FrancophonIA/ELRC3.0 huggingface dataset:
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jakavi on 23 August 2012.
Danish: Europa-Kommissionen udstedte en markedsføringstilladelse med gyldighed i hele Den Europæiske Union for Jakavi den 23. august 2012.
English: This is a summary of the European public assessment report (EPAR) for Jakavi.
Danish: Dette er et sammendrag af den europæiske offentlige vurderingsrapport (EPAR) for Jakavi.
English: Other information about Jakavi
Danish: Andre oplysninger om Jakavi
English: The full EPAR for Jakavi can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Danish: Den fuldstændige EPAR for Jakavi findes på agenturets websted under: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Jakavi is used to treat the following conditions:
Danish: Jakavi anvendes til behandling af følgende sygdomme:
English: A risk management plan has been developed to ensure that Jakavi is used as safely as possible.
Danish: Der er udarbejdet en risikostyringsplan for at sikre, at Jakavi anvendes så sikkert som muligt.
English: The patient's complete blood cell count must be taken before starting treatment and monitored during treatment.
Danish: Patienten skal have foretaget en komplet blodtælling før påbegyndelse af behandlingen og skal overvåges under behandlingen.
English: Treatment with Jakavi should only be started by a doctor who is experienced in treating patients with cancer medicines.
Danish: Behandlingen med Jakavi bør kun indledes af en læge med erfaring i behandling af patienter med kræftmedicin.
English: If the treatment is not considered effective enough, the dose can be increased by 5 mg up to 25 mg twice a day.
Danish: Hvis behandlingen ikke virker tilstrækkeligt, kan dosis sættes op med 5 mg, så den bliver på op til 25 mg to gange dagligt.
English: Jakavi is a medicine that contains the active substance ruxolitinib.
Danish: Jakavi er et lægemiddel, der indeholder det aktive stof ruxolitinib.
English: Jakavi must not be used in women who are pregnant or breastfeeding.
Danish: Jakavi må ikke anvendes af kvinder, der er gravide eller ammer.
English: What measures are being taken to ensure the safe and effective use of Jakavi?
Danish: Hvilke foranstaltninger træffes der for at sikre risikofri og effektiv anvendelse af Jakavi?
English: For more information about treatment with Jakavi, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.
Danish: Hvis du ønsker yderligere oplysninger om behandling med Jakavi, kan du læse indlægssedlen (også en del af denne EPAR) eller kontakte din læge eller dit apotek.
English: The main measure of effectiveness was the proportion of patients whose spleen had reduced in size by at least 35%, measured after six months in the first study and after one year in the second study.
Danish: Virkningen blev hovedsagelig bedømt på den andel af patienterne, hos hvem størrelsen af milten var reduceret med mindst 35 %, målt efter seks måneder i den første undersøgelse og efter et år i den anden undersøgelse.
English: It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Jakavi.
Danish: Det forklarer, hvordan Udvalget for Lægemidler til Mennesker (CHMP) vurderede lægemidlet og nåede frem til sin udtalelse til fordel for udstedelse af en markedsføringstilladelse og til sine anbefalinger om, hvordan Jakavi skal anvendes.
English: These blood cells migrate to organs including the spleen, causing them to become enlarged.
Danish: Disse blodceller vandrer til forskellige organer, herunder milten, der derved bliver forstørret.
English: What is the risk associated with Jakavi?
Danish: Hvilken risiko er der forbundet med Jakavi?
English: In polycythaemia vera, the company will extend the main study to provide long-term data on the safety and effectiveness of Jakavi.
Danish: For polycythæmia vera vil virksomheden udvide hovedundersøgelsen med henblik på at forelægge oplysninger om sikkerheden og virkningen af Jakavi på lang sigt.
English: Based on this plan, safety information has been included in the summary of product characteristics and the package leaflet for Jakavi, including the appropriate precautions to be followed by healthcare professionals and patients.
Danish: På baggrund af denne er der anført sikkerhedsoplysninger i produktresuméet og på indlægssedlen for Jakavi, herunder passende forholdsregler, som patienter og sundhedspersonale skal følge.
English: The first study compared Jakavi with placebo (a dummy treatment).
Danish: I den første undersøgelse blev Jakavi sammenlignet med placebo (virkningsløs behandling).
English: The second study compared Jakavi with the best available treatment, which included different types of medicines such as anti-cancer agents, hormones and immunosuppressants.
Danish: I den anden undersøgelse blev Jakavi sammenlignet med den bedste tilgængelige behandling, der bestod i forskellige typer lægemidler såsom kræftmedicin, hormoner og immundæmpende medicin.
English: The active substance in Jakavi, ruxolitinib, works by blocking a group of enzymes known as Janus kinases (JAKs), which are involved in the production and growth of blood cells.
Danish: Det aktive stof i Jakavi, ruxolitinib, virker ved at blokere en gruppe enzymer, der kaldes Janus-kinaser (JAK), som medvirker ved blodcellers dannelse og vækst.
English: In polycythaemia vera treatment should also be stopped when haemoglobin levels are very low.
Danish: Hos patienter med polycythæmia vera bør behandlingen også stoppes, hvis hæmoglobinniveauet er meget lavt.
English: Why has Jakavi been approved?
Danish: Hvorfor blev Jakavi godkendt?
English: In polycythaemia vera, the recommended starting dose is 10 mg twice a day.
Danish: Ved polycythæmia vera er den anbefalede startdosis 10 mg to gange dagligt.
English: This study, which compared Jakavi with best available treatment, looked at the percentage of patients who showed improvement in their condition, measured as requiring none or no more than one phlebotomy (a procedure to remove excess blood from the body) and whose spleen reduced by at least 35% in size, after 8 months of treatment.
Danish: Denne undersøgelse, hvor Jakavi blev sammenlignet med den bedste tilgængelige behandling, så nærmere på den procentdel af patienterne, hvis tilstand forbedredes, målt ved deres behov for ingen eller højst én phlebotomi (en procedure til fjernelse af overskydende blod fra kroppen), og hos hvem størrelsen af milten var reduceret med mindst 35 % efter otte måneders behandling.
English: In myelofibrosis, Jakavi was investigated in two main studies involving 528 patients.
Danish: Hvad angår myelofibrose var Jakavi genstand for to hovedundersøgelser med 528 patienter.
English: • myelofibrosis in adults who have splenomegaly (enlarged spleen) or symptoms related to the disease such as fever, night sweats, bone pain and weight loss.
Danish: • myelofibrose hos voksne, som har splenomegali (forstørret milt) eller symptomer på deres sygdom såsom feber, nattesved, knoglesmerter og vægttab.
English: The CHMP decided that Jakavi's benefits are greater than its risks and recommended that it be given marketing authorisation.
Danish: CHMP besluttede, at fordelene ved Jakavi opvejer risiciene og anbefalede udstedelse af en markedsføringstilladelse for Jakavi.
English: Myelofibrosis is a disease in which the bone marrow becomes very dense and rigid and produces abnormal, immature blood cells.
Danish: myelofibrose er en sygdom, hvor knoglemarven bliver meget tæt og stiv og producerer abnorme, umodne blodceller.
English: What is Jakavi?
Danish: Hvad er Jakavi?
English: In myelofibrosis, Jakavi was more effective than placebo and the best available treatment at reducing the size of the spleen.
Danish: Ved myelofibrose var Jakavi mere effektivt til at nedsætte størrelsen af milten end placebo og den bedste tilgængelige behandling.
English: • polycythaemia vera in adults who are resistant or intolerant to treatment with the medicine hydroxyurea.
Danish: • polycythæmia vera hos voksne, som er resistente over for eller ikke tåler behandling med lægemidlet hydroxyurea.
English: In myelofibrosis, the recommended starting dose is up to 20 mg twice a day depending on the platelet count.
Danish: Ved myelofibrose er den anbefalede startdosis op til 20 mg to gange dagligt, afhængigt af blodpladetallet.
English: Polycythaemia vera is a disease that mainly causes too many red blood cells to be produced, which can cause reduced blood flow to the organs due to ‘thickening' of the blood and occasionally the formation of blood clots.
Danish: Polycythæmia vera er en sygdom, som primært fører til en overproduktion af røde blodceller, hvilket kan reducere blodtilførslen til organerne, da blodet ”fortykkes”, og undertiden medføre dannelse af blodpropper.
English: A lower dose should be used in certain cases, including in patients reduced liver function or severely reduced kidney function, and in patients taking certain other medicines.
Danish: I visse tilfælde, herunder hos patienter med nedsat leverfunktion eller stærkt nedsat nyrefunktion bør der anvendes en lavere dosis.
English: In polycythaemia vera the CHMP considered that Jakavi is of benefit to patients who do not respond or are intolerant to treatment with hydroxyurea, while the safety profile is acceptable.
Danish: Hvad angår polycythæmia vera besluttede CHMP, at Jakavi er til fordel for patienter, som ikke reagerer på eller ikke tåler behandling med hydroxyurea, mens sikkerhedsprofilen er acceptabel.
English: In addition, the company that makes Jakavi is extending the main studies on myelofibrosis and will provide annual data on the effects of Jakavi in terms of how long patients live and how long they live without their disease getting worse or developing leukaemia.
Danish: Virksomheden, der fremstiller Jakavi, vil for myelofibrose udvide hovedundersøgeserne og vil hvert år forelægge oplysninger med hensyn til patienternes levetid, og hvor lang tid der går, uden at sygdommen bliver værre eller at de får leukæmi.
English: In polycythaemia vera, 21% (23 out of 110) of patients given Jakavi showed an improvement after 8 months of treatment, compared with 1% (1 out of 112) of patients given the best available treatment.
Danish: Ved polycythæmia vera havde 21 % (23 ud af 110) af patienterne, som fik Jakavi, opnået forbedring efter otte måneders behandling, sammenlignet med 1 % (1 ud af 112) af de patienter, der fik den bedste tilgængelige behandling.
English: In polycythaemia vera, Jakavi was studied in one main study which involved 222 patients who were resistant or intolerant to treatment with hydroxyurea.
Danish: Hvad angår polycythæmia vera blev Jakavi undersøgt i en hovedundersøgelse med 222 patienter, som var resistente over for eller ikke tåler behandling med hydroxyurea.
English: The Committee noted that the quality of life of patients treated with Jakavi was improved but that the medicine's effects had still to be evaluated in terms of extending the life of patients or delaying the progress of the disease or the onset of leukaemia.
Danish: Udvalget bemærkede, at livskvaliteten øges ved behandling med Jakavi, men at lægemidlets virkninger mangler at blive vurderet hvad angår livsforlængende virkning og forsinkelse i sygdommens udvikling eller i indsætten af leukæmi.
English: For the full list of all side effects and restrictions with Jakavi, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger og begrænsninger ved Jakavi fremgår af indlægssedlen.
English: In the first study, the target reduction in spleen size was achieved in 42% of patients treated with Jakavi (65 out of 155) compared with less than 1% of patients given placebo (1 out of 153).
Danish: I den første undersøgelse blev målet for mindskelsen af miltstørrelsen nået hos 42 % af de patienter, der blev behandlet med Jakavi (65 ud af 155), sammenlignet med mindre end 1 % af dem, der fik placebo (1 ud af 153).
English: By blocking JAKs, Jakavi reduces the abnormal production of blood cells, thereby reducing the symptoms of the diseases.
Danish: Jakavi blokerer JAK'erne og nedsætter derved den unormalt høje produktion af blodceller, så sygdomssymptomerne mindskes.
English: Jakavi can be used in three types of the disease: primary myelofibrosis (also known as chronic idiopathic myelofibrosis, where the cause is unknown), post-polycythaemia vera myelofibrosis (where the disease is linked to an overproduction of red blood cells) and postessential thrombocythaemia myelofibrosis (where the disease is linked to an overproduction of platelets, components that help the blood to clot).
Danish: Jakavi kan anvendes til tre typer af denne sygdom: primær myelofibrose (kaldes også kronisk idiopatisk myelofibrose, når årsagen er ukendt), post polycythæmia vera myelofibrose (hvor sygdommen er knyttet til overproduktion af røde blodlegemer) og post essentiel trombocytæmi myelofibrose (når sygdommen er knyttet til overproduktion af blodplader, som er den komponent, der medvirker til blodets størkning).
English: Treatment should be stopped if the patient's blood levels of platelets or neutrophils (a type of white blood cell) fall below certain thresholds, or if no improvement in spleen size or symptoms is seen after six months.
Danish: Behandlingen bør stoppes, hvis patientens blodpladetal eller neutrofiltal (en type hvide blodlegemer) kommer under bestemte tærskelværdier.
English: In the second study, the target reduction in spleen size was achieved in 29% of patients treated with Jakavi (41 out of 144) compared with 0% of patients receiving the best available treatment (0 out of 72).
Danish: I den anden undersøgelse nåedes målet for mindskelse af miltstørrelsen hos 29 % af de patienter, der blev behandlet med Jakavi (41 ud af 144), sammenlignet med 0 % af dem, der fik den bedste tilgængelige behandling (0 ud af 72).
English: In myelofibrosis and polycythaemia vera, there is too much JAK activity, leading to the abnormal production of blood cells.
Danish: Ved myelofibrose og polycythæmia vera er der for høj JAK-aktivitet, så der produceres unormalt mange umodne blodceller.
English: What is Jakavi used for?
Danish: Hvad anvendes Jakavi til?
English: With regard to safety, the Committee considered that the risk of infections is acceptable but should be monitored further, while other known risks, such as bleeding or a reduction in blood cell counts, can be appropriately managed.
Danish: Hvad angår sikkerheden fandt udvalget, at risikoen for infektioner er acceptabel, men bør overvåges yderligere.
English: How has Jakavi been studied?
Danish: Hvordan blev Jakavi undersøgt?
English: What benefit has Jakavi shown during the studies?
Danish: Hvilken fordel viser undersøgelserne, at der er ved Jakavi?
English: In myelofibrosis, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils), urinary tract infections (infection of the structures that carry urine), bleeding, bruising, weight gain, hypercholesterolaemia (high blood cholesterol levels), dizziness, headache and raised liver enzyme levels.
Danish: Ved myelofibrose er de hyppigste bivirkninger ved Jakavi (som optræder hos flere end 1 ud af 10 behandlede) trombocytopeni (for lavt antal blodplader), anæmi (for lavt antal røde blodlegemer), neutropeni (for lavt antal hvide blodlegemer af typen neutrofile), urinvejsinfektioner, blødning, blå mærker, vægtøgning, hyperkolesterolæmi (for højt kolesterolindhold i blodet), svimmelhed, hovedpine og forhøjet indhold af leverenzymer.
English: How is Jakavi used?
Danish: Hvordan anvendes Jakavi?
English: In myelofibrosis the CHMP considered that the reduction in spleen size and symptoms seen in patients taking Jakavi is clinically important.
Danish: Hvad angår myelofibrose fandt CHMP, at Jakavi medfører klinisk betydningsfuld reduktion af miltstørrelse og symptomer.
English: In polycythaemia vera, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), bleeding, bruising, hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridemia (high blood fat levels), dizziness, raised liver enzyme levels and high blood pressure.
Danish: Ved polycythæmia vera er de hyppigste bivirkninger ved Jakavi (som optræder hos flere end 1 ud af 10 behandlede) trombocytopeni (for lavt antal blodplader), anæmi (for lavt antal røde blodlegemer), blødning, blå mærker, hyperkolesterolæmi (for højt kolesterolindhold i blodet), hypertriglyceridæmi (for højt fedtindhold i blodet), svimmelhed, forhøjet indhold af leverenzymer og for højt blodtryk.
English: How does Jakavi work?
Danish: Hvordan virker Jakavi?
English: PC: {number} SN: {number} NN: {number}
Danish: PC: {nummer} SN: {nummer}
English: Date of first authorisation: 21 April 2008 Date of latest renewal: 20 December 2012
Danish: Dato for første markedsføringstilladelse: 21 april 2008 Dato for seneste fornyelse: 20 december 2012
English: Not everyone gets flares, but you could get a flare-up even if you are taking ADENURIC, and especially during the first weeks or months of treatment.
Danish: Ikke alle får udbrud, men De kunne få et udbrud, selv om De tager ADENURIC og især i behandlingens første uger eller måneder.
English: Your doctor might decide to permanently stop treatment with ADENURIC.
Danish: Lægen kan beslutte at stoppe behandlingen med ADENURIC permanent.
English: About 69 % of patients required no treatment change to achieve a final stable treatment.
Danish: Hos ca. 69 % af patienterne var det ikke nødvendigt at ændre behandlingen for at opnå en endelig og stabil behandling.
English: ANNEX II A. MANUFACTURER(S) RESPONSIBLE FOR BATCH RELEASE B. CONDITIONS OR RESTRICITONS REGARDING SUPPLY AND USE C. OTHER CONDITIONS AND REQUIREMENTS OF THE MARKETING AUTHORISATION D. CONDITIONS OR RESTRICTIONS WITH REGARD TO THE SAFE AND EFFECTIVE USE OF THE MEDICINAL PRODUCT
Danish: BILAG II A. FREMSTILLER(E) ANSVARLIG(E) FOR BATCHFRIGIVELSE B. BETINGELSER ELLER BEGRÆNSNINGER VEDRØRENDE UDLEVERING OG ANVENDELSE C. ANDRE FORHOLD OG BETINGELSER FOR MARKEDSFØRINGSTILLADELSEN D. BETINGELSER ELLER BEGRÆNSNINGER MED HENSYN TIL SIKKER OG EFFEKTIV ANVENDELSE AF LÆGEMIDLET
English: However, drug-drug and drug-disease interactions were not explored during this study.
Danish: Interaktion mellem lægemiddellægemiddel og lægemiddel-sygdom blev ikke undersøgt i dette studie.
English: The back of the blister pack is marked with the days of the week to help you check that you have taken a dose each day.
Danish: Ugedagene er angivet bag på blisterkortet for at hjælpe med at sikre, at De tager en dosis hver dag.
English: * p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg
Danish: * p < 0,001 versus allopurinol, # p < 0,001 versus 80 mg
English: Furthermore, the mean serum uric acid level was significantly lower with ADENURIC since the first 24 hours of treatment and at any following time point.
Danish: Desuden var middel serumurinsyreniveauet signifikant lavere med ADENURIC efter de første 24 timers behandling og ethvert tidspunkt derefter.
English: Patients should exercise caution before driving, using machinery or participating in dangerous activities until they are reasonably certain that ADENURIC does not adversely affect performance.
Danish: Patienterne bør udvise forsigtighed, inden de fører motorkøretøj, betjener maskiner eller deltager i farlige aktiviteter, indtil de er rimeligt sikre på, at ADENURIC ikke nedsætter deres evne hertil.
English: No data comparing ADENURIC with rasburicase are currently available.
Danish: Der er for nuværende ingen data til rådighed, der sammenligner ADENURIC med rasburicase.
English: Over time, gout flares will occur less often and be less painful if you keep taking ADENURIC every day.
Danish: Efterhånden vil urinsyregigt-udbruddene optræde mindre hyppigt, og de vil blive mindre smertefulde, hvis De bliver ved med at tage ADENURIC dagligt.
English: Plasma protein binding of the active metabolites ranges from about 82% to 91%.
Danish: De aktive metabolitters plasmaproteinbinding ligger i området fra cirka 82 % til 91 %.
English: Febuxostat tablets contain lactose.
Danish: Febuxostat tabletter indeholder lactose.
English: The requirements for submission of periodic safety updated reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Danish: • Periodiske, opdaterede sikkerhedsindberetninger (PSUR'er) Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel fremgår af listen over EU-referencedatoer (EURD list), som fastsat i artikel 107c, stk. 7, i direktiv 2001/83/EF, og alle efterfølgende opdateringer offentliggjort på den europæiske webportal for lægemidler.
English: The efficacy and safety of ADENURIC in the prevention and treatment of Tumor Lysis Syndrome was evaluated in the FLORENCE (FLO-01) study.
Danish: Den kliniske virkning og sikkerhed af ADENURIC ved forebyggelse og behandling af tumorlysesyndrom blev evalueret i FLORENCE-studiet (FLO-01).
English: Also contains lactose (as monohydrate).
Danish: Indeholder endvidere lactose (som monohydrat).
English: • If you have or have had renal disease and/or serious allergic reaction to Allopurinol (a medication used for the treatment of Gout)
Danish: • hvis De har eller tidligere har haft en nyresygdom og/eller en alvorlig allergisk reaktion på allopurinol (medicin til behandling af urinsur gigt)
English: INR and Factor VII activity were also not affected by the coadministration of febuxostat.
Danish: INR og faktor VII-aktivitet blev heller ikke påvirket ved samtidig administration af febuxostat.
English: These rates were similar to the rates reported on allopurinol (4.2%) (see section 4.4).
Danish: Disse hyppigheder lignede de hyppigheder, der blev rapporteret i forbindelse med allopurinol (4,2 %) (se pkt.
English: Following multiple oral doses of ADENURIC, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Danish: Efter gentagne orale doser af ADENURIC var Cmax og AUC henholdsvis 24 % og 12 % højere hos kvinder end hos mænd.
English: You should not use ADENURIC if you are breast feeding, or if you are planning to breastfeed.
Danish: De bør ikke tage ADENURIC, hvis De ammer, eller hvis De planlægger at amme.
English: Start taking ADENURIC two days before chemotherapy and continue its use according to your doctor's advice.
Danish: Begynd at tage ADENURIC to dage før kemoterapien og fortsæt i henhold til lægens anvisninger.
English: The MAH shall perform the required pharmacovigilance activities and interventions detailed in the agreed RMP presented in Module 1.8.2. of the Marketing Authorisation and any agreed subsequent updates of the RMP.
Danish: Indehaveren af markedsføringstilladelsen skal udføre de påkrævede aktiviteter og foranstaltninger vedrørende lægemiddelovervågning, som er beskrevet i den godkendte RPM, der fremgår af modul 1.8.2 i markedsføringstilladelsen, og enhver efterfølgende godkendt opdatering af RMP.
English: Do not stop taking ADENURIC without the advice of your doctor even if you feel better.
Danish: De må ikke holde op med at tage ADENURIC uden først at spørge Deres læge til råds - heller ikke selv om De har fået det bedre.
English: The endpoints (primary and secondary) were analysed according to the intention-to-treat (ITT) analysis including all subjects who were randomized and received at least one dose of double-blind study medication.
Danish: Endepunkterne (de primære og sekundære) blev analyseret i henhold til en intention-to-treat (ITT) analyse, der omfattede alle forsøgspersoner, der var randomiserede, og som modtog mindst en dosis af lægemidlet i det dobbeltblindede studie.