropeni samt febril neutropeni hos patienter behandlet med Polivy allerede i første behandlingsserie.
English: The primary endpoint of the study was complete response (CR) rate at end of treatment (6-8 weeks after Day 1 of Cycle 6 or last study treatment) as assessed by PET-CT by an Independent Review Committee (IRC).
Danish: Det primære endepunkt i studiet var forekomst af komplet respons efter afsluttet behandling (6-8 uger efter Dag 1 i behandlingsserie 6 eller sidste forsøgsbehandling) vurderet ved PET-CT af Independent Review Committee (IRC).
English: Tell your doctor or nurse straight away if you have any problems with a change in the sensitivity of your skin, especially in your hands or feet, such as:
Danish: Kontakt straks lægen eller sundhedspersonalet, hvis du oplever ændringer i hudens følsomhed, særligt i hænder eller fødder, som for eksempel:
English: Gently mix the intravenous bag by slowly inverting the bag.
Danish: Bland forsigtigt indholdet i den intravenøse pose ved langsomt at vende posen.
English: The European Medicines Agency will review new information on this medicine at least every year and this leaflet will be updated as necessary.
Danish: Det Europæiske Lægemiddelagentur vil mindst en gang om året vurdere nye oplysninger om dette lægemiddel, og denne indlægsseddel vil om nødvendigt blive ajourført.
English: Within each frequency grouping, adverse reactions are presented in the order of decreasing seriousness.
Danish: Bivirkningerne præsenteres inden for hver hyppighedsgruppe efter alvorlighedsgrad, i faldende rækkefølge.
English: ANNEX IV CONCLUSIONS ON THE GRANTING OF THE CONDITIONAL MARKETING AUTHORISATION PRESENTED BY THE EUROPEAN MEDICINES AGENCY
Danish: BILAG IV KONKLUSIONER VEDRØRENDE UDSTEDELSE AF MARKEDSFØRINGSTILLADELSE UNDER BETINGEDE OMSTÆNDIGHEDER OG FREMLAGT AF DET EUROPÆISKE LÆGEMIDDELAGENTUR
English: Sixty-four out of 80 patients (80%) had ECOG performance score (PS) of 0-1 and 14 out of 80 patients (18%) had ECOG PS of 2.
Danish: Ud af de 80 patienter havde 64 (80%) en ECOG-performance score på 0-1, og 14 ud af 80 patienter (18%) havde en ECOG-performance score på 2.
English: Patients experiencing new or worsening PN may require a delay, dose reduction, or discontinuation of Polivy (see section 4.2).
Danish: Patienter der oplever ny eller forværret PN kan have behov for dosisudsættelse, dosisreduktion eller seponering af Polivy (se pkt.
English: p-value (Log-Rank test, stratified***) Overall Response Rate* (INV-assessed) at End of Treatment** Responders (%) (CR, PR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Complete Response (%) (CR) Difference in response rate (%) [95% CI] p-value (CMH chi-squared test***) Partial Response (%) (PR) 95% CI Clopper-Pearson Best Overall Response Rate* (INV-assessed) Responders (%) (CR, PR) Difference in response rate (%) [95% CI] Complete Response (%) (CR) 95% CI Clopper-Pearson Partial Response (%) (PR) 95% CI Clopper-Pearson
Danish: p-værdi (logrank-test, stratificeret***) Objektiv responsrate* (INV-vurderet) ved behandlingens afslutning** Responderende (%) (CR, PR) Forskel i responsrate (%) (95% KI) p-værdi (CMH chi-squared test***) Komplet respons (%) (CR) Forskel i responsrate (%) (95% KI) p-værdi (CMH chi-squared test***) Partielt respons (%) (PR) 95% KI Clopper-Pearson Bedste objektive responsrate* (INV-vurderet) Responderende (%) (CR, PR) Forskel i responsrate (%) (95% KI) Komplet respons (%) (CR) 95% KI Clopper-Pearson Partielt respons (%) (PR) 95% KI Clopper-Pearson
English: Polivy must only be administered under the supervision of a healthcare professional experienced in the diagnosis and treatment of cancer patients.
Danish: Polivy må kun administreres under supervision af sundhedspersoner med erfaring i diagnosticering og behandling af kræftpatienter.
English: If you get infusion-related reactions or nerve damage, or if you feel tired, weak or dizzy (see section 4) do not drive, cycle or use tools or machines until the reaction stops.
Danish: Hvis du får bivirkninger ved infusionen eller nerveskader, føler dig træt, svag eller svimmel (se afsnit 4), må du ikke føre motorkøretøj, cykle eller håndtere værktøj og maskiner før bivirkningen er forsvundet.
English: MMAE binds to microtubules and kills dividing cells by inhibiting cell division and inducing apoptosis.
Danish: MMAE bindes til mikrotubuli og dræber celler, der deler sig, ved at hæmme celledeling og inducere apoptose.
English: The total storage plus transportation times of the diluted product should not exceed the storage duration specified in Table 6 (see section 6.3).
Danish: Den samlede opbevarings- og transporttid for det fortyndede produkt må ikke overstige opbevaringstiden angivet i tabel 6 (se pkt.
English: Peripheral neuropathy (PN)
Danish: Perifer neuropati (PN)
English: Pharmacotherapeutic group: antineoplastic agents; other antineoplastic agents; monoclonal antibodies ATC code: L01XC37
Danish: Farmakoterapeutisk klassifikation: antineoplastiske midler; andre antineoplastiske midler; monoklonale antistoffer, ATC-kode: L01XC37
English: Grade 3-4 Neutropenia
Danish: Grad 3-4 neutropeni
English: Name and address of the manufacturer of the biological active substance
Danish: Navn og adresse på fremstilleren af det (de) biologisk aktive stof
English: You may need medical treatment.
Danish: Det kan være nødvendigt at behandle dem.
English: Patients should be closely monitored during treatment for signs of bacterial, fungal, or viral infections and seek medical advice if signs and symptoms appear.
Danish: Patienter bør monitoreres tæt under behandlingen for tegn på bakterielle og virale infektioner samt svampeinfektioner og bør søge læge ved tegn eller symptomer på infektion.
English: This medicine should not be used in children or young people under the age of 18.
Danish: Dette lægemiddel må ikke bruges til børn eller unge under 18 år, da det ikke er undersøgt til denne aldersgruppe.
English: Based on population PK analysis, the predicted acMMAE concentration at the end of cycle 6 is approximately 80% of the theoretical steadystate value.
Danish: Baseret på den farmakokinetiske populationsanalyse, er den forventede acMMAE-koncentration ved afslutningen af serie 6 ca. 80% af den teoretiske steady-state-værdi.
English: Common arthralgia
Danish: Almindelig artralgi
English: The requirements for submission of PSURs for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD listen), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på Det Europæiske Lægemiddelagenturs hjemmeside http://www.ema.europa.eu.
English: Otherwise, upon complete resolution of symptoms, infusion may be resumed at 50% of the rate achieved prior to interruption.
Danish: Ved komplet ophør af symptomer kan infusionen fortsættes ved en rate på 50 % af raten givet inden afbrydelse.
English: Diffuse large B-cell lymphoma is a cancer that develops from B lymphocytes also called B-cells.
Danish: Diffust storcellet B-celle lymfom er en type kræft, der udvikles fra B-lymfocytterne, også kendt som B-celler.
English: • restart all treatment with a dose reduction of bendamustine from 90 mg/m2 to 70 mg/m2 or 70 mg/m2 to 50 mg/m2.
Danish: • genoptag al behandling med bendamustin i reduceret dosis fra 90 mg/m2 til 70 mg/m2 eller fra 70 mg/m2 til 50 mg/m2.
English: In the absence of infusion-related symptoms, the rate of infusion may be escalated in increments of 50 mg/hour every 30 minutes.
Danish: Ved fravær af infusionsrelaterede reaktioner kan infusionsraten øges i trin af 50 mg/time hvert 30. minut.
English: Follow applicable proper handling and disposal procedure (see section 6.6).
Danish: Følg den gældende håndterings- og afskaffelsesprocedure (se pkt.
English: The efficacy of Polivy was evaluated in an international, multicentre, open-label study (GO29365) which included a randomized cohort of 80 patients with previously treated DLBCL.
Danish: Polivys virkning er evalueret i et internationalt, ublindet multicenter-studie (GO29365), der inkluderede en randomiseret kohorte på 80 patienter, tidligere behandlet for DLBCL.
English: Testicular seminiferous tubule degeneration did not reverse following a 6-week treatment-free period and correlated with decreased testes weight and gross findings at recovery necropsy of small and/or soft testes in males given ≥ 2 mg/kg.
Danish: Testikulær degeneration af seminiferøse tubuli var ikke reversibel efter en 6-ugers behandlingsfri periode og korrelerede med nedsat testesvægt og svære fund ved dissektion af små og/eller bløde testes hos hanner, der havde fået ≥2 mg/kg.
English: However, treatment of pregnant rats with MMAE at 0.2 mg/kg caused embryolethality and foetal malformations (including protruding tongue, malrotated limbs, gastroschisis, and agnathia).
Danish: MMAEbehandling af gravide rotter med 0,2 mg/kg forårsagede dog embryoletalitet og føtale misdannelser (inklusive tungeprotrusion, fejlroterede lemmer, gastroschise og agnathia).
English: Polivy is compatible with intravenous infusion bags with product contacting materials of polyvinyl chloride (PVC) or polyolefins such as polyethylene (PE) and polypropylene.
Danish: Polivy er forligeligt med intravenøse infusionsposer af materialer indeholdende polyvinylchlorid (PVC) eller polyolefiner som polyethylen (PE) og polypropylen.
English: For dose modifications for Infusion-related reactions see Table 3.
Danish: For dosisændringer i forbindelse med infusionsrelaterede reaktioner, se tabel 3.
English: Permanently discontinue Polivy.
Danish: Afbryd Polivy behandling permanent.
English: • you have ever had brain or nerve problems such as: memory problems difficulty moving or sensations in your body such as feeling pins and needles, burning, pain and discomfort even from slight touch eyesight problems
Danish: • du har eller har haft hjerne- eller nerveproblemer, for eksempel: problemer med hukommelsen svært ved at bevæge dig eller har fornemmelser i kroppen, såsom prikken og stikken, brændende fornemmelse, smerte og ubehag ved let berøring.
English: Luxembourg/Luxemburg (Voir/siehe Belgique/Belgien)
Danish: (Voir/siehe Belgique/Belgien)
English: Women of childbearing potential/Contraception in males and females
Danish: Kvinder i den fødedygtige alder/Prævention til mænd og kvinder
English: • feeling weak or generally unwell.
Danish: • følelse af svaghed eller almen utilpashed
English: Active severe infections (see section 4.4).
Danish: Aktive, svære infektioner (se pkt.
English: If recovered to Grade ≤ 1 on or before Day 14, restart Polivy at a permanently reduced dose of 1.4 mg/kg.
Danish: Ved bedring til grad ≤1 inden eller på dag 14, genoptag Polivy-behandling ved permanent reduceret dosis på 1,4 mg/kg.
English: MMAE plasma concentrations followed formation rate limited kinetics.
Danish: Plasmakoncentrationen af MMAE følger formationsrate limiteret kinetik.
English: Sodium hydroxide (for pH-adjustment) Sucrose
Danish: Natriumhydroxid (til pH justering) Saccharose
English: If air is removed, an infusion set with a vented spike is required to ensure accurate dosing during the infusion.
Danish: Hvis luften fjernes, skal der anvendes infusionssæt med udluftningsventil for at sikre nøjagtig dosering under infusionen.
English: It is not known whether polatuzumab vedotin or its metabolites are excreted in human breast milk.
Danish: Det vides ikke om polatuzumab vedotin eller dets metabolitter udskilles i human brystmælk.
English: Complete blood counts should be monitored prior to each dose of Polivy.
Danish: Patienten bør have monitoreret fuldt blodbillede inden hver dosis Polivy.
English: Polivy and any concomitant chemotherapy should be withheld if PML is suspected and permanently discontinued if the diagnosis is confirmed.
Danish: Behandling med Polivy og eventuel samtidig kemoterapi bør afbrydes ved mistanke om PML og permanent seponeres, hvis diagnosen bekræftes.
English: • if a bendamustine dose reduction to 50 mg/m2 has already occurred, discontinue all treatment.
Danish: • hvis bendamustindosis allerede er reduceret til 50 mg/m2 skal al behandling seponeres.
English: • unusual bleeding or bruising under the skin
Danish: • unormal blødning eller blå mærker under huden
English: Bendamustine does not affect acMMAE and unconjugated MMAE plasma AUC.
Danish: Bendamustin påvirker ikke acMMAE- eller ukonjugeret MMAE-plasma-AUC.
English: The diluted solution must be discarded if storage time exceeds the limits specified in Table 6.
Danish: Den fortyndede opløsning skal kasseres, hvis opbevaringstiden overskrider det, der er specificeret i tabel 6.
English: Polivy, bendamustine and rituximab can be administered in any order on Day 1 of each cycle.
Danish: Polivy, bendamustin og rituximab kan på dag 1 i hver serie administreres i den rækkefølge, der passer.
English: Immunogenicity assay results are highly dependent on several factors including assay sensitivity and specificity, assay methodology, sample handling, timing of sample collection, concomitant medications and underlying disease.
Danish: Resultater af immungenicitetsundersøgelser afhænger i meget høj grad af flere faktorer, inklusive testens følsomhed og specificitet, metode, håndtering af prøver, tidspunkt for prøvetagning, samtidig behandling samt underliggende sygdom.
English: MMAE was not mutagenic in the bacterial reverse mutation assay (Ames test) or the L5178Y mouse lymphoma forward mutation assay.
Danish: MMAE var ikke mutagent i bakterielle reverse-mutationsassay (Ames-test) eller i L5178Y-muselymfom forwardmutationsassay.
English: For dose modifications for myelosuppression see Table 2.
Danish: For dosisændringer i forbindelse med myelosuppression, se tabel 2.
English: Your doctor will check your blood to test your liver function before and regularly during treatment.
Danish: Lægen vil sørge for, at du får taget blodprøver og kontrolleret din leverfunktion, inden du får behandlingen og jævnligt under behandlingen.
English: Based on a population PK analysis, the conjugate (acMMAE) is primarily eliminated by non-specific linear clearance pathway with a value of 0.9 L/day.
Danish: Baseret på en farmakokinetisk populationsanalyse, elimineres konjugatet (acMMAE) primært ved uspecifik lineær clearance i en værdi på 0,9 l/dag.
English: This includes any possible side effects not listed in this leaflet you can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
Danish: Du eller din pårørende kan også indberette bivirkninger direkte til Lægemiddelstyrelsen via det nationale rapporteringssystem anført i Appendiks V. Ved at indrapportere bivirkninger kan du hjælpe med at fremskaffe mere information om sikkerheden af dette lægemiddel.
English: If not already premedicated, premedication with an antihistamine and anti-pyretic should be administered to patients prior to Polivy.
Danish: Hvis patienten ikke allerede er præmedicineret, bør præmedicinering med antihistamin og antipyretikum administreres inden Polivy.
English: If you get any side effects, talk to your doctor, pharmacist or nurse.
Danish: Hvis du oplever bivirkninger, bør du tale med din læge, sygeplejerske eller apoteketspersonalet.
English: Liver damage
Danish: Lever skade
English: CD79b expression is restricted to normal cells within the B-cell lineage (with the exception of plasma cells) and malignant B-cells; it is expressed in > 95% of diffuse large B-cell lymphoma.
Danish: CD79bekspression er begrænset til normale celler i B-cellelinjen (bortset fra plasmaceller) og maligne Bceller, det er til stede i >95% af diffuse, storcellede B-cellelymfomer.
English: In another study, two cases of serious hepatic toxicity (hepatocellular injury and hepatic steatosis) were reported and were reversible.
Danish: Der er i et andet studie rapporteret 2 tilfælde af alvorlig levertoksicitet (cellulær leverskade og leversteatose), som var reversible.
English: Systemic exposure (AUC) in rats at a dose of 0.2 mg/kg MMAE is approximately 50% of the AUC in patients who received the recommended dose of 1.8 mg/kg Polivy every 21-days.
Danish: Systemisk optagelse (AUC) af MMAE hos rotter ved en dosis på 0,2 mg/kg er ca. 50% af AUC hos patienter, der fik den anbefalede dosis Polivy på 1,8 mg/kg hver 21. dag.
English: Polivy is for intravenous use.
Danish: Polivy er til intravenøst brug.
English: MMAE was genotoxic in the rat bone marrow micronucleus study probably through an aneugenic mechanism.
Danish: MMAE var genotoksisk i rotte-knoglemarvsmikronukleusstudiet, sandsynligvis gennem en aneugen mekanisme.
English: • have a fever
Danish: • får feber
English: Polivy is given to treat “diffuse large B-cell lymphoma” that has come back or has not got better with at least one previous therapy and when you cannot receive a stem cell transplant.
Danish: Polivy gives som behandling mod diffust storcellet B-celle lymfom, som enten er kommet igen eller hvor mindst én tidligere behandling ikke har haft effekt, og hvis du ikke kan få stamcelletransplantation.
English: MARKETING AUTHORISATION NUMBER(S) EU/1/19/1388/001
Danish: EU/1/19/1388/001
English: Polivy has minor influence on the ability to drive and use machines.
Danish: Polivy påvirker kun i mindre grad evnen til at føre motorkøretøj og betjene maskiner.
English: If you stop receiving Polivy
Danish: Hvis du holder op med at bruge Polivy
English: If you miss an appointment, make another one straight away.
Danish: Hvis du ikke kan møde til en behandling, skal du straks lave en ny aftale.
English: Solution for infusion storage conditions1
Danish: Opbevaringsbetingelser for infusionsopløsning1
English: Polivy is not recommended during pregnancy and in women of childbearing potential not using contraception unless the potential benefit for the mother outweighs the potential risk to the foetus.
Danish: Behandling med Polivy frarådes under graviditet og hos kvinder, der kan blive gravide og ikke bruger prævention, med mindre den potentielle fordel for kvinden opvejer den potentielle risiko for fostret.
English: For the first instance of Grade 3 wheezing, bronchospasm, or generalized urticaria, permanently discontinue Polivy.
Danish: Ved første forekomst af grad 3 hvæsen, bronkospasme eller generaliseret urticaria, skal Polivy behandlingen afbrydes permanent.
English: Pre-existing liver disease, elevated baseline liver enzymes, and concomitant medicinal products may increase the risk.
Danish: Allerede eksisterende leversygdom, forhøjede leverenzymer ved baseline samt samtidig behandling med andre lægemidler, kan øge risikoen.
English: In order to further confirm the safety and efficacy of polatuzumab vedotin in combination with BR the MAH will provide the primary CSR for study GO29365 including the primary analysis of Arm H (n=64) as well as a pooled analysis of Arm G (n=42) and Arm H (n=64).
Danish: For yderligere at bekræfte sikkerheden og effektiviteten af polatuzumab vedotin i kombination med BR vil indehaveren af markedsføringstilladelsen levere den primære CSR for studiet GO29365 inklusiv den primære analyse af arm H (antal=64) samt en poolet analyse af arm G (antal=42) og arm H (antal=64).
English: Across seven clinical studies, 14 out of 536 (2.6%) patients tested positive for anti-polatuzumab vedotin antibodies at one or more post-baseline time points.
Danish: På tværs af 7 kliniske studier, blev 14 ud af 536 (2,6%) patienter testet positive for anti-polatuzumab vedotin-antistoffer på ét eller flere måletidspunkter efter baseline.
English: Direct the stream toward the wall of the vial and not directly on the lyophilized cake.
Danish: Sprøjt væsken mod siden i hætteglasset og ikke direkte på lyofilisatet.
English: This includes medicines obtained without a prescription and herbal medicines.
Danish: Dette gælder også medicin, der ikke er på recept og naturlægemidler.
English: In vitro data indicate that MMAE is a P-gp substrate but does not inhibit P-gp at clinically relevant concentrations.
Danish: In vitro data indikerer, at MMAE er et P-gp-substrat, men hæmmer ikke P-gp ved klinisk relevante koncentrationer.
English: More frequent lab monitoring and/or Polivy delays or discontinuation should be considered for patients with Grade 3 or Grade 4 neutropenia and thrombocytopenia (see section 4.2).
Danish: Hyppigere laboratoriemonitorering og/eller udsættelse eller seponering af Polivy bør overvejes hos patienter med grad 3 eller 4 neutropeni og trombocytopeni (se pkt.
English: • If you have peripheral neuropathy, your doctor may lower your dose to 1.4 mg for each kilogram of your body weight.
Danish: • Hvis du har perifer neuropati, kan lægen vælge at sætte din dosis ned til 1,4 mg pr. kg.
English: Polivy is given under the supervision of a doctor experienced in giving such treatments.
Danish: Polivy gives under vejledning af en læge med erfaring i den slags behandlinger.
English: PN has been reported in patients treated with Polivy as early as the first cycle of treatment, and the risk increases with sequential doses.
Danish: Der er rapporteret perifer neuropati (PN) hos patienter behandlet med Polivy allerede i første behandlingsserie, og risikoen stiger ved efterfølgende doser.
English: Patients should be monitored for symptoms of PN such as hypoesthesia, hyperesthesia, paraesthesia, dysesthesia, neuropathic pain, burning sensation, muscle weakness, or gait disturbance.
Danish: Patienterne bør monitoreres for symptomer på PN som hypoæstesi, hyperæstesi, paræstesi, dysæstesi, neuropatiske smerter, brændende fornemmelse, muskelsvaghed og gangforstyrrelser.
English: You will be given 6 treatment cycles of Polivy in combination with two other medicines called rituximab and bendamustine.
Danish: Du vil få 6 behandlingsserier med Polivy i kombination med 2 andre lægemidler, som hedder rituximab og bendamustin.
English: In both rats and cynomolgus monkeys, the predominant systemic toxicities associated with administration of MMAE and polatuzumab vedotin included reversible bone marrow toxicity and associated peripheral blood cell effects.
Danish: Hos både rotter og cynomolgusaber omfattede de dominerende systemiske toksiciteter forbundet med administration af MMAE og polatuzumab vedotin reversibel knoglemarvstoksicitet og den dermed forbundne påvirkning af de perifere blodceller.
English: The median number of prior therapies was 2 (range: 1-7), with 29% (n = 23) receiving one prior therapy, 25% (n = 20) receiving 2 prior therapies, and 46% (n = 37) receiving 3 or more prior therapies.
Danish: Medianen for antal tidligere behandlinger var 2 (1-7); 29% (n = 23) havde én tidligere behandling, 25% (n = 20) havde 2 tidligere behandlinger, og 46% (n = 37) havde 3 eller flere tidligere behandlinger.
English: Due to limited clinical experience in patients treated with 1.8 mg/kg Polivy at a total dose >240 mg, it is recommended not to exceed the dose 240 mg/cycle.
Danish: På grund af begrænset klinisk erfaring hos patienter behandlet med 1,8 mg/kg Polivy, totaldosis >240 mg, frarådes doser på >240 mg/serie.
English: Dose modification1
Danish: Dosisændring1
English: What other medicines Polivy is given with
Danish: Hvilken anden medicin gives Polivy sammen med?
English: The monoclonal antibody part of the medicine attaches to a target on B cells.
Danish: Den monoklonale antistof-del af lægemidlet fastgøres til et mål på B-celler.