natgillin/translations-raw huggingface dataset:
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.
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.
Tag ikke Jakavi - hvis du er allergisk over for ruxolitinib eller et af de øvrige indholdsstoffer (angivet i punkt 6).
Do not take Jakavi - if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6).
Din læge kan måske være nødsaget til at udskrive en anden dosis af Jakavi.
Your doctor may need to prescribe a different dose of Jakavi.
Individuelle komponenter af primært respons ved uge
Individual components of primary response at week 32
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.
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.
Der var en rapport om CTCAE grad 3 postherpetisk neuralgi blandt PV-patienter.
There was one report of CTCAE grade 3 post-herpetic neuralgia amongst the PV patients.
110 patienter blev randomiseret til ruxolitinib-armen og 112 patienter til BAT-armen.
110 patients were randomised to the ruxolitinib arm and 112 patients to the BAT arm.
Den kumulative bivirkningsfrekvens i disse studier steg proportionalt med længden af opfølgningsperioden.
The cumulative frequency of adverse events in these studies increased proportionally to the increase in the follow-up time.
Polycythæmia vera (PV)
Polycythaemia vera (PV)
COMFORT-II var en åben, randomiseret undersøgelse med 219 patienter.
COMFORT-II was an open-label, randomised study in 219 patients.
Uomdannet lægemiddel udgjorde mindre end 1% of den udskilte, samlede radioaktivitet.
Unchanged parent substance accounted for less than 1% of the excreted total radioactivity.
Tal med din læge om, hvordan du kan træffe passende forholdsregler for at undgå at blive gravid, mens du tager Jakavi.
Talk to your doctor about how to take appropriate measures to avoid becoming pregnant during your treatment with Jakavi.
Hæmatopoetiske vækstfaktorer
Haematopoietic growth factors
Det er især vigtigt, at du fortæller, hvis du har taget nogle af følgende præparater, som indeholder et eller flere af følgende aktive stoffer, da din læge kan være nødsaget til at justere din dosis af Jakavi.
It is particularly important that you mention any of the following medicines containing any of the following active substances, as your doctor may need to adjust the Jakavi dose for you.
Den ordinerende læge bør være opmærksom på risikoen for falsk negative resultater af kutane tuberkulintest, specielt hos patienter som er alvorligt syge eller immunkompromitterede.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
Patienterne skal monitoreres omhyggeligt med hensyn til sikkerhed og effekt under behandling med ruxolitinib.
Patients should be carefully monitored with regard to safety and efficacy during ruxolitinib treatment.
Lægemidler, der hæmmer disse enzymer kan derfor give anledning til stigning i eksponering af ruxolitinib.
Thus, medicinal products inhibiting these enzymes can give rise to increased ruxolitinib exposure.
Mens du tager Jakavi, må du aldrig begynde at tage ny medicin uden først at spørge den læge til råds, som har ordineret Jakavi.
While you are taking Jakavi you should never start a new medicine without checking first with the doctor who prescribed Jakavi.
Neutropeni b
Neutropenia b
Medmindre pludseligt ophør er nødvendigt, kan gradvis nedtrapning af Jakavi-dosis overvejes, omend det ikke er bevist, at dette er nyttigt.
Unless abrupt discontinuation is required, gradual tapering of the dose of Jakavi may be considered, although the utility of the tapering is unproven.
Der er ingen kendt modgift mod overdosering af Jakavi.
There is no known antidote for overdoses with Jakavi.
Det reducerer den metaboliske eksponering kun at dosere på dialysedage, men også den farmakodynamiske effekt, specielt på dagene mellem dialyse.
Dosing only on dialysis days reduces the metabolite exposure, but also the pharmacodynamic effect, especially on the days between dialysis.
Hvis du har glemt at tage Jakavi, skal du blot tage næste dosis til sædvanlig tid.
If you forgot to take Jakavi simply take your next dose at the scheduled time.
Dette kan resultere i øget systemisk eksponering for substrater til disse transportere, såsom dabigatranetexilat, ciclosporin, rosuvastatin og potentielt digoxin.
This may result in increased sytemic exposure of substrates of these transporters, such as dabigatran etexilate, ciclosporin, rosuvastatin and potentially digoxin.
Hvis du oplever visse bivirkninger (fx blodsygdomme), er din læge måske nødt til at ændre den mængde Jakavi, du skal tage, eller bede dig om at holde op med at tage Jakavi i et stykke tid.
If you experience certain side effects (e.g. blood disorders), your doctor might need to change the amount of Jakavi you have to take or tell you to stop taking Jakavi for a while.
Juvenile rotter er mere følsomme end voksne rotter overfor ruxolitinibs toksicitet.
Juvenile rats are more sensitive than adult rats to ruxolitinib toxicity.
Ruxolitinib-doseringen kan titreres for at reducere risikoen for cytopeni.
Ruxolitinib dose can be titrated to reduce the risk of cytopenia.
Din læge vil omhyggeligt undersøge, om du har nogle tegn eller symptomer på infektioner inden og under behandlingen med Jakavi.
Your doctor will carefully check if you have any signs or symptoms of infection before starting and during your treatment with Jakavi.
Progressiv multifokal leukoencefalopati (PML) er blevet rapporteret ved Jakavi-behandling.
Progressive multifocal leukoencephalopathy (PML) has been reported with Jakavi treatment.
Stigning i systolisk blodtryk
Increased systolic blood pressure
Dette kan dog relateres til den høje ruxolitinib-dosering, der resulterer i farmakodynamiske effekter i nærheden af Emax.
However, this could be related to the high ruxolitinib dose resulting in pharmacodynamic effects near Emax.
Advarsler og forsigtighedsregler Kontakt lægen eller apoteketspersonalet, før du tager Jakavi - hvis du har infektioner.
Warnings and precautions Talk to your doctor or pharmacist before taking Jakavi - if you have any infections.
Samlet set var ruxolitinibs farmakodynamiske aktivitet lignende, hvilket tyder på, at CYP3A4induktionen medførte en minimal farmakodynamisk effekt.
Overall, the ruxolitinib pharmacodynamic activity was similar, suggesting the CYP3A4 induction resulted in minimal effect on the pharmacodynamics.
Ruxolitinib elimineres hovedsagelig via metabolisering.
Ruxolitinib is mainly eliminated through metabolism.
Baseret på en human massebalanceundersøgelse er den orale absorption af ruxolitinib som ruxolitinib eller metabolitter dannet under første passage 95% eller højere.
Based on a human mass balance study, oral absorption of ruxolitinib, as ruxolitinib or metabolites formed under first-pass, is 95% or greater.
MINDSTEKRAV TIL MÆRKNING PÅ BLISTER ELLER STRIP
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS
Den gennemsnitlige eliminationshalveringstid for ruxolitinib er ca. 3 timer.
The mean elimination half-life of ruxolitinib is approximately 3 hours.
Der har været tilfælde, hvor patienter, som ophørte med Jakavi, oplevede alvorligere hændelser, især i forbindelse med samtidig akut sygdom.
There have been cases of patients discontinuing Jakavi who sustained more severe events, particularly in the presence of acute intercurrent illness.
Antal (%) personer med miltvolumen reduceret med
Number (%) of subjects with spleen volume reduced by
Følgende kan øge risikoen for bivirkninger med Jakavi: - Nogle former for medicin til behandling af infektioner.
The following may increase the risk of side effects with Jakavi: - Some medicines used to treat infections.
Lægerne skal oplyse patienterne om de tidlige tegn og symptomer på herpes zoster og tilråde, at der søges behandling så tidligt som muligt.
Physicians should educate patients about early signs and symptoms of herpes zoster, advising that treatment should be sought as early as possible.
Ved klinisk relevante koncentrationer af ruxolitinib er bindingen til plasmaproteiner in vitro ca. 97%, for det meste til albumin.
At clinically relevant concentrations of ruxolitinib, binding to plasma proteins in vitro is approximately 97%, mostly to albumin.
Ruxolitinib nedsatte fostervægt og øgede postimplantationstab i dyrestudier.
Ruxolitinib decreased foetal weight and increased post-implantation loss in animal studies.
Det er ukendt, om ruxolitinib og/eller metabolitter udskilles i human mælk.
It is unknown whether ruxolitinib and/or its metabolites are excreted in human milk.
En risiko for børn, der ammes, kan ikke udelukkes.
A risk to the breast-fed child cannot be excluded.
Behandling med Jakavi har været associeret med stigninger i lipidparametre herunder totalkolesterol, high-density lipoprotein (HDL) kolesterol, low-density lipoprotein (LDL) kolesterol og triglycerider.
Treatment with Jakavi has been associated with increases in lipid parameters including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
Common Terminology Criteria for Adverse Events (CTCAE) version 3.0; grad 1 = let, grad 2 = moderat, grad 3 = svær, grad 4 = livstruende d
Common Terminology Criteria for Adverse Events (CTCAE) version 3.0; grade 1 = mild, grade 2 = moderate, grade 3 = severe, grade 4 = life-threatening d
Eksponeringen for ruxolitinibs aktive metabolitter var uforandret.
The exposure of ruxolitinib active metabolites was unchanged.
Det er ikke nødvendigt med nogen specifik dosisjustering hos patienter med mild eller moderat nedsat nyrefunktion.
Renal impairment No specific dose adjustment is needed in patients with mild or moderate renal impairment.
I en præ- og postnatal undersøgelse observeredes en let forlænget gestationsperiode, en reduktion af antallet af implantationssteder og en reduktion af antallet af fødte hvalpe.
In a pre- and post-natal development study, a slightly prolonged gestation period, reduced number of implantation sites, and reduced number of pups delivered were observed.
Du skal have taget flere blodprøver under behandlingen, for at din læge kan holde øje med, hvor mange blodlegemer (hvide blodlegemer, røde blodlegemer og blodplader) der er i din krop, samt vurdere, hvordan du reagerer på behandlingen, og om Jakavi har en uønsket virkning på disse blodlegemer.
You will need to have further blood tests during treatment so that your doctor can monitor the amount of blood cells (white cells, red cells and platelets) in your body and assess how you are responding to the treatment and whether Jakavi is having an unwanted effect on these cells.
Andre bivirkninger ved Jakavi
Other side effects with Jakavi
Alvorlige bakterielle, mycobakterielle, fungale, virale og andre opportunistiske infektioner er forekommet hos patienter behandlet med Jakavi.
Serious bacterial, mycobacterial, fungal, viral and other opportunistic infections have occurred in patients treated with Jakavi.
Læger bør være særligt opmærksomme på PML-symptomer, som patienter ikke nødvendigvis selv bemærker (fx kognitive, neurologiske eller psykiatriske symptomer eller tegn).
Physicians should be particularly alert to symptoms suggestive of PML that patients may not notice (e.g., cognitive, neurological or psychiatric symptoms or signs).
Tuberkulose er blevet rapporteret hos patienter behandlet med Jakavi.
Tuberculosis has been reported in patients receiving Jakavi.
Hvis du har spørgsmål til, hvordan Jakavi virker, eller hvorfor det er ordineret til dig, skal du spørge din læge.
If you have any questions about how Jakavi works or why this medicine has been prescribed for you, ask your doctor.
COMFORT-I var en dobbeltblind, randomiseret, placebo-kontrolleret undersøgelse med 309 patienter, som var refraktære over for eller ikke kandidater til tilgængelig terapi.
COMFORT-I was a double-blind, randomised, placebo-controlled study in 309 patients who were refractory to or were not candidates for available therapy.
Sikkerheden af Jakavi er vurderet hos 184 patienter med PV i to åbne, randomiserede, kontrollerede studier, fase 3studiet RESPONSE og fase 3bstudiet RESPONSE 2.
The safety of Jakavi was assessed in 184 patients with PV in two open-label, randomised, controlled studies, the phase 3 RESPONSE study and the phase 3b RESPONSE 2 study.
Hvis noget af det ovenstående gælder for dig, skal du fortælle det til lægen, som vil bestemme om du skal begynde at tage Jakavi.
If either of the above applies to you, tell your doctor who will then decide whether you should start treatment with Jakavi.
Det er observeret, at patienter med lav trombocyttælling (<200.000/mm 3) ved behandlingsstart med større sandsynlighed udvikler trombocytopeni under behandlingen.
It has been observed that patients with low platelet counts (<200,000/mm 3) at the start of therapy are more likely to develop thrombocytopenia during treatment.
Symptombyrden blev vurderet ved brug af en elektronisk patientdagbog med MPN-SAF samlet symptomscore (TSS), som bestod af 14 spørgsmål.
Symptom burden was assessed using the MPN-SAF total symptom score (TSS) electronic patient diary, which consisted of 14 questions.
Hos diegivende rotter udskiltes ruxolitinib og/eller dets metabolitter i mælken i en koncentration, som var 13 gange højere end i moderrottens plasma.
In lactating rats, ruxolitinib and/or its metabolites were excreted into the milk with a concentration that was 13-fold higher than the maternal plasma concentration.
Polycythæmia vera
Polycythaemia vera
Patienter, som oplever svimmelhed efter indtagelse af Jakavi skal dog afholde sig fra at føre motorkøretøj eller betjene maskiner.
However, patients who experience dizziness after the intake of Jakavi should refrain from driving or using machines.
Antal (%) forsøgspersoner med en reduktion i miltvolumen på ≥35% 95% konfidensintervaller p-værdi
Number (%) of subjects with spleen volume reduced by ≥35% 95% confidence intervals p-value
Det er muligt at en stigning i ruxolitinib-dosis er nødvendig hos den pågældende patient, når behandling påbegyndes med en stærk enzym-inducer.
It is possible that in the individual patient, an increase of the ruxolitinib dose is needed when initiating treatment with a strong enzyme inducer.
Behandlingen kan fortsættes, så længe fordele opvejer ulemper.
Treatment may be continued as long as the benefit-risk remains positive.
Der var ikke tegn på teratogen effekt hos rotter og kaniner.
There was no evidence of a teratogenic effect in rats and rabbits.
Doseringen af Jakavi afhænger af patientens blodcelletal.
The dose of Jakavi depends on the patient's blood cell count.
Du må ikke tage Jakavi under graviditet.
Do not take Jakavi during pregnancy.
Mediantiden til trombocyttallet igen var over 50.000/mm var 14 dage.
The median time to recovery of platelet counts above 50,000/mm was 14 days.
I kliniske studier med MF vendte den totale MF-symptomscore gradvis tilbage til baseline-værdien inden for 7 dage efter seponering (se pkt.
In clinical studies in MF the total symptom score for MF symptoms gradually returned to baseline value within 7 days after dose discontinuation (see section 4.4).
Dette omfatter receptpligtig medicin, håndkøbsmedicin og naturlægemidler eller alternativ medicin.
This includes prescription medicines, non-prescription medicines and herbal or alternative medicines.
Som en forsigtighedsforanstaltning er brug af Jakavi under graviditet kontraindiceret (se pkt.
As a precautionary measure, the use of Jakavi during pregnancy is contraindicated (see section 4.3).
Uønsket blodtryksfald kombineret med stigende hjertefrekvens er iagttaget i en telemetrisk undersøgelse med hunde, og et uønsket fald i minutvolumen er iagttaget i en respirationsundersøgelse med rotter.
Adverse decreases in blood pressure along with increases in heart rate were noted in a dog telemetry study, and an adverse decrease in minute volume was noted in a respiratory study in rats.
I kliniske undersøgelser absorberes ruxolitinib hurtigt efter oral administration med maksimal plasmakoncentration (Cmax) ca. 1 time efter indtagelse af dosis.
In clinical studies, ruxolitinib is rapidly absorbed after oral administration with maximal plasma concentration (Cmax) achieved approximately 1 hour post-dose.
Ruxolitinib er evalueret i studier af sikkerhedsfarmakologi, gentagen dosis-toksicitet, genotoksicitet, reproduktionstoksicitet og i et carcinogenicitetsstudie.
Ruxolitinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicity studies and in a carcinogenicity study.
Bivirkningerne under kliniske undersøgelser (Tabel 1) er ordnet efter MedDRA-systemorganklasser.
Adverse drug reactions from clinical studies (Table 1) are listed by MedDRA system organ class.
Derfor forventes der ikke en stigning i eksponeringen af CYP3A4-substrater ved kombination med ruxolitinib.
Therefore, no increase in exposure of CYP3A4 substrates is anticipated when combining them with ruxolitinib.
Bedste tilgængelige behandling (N=72)
Best available therapy (N=72)
Blod og lymfesystem b,d
Blood and lymphatic system disorders b,d
Frekvens for MF patienter Frekvens for PV patienter
Frequency category for PV patients
MF og PV er myeloproliferative neoplasier, som man ved er forbundet med dysreguleret JAK1- og JAK2-signalering.
MF and PV are myeloproliferative neoplasms known to be associated with dysregulated JAK1 and JAK2 signalling.
Dog skal patienterne overvåges nøje for cytopeni, når der påbegyndes behandling med en moderat CYP3A4-hæmmer.
However, patients should be closely monitored for cytopenias when initiating therapy with a moderate CYP3A4 inhibitor.
Fravær af indikation for flebotomi blev defineret som bekræftet HCT på >45%, dvs. mindst 3 procentpoint højere end HCT ved baseline eller en bekræftet HCT på >48% alt efter, hvilken der var lavest.
Phlebotomy eligibility was defined as a confirmed HCT of >45%, i.e. at least 3 percentage points higher than the HCT obtained at baseline or a confirmed HCT of >48%, depending on which was lower.
Clearance var 12,7 l/t hos PV-patienter med en inter-individuel variation på 42%, og der var tilsyneladende ingen forbindelse mellem oral clearance og køn, patientalder eller race baseret på en populationsfarmakokinetisk evaluering hos PVpatienter.
Clearance was 12.7 l/h in PV patients, with a 42% inter-subject variability and no relationship was apparent between oral clearance and gender, patient age or race, based on a population pharmacokinetic evaluation in PV patients.
Substanser transporteret af P-glykoprotein eller andre transportere Ruxolitinib kan hæmme P-glykoprotein og brystcancer-resistent protein (BCRP) i tarmen.
Substances transported by P-glycoprotein or other transporters Ruxolitinib may inhibit P-glycoprotein and breast cancer resistance protein (BCRP) in the intestine.
Ved PV skal behandlingen også afbrydes, hvis hæmoglobin er under 8 g/dl.
In PV, treatment should also be interrupted when haemoglobin is below 8 g/dl.
- Bivirkninger er set under behandling eller op til 28 dage efter endt behandling.
- ADRs reported are on treatment or up to 28 days post treatment end date.
Den mediane eksponeringsvarighed for Jakavi i den randomiserede studieperiode var 7,85 måneder (0,03 til 7,85 måneder).
The median duration of exposure to Jakavi during the randomised study periods was 7.85 months (range 0.03 to 7.85 months).
Blødning (enhver blødning inklusive intrakraniel og gastrointestinal blødning, blå mærker og andre blødninger)
Bleeding (any bleeding including intracranial, and gastrointestinal bleeding, bruising and other bleeding)
Demografi og sygdomskarakteristika ved baseline var sammenlignelige mellem de to behandlingsarme.
Baseline demographics and disease characteristics were comparable between the two treatments arms.
Disse enzymer formidler signaleringen af flere cytokiner og vækstfaktorer, som er vigtige for hæmatopoese og immunfunktion.
These mediate the signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function.
Den forventede orale clearance var 17,7 l/time hos kvinder og 22,1 l/time hos mænd med en inter-individuel variation blandt MF-patienter på 39%.
The predicted oral clearance was 17.7 l/h in women and 22.1 l/h in men, with 39% inter-subject variability in MF patients.
90429 Nürnberg
D-90429 Nuremberg
Interaktioner, der medfører dosisreduktion af ruxolitinib
Interactions resulting in dose reduction of ruxolitinib
- Nefazodon, medicin som bruges til behandling af depression.
- Nefazodone, a medicine to treat depression.
BAT blev bestemt af investigatoren fra patient til patient og inkluderede hydroxycarbamid (59,5%), interferon/pegyleret interferon (11,7%), anagrelid (7,2%), pipobroman (1,8%) og observation (15,3%).
BAT was selected by the investigator on a patient-bypatient basis and included hydroxyurea (59.5%), interferon/pegylated interferon (11.7%), anagrelide (7.2%), pipobroman (1.8%) and observation (15.3%).
Derfor forventes det ikke, at den kontraceptive effekt af denne kombination vil blive kompromitteret ved administration sammen med ruxolitinib.
Therefore, it is not anticipated that the contraceptive efficacy of this combination will be compromised by co-administration of ruxolitinib.
Frekvens er baseret på bivirkningsdata.
Frequency is based on adverse event data.
Ruxolitinib er et stof tilhørende klasse 1 ifølge det biofarmaceutiske klassifikationssystem med høj permeabilitet, høj solubilitet og hurtig opløsning.
Ruxolitinib is a Biopharmaceutical Classification System (BCS) class 1 compound, with high permeability, high solubility and rapid dissolution characteristics.
Det er uvist om den øgede metaboliteksponering har betydning for den kliniske sikkerhed.
It is unknown whether the increased metabolite exposure is of safety concern.
Trombocyttransfusioner kan dog være klinisk indiceret.
However, platelet transfusions may be required as clinically indicated.
Frakturer og tidlig aflivning af rotter blev observeret ved doser på ≥30 mg/kg/dag, når behandlingen startede på dag 7 postnatalt.
Fractures and early termination of rats were observed at doses ≥30 mg/kg/day when treatment was started on postnatal day 7.
Ved PV skal dosisreduktion også overvejes, hvis hæmaglobin falder til under 12 g/dl, og dosisreduktion anbefales, hvis det falder til under 10 g/dl.
In PV, dose reductions should also be considered if haemoglobin decreases below 12 g/dl and is recommended if it decreases below 10 g/dl.
Bortset fra knogleudvikling, var virkningerne af ruxolitinib hos juvenile rotter sammenlignelig med dem hos voksne rotter.
Other than bone development, the effects of ruxolitinib in juvenile rats were similar to those in adult rats.
Doserne kan titreres under hensyntagen til sikkerhed og effekt.
Doses may be titrated based on safety and efficacy.
Det kan også overvejes at justere dosis eller afbryde behandlingen hos patienter, der udvikler anæmi.
Dose modifications or interruption for patients developing anaemia may also be considered.
Ruxolitinib var ikke karcinogent i den transgene Tg.rasH2-musemodel.
Ruxolitinib was not carcinogenic in the Tg.rasH2 transgenic mouse model.
Enzym-induktorer
Enzyme inducers
Anæmi, trombocytopeni og neutropeni er dosisrelaterede virkninger.
Anaemia, thrombocytopenia and neutropenia are dose-related effects.