FrancophonIA/ELRC3.0 huggingface dataset:
English: Post-Authorisation efficacy study to provide long-term efficacy and safety data of ruxolitinib including (late) achievement of response, duration of (various) responses, as well as incidence of AEs including haematological transformation and second malignancies from the study B2301.
Danish: Virkningsstudie efter godkendelse (PAES) for at opnå langtidsdata for effekt og sikkerhed for ruxolitinib, inklusive (sen) opnåelse af respons, varighed af (forskellige) respons, såvel som incidensen af bivirkninger inklusive hæmatologisk transformation og sekundær malignitet fra studie B2301.
English: Doses were then adjusted in individual patients based on tolerability and efficacy with a maximum dose of 25 mg twice daily.
Danish: Dosis blev herefter justeret individuelt hos patienterne baseret på tolerabilitet og effekt med en maksimal dosis på 25 mg to gange dagligt.
English: If you have questions about how long to take Jakavi, talk to your doctor or pharmacist.
Danish: Hvis du har spørgsmål om, hvor længe du skal tage Jakavi, så tal med din læge eller apoteket.
English: It is recommended that, for patients who have demonstrated some degree of clinical improvement, ruxolitinib therapy be discontinued if they sustain an increase in their spleen length of 40% compared with baseline size (roughly equivalent to a 25% increase in spleen volume) and no longer have tangible improvement in disease-related symptoms.
Danish: Det anbefales at patienter, der har vist en grad af klinisk forbedring, ophører med ruxolitinibbehandlingen, hvis de bevarer en øgning i længden af milten på 40% sammenlignet med baselinestørrelse (ca. svarende til en 25% øgning i miltvolumen) og ikke længere har konkret forbedring af sygdomsrelaterede symptomer.
English: However, the exposure margins compared to the highest clinical dose were low and the results are therefore of limited relevance for humans.
Danish: Eksponeringsmaginer var dog lave sammenlignet med den højest kliniske dosis og resultaterne har derfor begrænset relevans hos mennesker.
English: Myelofibrosis
Danish: Myelofibrose
English: Ruxolitinib is mainly metabolised by CYP3A4 (>50%), with additional contribution from CYP2C9.
Danish: Ruxolitinib metaboliseres hovedsagelig af CYP3A4 (>50%) med yderligere bidrag fra CYP2C9.
English: Jakavi is used to treat adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare form of blood cancer.
Danish: Jakavi anvendes til behandling af voksne patienter med en forstørret milt eller med symptomer, der er relateret til myelofibrose, en sjælden form for blodkræft.
English: Most patients (>80%) had received at least two phlebotomies in the last 24 weeks prior to screening.
Danish: De fleste patienter havde fået mindst to flebotomier i de sidste 24 uger inden screening.
English: Ruxolitinib was not mutagenic or clastogenic.
Danish: Ruxolitinib var ikke mutagent eller klastogent.
English: In the best available therapy arm, 47% of patients received hydroxyurea and 16% of patients received glucocorticoids.
Danish: I den bedst tilgængelige terapi-arm fik 47% af patienterne hydroxycarbamid og 16% glukokortikoider.
English: When you stop taking Jakavi, the myelofibrosis symptoms may come back.
Danish: Når du stopper med at tage Jakavi, kan myelofibrose-symptomerne komme tilbage.
English: Jakavi can relieve the symptoms, reduce spleen size and the volume of red blood cells produced in patients with polycythaemia vera by selectively blocking enzymes called Janus Associated Kinases (JAK1 and JAK2), thus potentially reducing the risk of serious blood or vascular complications.
Danish: Jakavi kan lindre symptomerne, reducere miltens størrelse og nedsætte mængden af røde blodlegemer hos patienter med polycythæmia vera ved selektivt at blokere enzymer, som kaldes Janus-associerede kinaser (JAK1 og JAK2), og således potentielt nedsætte risikoen for alvorlige komplikationer i blod- eller blodkar.
English: Hydroxypropylcellulose 300 to 600 cps Lactose monohydrate
Danish: Hydroxypropylcellulose, 300 til 600 cps Lactosemonohydrat
English: Talk to your doctor or pharmacist during your treatment with Jakavi - if you experience unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections (these are signs of blood disorders).
Danish: Tal med din læge eller apotekspersonalet, mens du behandles med Jakavi - hvis du oplever uventede blå mærker og/eller blødninger, usædvanlig træthed, åndenød under motion eller i hvile, usædvanlig bleg hud eller hyppige infektioner (dette er tegn på blodsygdomme).
English: The mean Cmax was moderately decreased (24%) while the mean AUC was nearly unchanged (4% increase) on dosing with a high-fat meal.
Danish: Medianværdien af Cmax faldt moderat (24%), mens middelværdien af AUC var næsten uændret (4% forøgelse) efter dosering sammen med et måltid med højt fedtindhold.
English: Polycythaemia vera is a disorder of the bone marrow, in which the marrow produce too many red blood cells.
Danish: Polycytæmia vera er en sygdom i knoglemarven, hvor knoglemarven producerer for mange røde blodlegemer.
English: It is not known whether the Janus Associated Kinase (JAK) inhibition by ruxolitinib reduces the efficacy of the haematopoietic growth factors or whether the haematopoietic growth factors affect the efficacy of ruxolitinib (see section 4.4).
Danish: Det vides ikke, om den Janus associerede kinase (JAK) hæmning af ruxolitinib reducerer effekten af de hæmatopoietiske vækstfaktorer eller om de hæmatopoietiske vækstfaktorer påvirker effekten af ruxolitinib (se pkt.
English: Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue.
Danish: Myelofibrose er en sygdom i knoglemarven, hvor marven erstattes af arvæv.
English: The basis for the dysregulation is believed to include high levels of circulating cytokines that activate the JAK-STAT pathway, gain-of-function mutations such as JAK2V617F, and silencing of negative regulatory mechanisms.
Danish: Årsagerne til dysreguleringen menes at omfatte høje niveauer af cirkulerende cytokiner, som aktiverer JAK-STAT-signalvejen, gain of function-mutationer, som for eksempel JAK2V617F, og undertrykkelse af negative reguleringsmekanismer.
English: After recovery of blood counts above these levels, dosing may be re-started at 5 mg twice daily and gradually increased based on careful monitoring of complete blood cell count, including a white blood cell count differential.
Danish: Når blodtallene igen er over disse niveauer, kan doseringen genoptages med 5 mg to gange dagligt og gradvist øges på grundlag af omhyggelig monitorering af komplet blodtælling inklusive differentialtælling.
English: Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”.
Danish: Brug ikke lægemidlet efter den udløbsdato, der står på yderkarton eller blister efter EXP. Udløbsdatoen er den sidste dag i den nævnte måned.
English: Similarly, patients with PV also presented with baseline elevations in inflammatory markers and these markers were decreased following treatment with ruxolitinib.
Danish: Tilsvarende havde patienter med PV forhøjede inflammatoriske markører ved baseline, og disse markører faldt efter behandling med ruxolitinib.
English: At week 32, 49% and 64% of patients treated with ruxolitinib achieved a ≥50% reduction in TSS-14 and TSS-5, respectively, compared to only 5% and 11% of patients on BAT.
Danish: Ved uge 32 opnåede 49% og 64% af patienterne behandlet med ruxolitinib en ≥50% reduktion i henholdsvis TSS-14 og TSS-5, sammenlignet med kun 5% og 11% af patienterne behandlet med BAT.
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE18
Danish: Farmakoterapeutisk klassifikation: Antineoplastiske stoffer, proteinkinasehæmmere, ATC-kode: L01XE18
English: However, the exposure margins compared to the highest clinical dose were low and the results are therefore of limited relevance for humans (see section 5.3).
Danish: Eksponeringsmarginerne var dog lave sammenlignet med den højeste kliniske dosis og resultaterne har derfor begrænset relevans for mennesker (se pkt.
English: c grade 3 (> 5x - 20 x ULN)
Danish: 3 (>5-20 x ULN)
English: These dose recommendations are based on simulations and any dose modification in ESRD should be followed by careful monitoring of safety and efficacy in individual patients.
Danish: Disse dosisanbefalinger er baseret på simulationer, og enhver dosisjustering ved nyresygdom i slutstadiet skal efterfølges af omhyggelig monitorering af sikkerhed og effekt hos den individuelle patient.
English: Teratogenicity was not observed in rats or rabbits.
Danish: Der blev ikke observeret teratogenicitet hos rotter og kaniner.
English: Discontinuation due to adverse events, regardless of causality, was observed in 2.2% of patients.
Danish: Seponering af behandling pga. bivirkninger, uden hensyn til kausalitet, blev observeret hos 2,2% af patienterne.
English: The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
Danish: Den maksimale anbefalede startdosis til disse patienter er 5 mg to gange dagligt, og der bør udvises forsigtighed med hensyn til titrering.
English: Do not breast-feed while taking Jakavi.
Danish: Du må ikke amme, mens du tager Jakavi.
English: The European Medicines Agency has waived the obligation to submit the results of studies with Jakavi in all subsets of the paediatric population for the treatment of MF and PV (see section 4.2 for information on paediatric use).
Danish: Det Europæiske Lægemiddelagentur har dispenseret fra kravet om at fremlægge resultaterne af studier med Jakavi i alle undergrupper af den pædiatriske population ved behandling af MF og PV (se pkt.
English: Improvement in perception of treatment benefit was also higher in patients treated with ruxolitinib at week 32 (78% versus 33%).
Danish: Forbedringer i opfattelsen af behandlingsfordele ved uge 32 var også højere hos patienter behandlet med ruxolitinib (78% mod 33%).
English: Patients with a haemoglobin level below 10.0 g/dl at the beginning of the treatment have a higher risk of developing a haemoglobin level below 8.0 g/dl during treatment compared to patients with a higher baseline haemoglobin level (79.3% versus 30.1%).
Danish: Patienter med et hæmoglobinniveau under 10,0 g/dl i begyndelsen af behandlingen har i løbet af behandlingen en højere risiko for udvikling af et hæmoglobinniveau, der er under 8,0 g/dl sammenlignet med patienter med et højere baseline hæmoglobinniveau (79,3% vs. 30%).
English: Parent compound is the predominant entity in human plasma, representing approximately 60% of the drug-related material in circulation.
Danish: Ikke metaboliseret lægemiddel er den fremherskende forbindelse i humant plasma og udgør ca. 60% af det cirkulerende lægemiddel.
English: An extended follow-up of patients treated with ruxolitinib showed no trends towards an increase in the rate of sepsis over time.
Danish: En forlænget opfølgningsperiode for patienter behandlet med ruxolitinib viste ingen tegn på en stigning i sepsis-tilfælde over tid.
English: If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily, up to the maximum dose of 25 mg twice daily.
Danish: Hvis effekten anses for utilstrækkelig, og blodtallene er passende, kan dosis øges med maksimalt 5 mg to gange dagligt op til en maksimaldosis på 25 mg to gange dagligt.
English: Therefore, you should not stop taking Jakavi without discussing it with your doctor.
Danish: Derfor må du ikke stoppe med at tage Jakavi uden først at have talt med lægen om det.
English: Following interruption or discontinuation of Jakavi, symptoms of MF may return over a period of approximately one week.
Danish: Efter afbrydelse af eller ophør med Jakavi kan myelofibrosesymptomerne vende tilbage over en periode på ca. en uge.
English: Anaemia or thrombocytopenia CTCAE grade 3 and 4 were reported in respectively 1.1% or 3.3%.
Danish: Anæmi og trombocytopeni CTCAE grad 3 og 4 blev rapporteret hos henholdsvis 1,1% og
English: Based on studies in healthy subjects, no relevant differences in ruxolitinib pharmacokinetics were observed with regard to gender and race.
Danish: Baseret på studier med raske forsøgspersoner blev der ikke observeret relevante forskelle i ruxolitinibs farmakokinetik med hensyn til køn eller race.
English: Reduced bone growth was observed at doses ≥5 mg/kg/day when treatment started on postnatal day 7 (comparable to human newborn) and at ≥15 mg/kg/day when treatment started on postnatal days 14 or 21 (comparable to human infant, 1-3 years).
Danish: Reduceret knogletilvækst blev observeret ved doser på ≥5 mg/kg/dag, når behandlingen startede på dag 7 postnatalt (sammenlignelig med humane nyfødte) og på ≥15 mg/kg/dag, når behandlingen startede på dag 14 eller 21 postnatalt (sammenlignelig med humane småbørn på 1-3 år).
English: Key secondary endpoints included the proportion of patients who achieved the primary endpoint and remained free from progression at week 48, as well as the proportion of patients achieving complete haematological remission at week 32.
Danish: De vigtigste sekundære endepunkter inkluderede andelen af patienter, som opnåede det primære endepunkt og forblev progressionsfri ved uge 48, såvel som andelen af patiener, der opnåede fuldstændig hæmatologisk remission ved uge 32.
English: In the PV population, the CTCAE grade 3 and 4 events were reported in 2.7%, while in the MF patients the frequency was 42.56%.
Danish: I PV-populationen blev CTCAE grad 3 og 4 rapporteret hos 2,7%, mens frekvensen var 42,56% for MF-patienter.
English: Table 3 Percentage of patients with ≥35% reduction from baseline in spleen volume by JAK mutation status (safety set)
Danish: Tabel 3 Procentdel af patienter med ≥35% reduktion fra baseline i miltvolumen ved JAK mutationsstatus (sikkerhed)
English: Raised aspartate aminotransferase b
Danish: Forhøjet aspartataminotransferase b
English: In juvenile rat studies, administration of ruxolitinib resulted in effects on growth and bone measures.
Danish: I studier med juvenile rotter medførte administration af ruxolitinib påvirkninger af vækst- og knogle parametre.
English: A whole body autoradiography study in rats has shown that ruxolitinib does not penetrate the blood-brain barrier.
Danish: En radiografisk undersøgelse af hele kroppen hos rotter har vist, at ruxolitinib ikke trænger igennem blod-hjernebarrieren.
English: These were all CTCAE grade 1 and 2 with the exception of one CTCAE grade 3 raised alanine aminotransferase event.
Danish: Disse var alle grad 1 eller 2 med undtagelse af ét tilfælde af grad 3 forhøjet alaninaminotransferase.
English: Of 301 patients, 111 (36.9%) had a baseline platelet count of between 100,000/mm and 200,000/mm and 190 (63.1%) had a baseline platelet count of
Danish: Ud af 301 patienter havde 111 (36,9%) et baselinetrombocytniveau på mellem 100.000/mm og 200.000/mm 3, og 190 patienter (63,1%) havde et baseline-trombocytniveau >200.000/mm
English: The following may reduce the effectiveness of Jakavi: - Avasimibe, a medicine to treat heart disease.
Danish: Følgende kan nedsætte virkningen af Jakavi: - Avasimib, medicin som bruges til behandling af hjertesygdom.
English: A randomised, open-label, active-controlled phase 3 study (RESPONSE) was conducted in 222 patients with PV who were resistant to or intolerant of hydroxyurea defined based on the European LeukemiaNet (ELN) international working group published criteria.
Danish: Et randomiseret, åbent, aktivt kontrolleret fase 3-studie (RESPONSE) er gennemført med 222 patienter med PV, som var refraktære over for eller ikke tålte hydroxycarbamid, defineret ved Europæisk Leukæmi Nets (ELN) internationale arbejdsgruppes publicerede kriterier.
English: If you interrupt your treatment with Jakavi your myelofibrosis-related symptoms may come back.
Danish: Hvis du afbryder behandlingen med Jakavi, kan dine myelofibrose-relaterede symptomer vende tilbage.
English: Patients should be closely monitored (e.g. twice weekly) for cytopenias and dose titrated based on safety and efficacy (see section 4.2).
Danish: Patienterne skal monitoreres nøje (fx to gange om ugen) for cytopeni, og dosis skal titreres under hensyntagen til sikkerhed og effekt (se pkt.
English: Target organs associated with the pharmacological action of ruxolitinib in repeated dose studies include bone marrow, peripheral blood and lymphoid tissues.
Danish: Målorganer, som er forbundet med ruxolitinibs farmakologiske aktivitet i gentagne dosisstudier, omfatter knoglemarv og perifert blod og lymfevæv.
English: The adverse drug reactions listed below reflect the randomised study period (up to week 32 for RESPONSE and up to week 28 for RESPONSE 2) with equivalent exposure to ruxolitinib and Best Available Therapy (BAT).
Danish: Listen over bivirkninger herunder reflekterer den randomiserede studieperiode (op til 32 uger for RESPONSE og op til 28 uger for RESPONSE 2) med ækvivalent eksponering for ruxolitinib og bedst tilgængelig behandling (Best Available Therapy (BAT)).
English: The safety and efficacy of these co-administrations are not known (see section 4.5).
Danish: Sikkerhed og effekt af disse samtidige administrationer er ikke kendt (se pkt.
English: Jakavi contains the active substance ruxolitinib.
Danish: Jakavi indeholder det aktive stof ruxolitinib.
English: Patients diagnosed with hepatic impairment while receiving ruxolitinib should have complete blood counts, including a white blood cell count differential, monitored at least every one to two weeks for the first 6 weeks after initiation of therapy with ruxolitinib and as clinically indicated thereafter once their liver function and blood counts have been stabilised.
Danish: Hos patienter, som er diagnosticeret med nedsat leverfunktion under behandling med ruxolitinib, skal komplet blodtælling inklusive differentialtælling udførres mindst hver eller hver anden uge de første 6 uger efter, at behandling med ruxolitinib er påbegyndt, og derefter som klinisk indiceret, når deres leverfunktion og blodtællinger er stabiliseret.
English: Table 2 Percentage of patients with ≥35% reduction from baseline in spleen volume at week 24 in COMFORT-I and at week 48 in COMFORT-II (ITT)
Danish: Tabel 2 Procentdel af patienter med en reduktion i miltvolumen på ≥35% i forhold til baseline ved uge 24 i COMFORT-I og ved uge 48 i COMFORT-II (ITT)
English: Complete blood count, including a white blood cell count differential, should be monitored every 2-4 weeks until Jakavi doses are stabilised, and then as clinically indicated (see section 4.4).
Danish: Komplet blodtælling inklusive en differentialtælling skal udføres hver 2.- 4. uge, indtil Jakavi-doserne er stabiliseret og derefter som klinisk indiceret (se pkt.
English: Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively).
Danish: Ruxolitinib er en selektiv hæmmer af de Janus-associerede kinaser (JAK's) JAK1 og JAK2 (IC50værdier på 3,3 nM og 2,8 nM for henholdsvis JAK1- og JAK2-enzymer).
English: More frequent monitoring of haematology parameters and of clinical signs and symptoms of Jakavi-related adverse drug reactions is recommended for patients with baseline haemoglobin below 10.0 g/dl.
Danish: Der anbefales hyppigere monitorering af hæmatologi-parametre og kliniske tegn og symptomer på Jakavirelaterede bivirkninger for patienter med baseline hæmoglobin under 10,0 g/dl.
English: Patients in the ruxolitinib arm had PV diagnosis for a median of 8.2 years and had previously received hydroxyurea for a median of approximately 3 years.
Danish: Patienter i ruxolitinib-armen havde i gennemsnit haft PV-diagnosen i 8,2 år og havde tidligere været behandlet med hydroxycarbamid i gennemsnitligt 3 år.
English: Mild or moderate CYP3A4 inhibitors (such as, but not limited to, ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine)
Danish: Milde eller moderate CYP3A4-hæmmere (såsom, men ikke begrænset, til ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidin)
English: 3, with the goal of avoiding dose interruptions for thrombocytopenia.
Danish: 3, med det formål at undgå doseringsafbrydelse på grund af trombocytopeni.
English: Other interactions to be considered affecting ruxolitinib
Danish: Andre interaktioner, der skal tages hensyn til, som påvirker ruxolitinib
English: Thrombocytopenia was generally reversible with dose reduction or dose interruption.
Danish: Trombocytopeni var generelt reversibel via dosisreduktion eller doseringsafbrydelse.
English: The margins (based on unbound Cmax) at the non-adverse level in the dog and rat studies were 15.7-fold and 10.4-fold greater, respectively, than the maximum human recommended dose of 25 mg twice daily.
Danish: Marginerne (baseret på ubundet Cmax) på det ikke-uønskede niveau i hunde- og rottestudierne var henholdsvis 15,7 og 10,4 gange større end den maksimale, anbefalede dosis til mennesker på 25 mg to gange dagligt.
English: Animal studies have shown that ruxolitinib is embryotoxic and foetotoxic.
Danish: Dyreforsøg har påvist, at ruxolitinib er embryotoksisk og føtotoksisk.
English: Lipid monitoring and treatment of dyslipidaemia according to clinical guidelines is recommended.
Danish: Monitorering af lipidparametre og behandling af dyslipidæmi i henhold til kliniske guidelines anbefales.
English: PVC/PCTFE/Aluminium blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets.
Danish: PVC/PCTFE/aluminium blisterpakninger indeholdende 14 eller 56 tabletter eller multipakninger indeholdende 168 (3 pakninger med 56) tabletter.
English: In the randomised period of the pivotal studies, anaemia was less frequent in PV patients than in MF patients (40.8% versus 82.4%).
Danish: I den randomiserede periode af de pivotale studier var anæmi mindre hyppig hos PV-patienter end hos MF-patienter (40,8% versus 82,4%).
English: - Mibefradil or diltiazem, medicines to treat hypertension and chronic angina pectoris.
Danish: - Mibefradil eller diltiazem, medicin som bruges til behandling af forhøjet blodtryk og kronisk angina pectoris.
English: Upon discontinuation, MF patients may experience a return of MF symptoms such as fatigue, bone pain, fever, pruritus, night sweats, symptomatic splenomegaly and weight loss.
Danish: Efter seponering kan MF-patienter opleve tilbagevenden af myelofibrosesymptomer som for eksempel træthed, knoglesmerter, feber, pruritus, nattesved, symptomatisk splenomegali og vægttab.
English: In a thorough QT study in healthy subjects, there was no indication of a QT/QTc prolonging effect of ruxolitinib in single doses up to a supratherapeutic dose of 200 mg, indicating that ruxolitinib has no effect on cardiac repolarisation.
Danish: I en grundig QT-undersøgelse med sunde forsøgspersoner var der ingen tegn på en QT/QTcforlængende effekt af ruxolitinib ved enkeltdoser op til en supraterapeutisk dosis på 200 mg, hvilket tyder på, at ruxolitinib ikke har nogen effekt på kardiel repolarisering.
English: Subsequent doses should be adjusted based on careful monitoring of safety and efficacy.
Danish: Efterfølgende doser skal baseres på omhyggelig monitorering af sikkerhed og effekt.
English: If you accidentally take more Jakavi than your doctor prescribed, contact your doctor or pharmacist immediately.
Danish: Hvis du er kommet til at tage mere Jakavi, end din læge har ordineret, skal du straks kontakte enten din læge eller apoteket.
English: Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anaemia and thrombocytopenia.
Danish: Gentagne højere doser end de anbefalede medfører øget myelosuppression, herunder leukopeni, anæmi og trombocytopeni.
English: Baseline elevations in inflammatory markers associated with constitutional symptoms such as TNFα, IL-6 and CRP in subjects with MF were decreased following treatment with ruxolitinib.
Danish: Baseline-forhøjelser af inflammatoriske markører forbundet med konstitutionelle symptomer som for eksempel TNFα, IL-6 og CRP hos forsøgspersoner med MF faldt efter behandling med ruxolitinib.