FrancophonIA/ELRC3.0 huggingface dataset:
English: What Jakavi is and what it is used for What you need to know before you take Jakavi How to take Jakavi
Slovenian: Kaj je zdravilo Jakavi in za kaj ga uporabljamo Kaj morate vedeti, preden boste vzeli zdravilo Jakavi Kako jemati zdravilo Jakavi Možni neželeni učinki
English: Ruxolitinib is mainly metabolised by CYP3A4 (>50%), with additional contribution from CYP2C9.
Slovenian: Ruksolitinib se presnavlja zlasti s CYP3A4 (>50 %), del pa prispeva tudi CYP2C9.
English: Treatment with Jakavi can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia.
Slovenian: Zdravljenje z zdravilom Jakavi lahko povzroči hematološke neželene učinke, med drugim trombocitopenijo, anemijo in nevtropenijo.
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).
Slovenian: Če ženska zanosi v času zdravljenja z zdravilom Jakavi, je treba pri vsaki posamezni bolnici oceniti razmerje med koristmi in tveganji in jo natančno poučiti o možnih tveganjih za plod (glejte poglavje 5.3).
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%).
Slovenian: Pri bolnikih, ki imajo na začetku zdravljenja koncentracijo hemoglobina manj kot 10,0 g/dl, je tveganje, da se jim bo med zdravljenjem koncentracija hemoglobina znižala pod 8,0 g/dl, večje kot pri bolnikih z višjo izhodiščno koncentracijo hemoglobina (79,3 % v primerjavi s 30,1 %).
English: Tuberculosis has been reported in patients receiving Jakavi.
Slovenian: Pri bolnikih, ki so prejemali zdravilo Jakavi, so poročali o tuberkulozi.
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%.
Slovenian: V populaciji bolnikov s pravo policitemijo so o dogodkih stopnje 3 in 4 po CTCAE poročali pri 2,7 % bolnikov, medtem ko je bila pogostnost teh dogodkov pri bolnikih z mielofibrozo 42,56 %.
English: Multipack: 168 (3 packs of 56) tablets.
Slovenian: Skupno pakiranje: 168 (3 pakiranja po 56) tablet.
English: Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5-200 mg.
Slovenian: Povprečna najvišja koncentracija (Cmax) ruksolitiniba in skupna izpostavljenost ruksolitinibu (AUC) sta naraščali sorazmerno z višanjem enkratnih odmerkov od 5 do 200 mg.
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.
Slovenian: Zdravilo Jakavi lahko pri bolnikih s pravo policitemijo olajša simptome, zmanjša velikost vranice in količino eritrocitov, saj selektivno zavira encime z imenom Janus kinaze (JAK1 in JAK2) in s tem lahko zmanjša tveganje za resne krvne in žilne zaplete.
English: Substances transported by P-glycoprotein or other transporters Ruxolitinib may inhibit P-glycoprotein and breast cancer resistance protein (BCRP) in the intestine.
Slovenian: Učinkovine, ki jih prenaša P-glikoprotein ali drugi prenašalci Ruksolitinib lahko zavira P-glikoprotein in protein rezistence pri raku dojke (BCRP - Breast Cancer Resistance Protein) v črevesju.
English: Bruising events were more frequently reported in patients taking ruxolitinib compared with the reference treatments (21.3% versus 11.6%).
Slovenian: O podplutbah so pogosteje poročali pri bolnikih, ki so prejemali ruksolitinib, v primerjavi s tistimi, ki so prejemali primerjalno zdravilo (21,3 % v primerjavi z 11,6 %).
English: Myelofibrosis is a disorder of the bone marrow, in which the marrow is replaced by scar tissue.
Slovenian: Mielofibroza je bolezen kostnega mozga, pri kateri kostni mozeg začne nadomeščati brazgotinsko tkivo.
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
Slovenian: Skupno število bolnikov je bilo 301, od tega jih je 111 (36,9 %) imelo ob izhodišču število trombocitov med 100.000/mm in 200.000/mm 190 bolnikov (63,1 %) pa je imelo ob izhodišču število trombocitov >200.000/mm
English: Another study in healthy subjects indicated that ruxolitinib does not affect the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel.
Slovenian: Druga študija na zdravih osebah je pokazala, da ruksolitinib ne vpliva na farmakokinetiko peroralnega kontraceptiva, ki vsebuje etinilestradiol in levonorgestrel.
English: An extended follow-up of patients treated with ruxolitinib showed no trends towards an increase in the rate of sepsis over time.
Slovenian: Podaljšano spremljanje bolnikov, ki so se zdravili z ruksolitinibom, ni pokazalo tendence k povečanju pogostnosti sepse s časom.
English: A dose reduction of approximately 50% is recommended for patients with hepatic impairment (see section 4.2).
Slovenian: Pri bolnikih z okvaro jeter je priporočeno približno 50 % zmanjšanje odmerka (glejte poglavje 4.2).
English: Do not take Jakavi during pregnancy.
Slovenian: Med nosečnostjo ne jemljite zdravila Jakavi.
English: Talk to your doctor about how to take appropriate measures to avoid becoming pregnant during your treatment with Jakavi.
Slovenian: Z zdravnikom se pogovorite o ustreznih ukrepih za preprečevanje zanositve v času zdravljenja z zdravilom Jakavi.
English: Jakavi is used to treat adult patients with an enlarged spleen or with symptoms related to myelofibrosis, a rare form of blood cancer.
Slovenian: Zdravilo Jakavi uporabljamo za zdravljenje odraslih bolnikov s povečano vranico ali simptomi mielofibroze, ki je redka oblika krvnega raka.
English: No data is available for dosing patients who are undergoing peritoneal dialysis or continuous venovenous haemofiltration (see section 5.2).
Slovenian: O odmerjanju pri bolnikih, ki se zdravijo s peritonealno dializo ali s kontinuirano venovensko hemofiltracijo, ni na voljo nobenih podatkov (glejte poglavje 5.2).
English: A whole body autoradiography study in rats has shown that ruxolitinib does not penetrate the blood-brain barrier.
Slovenian: Rezultati študije z avtoradiografijo celega telesa na podganah so pokazali, da ruksolitinib ne prehaja krvnomožganske pregrade.
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).
Slovenian: Zmanjšano rast kosti so opažali pri odmerjanju ≥5 mg/kg/dan, če so z odmerjanjem začeli 7. dan po rojstvu (kar je primerljivo z obdobjem novorojenčka pri človeku), in pri odmerjanju ≥15 mg/kg/dan, če so z odmerjanjem začeli 14. ali 21. dan po rojstvu (kar je primerljivo z obdobjem malčka v starosti od 1 do 3 let pri človeku).
English: 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.
Slovenian: Pri bolnikih z mielofibrozo je predviden očistek po peroralnem vnosu pri ženskah znašal 17,7 l/h, pri moških pa 22,1 l/h, pri čemer je znašala interindividualna variabilnost 39 %.
English: At clinically relevant concentrations of ruxolitinib, binding to plasma proteins in vitro is approximately 97%, mostly to albumin.
Slovenian: In vitro se ruksolitinib pri koncentracijah, ki so klinično pomembne, v približno 97 % veže na beljakovine v plazmi, večinoma na albumine.
English: Thrombocytopenia is generally reversible and is usually managed by reducing the dose or temporarily withholding Jakavi (see sections 4.2 and 4.8).
Slovenian: Trombocitopenija je večinoma reverzibilna in jo je običajno mogoče odpraviti z znižanjem odmerka ali z začasno prekinitvijo jemanja zdravila Jakavi (glejte poglavji 4.2 in 4.8).
English: 56 tablets.
Slovenian: 56 tablet.
English: Dual CYP2C9 and CYP3A4 inhibitors
Slovenian: Dvojni zaviralci CYP2C9 in CYP3A4
English: In phase 3 clinical studies in MF, neither CTCAE grade 3 or 4 hypercholesterolaemia, raised aspartate aminotransferase nor CTCAE grade 4 raised alanine aminotransferase were observed.
Slovenian: V kliničnih študijah faze 3 pri bolnikih z mielofibrozo niso opažali niti hiperholesterolemije stopnje 3 ali 4 po CTCAE, zvišane vrednosti aspartat aminotransferaze, niti zvišane vrednosti alanin aminotransferaze stopnje 4 po CTCAE.
English: - The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate.
Slovenian: - Druge sestavine zdravila so: mikrokristalna celuloza, magnezijev stearat, brezvodni koloidni silicijev dioksid, natrijev karboksimetilškrob, povidon, hidroksipropilceluloza, laktoza monohidrat.
English: It may be necessary to treat your infection before starting Jakavi.
Slovenian: Okužbo bo verjetno treba ozdraviti pred začetkom zdravljenja z zdravilom Jakavi.
English: Following a single ruxolitinib dose of 25 mg, the exposure of ruxolitinib was similar in subjects with various degrees of renal impairment and in those with normal renal function.
Slovenian: Po odmerjanju enkratnega odmerka 25 mg je bila izpostavljenost ruksolitinibu podobna pri bolnikih z različnimi stopnjami okvare ledvic in pri osebah z normalno ledvično funkcijo.
English: Ruxolitinib has been evaluated in safety pharmacology, repeated dose toxicity, genotoxicity and reproductive toxicity studies and in a carcinogenicity study.
Slovenian: Ruksolitinib so ocenjevali v študijah farmakološke varnosti, toksičnosti pri ponavljajočih se odmerkih, genotoksičnosti in škodljivega vpliva na sposobnost razmnoževanja ter v študiji kancerogenega potenciala.
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.
Slovenian: Za bolnike, pri katerih je prišlo do določenega kliničnega izboljšanja, je priporočljiva prekinitev zdravljenja z ruksolitinibom, če pri njih dolžina vranice ostane povečana za 40 % od izhodiščne vrednosti (kar približno ustreza 25 % povečanju volumna vranice), pri simptomih bolezni pa ni več opaznega izboljšanja.
English: Tablets
Slovenian: tableta
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.
Slovenian: Pri bolnikih, pri katerih odkrijejo okvaro jeter v času zdravljenja z ruksolitinibom, je treba spremljati celotno krvno sliko, vključno z diferencialno belo krvno sliko, najmanj na en do dva tedna v prvih 6 tednih po začetku zdravljenja z ruksolitinibom, kasneje, ko se jetrna funkcija in število krvnih celic stabilizirata, pa glede na klinične indikacije.
English: 14 tablets
Slovenian: 14 tablet
English: Avoid the concomitant use of ruxolitinib with fluconazole doses greater than 200 mg daily.
Slovenian: Sočasni uporabi ruksolitiniba in odmerkov flukonazola, ki presegajo 200 mg na dan, se je treba izogibati.
English: If you have questions about how long to take Jakavi, talk to your doctor or pharmacist.
Slovenian: Če vas zanima, kako dolgo je treba jemati zdravilo Jakavi, se obrnite na zdravnika ali farmacevta.
English: MF patients did not become refractory to the pharmacodynamic effects of ruxolitinib treatment over time.
Slovenian: Bolniki z mielofibrozo sčasoma niso postali neodzivni na farmakodinamične učinke ruksolitiniba.
English: When you stop taking Jakavi, the myelofibrosis symptoms may come back.
Slovenian: Ko prenehate jemati zdravilo Jakavi, se lahko simptomi mielofibroze ponovijo.
English: Based on studies in healthy subjects, no relevant differences in ruxolitinib pharmacokinetics were observed with regard to gender and race.
Slovenian: Po podatkih študij pri zdravih osebah niso opažali pomembnih razlik v farmakokinetičnih lastnostih ruksolitiniba glede na spol ali raso.
English: At clinically relevant concentrations, ruxolitinib does not inhibit CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 or CYP3A4 and is not a potent inducer of CYP1A2, CYP2B6 or CYP3A4 based on in vitro studies.
Slovenian: Po podatkih študij in vitro ruksolitinib v klinično pomembnih koncentracijah ne zavira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ali CYP3A4 in ni močan induktor CYP1A2, CYP2B6 ali CYP3A4.
English: Neutropenia (absolute neutrophil count <500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
Slovenian: Nevtropenija (absolutno število nevtrofilcev <500) je bila večinoma reverzibilna in jo je bilo mogoče odpraviti z začasno prekinitvijo jemanja zdravila Jakavi (glejte poglavji 4.2 in 4.8).
English: c grade 3 (> 5x - 20 x ULN)
Slovenian: (> 5x - 20 x ZMN)
English: It is possible that in the individual patient, an increase of the ruxolitinib dose is needed when initiating treatment with a strong enzyme inducer.
Slovenian: Povsem možno je, da bi posamezni bolniki ob uvedbi močnega induktorja encimov potrebovali višji odmerek ruksolitiniba.
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.
Slovenian: Vrednosti s konstitucijskimi simptomi povezanih označevalcev vnetja, kot so TNFα, IL-6 in CRP, ki so bile pri osebah z mielofibrozo ob izhodišču zvišane, so se po zdravljenju z ruksolitinibom znižale.
English: Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets
Slovenian: Tablete Jakavi so na voljo v pretisnih omotih v pakiranju, ki vsebuje 14 ali 56 tablet oziroma v skupnem pakiranju, ki vsebuje 168 (3 pakiranja po 56) tablet.
English: 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.
Slovenian: Primernost za flebotomijo je bila opredeljena kot potrjena vrednost hematokrita >45 %, torej najmanj za 3 odstotne točke višjo vrednost hematokrita od izhodiščne ali potrjeno vrednost hematokrita >48 % (doseganje nižje vrednosti od obeh možnosti).
English: In this arm, 83% of patients were still on treatment at the time of the week 80 data cut-off. Of patients who achieved a primary response at week 32, 80% maintained their response for at least 48 weeks after the initial response.
Slovenian: Med bolniki, ki so dosegli primarni odziv do 32. tedna, jih je 80 % uspelo ohraniti odziv še najmanj 48 tednov po začetnem odzivu.
English: However, this could be related to the high ruxolitinib dose resulting in pharmacodynamic effects near Emax.
Slovenian: Po drugi strani pa je za to lahko odgovoren tudi visok odmerek ruksolitiniba, ki je omogočil farmakodinamično učinkovitost blizu maksimalne (Emax).
English: Anaemia, thrombocytopenia and neutropenia are dose-related effects.
Slovenian: Anemija, trombocitopenija in nevtropenija so odvisne od velikosti odmerka.
English: If you accidentally take more Jakavi than your doctor prescribed, contact your doctor or pharmacist immediately.
Slovenian: Če ste vzeli večji odmerek zdravila Jakavi, kot bi smeli Če pomotoma vzamete več zdravila Jakavi, kot vam je predpisal zdravnik, takoj obvestite zdravnika ali farmacevta.
English: Baseline demographics and disease characteristics were comparable between the two treatments arms.
Slovenian: Osnovne demografske karakteristike bolnikov in značilnosti njihove bolezni ob izhodišču so bile primerljive med obema zdravljenima skupinama.
English: Therapeutic drug monitoring (TDM) or clinical monitoring of the affected substance is advised.
Slovenian: Svetuje se terapevtsko ali klinično spremljanje uporabe tovrstne učinkovine.
English: CYP3A4 inducers (such as, but not limited to, avasimibe, carbamazepine, phenobarbital, phenytoin, rifabutin, rifampin (rifampicin), St.John's wort (Hypericum perforatum)) Patients should be closely monitored and the dose titrated based on safety and efficacy (see section 4.2).
Slovenian: Induktorji CYP3A4 (kot so med drugim avasimib, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampin (rifampicin), šentjanževka (Hypericum perforatum)) Bolnike je treba skrbno spremljati in odmerke titrirati glede na varnost in učinkovitost (glejte poglavje 4.2).
English: c grade 3 (<8.0 - 6.5g/dl)
Slovenian: (<8,0 - 6,5 g/dl)
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%).
Slovenian: V randomiziranem delu ključnih študij je bila anemija manj pogosta pri bolnikih s pravo policitemijo kot pri bolnikih z mielofibrozo (40,8 % v primerjavi z 82,4 %).
English: Secondary endpoints included duration of maintenance of a ≥35% reduction from baseline in spleen volume, proportion of patients who had ≥50% reduction in total symptom score, changes in total symptom scores from baseline to week 24, as measured by the modified MF Symptom Assessment Form (MFSAF) v2.0 diary, and overall survival.
Slovenian: Sekundarni cilji opazovanja so vključevali trajanje ohranitve zmanjšanja volumna vranice za ≥35 % od izhodiščne vrednosti, delež bolnikov, pri katerih je prišlo do ≥50 % zmanjšanja skupne ocene vseh simptomov in spremembe seštevka ocen vseh simptomov od izhodišča do konca 24. tedna, kar so ocenjevali s pomočjo dnevnika s preoblikovanim Obrazcem za ocenjevanje simptomov pri mielofibrozi (MFSAF - Myelofibrosis Symptom Assessment Form), različica 2.0, in celotno preživetje.
English: 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.
Slovenian: V telemetrični študiji na psih so opažali neželeno znižanje krvnega tlaka in sočasno zvišanje srčne frekvence, v respiratorni študiji na podganah pa so opažali neželeno zmanjšanje minutnega volumna srca.
English: A significantly higher proportion of patients in the Jakavi group achieved ≥35% reduction from baseline in spleen volume (Table 2) regardless of the presence or absence of the JAK2V617F mutation or the disease subtype (primary MF, post-polycythaemia vera MF, post-essential thrombocythaemia MF).
Slovenian: Do zmanjšanja volumna vranice za ≥35 % od izhodiščne vrednosti je prišlo pri statistično značilno večjem odstotku bolnikov v skupini z zdravilom Jakavi (Preglednica 2) ne glede na prisotnost oziroma odsotnost mutacije JAK2V617F in ne glede na podvrsto bolezni (primarno mielofibrozo, mielofibrozo pri pravi policitemiji ali mielofibrozo pri esencialni trombocitemiji).
English: Most of these patients had histories of extended treatment with hydroxyurea and prior NMSC or pre-malignant skin lesions.
Slovenian: Večina teh bolnikov je imela v anamnezi dolgotrajno zdravljenje s hidroksiureo in premaligne kožne spremembe oziroma predstopnje nemelanomskega kožnega raka.
English: If you forget to take Jakavi
Slovenian: Če ste pozabili vzeti zdravilo Jakavi
English: You should continue taking Jakavi for as long as your doctor tells you to.
Slovenian: Zdravljenje z zdravilom Jakavi morate nadaljevati, dokler vam tako svetuje zdravnik.
English: By blocking the action of certain enzymes (called Janus Associated Kinases), Jakavi can reduce the size of the spleen in patients with myelofibrosis and relieve symptoms such as fever, night sweats, bone pain and weight loss in patients with myelofibrosis.
Slovenian: Z zaviranjem delovanja določenih encimov (ki jih imenujemo Janus kinaze ali angleško Janus Associated Kinases) lahko zdravilo Jakavi pri bolnikih z mielofibrozo zmanjša velikost vranice in blaži simptome, kot so zvišana telesna temperatura, nočno znojenje, bolečine v kosteh in zmanjšanje telesne mase.
English: There are limited data to determine the best dosing options for patients with end-stage renal disease (ESRD) on haemodialysis.
Slovenian: Na voljo je le malo podatkov, na podlagi katerih bi bilo mogoče določiti najboljše možnosti odmerjanja za bolnike s končno ledvično odpovedjo, ki se zdravijo s hemodializo.
English: Discontinuation due to adverse events, regardless of causality, was observed in 2.2% of patients.
Slovenian: Do prekinitve zdravljenja zaradi neželenega dogodka ne glede na vzročno povezanost z zdravilom je prišlo pri 2,2 % bolnikov.
English: Parent compound is the predominant entity in human plasma, representing approximately 60% of the drug-related material in circulation.
Slovenian: Pri človeku je v plazmi v največji meri prisotna matična učinkovina, ki predstavlja približno 60 % vseh z zdravilom povezanih snovi v krvnem obtoku.
English: In the phase 3 pivotal clinical studies in MF an increase in systolic blood pressure of 20 mmHg or more from baseline was recorded in 31.5% of patients on at least one visit compared with 19.5% of the control-treated patients.
Slovenian: V ključnih študijah faze 3 z bolniki z mielofibrozo so zabeležili zvišanje sistoličnega krvnega tlaka za 20 mmHg ali več od izhodiščne vrednosti pri najmanj enem obisku pri 31,5 % bolnikov v primerjavi z 19,5 % kontrolnih bolnikov.
English: In COMFORT-I and COMFORT-II, patient baseline demographics and disease characteristics were comparable between the treatment arms.
Slovenian: V študijah COMFORT-I in COMFORT-II so bile osnovne demografske karakteristike bolnikov in značilnosti njihove bolezni ob izhodišču primerljive med obema zdravljenima skupinama.
English: In a population pharmacokinetic evaluation in MF patients, no relationship was apparent between oral clearance and patient age or race.
Slovenian: Pri vrednotenju populacijske farmakokinetike pri bolnikih z mielofibrozo se ni pokazala nikakršna povezava med očistkom zdravila po peroralnem vnosu in starostjo ali raso bolnika.
English: These were all CTCAE grade 1 and 2 with the exception of one CTCAE grade 3 raised alanine aminotransferase event.
Slovenian: Vsi navedeni neželeni učinki so bili stopnje 1 ali 2 po CTCAE razen enega primera zvišanja vrednosti alanin aminotransferaze stopnje 3 po CTCAE.
English: Interactions resulting in dose reduction of ruxolitinib
Slovenian: Interakcije, zaradi katerih je treba znižati odmerke ruksolitiniba
English: If you stop taking Jakavi
Slovenian: Če ste prenehali jemati zdravilo Jakavi
English: What Jakavi contains - The active substance of Jakavi is ruxolitinib.
Slovenian: Kaj vsebuje zdravilo Jakavi - Učinkovina zdravila Jakavi je ruksolitinib.
English: The mean change in the global health status at week 24, as measured by EORTC QLQ C30 was +12.3 for Jakavi and -3.4 for placebo (p<0.0001).
Slovenian: Po 24 tednih je povprečna sprememba ocene celotnega zdravstvenega stanja po vprašalniku EORTC QLQ-C30 pri uporabi zdravila Jakavi znašala +12,3, pri uporabi placeba pa -3,4 (p<0,0001).
English: Table 3 Percentage of patients with ≥35% reduction from baseline in spleen volume by JAK mutation status (safety set)
Slovenian: Preglednica 3: Odstotki bolnikov, pri katerih je prišlo do zmanjšanja volumna vranice za ≥35 % od izhodiščne vrednosti glede na status JAK mutacije (populacija bolnikov za oceno varnosti)
English: Complete blood counts should be monitored as clinically indicated and dose adjusted as required (see sections 4.2 and 4.8).
Slovenian: Celotno krvno sliko je treba spremljati glede na klinične indikacije in v skladu s tem prilagajati odmerjanje (glejte poglavji 4.2 in 4.8).