FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of side effects of Namuscla, see the package leaflet.
Danish: Den fuldstændige liste over bivirkninger ved Namuscla fremgår af indlægssedlen.
English: How is Namuscla used?
Danish: Hvordan anvendes Namuscla?
English: What benefits of Namuscla have been shown in studies?
Danish: Hvilke fordele viser studierne, at der er ved Namuscla?
English: Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Namuscla have also been included in the summary of product characteristics and the package leaflet.
Danish: Der er desuden anført anbefalinger og forholdsregler i produktresuméet og indlægssedlen, som patienter og sundhedspersonale skal følge for at sikre risikofri og effektiv anvendelse af Namuscla.
English: How does Namuscla work?
Danish: Hvordan virker Namuscla?
English: Muscle stiffness was self-assessed by each patient before and after treatment, and scored on a scale running from 0 to 100 (most severe).
Danish: Graden af muskelstivhed blev vurderet af den enkelte patient før og efter behandling og bedømt på en skala fra 0 til 100 (værst mulig stivhed).
English: Long-term safety:
Danish: Langtids-sikkerhed:
English: Both key secondary endpoints were also met.
Danish: De 2 vigtigste sekundære endepunkter blev også nået.
English: Appropriate supportive treatment should be given.
Danish: Der skal gives passende understøttende behandling.
English: This is a long-term treatment.
Danish: Dette er en længerevarende behandling.
English: Tuberculosis e
Danish: Tuberkulose e
English: Date of first authorisation: 23 August 2012 Date of latest renewal: 24 April 2017
Danish: Dato for første markedsføringstilladelse: 23. august 2012 Dato for seneste fornyelse: 24. april 2017
English: JAK mutation status
Danish: JAK mutationsstatus
English: Patients should be assessed for the risk of developing serious infections.
Danish: Patienter bør vurderes for risikoen for at udvikle alvorlige infektioner.
English: The median age was 60 years (range 33 to 90 years).
Danish: Gennemsnitsalderen var 60 år (fra 33 til 90 år).
English: These ADRs are discussed in the text.
Danish: Disse bivirkninger er diskuteret i teksten.
English: - if you notice skin changes.
Danish: - hvis du bemærker ændringer i huden.
English: Effects of age, gender or race
Danish: Virkning for alder, køn og race
English: This medicine is not intended for use by children or adolescents aged below 18 years because it has not been studied in this age group.
Danish: Denne medicin er ikke beregnet til brug til børn eller unge under 18 år, da den ikke har været undersøgt til denne aldersgruppe.
English: Your doctor will also regularly check the level of lipids (fat) in your blood.
Danish: Din læge vil også regelmæssigt undersøge dine niveauer af lipider (fedtstoffer) i blodet.
English: Tell your doctor immediately if you experience any of the following side effects.
Danish: Fortæl straks din læge, hvis du oplever nogen af følgende bivirkninger.
English: These may be signs of a serious brain infection and your doctor may suggest further testing and follow-up.
Danish: Dette kan være tegn på en alvorlig hjerneinfektion, og din læge kan foreslå yderligere undersøgelser og opfølgning.
English: The majority of patients (68.4%) were treated for at least 9 months.
Danish: Størstedelen af patienterne (68,4%) blev behandlet i mindst 9 måneder.
English: Comparative data regarding long-term survival and incidence of disease complications is missing.
Danish: Sammenlignende data vedrørende langtidsoverlevelse og hyppigheden af sygdomskomplikationer mangler.
English: It is possible that the potential inhibition of P-gp and BCRP in the intestine can be minimised if the time between administrations is kept apart as long as possible.
Danish: Det er muligt at den potentielle hæmning af P-gp og BCRP i tarmen kan minimeres, hvis tiden mellem administrationerne holdes adskilt så længe som muligt.
English: Uncommon (may affect up to 1 in 100 people): - tuberculosis
Danish: Ikke almindelig (kan forekomme hos op til 1 ud af 100 personer): tuberkulose
English: if you have ever had tuberculosis.
Danish: - hvis du nogensinde har haft tuberkulose.
English: - if you have or have ever had any liver problems.
Danish: - hvis du har eller nogensinde har haft leverproblemer.
English: The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2-week intervals.
Danish: Startdosis bør ikke øges inden for de første fire uger af behandlingen og derefter ikke hyppigere end med intervaller på 2 uger.
English: Final CSR: December 2019
Danish: Endelig studierapport: december 2019
English: Lipid abnormalities/elevations
Danish: Lipid abnormaliteter/stigninger
English: You should take Jakavi every day at the same time, either with or without food.
Danish: Du skal tage Jakavi på samme tidspunkt hver dag, enten sammen med eller uden mad.
English: Frequency is based on laboratory values.
Danish: Frekvens er baseret på laboratorieværdier.
English: Not all pack sizes or types may be marketed.
Danish: Ikke alle pakningsstørrelser eller typer er nødvendigvis markedsført.
English: (64.2% versus 38.5%).
Danish: (64,2% mod 38,5%).
English: Percentage e of patients
Danish: Procent af patienter
English: Infections generally associated with immunosuppression were noted in dogs.
Danish: Infektioner, som generelt sættes i forbindelse med immunsuppression er iagttaget hos hunde.
English: The effects were generally more severe when administration was initiated earlier in the postnatal period.
Danish: Virkningerne var generelt mere alvorlige, når adminstration blev initieret tidligere i den postnatale periode.
English: Before starting treatment, patients should be evaluated for active and inactive (“latent”) tuberculosis, as per local recommendations.
Danish: Før behandlingsstart skal patienten evalueres for aktiv og inaktiv (”latent”) tuberkulose i henhold til lokale anbefalinger.
English: It is important that you tell your doctor if you have ever had tuberculosis or if you have been in close contact with someone who has or has had tuberculosis.
Danish: Det er vigtigt, at du fortæller din læge, hvis du nogensinde har haft tuberkulose, eller hvis du har været i tæt kontakt med nogen, der har eller har haft tuberkulose.
English: Not all packs may be marketed in your country.
Danish: Ikke alle pakningsstørrelser er nødvendigvis markedsført i dit land.
English: However the treatment should be discontinued after 6 months if there has been no reduction in spleen size or improvement in symptoms since initiation of therapy.
Danish: Behandlingen skal dog afbrydes efter 6 måneder, hvis der ikke har været nogen reduktion i miltstørrelse eller forbedring af symptomer siden påbegyndelse af behandlingen.
English: Elderly patients (≥65 years) No additional dose adjustments are recommended for elderly patients.
Danish: Ældre patienter(≥65 år) Der anbefales ingen yderligere dosisjusteringer hos ældre patienter.
English: Your doctor will tell you if you should take one or two doses and how many tablets to take for each dose.
Danish: Din læge vil fortælle dig, om du skal tage en enkelt eller to doser, og hvor mange tabletter du skal tage i hver dosis.
English: Single doses up to 200 mg have been given with acceptable acute tolerability.
Danish: Enkeltdoser på op til 200 mg er givet med acceptabel akut tolerabilitet.
English: Your doctor will always tell you exactly how many Jakavi tablets to take.
Danish: Din læge vil altid fortælle dig nøjagtigt, hvor mange Jakavi-tabletter du skal tage.
English: Dose proportionality was demonstrated in the single and multiple dose studies.
Danish: Dosisproportionaliteten vistes i enkelt- og flerdosisstudierne.
English: - if you have ever had skin cancer.
Danish: - hvis du nogensinde har haft hudkræft.
English: If PML is suspected, further dosing must be suspended until PML has been excluded.
Danish: Hvis der er mistanke om PML, skal yderligere dosering indstilles, indtil PML er udelukket.
English: It is important that you tell your doctor if you have ever had hepatitis B. - if you have any kidney problems.
Danish: Det er vigtigt, at du fortæller det til din læge, hvis du nogensinde har haft hepatitis B. - hvis du har nyreproblemer.
English: The requirements for submission of periodic safety update 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: Kravene for fremsendelse af periodiske, opdaterede sikkerhedsindberetninger for dette lægemiddel frem 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: It has not been established whether abrupt discontinuation of Jakavi contributed to these events.
Danish: Det er ikke fastslået, om pludseligt ophør med Jakavi bidrog til disse hændelser.
English: The blood becomes thicker as a result of the increased red blood cells.
Danish: Blodet bliver tykkere som følge af det øgede antal røde blodlegemer.
English: Two major and active metabolites are present in plasma representing 25% and 11% of parent AUC.
Danish: To aktive hovedmetabolitter er tilstede i plasma og udgør 25% og 11% af AUC.
English: Your doctor will regularly monitor your condition to make sure that the treatment is having the desired effect.
Danish: Din læge vil kontrollere din tilstand regelmæssigt for at sikre, at behandlingen virker, som den skal.
English: There are no data from the use of Jakavi in pregnant women.
Danish: Der er ingen data fra anvendelse af Jakavi til gravide kvinder.
English: Treatment benefit perception was measured by the Patient Global Impression of Change (PGIC) questionnaire.
Danish: Opfattelsen af behandlingsfordele blev målt ved Patient Global Impression of Change (PGIC) spørgeskema.
English: If a dose is missed, the patient should not take an additional dose, but should take the next usual prescribed dose.
Danish: Hvis en dosis glemmes, må patienten ikke tage en ekstra dosis, men skal tage den næste sædvanlige, ordinerede dosis.
English: Your doctor may need to adjust the dose or stop treatment.
Danish: Din læge er måske nødt til at justere dosis eller stoppe behandlingen.
English: This pattern was observed in patients regardless of whether they had received transfusion during therapy.
Danish: Dette mønster observeredes, uanset om patienterne havde modtaget transfusion under behandlingen.
English: Renal function was determined using both Modification of Diet in Renal Disease (MDRD) and urinary creatinine.
Danish: Nyrefunktion blev bestemt ved brug af både Modification of Diet in Renal Disease (MDRD) og urinkreatinin.
English: This may require further observation, as certain types of skin cancer (non-melanoma) have been reported.
Danish: Dette kan kræve yderligere observation, da der har været indberetninger om visse typer af hudkræft (ikke modermærke-kræft).
English: Most of the side effects of Jakavi are mild to moderate and will generally disappear after a few days to a few weeks of treatment.
Danish: De fleste af bivirkningerne ved Jakavi er milde til moderate og forsvinder generelt efter nogle få dages eller få ugers behandling.
English: The abnormal marrow can no longer produce enough normal blood cells and as a result the spleen becomes significantly enlarged.
Danish: Den unormale marv kan ikke længere producere tilstrækkeligt med normale blodlegemer, og derfor bliver milten betydeligt forstørret.
English: Your doctor may perform tests to see if you have tuberculosis or any other infections.
Danish: Din læge kan foretage nogle undersøgelser for at se, om du har tuberkulose eller andre infektioner.
English: Periodic skin examination is recommended for patients who are at increased risk for skin cancer.
Danish: Det anbefales at foretage regelmæssige undersøgelser af huden hos patienter, som har en øget risiko for hudkræft.
English: The study met its primary objective and a higher proportion of patients in the Jakavi group achieved the primary composite endpoint and each of its individual components.
Danish: Studiet opnåede det primære endepunkt, og en højere andel af patienter i Jakavi-gruppen opnåede det primære sammensatte endepunkt og hver af dets individuelle komponenter.
English: P value: < .0001 Odds ratio (ruxolitinib/BAT) and 95% CI:
Danish: P-værdi: < 0,0001 Odds ratio (ruxolitinib/BAT) og 95% CI:
English: Effects of ruxolitinib on other medicinal products
Danish: Effekt af ruxolitinib på andre lægemidler
English: These metabolites have one half to one fifth of the parent JAK-related pharmacological activity.
Danish: Disse metabolitter har mellem det halve og en femtedel af den oprindelige JAK-relaterede farmakologiske aktivitet.
English: Activating mutations in JAK2 (V617F or exon 12) are found in >95% of PV patients.
Danish: Aktiverede mutationer i JAK2 (V617F eller exon 12) er fundet hos >95% af PV-patienter.
English: Jakavi has no or negligible sedating effect.
Danish: Jakavi har ingen eller kun ringe sederende effekt.
English: After 48 weeks
Danish: Efter 48 uger
English: The half-life was prolonged from 3.7 to 6.0 hours with concurrent ketoconazole administration.
Danish: Halveringstiden forlænges fra 3,7 til 6,0 timer ved samtidig administration af ketoconazol.
English: Jakavi is to be taken orally, with or without food.
Danish: Jakavi indtages oralt sammen med eller uden mad.
English: Frequency is based on all patients exposed to ruxolitinib in clinical studies (N=4755)
Danish: Frekvens er baseret på alle patienter eksponeret for ruxolitinib i kliniske studier (N=4.755)
English: Treatment with Jakavi should not be started until active serious infections have resolved.
Danish: Behandling med Jakavi bør ikke påbegyndes, før alvorlige, aktive infektioner er afhjulpet.
English: In addition, the corresponding frequency category for each adverse drug reaction is based on the following convention: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Danish: Derudover er den tilsvarende frekvenskategori for hver bivirkning baseret på følgende konvention: meget almindelig (≥1/10); almindelig (≥1/100 til <1/10); ikke almindelig (≥1/1.000 til <1/100); sjælden (≥1/10.000 til <1/1.000); meget sjælden (<1/10.000).
English: Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
Danish: Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spanien
English: The safety and efficacy of Jakavi in children and adolescents aged up to 18 years have not been established.
Danish: Jakavis sikkerhed og virkning hos børn og unge i alderen op til 18 år er ikke klarlagt.
English: When adjusted for exposure, the adverse events rates were generally comparable with those observed during the comparative periods of the randomised studies.
Danish: Når der justeres for eksponering, var hyppigheden af bivirkningerne generelt sammenlignelige med dem, der blev observeret under de komparative perioder af de randomiserede studier.
English: The mean volume of distribution at steady state is approximately 75 litres in MF and PV patients.
Danish: Det gennemsnitlige distributionsvolumen ved steady state er ca. 75 liter hos MF- og PV-patienter.
English: Patients developing anaemia may require blood transfusions.
Danish: Hos patienter, der udvikler anæmi, kan blodtransfusioner være nødvendige.
English: If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine.
Danish: Hvis du er gravid eller ammer, har mistanke om, at du er gravid, eller planlægger at blive gravid, skal du spørge din læge eller apoteketspersonalet til råds, før du tager dette lægemiddel.
English: One patient (0.3%) discontinued treatment because of anaemia.
Danish: Én patient (0,3%) måtte ophøre med behandlingen på grund af anæmi.
English: Jakavi treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Danish: Behandling med Jakavi må kun påbegyndes af en læge med erfaring i administration af cancerhæmmende lægemidler.
English: 168 tablets (3x56)
Danish: 168 tabletter (3x56)
English: Patients with chronic HBV infection should be treated and monitored according to clinical guidelines.
Danish: Patienter med kronisk HBV-infektion skal behandles og overvåges i henhold til kliniske retningslinjer.
English: Your doctor may want to gradually reduce the amount of Jakavi taken each day, before stopping it completely.
Danish: Din læge vil måske gradvist nedsætte den mængde Jakavi, du tager hver dag, før du helt stopper med behandlingen.
English: Children and adolescents
Danish: Brug til børn og unge
English: Very common a
Danish: Meget almindelig a
English: - if you are taking other medicines (see section “Other medicines and Jakavi”).
Danish: - hvis du tager anden medicin (se punktet ”Brug af anden medicin sammen med Jakavi”).
English: It may be necessary to treat your infection before starting Jakavi.
Danish: Det kan være nødvendigt at behandle din infektion, før du starter med at tage Jakavi.
English: Figure 1 Patients achieving the primary endpoint and components of the primary endpoint at week 32
Danish: Figur 1 Patienter, som opnåede det primære endepunkt og komponenter af det primære endepunkt ved uge 32
English: Before you start treatment with Jakavi, your doctor will perform blood tests to determine the best starting dose for you.
Danish: Før du starter behandlingen med Jakavi, vil din læge tage nogle blodprøver for at finde frem til den bedste startdosis til dig.
English: - Rifabutin or rifampicin, medicines used to treat tuberculosis (TB).
Danish: - Rifabutin eller rifampicin, medicin som bruges til behandling af tuberkulose (TB).
English: The sum total of all active metabolites contributes to 18% of the overall pharmacodynamics of ruxolitinib.
Danish: Summen af alle aktive metabolitter bidrager til 18% af ruxolitinibs samlede farmakodynamik.
English: Therapeutic drug monitoring (TDM) or clinical monitoring of the affected substance is advised.
Danish: Det tilrådes at udføre terapeutisk lægemiddelmonitorering (TDM) eller klinisk monitorering af de pågældende substanser.
English: In case pregnancy should occur during treatment with Jakavi, a risk/benefit evaluation must be carried out on an individual basis with careful counselling regarding potential risks to the foetus (see section 5.3).
Danish: Skulle graviditet opstå under behandling med Jakavi, må der foretages en individuel risk/benefit-vurdering med omhyggelig rådgivning vedrørende potentielle risici for fostret (se pkt.
English: - if you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision.
Danish: - hvis du har nogen af følgende symptomer, eller hvis nogen tæt på dig bemærker, at du har nogle af disse symptomer: forvirring eller vanskelighed ved at tænke, tab af balance eller gangbesvær, klodsethed, talebesvær, nedsat styrke eller svaghed i den ene side af kroppen, sløret syn og/eller synstab.
English: During the treatment your doctor may recommend a lower or higher dose to you if the results of blood tests show that this is necessary, if you have problems with your liver or kidneys, or if you also need treatment with certain other medicines.
Danish: Under behandlingen råder din læge dig måske til at tage en lavere eller højere dosis, hvis resultaterne af blodprøverne viser, at det er nødvendigt, hvis du har problemer med lever eller nyrer, eller hvis du også har brug for behandling med visse andre former for medicin.
English: There was no clear relationship between AUC and the degree of hepatic impairment based on Child-Pugh scores.
Danish: Der var ingen tydelig sammenhæng mellem AUC og graden af nedsat leverfunktion baseret på Child-Pugh-scorer.
English: Table 1 Frequency category of adverse drug reactions reported in the phase 3 studies (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2)
Danish: Tabel 1 Bivirkningsfrekvens rapporteret i fase 3-studier (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2)
English: Myelofibrosis (MF)
Danish: Myelofibrose (MF)
English: Your doctor will measure the amount of blood cells in your body and find the best dose for you, particularly if you have liver or kidney problems.
Danish: Din læge vil måle antallet af blodlegemer i din krop og finde frem til den bedste dosering til dig, specielt hvis du har lever- eller nyreproblemer.
English: Additional analyses from the RESPONSE study to assess durability of response were conducted at week 80 only in the Jakavi arm.
Danish: Supplerende analyser fra RESPONSE-studiet for at vurdere responsvarigheden blev for Jakavi-armen kun udført ved uge 80.
English: Jakavi can help reduce the risk of serious blood or vascular complications.
Danish: Jakavi kan hjælpe med at reducere risikoen for alvorlige komplikationer i blod eller blodkar.
English: You should continue taking Jakavi for as long as your doctor tells you to.
Danish: Du skal fortsætte med at tage Jakavi, så længe din læge siger, at du skal gøre det.
English: The safety assessment was based on a total of 982 patients (with MF or PV) receiving Jakavi in phase 2 and 3 studies.
Danish: Sikkerhedsvurderingen er baseret på i alt 982 patienter (med MF eller PV), som fik Jakavi i fase 2- og 3-studier.
English: Patients should be monitored for any of these new or worsening symptoms or signs, and if such symptoms/signs occur, referral to a neurologist and appropriate diagnostic measures for PML should be considered.
Danish: Patienter bør monitoreres for alle nye eller forværrede symptomer eller tegn på PML, og hvis sådanne symptomer/tegn opstår, bør det overvejes at konsultere en neurolog for at få foretaget passende diagnostiske undersøgelser for PML.
English: Do not take Jakavi - if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6).
Danish: Tag ikke Jakavi - hvis du er allergisk over for ruxolitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6).
English: Your doctor may need to prescribe a different dose of Jakavi.
Danish: Din læge kan måske være nødsaget til at udskrive en anden dosis af Jakavi.
English: Individual components of primary response at week 32
Danish: Individuelle komponenter af primært respons ved uge
English: In both studies, patients had palpable splenomegaly at least 5 cm below the costal margin and risk category of intermediate-2 or high risk based on the International Working Group (IWG) Consensus Criteria.
Danish: I begge studier havde patienterne palpabel splenomegali mindst 5 cm under costalranden og i risikokategorierne intermediær-2 eller højrisiko, baseret på International Working Group (IWG) Consensus Criteria.
English: There was one report of CTCAE grade 3 post-herpetic neuralgia amongst the PV patients.
Danish: Der var en rapport om CTCAE grad 3 postherpetisk neuralgi blandt PV-patienter.
English: 110 patients were randomised to the ruxolitinib arm and 112 patients to the BAT arm.
Danish: 110 patienter blev randomiseret til ruxolitinib-armen og 112 patienter til BAT-armen.
English: The cumulative frequency of adverse events in these studies increased proportionally to the increase in the follow-up time.
Danish: Den kumulative bivirkningsfrekvens i disse studier steg proportionalt med længden af opfølgningsperioden.
English: Polycythaemia vera (PV)
Danish: Polycythæmia vera (PV)
English: COMFORT-II was an open-label, randomised study in 219 patients.
Danish: COMFORT-II var en åben, randomiseret undersøgelse med 219 patienter.
English: Unchanged parent substance accounted for less than 1% of the excreted total radioactivity.
Danish: Uomdannet lægemiddel udgjorde mindre end 1% of den udskilte, samlede radioaktivitet.