natgillin/translations-raw huggingface dataset:
Listen over bivirkninger herunder reflekterer den randomiserede studieperiode (op til 32 uger for RESPONSE og op til 28 uger for RESPONSE 2) med ækvivalent eksponering for ruxolitinib og bedst tilgængelig behandling (Best Available Therapy (BAT)). 
The adverse drug reactions listed below reflect the randomised study period (up to week 32 for RESPONSE and up to week 28 for RESPONSE 2) with equivalent exposure to ruxolitinib and Best Available Therapy (BAT).
Sikkerhed og effekt af disse samtidige administrationer er ikke kendt (se pkt. 
The safety and efficacy of these co-administrations are not known (see section 4.5).
Jakavi indeholder det aktive stof ruxolitinib. 
Jakavi contains the active substance ruxolitinib.
Hos patienter, som er diagnosticeret med nedsat leverfunktion under behandling med ruxolitinib, skal komplet blodtælling inklusive differentialtælling udførres mindst hver eller hver anden uge de første 6 uger efter, at behandling med ruxolitinib er påbegyndt, og derefter som klinisk indiceret, når deres leverfunktion og blodtællinger er stabiliseret. 
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.
Tabel 2 Procentdel af patienter med en reduktion i miltvolumen på ≥35% i forhold til baseline ved uge 24 i COMFORT-I og ved uge 48 i COMFORT-II (ITT) 
Table 2 Percentage of patients with ≥35% reduction from baseline in spleen volume at week 24 in COMFORT-I and at week 48 in COMFORT-II (ITT)
Komplet blodtælling inklusive en differentialtælling skal udføres hver 2.- 4. uge, indtil Jakavi-doserne er stabiliseret og derefter som klinisk indiceret (se pkt. 
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).
Ruxolitinib er en selektiv hæmmer af de Janus-associerede kinaser (JAK's) JAK1 og JAK2 (IC50værdier på 3,3 nM og 2,8 nM for henholdsvis JAK1- og JAK2-enzymer). 
Ruxolitinib is a selective inhibitor of the Janus Associated Kinases (JAKs) JAK1 and JAK2 (IC50 values of 3.3 nM and 2.8 nM for JAK1 and JAK2 enzymes, respectively).
Der anbefales hyppigere monitorering af hæmatologi-parametre og kliniske tegn og symptomer på Jakavirelaterede bivirkninger for patienter med baseline hæmoglobin under 10,0 g/dl. 
More frequent monitoring of haematology parameters and of clinical signs and symptoms of Jakavi-related adverse drug reactions is recommended for patients with baseline haemoglobin below 10.0 g/dl.
Patienter i ruxolitinib-armen havde i gennemsnit haft PV-diagnosen i 8,2 år og havde tidligere været behandlet med hydroxycarbamid i gennemsnitligt 3 år. 
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.
Milde eller moderate CYP3A4-hæmmere (såsom, men ikke begrænset, til ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidin) 
Mild or moderate CYP3A4 inhibitors (such as, but not limited to, ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine)
3, med det formål at undgå doseringsafbrydelse på grund af trombocytopeni. 
3, with the goal of avoiding dose interruptions for thrombocytopenia.
Andre interaktioner, der skal tages hensyn til, som påvirker ruxolitinib 
Other interactions to be considered affecting ruxolitinib
Trombocytopeni var generelt reversibel via dosisreduktion eller doseringsafbrydelse. 
Thrombocytopenia was generally reversible with dose reduction or dose interruption.
Marginerne (baseret på ubundet Cmax) på det ikke-uønskede niveau i hunde- og rottestudierne var henholdsvis 15,7 og 10,4 gange større end den maksimale, anbefalede dosis til mennesker på 25 mg to gange dagligt. 
The margins (based on unbound Cmax) at the non-adverse level in the dog and rat studies were 15.7-fold and 10.4-fold greater, respectively, than the maximum human recommended dose of 25 mg twice daily.
Dyreforsøg har påvist, at ruxolitinib er embryotoksisk og føtotoksisk. 
Animal studies have shown that ruxolitinib is embryotoxic and foetotoxic.
Monitorering af lipidparametre og behandling af dyslipidæmi i henhold til kliniske guidelines anbefales. 
Lipid monitoring and treatment of dyslipidaemia according to clinical guidelines is recommended.
PVC/PCTFE/aluminium blisterpakninger indeholdende 14 eller 56 tabletter eller multipakninger indeholdende 168 (3 pakninger med 56) tabletter. 
PVC/PCTFE/Aluminium blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets.
I den randomiserede periode af de pivotale studier var anæmi mindre hyppig hos PV-patienter end hos MF-patienter (40,8% versus 82,4%). 
In the randomised period of the pivotal studies, anaemia was less frequent in PV patients than in MF patients (40.8% versus 82.4%).
- Mibefradil eller diltiazem, medicin som bruges til behandling af forhøjet blodtryk og kronisk angina pectoris. 
- Mibefradil or diltiazem, medicines to treat hypertension and chronic angina pectoris.
Efter seponering kan MF-patienter opleve tilbagevenden af myelofibrosesymptomer som for eksempel træthed, knoglesmerter, feber, pruritus, nattesved, symptomatisk splenomegali og vægttab. 
Upon discontinuation, MF patients may experience a return of MF symptoms such as fatigue, bone pain, fever, pruritus, night sweats, symptomatic splenomegaly and weight loss.
I en grundig QT-undersøgelse med sunde forsøgspersoner var der ingen tegn på en QT/QTcforlængende effekt af ruxolitinib ved enkeltdoser op til en supraterapeutisk dosis på 200 mg, hvilket tyder på, at ruxolitinib ikke har nogen effekt på kardiel repolarisering. 
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.
Efterfølgende doser skal baseres på omhyggelig monitorering af sikkerhed og effekt. 
Subsequent doses should be adjusted based on careful monitoring of safety and efficacy.
Hvis du er kommet til at tage mere Jakavi, end din læge har ordineret, skal du straks kontakte enten din læge eller apoteket. 
If you accidentally take more Jakavi than your doctor prescribed, contact your doctor or pharmacist immediately.
Gentagne højere doser end de anbefalede medfører øget myelosuppression, herunder leukopeni, anæmi og trombocytopeni. 
Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anaemia and thrombocytopenia.
Baseline-forhøjelser af inflammatoriske markører forbundet med konstitutionelle symptomer som for eksempel TNFα, IL-6 og CRP hos forsøgspersoner med MF faldt efter behandling med ruxolitinib. 
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.
MF-patienter udviser dysreguleret JAK-signalering uanset JAK2V617F-mutationsstatus. 
MF patients exhibit dysregulated JAK signalling regardless of JAK2V617F mutation status.
In vitro data indikerer, at ruxolitinib kan hæmme P-gp og BCRP. 
In vitro data indicate that ruxolitinib may inhibit P-gp and BCRP.
Startdosis af Jakavi skal reduceres med ca. 50% til patienter med nedsat leverfunktion. 
The starting dose of Jakavi should be reduced by approximately 50% in patients with hepatic impairment.
I begge studier tilskrives den lavere dødeligehed i ruxolitinib-armen hovedsagelig resultaterne fra undergrupperne post-polycythæmia vera og post-essentiel trombocytose. 
In both studies, the lower death rates noted in the ruxolitinib arm were predominantly driven by the results obtained in the post polycythaemia vera and post essential thrombocythaemia subgroups.
En signifikant højere procentdel af patienterne i Jakavi-gruppen opnåede en reduktion i miltvolumen på ≥35% (Tabel 2) i forhold til baseline uanset tilstedeværelse eller fravær af JAK2V617F-mutationen eller sygdomsundertype (primær MF, MF efter polycythæmia vera, MF efter essentiel trombocytose). 
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).
I klinisk relevante koncentrationer hæmmer ruxolitinib ikke CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 eller CYP3A4 og er ikke en stærk induktor af CYP1A2, CYP2B6 eller CYP3A4, baseret på in vitro studier. 
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.
I de to pivotale studier, COMFORT-I og COMFORT-II, var den mediane eksponeringsvarighed af Jakavi 10,8 måneder (fra 0,3 til 23,5 måneder) i randomiseringsperioden. 
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).
Der er begrænset data til at anbefale en startdosis til patienter med trombocyttal mellem 50.000/mm og <100.000/mm3. 
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and <100,000/mm 3.
Der blev ikke rapporteret intrakranielle eller gastrointestinale blødningshændelser hos patienter, som fik ruxolitinib. 
No intracranial bleeding or gastrointestinal haemorrhage events were reported in patients receiving ruxolitinib.
Intrakraniel blødning 
Intracranial bleeding
Der anbefales ingen dosisjustering, når ruxolitinib administreres sammen med milde eller moderate CYP3A4-hæmmere (f.eks. erythromycin). 
No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors (e.g. erythromycin).
Dosisreduktion skal overvejes, hvis trombocyttallet falder til under 100.000/mm 
Dose reductions should be considered if the platelet count decreases below 100,000/mm
Signifikant flere patienter behandlet med Jakavi (23%) opnåede primært respons (p<0,0001) sammenlignet med BAT (0,9%). 
Significantly more patients treated with Jakavi (23%) achieved a primary response (p<0.0001) compared to BAT (0.9%).
Der foreligger ingen data om ruxolitinibs effekt på human fertilitet. 
There are no human data on the effect of ruxolitinib on fertility.
Ruxolitinib er elimineret gennem metabolisme katalyseret ved CYP3A4 og CYP2C9. 
Ruxolitinib is eliminated through metabolism catalysed by CYP3A4 and CYP2C9.
Frekvensen af svær (dvs. CTCAE grad 3 og 4) trombocytopeni var lavere hos PV-patienter (2,7%) end hos MF-patienter (11,6%). 
The frequency of severe (i.e. CTCAE grade 3 and 4) thrombocytopenia was lower in PV (2.7%) than in MF (11.6%) patients.
66% af patienterne behandlet med ruxolitinib rapporterede en forbedring allerede fire uger efter behandlingsstart sammenlignet med 19% af patienterne behandlet med BAT. 
66% of patients treated with ruxolitinib compared to 19% treated with BAT reported an improvement as early as four weeks after beginning treatment.
Patienterne randomiseredes i forholdet 2:1 til ruxolitinib og bedste tilgængelige terapi. 
Patients were randomised 2:1 to ruxolitinib versus best available therapy.
To randomiserede fase 3-undersøgelser (COMFORT-I og COMFORT-II) blev gennemført med patienter med MF (primær MF, MF efter polycythæmia vera eller MF efter essentiel trombocytose). 
Two randomised phase 3 studies (COMFORT-I and COMFORT-II) were conducted in patients with MF (primary MF, post-polycythaemia vera MF or post-essential thrombocythaemia MF).
I kliniske fase 3studier med MF sås hverken CTCAE grad 3 eller 4 hyperkolesterolæmi eller forhøjet aspartataminotransferase eller CTCAE grad 4 forhøjet alaninaminotransferanse 
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.
- Phenytoin, carbamazepin eller phenobarbital og andre midler mod epilepsi, som bruges til at standse krampeanfald. 
- Phenytoin, carbamazepine or phenobarbital and other anti-epileptics used to stop seizures or fits.
En patient, som blev behandlet med ruxolitinib, oplevede en grad 3 blødningshændelse (post-procedural blødning). 
One patient treated with ruxolitinib experienced a grade 3 bleeding event (post-procedural bleeding); no grade 4 bleeding was reported.
Hos hvalpene observeredes et fald i den gennemsnitlige initiale kropsvægt samt en kort periode med nedsat stigning i den gennemsnitlige kropsvægt. 
In the pups, decreased mean initial body weights and short period of decreased mean body weight gain were observed.
Der blev rapporteret sepsis hos 3,0% af patienterne i kliniske fase 3-studier. 
In phase 3 clinical studies sepsis was reported in 3.0% of patients.
Dette omfatter medicin, der bruges til behandling af svampeinfektioner (fx ketoconazol, itraconazol, posaconazol, fluconazol og voriconazol), medicin, der bruges til behandling af visse typer bakterieinfektioner (antibiotika, som fx clarithromycin, telithromycin, ciprofloxacin eller erythromycin), lægemidler, der bruges til behandling af virusinfektioner, herunder HIV-infektion/AIDS (fx amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), og lægemidler, der bruges til behandling af hepatitis C (boceprevir, telaprevir). 
These include medicines used to treat fungal diseases (such as ketoconazole, itraconazole, posaconazole, fluconazole and voriconazole), medicines used to treat certain types of bacterial infections (antibiotics such as clarithromycin, telithromycin, ciprofloxacin, or erythromycin), medicines to treat viral infections, including HIV infection/AIDS (such as amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, saquinavir), medicines to treat hepatitis C (boceprevir, telaprevir).
Hyperkolesterolæmi b 
Hypercholesterolaemia b
Der er rapporteret stigning i hepatitis B-virusmængde (HBV-DNA-titer), med eller uden tilsvarende stigninger i alanin-aminotransferase og aspartat-aminotransferase, hos patienter med kronisk HBVinfektion i behandling med Jakavi. 
Hepatitis B viral load (HBV-DNA titre) increases, with and without associated elevations in alanine aminotransferase and aspartate aminotransferase, have been reported in patients with chronic HBV infections taking Jakavi.
Et andet randomiseret, åbent, aktiv-kontrolleret fase 3b-studie (RESPONSE 2) blev udført hos 149 PV-patienter, som var resistente eller intolerante overfor hydroxycarbamid, men som ikke havde palpabel splenomegali. 
A second randomised, open label, active-controlled phase 3b study (RESPONSE 2) was conducted in 149 PV patients who were resistant to, or intolerant of, hydroxyurea but without palpable splenomegaly.
Ved at blokere virkningen af visse enzymer (kaldet Janus-associerede kinaser) kan Jakavi reducere miltens størrelse hos patienter med myelofibrose og lindre symptomer, som fx feber, nattesved, knoglesmerter og vægttab. 
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.
Anæmi b 
Anaemia b
Ruxolitinib medførte 2 timer efter doseringen en maksimal hæmning af STAT3-fosforylering, som 8 timer senere igen var tæt på baseline hos både sunde forsøgspersoner og MF-patienter, hvilket tyder på, at der ikke sker nogen akkumulering, hverken af uomdannet lægemiddel eller aktive metabolitter. 
Ruxolitinib resulted in maximal inhibition of STAT3 phosphorylation 2 hours after dosing which returned to near baseline by 8 hours in both healthy subjects and MF patients, indicating no accumulation of either parent or active metabolites.
I COMFORT-II-studiet var anvendelsen af erytrocyttransfusioner 53,4% i Jakavi-armen og 41,1% i armen med bedste tilgængelige terapi. 
In the COMFORT-II study the rate of packed red blood cell transfusions was 53.4% in the Jakavi arm and 41.1% in the best available therapy arm.
De tilgængelige farmakodynamiske/toksikologiske data fra dyreforsøg viser, at ruxolitinib/metabolitter udskilles i human mælk (se pkt. 
Available pharmacodynamic/toxicological data in animals have shown excretion of ruxolitinib and its metabolites in milk (see section 5.3).
Hæmodialyse forventes ikke at fremskynde elimineringen af ruxolitinib. 
Haemodialysis is not expected to enhance the elimination of ruxolitinib.
Efter en enkelt dosis ruxolitinib på 25 mg til patienter med forskellige grader af nedsat leverfunktion steg den gennemsnitlige AUC for ruxolitinib hos patienter med let, moderat og stærkt nedsat leverfunktion med henholdsvis 87%, 28% og 65% sammenlignet med patienter med normal leverfunktion. 
Following a single ruxolitinib dose of 25 mg in patients with varying degrees of hepatic impairment, the mean AUC for ruxolitinib was increased in patients with mild, moderate and severe hepatic impairment by 87%, 28% and 65%, respectively, compared to patients with normal hepatic function.
Bedst tilgængelige behandling 
Best available therapy
Behandling med Jakavi kan give hæmatologiske bivirkninger, herunder trombocytopeni, anæmi og neutropeni. 
Treatment with Jakavi can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia.
Ruxolitinib hæmmer JAK-STAT-signalering og celleproliferation i cytokinafhængige cellemodeller af hæmatologiske maligniteter samt i Ba/F3-celler, som er gjort cytokinuafhængige ved at udtrykke det JAK2V617F-muterede protein, med IC50 fra 80-320 nM. 
Ruxolitinib inhibits JAK-STAT signalling and cell proliferation of cytokine-dependent cellular models of haematological malignancies, as well as of Ba/F3 cells rendered cytokine-independent by expressing the JAK2V617F mutated protein, with IC50 ranging from 80-320 nM.
Der iagttoges ingen påvirkninger af fertiliteten. 
No effects were noted on fertility.
Trafik- og arbejdssikkerhed Hvis du føler dig svimmel, når du har taget Jakavi, må du ikke køre bil eller betjene maskiner. 
Driving and using machines If you experience dizziness after taking Jakavi, do not drive or use machines.
Der er ingen tilgængelige data vedrørende dosering til patienter, som behandles med peritonealdialyse eller kontinuerlig venovenøs hæmofiltration (se pkt. 
No data is available for dosing patients who are undergoing peritoneal dialysis or continuous venovenous haemofiltration (see section 5.2).
MF-patienter blev ikke refraktære med hensyn til de farmakodynamiske virkninger efter længere tids behandling med ruxolitinib. 
MF patients did not become refractory to the pharmacodynamic effects of ruxolitinib treatment over time.
I COMFORT-I og COMFORT-II var de demografiske og sygdomsmæssige karakteristika for patienterne i de to behandlingsarme sammenlignelige. 
In COMFORT-I and COMFORT-II, patient baseline demographics and disease characteristics were comparable between the treatment arms.
Ruxolitinib hæmmer cytokininduceret STAT3-fosforylering i fuldblod fra sunde forsøgspersoner, MFpatienter og PV-patienter. 
Ruxolitinib inhibits cytokine-induced STAT3 phosphorylation in whole blood from healthy subjects, MF patients and PV patients.
Jakavi er indiceret til behandling af sygdomsrelateret splenomegali eller symptomer hos voksne patienter med primær myelofibrose (også kaldet kronisk idiopatisk myelofibrose), myelofibrose efter polycythæmia vera eller myelofibrose efter essentiel trombocytose. 
Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
Lægerne skal holde patienter, der behandles med Jakavi, under nøje observation for symptomer på infektioner og straks påbegynde passende behandling. 
Physicians should carefully observe patients receiving Jakavi for signs and symptoms of infections and initiate appropriate treatment promptly.
Komplet blodtælling skal monitoreres som klinisk indiceret, og dosis justeres efter behov (se pkt. 
Complete blood counts should be monitored as clinically indicated and dose adjusted as required (see sections 4.2 and 4.8).
Liste over bivirkninger fra kliniske studier i tabel 
Tabulated list of adverse drug reactions from clinical studies
Patienter med trombocyttal på 100.000/mm til 200.000/mm 3, før de startede med ruxolitinib, havde en højere frekvens af trombocytopeni grad 3 eller 4 end patienter med trombocyttal på >200.000/mm 
Patients with a platelet count of 100,000/mm to 200,000/mm before starting ruxolitinib had a higher frequency of grade 3 or 4 thrombocytopenia compared to patients with platelet count >200,000/mm
50% dosisreduktion bør overvejes, når der anvendes lægemidler, som både hæmmer CYP2C9- og CYP3A4-enzymer (fx fluconazol). 
50% dose reduction should be considered when using medicinal products which are dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole).
Jakavi-tabletterne leveres i blisterpakninger indeholdende 14 eller 56 tabletter eller multipakninger indeholdende 168 (3 pakninger med 56) tabletter. 
Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets
Under det kliniske forsøg vurderes alvorligheden af bivirkninger på grundlag af CTCAE, hvor grad 1 = mild, grad 2 = moderat, grad 3 = svær og grad 4 = livstruende. 
In the clinical study programme the severity of adverse drug reactions was assessed based on the CTCAE, defining grade 1 = mild, grade 2 = moderate, grade 3 = severe and grade 4=life-threatening.
14 tabletter 
14 tablets
Gastrointestinal blødning 
Gastrointestinal bleeding
De sekundære endepunkter omfattede varigheden af en vedligeholdt reduktion i miltvolumen på ≥35% i forhold til baseline, andelen af patienter med ≥50% reduktion af den samlede symptomscore, ændringer i den samlede symptomscore fra baseline til uge 24, målt efter den modificerede MF Symptom Assessment Form (MFSAF)-dagbog, v2.0, samt den samlede overlevelse. 
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.
Primært sammensat endepunkt ved uge 32 
Primary composite endpoint at week 32
CYP3A4-induktorer (såsom, men ikke begrænset til avasimib, carbamazepin, phenobarbital, phenytoin, rifabutin, rifampicin, perikon (Hypericum perforatum)) Patienterne skal monitoreres nøje, og dosis skal titreres under hensyntagen til sikkerhed og effekt (se pkt. 
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).
1 og 2 
c grade 1 and 2
Neutropeni (absolut neutrofiltælling <500) var generelt reversibel og håndteredes ved at afbryde behandlingen med Jakavi midlertidigt (se pkt. 
Neutropenia (absolute neutrophil count <500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
Multipakning: 168 (3 pakninger med 56) tabletter 
Multipack: 168 (3 packs of 56) tablets.
Non-melanom hudkræft, inklusive basalcelle-, pladecelle- og Merkelcelle-karcinom, er rapporteret hos patienter behandlet med ruxolininib. 
Non-melanoma skin cancers (NMSCs), including basal cell, squamous cell, and Merkel cell carcinoma, have been reported in patients treated with ruxolitinib.
Nervesystemet Svimmelhed a 
Nervous system disorders Dizziness a