natgillin/translations-raw huggingface dataset:
In the best available therapy arm, 47% of patients received hydroxyurea and 16% of patients received glucocorticoids.
U skupini koja je primala najbolju dostupnu terapiju, 47% bolesnika primalo je hidroksiureju, a 16% bolesnika primalo je glukokortikoide.
There are no data from the use of Jakavi in pregnant women.
Nema podataka o primjeni Jakavija u trudnica.
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.
Bolesnici u skupini koja je primala ruksolitinib imali su dijagnozu PV-a tijekom medijana od 8,2 godine i prethodno su primali hidroksiureju tijekom medijana od otprilike 3 godine.
- ADRs reported are on treatment or up to 28 days post treatment end date.
- Prijavljene nuspojave na lijek pojavile su se tijekom liječenja ili do 28 dana nakon zadnjeg dana liječenja.
If you interrupt your treatment with Jakavi your myelofibrosis-related symptoms may come back.
Ako prekinete liječenje Jakavijem Vaši simptomi povezani s mijelofibrozom mogli bi se vratiti.
If you accidentally take more Jakavi than your doctor prescribed, contact your doctor or pharmacist immediately.
Ako slučajno uzmete više Jakavija nego što Vam je liječnik propisao, odmah se obratite svom liječniku ili ljekarniku.
Haemodialysis is not expected to enhance the elimination of ruxolitinib.
Ne očekuje se da će hemodijaliza povećati eliminaciju ruksolitiniba.
Based on studies in healthy subjects, no relevant differences in ruxolitinib pharmacokinetics were observed with regard to gender and race.
Na temelju ispitivanja u zdravih ispitanika nisu bile uočene relevantne razlike u farmakokinetici ruksolitiniba s obzirom na spol i rasu.
Ruxolitinib is mainly metabolised by CYP3A4 (>50%), with additional contribution from CYP2C9.
Ruksolitinib se uglavnom metabolizira putem CYP3A4 (>50%), uz dodatni doprinos CYP2C9.
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.
Preporučuje se da se u bolesnika kod kojih je vidljiv određeni stupanj kliničkog poboljšanja, terapija ruksolitinibom prekine ako perzistira povećanje u duljini slezene od 40% u usporedbi s početnom duljinom (otprilike ekvivalentno povećanju volumena slezene od 25%) i ako više nemaju opipljivih poboljšanja simptoma povezanih s bolešću.
In COMFORT-I and COMFORT-II, patient baseline demographics and disease characteristics were comparable between the treatment arms.
U COMFORT-I i COMFORT-II, početne demografske karakteristike bolesnika i karakteristike bolesti bile su usporedive između terapijskih skupina.
In a population pharmacokinetic evaluation in MF patients, no relationship was apparent between oral clearance and patient age or race.
U ocjenjivanju populacijske farmakokinetike u bolesnika s MF-om nije bilo očite veze između oralnog klirensa i bolesnikove dobi ili rase.
Based on a human mass balance study, oral absorption of ruxolitinib, as ruxolitinib or metabolites formed under first-pass, is 95% or greater.
Na temelju ispitivanja masene bilance u ljudi, oralna apsorpcija ruksolitiniba, koja obuhvaća ruksolitinib ili metabolite koji se stvaraju uslijed prvog prolaska kroz jetru, je 95% ili veća.
MF patients did not become refractory to the pharmacodynamic effects of ruxolitinib treatment over time.
Bolesnici s MF-om nisu postali refraktorni na farmakodinamičke učinke liječenja ruksolitinibom tijekom vremena.
Jakavi treatment should only be initiated by a physician experienced in the administration of anti-cancer medicinal products.
Liječenje Jakavijem smije započeti samo liječnik koji ima iskustva u primjeni antitumorskih lijekova.
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%.
U populaciji s PV-om, događaji stupnja 3 i 4 prema CTCAE-u bili su prijavljeni u 2,7%, dok je u bolesnika s MF-om učestalost bila 42,56%.
In animal studies, no effect on fertility was observed.
U ispitivanjima na životinjama nije uočen učinak na plodnost.
Some are very common (may affect more than 1 in 10 people), some are common (may affect up to 1 in 10 people): - any sign of bleeding in the brain, such as sudden altered level of consciousness, persistent headache, numbness, tingling, weakness or paralysis (common) - any sign of bleeding in the stomach or intestine, such as passing black or bloodstained stools, or vomiting blood (common) - unexpected bruising and/or bleeding, unusual tiredness, shortness of breath during exercise or at rest, unusually pale skin, or frequent infections (possible symptoms of blood disorders) (very common) - painful skin rash with blisters (possible symptoms of shingles (herpes zoster)) (common) - fever, chills or other symptoms of infections (very common) - low level of red blood cells (anaemia), low level of white blood cells (neutropenia) or low level of platelets (thrombocytopenia) (very common)
Neke su vrlo česte (mogu se javiti u više od 1 na 10 osoba), neke su česte (mogu se javiti u do 1 na 10 osoba): - bilo koji znak krvarenja u mozgu, kao što je iznenadna promjena razine svijesti, ustrajna glavobolja, obamrlost, trnci, slabost ili paraliza (često) - bilo koji znak krvarenja u želucu ili crijevima, kao što su crna ili krvava stolica ili povraćanje krvi (često) - neočekivane modrice i/ili krvarenje, neuobičajen umor, nedostatak zraka tijekom fizičke aktivnosti ili u mirovanju, neuobičajeno blijeda koža ili česte infekcije (mogući simptomi poremećaja krvi) (vrlo često) - bolni kožni osip s mjehurićima (mogući simptomi herpesa zoster) (često) - vrućica, zimica ili drugi simptomi infekcija (vrlo često) - niska razina eritrocita (anemija), niska razina leukocita (neutropenija) ili niska razina trombocita (trombocitopenija) (vrlo često)
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).
Kompletnu krvnu sliku, uključujući i diferencijalnu krvnu sliku leukocita, treba pratiti svaka 2-4 tjedna dok se doze Jakavija ne stabiliziraju, a nakon toga u skladu s kliničkim indikacijama (vidjeti dio 4.4).
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.
Ispitivanje djelotvornosti nakon stavljanja lijeka u promet radi pružanja podataka o dugoročnoj djelotvornosti i sigurnosti primjene ruksolitiniba uključujući (kasno) postignute odgovore, trajanje (različitih) odgovora, kao i incidenciju štetnih događaja uključujući hematološku transformaciju i sekundarne malignitete iz ispitivanja B2301.
Animal studies have shown that ruxolitinib is embryotoxic and foetotoxic.
Ispitivanja na životinjama pokazala su da je ruksolitinib embriotoksičan i fetotoksičan.
Anaemia b
Anemija b
This includes prescription medicines, non-prescription medicines and herbal or alternative medicines.
To uključuje lijekove koji se izdaju na recept, lijekove koji se izdaju bez recepta te biljne ili alternativne lijekove.
Neutropenia (absolute neutrophil count <500) was generally reversible and was managed by temporarily withholding Jakavi (see sections 4.2 and 4.8).
Neutropenija (apsolutni broj neutrofila <500) općenito je bila reverzibilna i kontrolirana privremenim prekidom primjene Jakavija (vidjeti dijelove 4.2 i 4.8).
Physicians should educate patients about early signs and symptoms of herpes zoster, advising that treatment should be sought as early as possible.
Liječnici trebaju upoznati bolesnike s ranim znakovima i simptomima herpesa zostera, te ih upozoriti da liječenje treba započeti čim je moguće prije.
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.
U programu kliničkih ispitivanja težina nuspojava na lijek bila je ocijenjena na temelju CTCAE-a, koji definira stupanj 1= blago, stupanj 2= umjereno, stupanj 3= teško i stupanj 4= opasno po život.
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.
Predviđeni oralni klirens bio je 17,7 l/h u žena te 22,1 l/h u muškaraca, uz varijabilnost između ispitanika s MF-om od 39%.
Lipid monitoring and treatment of dyslipidaemia according to clinical guidelines is recommended.
Preporučuje se praćenje lipida i liječenje dislipidemije prema kliničkim smjernicama.
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.
Pri klinički relevantnim koncentracijama, ruksolitinib ne inhibira CYP1A2, CYP2B6, CYP2C8, CYP2C9, CYP2C19, CYP2D6 ili CYP3A4 i nije snažan CYP1A2, CYP2B6 ili CYP3A4 induktor na temelju in vitro ispitivanja.
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.
U osnovnom ispitivanju QT intervala u zdravih ispitanika nije bilo naznaka učinka ruksolitiniba u obliku produljenja QT/QTc intervala pri jednostrukim dozama do supraterapijske doze od 200 mg, što upućuje na to da ruksolitinib nema učinak na srčanu repolarizaciju.
Discontinuation due to adverse events, regardless of causality, was observed in 2.2% of patients.
Prekid uzrokovan štetnim događajima, bez obzira na uzročno-posljedičnu vezu, bio je uočen u 2,2% bolesnika.
No intracranial bleeding or gastrointestinal haemorrhage events were reported in patients receiving ruxolitinib.
Nisu bili zabilježeni događaji intrakranijalnog krvarenja ili gastrointestinalnog krvarenja u bolesnika koji su primali ruksolitinib.
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.
Bolesnicima kojima je dijagnosticirano oštećenje jetre dok uzimaju ruksolitinib treba pratiti kompletnu krvnu sliku, uključujući i diferencijalnu krvnu sliku leukocita, najmanje svakih tjedan do dva tijekom prvih 6 tjedana od uvođenja terapije ruksolitinibom te u skladu s kliničkim indikacijama nakon što im se funkcija jetre i krvna slika stabiliziraju.
Ruxolitinib is eliminated through metabolism catalysed by CYP3A4 and CYP2C9.
Ruksolitinib se eliminira kroz metabolizam kataliziran pomoću CYP3A4 i CYP2C9.
In PV, dose reductions should also be considered if haemoglobin decreases below 12 g/dl and is recommended if it decreases below 10 g/dl.
Kod PV-a, smanjivanje doze treba razmotriti i ako se hemoglobin smanji ispod 12 g/dl te se preporučuje ako se smanji ispod 10 g/dl.
P value: < .0001 Odds ratio (ruxolitinib/BAT) and 95% CI:
P-vrijednost: < 0,0001 Omjer izgleda (ruksolitinib/NDT) i 95% CI:
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.
Vjeruje se da temelj za disregulaciju uključuje visoke razine cirkulirajućih citokina koje aktiviraju put JAK-STAT, mutacije dobivanja nove funkcije (engl. gain-offunction) kao što su JAK2V617F, te zatomljavanje negativnih regulatornih mehanizama.
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).
Nije poznato smanjuje li inhibicija Janus kinaze (JAK) koju vrši ruksolitinib djelotvornost hematopoetskih čimbenika rasta ili utječu li hematopoetski čimbenici rasta na djelotvornost ruksolitiniba (vidjeti dio 4.4).
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).
Oni uključuju lijekove za liječenje gljivičnih bolesti (kao što su ketokonazol, itrakonazol, posakonazol, flukonazol i vorikonazol), lijekove koji se primjenjuju za liječenje određenih vrsta bakterijskih infekcija (antibiotici kao što su klaritromicin, telitromicin, ciprofloksacin, ili eritromicin), lijekove za liječenje virusnih infekcija, uključujući infekciju HIV-om/AIDS (kao što su amprenavir, atazanavir, indinavir, lopinavir/ritonavir, nelfinavir, ritonavir, sakvinavir), lijekove za liječenje hepatitisa C (boceprevir, telaprevir).
Anaemia, thrombocytopenia and neutropenia are dose-related effects.
Anemija, trombocitopenija i neutropenija su nuspojave povezane s dozom.
Significantly more patients treated with Jakavi (23%) achieved a primary response (p<0.0001) compared to BAT (0.9%).
Značajno više bolesnika liječenih Jakavijem (23%) postiglo je primarni odgovor (p<0,0001) u usporedbi s NDT-om (0,9%).
What Jakavi contains - The active substance of Jakavi is ruxolitinib.
Što Jakavi sadrži - Djelatna tvar Jakavija je ruksolitinib.
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.
Granice (na temelju nevezanog Cmax) pri razinama koje nisu štetne u ispitivanjima na psima i štakorima bila su 15,7 odnosno 10,4-puta veća od najveće preporučene doze u ljudi od 25 mg dvaput na dan.
There was no clinically relevant change in the pharmacokinetics of ruxolitinib upon administration with a high-fat meal.
Nije bilo klinički relevantne promjene u farmakokinetici ruksolitiniba po primjeni obroka s visokim udjelom masnoća.
The maximum recommended starting dose in these patients is 5 mg twice daily and the patients should be titrated cautiously.
Najveća preporučena početna doza u tih bolesnika iznosi 5 mg dvaput na dan, pri čemu dozu kod tih bolesnika treba oprezno titrirati.
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).
Značajno viši udio bolesnika u skupini koja je primala Jakavi postigao je smanjenje volumena slezene ≥35% u odnosu na početnu vrijednosti (Tablica 2) bez obzira na prisutnost ili odsutnost JAK2V617F mutacije ili podtipa bolesti (primarni MF, MF kao posljedica policitemije vere, MF kao posljedica esencijalne trombocitopenije).
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)
Tablica 2 Postotak bolesnika sa smanjenjem u volumenu slezene ≥35% od početne vrijednosti u 24. tjednu u COMFORT-I, te u 48. tjednu u COMFORT-II (ITT)
Target organs associated with the pharmacological action of ruxolitinib in repeated dose studies include bone marrow, peripheral blood and lymphoid tissues.
Ciljni organi povezani s farmakološkim djelovanjem ruksolitiniba u ispitivanjima ponovljenih doza uključuju koštanu srž, perifernu krvi i limfoidna tkiva.
Further dose modifications should be based on the safety and efficacy of the medicinal product (see sections 4.2 and 5.2).
Daljnje promjene doze trebaju se temeljiti na sigurnosti i djelotvornosti lijeka (vidjeti dijelove 4.2 i 5.2).
MF patients exhibit dysregulated JAK signalling regardless of JAK2V617F mutation status.
MF-om pokazuju disreguliranu JAK signalizaciju bez obzira na status mutacije JAK2V617F.
When you stop taking Jakavi, the myelofibrosis symptoms may come back.
Kad prestanete uzimati Jakavi, simptomi mijelofibroze mogli bi se vratiti.
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.
Ruksolitinib je rezultirao maksimalnom inhibicijom STAT3 fosforilacije 2 sata nakon doze koja se vratila na vrijednost blizu početne nakon 8 sati kod zdravih ispitanika i kod bolesnika s MF-om, što upućuje na to nema nakupljanja ni osnovne tvari ni aktivnih metabolita.
During the randomised period, dose holding or reductions due to neutropenia were reported in 1.0% of patients, and 0.3% of patients discontinued treatment because of neutropenia.
Tijekom razdoblja randomizacije, zadržavanje iste doze ili smanjenja doze zbog neutropenije bila su prijavljena u 1,0% bolesnika, a 0,3% bolesnika prekinulo je terapiju zbog neutropenije.
If you forget to take Jakavi
Ako ste zaboravili uzeti Jakavi
Table 3 Percentage of patients with ≥35% reduction from baseline in spleen volume by JAK mutation status (safety set)
Tablica 3 Postotak bolesnika sa smanjenjem volumena slezene ≥35% u odnosu na početnu vrijednost prema statusu JAK mutacije (sigurnosna skupina)
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.
U kliničkim ispitivanjima MF-a faze 3 nisu bili uočeni ni hiperkolesterolemija stupnja 3 ili 4 prema CTCAE-u, ni povišenje aspartat aminotransferaze, ni povišenje alanin aminotransferaze stupnja 4 prema CTCAE-u.
Patients were randomised 2:1 to ruxolitinib versus best available therapy.
Bolesnici su bili randomizirani u omjeru 2:1 na ruksolitinib u odnosu na najbolju dostupnu terapiju.
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).
Smanjeni rast kostiju bio je uočen pri dozama ≥5 mg/kg/dan kada je liječenje započelo 7. postnatalnog dana (usporedivo s ljudskim novorođenčem) i pri dozama ≥15 mg/kg/dan kada je liječenje započelo 14. ili 21. postnatalnog dana (usporedivo s ljudskim dojenčem u dobi od 1. do 3. godine).
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.
Međutim, AUC vrijednosti metabolita ruksolitiniba u plazmi bile su sklone povećavanju uz povećanu težinu oštećenja bubrega te su bile najizraženije povećane u ispitanika s teškim oštećenjem bubrega.
Within each system organ class, the adverse drug reactions are ranked by frequency, with the most frequent reactions first.
Unutar svake klasifikacije organskog sustava, nuspojave na lijek su poredane po učestalosti, pri čemu su najučestalije nuspojave navedene prve.
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%).
U bolesnika s razinom hemoglobina ispod 10,0 g/dl na početku liječenja veći je rizik od pada razine hemoglobina ispod 8,0 g/dl tijekom liječenja u usporedbi s bolesnicima s višom početnom razinom hemoglobina (79,3% u odnosu na 30,1%).
Treatment with Jakavi has been associated with increases in lipid parameters including total cholesterol, high-density lipoprotein (HDL) cholesterol, low-density lipoprotein (LDL) cholesterol, and triglycerides.
Liječenje Jakavijem je povezano s povišenjima u lipidnim parametrima, uključujući ukupni kolesterol, kolesterol vezan na lipoproteine visoke gustoće (HDL), kolesterol vezan na lipoproteine niske gustoće (LDL) i trigliceride.
Adverse drug reactions from clinical studies (Table 1) are listed by MedDRA system organ class.
Nuspojave na lijek iz kliničkih ispitivanja (Tablica 1) navedene su prema klasifikaciji organskih sustava po MedDRA-i.
Dose modifications
Promjene doze
Most of these patients had histories of extended treatment with hydroxyurea and prior NMSC or pre-malignant skin lesions.
Većina tih bolesnika imala je u anamnezi produljeno liječenje hidroksiurejom i prethodni nemelanomski rak kože ili premaligne kožne lezije.
14 tablets
14 tableta
Thrombocytopenia was generally reversible with dose reduction or dose interruption.
Trombocitopenija je općenito bila reverzibilna uz smanjenje doze ili prekid uzimanja doze.
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.
U ispitivanju pred- i postnatalnog razvoja bilo je uočeno blago produženo razdoblje gestacije, smanjeni broj mjesta implantacije te smanjeni broj štenadi u okotu.
In the randomised period of the pivotal studies, anaemia was less frequent in PV patients than in MF patients (40.8% versus 82.4%).
U razdoblju randomizacije ključnih ispitivanja, anemija je bila manje učestala u bolesnika s PV-om nego u bolesnika s MF-om (40,8% naspram 82,4%).
These ADRs are discussed in the text.
Ove su nuspojave na lijek opisane u tekstu.
With these updated data, therapy discontinuation due to adverse events was observed in 27.4% of patients treated with ruxolitinib.
S tim ažuriranim podacima, prekid terapije zbog štetnih događaja uočen je u 27,4% bolesnika liječenih ruksolitinibom.
Mean ruxolitinib Cmax and total exposure (AUC) increased proportionally over a single dose range of 5-200 mg.
Srednji Cmax i ukupna izloženost (AUC) ruksolitinibu razmjerno su se povećali u rasponu jednostruke doze od 5 do 200 mg.
110 patients were randomised to the ruxolitinib arm and 112 patients to the BAT arm.
110 bolesnika bilo je randomizirano u skupinu koja je primala ruksolitinib, a 112 bolesnika u skupinu koja je primala NDT.
Bruising events were more frequently reported in patients taking ruxolitinib compared with the reference treatments (21.3% versus 11.6%).
Modrice su bile češće prijavljivane u bolesnika koji su uzimali ruksolitinib u usporedbi s referentnim terapijama (21,3% u odnosu na 11,6%).
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.
Nakon jednokratne doze ruksolitiniba od 25 mg u bolesnika s različitim stupnjevima oštećenja jetre, srednji AUC za ruksolitinib bio je povećan u bolesnika s blagim, umjerenim i teškim oštećenjem jetre za 87%, 28% odnosno 65%, u usporedbi s bolesnicima s normalnom funkcijom jetre.
There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and <100,000/mm 3.
Postoje ograničene informacije o preporučenoj početnoj dozi za bolesnike s brojem trombocita između 50 000/mm i <100 000/mm
For patients with end-stage renal disease on haemodialysis the starting dose for MF patients should be based on platelet counts (see section 4.2).
Za bolesnike s terminalni bubrežnim zatajenjem koji su na hemodijalizi, početna se doza za bolesnike s MF-om treba temeljiti na razinama trombocita (vidjeti dio 4.2).
Cytoreductive therapies
Citoreduktivne terapije
Fractures and early termination of rats were observed at doses ≥30 mg/kg/day when treatment was started on postnatal day 7.
Prijelomi i rana smrt štakora uočeni su pri dozama ≥30 mg/kg/dan kada je liječenje započelo 7. postnatalnog dana.