natgillin/translations-raw huggingface dataset:
Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets
Jakavi tablete su dostupne u blister pakiranjima koja sadrže 14 ili 56 tableta ili višestrukim pakiranjima koja sadrže 168 (3 pakiranja od 56) tableta.
Very common a
Vrlo često a
3, with the goal of avoiding dose interruptions for thrombocytopenia.
3, kako bi se izbjegao prekid u doziranju zbog trombocitopenije.
Additional dose modifications should be made with careful monitoring of safety and efficacy (see sections 4.2 and 5.2).
Dodatne modifikacije doze trebaju se vršiti uz pažljivo praćenje sigurnosti i djelotvornosti (vidjeti dijelove 4.2 i 5.2).
The frequency of severe (i.e. CTCAE grade 3 and 4) thrombocytopenia was lower in PV (2.7%) than in MF (11.6%) patients.
Učestalost teške (tj. stupnja 3 i 4 prema CTCAE-u) trombocitopenije bila je niža u bolesnika s PV-om (2,7%) nego u onih s MF-om (11,6%).
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).
Dva randomizirana ispitivanja faze 3 (COMFORT-I i COMFORT-II) bila su provedena u bolesnika s MF-om (primarni MF, MF kao posljedica policitemije vere ili MF kao posljedica esencijalne trombocitopenije).
The safety and efficacy of this co-administration is not known (see section 4.4).
Sigurnost i djelotvornost ove istodobne primjene nisu poznate (vidjeti dio 4.4).
No effects were noted on fertility.
Nisu bili uočeni učinci na plodnost.
Tabulated list of adverse drug reactions from clinical studies
Tablični popis nuspojava na lijek iz kliničkih ispitivanja
Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anaemia and thrombocytopenia.
Opetovane doze više od preporučenih povezane su s povećanom mijelosupresijom koja uključuje leukopeniju, anemiju i trombocitopeniju.
50% dose reduction should be considered when using medicinal products which are dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole).
Treba razmotriti smanjenje doze za 50% kada se primjenjuju lijekovi koji su dvostruki inhibitori enzima CYP2C9 i CYP3A4 (npr. flukonazol).
Key secondary endpoints included the proportion of patients who achieved the primary endpoint and remained free from progression at week 48, as well as the proportion of patients achieving complete haematological remission at week 32.
Ključne mjere sekundarnih ishoda uključivali su udio bolesnika koji su postigli mjeru primarnog ishoda i nisu imali progresiju do 48. tjedna, kao i udio bolesnika koji su postigli potpunu hematološku remisiju do 32. tjedna.
In these clinical studies, discontinuation due to adverse events, regardless of causality, was observed in 11.3% of patients.
U tim kliničkim ispitivanjima prekidi terapije uzrokovani štetnim događajima, bez obzira na uzročnoposljedičnu vezu, uočeni su u 11,3% bolesnika.
Polycythaemia vera
Policitemija vera
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.
U oba ispitivanja niže stope smrtnosti zabilježene u ruksolitinib skupini bile su uglavnom uzrokovane rezultatima dobivenima u podskupinama s mijelofibrozom nakon policitemije vere i mijelofibrozom nakon esencijalne trombocitemije.
Thrombocytopenia is generally reversible and is usually managed by reducing the dose or temporarily withholding Jakavi (see sections 4.2 and 4.8).
Trombocitopenija je općenito reverzibilna i obično se kontrolira smanjenjem doze ili privremenim prekidom primjene Jakavija (vidjeti dijelove 4.2 i 4.8).
The starting dose of Jakavi was 10 mg twice daily.
Početna doza Jakavija bila je 10 mg dvaput na dan.
If you stop taking Jakavi
Ako prestanete uzimati Jakavi
56 tablets.
56 tableta.
- St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
- Gospina trava (Hypericum perforatum), biljni lijek koji se primjenjuje za liječenje depresije.
Not all packs may be marketed in your country.
Na tržištu se ne moraju nalaziti sve veličine pakiranja.
The starting dose of Jakavi should be reduced in patients with severe renal impairment.
Početnu dozu Jakavija treba smanjiti u bolesnika s teškim oštećenjem bubrega.
Treatment with Jakavi can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia.
Liječenje Jakavijem može uzrokovati hematološke nuspojave na lijek, koje uključuju trombocitopeniju, anemiju i neutropeniju.
The most frequently reported adverse drug reactions were thrombocytopenia and anaemia.
Najčešće prijavljene nuspojave na lijek bile su trombocitopenija i anemija.
There are limited data to determine the best dosing options for patients with end-stage renal disease (ESRD) on haemodialysis.
Postoje ograničeni podaci za određivanje najbolje doze u bolesnika s terminalnim bubrežnim zatajenjem koji su na hemodijalizi.
Description of selected adverse drug reactions
Opis odabranih nuspojava uz lijek
Time points
Vremenske točke
Based on unbound AUC, the exposure at the NOAEL (no observed adverse effect level) in juvenile rats treated as early as postnatal day 7 was 0.3-fold that of adult patients at 25 mg twice daily, while reduced bone growth and fractures occurred at exposures that were 1.5- and 13-fold that of adult patients at 25 mg twice daily, respectively.
Na temelju nevezanog AUC-a, izloženost pri razini na kojoj nije uočen nikakav štetan učinak (no observed adverse effect level, NOAEL) u mladih štakora liječenih već od 7. postnatalnog dana iznosila je 0,3 puta one u odraslih bolesnika pri dozi od 25 mg dvaput dnevno, dok su se smanjeni rast kostiju i prijelomi javili pri izloženostima koje su bile 1,5 odnosno 13 puta veće od one u odraslih bolesnika pri dozi do 25 mg dvaput dnevno.
c grade 3 (> 5x - 20 x ULN)
c stupanj 3 (> 5x - 20 x GGN)
Myelofibrosis
Mijelofibroza
Very common (may affect more than 1 in 10 people): - high level of cholesterol or fat in the blood (hypertriglyceridaemia) - abnormal liver function test results - dizziness - headache - urinary tract infections - weight gain
Vrlo česte (mogu se javiti u više od 1 na 10 ljudi): - visoka razina kolesterola ili masnoća u krvi (hipertrigliceridemija) - poremećeni rezultati ispitivanja jetrene funkcije - omaglica - glavobolja - infekcije mokraćnog sustava - porast tjelesne težine
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.
Ruksolitinib inhibira JAK-STAT signalizaciju i proliferaciju stanica u celularnim modelima o citokinu ovisnih hematoloških malignosti, kao i onu Ba/F3 stanica koje je ekspresija JAK2V617F mutiranog proteina učinila neovisnim o citokinima, uz IC50 u rasponu od 80-320 nM.
Physicians should carefully observe patients receiving Jakavi for signs and symptoms of infections and initiate appropriate treatment promptly.
Liječnici trebaju u bolesnika koji primaju Jakavi pažljivo pratiti pojavu znakova i simptoma infekcija te pravovremeno započeti odgovarajuće liječenje.
Gastrointestinal bleeding
Gastrointestinalno krvarenje
Therefore, it is not anticipated that the contraceptive efficacy of this combination will be compromised by co-administration of ruxolitinib.
Stoga se ne očekuje da će istodobna primjena ruksolitiniba kompromitirati kontraceptivnu djelotvornost ove kombinacije.
- The recommended starting dose in myelofibrosis is 15 mg twice daily or 20 mg twice daily,
- Preporučena početna doza kod mijelofibroze je 15 mg dvaput na dan ili 20 mg dvaput na dan,
At week 32, 49% and 64% of patients treated with ruxolitinib achieved a ≥50% reduction in TSS-14 and TSS-5, respectively, compared to only 5% and 11% of patients on BAT.
U 32. tjednu 49% odnosno 64% bolesnika liječenih ruksolitinibom postiglo je smanjenje ≥50% u UZS-14 odnosno UZS-5, u usporedbi sa samo 5% odnosno 11% bolesnika na NDT-u.
Haematocrit control without phlebotomy
Kontrola hematokrita bez flebotomije
Driving and using machines If you experience dizziness after taking Jakavi, do not drive or use machines.
Ako osjetite omaglicu nakon uzimanja Jakavija, nemojte upravljati vozilom ili strojevima.
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
Od 301 bolesnika, 111 (36,9%) imalo je početni broj trombocita između 100 000/mm i 200 000/mm
The three most frequent non-haematological laboratory abnormalities (any CTCAE grade) identified as adverse reactions were raised aspartate aminotransferase (26.1%), raised alanine aminotransferase (22.3%) and hypercholesterolaemia (20.7%).
Tri najučestalije nehematološke laboratorijske abnormalnosti (bilo kojeg stupnja prema CTCAE-u) identificirane kao nuspojave bile su povišena aspartat aminotransferaza (26,1%), povišena alanin aminotransferaza (22,3%) i hiperkolesterolemija (20,7%).
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.
Od bolesnika koji su postigli primarni odgovor u 32. tjednu, 80% ih je zadržalo odgovor najmanje 48 tjedana nakon početnog odgovora.
In patients with severe renal impairment (creatinine clearance less than 30 ml/min) the recommended starting dose based on platelet count for MF patients should be reduced by approximately 50% to be administered twice daily.
U bolesnika s teškim oštećenjem bubrega (klirens kreatinina manji od 30 ml/min) preporučenu početnu dozu temeljenu na broju trombocita za bolesnike s MF-om treba smanjiti za otprilike 50% te je primjenjivati dvaput na dan.
A study in healthy subjects indicated that ruxolitinib did not inhibit the metabolism of the oral CYP3A4 substrate midazolam.
Ispitivanje u zdravih ispitanika ukazalo je da ruksolitinib nije inhibirao metabolizam peroralnog midazolama, supstrata CYP3A4.
MINIMUM PARTICULARS TO APPEAR ON BLISTER OR STRIPS
PODACI KOJE MORA NAJMANJE SADRŽAVATI BLISTER ILI STRIP BLISTERI
These metabolites have one half to one fifth of the parent JAK-related pharmacological activity.
Ti metaboliti imaju polovicu do petinu farmakološke aktivnosti koju posjeduje početna tvar na JAK.
In the pups, decreased mean initial body weights and short period of decreased mean body weight gain were observed.
Kod štenadi je bila uočena smanjena srednja početna tjelesna težina i kratko razdoblje smanjenog povećanja srednje tjelesne težine.
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).
CYP3A4 induktori (kao što su, između ostalih, avasimib, karbamazepin, fenobarbital, fenitoin, rifabutin, rifampin (rifampicin), gospina trava (Hypericum perforatum)) Bolesnike treba pažljivo pratiti te dozu titrirati na temelju sigurnosti i djelotvornosti (vidjeti dio 4.2).
There are no human data on the effect of ruxolitinib on fertility.
Nema podataka za ljude o učinku ruksolitiniba na plodnost.
Anaemia or thrombocytopenia CTCAE grade 3 and 4 were reported in respectively 1.1% or 3.3%.
Anemija ili trombocitopenija stupnja 3 ili 4 prema CTCAE-u bile su prijavljene u 1,1%, odnosno 3,3%.
Mild or moderate CYP3A4 inhibitors (such as, but not limited to, ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine)
Blagi ili umjereni CYP3A4 inhibitori (kao što su, između ostalih, ciprofloksacin, eritromicin, amprenavir, atazanavir, diltiazem, cimetidin)
The recommended starting dose for PV patients with severe renal impairment is 5 mg twice daily.
Preporučena početna doza za bolesnike s PV-om s teškim oštećenjem bubrega je 5 mg dvaput na dan.
Another study in healthy subjects indicated that ruxolitinib does not affect the pharmacokinetics of an oral contraceptive containing ethinylestradiol and levonorgestrel.
Drugo ispitivanje u zdravih ispitanika ukazalo je da ruksolitinib ne utječe na farmakokinetiku oralnog kontraceptiva koji sadrži etinilestradiol i levonorgestrel.
Ruxolitinib inhibits cytokine-induced STAT3 phosphorylation in whole blood from healthy subjects, MF patients and PV patients.
Ruksolitinib inhibira fosforilaciju STAT3 potaknutu citokinima u punoj krvi zdravih ispitanika, bolesnika s MF-om i bolesnika s PV-om.
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).
Janus Associated Kinases) JAK1 i JAK2 (IC50 vrijednost od 3,3 nM za enzim JAK1, odnosno 2,8 nM za JAK2).
An extended follow-up of patients treated with ruxolitinib showed no trends towards an increase in the rate of sepsis over time.
Produženo praćenje bolesnika liječenih ruksolitinibom nije pokazalo trend povećanja stope sepse tijekom vremena.
Figure 1 Patients achieving the primary endpoint and components of the primary endpoint at week 32
Slika 1 Bolesnici koji su postigli mjeru primarnog ishoda i komponente mjere primarnog ishoda u 32. tjednu
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.
Preporučuje se učestalije praćenje hematoloških parametara i kliničkih znakova i simptoma nuspojava na lijek povezanih s Jakavijem za bolesnike s početnom razinom hemoglobina ispod 10,0 g/dl.
Dose reductions should be considered if the platelet count decreases below 100,000/mm
Treba razmotriti smanjivanje doze ako se razina trombocita snizi na manje od 100 000/mm
How Jakavi works
Kako Jakavi djeluje
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.
U ključnim kliničkim ispitivanjima MF-a faze 3 zabilježeno je povišenje sistoličkog krvnog tlaka od 20 mmHg ili više u odnosu na početnu vrijednost u 31,5% bolesnika tijekom barem jednog posjeta u usporedbi s 19,5% bolesnika koji su primali kontrolnu terapiju.
- The other ingredients are: microcrystalline cellulose, magnesium stearate, colloidal anhydrous silica, sodium starch glycolate, povidone, hydroxypropylcellulose, lactose monohydrate.
- Drugi sastojci su: mikrokristalična celuloza, magnezijev stearat, koloidni bezvodni silicijev dioksid, natrijev škroboglikolat, povidon, hidroksipropilceluloza, laktoza hidrat.
- The maximum dose is 25 mg twice daily.
- Najveća doza je 25 mg dvaput na dan.
Ruxolitinib is a Biopharmaceutical Classification System (BCS) class 1 compound, with high permeability, high solubility and rapid dissolution characteristics.
Biopharmaceutical Classification System, BCS), visoke permeabilnosti, visoke topivosti i brzog otapanja.
The concomitant use of cytoreductive therapies or haematopoietic growth factors with Jakavi has not been studied.
Istodobna primjena citoreduktivnih terapija ili hematopoetskih čimbenika rasta s Jakavijem nije do sada ispitivana.
Treatment benefit perception was measured by the Patient Global Impression of Change (PGIC) questionnaire.
Patient Global Impression of Change, PGIC).
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.
Nakon jednokratne doze ruksolitiniba od 25 mg, izloženost ruksolitinibu bila je slična u ispitanika s različitim stupnjevima oštećenja bubrega te u onih s normalnom funkcijom bubrega.
A single dose of 15 mg is recommended for MF patients with platelet count between 100,000/mm and 200,000/mm
Jednokratna doza od 15 mg se preporučuje za bolesnike s MF-om s brojem trombocita između 100 000/mm i 200 000/mm
In COMFORT-I, 45.9% subjects in the Jakavi group achieved a ≥50% improvement from baseline in the week 24 total symptom score (measured using MFSAF diary v2.0), as compared to 5.3% in the placebo group (p<0.0001 using chi-square test).
U ispitivanju COMFORT-I, 45,9% ispitanika u skupini koja je primala Jakavi postiglo je poboljšanje ≥50% u odnosu na početnu vrijednosti u ukupnom zbroju simptoma u 24. tjednu (mjereno pomoću dnevnika MFSAF v2.0), u usporedbi s 5,3% u placebo skupini (p<0,0001 koristeći hi-kvadrat test).
It is unknown whether ruxolitinib and/or its metabolites are excreted in human milk.
Nije poznato izlučuje li se ruksolitinib i/ili metaboliti u majčino mlijeko u ljudi.
Complete blood counts should be monitored as clinically indicated and dose adjusted as required (see sections 4.2 and 4.8).
Kompletnu krvnu sliku treba pratiti sukladno kliničkim indikacijama te prema potrebi prilagoditi dozu (vidjeti dijelove 4.2 i 4.8).
Therapeutic drug monitoring (TDM) or clinical monitoring of the affected substance is advised.
Savjetuje se terapijsko praćenje koncentracije lijeka ili kliničko praćenje tvari na koje to utječe.
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
Bolesnici s brojem trombocita od 100 000/mm do 200 000/mm prije početka liječenja ruksolitinibom imali su veću učestalost trombocitopenije stupnja 3 ili 4 u usporedbi s bolesnicima s razinom trombocita >200 000/mm
In juvenile rat studies, administration of ruxolitinib resulted in effects on growth and bone measures.
U ispitivanjima na mladim štakorima primjena ruksolitiniba rezultirala je učincima na rast i dimenziju kostiju.
In the randomised, placebo-controlled study COMFORT-I 60.6% of Jakavi-treated MF patients and 37.7% of placebo-treated MF patients received red blood cell transfusions during randomised treatment.
U randomiziranom, placebom kontroliranom ispitivanju COMFORT-I 60,6% bolesnika s MF-om liječenih Jakavijem i 37,7% bolesnika s MF-om koji su primali placebo primilo je transfuziju eritrocita tijekom randomiziranog liječenja.
The three most frequent non-haematological adverse drug reactions were bruising (21.3%), dizziness (15.3%) and headache (14.0%).
Tri najučestalije nehematološke nuspojave na lijek bile su modrice (21,3%), omaglica (15,3%) i glavobolja (14,0%).
The three most frequent non-haematological laboratory abnormalities were raised alanine aminotransferase (27.2%), raised aspartate aminotransferase (19.9%) and hypercholesterolaemia (16.9%).
Tri najučestalije nehematološke laboratorijske patološke vrijednosti bile su povišena alanin aminotransferaza (27,2%), povišena aspartat aminotransferaza (19,9%) i hiperkolesterolemija (16,9%).
Hypercholesterolaemia b
Hiperkolesterolemija b
In the phase 3 pivotal studies in MF, grade 3 or 4 urinary tract infection was reported in 1.0% of patients, herpes zoster in 4.3% and tuberculosis in 1.0%.
U ključnim ispitivanjima MF-a faze 3 infekcije mokraćnog sustava stupnja 3 ili 4 bile su prijavljene u 1,0% bolesnika, herpes zoster u 4,3% te tuberkuloza u 1,0%.
Other bleeding events (including events such as epistaxis, post-procedural haemorrhage and haematuria) were reported in 13.3% of patients treated with ruxolitinib and 10.3% treated with reference treatments.
Ostali događaji krvarenja (uključujući događaje kao što je epistaksa, postproceduralno krvarenje i hematurija) bili su prijavljeni u 13,3% bolesnika liječenih ruksolitinibom te u 10,3% liječenih referentnim terapijama.
Gastrointestinal bleeding was reported in 5.0% of patients exposed to ruxolitinib compared to 3.1% exposed to reference treatments.
Gastrointestinalno krvarenje bilo je prijavljeno u 5,0% bolesnika izloženih ruksolitinibu u usporedbi s 3,1% bolesnika izloženih referentnim terapijama.
Novartis Farmacéutica S.A. Ronda de Santa Maria 158 08210 Barberà del Vallès, Barcelona Spain
08210 Barberà del Vallès, Barcelona Španjolska
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.
Jakavi je indiciran za liječenje splenomegalije povezane s bolesti ili simptoma u odraslih bolesnika s primarnom mijelofibrozom (koja se naziva i kroničnom idiopatskom mijelofibrozom), mijelofibrozom nakon policitemije vere ili mijelofibrozom nakon esencijalne trombocitemije.
No effects were noted in an evaluation of the neuropharmacological effects of ruxolitinib.
Nisu bili uočeni nikakvi učinci u procjenjivanju neurofarmakoloških učinaka ruksolitiniba.
A causal relationship to ruxolitinib has not been established.
Uzročno-posljedična veza s ruksolitinibom nije utvrđena.
In phase 3 clinical studies in MF, median time to onset of first CTCAE grade 2 or higher anaemia was 1.5 months.
U kliničkim ispitivanjima MF-a faze 3, medijan vremena do prve anemije stupnja 2 ili višeg prema CTCAE-u bio je 1,5 mjesec.
Ruxolitinib dose can be titrated to reduce the risk of cytopenia.
Doza ruksolitiniba može se titrirati da bi se smanjio rizik od citopenije.
In the randomised period of the pivotal studies, the rate of patients experiencing thrombocytopenia was lower in PV (16.8%) patients compared to MF (69.8%) patients.
U razdoblju randomizacije ključnih ispitivanja, stopa bolesnika u kojih se pojavila trombocitopenija bila je niža kod bolesnika s PV-om (16,8%) u usporedbi s bolesnicima s MF-om (69,8%).
INTERMEDIATE CARTON OF MULTIPACK
SREDNJA KUTIJA VIŠESTRUKOG PAKIRANJA
More frequent monitoring (e.g. twice a week) of haematology parameters and of clinical signs and symptoms of ruxolitinib-related adverse drug reactions is recommended while on strong CYP3A4 inhibitors or dual inhibitors of CYP2C9 and CYP3A4 enzymes.
Preporučuje se učestalije praćenje (npr. dvaput tjedno) hematoloških parametara te kliničkih znakova i simptoma nuspojava na lijek povezanih s ruksolitinibom tijekom primjene snažnih CYP3A4 inhibitora ili dvostrukih inhibitora enzima CYP2C9 i CYP3A4.
Haematological adverse reactions (any CTCAE grade) included anaemia (40.8%) and thrombocytopenia (16.8%).
Hematološke nuspojave (bilo kojeg stupnja prema CTCAE-u) uključivale su anemiju (40,8%) i trombocitopeniju (16,8%).
In the randomised period of the pivotal study in PV patients, neutropenia was reported in three patients (1.6%) of which one patient developed CTCAE grade 4 neutropenia.
U razdoblju randomizacije ključnog ispitivanja u bolesnika s PV-om neutropenija je bila prijavljena u tri bolesnika (1,6%), od čega se u jednoga bolesnika razvila neutropenija stupnja 4 prema CTCAE-u.
The dose of Jakavi depends on the patient's blood cell count.
Doza Jakavija ovisi o bolesnikovoj krvnoj slici.
In COMFORT-II, after a median follow-up of 55.9 months, the death rate in patients randomised to the ruxolitinib arm was 40.4% (59 of 146 patients) versus 47.9% (35 of 73 patients) in patients randomized to best available therapy (BAT).
U ispitivanju COMFORT-II, nakon medijana praćenja od 55,9 mjeseci, stopa smrtnosti u bolesnika randomiziranih na ruksolitinib bila je 40,4% (59 od 146 bolesnika) naspram 47,9% (35 od 73 bolesnika) u bolesnika randomiziranih na najbolju dostupnu terapiju (NDT).
- if you have any of the following symptoms or if anyone close to you notices that you have any of these symptoms: confusion or difficulty thinking, loss of balance or difficulty walking, clumsiness, difficulty speaking, decreased strength or weakness on one side of your body, blurred and/or loss of vision.
- ako osjetite vrućicu, zimicu ili druge simptome infekcija. - ako imate kroničan kašalj s krvavo obojenim iskašljajem, vrućicu, noćno znojenje i gubitak tjelesne težine (to mogu biti znakovi tuberkuloze). - ako imate bilo koji od sljedećih simptoma ili ako netko blizu Vas primijeti da imate bilo koji od ovih simptoma: smetenost ili poteškoće u razmišljanju, gubitak ravnoteže ili poteškoće u hodanju, nespretnost, poteškoće s govorom, smanjena snaga ili slabost na jednoj strani tijela, zamućeni vid i/ili gubitak vida.
Stopping Jakavi
Prekid uzimanja Jakavija