FrancophonIA/ELRC3.0 huggingface dataset:
English: Absorption Elotuzumab is dosed via intravenous route and therefore is immediately and completely bioavailable.
Danish: Absorption Elotuzumab indgives intravenøst og derfor opnås omgående og fuldstændig biotilgængelighed.
English: The pre-planned final OS analysis was performed after 212 deaths in the E-Ld arm and 225 deaths in the Ld arm.
Danish: Den planlagte endelige OS-analyse blev udført efter 212 dødsfald i E-Ld-armen og 225 dødsfald i Ldarmen.
English: What you need to know before you use Empliciti 3.
Danish: Det skal du vide, før du begynder at bruge Empliciti 3.
English: Probability progression free (%)
Danish: Sandsynlighed for progressionsfri overlevelse (%)
English: This medicine contains less than 1 mmol sodium (23 mg) per dose, that is to say essentially ‘sodium free'.
Danish: Denne medicin indeholder mindre end 1 mmol (23 mg) natrium pr. dosis, dvs. den er i det væsentlige natrium-fri.
English: Thus, hepatic functional impairment is not likely to alter its clearance.
Danish: Derfor vil nedsat leverfunktion sandsynligvis ikke ændre dets clearance.
English: Patients with cardiac amyloidosis or plasma cell leukemia were excluded from this study.
Danish: Patienter med kardiel amyloidose eller plasmacelleleukæmi blev udelukket fra dette studie.
English: Patients had to recover after transplant for a minimum of 12 weeks from autologous stem cell transplant (SCT), and 16 weeks from allogeneic SCT.
Danish: Patienter skulle komme sig i minimum 12 uger efter autolog stamcelletransplantation (SCT) og 16 uger efter allogen SCT.
English: It will be given into a vein (intravenously) as a drip (infusion) over several hours.
Danish: Det gives som drop (infusion) i en vene (intravenøst) over en periode på flere timer.
English: Non-clinical safety information primarily consists of limited in vitro human cell/tissue studies where no safety findings were identified.
Danish: De prækliniske sikkerhedsoplysninger stammer hovedsageligt fra begrænsede in vitro studier med humane celler/humant væv, hvor der ikke kunne identificeres sikkerhedsproblemer.
English: Lenalidomide and pomalidomide are expected to be harmful for an unborn baby.
Danish: Lenalidomid og pomalidomid forventes at være skadelige for det ufødte barn.
English: Lenalidomide and pomalidomide are present in the blood and sperm of patients receiving the medicine.
Danish: Lenalidomid og pomalidomid findes i blod og sæd hos patienter, der får lægemidlerne.
English: Because elotuzumab does not recognize non-human forms of SLAMF7 protein, in vivo safety data from animal studies are irrelevant.
Danish: Eftersom elotuzumab ikke genkender ikke humane typer af SLAMF7-proteinet, er in vivo sikkerhedsdata fra dyrestudier irrelevante.
English: If the dose of one medicine in the regimen is delayed, interrupted, or discontinued, the treatment with the other medicinal products may continue as scheduled.
Danish: Hvis dosis af et af lægemidlerne i regimet udskydes, eller behandlingen afbrydes eller seponeres, kan behandlingen med de andre lægemidler fortsætte som planlagt.
English: Target-mediated clearance of elotuzumab increased with higher serum M-protein concentrations.
Danish: Target-medieret clearance for elotuzumab steg ved højere serumM-proteinkoncentrationer.
English: A pre-specified analysis for 3-year PFS rate was performed based on a minimum follow-up time of 33 months.
Danish: En præspecificeret analyse for PFS-rate ved år 3 blev udført baseret på en opfølgningsperiode på mindst 33 måneder.
English: Overall survival (OS) was a secondary endpoint with the pre-planned final OS analysis to occur after at least 427 deaths.
Danish: Samlet overlevelse (OS) var et sekundært endepunkt, hvor den planlagte endelige OS-analyse udføres efter mindst 427 dødsfald.
English: The maximum infusion rate should not exceed 5 mL/min.
Danish: Den maksimale infusionshastighed bør ikke overstige 5 ml/min.
English: More than one vial of Empliciti may be needed to give the total dose for the patient.
Danish: Det kan være nødvendigt med mere end et Emplicitihætteglas for at kunne give patienten den totale dosis.
English: A pre-specified final analysis for OS was performed based on at least 427 deaths with a minimum follow-up time of 70.6 months.
Danish: En præspecificeret endelig analyse for OS blev udført baseret på mindst 427 dødsfald med en opfølgningsperiode på mindst 70,6 måneder.
English: This interference can impact the determination of complete response and possibly relapse from complete response in patients with IgG kappa myeloma protein.
Danish: Denne interferens kan påvirke bestemmelsen af komplet respons og muligt recidiv fra komplet respons hos patienter med IgG kappa myelomprotein.
English: Efficacy results are presented in Table 8 and Figure 1.
Danish: Effektresultater er vist i tabel 8 og figur 1.
English: When the symptoms go away or improve, the infusion can be continued more slowly and speeded up gradually if the symptoms do not recur.
Danish: Når symptomerne er forsvundet eller aftaget, kan infusionen fortsættes med en langsommere hastighed, som gradvist øges, hvis symptomerne ikke vender tilbage.
English: Second Primary Malignancies
Danish: Andre primære maligniteter
English: Patients experiencing infusion reactions should be advised not to drive and use machines until symptoms abate.
Danish: Patienter, der oplever infusionsreaktioner, bør frarådes at køre bil og betjene maskiner, indtil symptomerne er aftaget.
English: Complete response (CR) + stringent complete response (sCR).
Danish: Komplet respons (CR) + stringent komplet respons (sCR).
English: In these 19 patients, anti-product antibodies occurred within the first 2 months of the initiation of Empliciti treatment.
Danish: Ud af disse 19 patienter forekom antistoffer mod lægemidlet i løbet af de første 2 måneder efter opstart med behandling med Empliciti.
English: The median OS in the E-Ld arm was 48.30 months compared with 39.62 months in the Ld arm.
Danish: Median-OS i E-Ldarmen var 48,30 måneder sammenlignet med 39,62 måneder i Ld-armen.
English: After dilution, the infusion must be completed within 24 hours of preparation.
Danish: Efter fortynding skal infusionen være afsluttet inden for 24 timer.
English: Rate (incidence rate/100 patient years)
Danish: Forekomst (frekvens/100 patientår)
English: Uncommon (may affect up to 1 in 100 people) Sudden life-threatening allergic reaction (anaphylactic reaction)
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer) Pludselig, livsfarlig allergisk reaktion (anafylaktisk reaktion)
English: Empliciti is taken in treatment cycles that are 28 days (4 weeks) long in combination with other medicines used to treat multiple myeloma.
Danish: Empliciti gives i behandlingscyklusser, som varer 28 dage (4 uger), i kombination med anden medicin der bruges til at behandle myelomatose.
English: Conditions for use of medicinal products used with Empliciti Empliciti is used in combination with other medicinal products; therefore, the conditions for use applicable to those medicinal products also apply to the combination therapy.
Danish: Betingelser for anvendelse for lægemidler sammen med Empliciti Empliciti anvendes i kombination med andre lægemidler; derfor gælder betingelserne for anvendelse for disse lægemidler også for kombinationsbehandlingen.
English: Elotuzumab will be given in combination with lenalidomide, which is contraindicated during pregnancy.
Danish: Elotuzumab gives i kombination med lenalidomid, som er kontraindiceret under graviditet.
English: Method of administration Empliciti is for intravenous use only.
Danish: Administration Empliciti er kun til intravenøs anvendelse.
English: Cycle
Danish: Cyklus
English: In case of detection of additional peaks on serum immunofixation, the possibility of a biclonal gammopathy should be excluded.
Danish: Hvis der detekteres yderlige toppe ved serum immunfiksering, skal muligheden for biklonal gammopati udelukkes.
English: Avoid vigorous agitation, DO NOT SHAKE.
Danish: Undgå voldsomme bevægelser, MÅ IKKE OMRYSTES.
English: Data on the efficacy and safety of Empliciti in patients ≥ 85 years of age are very limited.
Danish: Der foreligger kun meget begrænsede data om Empliciti virkning og sikkerhed hos patienter ≥ 85 år.
English: Final volume of reconstituted Empliciti in the vial
Danish: Endeligt volumen af rekonstitueret Empliciti i hætteglasset
English: A total of 40 (67%) patients were alive in the E-Pd arm and 29 (51%) in the Pd arm.
Danish: I alt var 40 (67%) af patienterne i live i E-Pd-armen og 29 (51%) i Pd-armen.
English: In study CA204125, all of the reported infusion reactions occurred during the first treatment cycle and were ≤ Grade 2.
Danish: I forsøget CA204125 forekom alle de rapporterede infusionsreaktioner under den første behandlingscyklus og var ≤ grad 2.
English: In the same line, no carcinogenicity data are available for elotuzumab in animals, nor were fertility and embryo-foetal toxicity studies performed.
Danish: Ligeledes foreligger der ingen karcinogenicitetsdata for elotuzumab hos dyr, og der blev heller ikke udført fertilitetsstudier eller studier af embryoføtal toksicitet.
English: Based on a population PK analysis using data from 440 patients, the clearance of elotuzumab increased with increasing body weight supporting a weight-based dose.
Danish: Baseret på resultaterne fra en populationsfarmakokinetisk analyse med data fra 440 patienter steg elotuzumab-clearance med stigende kropsvægt, hvilket understøtter en vægtbaseret dosis.
English: Depending on the seriousness of the infusion reactions, you may require additional treatment to prevent complications and reduce your symptoms, or your infusion of Empliciti may be interrupted.
Danish: Afhængigt af hvor alvorlige infusionsreaktionerne er, kan du have behov for yderligere behandling for at forebygge komplikationer og lindre symptomerne, eller infusionen med Empliciti kan blive afbrudt.
English: Empliciti is unlikely to affect your ability to drive or use machines.
Danish: Det er usandsynligt, at Empliciti påvirker din evne til at køre bil eller betjene maskiner.
English: The product should be used immediately.
Danish: Lægemidlet skal anvendes straks.
English: How to use Empliciti 4.
Danish: Sådan skal du bruge Empliciti 4.
English: The active substance is elotuzumab.
Danish: Aktivt stof: elotuzumab.
English: Grade 3 infusion reactions occurred in 1% of patients.
Danish: Grad 3 infusionsreaktioner forekom hos 1% af patienterne.
English: Table 12: Reconstitution instructions Strength
Danish: Tabel 12: Vejledning i rekonstitution Styrke
English: Studies to evaluate the effect of elotuzumab on fertility have not been performed.
Danish: Der er ikke udført studier til vurdering af elotuzumabs virkning på fertilitet.
English: Dexamethasone was administered on day 1, 8, 15 and 22 of each cycle.
Danish: Dexamethason blev administreret på dag 1, 8, 15 og 22 i hver cyklus.
English: See Method of administration below for instruction on infusion rates.
Danish: Se Administration nedenfor for vejledning om infusionshastighed.
English: The median number of treatment cycles was 19 for the Empliciti arm and 14 for the comparator arm.
Danish: Det mediane antal behandlingscyklusser var 19 i Empliciti armen og 14 i komparatorarmen.
English: In case of overdose, patients should be closely monitored for signs or symptoms of adverse reactions, and appropriate symptomatic treatment instituted.
Danish: I tilfælde af overdosering bør patienten monitoreres tæt for tegn og symptomer på bivirkninger og passende symptomatisk behandling iværksættes.
English: Treatment should continue until disease progression or unacceptable toxicity.
Danish: Behandlingen bør fortsætte indtil sygdomsprogression eller uacceptabel toksicitet.
English: Grade 3/4 frequency
Danish: Samlet hyppighed Grad 3/4 hyppighed
English: Refer to the Summary of Product Characteristics for requirements regarding contraception due to presence and transmission in sperm and for additional detail.
Danish: Se produktresumeet for forholdsregler vedrørende prævention på grund af tilstedeværelse og overførsel i sæd og for yderligere oplysninger.
English: Multiple myeloma is a cancer of a type of white blood cell called plasma cells.
Danish: Myelomatose er kræft i en bestemt type hvide blodlegemer kaldet plasmaceller.
English: 28-Day Cycles 1 & 2
Danish: 28-dages cyklusser 1 & 2
English: The primary endpoint was investigator assessed PFS by modified International Myeloma Working Group (IMWG) criteria.
Danish: Det primære endepunkt var investigatorvurderet PFS ved modificeret International Myeloma Working Group (IMWG)-kriterie.
English: No animal data are present regarding the effect on reproductive toxicity because of the lack of an adequate animal model.
Danish: Der foreligger ingen data fra dyr vedrørende reproduktionstoksicitet, da der ikke findes fyldestgørende dyremodeller.
English: However, if you get an infusion reaction (fever, chills, high blood pressure see section 4 “Possible side effects”), do not drive, cycle or use machines until the reaction stops.
Danish: Hvis du imidlertid får en infusionsreaktion (feber, kulderystelser, højt blodtryk, se afsnit 4 “Bivirkninger”), må du ikke køre bil, cykle eller betjene maskiner, før reaktionen er forsvundet.
English: The following side effects have been reported in clinical trials with elotuzumab:
Danish: Følgende bivirkninger er blevet rapporteret i kliniske forsøg med elotuzumab:
English: Empliciti should not be used during pregnancy unless the clinical condition of the woman requires treatment with elotuzumab.
Danish: Empliciti bør ikke anvendes under graviditet, medmindre kvindens kliniske tilstand kræver behandling med elotuzumab.
English: Patients who were refractory to lenalidomide were excluded and 6% of patients had prior lenalidomide treatment.
Danish: Patienter, som var refraktære over for lenalidomid, blev ekskluderet; 6% af patienterne var tidligere blevet behandlet med lenalidomid.
English: The rate of mild to moderate infusion reactions was > 50% in patients who were not premedicated.
Danish: Forekomsten af lette til moderate infusionsreaktioner var > 50% hos patienter, der ikke var præmedicinerede.
English: No dose adjustment is required for Empliciti in patients over 65 years of age (see section 5.2).
Danish: Dosisjustering af Empliciti er ikke nødvendig hos patienter over 65 år (se pkt.
English: Tell your doctor or nurse straight away if you feel unwell during infusion.
Danish: Fortæl det straks til lægen eller sundhedspersonalet, hvis du begynder at føle dig utilpas under infusionen.
English: Vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion.
Danish: Vitale funktioner bør monitoreres hvert 30. minut i 2 timer efter afsluttet Empliciti-infusion.
English: Infusion reactions Empliciti has been associated with infusion reactions (see section 2 “Warnings and precautions”).
Danish: Empliciti er forbundet med infusionsreaktioner (se afsnit 2 “Advarsler og forsigtighedsregler”).
English: If any of the symptoms of infusion reaction reach Grade ≥ 2, Empliciti infusion must be interrupted and appropriate medical and supportive measures instituted.
Danish: Hvis nogen af symptomerne når ≥ grad 2, skal infusion af Empliciti afbrydes og passende medicinsk og understøttende behandling iværksættes.
English: The presence of elotuzumab in patient's serum may cause a small peak in the early gamma region on SPEP that is IgGƙ on serum immunofixation.
Danish: Tilstedeværelse af elotuzumab i patientens serum kan forårsage en lille top i starten af gammaregionen på SPEP, som er IgGƙ ved serum immunfiksering.
English: It is not known, whether elotuzumab passes into breast milk or if there is any risk to the breast-fed infant.
Danish: Man ved ikke, om elotuzumab udskilles i mælken, eller om det udgør en risiko for spædbørn, der ammes.
English: * Elotuzumab is produced in NS0 cells by recombinant DNA technology.
Danish: * Elotuzumab er fremstillet i NS0-celler ved rekombinant DNA-teknologi.
English: A slight back pressure may be experienced during administration of the water for injections, which is considered normal.
Danish: Et mindre tilbagetryk kan forekomme, når vand til injektionsvæsker tilsættes, hvilket anses for normalt.
English: If a ≥ Grade 2 infusion reaction occurs during Empliciti administration, the infusion must be interrupted.
Danish: Hvis der under administration af Empliciti opstår en infusionsreaktion ≥ grad 2, skal infusionen afbrydes.
English: Dose delay, interruption, or discontinuation
Danish: Udskydelse af dosis, afbrydelse eller seponering
English: Low white blood cell count
Danish: Lavt antal hvide blodlegemer
English: Thirty-five percent (35%) of patients were refractory (progression during or within 60 days of last therapy) and 65% were relapsed (progression after 60 days of last therapy).
Danish: 35% af patienterne var refraktære (progression under eller inden for 60 dage efter sidste behandling), og 65% oplevede recidiv (progression efter 60 dage efter sidste behandling).
English: Before starting treatment with Empliciti, you must also read the package leaflet warnings and precautions of all medicines to be taken in combination with Empliciti for information related to these medicines.
Danish: Før du begynder behandling med Empliciti, skal du også læse afsnittet om advarsler og forsigtighedsregler i indlægssedlerne for al den medicin, du skal tage i kombination med Empliciti, for at få oplysninger om disse lægemidler.
English: Stopping your treatment with Empliciti may stop the effect of the medicine.
Danish: Hvis du stopper behandlingen med Empliciti, kan virkningen af medicinen ophøre.
English: If you are given too much Empliciti
Danish: Hvis du har fået for meget Empliciti
English: Neutralizing antibodies were detected in 2 of 53 patients.
Danish: Neutraliserende antistoffer blev målt hos 2 ud af 53 patienter.
English: Before each infusion of Empliciti, you will be given medicines to reduce infusion reaction (see section 3 “How to use Empliciti, Medicines given before each infusion”).
Danish: Inden hver infusion af Empliciti vil du få medicinfor at mindske infusionsreaktioner (se afsnit 3 “Sådan skal du bruge Empliciti, Medicin du får før hver infusion”).
English: Empliciti contains the active substance elotuzumab, which is a monoclonal antibody, a type of protein designed to recognise and attach to a specific target substance in the body.
Danish: Empliciti indeholder det aktive stof elotuzumab, som er et monoklonalt antistof, en type protein, der er designet til at genkende og binde sig til et bestemt målstof i kroppen.
English: Chemical and physical in use stability of the reconstituted and diluted solution has been demonstrated for 24 hours at 2°C - 8°C and protected from light.
Danish: Der er påvist kemisk og fysisk stabilitet af den rekonstituerede og fortyndede infusionsvæske i 24 timer ved 2°C - 8°C og beskyttet mod lys.
English: In study CA204004, the most common symptoms of an infusion reaction included fever, chills, and hypertension.
Danish: I forsøget CA204004 var de hyppigste symptomer på en infusionsreaktion feber, kulderystelser og hypertension.
English: Premedication Empliciti (mg/kg) intravenously Pomalidomide (4 mg) orally
Danish: Præmedicinering Empliciti (mg/kg) intravenøst Pomalidomid (4 mg) oralt
English: In patients who experience an infusion reaction, vital signs should be monitored every 30 minutes for 2 hours after the end of the Empliciti infusion.
Danish: Hos patienter, som oplever en infusionsreaktion, skal de vitale funktioner monitoreres hvert 30. minut i 2 timer efter afsluttet Empliciti-infusion.
English: The rate of haematologic malignancies were the same between the two treatment arms (1.6%).
Danish: Hyppigheden af hæmatologiske maligniteter var ens i de to behandlingsarme (1,6%).
English: Table 5: Adverse reactions in patients with multiple myeloma treated with Empliciti System Organ Class
Danish: Tabel 5: Bivirkninger hos patienter med myelomatose, som blev behandlet med Empliciti Systemorganklasse
English: In nonclinical models, elotuzumab has demonstrated synergistic activity when combined with lenalidomide, pomalidomide or bortezomib.
Danish: I ikke-kliniske modeller har elotuzumab vist synergistisk aktivitet, når det kombineres med lenalidomid, pomalidomid eller bortezomib.
English: Five percent (5%) of patients required interruption of the administration of Empliciti for a median of 25 minutes due to infusion reaction, and 1% of patients discontinued due to infusion reactions.
Danish: Hos 5% af patienterne var det nødvendigt at afbryde administrationen af Empliciti i en median periode på 25 minutter på grund af en infusionsreaktion, og hos 1% af patienterne var det nødvendigt at indstille administrationen på grund af infusionsreaktioner.
English: The reconstituted solution is colourless to slightly yellow and clear to very opalescent.
Danish: Det rekonstituerede koncentrat er farveløst til let gulligt og klart til meget opaliserende.
English: Elotuzumab only recognizes human SLAMF7 protein.
Danish: Elotuzumab genkender kun det humane SLAMF7-protein.
English: The Summary of Product Characteristics for all medicinal products used in combination with Empliciti must be consulted before starting therapy.
Danish: Produktresumeerne for alle lægemidler, der anvendes i kombination med Empliciti, skal læses, før behandlingen påbegyndes.
English: In cycles 1 and 2, once weekly on days 1, 8, 15, and 22.
Danish: I cyklus 1 og 2, en gang om ugen på dag 1, 8, 15 og 22.
English: These side effects mostly occur during or after the infusion of the first dose.
Danish: Disse reaktioner forekommer som oftest under eller efter den første infusion.
English: Each vial contains a slight overfill to ensure sufficient extractable volume.
Danish: Hvert hætteglas indeholder en ekstra mængde for at sikre tilstrækkelig udtagelig volumen.
English: Post-reconstitution concentration
Danish: Koncentration efter rekonstitution
English: After the remaining solids are completely dissolved, allow the reconstituted solution to stand for 5 to 10 minutes.
Danish: Når det sidste faste stof er helt opløst, skal det rekonstituerede koncentrat hvile i 5 til 10 minutter.
English: For instructions on reconstitution and dilution of Empliciti before administration, see section 6.6.
Danish: For instruktioner om rekonstitution og fortynding af Empliciti før administration, se pkt.
English: If any medicine in the treatment is delayed, interrupted, or discontinued, your doctor will decide how your treatment should be continued.
Danish: Hvis behandlingen med et eller flere af lægemidlerne i din behandling udskydes, afbrydes eller ophører, vil lægen beslutte, hvordan din behandling skal fortsætte.
English: There is no relevant use of Empliciti in the paediatric population for the indication of multiple myeloma.
Danish: Pædiatrisk population Det er ikke relevant at anvende Empliciti i den pædiatriske population til indikationen myelomatose.
English: The incidence of SPMs was higher with Empliciti treatment than with control (see section 4.4).
Danish: Forekomsten af SPM var højere med Empliciti-behandlingen end med kontrolbehandlingen (se pkt.
English: Elotuzumab is not expected to be excreted into human milk.
Danish: Det forventes ikke, at Elotuzumab udskilles i human mælk.
English: PVC infusion sets polyethersulfone and nylon in-line filters with pore sizes of 0.2 μm to 1.2 μm.
Danish: PVC-infusionssæt polyethersulfon og in-line-filter af nylon med en porestørrelse på 0,2 μm til 1,2 μm.
English: Amount of water for injections, required for reconstitution
Danish: Mængde vand til injektionsvæsker til rekonstitution
English: Median OS in months [95% CI]
Danish: Median OS i måneder [95% CI]
English: When lenalidomide is used, particular attention to pregnancy testing and prevention requirements is needed (see “Pregnancy and breast-feeding” in this section).
Danish: Når du behandles med lenalidomid, er det især vigtigt at være opmærksom på, at der skal laves graviditetstest, og at der skal anvendes prævention (se “Graviditet og amning” i dette afsnit).
English: Lenalidomide (25 mg) orally
Danish: Lenalidomid (25 mg) oralt
English: Elotuzumab attaches to a target protein called SLAMF7.
Danish: Elotuzumab kobler sig til et målprotein kaldet SLAMF7.