natgillin/translations-raw huggingface dataset:
Jakavi must not be used during breast-feeding (see section 4.3) and breast-feeding should therefore be discontinued when treatment is started. 
Zdravila Jakavi se v obdobju dojenja ne sme uporabljati (glejte poglavje 4.3), zato je treba ob začetku zdravljenja z dojenjem prenehati.
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. 
Večina neželenih učinkov zdravila Jakavi je blago do zmerno izraženih in večinoma izzvenijo po nekaj dneh do nekaj tednih zdravljenja.
If either of the above applies to you, tell your doctor who will then decide whether you should start treatment with Jakavi. 
Če kaj od navedenega velja za vas, povejte zdravniku, ki bo odločil, ali lahko začnete jemati zdravilo Jakavi.
Jakavi treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products. 
Zdravljenje z zdravilom Jakavi sme uvesti samo zdravnik, ki ima izkušnje z uporabo zdravil proti raku.
The sum total of all active metabolites contributes to 18% of the overall pharmacodynamics of ruxolitinib. 
Vsi aktivni presnovki skupaj prispevajo 18 % skupne farmakodinamične aktivnosti ruksolitiniba.
Table 1 Frequency category of adverse drug reactions reported in the phase 3 studies (COMFORT-I, COMFORT-II, RESPONSE, RESPONSE 2) 
Preglednica 1: Kategorije pogostnosti neželenih učinkov, o katerih so poročali v študijah faze 3 (COMFORT-I, COMFORT-II, RESPONSE in RESPONSE 2)
This is a long-term treatment. 
Zdravljenje s tem zdravilom je dolgotrajno.
Warnings and precautions Talk to your doctor or pharmacist before taking Jakavi - if you have any infections. 
Opozorila in previdnostni ukrepi Pred začetkom jemanja zdravila Jakavi se posvetujte z zdravnikom ali farmacevtom: - če imate kakršno koli okužbo.
It is not known whether the Janus Associated Kinase (JAK) inhibition by ruxolitinib reduces the efficacy of the haematopoietic growth factors or whether the haematopoietic growth factors affect the efficacy of ruxolitinib (see section 4.4). 
Ni znano, ali ruksolitinib z zaviranjem Janus kinaz (JAK) zmanjšuje učinkovitost hematopoetskih rastnih dejavnikov oziroma ali hematopoetski rastni dejavniki vplivajo na učinkovitost ruksolitiniba (glejte poglavje 4.4).
The starting dose should not be increased within the first four weeks of treatment and thereafter no more frequently than at 2-week intervals. 
V prvih štirih tednih zdravljenja se začetnega odmerka ne sme zviševati, kasneje pa je odmerke mogoče zviševati v presledkih najmanj 2 tednov.
Other than bone development, the effects of ruxolitinib in juvenile rats were similar to those in adult rats. 
Razen vpliva na razvoj kosti so bili učinki ruksolitiniba pri podganjih mladičih podobni kot pri odraslih podganah.
Additional analyses from the RESPONSE study to assess durability of response were conducted at week 80 only in the Jakavi arm. 
Nadaljnje analize podatkov iz študije RESPONSE za oceno trajanja odziva po 80 tednih zdravljenja so opravili samo v skupini z zdravilom Jakavi.
There are no data from the use of Jakavi in pregnant women. 
Podatkov o uporabi zdravila Jakavi pri nosečnicah ni.
This can include medical history, possible previous contact with tuberculosis, and/or appropriate screening such as lung x-ray, tuberculin test and/or interferon-gamma release assay, as applicable. 
To lahko vključuje zdravstveno anamnezo, poizvedbo po morebitnih predhodnih stikih z bolniki s tuberkulozo in/ali ustrezne preiskave, kot so rentgensko slikanje pljuč, tuberkulinski test in/ali test sproščanja interferona gama, če je potrebno.
Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised. 
Zdravniki morajo biti pozorni na možnost lažno negativnih rezultatov pri tuberkulinskem kožnem testu, zlasti pri bolnikih, ki so zelo bolni ali imajo zavrt imunski sistem.
Ruxolitinib is mainly eliminated through metabolism. 
Ruksolitinib se večinoma izloča s pomočjo metabolizma.
Do not use this medicine after the expiry date which is stated on the carton or blister after “EXP”. 
Tega zdravila ne smete uporabljati po datumu izteka roka uporabnosti, ki je naveden na škatli ali pretisnem omotu poleg oznake “Uporabno do ali EXP”.
The European Medicines Agency has waived the obligation to submit the results of studies with Jakavi in all subsets of the paediatric population for the treatment of MF and PV (see section 4.2 for information on paediatric use). 
Evropska agencija za zdravila je odstopila od zahteve za predložitev rezultatov študij z zdravilom Jakavi za vse podskupine pediatrične populacije glede zdravljenja mielofibroze in prave policitemije (za podatke o uporabi pri pediatrični populaciji glejte poglavje 4.2).
The abnormal marrow can no longer produce enough normal blood cells and as a result the spleen becomes significantly enlarged. 
V tako prizadetem kostnem mozgu ne more več nastajati dovolj normalnih krvnih celic, zato se izrazito poveča vranica.
Physicians should educate patients about early signs and symptoms of herpes zoster, advising that treatment should be sought as early as possible. 
Zdravniki morajo bolnike poučiti o zgodnjih znakih in simptomih herpesa zostra in jim svetovati, da čimprej poiščejo ustrezno pomoč in začnejo z zdravljenjem.
Women of child-bearing potential should use effective contraception during the treatment with Jakavi. 
Ženske v rodni dobi morajo v času zdravljenja z zdravilom Jakavi uporabljati učinkovito kontracepcijo.
Adverse drug reactions from clinical studies (Table 1) are listed by MedDRA system organ class. 
Neželeni učinki zdravila iz kliničnih študij (preglednica 1) so navedeni glede na organski sistem po MedDRA klasifikaciji.
After recovery of blood counts above these levels, dosing may be re-started at 5 mg twice daily and gradually increased based on careful monitoring of complete blood cell count, including a white blood cell count differential. 
Ko se število krvnih celic zviša nad navedeni vrednosti, je mogoče ponovno začeti z odmerjanjem 5 mg dvakrat na dan in odmerek postopno zviševati na podlagi skrbnega spremljanja celotne krvne slike, vključno z diferencialno belo krvno sliko.
If you forgot to take Jakavi simply take your next dose at the scheduled time. 
Če ste pozabili vzeti odmerek zdravila Jakavi, vzemite le naslednjega ob predvidenem času.
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. 
Varnost zdravila Jakavi so ocenjevali pri 184 bolnikih s pravo policitemijo v dveh odprtih, randomiziranih, kontroliranih študijah: v študiji faze 3 z imenom RESPONSE in v študiji faze 3b z imenom RESPONSE 2.
This may result in increased sytemic exposure of substrates of these transporters, such as dabigatran etexilate, ciclosporin, rosuvastatin and potentially digoxin. 
To lahko poveča sistemsko izpostavljenost substratom teh prenašalcev, na primer dabigatran eteksilatu, ciklosporinu, rosuvastatinu in potencialno tudi digoksinu.
These ADRs are discussed in the text. 
Ti neželeni učinki so opisani v besedilu.
These mediate the signalling of a number of cytokines and growth factors that are important for haematopoiesis and immune function. 
Te kinaze omogočajo signaliziranje s številnimi citokini in rastnimi dejavniki, ki so pomembni pri hematopoezi in imunski funkciji.
Periodic skin examination is recommended for patients who are at increased risk for skin cancer. 
Pri bolnikih s povečanim tveganjem za kožnega raka je priporočeno redno pregledovanje kože.
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. 
Med zdravljenjem boste opravljali še druge krvne preiskave, tako da bo zdravnik lahko spremljal število posameznih vrst krvnih celic v vašem telesu (število levkocitov, eritrocitov in trombocitov), ocenil, kako se odzivate na zdravljenje, in ugotovil, ali zdravilo Jakavi morda neželeno učinkuje na navedene celice.
Following interruption or discontinuation of Jakavi, symptoms of MF may return over a period of approximately one week. 
Po začasni ali dokončni prekinitvi jemanja zdravila Jakavi se simptomi mielofibroze lahko ponovijo v roku približno enega tedna.
When adjusted for exposure, the adverse events rates were generally comparable with those observed during the comparative periods of the randomised studies. 
Po prilagajanju na trajanje izpostavljenosti so bile pogostnosti neželenih dogodkov večinoma približno enake kot v primerjalnih obdobjih randomiziranih študij.
If you have any questions about how Jakavi works or why this medicine has been prescribed for you, ask your doctor. 
Če vas zanima, kako zdravilo Jakavi deluje ali zakaj so vam predpisali to zdravilo, se obrnite na zdravnika.
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. 
V obeh študijah so imeli bolniki povečanje vranice, tipno najmanj 5 cm pod rebrnim lokom in kategorijo tveganja srednje stopnje 2 ali visoke v skladu z dokumentom Dogovorjeni kriteriji mednarodne delovne skupine (International Working Group (IWG) Consensus Criteria).
Symptom burden was assessed using the MPN-SAF total symptom score (TSS) electronic patient diary, which consisted of 14 questions. 
Obseg prisotnih simptomov bolezni so ocenjevali s pomočjo elektronskega dnevnika bolnika s skupno oceno simptomov (TSS - Total Symptom Score,) na lestvici MPN-SAF, ki je obsegala 14 vprašanj.
In animal studies, no effect on fertility was observed. 
V študijah na živalih niso opažali nobenega vpliva na plodnost.
Individual components of primary response at week 32 
posamezni cilji opazovanja za posamezni odziv po 32 tednih
Patients in the ruxolitinib arm had PV diagnosis for a median of 8.2 years and had previously received hydroxyurea for a median of approximately 3 years. 
Bolniki v skupini z ruksolitinibom so imeli diagnozo prave policitemije že mediano 8,2 leta, predhodno pa so prejemali hidroksiureo mediano približno 3 leta.
As a precautionary measure, the use of Jakavi during pregnancy is contraindicated (see section 4.3). 
Iz previdnosti je uporaba zdravila Jakavi med nosečnostjo kontraindicirana (glejte poglavje 4.3).
In the best available therapy arm, 47% of patients received hydroxyurea and 16% of patients received glucocorticoids. 
V skupini z najboljšim razpoložljivim zdravilom je 47 % bolnikov prejemalo hidroksiureo, 16 % pa glukokortikoide.
The median time to recovery of platelet counts above 50,000/mm was 14 days. 
Mediana vrednost časa od števila trombocitov nad 50.000/mm do normalizacije je bila 14 dni.
In PV, treatment should also be interrupted when haemoglobin is below 8 g/dl. 
Pri pravi policitemiji je treba zdravljenje prekiniti tudi v primeru, ko je vrednost hemoglobina pod 8 g/dl.
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. 
Če opazite določene neželene učinke (na primer bolezni krvi), vam bo zdravnik morda moral spremeniti odmerek zdravila Jakavi, ki ga morate jemati, ali pa vam bo naročil, da začasno prenehate jemati zdravilo Jakavi.
COMFORT-I was a double-blind, randomised, placebo-controlled study in 309 patients who were refractory to or were not candidates for available therapy. 
COMFORT-I je bila dvojno slepa, randomizirana, s placebom kontrolirana študija s 309 bolniki, ki niso bili odzivni na razpoložljiva zdravila oziroma niso bili primerni za zdravljenje z njimi.
Overall, the ruxolitinib pharmacodynamic activity was similar, suggesting the CYP3A4 induction resulted in minimal effect on the pharmacodynamics. 
V celoti je bila farmakodinamična aktivnost ruksolitiniba podobna, kar kaže, da je indukcija CYP3A4 le malo vplivala na farmakodinamiko.
If efficacy is considered insufficient and blood counts are adequate, doses may be increased by a maximum of 5 mg twice daily, up to the maximum dose of 25 mg twice daily. 
Če se odmerjanje ne zdi dovolj učinkovito, število krvnih celic pa je ustrezno, je mogoče odmerek zvišati za največ 5 mg dvakrat na dan do najvišjega odmerka 25 mg dvakrat na dan.
What you need to know before you take Jakavi 
Kaj morate vedeti, preden boste vzeli zdravilo Jakavi
It is unknown whether ruxolitinib and/or its metabolites are excreted in human milk. 
Ni znano, ali se ruksolitinib in/ali njegovi presnovki izločajo v materino mleko.
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. 
V študiji razvoja v antenatalnem in postnatalnem obdobju so opažali nekoliko podaljšano trajanje gestacije, zmanjšano število mest za nidacijo in zmanjšano število skotenih mladičev.
This includes prescription medicines, non-prescription medicines and herbal or alternative medicines. 
To vključuje zdravila, ki jih dobite na zdravniški recept, zdravila, ki jih dobite brez recepta, in zeliščna ali alternativna zdravila.
Jakavi is to be taken orally, with or without food. 
Zdravilo Jakavi je treba jemati peroralno, s hrano ali brez nje.
Post-Authorisation efficacy study to provide long-term efficacy and safety data of ruxolitinib including (late) achievement of response, duration of (various) responses, as well as incidence of AEs including haematological transformation and second malignancies from the study B2301. 
Študija učinkovitosti po pridobitvi dovoljenja za promet z zdravilom za pridobitev podatkov o dolgoročni učinkovitosti in varnosti ruksolitiniba, vključno s podatki o (poznem) doseganju odziva, trajanju (raznih) odzivov in o pogostnosti neželenih dogodkov, vključno s hematološko transformacijo in razvojem drugega malignoma, kar vključuje tudi podatke iz študije B2301.
In the randomised period of the two pivotal studies, COMFORT-I and COMFORT-II, the median duration of exposure to Jakavi was 10.8 months (range 0.3 to 23.5 months). 
V randomiziranem delu dveh ključnih študij (COMFORT-I in COMFORT-II) je mediana trajanja izpostavljenosti zdravilu Jakavi znašala 10,8 meseca (od 0,3 do 23,5 meseca).
The effect of Jakavi on viral replication in patients with chronic HBV infection is unknown. 
Vpliv zdravila Jakavi na replikacijo virusa pri bolnikih s kronično okužbo z virusom hepatitisa B ni znan.
If you receive dialysis, take either one single dose or two separate doses of Jakavi only on dialysis days, after the dialysis has been completed. 
Če se zdravite z dializo, vzemite ali samo en odmerek ali dva ločena odmerka zdravila Jakavi samo na dan, ko imate dializo, in sicer po končanem postopku dialize.
Not all packs may be marketed in your country. 
Na trgu morda ni vseh navedenih pakiranj.
Juvenile rats are more sensitive than adult rats to ruxolitinib toxicity. 
Podganji mladiči so bolj občutljivi na toksično delovanje ruksolitiniba kot odrasle podgane.
The safety assessment was based on a total of 982 patients (with MF or PV) receiving Jakavi in phase 2 and 3 studies. 
Ocena varnosti zdravila temelji na podatkih skupno 982 bolnikov (z mielofibrozo ali pravo policitemijo), ki so prejemali zdravilo Jakavi v študijah faze 2 in 3.
Available pharmacodynamic/toxicological data in animals have shown excretion of ruxolitinib and its metabolites in milk (see section 5.3). 
Razpoložljivi farmakodinamski/toksikološki podatki iz študij na živalih kažejo, da se ruksolitinib in njegovi presnovki izločajo v mleku samic (glejte poglavje 5.3).
Unless abrupt discontinuation is required, gradual tapering of the dose of Jakavi may be considered, although the utility of the tapering is unproven. 
Če nenadna prekinitev jemanja zdravila Jakavi ni nujno potrebna, velja poskusiti s postopnim zniževanjem odmerka zdravila Jakavi, čeprav prednost postopnega ukinjanja zdravila ni dokazana.
Other medicines and Jakavi 
Druga zdravila in zdravilo Jakavi
Lipid monitoring and treatment of dyslipidaemia according to clinical guidelines is recommended. 
Priporočena sta spremljanje vrednosti lipidov in zdravljenje dislipidemije v skladu s kliničnimi smernicami.
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. 
Morda je potencialno zaviranje P-glikoproteina oziroma BRCP v črevesju mogoče zmanjšati s čim daljšim intervalom med odmerjanjem enih in drugih učinkovin.
If PML is suspected, further dosing must be suspended until PML has been excluded. 
V primeru suma na PML je treba odmerjanje zdravila začasno prekiniti, dokler diagnoza PML ni izključena.
Jakavi contains lactose (milk sugar). 
Zdravilo Jakavi vsebuje laktozo (mlečni sladkor).
In phase 3 clinical studies sepsis was reported in 3.0% of patients. 
V kliničnih študijah faze 3 so poročali o sepsi pri 3,0 % bolnikov.
Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE18 
Farmakoterapevtska skupina: zdravila z delovanjem na novotvorbe (citostatiki), zaviralci proteinkinaze; oznaka ATC: L01XE18
Dosing only on dialysis days reduces the metabolite exposure, but also the pharmacodynamic effect, especially on the days between dialysis. 
Pri odmerjanju zdravila samo na dializne dni je izpostavljenost presnovkom manjša kot sicer, hkrati pa je manjši tudi farmakodinamični učinek zdravila, zlasti v dneh med dializnimi postopki.
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. 
Vendar če po 6 mesecih ne pride do zmanjšanja velikosti vranice ali do izboljšanja simptomov od začetka zdravljenja, je treba z zdravljenjem prekiniti.
Renal function was determined using both Modification of Diet in Renal Disease (MDRD) and urinary creatinine. 
Delovanje ledvic so določali po metodi Modification of Diet in Renal Disease (MDRD) in glede na vrednost kreatinina v urinu.
Complete blood count, including a white blood cell count differential, should be monitored every 2-4 weeks until Jakavi doses are stabilised, and then as clinically indicated (see section 4.4). 
Celotno krvno sliko, vključno z diferencialno belo krvno sliko, je treba določati vsake 2-4 tedne, dokler ne pride do stabilizacije odmerka zdravila Jakavi, in nato ponovno, kadar je klinično indicirano (glejte poglavje 4.4).
However, plasma AUC values of ruxolitinib metabolites tended to increase with increasing severity of renal impairment, and were most markedly increased in the subjects with severe renal impairment. 
Vrednosti AUC presnovkov ruksolitiniba v plazmi pa so se zviševale z večjo izraženostjo ledvične okvare in so bile najbolj izrazito zvišane pri bolnikih s hudo okvaro ledvic.
In clinical studies, ruxolitinib is rapidly absorbed after oral administration with maximal plasma concentration (Cmax) achieved approximately 1 hour post-dose. 
V kliničnih študijah se je ruksolitinib po peroralnem vnosu hitro absorbiral in dosegel najvišjo koncentracijo (Cmax) v plazmi približno 1 uro po odmerjanju.
The dose of Jakavi depends on the patient's blood cell count. 
Odmerek zdravila Jakavi je odvisen od bolnikove krvne slike.
One patient treated with ruxolitinib experienced a grade 3 bleeding event (post-procedural bleeding); no grade 4 bleeding was reported. 
Pri enem bolniku, ki je prejemal ruksolitinib, je prišlo do krvavitve stopnje 3 (šlo je za krvavitev po posegu), o krvavitvi stopnje 4 niso poročali.
The mean elimination half-life of ruxolitinib is approximately 3 hours. 
Povprečen razpolovni čas izločanja ruksolitiniba je približno 3 ure.
The basis for the dysregulation is believed to include high levels of circulating cytokines that activate the JAK-STAT pathway, gain-of-function mutations such as JAK2V617F, and silencing of negative regulatory mechanisms. 
Domnevajo, da so med mehanizmi, ki povzročajo iztirjenost, visoka koncentracija cirkulirajočih citokinov, ki aktivirajo JAK-STAT, mutacije za pridobitev funkcije, kot je mutacija JAK2V617F, in utišanje negativnih regulacijskih mehanizmov.
A randomised, open-label, active-controlled phase 3 study (RESPONSE) was conducted in 222 patients with PV who were resistant to or intolerant of hydroxyurea defined based on the European LeukemiaNet (ELN) international working group published criteria. 
Randomizirano, odprto, aktivno kontrolirano študijo faze 3 (z oznako RESPONSE) so izvajali pri 222 bolnikih s pravo policitemijo, pri katerih ni prišlo do ustreznega odziva na zdravljenje s hidroksiureo ali je niso prenašali po opredelitvi v skladu s kriteriji, ki jih je objavila mednarodna delovna skupina Evropske mreže za levkemije (ELN - European LeukemiaNet).
Physicians should carefully observe patients receiving Jakavi for signs and symptoms of infections and initiate appropriate treatment promptly. 
Bolnike, ki prejemajo zdravilo Jakavi, morajo zdravniki skrbno opazovati glede pojavljanja znakov in simptomov okužb in v takem primeru takoj uvesti ustrezno zdravljenje.
Further dose modifications should be based on the safety and efficacy of the medicinal product (see sections 4.2 and 5.2). 
Nadaljnje spreminjanje odmerka mora temeljiti na varnosti in učinkovitosti zdravila (glejte poglavji 4.2 in 5.2).
While you are taking Jakavi you should never start a new medicine without checking first with the doctor who prescribed Jakavi. 
V času jemanja zdravila Jakavi ne smete začeti z jemanjem novega zdravila, ne da bi prej vprašali zdravnika, ki vam je predpisal zdravilo Jakavi.
Very common 
pogosti zelo pogosti
In a thorough QT study in healthy subjects, there was no indication of a QT/QTc prolonging effect of ruxolitinib in single doses up to a supratherapeutic dose of 200 mg, indicating that ruxolitinib has no effect on cardiac repolarisation. 
V poglobljeni študiji intervala QT pri zdravih osebah ni bilo nobenih znakov, da bi ruksolitinib podaljševal interval QT/QTc pri odmerjanju v enkratnih odmerkih tudi do supraterapevtskih vrednosti 200 mg, kar kaže na dejstvo, da ruksolitinib ne vpliva na repolarizacijo srca.
Activating mutations in JAK2 (V617F or exon 12) are found in >95% of PV patients. 
Mutacije, ki aktivirajo procese signalne poti JAK2 (V617F ali ekson 12) so našli pri več kot 95 % bolnikov s pravo policitemijo.
The terminal elimination half-life was prolonged in patients with hepatic impairment compared to healthy controls (4.1-5.0 hours versus 2.8 hours). 
Pri bolnikih z okvaro jeter je bil končni razpolovni čas izločanja daljši kot pri zdravih kontrolah (4,1-5,0 ur v primerjavi z 2,8 ure).
Bleeding (any bleeding including intracranial, and gastrointestinal bleeding, bruising and other bleeding) 
c zelo pogosti krvavitev (kakršna koli krvavitev, vključno z intrakranialno in gastrointestinalno krvavitvijo, podplutbo ali drugo krvavitvijo)
PVC/PCTFE/Aluminium blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets. 
PVC/PCTFE/Aluminijev pretisni omot v pakiranju, ki vsebuje 14 ali 56 tablet oziroma v skupnem pakiranju, ki vsebuje 168 (3 pakiranja po 56) tablet.
Do not take Jakavi - if you are allergic to ruxolitinib or any of the other ingredients of this medicine (listed in section 6). 
Ne jemljite zdravila Jakavi - če ste alergični na ruksolitinib ali katero koli sestavino tega zdravila (navedeno v poglavju 6); - če ste noseči ali dojite.
Oral use Read the package leaflet before use. 
peroralna uporaba Pred uporabo preberite priloženo navodilo!
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). 
V kliničnih študijah z bolniki z mielofibrozo se je skupna ocena izraženosti simptomov mielofibroze postopoma vrnila na izhodiščno vrednost v 7 dneh po prekinitvi odmerjanja (glejte poglavje 4.4).