natgillin/translations-raw huggingface dataset:
No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors (e.g. erythromycin).
Ne preporučuje se prilagođavanje doze kada se ruksolitinib primjenjuje istodobno s blagim ili umjerenim CYP3A4 inhibitorima (npr. eritromicinom).
c grade 3 (50,000 - 25,000/mm
c stupanj 3 (50 000 - 25 000/mm
Percentage e of patients
Postotak bolesnika
Haematocrit control was achieved in 60% of patients in the Jakavi arm compared to 18.8% in the BAT arm and a ≥35% reduction in spleen volume was achieved in 40% of patients in the Jakavi arm compared to 0.9% in the BAT arm (Figure 1).
Kontrola hematokrita bila je postignuta u 60% bolesnika u Jakavi skupini u usporedbi s 18,8% u NDT skupini, a smanjenje ≥35% u volumenu slezene postignuto je u 40% bolesnika u Jakavi skupini u usporedbi s 0,9% u NDT skupini (Slika 1).
Haematological adverse drug reactions (any Common Terminology Criteria for Adverse Events [CTCAE] grade) included anaemia (82.4%), thrombocytopenia (69.8%) and neutropenia (16.6%).
Common Terminology Criteria for Adverse Events, CTCAE)) uključivale su anemiju (82,4%), trombocitopeniju (69,8%) i neutropeniju (16,6%).
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.
U ispitivanju COMFORT-II stopa transfuzija koncentrata eritrocita bila je 53,4% u Jakavi kraku te 41,1% u kraku s najboljom dostupnom terapijom.
Treatment should be discontinued for platelet counts less than 50,000/mm or absolute neutrophil counts less than 500/mm
Liječenje treba prekinuti ako je broj trombocita manji od 50 000/mm ili ako je apsolutni broj neutrofila manji od 500/mm
c grade 3 (<8.0 - 6.5g/dl)
c stupanj 3 (<8,0 - 6,5 g/dl)
How to take Jakavi
Kako uzimati Jakavi
During the randomised period, platelet transfusions were administered to 4.7% of patients receiving ruxolitinib and to 4.0% of patients receiving control regimens.
Tijekom razdoblja randomizacije, transfuzije trombocita bile su primijenjene kod 4,7% bolesnika koji su primali ruksolitinib te kod 4,0% bolesnika koji su primali kontrolne režime.
The key secondary endpoint defined as the proportion of patients achieving complete haematological remission at week 28 was also met (23.0% in the Jakavi arm versus 5.3% in the BAT arm).
Ključna mjera sekundarnog ishoda definirana kao udio bolesnika koji su postigli kompletnu hematološku remisiju u 28. tjednu je također postignuta (23,0% u Jakavi skupini u odnosu na 5,3% u skupini s najboljom dostupnom terapijom).
Hepatobiliary disorders Raised alanine aminotransferase b
Poremećaji jetre i žuči Povišena alanin aminotransferaza b
Intracranial bleeding was reported in 1% of patients exposed to ruxolitinib and 0.9% exposed to reference treatments.
Intrakranijalno krvarenje bilo je prijavljeno u 1% bolesnika izloženih ruksolitinibu te u 0,9% bolesnika izloženih referentnim terapijama.
In patients with any hepatic impairment the recommended starting dose based on platelet count should be reduced by approximately 50% to be administered twice daily.
U bolesnika s bilo kakvim oštećenjem jetre preporučenu početnu dozu temeljenu na broju trombocita treba smanjiti za otprilike 50% te primjenjivati dvaput na dan.
Long term safety data from two pivotal phase 3 studies assessed 457 patients with MF who were treated with ruxolitinib, including patients initially randomised to ruxolitinib (n=301; exposure 0.368.1 months, median exposure 33.4 months) and patients who received ruxolitinib after crossing over from control treatments (n=156; exposure: 0.5-59.8 months, median exposure 25.0 months).
Podaci dugoročne sigurnosti iz dva ključna ispitivanja faze 3 procjenjivali su 457 bolesnika s MF-om liječenih ruksolitinibom, uključujući bolesnike inicijalno randomizirane na ruksolitinib (n=301; izloženost 0,3-68,1 mjeseci, medijan izloženosti 33,4 mjeseca) i bolesnike koji su primali ruksolitinib nakon prelaska iz kontrolnih skupina (n=156; izloženost 0,5-59,8 mjeseci, medijan izloženosti 25,0 mjeseca).
The primary endpoint defined as the proportion of patients achieving HCT control (absence of phlebotomy eligibility) at week 28 was met (62.2% in the Jakavi arm versus 18.7% in the BAT arm).
Mjera primarnog ishoda definirana kao udio bolesnika koji su postigli kontrolu hematokrita (odsutnost prikladnosti za flebotomiju) u 28. tjednu je postignuta (62,2% u Jakavi skupini u odnosu na 18,7% u skupini s najboljom dostupnom terapijom).
Other bleeding (including epistaxis, post-procedural haemorrhage and haematuria)
Druga krvarenja (uključujući epistaksu, postproceduralno krvarenje i hematuriju)
The primary efficacy endpoint was proportion of subjects achieving ≥35% reduction from baseline in spleen volume at week 24 as measured by Magnetic Resonance Imaging (MRI) or Computed Tomography (CT).
Mjera primarnog ishoda djelotvornosti bio je udio ispitanika koji su postigli smanjenje ≥35% od početne vrijednosti u volumenu slezene u 24. tjednu mjereno magnetskom rezonancijom (MR) ili kompjuteriziranom tomografijom (CT).
Jakavi is also used to treat patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Jakavi se primjenjuje i za liječenje bolesnika s policitemijom verom koji su otporni na ili ne podnose hidroksiureju.
In the comparative period of phase 3 studies in PV patients, bleeding events (including intracranial and gastrointestinal, bruising and other bleeding events) were reported in 16.8% of patients treated with ruxolitinib, 15.3% of patients receiving best available therapy in RESPONSE study and 12.0% of patients receiving best available therapy in RESPONSE 2 study.
U komparativnom razdoblju ispitivanja faze 3 u bolesnika s PV-om, događaji krvarenja (uključujući intrakranijalno i gastrointestinalno, stvaranje modrica i druge događaje krvarenja) bili su zabilježeni u 16,8% bolesnika liječenih ruksolitinibom, u 15,3% bolesnika koji su primali najbolju dostupnu terapiju u RESPONSE ispitivanju te u 12,0% bolesnika koji su primali najbolju dostupnu terapiju u RESPONSE 2 ispitivanju.
Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Jakavi je indiciran za liječenje odraslih bolesnika s policitemijom verom koji su otporni na ili ne podnose hidroksiureju.
Jakavi contains the active substance ruxolitinib.
Jakavi sadrži djelatnu tvar ruksolitinib.
The proportion of patients achieving a complete haematological remission was 23.6% on Jakavi compared to 8.0% on BAT (p=0.0013) and the proportion of patients achieving a durable primary response at week 48 was 20% on Jakavi and 0.9% on BAT (p<0.0001).
Udio bolesnika koji su postigli kompletnu hematološku remisiju bio je 23,6% na Jakaviju u usporedbi s 8,0% na NDT-u (p=0,0013), a udio bolesnika koji su postigli trajan primarni odgovor u 48. tjednu bio je 20% na Jakaviju i 0,9% na NDT-u (p<0,0001).
10 g/litre below baseline after 8 to 12 weeks of therapy and then gradually recovered to reach a new steady state that was approximately 5 g/litre below baseline.
U bolesnika koji primaju ruksolitinib srednja sniženja hemoglobina dostigla su najnižu vrijednost od otprilike 10 g/litri ispod početne vrijednosti nakon 8 do 12 tjedana terapije i zatim se postupno vratila te postigla novo stanje dinamičke ravnoteže koje je bilo otprilike 5 g/litri ispod početne vrijednosti.
- Cimetidine, a medicine to treat heartburn.
- Cimetidin, lijek za liječenje žgaravice.
The primary composite endpoint was the proportion of patients achieving both an absence of phlebotomy eligibility (HCT control) and a ≥35% reduction in spleen volume from baseline at week 32.
Mjera primarnog kompozitnog ishoda bio je udio bolesnika koji su postigli i odsutnost prikladnosti za flebotomiju (kontrola hematokrita) i smanjenje ≥35% u volumenu slezene u 32. tjednu u odnosu na početnu vrijednost.
Final CSR: December 2019
Prosinac 2019.
Tuberculosis has been reported in patients receiving Jakavi.
U bolesnika koji primaju Jakavi zabilježena je tuberkuloza.
Primary composite endpoint at week 32
Mjera primarnog kompozitnog ishoda u 32. tjednu
There was a 31% reduction in the risk of death in the ruxolitinib arm as compared to placebo (HR 0.69; 95% CI 0.50-0.96; p=0.025).
U ruksolitinib skupini opaženo je 31%-tno smanjenje rizika od smrti u odnosu na placebo (HR 0,69; 95% CI 0,50-0,96; p=0,025).
Additional analyses from the RESPONSE study to assess durability of response were conducted at week 80 only in the Jakavi arm.
U 80. tjednu su provedene dodatne analize u skupini koja je primala Jakavi u RESPONSE ispitivanju radi procjene trajanja odgovora.
Jakavi contains lactose
Jakavi sadrži laktozu
The starting dose of Jakavi was based on platelet count.
Početna doza Jakavija temeljila se na broju trombocita.
Renal function was determined using both Modification of Diet in Renal Disease (MDRD) and urinary creatinine.
Funkcija bubrega bila je utvrđena uporabom formule za modifikaciju prehrane kod bubrežne bolesti i kreatinina u mokraći.
In the phase 3 clinical studies in MF, in patients who developed grade 3 or 4 thrombocytopenia, the median time to onset was approximately 8 weeks.
U kliničkim ispitivanjima MF-a faze 3, u bolesnika koji su razvili trombocitopeniju stupnja 3 ili 4, medijan vremena do nastupa bio je otprilike 8 tjedana.
In the phase 3 clinical studies in MF, in patients who developed grade 3 or 4 neutropenia, the median time to onset was 12 weeks.
U kliničkim ispitivanjima MF-a faze 3, u bolesnika koji su razvili neutropeniju stupnja 3 ili 4, medijan vremena do nastupa bio je 12 tjedana.
Pharmacokinetic/pharmacodynamic simulations based on available data in this population suggest that the starting dose for MF patients with ESRD on haemodialysis is a single dose of 15-20 mg or two doses of 10 mg given 12 hours apart, to be administered post-dialysis and only on the day of haemodialysis.
Farmakokinetičke/farmakodinamičke simulacije temeljene na dostupnim podacima za ovu populaciju upućuju na to da je početna doza za bolesnike s MF-om s terminalnim bubrežnim zatajenjem koji su na hemodijalizi jednokratna doza od 15-20 mg ili dvije doze od 10 mg dane u razmaku od 12 sati, koja se treba primijeniti nakon hemodijalize i to samo na dan hemodijalize.
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.
Mjere sekundarnih ishoda uključivali su trajanje održavanja smanjenja ≥35% od početne vrijednosti u volumenu slezene, udio bolesnika koji su imali smanjenje ≥50% u ukupnom zbroju simptoma, promjene u ukupnom zbroju simptoma od početne vrijednosti do 24. tjedna mjereno modificiranim dnevnikom za procjenu simptoma MF-a (engl.
Following a single oral dose of [14C]-labelled ruxolitinib in healthy adult subjects, elimination was predominately through metabolism, with 74% of radioactivity excreted in urine and 22% via faeces.
C]-označenog ruksolitiniba u zdravih odraslih ispitanika, eliminacija je uglavnom bila putem metabolizma, pri čemu je 74% radioaktivnosti bilo izlučeno u mokraću te 22% putem stolice.
mean values showed little difference between the ruxolitinib-treated and the control-treated MF patients.
U ispitivanju COMFORT-II srednje vrijednosti pokazale su neznatne razlike između bolesnika s MF-om liječenih ruksolitinibom i onih koji su primali kontrolnu terapiju.
Hypertriglyceridaemia b
Hipertrigliceridemija b
Constipation a
Konstipacija a
c grade 4 (<6.5g/dl)
c stupanj 4 (<6,5 g/dl)
In healthy subjects given ruxolitinib (50 mg single dose) following the potent CYP3A4 inducer rifampicin (600 mg daily dose for 10 days), ruxolitinib AUC was 70% lower than after administration of ruxolitinib alone.
U zdravih ispitanika koji su uzeli ruksolitinib (jednokratna doza od 50 mg) nakon snažnog CYP3A4 induktora rifampicina (dnevna doza od 600 mg tijekom 10 dana), AUC ruksolitiniba bio je 70% niži nego nakon primjene samog ruksolitiniba.
In the randomised period of the pivotal study in PV patients, one (0.5%) CTCAE grade 3 and no grade 4 urinary tract infection was reported.
U razdoblju randomizacije ključnog ispitivanja u bolesnika s PV-om prijavljena je jedna (0,5%) infekcija mokraćnog sustava stupnja 3 i niti jedna stupnja 4 prema CTCAE-u.
14 tablets 56 tablets
14 tableta 56 tableta
The rate of herpes zoster was similar in PV (4.3%)
Stopa herpes zostera bila je slična u bolesnika s PV-om (4,3%) i u bolesnika s MF-om (4,0%).
- A subject with multiple occurrence of an adverse drug reaction (ADR) is counted only once in that ADR category.
- Ispitanik u kojeg se više puta pojavi jedna nuspojava na lijek broji se samo jedanput u toj kategoriji nuspojava na lijek.
Secondary endpoints included proportion of patients achieving a ≥35% reduction of spleen volume from baseline at week 24 and duration of maintenance of a ≥35% reduction from baseline spleen volume.
Mjere sekundarnih ishoda uključivali su udio bolesnika koji su postigli smanjenje u volumenu slezene ≥35% u odnosu na početnu vrijednost do 24. tjedna i trajanje održavanja smanjenja ≥35% od početne vrijednosti volumena slezene.
Long-term safety was evaluated using data from two phase 3 studies including data from patients initially randomised to ruxolitinib (n=184; exposure 0.03 to 43.5 months, median exposure 18.9 months) and patients who received ruxolitinib after crossing over from control treatments (n=149; exposure: 0.2 to 33.5 months, median exposure 12.0 months): With longer exposure, the cumulative frequency of adverse events increased but no new safety findings emerged.
Dugoročna sigurnost je bila ocjenjivana korištenjem podataka iz dva ispitivanja faze 3 uključujući podatke od bolesnika inicijalno randomiziranih na ruksolitinib (n=184; izloženost 0,03 do 43,5 mjeseci, medijan izloženosti 18,9 mjeseci) i bolesnika koji su primali ruksolitinib nakon prelaska iz kontrolnih skupina liječenja (n=149; izloženost: 0,2 do 33,5 mjeseci, medijan izloženosti 12,0 mjeseci).
Non-melanoma skin cancers (NMSCs), including basal cell, squamous cell, and Merkel cell carcinoma, have been reported in patients treated with ruxolitinib.
Slučajevi nemelanomskog raka kože, uključujući karcinom bazalnih stanica, skvamoznih stanica i Merkelovih stanica, prijavljeni su u bolesnika liječenih ruksolitinibom.
OUTER CARTON OF MULTIPACK
VANJSKA KUTIJA VIŠESTRUKOG PAKIRANJA
Other side effects with Jakavi
Druge nuspojave s Jakavijem
If Jakavi is to be co-administered with strong CYP3A4 inhibitors or dual inhibitors of CYP3A4 and CYP2C9 enzymes (e.g. fluconazole), the unit dose of Jakavi should be reduced by approximately 50%, to be administered twice daily (for monitoring frequency see sections 4.2 and 4.5).
Ako se Jakavi primjenjuje istodobno sa snažnim CYP3A4 inhibitorima ili dvostrukim inhibitorima enzima CYP3A4 i CYP2C9 (npr. flukonazolom), jediničnu dozu Jakavija treba smanjiti za otprilike 50%, te primjenjivati dvaput dnevno (za učestalost praćenja vidjeti dijelove 4.2 i 4.5).
Headache a
Glavobolja a
Renal impairment No specific dose adjustment is needed in patients with mild or moderate renal impairment.
Nije potrebno prilagođavanje doze u bolesnika s blagim do umjerenim oštećenjem bubrega.
The safety and efficacy of these co-administrations are not known (see section 4.5).
Sigurnost i djelotvornost istodobne primjene nisu poznate (vidjeti dijelove 4.5).
Subsequent doses (single dose of 20 mg or two doses of 10 mg given 12 hours apart in MF patients; single dose of 10 mg or two doses of 5 mg given 12 hours apart in PV patients) should be administered only on haemodialysis days following each dialysis session.
Naknadne doze (jednokratna doza od 20 mg ili dvije doze od 10 mg dane u razmaku od 12 sati u bolesnika s MF-om; jednokratna doza od 10 mg ili dvije doze od 5 mg dane u razmaku od 12 sati u bolesnika s PV-om) treba primjenjivati samo u dane hemodijalize i to nakon svakog postupka dijalize.
The three most frequent non-haematological adverse reactions were dizziness (9.2%), constipation (8.7%) and hypertension (6.5%).
Tri najučestalije nehematološke nuspojave bile su omaglica (9,2%), konstipacija (8,7%) i hipertenzija
The primary efficacy endpoint was proportion of patients achieving ≥35% reduction from baseline in spleen volume at week 48 as measured by MRI or CT.
Mjera primarnog ishoda djelotvornosti bio je udio bolesnika koji su postigli smanjenje ≥35% u odnosu na početnu vrijednost u volumenu slezene u 48. tjednu, mjereno MR-om ili CT-om.
In COMFORT-II, after a median follow-up of 34.7 months, the death rate in patients randomised to ruxolitinib was 19.9% versus 30.1% in patients randomised to best available treatment (BAT); HR 0.48; 95% CI 0.28-0.85; p=0.009.
U ispitivanju COMFORT-II, nakon medijana praćenja od 34,7 mjeseci, stopa smrtnosti u bolesnika randomiziranih na ruksolitinib bila je 19,9% naspram 30,1% u bolesnika randomiziranih na najbolju dostupnu terapiju (NDT); HR 0,48; 95% CI 0,28-0,85; p=0,009.
Common (may affect up to 1 in 10 people): - fever, cough, difficult or painful breathing, wheezing, pain in chest when breathing (possible symptoms of pneumonia) - frequently passing wind (flatulence)
Česte (mogu se javiti u manje od 1 na 10 ljudi): - vrućica, kašalj, otežano ili bolno disanje, piskanje, bol u prsnom košu prilikom disanja (mogući simptomi upale pluća) - učestali vjetrovi (nadutost) - zatvor - visoki krvni tlak (hipertenzija), koji također može uzrokovati omaglicu i glavobolje
The concomitant use of cytoreductive therapies and ruxolitinib has not been studied.
Istodobna primjena citoreduktivnih terapija i ruksolitiniba nije do sada ispitivana.
Time point After 24 weeks
Nakon 24 tjedna
Haematopoietic growth factors
Hematopoetski čimbenici rasta
c grade 3 (<1,000 - 500/mm
c stupanj 3 (<1000 - 500/mm
Jakavi contains lactose.
Jakavi sadrži laktozu.
c grade 4 (<500/mm
c stupanj 4 (<500/mm
The maximum dose of ruxolitinib is 25 mg twice daily.
Najveća dopuštena doza ruksolitiniba je 25 mg dvaput na dan.
There was a 33% reduction in risk of death in the ruxolitinib arm compared to the BAT arm (HR 0.67; 95% CI 0.44-1.02; p=0.062).
U ruksolitinib skupini opaženo je 33%-tno smanjenje rizika od smrti u odnosu na NDT skupinu (HR 0,67; 95% CI 0,44-1,02; p=0,062).
In COMFORT-I, after a median follow-up of 61.7 months, the death rate in patients randomised to the ruxolitinib arm was 44.5% (69 of 155 patients) versus 53.2% (82 of 154) in patients randomised to placebo.
U ispitivanju COMFORT-I, nakon medijana praćenja od 61,7 mjeseci, stopa smrtnosti u bolesnika randomiziranih u skupinu koja je primala ruksolitinib bila je 44,5% (69 od 155 bolesnika) naspram 53,2% (82 od 154) u bolesnika randomiziranih na placebo.
Most of the patients with bleeding events during the treatment reported bruising
Većina bolesnika s događajima krvarenja tijekom liječenja prijavila je modrice (65,3%).
In the randomised period of the pivotal study in PV patients, the mean systolic blood pressure increased by 0.65 mmHg in the ruxolitinib arm versus a decrease of 2 mmHg in the BAT arm.
U razdoblju randomizacije ključnog ispitivanja u bolesnika s PV-om, srednji sistolički krvni tlak povećao se za 0,65 mmHg u skupini koja je primala ruksolitinib naspram smanjenja od 2 mmHg u skupini koja je primala najbolju dostupnu terapiju.
A single dose of 20 mg or two doses of 10 mg given 12 hours apart is recommended for MF patients with platelet count of >200,000/mm Subsequent doses (single administration or two doses of 10 mg given 12 hours apart) should be administered only on haemodialysis days following each dialysis session.
Jednokratna doza od 20 mg ili dvije doze od 10 mg dane u razmaku od 12 sati se preporučuju za bolesnike s MF-om s brojem trombocita >200 000/mm Naknadne doze (jednokratna primjena ili dvije doze od 10 mg dane u razmaku od 12 sati) treba primjenjivati samo u dane hemodijalize i to nakon svakog postupka dijalize.
c grade 4 (<25,000/mm
c stupanj 4 (<25 000/mm
When administering ruxolitinib with strong CYP3A4 inhibitors the unit dose of ruxolitinib should be reduced by approximately 50%, to be administered twice daily.
Kada se ruksolitinib primjenjuje sa snažnim CYP3A4 inhibitorima, jediničnu dozu ruksolitiniba treba smanjiti za otprilike 50% te primjenjivati dvaput na dan.
In COMFORT-I, after a median follow-up of 34.3 months, the death rate in patients randomised to the ruxolitinib arm was 27.1% versus 35.1% in patients randomised to placebo; HR 0.687; 95% CI 0.459-1.029; p=0.0668.
U ispitivanju COMFORT-I, nakon medijana praćenja od 34,3 mjeseca, stopa smrtnosti u bolesnika randomiziranih u skupinu koja je primala ruksolitinib bila je 27,1% naspram 35,1% u bolesnika randomiziranih na placebo; HR 0,687; 95% CI 0,459-1,029; p=0,0668.
Nervous system disorders Dizziness a
Poremećaji živčanog sustava Omaglica a
In healthy subjects co-administration of ruxolitinib (10 mg single dose) with a dual CYP2C9 and CYP3A4 inhibitor, fluconazole, resulted in ruxolitinib Cmax and AUC that were higher by 47% and 232%, respectively, than with ruxolitinib alone.
U zdravih ispitanika istodobna primjena ruksolitiniba (jednokratna doza od 10 mg) s dvostrukim CYP2C9 i CYP3A4 inhibitorom, flukonazolom, za posljedicu je imala Cmax i AUC ruksolitiniba koji su bili viši za 47% odnosno 232% nego sa samim ruksolitinibom.
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.
U bolesnika s kroničnim HBV infekcijama koji su primali Jakavi zabilježena su povećanja virusnog opterećenja hepatitisom B (titar HBV-DNK), s povezanim povišenjima alanin aminotransferaze i aspartat aminotransferaze ili bez njih.
Treatment should be discontinued in patients with platelet count less than 50,000/mm or absoute neutrophil count less than 500/mm
Liječenje treba prekinuti u bolesnika s brojem trombocita manjim od 50 000/mm ili apsolutnim brojem neutrofila manjim od
The recommended starting dose of ruxolitinib in MF is 15 mg twice daily for patients with a platelet count between 100,000/mm and 200,000/mm and 20 mg twice daily for patients with a platelet count of >200,000/mm 3.
Preporučena početna doza ruksolitiniba za MF je 15 mg dvaput na dan za bolesnike s brojem trombocita između 100 000/mm i 200 000/mm 3, te 20 mg dvaput na dan za bolesnike s brojem trombocita od >200 000/mm 3. Preporučena početna doza ruksolitiniba za PV je 10 mg primijenjeno peroralno dvaput na dan.
Serious bacterial, mycobacterial, fungal, viral and other opportunistic infections have occurred in patients treated with Jakavi.
Kod bolesnika liječenih Jakavijem javile su se ozbiljne bakterijske, mikobakterijske, gljivične, virusne i druge oportunističke infekcije.
Patients should be carefully monitored with regard to safety and efficacy during ruxolitinib treatment.
Kod bolesnika tijekom liječenja ruksolitinibom treba pažljivo motriti sigurnost i djelotvornost.
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.
Sigurnost Jakavija ocjenjivala se u 184 bolesnika s PV-om u dva otvorena, randomizirana, kontrolirana ispitivanja, ispitivanju faze 3 RESPONSE i ispitivanju faze 3b RESPONSE 2. Nuspojave na lijek navedene u nastavku obuhvaćaju razdoblje randomizacije (do 32. tjedna za RESPONSE i do 28. tjedna za RESPONSE 2) s ekvivalentnom izloženošću ruksolitinibu i najboljoj dostupnoj terapiji (NDT).
In healthy subjects co-administration of ruxolitinib (10 mg single dose) with erythromycin 500 mg twice daily for four days resulted in ruxolitinib Cmax and AUC that were higher by 8% and 27%, respectively, than with ruxolitinib alone.
U zdravih ispitanika istodobna primjena ruksolitiniba (jednokratna doza od 10 mg) s eritromicinom 500 mg dvaput na dan tijekom četiri dana rezultirala je time da je Cmax ruksolitiniba bio viši za 8%, a AUC za 27% nego sa samim ruksolitinibom.
Excipient with known effect Each tablet contains 285.80 mg lactose monohydrate.
Svaka tableta sadrži 285,80 mg laktoze hidrat.
Positive (N=121) n (%)
Pozitivan (N=121) n (%)