FrancophonIA/ELRC3.0 huggingface dataset:
English: To minimise doxorubicin-related cardiotoxicity, the use of appropriate cardioprotective measures (LVEF measurement, such as ECHO or MUGA scan, ECG monitoring, and/or use of cardioprotective agents) should be considered and planned in all patients before the start and throughout the treatment.
Danish: For at minimere doxorubicin-relateret kardiotoksicitet bør relevante kardiobeskyttende foranstaltninger (måling af LVEF såsom ECHO eller MUGA-scanning, EKG-monitorering og/eller brug af kardiobeskyttende midler) overvejes og planlægges hos alle patienter før og under behandlingen.
English: From a microbiological point of view the prepared dosing solution should be used immediately.
Danish: Af mikrobiologisk hensyn bør den klargjorte dosis administreres med det samme.
English: Human IgG is excreted in human milk, therefore breast-feeding is not recommended during treatment with olaratumab and for at least 3 months following the last dose.
Danish: Humant IgG udskilles i human mælk, og derfor anbefales amning ikke under behandling med olaratumab og i mindst 3 måneder efter den sidste dosis.
English: In severe cases, you may experience very low blood pressure, feel faint, and experience breathing distress caused by narrowing of the airways, which could be life-threatening.
Danish: I alvorlige tilfælde kan du få meget lavt blodtryk, føle, du vil besvime, og få svært ved at trække vejret pga. sammensnøring af luftvejene, hvilket kan være livstruende.
English: To be taken into consideration by patients on a controlled sodium diet.
Danish: Dette bør tages i betragtning ved administration til patienter på en natriumkontrolleret diæt.
English: Very rare (< 1/10,000)
Danish: Meget sjælden (< 1/10.000)
English: Glycine (E640)
Danish: Glycin (E 640)
English: c Infusion-related reactions includes anaphylactic reactions/anaphylactic shock.
Danish: c Infusionsrelaterede reaktioner inkluderer anafylaktiske reaktioner/anafylaktisk chok.
English: IRRs were reported in 12.5 % of patients and mainly present as chills, fever or dyspnoea.
Danish: IRR'er blev rapporteret hos 12,5 % af patienterne og var overvejende kulderystelser, feber eller dyspnø.
English: Progression free survival, months* Median (95 % CI) Hazard ratio (95 % CI) p-value Overall survival, months Median (95 % CI) Hazard ratio (95 % CI) p-value Abbreviations: CI = confidence interval * By investigator assessment **Met phase 2 protocol defined significance level of 0.19
Danish: Progressionsfri overlevelse, måneder* Median (95 % CI) Hazard ratio (95 % CI) p-værdi Samlet overlevelse, måneder Median (95 % CI) Hazard ratio (95 % CI) p-værdi Forkortelser: CI = konfidensinterval.
English: If not used immediately, in-use storage times and conditions before use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8 ºC and up to an additional 8 hours at room temperature (below 25 ºC).
Danish: Hvis det ikke anvendes med det samme, er opbevaringstider og -betingelser brugerens eget ansvar og må normalt ikke overstige 24 timer ved 2°C til 8°C og yderligere op til 8 timer ved stuetemperatur (under 25°C).
English: No clinically meaningful difference in doxorubicin-related cardiotoxicity was observed between the two treatment arms of the study.
Danish: Der blev ikke observeret nogen klinisk relevant forskel i doxorubicin-relateret kardiotoksicitet mellem de to behandlingsarme i studiet.
English: On the basis of the scientific conclusions for olaratumab the CHMP is of the opinion that the benefitrisk balance of the medicinal product(s) containing olaratumab is unchanged subject to the proposed changes to the product information.
Danish: På baggrund af de videnskabelige konklusioner for olaratumab er CHMP af den opfattelse, at benefit/risk-forholdet for det lægemiddel/de lægemidler, der indeholder olaratumab, forbliver uændret under forudsætning af, at de foreslåede ændringer indføres i produktinformationen.
English: Other non-haematology toxicities
Danish: Anden ikke-hæmatologisk toksicitet
English: It is not known whether olaratumab is excreted in human milk.
Danish: Det er ukendt, om olaratumab udskilles i human mælk.
English: For subsequent infusions, the dose should be reduced to 12 mg/kg for serious Grade 3 toxicities and to 10 mg/kg for Grade 4 toxicities.
Danish: Ved efterfølgende infusioner skal dosis reduceres til 12 mg/kg ved alvorlig grad 3 toksicitet og til 10 mg/kg ved grad 4 toksicitet.
English: Vaccination with a live vaccine should be avoided in patients receiving olaratumab in combination with doxorubicin.
Danish: Vaccination med levende vacciner bør undgås hos patienter i behandling med olaratumab i kombination med doxorubicin.
English: Ask your doctor if you can breast-feed during or after treatment with Lartruvo.
Danish: Spørg lægen, om du kan amme under eller efter behandling med Lartruvo.
English: Overall, a low incidence of both treatment emergent anti-drug antibodies and neutralising antibodies were detected in clinical trial samples.
Danish: Samlet set var der en lav incidens af både behandlingsrelaterede anti-drug-antistoffer og neutraliserende antistoffer i prøver fra kliniske studier.
English: Administer via an infusion pump.
Danish: Administeres via en infusionspumpe.
English: Randomisation was stratified by PDGFR-α expression (positive versus negative), number of previous lines of treatment (0 versus 1 or more lines), histological tumour type (leiomyosarcoma, synovial sarcoma, and others) and ECOG performance status (0 or 1 versus 2).
Danish: Randomiseringen blev stratificeret efter PDGFR-α-ekspression (positiv versus negativ), antal tidligere behandlingslinjer (0 versus 1 eller flere linjer), histologisk tumortype (leiomyosarkom, synovialt sarkom og andre) og ECOG-performancestatus (0 eller 1 versus
English: Lartruvo contains the active substance olaratumab, which belongs to a group of medicines called monoclonal antibodies.
Danish: Lartruvo indeholder det aktive stof olaratumab, som tilhører en gruppe af lægemidler, der kaldes monoklonale antistoffer.
English: Olaratumab therapy must be initiated and supervised by physicians experienced in oncology.
Danish: Behandling med olaratumab skal indledes og superviseres af læger med onkologisk erfaring.
English: Coagulation parameters should be monitored in patients with conditions predisposing to bleeding, such as anticoagulant use.
Danish: Koagulationsparametre skal monitoreres hos patienter med tilstande, der disponerer til blødning, såsom behandling med antikoagulantia.
English: Kaplan-Meier curves of overall survival for Lartruvo plus doxorubicin versus doxorubicin alone
Danish: Kaplan-Meier-kurver for samlet overlevelse for Lartruvo plus doxorubicin versus doxorubicin alene
English: Absorption Olaratumab is administered as an intravenous infusion only.
Danish: Absorption Olaratumab administreres kun som intravenøs infusion.
English: Patients were required to have histologically or cytologically confirmed, advanced soft tissue sarcoma and ECOG performance status of 0-2.
Danish: Det var et krav, at patienterne havde histologisk eller cytologisk bekræftet avanceret bløddelssarkom og en ECOG-performancestatus på 0-2.
English: Platelets help your blood to clot and a low platelet count may increase the risk of bleeding.
Danish: Blodplader hjælper blodet med at størkne, og et lavt antal blodplader kan øge risikoen for blødning.
English: Fertility There are no data on the effect of olaratumab on human fertility.
Danish: Fertilitet Der foreligger ingen data om olaratumabs indvirkning på fertiliteten hos mennesker.
English: • Paracetamol, H1 antagonist and dexamethasone should be administered as needed (see premedication section)
Danish: • Administrer paracetamol, H1-antagonist og dexamethason efter behov (se afsnittet om præmedicinering).
English: Neutrophil count should be monitored during the treatment with olaratumab and doxorubicin and supportive care should be administered such as antibiotics or G-CSF as per local guidelines.
Danish: Neutrofiltallet skal monitoreres under behandlingen med olaratumab og doxorubicin, og understøttende behandling som antibiotika eller G-CSF skal administreres i henhold til lokale retningslinjer.
English: Your doctor may consider slowing the Lartruvo infusion or interrupting it to manage these symptoms.
Danish: Lægen kan muligvis give Lartruvo-infusionen langsommere eller afbryde den for at behandle disse symptomer.
English: When olaratumab attaches to PDGFR-α it may prevent cancer cell growth and survival.
Danish: Når olaratumab binder til PDGFR-α, kan det forhindre, at kræftcellen vokser og overlever.
English: There was a higher incidence of Grade ≥3 adverse reactions, adverse reactions leading to discontinuation and a higher rate of haematological toxicity in the elderly population compared to the overall study population (see section 4.2).
Danish: Der var en højere forekomst af grad ≥ 3 bivirkninger, bivirkninger, som medførte seponering, og af hæmatologisk toksicitet hos den ældre population sammenlignet med den samlede studiepopulation (se pkt.
English: More than 25 different soft tissue sarcoma subtypes were represented in this trial, the most frequent being leiomyosarcoma (38.4 %), undifferentiated pleomorphic sarcoma (18.1 %) and liposarcoma (17.3 %).
Danish: Flere end 25 forskellige undertyper af bløddelssarkom var repræsenteret i dette studie, hvor de hyppigste var leiomyosarkom (38,4 %), udifferentieret pleomorft sarkom (18,1 %) og liposarkom (17,3 %).
English: EU/1/16/1143/003 - 2 vials of 19 mL.
Danish: EU/1/16/1143/003 - 2 hætteglas a 19 ml.
English: The risk of toxicity rises with increasing cumulative doses and is higher in individuals with a history of cardiomyopathy, mediastinal irradiation or pre-existing cardiac disease.
Danish: Risikoen for toksicitet øges med stigende kumulative doser og er højere hos personer med kardiomyopati, mediastinal bestråling eller hjertesygdom i anamnesen.
English: It is not known whether olaratumab gets into breast milk and if the breast-fed infant is at risk of harm.
Danish: Det vides ikke, om olaratumab går over i mælken hos mennesker, og om det ammede spædbarn udsættes for en risiko.
English: A low white blood cell count may increase your risk for infection.
Danish: Et lavt antal hvide blodlegemer kan øge risikoen for af få en infektion.
English: In a study of olaratumab in combination with liposomal doxorubicin, there was one case of fatal intracranial haemorrhage in a patient who had experienced a fall while on treatment.
Danish: I et studie med olaratumab i kombination med liposomal doxorubicin var der ét tilfælde af dødelig intrakraniel blødning hos en patient, som havde haft et fald i løbet af behandlingen.
English: Difference in objective response rate [complete response (CR) + partial response (PR)] according to investigator assessment was not statistically significant (18.2 % vs 11.9 % in patients randomised to olaratumab plus doxorubicin compared to patients randomized to doxorubicin respectively).
Danish: Forskellen i objektiv responsrate (komplet respons [CR] + partielt respons [PR]), baseret på investigators vurdering, var ikke statistisk signifikant (18,2 % vs. 11,9 % henholdsvis hos patienter, der var randomiseret til olaratumab plus doxorubicin, og patienter, der var randomiseret til doxorubicin).
English: The most frequently occurring ADRs were nausea, musculoskeletal pain, neutropenia and mucositis.
Danish: De hyppigst forekommende bivirkninger var kvalme, muskuloskeletale smerter, neutropeni og mucositis.
English: Based on cases of anaphylactic reaction and anaphylactic shock reported in the post-marketing setting, these adverse drug reactions should be specifically be mentioned under the category of infusion-related reactions in section 4.8 of the SmPC.
Danish: På baggrund af rapporterede tilfælde af anafylaktisk reaktion og anafylaktisk chok efter markesføring, skal disse bivirkninger nævnes specifikt under kategorien infusionsrelaterede reaktioner i punkt 4.8 i produktresuméet.
English: No animal studies have been performed to test olaratumab for potential of carcinogenicity, genotoxicity, or fertility impairment.
Danish: Der er ikke udført dyrestudier med henblik på at undersøge olaratumabs karcinogene potentiale, genotoksiske potentiale eller potentiale til at nedsætte fertiliteten.
English: Olaratumab is a human IgG1 monoclonal antibody produced in murine (NS0) cells by recombinant DNA technology.
Danish: Olaratumab er et humant monoklonalt IgG1-antistof og fremstilles i murine (NS0) celler ved rekombinant DNA-teknologi.
English: Non-clinical data reveal no special hazard for humans based on repeat dose toxicity studies in monkeys.
Danish: Prækliniske data viser ingen speciel risiko for mennesker vurderet ud fra studier af toksicitet efter gentagne doser hos aber.
English: The foetal effects in mice administered the surrogate antibody occurred at exposures less than the AUC exposure at the maximum recommended human dose of 15 mg/kg olaratumab.
Danish: Fosterpåvirkningen hos mus, som fik administreret surrogat-antistoffet, forekom efter eksponeringer, der var lavere end eksponeringen (AUC) ved den maksimale anbefalede terapeutiske dosis på 15 mg/kg olaratumab hos mennesker.
English: Infusion-related reactions (IRRs)
Danish: Infusionsrelaterede reaktioner(IRR'er)
English: In the event that intravenous administration of an H1 antagonist is not possible, equivalent alternative premedication should be given (e.g. oral diphenhydramine hydrochloride at least 90 minutes prior to the infusion).
Danish: Hvis intravenøs administration af en H1-antagonist ikke er mulig, bør der præmedicineres med et tilsvarende andet lægemiddel (f.eks. oralt diphenhydraminhydrochlorid mindst 90 minutter før infusionen).
English: There is no experience with Lartruvo overdose in human clinical trials.
Danish: Der er ingen erfaring med overdosering af Lartruvo fra kliniske studier hos mennesker.
English: The most frequent ADRs associated with permanent treatment discontinuation occurred in 3 (4.7 %) patients of which the most frequent were infusion-related reactions (3.1 %) and mucositis (1.6 %).
Danish: De hyppigste bivirkninger forbundet med permanent seponering forekom hos 3 (4,7 %) patienter, hvor de hyppigste var infusionsrelaterede reaktioner (3,1 %) og mucositis (1,6 %).
English: Do not use this medicine after the expiry date which is stated on the outer carton and vial label after EXP.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på den ydre karton og etiketten på hætteglasset efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: The PopPK model-based mean (CV %) clearance for olaratumab was 0.56 L/day (33 %).
Danish: På basis af en PopPK-model var den gennemsnitlige (CV %) clearance af olaratumab 0,56 l/dag (33 %).
English: All patients receiving more than 4 cycles of doxorubicin received dexrazoxane.
Danish: Alle patienter, der fik flere end 4 serier med doxorubicin, fik dexrazoxan.
English: The Phase 2 portion of the study was a randomised, open label study of olaratumab plus doxorubicin versus doxorubicin alone.
Danish: Fase 2-delen af studiet var et randomiseret, åbent studie med olaratumab plus doxorubicin versus doxorubicin alene.
English: There is no known antidote to Lartruvo overdose.
Danish: Der findes ingen kendt antidot i tilfælde af overdosering med Lartruvo.
English: Olaratumab is a targeted, recombinant, fully human immunoglobulin G subclass 1 (IgG1) monoclonal antibody that specifically binds PDGFR-α, blocking PDGF AA, -BB, and -CC binding and receptor activation.
Danish: Olaratumab er et målrettet, rekombinant, fuldt humant immunglobulin G1 (IgG1) monoklonalt antistof, der specifikt binder til PDGFR-α og dermed blokerer for binding af PDGF-AA, -BB og -CC og receptoraktivering.
English: Patients in the olaratumab plus doxorubicin arm could continue on olaratumab monotherapy until disease progression, unacceptable toxicity or any other reason for treatment discontinuation occurred.
Danish: Patienterne i olaratumab plus doxorubicin-armen kunne fortsætte med olaratumab-monoterapi indtil sygdomsprogression, uacceptabel toksicitet eller andre årsager til seponering.
English: For intravenous use after dilution.
Danish: Til intravenøs anvendelse efter fortynding.
English: In order to further confirm the efficacy and safety of olaratumab in the treatment of patients with advanced soft tissue sarcoma, the MAH should submit the clinical study report of the phase III study JGDJ comparing doxorubicin plus olaratumab versus doxorubicin in patients with advanced or metastatic STS (including exploratory biomarker data).
Danish: For yderligere at bekræfte olaratumabs virkning og sikkerhed ved behandling af patienter med avanceret bløddelssarkom (STS) skal indehaveren af markedsføringstilladelsen fremsende den kliniske studierapport fra fase 3-studiet JGDJ, som sammenligner doxorubicin plus olaratumab versus doxorubicin hos patienter med avanceret eller metastatisk STS (herunder eksplorative biomarkørdata).
English: No other formal DDI studies with olaratumab and medicinal products commonly used in cancer patients, including those with STS (e.g. antiemetics, analgesics, anti-diarrheal drugs, oral contraceptives, etc.), have been performed.
Danish: Der er ikke udført formelle DDI-studier med olaratumab og andre lægemidler, der almindeligvis bruges hos cancerpatienter, herunder patienter med bløddelssarkom (f.eks. antiemetika, analgetika, lægemidler mod diarré, orale kontraceptiva osv.).
English: Women of childbearing potential should be advised to use effective contraception during treatment and for at least 3 months following the last dose of olaratumab.
Danish: Fertile kvinder skal rådes til at anvende sikker kontraception under behandlingen og i mindst 3 måneder efter den sidste olaratumabdosis.
English: The frequency of anaphylactic reactions/anaphylactic shock is already calculated as part of grade 3-4 infusion-related reactions in the table of Adverse Drug Reactions (ADRs) in the same section of the SmPC.
Danish: Hyppigheden af anafylaktiske reaktioner/anafylaktisk chok er allerede beregnet som en del af grad 3-4 infusionsrelaterede reaktioner i tabellen for bivirkninger under samme punkt i produktresuméet.
English: Inspect the contents of the vials for particulate matter and discolouration.
Danish: Kontroller indholdet af hætteglassene for partikler og misfarvning.
English: If you have a severe infusion-related reaction, your doctor may recommend reducing the dose of Lartruvo or stop your treatment with Lartruvo.
Danish: Hvis du får en alvorlig infusionsrelateret reaktion, kan lægen anbefale, at du får en nedsat dosis af Lartruvo eller stoppe din behandling med Lartruvo.
English: A total of 133 patients were randomised, of whom 129 received at least one dose of study treatment (64 in the olaratumab plus doxorubicin arm and 65 in the doxorubicin arm).
Danish: I alt 133 patienter blev randomiseret, og af disse fik 129 mindst én dosis af studiebehandlingen (64 i olaratumab plus doxorubicin-armen og 65 i doxorubicin-armen).
English: Olaratumab and doxorubicin were administered by intravenous infusion.
Danish: Olaratumab og doxorubicin blev administreret som intravenøs infusion.
English: For serious Grade ≥ 3 non-haematologic toxicity deemed related to olaratumab, the dose of olaratumab should be withheld until toxicity is ≤ Grade 1 or has returned to pretreatment baseline.
Danish: Ved alvorlig ikke-hæmatologisk toksicitet af grad > 3, der vurderes at være relateret til olaratumab, bør dosering af olaratumab udskydes, indtil toksiciteten er ≤ grad 1 eller tilbage til baseline-niveau før behandlingen.
English: Olaratumab is not recommended during pregnancy and in women of childbearing potential not using contraception, unless the potential benefit justifies the potential risk to the foetus.
Danish: Olaratumab bør ikke anvendes under graviditet og til kvinder i den fertile alder, som ikke anvender sikker kontraception, medmindre den potentielle fordel opvejer den potentielle risiko for fosteret.
English: Avoid getting pregnant while receiving this medicine and for at least 3 months after the last dose of Lartruvo as this medicine may harm your unborn child. Talk to your doctor about the best contraception for you.
Danish: Du skal undgå at blive gravid, mens du er i behandling med dette lægemiddel og i mindst 3 måneder efter den sidste dosis af Lartruvo, da dette lægemiddel kan skade det ufødte barn.
English: The population pharmacokinetic (PopPK) model-based mean (CV %) volume of distribution of olaratumab at steady state (Vss) was 7.7 L (16 %).
Danish: På basis af en populationsfarmakokinetik (PopPK) model var det gennemsnitlige (CV %) fordelingsvolumen af olaratumab ved steady state (Vss) 7,7 l (16 %).
English: No data were available from patients with severe renal impairment (CLcr 15-29 mL/min).
Danish: Der var ingen data for patienter med svært nedsat nyrefunktion (CLcr 15-29 ml/min).
English: In a dedicated DDI study, no pharmacokinetic interactions were observed in patients between olaratumab and doxorubicin.
Danish: I et målrettet DDI- (drug-drug interaction) studie blev der ikke observeret farmakokinetisk interaktion mellem olaratumab og doxorubicin hos patienterne.
English: What you need to know before you are given Lartruvo 3.
Danish: Det skal du vide, før du får Lartruvo 3.
English: As doxorubicin is rapidly metabolised and predominantly eliminated by the biliary system, the toxicity of doxorubicin is enhanced in patients with hepatic impairment.
Danish: Da doxorubicin metaboliseres hurtigt og primært elimineres via galdesystemet, øges toksiciteten af doxorubicin hos patienter med nedsat leverfunktion.
English: If you have an infusion-related reaction during treatment, your doctor or nurse may slow down or stop your Lartruvo infusion.
Danish: Hvis du får en infusionsrelateret reaktion under behandlingen, vil lægen eller sygeplejersken give infusionen langsommere eller stoppe infusionen af Lartruvo.
English: Patients were randomised in a 1:1 ratio to either olaratumab (15 mg/kg) on Day 1 and Day 8 plus doxorubicin (75 mg/m²) on Day 1 of each 21-day cycle for up to 8 cycles or doxorubicin (75 mg/m2) alone on Day 1 of each 21-day cycle, also for up to 8 cycles.
Danish: Patienterne blev randomiseret i forholdet 1:1 til enten olaratumab (15 mg/kg) på dag 1 og dag 8 plus doxorubicin (75 mg/m²) på dag 1 i hver 21-dages-serie i op til 8 serier eller doxorubicin (75 mg/m2) alene på dag 1 i hver 21-dages-serie, også i op til 8 serier.
English: There are very limited data regarding olaratumab administration in patients with moderate hepatic impairment.
Danish: Der er meget begrænsede data om administration af olaratumab til patienter med moderat nedsat leverfunktion.
English: Manufacturer Lilly S.A.
Danish: Fremstiller Lilly S.A.
English: Marketing Authorisation Holder Eli Lilly Nederland B.V.
Danish: Indehaver af markedsføringstilladelsen Eli Lilly Nederland B.V.
English: Lartruvo is given in combination with the medicine doxorubicin for up to 8 cycles and then it is given on its own.
Danish: Lartruvo gives i kombination med lægemidlet doxorubicin i op til 8 serier og gives herefter alene.
English: Infusion-related reactions (IRRs), including anaphylactic reactions, were reported in clinical trials with olaratumab.
Danish: Der er blevet rapporteret infusionsrelaterede reaktioner (IRR'er), herunder anafylaktiske reaktioner, i kliniske studier med olaratumab.
English: Any unused portion of olaratumab left in a vial should be discarded, as the product contains no antimicrobial preservatives.
Danish: Ikke anvendt olaratumab i et hætteglas skal kasseres, da præparatet ikke indeholder antimikrobielle konserveringsmidler.
English: A statistically significant improvement in OS was seen in the olaratumab plus doxorubicin arm in comparison to treatment with doxorubicin alone in the overall population.
Danish: Der blev set en statistisk signifikant forbedring i OS i olaratumab plus doxorubicin-armen sammenlignet med doxorubicin alene i den samlede population.
English: If a Grade 3 toxicity recurs despite the dose reduction, the dose should be reduced further to 10 mg/kg.
Danish: Hvis en grad 3 toksicitet vender tilbage på trods af dosisreduktion, skal dosis reduceres yderligere til 10 mg/kg.