FrancophonIA/ELRC3.0 huggingface dataset:
English: As monoclonal antibodies are not metabolised by cytochrome P450 (CYP) enzymes or other drug metabolising enzymes, inhibition or induction of these enzymes by co-administered medicinal products is not anticipated to affect the pharmacokinetics of olaratumab.
Danish: Da monoklonale antistoffer ikke metaboliseres af CYP-enzymer eller andre lægemiddelmetaboliserende enzymer, forventes det ikke, at hæmning eller induktion af disse enzymer af samtidigt administrerede lægemidler vil påvirke olaratumabs farmakokinetik.
English: Very Common None reported
Danish: Ingen rapporteret
English: Other medicines and Lartruvo Tell your doctor if you are taking, have recently taken or might take any other medicines.
Danish: Brug af anden medicin sammen med Lartruvo Fortæl lægen, hvis du tager anden medicin eller har gjort det for nylig.
English: Olaratumab recognises and attaches specifically to a protein known as platelet-derived growth factor receptor-α (PDGFR-α).
Danish: Olaratumab genkender og binder til et specifikt protein, der kaldes trombocytafledt vækstfaktorreceptor-α (PDGFR-α).
English: Posology adjustments for olaratumab
Danish: Justering af olaratumabdosis
English: If neutropenic fever/infection or Grade 4 neutropenia lasting longer than 1 week occurs, administration of olaratumab should be temporarily discontinued until the absolute neutrophil count is 1,000 / µL or higher and then the dose of olaratumab should be resumed at the reduced dose of 12 mg/kg.
Danish: Hvis der opstår neutropenisk feber/infektion eller grad 4 neutropeni, som varer længere end 1 uge, bør administration af olaratumab midlertidigt afbrydes, indtil det absolutte neutrofiltal er 1.000/µl eller højere, og herefter bør olaratumab-behandlingen genoptages med en reduceret dosis på 12 mg/kg.
English: The median cumulative dose of doxorubicin was 487.6 mg/m2 in the olaratumab plus doxorubicin arm and 299.6 mg/m2 in the doxorubicin alone arm.
Danish: Den akkumulerede mediandosis af doxorubicin var 487,6 mg/m2 i olaratumab plus doxorubicin-armen og 299,6 mg/m2 i armen med doxorubicin alene.
English: The number of patients receiving post-study systemic therapy was similar between arms.
Danish: Antallet af patienter, der fik systemisk behandling efter studiets afslutning, var af samme størrelsesorden i de to arme.
English: Olaratumab is a human monoclonal antibody.
Danish: Olaratumab er et humant monoklonalt antistof.
English: In some patients there was a recurrence of pain .The pain did not worsen with time or during recurrence.
Danish: Smerten forværredes ikke over tid eller ved tilbagefald.
English: In case of recurrence of a Grade 4 toxicity, treatment with olaratumab should be permanently discontinued.
Danish: Hvis en grad 4 toksicitet vender tilbage, skal olaratumab seponeres permanent.
English: - Infusion-related reaction
Danish: - Infusionsrelateret reaktion
English: Symptoms of IRRs included flushing, shortness of breath, bronchospasm, or fever/chills, and in some cases manifested as severe hypotension, anaphylactic shock, or fatal cardiac arrest.
Danish: Symptomer på IRR'er omfattede blussen, åndenød, bronkospasme og feber/kulderystelser og i visse tilfælde manifesteret med svær hypotension, anafylaktisk shock eller hjertestop med dødelig udgang.
English: Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (calculated creatinine clearance [CLcr] 60-89 mL/min, n = 43), or moderate (CLcr 30-59 mL/min, n = 15) renal impairment compared to patients with normal renal function (CLcr ≥90 mL/min, n = 85).
Danish: På basis af en PopPK-analyse var der ingen klinisk relevante forskelle i olaratumabs clearance hos patienter med let nedsat (beregnet kreatininclearance [CLcr] 60-89 ml/min, n = 43) eller moderat nedsat (CLcr 30-59 ml/min, n = 15) nyrefunktion sammenlignet med patienter med normal nyrefunktion (CLcr ≥ 90 ml/min, n = 85).
English: The rate of treatment-emergent cardiac dysfunction was comparable between the two treatment arms (7.8 % in the Investigational Arm and 6.2 % in the Control Arm).
Danish: Forekomsten af kardial dysfunktion opstået under behandlingen var sammenlignelig i de to arme (7,8 % i den eksperimentelle arm og 6,2 % i kontrolarmen).
English: The container should be gently inverted to ensure adequate mixing.
Danish: Vend forsigtigt beholderen op og ned for at sikre, at indholdet blandes tilstrækkeligt.
English: For all subsequent infusions, premedication with the following (or equivalent medicinal products) diphenhydramine hydrochloride (intravenously), paracetamol, and dexamethasone, should be given.
Danish: Ved alle efterfølgende infusioner bør der præmedicineres med følgende (eller tilsvarende lægemidler) diphenhydraminhydrochlorid (intravenøst), paracetamol og dexamethason.
English: 3528 BJ Utrecht The Netherlands
Danish: 3528 BJ Utrecht Holland
English: - Reduction in the number of white blood cells Lartruvo and doxorubicin may decrease the number of white blood cells (including neutrophils).
Danish: Lartruvo og doxorubicin kan nedsætte antallet af hvide blodlegemer (herunder neutrofile granulocytter).
English: Lartruvo has been administered in a Phase 1 study up to 20 mg/kg on days 1 and 8 of a 21 day cycle without reaching a maximum tolerated dose.
Danish: I et fase 1-studie er Lartruvo blevet administreret i doser på op til 20 mg/kg på dag 1 og dag 8 i en 21-dages-serie, uden at en maksimalt tolereret dosis blev nået.
English: Any unused medicines or waste material should be disposed of in accordance with local requirements.
Danish: Ikke anvendt lægemiddel samt affald heraf skal bortskaffes i henhold til lokale retningslinjer.
English: Patients should be monitored during the infusion for signs and symptoms of IRRs in a setting with available resuscitation equipment.
Danish: Patienterne skal monitoreres for tegn og symptomer på IRR'er under infusionen, og der skal være adgang til genoplivningsudstyr.
English: In case of overdose, use supportive therapy.
Danish: I tilfælde af overdosering skal der gives understøttende behandling.
English: Soft tissue sarcoma is a cancer that starts in the soft tissues, such as the muscles, fat, cartilage and blood vessels.
Danish: Bløddelskarcinom er en kræftsygdom, der starter i bløddelene, f.eks. musklerne, fedtvævet, brusk eller blodkar.
English: The dose and volume of olaratumab needed should be calculated to prepare the infusion solution.
Danish: Den dosis og det volumen af olaratumab, der skal bruges til at klargøre infusionsvæsken, skal beregnes.
English: Very common (may affect more than 1 in 10 people): - nausea - pain in your muscles, joints or bones (musculoskeletal pain) - low white blood cell counts (including neutrophils and lymphocytes which may increase the
Danish: Meget almindelige bivirkninger (kan forekomme hos flere end 1 ud af 10 patienter): - kvalme - smerter i muskler, led eller knogler (muskuloskeletale smerter) - lavt antal hvide blodlegemer (herunder neutrofile granulocytter og lymfocytter, hvilket kan øge risikoen for infektion) - smerter eller sår i munden eller svælget (mucositis) - opkastning - diarré - hovedpine - infusionsrelaterede reaktioner.
English: The European Medicines Agency has deferred the obligation to submit the results of studies with olaratumab in one or more subsets of the paediatric population in soft tissue sarcoma (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har udsat forpligtelsen til at fremlægge resultaterne af studier med olaratumab i en eller flere undergrupper af den pædiatriske population med bløddelssarkom (se pkt.
English: The recommended dose of olaratumab is 15 mg/kg administered by intravenous infusion on days 1 and 8 of each 3 week cycle until disease progression or unacceptable toxicity.
Danish: Den anbefalede dosis af olaratumab er 15 mg/kg som intravenøs infusion på dag 1 og dag 8 i hver 3-ugers-serie indtil sygdomsprogression eller uacceptabel toksicitet.
English: Refer to doxorubicin SmPC for appropriate monitoring of hepatic function and doxorubicin dose adjustments in patients with impaired liver function.
Danish: Der henvises til produktresuméet for doxorubicin vedrørende relevant monitorering af leverfunktionen samt dosisjustering af doxorubicin hos patienter med nedsat leverfunktion.
English: If not used immediately, the dosing solution should be stored under refrigeration for up to 24 hours at 2 °C to 8 °C and up to an additional 8 hours at room temperature (up to 25 °C) assuming dilution has taken place in controlled and validated aseptic conditions.
Danish: Administreres den klargjorte infusionsvæske ikke med det samme, kan den opbevares i op til 24 timer ved 2°C - 8°C i køleskab og yderligere i op til 8 timer ved stuetemperatur (op til 25°C) under den forudsætning, at fortynding er udført under kontrollerede og validerede aseptiske forhold.
English: - The other ingredients are mannitol, glycine, L-histidine monohydrochloride monohydrate, L-histidine, sodium chloride (see section 2 “Lartruvo contains sodium”), polysorbate 20 and water for injections.
Danish: - Øvrige indholdsstoffer: mannitol, glycin, L-histidinmonohydrochloridmonohydrat, L-histidin, natriumchlorid (se afsnit 2 "Lartruvo indeholder natrium"), polysorbat 20 og vand til injektionsvæsker.
English: If particulate matter is identified, discard the infusion solution.
Danish: Hvis der observeres partikler, skal infusionsopløsningen kasseres.
English: Conversely, olaratumab is not anticipated to affect the pharmacokinetics of co-administered medicinal products.
Danish: Tilsvarende forventes olaratumab ikke at påvirke farmakokinetikken af samtidigt administrerede lægemidler.
English: Women of childbearing potential/contraception in females Women of childbearing potential should be advised to avoid becoming pregnant while on olaratumab and should be informed of the potential hazard to the pregnancy and foetus.
Danish: Fertile kvinder skal rådes til at undgå graviditet under behandlingen med olaratumab og skal informeres om den mulige risiko for graviditeten og fosteret.
English: If you experience significant bleeding, symptoms may include extreme tiredness, weakness, dizziness or changes in the colour of your stools.
Danish: Symptomerne på en væsentlig blødning kan omfatte ekstrem træthed, svaghed, svimmelhed og ændringer i farven på afføringen.
English: If neutropenic fever/infection or Grade 4 neutropenia lasting longer than 1 week recurs despite dose reduction, the dose should be reduced further to 10 mg/kg.
Danish: Hvis neutropenisk feber/infektion eller grad 4 neutropeni, som varer længere end 1 uge, vender tilbage på trods af dosisreduktion, skal dosis reduceres yderligere til 10 mg/kg.
English: Reproductive and development toxicity study conducted with an anti-murine PDGFRα antibody in mice showed foetal malformations and skeletal alterations (see section 5.3).
Danish: Et studie af reproduktions- og udviklingstoksicitet hos mus udført med et anti-murint PDGFRα-antistof viste føtale misdannelser og skeletforandringer (se pkt.
English: No data were available from patients with severe hepatic impairment (total bilirubin > 3.0 times ULN and any AST level).
Danish: Der var ingen data for patienter med svært nedsat leverfunktion (total-bilirubin > 3,0 x ULN og et hvilket som helst ASAT-niveau).
English: Do not store any unused portion of the infusion solution for reuse.
Danish: Ikke anvendt infusionsvæske må ikke opbevares til genbrug.
English: What Lartruvo contains - The active substance is olaratumab.
Danish: Lartruvo indeholder: - Aktivt stof: olaratumab.
English: There are no data regarding olaratumab administration in patients with severe renal impairment (calculated creatinine clearance < 30 mL/min) (see section 5.2).
Danish: Der foreligger ingen data om administration af olaratumab til patienter med svært nedsat nyrefunktion (beregnet kreatininclearance < 30 ml/min) (se pkt.
English: Known toxicities reported for doxorubicin, observed in the combination of olaratumab and doxorubicin include fatigue, anaemia, thrombocytopenia and alopecia.
Danish: Kendte bivirkninger for doxorubicin og observeret ved kombinationen af olaratumab og doxorubicin inkluderer træthed, anæmi, trombocytopeni og alopeci.
English: After dilution in sodium chloride 9 mg/mL (0.9 %) solution for injection, olaratumab is administered as an intravenous infusion over approximately 60 minutes.
Danish: Efter fortynding med 9 mg/ml (0,9 %) natriumchloridinjektionsvæske administreres olaratumab som en intravenøs infusion over ca. 60 minutter.
English: It is available in packs of: - 1 vial of 19 mL - 2 vials of 19 mL - 1 vial of 50 mL
Danish: Det fås i pakninger med: - 1 hætteglas med 19 ml - 2 hætteglas med 19 ml - 1 hætteglas med 50 ml
English: During Cycles 5 to 8 on both arms, dexrazoxane (dosed at a ratio of 10:1 to the administered dose of doxorubicin) could be administered on Day 1 of each cycle at the investigator's discretion to reduce potential doxorubicin-related cardiotoxicity.
Danish: I serie 5 til 8 kunne dexrazoxan (med et dosisforhold mellem dexrazoxan og doxorubicin på 10:1) blive administreret på dag 1 i hver serie i henhold til investigators vurdering for at reducere potentiel doxorubicin-relateret kardiotoksicitet.
English: Administration of an anti-murine PDGFR- α surrogate antibody to pregnant mice during organogenesis at 50 and 150 mg/kg resulted in increased malformations (abnormal eyelid development) and skeletal alterations (frontal/parietal additional ossification site).
Danish: Administration af et anti-murint PDGFR-α-surrogat-antistof i doser på 50 mg/kg og 150 mg/kg til drægtige mus under organogenesen resulterede i en øget forekomst af misdannelser (anormal udvikling af øjenlåg) og skeletale forandringer (yderligere ossifikationssted frontalt/parietalt).
English: For patients who experience Grade 1 or 2 IRR, the infusion should be interrupted and paracetamol, H1 antagonist and dexamethasone (or equivalent medicinal products) administered as needed.
Danish: Infusionen bør afbrydes hos patienter, der får en IRR af grad 1 eller 2, og paracetamol, en H1-antagonist og dexamethason (eller tilsvarende lægemidler) bør administreres efter behov.
English: Detailed instructions for your doctor or your nurse on how to prepare Lartruvo infusion are included at the end of this package leaflet (see ‘Handling instructions').
Danish: Sidst i denne indlægsseddel er der detaljerede instruktioner i, hvordan læger og sundhedspersonale skal klargøre Lartruvo til infusion (se 'Instruktioner i håndtering').
English: This product is preservative free.
Danish: Dette præparat indeholder ingen konserveringsmidler.
English: What you need to know before you are given Lartruvo
Danish: Det skal du vide, før du får Lartruvo
English: If particulate matter or discolouration is identified, the vial must be discarded.
Danish: Hvis der observeres partikler eller misfarvning, skal hætteglasset kasseres.
English: Vials contain 190 mg or 500 mg as a 10 mg/mL solution of olaratumab; calculate the dose and volume of olaratumab needed to prepare the infusion solution.
Danish: Hætteglassene indeholder 190 mg eller 500 mg som en olaratumab-opløsning på 10 mg/ml; beregn den dosis og det volumen af olaratumab, der skal bruges til at klargøre infusionsvæsken.
English: Based on a PopPK analysis, no clinically meaningful differences in the clearance of olaratumab were observed in patients with mild (total bilirubin within upper limit of normal [ULN] and AST>ULN, or total bilirubin > 1.0-1.5 times ULN and any AST level, n = 16), or moderate (total bilirubin > 1.5-3.0 times ULN, n = 1) hepatic impairment compared to patients with normal hepatic function (total bilirubin and AST ≤ ULN, n = 126).
Danish: På basis af en PopPK-analyse var der ingen klinisk relevante forskelle i olaratumabs clearance hos patienter med let nedsat (total-bilirubin ≤ øvre normalgrænse [ULN] og ASAT > ULN eller total-bilirubin > 1,0-1,5 x ULN og et hvilket som helst ASAT-niveau, n = 16) eller moderat nedsat (total-bilirubin > 1,5-3,0 x ULN, n = 1) leverfunktion sammenlignet med patienter med normal leverfunktion (total-bilirubin og ASAT ≤ ULN, n = 126).
English: Infusion-related reactions (IRRs) Recommendations for the management of olaratumab IRRs are provided in table 1.
Danish: Infusionsrelaterede reaktioner (IRR'er) I tabel 1 er der givet anbefalinger til håndtering af IRR'er ved olaratumab.
English: Your doctor will check your white blood cell counts prior to treatment with Lartruvo.
Danish: Lægen vil kontrollere dit antal af hvide blodlegemer, før du starter behandling med Lartruvo.
English: Polysorbate 20 (E432)
Danish: Polysorbat 20 (E 432) Vand til injektionsvæsker
English: The recommended dose of Lartruvo is 15 mg per kilogram of your body weight on days 1 and 8 of each 3-week cycle.
Danish: Den anbefalede dosis af Lartruvo er 15 mg pr. kilo kropsvægt på dag 1 og dag 8 i hver behandlingsserie, som varer 3 uger.
English: ADRs which were reported in patients with soft tissue sarcoma treated with olaratumab in combination with doxorubicin in the Phase 2 study are listed below in Table 2 in MedDRA body system organ class, frequency and grade of severity.
Danish: Bivirkninger, der blev rapporteret i fase 2-studiet hos patienter med bløddelssarkom i behandling med olaratumab plus doxorubicin, er anført nedenfor i tabel 2 i henhold til MedDRA-systemorganklasse, hyppighed og sværhedsgrad.
English: In the phase 2 trial, patients in both treatment groups that received 5 or more cycles of doxorubicin received dexrazoxane prior to each dose of doxorubicin from cycle 5 onwards to minimize the risk of doxorubicin-related cardiotoxicity (see sections 4.8 and 5.1).
Danish: I fase 2-studiet fik patienter i begge behandlingsgrupper, der fik 5 eller flere serier med doxorubicin, dexrazoxan forud for hver doxorubicindosis fra serie 5 og fremefter for at minimere risikoen for doxorubicin-relateret kardiotoksicitet (se pkt.
English: The content of the vials should be inspected for particulate matter and discolouration (the concentrate for solution for infusion should be clear to slightly opalescent and colourless to slightly yellow without visible particles) prior to administration.
Danish: Indholdet af hætteglassene skal kontrolleres for partikler og misfarvning (koncentratet skal være klart til let opaliserende og farveløst til svagt gult uden synlige partikler) inden administration.
English: Olaratumab is an antagonist of platelet derived growth factor receptor-α (PDGFR-α), expressed on tumour and stromal cells.
Danish: Olaratumab er en antagonist af trombocytafledt vækstfaktorreceptor-α (PDGFR-α), udtrykt på tumorog stromaceller.
English: Lartruvo is used in combination with another anti-cancer medicine called doxorubicin for the treatment of adults with advanced soft tissue sarcoma who have not been previously treated with doxorubicin.
Danish: Lartruvo anvendes i kombination med et andet lægemiddel mod kræft, kaldet doxorubicin, til behandling af voksne med fremskredent bløddelskarcinom, som ikke tidligere er blevet behandlet med doxorubicin.
English: Olaratumab should be immediately and permanently discontinued in patients who experience Grade 3 or 4 IRR (see sections 4.2 and 4.8).
Danish: Olaratumab skal seponeres omgående og permanent hos patienter, der får en IRR af grad 3 eller 4 (se pkt.
English: What Lartruvo looks like and contents of the pack Lartruvo concentrate for solution for infusion (sterile concentrate) is a clear to slightly opalescent and colourless to slightly yellow liquid supplied in a glass vial with an elastomeric stopper.
Danish: Lartruvo koncentrat til infusionsvæske, opløsning (sterilt koncentrat) er en klar til let opaliserende og farveløs til svagt gul væske i et hætteglas af glas med elastomerprop.
English: Data on very elderly patients (> 75 years) are very limited (see sections 4.8 and 5.1).
Danish: Der er kun meget begrænsede data for ældre patienter > 75 år (se pkt.
English: Excipients: mannitol, glycine, sodium chloride, L-histidine monohydrochloride monohydrate, L-histidine, polysorbate 20 and water for injections.
Danish: Hjælpestoffer: mannitol, glycin, natriumchlorid, L-histidinmonohydrochloridmonohydrat, L-histidin, polysorbat 20 og vand til injektionsvæsker.
English: The efficacy and safety of olaratumab was assessed in a Phase 1b/2, multi-centre study in anthracycline naïve patients with histologically or cytologically confirmed, advanced soft tissue sarcoma not amenable to receive surgery or radiotherapy with curative intent.
Danish: Olaratumabs virkning og sikkerhed blev vurderet i et fase 1b/2-multicenterstudie hos patienter med histologisk eller cytologisk bekræftet avanceret bløddelssarkom, som ikke var egnede til kurativ behandling med operation eller strålebehandling, og som ikke tidligere var blevet behandlet med antracykliner.
English: The rate of cardiac arrhythmias was similar in both arms (15.6 % in the Investigational Arm and 15.4 % in the Control Arm).
Danish: Forekomsten af hjertearytmier var af samme størrelsesorden i de to arme (15,6 % i den eksperimentelle arm og 15,4 % i kontrolarmen).
English: Your doctor will give you other medicines before you receive Lartruvo to reduce the risk of infusionrelated reactions.
Danish: Inden du får Lartruvo, vil lægen give dig andre lægemidler for at nedsætte risikoen for reaktioner i forbindelse med infusionen.
English: Symptoms may include back pain, chest pain and/or tightness, chills, fever, flushing, difficulty in breathing and wheezing.
Danish: Symptomerne kan omfatte rygsmerter, brystsmerter og/eller en snørende fornemmelse omkring brystkassen, kulderystelser, feber, blussen, åndedrætsbesvær og hiven efter vejret.
English: Table 2: Adverse reactions in patients receiving olaratumab plus doxorubicin for soft tissue sarcoma during the Phase 2 portion of a Phase 1b/2 study
Danish: Tabel 2: Bivirkninger hos patienter, som fik olaratumab plus doxorubicin mod bløddelssarkom i fase 2-delen af fase 1b/2-studiet
English: MARKETING AUTHORISATION NUMBER(S) EU/1/16/1143/001
Danish: MARKEDSFØRINGSTILLADELSESNUMMER (-NUMRE) EU/1/16/1143/001
English: b Once the infusion rate has been reduced for a Grade 1 or 2 infusion-related reaction, it is recommended that the lower infusion rate be utilized for all subsequent infusions.
Danish: a Grad i henhold til National Cancer Institute Common Terminology Criteria for Adverse Events b Når infusionshastigheden er blevet nedsat på grund af en infusionsrelateret reaktion af grad 1 eller 2, anbefales det at benytte den lavere infusionshastighed ved alle efterfølgende infusioner.
English: Please refer to doxorubicin SmPC for recommendation on cardiac monitoring.
Danish: Der henvises til produktresuméet for doxorubicin vedrørende anbefalinger om kardial monitorering.
English: For subsequent cycles, premedication with an H1 antagonist (e.g., diphenhydramine) should be given intravenously 30-60 minutes prior to each dose of olaratumab.
Danish: I de efterfølgende serier bør en H1-antagonist (f.eks. diphenhydramin) gives intravenøst 30-60 minutter forud for hver dosis af olaratumab.
English: Before starting treatment you must tell your doctor if you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid eller planlægger at blive gravid, skal du fortælle det til lægen, før behandlingen påbegyndes.
English: You should tell your doctor about any of the following:
Danish: Advarsler og forsigtighedsregler Du skal fortælle lægen om følgende:
English: Pack of 1 vial of 50 mL.
Danish: Pakning med 1 hætteglas a 50 ml.
English: Scientific conclusions and grounds for the variation to the terms of the marketing
Danish: VIDENSKABELIGE KONKLUSIONER OG BEGRUNDELSER FOR ÆNDRING AF FOR MARKEDSFØRINGSTILLADELSEN/-TILLADELSERNE
English: Lartruvo is administered in combination with doxorubicin for up to 8 cycles of treatment, followed by Lartruvo monotherapy in patients whose disease has not progressed.
Danish: Lartruvo administreres i kombination med doxorubicin i op til 8 behandlingsserier og derefter som Lartruvo-monoterapi til patienter, hvis sygdom ikke er progredieret.