FrancophonIA/ELRC3.0 huggingface dataset:
English: Stopping Jakavi
Slovak: Ukončenie liečby s Jakavi
English: The starting dose of Jakavi should be reduced in patients with severe renal impairment.
Slovak: U pacientov s ťažkou poruchou funkcie obličiek je potrebné znížiť počiatočnú dávku Jakavi.
English: 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.
Slovak: % znížením skóre celkových príznakov, zmeny v celkových skóre príznakov v porovnaní s východiskovou hodnotou v 24. týždni hodnotené pomocou modifikovaného MFSAF (Myelofibrosis Symptom Assessment Form) v2.0 denníka, a celkové prežívanie.
English: Dose reductions should be considered if the platelet count decreases below 100,000/mm
Slovak: Ak počet krvných doštičiek klesne pod 100 000/mm
English: 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%.
Slovak: % pacientov, kým frekvencia u pacientov s MF bola 42,56 %.
English: The three most frequent non-haematological laboratory abnormalities were raised alanine aminotransferase (27.2%), raised aspartate aminotransferase (19.9%) and hypercholesterolaemia (16.9%).
Slovak: Tri najčastejšie iné ako hematologické abnormálne laboratórne nálezy boli zvýšená alanínaminotrasferáza (27,2
English: However, patients should be closely monitored for cytopenias when initiating therapy with a moderate CYP3A4 inhibitor.
Slovak: Pri začatí liečby so stredne silnými CYP3A4 inhibítormi je však potrebné pacientov dôsledne monitorovať so zameraním na cytopénie.
English: (4.7% versus 3.1%).
Slovak: % oproti 33 %).
English: 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%).
Slovak: Tromi najčastejšími nehematologickými laboratórnymi abnormalitami (akéhokoľvek stupňa podľa CTCAE) identifikovaných ako nežiaduce reakcie boli zvýšená aspartátaminotransferáza (26,1
English: 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.
Slovak: Vo fáze randomizácie v pivotných štúdiách bol podiel pacientov, u ktorých sa vyskytla trombocytopénia nižší u pacientov s PV (16,8
English: The frequency of severe (i.e. CTCAE grade 3 and 4) thrombocytopenia was lower in PV (2.7%) than in MF (11.6%) patients.
Slovak: CTCAE stupňa 3 a 4) bola nižšia u pacientov s PV (2,7
English: Positive (N=121) n (%)
Slovak: Pozitívn y (N=121) n (%)
English: 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.
Slovak: Primárnym zloženým cieľovým ukazovateľom bolo percento pacientov, ktorí dosiahli aj absenciu indikácie flebotómie (kontrola HCT) a ≥35
English: The mean change in the global health status at week 24, as measured by EORTC QLQ C30 was +12.3 for Jakavi and -3.4 for placebo (p<0.0001).
Slovak: QLQ C30 bola +12,3 u Jakavi a -3,4 u placeba (p<
English: Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets
Slovak: Jakavi 10 mg tablety Jakavi 15 mg tablety Jakavi 20 mg tablety
English: Time point After 24 weeks
Slovak: Po 24 týždňoch
English: Activating mutations in JAK2 (V617F or exon 12) are found in >95% of PV patients.
Slovak: 95 % pacientov s PV sa vyskytujú aktivujúce mutácie JAK2 (V617F alebo exón 12).
English: Excipient with known effect Each tablet contains 285.80 mg lactose monohydrate.
Slovak: Každá tableta obsahuje 285,80 mg monohydrátu laktózy.
English: The probability of maintaining spleen response (≥35% reduction) on Jakavi for at least 24 weeks was 89% in COMFORT-I and 87% in COMFORT-II; 52% maintained spleen responses for at least 48 weeks in COMFORT-II.
Slovak: % redukcia) na Jakavi v priebehu najmenej 24 týždňov bola 89 % v štúdii COMFORT
English: With these updated data, therapy discontinuation due to adverse events was observed in 27.4% of patients treated with ruxolitinib.
Slovak: Podľa týchto aktualizovaných údajov sa ukončenie liečby z dôvodu nežiaducich udalostí pozorovalo u 27,4%
English: Fractures and early termination of rats were observed at doses ≥30 mg/kg/day when treatment was started on postnatal day 7.
Slovak: Pri dávkach ≥30 mg/kg/deň, keď sa liečba začala na 7. postnatálny deň, sa pozorovali zlomeniny a predčasné uhynutia potkanov.
English: 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.
Slovak: U zdravých jedincov súčasné podávanie ruxolitinibu (jednotlivá dávka 10 mg) s duálnym CYP2C9 a CYP3A4 inhibítorom, flukonazolom, viedlo k zvýšeniu Cmax ruxolitinibu o 47 % a AUC o 232
English: 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).
Slovak: Sekundárny ukazovateľ, definovaný ako percento pacientov, ktorí dosiahli úplnú hematologickú remisiu v 28. týždni, bol tiež splnený (23,0
English: 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.
Slovak: % zmenšenie objemu sleziny v 24. týždni v porovnaní s východiskovou hodnotou a trvanie ≥35% zmenšenia objemu sleziny v porovnaní s východiskovou hodnotou.
English: There was no evidence of a teratogenic effect in rats and rabbits.
Slovak: U králikov a potkanov nebol zaznamenaný dôkaz o teratogénnom účinku.
English: A randomised, open-label, active-controlled phase 3 study (RESPONSE) was conducted in 222 patients with PV who were resistant to or intolerant of hydroxyurea defined based on the European LeukemiaNet (ELN) international working group published criteria.
Slovak: 3. fázy (RESPONSE) bolo vykonané u 222 pacientov s PV s rezistenciou alebo intoleranciou na hydroxyureu definované podľa publikovaných kritérií medzinárodnej pracovnej skupiny European LeukemiaNet (ELN). 110 pacientov bolo randomizovaných do skupiny s ruxolitinibom a 112 pacientov do skupiny s BAT.
English: 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.
Slovak: Vo fáze randomizácie v pivotnej štúdii u pacientov s PV bola neutropénia hlásená u troch pacientov (1,6
English: The mean Cmax was moderately decreased (24%) while the mean AUC was nearly unchanged (4% increase) on dosing with a high-fat meal.
Slovak: %), kým priemerná AUC zostala takmer nezmenená (4
English: Excipient with known effect Each tablet contains 71.45 mg lactose monohydrate.
Slovak: Každá tableta obsahuje 71,45 mg monohydrátu laktózy.
English: Hypertriglyceridaemia b
Slovak: Hypertriglyceridémia b
English: Haematological adverse drug reactions (any Common Terminology Criteria for Adverse Events [CTCAE] grade) included anaemia (82.4%), thrombocytopenia (69.8%) and neutropenia (16.6%).
Slovak: K hematologickým nežiaducim reakciám na liek (všetkých stupňov škály spoločných kritérií pre názvoslovie nežiaducich udalostí [CTCAE]) patrila anémia (82,4
English: Thrombocytopenia b
Slovak: Trombocytopénia b
English: c grade 3 (<1,000 - 500/mm
Slovak: 1 000 - 500/mm
English: Intracranial bleeding was reported in 1% of patients exposed to ruxolitinib and 0.9% exposed to reference treatments.
Slovak: % pacientov exponovaných ruxolitinib a u 0,9 % pacientov exponovaných referenčnej liečbe.
English: The three most frequent non-haematological adverse drug reactions were bruising (21.3%), dizziness (15.3%) and headache (14.0%).
Slovak: Tri najčastejšie iné ako hematologické nežiaduce reakcie na liek boli tvorenie podliatin (21,3
English: Jakavi contains the active substance ruxolitinib.
Slovak: Jakavi obsahuje liečivo ruxolitinib.
English: - The recommended starting dose in myelofibrosis is 15 mg twice daily or 20 mg twice daily,
Slovak: - Odporúčaná počiatočná dávka pri myelofibróze je 15 mg dvakrát denne alebo 20 mg dvakrát denne, v závislosti od počtu krvných buniek.
English: Jakavi 20 mg tablets
Slovak: Jakavi 20 mg tablety
English: Hepatobiliary disorders Raised alanine aminotransferase b
Slovak: Zvýšená alanínaminotransferáza b
English: MF patients did not become refractory to the pharmacodynamic effects of ruxolitinib treatment over time.
Slovak: Počas liečby ruxolitinibom sa u pacientov s MF nevytvorila odolnosť voči jeho farmakodynamickým účinkom.
English: Positive (N=113) n (%)
Slovak: Pozitívn y (N=113) n (%)
English: 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.
Slovak: Predpokladá sa že k základom týchto porúch patrí vysoká hladina cirkulujúcich cytokínov, ktoré aktivujú JAK-STAT dráhou, mutácie pridávajúce funkcie ako napr.
English: Positive (N=49) n (%)
Slovak: Pozitívn y (N=49) n (%)
English: Excipient with known effect Each tablet contains 142.90 mg lactose monohydrate.
Slovak: Každá tableta obsahuje 142,90 mg monohydrátu laktózy.
English: 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).
Slovak: (59 zo 146 pacientov) oproti 47,9% (35 zo 73 pacientov) randomizovaných na najlepšiu dostupnú liečbu (BAT, best available therapy).
English: The three most frequent non-haematological adverse reactions were dizziness (9.2%), constipation (8.7%) and hypertension (6.5%).
Slovak: Tromi najčastejšími nehematologickými nežiaducimi reakciami boli závrat (9,2
English: Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets ruxolitinib
Slovak: Jakavi 10 mg tablety Jakavi 15 mg tablety Jakavi 20 mg tablety ruxolitinib
English: Excipient with known effect Each tablet contains 214.35 mg lactose monohydrate.
Slovak: Každá tableta obsahuje 214,35 mg monohydrátu laktózy.
English: Number (%) of subjects with spleen volume reduced by
Slovak: (%) pacientov s objemom sleziny zmenšeným o ≥35
English: Negative (N=35) n (%)
Slovak: Negatívn y (N=35) n (%)
English: Cellulose, microcrystalline Magnesium stearate Silica, colloidal anhydrous Sodium starch glycolate (Type A) Povidone K30
Slovak: Zoznam pomocných látok mikrokryštalická celulóza magnéziumstearát koloidný bezvodý oxid kremičitý sodná soľ karboxymetylcelulózy (typ A) povidón K30 hydroxypropylcelulóza 300 až 600 cps monohydrát laktózy
English: The starting dose of Jakavi was based on platelet count.
Slovak: Počiatočná dávka Jakavi sa stanovila na základe počtu krvných doštičiek.
English: 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.
Slovak: U pacientov s rôznym stupňom poruchy funkcie pečene, sa priemerná AUC ruxolitinibu po jednorazovej dávke 25 mg zvýšila u pacientov s miernou poruchou funkcie pečene o 87
English: - Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
Slovak: - Každá tableta Jakavi 20 mg obsahuje 20 mg ruxolitinibu.
English: Hepatic impairment
Slovak: Liečivá prenášané
English: 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.
Slovak: % zmenšenie objemu sleziny v 48. týždni v porovnaní s východiskovou hodnotou, merané MRI alebo CT.
English: Strong CYP3A4 inhibitors (such as, but not limited to, boceprevir, clarithromycin, indinavir, itraconazole, ketoconazole, lopinavir/ritonavir, ritonavir, mibefradil, nefazodone, nelfinavir, posaconazole, saquinavir, telaprevir, telithromycin, voriconazole) In healthy subjects co-administration of ruxolitinib (10 mg single dose) with a strong CYP3A4 inhibitor, ketoconazole, resulted in ruxolitinib Cmax and AUC that were higher by 33% and 91%, respectively, than with ruxolitinib alone.
Slovak: Silné CYP3A4 inhibítory (ako sú, ale nie len, boceprevir, klaritromycín, indinavir, itrakonazol, ketokonazol, lopinavir/ritonavir, ritonavir, mibefradil, nefazodón, nelfinavir, posakonazol, sakvinavir, telaprevir, telitromycín, vorikonazol)
English: A complete blood cell count, including a white blood cell count differential, must be performed before initiating therapy with Jakavi.
Slovak: Pred začatím liečby s Jakavi je potrebné urobiť kompletný krvný obraz, vrátane diferenciálneho počtu bielych krviniek.
English: Jakavi 10 mg tablets
Slovak: Jakavi 10 mg tablety
English: 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.
Slovak: Iné prípady krvácania (vrátane epistaxy, post-procedurálnej hemorágie a hematúrie) boli hlásené u 13,3
English: Other than bone development, the effects of ruxolitinib in juvenile rats were similar to those in adult rats.
Slovak: Vo všeobecnosti boli nežiadúce účinky závažnejšie ak sa s liečbou začalo v kratšom čase po narodení Okrem vývoja kostí, boli nežiadúce účinky ruxolitinibu u mladých potkanov podobné ako u dospelých potkanov.
English: Jakavi 5 mg tablets
Slovak: Jakavi 5 mg tablety
English: Jakavi 10 mg tablets EU/1/12/773/014-016
Slovak: Jakavi 10 mg tablety EU/1/12/773/014-016
English: Jakavi 5 mg tablets EU/1/12/773/004-006
Slovak: Jakavi 5 mg tablety EU/1/12/773/004-006
English: Jakavi 20 mg tablets EU/1/12/773/010-012
Slovak: Jakavi 20 mg tablety EU/1/12/773/010-012
English: 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
Slovak: U pacientov, ktorí mali pred začiatkom liečby s ruxolitinibom počet krvných doštičiek od 100 000/mm do 200 000/mm
English: 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.
Slovak: Vo fáze randomizácie v pivotnej štúdii bola u pacientov s PV hlásená jedna infekcia močového traktu (0,5
English: Negative (N=27) n (%)
Slovak: Negatívn y (N=27) n (%)
English: Jakavi 15 mg tablets EU/1/12/773/007-009
Slovak: Jakavi 15 mg tablety EU/1/12/773/007-009
English: 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).
Slovak: % zmenšenie objemu sleziny sa dosiahlo u 40 % pacientov v skupine s Jakavi v porovnaní s 0,9
English: was 0-2 mmHg on ruxolitinib versus a decrease of 2-5 mmHg in the placebo arm.
Slovak: V skúšaní COMFORT-I (pacienti s MF) bol oproti východiskovej hodnote pri ruxolitinibe priemerne zvýšený systolický krvný tlak o 0 - 2 mmHg v porovnaní s poklesom o 2 - 5 mmHg v ramene s placebom.
English: Negative (N=20) n (%)
Slovak: Negatívn y (N=20) n (%)
English: - Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib.
Slovak: - Každá tableta Jakavi 5 mg obsahuje 5 mg ruxolitinibu.
English: - Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
Slovak: - Každá tableta Jakavi 15 mg obsahuje 15 mg ruxolitinibu.
English: Jakavi 15 mg tablets
Slovak: Jakavi 15 mg tablety
English: Bleeding In the phase 3 pivotal studies in MF bleeding events (including intracranial and gastrointestinal,
Slovak: V porovnateľnom období štúdií 3. fázy u pacientov s PV boli hlásené prípady krvácania (vrátane intrakraniálneho a gastrointestináneho krvácania, tvorby podliatin a iného krvácania) u 16,8
English: Jakavi 20 mg tablets are white to almost white elongated tablets with “NVR” debossed on one side and “L20” debossed on the other side.
Slovak: Jakavi 20 mg tablety sú biele až takmer biele podlhovasté tablety, s „NVR“ vyrazeným na jednej strane a „L20“ vyrazeným na druhej strane.
English: bruising and other bleeding events) were reported in 32.6% of patients exposed to ruxolitinib and
Slovak: 3. fázy s MF boli prípady krvácania (vrátane intrakraniálneho a gastrointestinálneho krvácania, podliatin a iných prípadov krvácania) hlásené u 32,6 % pacientov liečených ruxolitinibom a u 23,2
English: No dose adjustment is recommended when ruxolitinib is co-administered with mild or moderate CYP3A4 inhibitors (e.g. erythromycin).
Slovak: Keď sa ruxolitinib podáva súčasne s miernymi alebo stredne silnými CYP3A4 inhibítormi (napr. erytromycín), nie je potrebná úprava dávky.
English: In COMFORT-I and COMFORT-II, patient baseline demographics and disease characteristics were comparable between the treatment arms.
Slovak: Základné demografické charakteristiky a charakteristika ochorenia pacientov boli porovnateľné pre obe ramená v štúdiách COMFORT-I a COMFORT-II.
English: - Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
Slovak: - Každá tableta Jakavi 10 mg obsahuje 10 mg ruxolitinibu.
English: .RUX .BAT
Slovak: .RUX
English: Round curved white to almost white tablets of approximately 9.3 mm in diameter with “NVR” debossed on one side and “L10” debossed on the other side.
Slovak: Okrúhle zaoblené biele až takmer biele tablety v priemere približne 9,3 mm, s „NVR“ vyrazeným na jednej strane a „L10“ vyrazeným na druhej strane.
English: Elongated curved white to almost white tablets of approximately 16.5 x 7.4 mm with “NVR” debossed one one side and “L20” debossed on the other side.
Slovak: Podlhovasté zaoblené biele až takmer biele tablety v priemere približne 16,5 x 7,4 mm, s „NVR“ vyrazeným na jednej strane a „L20“ vyrazeným na druhej strane.
English: ≥35% reduction in spleen volume
Slovak: Tabuľka 3 Percento pacientov s ≥35
English: Ruxolitinib is mainly metabolised by CYP3A4 (>50%), with additional contribution from CYP2C9.
Slovak: Ruxolitinib je prevažne metabolizovaný enzýmom CYP3A4 (>
English: Nervous system disorders Dizziness a
Slovak: Poruchy ciev Hypertenzia a
English: 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.
Slovak: % zníženie TSS-5, v porovnaní s iba 5 % a 11
English: Jakavi 20 mg tablets ruxolitinib
Slovak: Jakavi 20 mg tablety ruxolitinib
English: c grade 4 (<500/mm
Slovak: c stupeň 4 (<
English: 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.
Slovak: Počas podávania silných CYP3A4 inhibítorov alebo duálnych inhibítorov enzýmov CYP2C9 a CYP3A4 sa odporúča častejšie monitorovanie (napr. dvakrát do týždňa) hematologických parametrov a klinických prejavov a príznakov nežiaducich reakcií na liek spojených s ruxolitinibom.
English: Round curved white to almost white tablets of approximately 7.5 mm in diameter with “NVR” debossed on one side and “L5” debossed on the other side.
Slovak: Okrúhle zaoblené biele až takmer biele tablety v priemere približne 7,5 mm, s „NVR“ vyrazeným na jednej strane a „L5“ vyrazeným na druhej strane.
English: Jakavi 10 mg tablets are white to almost white round tablets with “NVR” debossed on one side and “L10” debossed on the other side.
Slovak: Jakavi 10 mg tablety sú biele až takmer biele okrúhle tablety, s „NVR“ vyrazeným na jednej strane a „L10“ vyrazeným na druhej strane.
English: OUTER CARTON OF MULTIPACK
Slovak: BYŤ UVEDENÉ NA VONKAJŠOM OBALE VONKAJŠIA ŠKATUĽA MULTIBALENIA
English: Ovaloid curved white to almost white tablets of approximately 15.0 x 7.0 mm with “NVR” debossed on one side and “L15” debossed on the other side.
Slovak: Oválne zaoblené biele až takmer biele tablety v priemere približne 15,0 x 7,0 mm, s „NVR“ vyrazeným na jednej strane a „L15“ vyrazeným na druhej strane.
English: Follow all the doctor's instructions carefully.
Slovak: Čo potrebujete vedieť predtým, ako užijete Jakavi Dôsledne dodržujte všetky pokyny lekára.
English: Jakavi 15 mg tablets are white to almost white oval tablets with “NVR” debossed on one side and “L15” debossed on the other side.
Slovak: Jakavi 15 mg tablety sú biele až takmer biele oválne tablety, s „NVR“ vyrazeným na jednej strane a „L15“ vyrazeným na druhej strane.
English: 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.
Slovak: V štúdii COMFORT-II bol podiel transfúzií s červenými krvinkami 53,4
English: Jakavi 5 mg tablets ruxolitinib
Slovak: Jakavi 5 mg tablety ruxolitinib
English: - Cimetidine, a medicine to treat heartburn.
Slovak: - Cimetidín, liek proti páleniu záhy.
English: In PV, treatment should also be interrupted when haemoglobin is below 8 g/dl.
Slovak: Liečba sa musí prerušiť pri počte krvných doštičiek nižšom ako 50 000/mm alebo pri absolútnom počte neutrofilov nižšom ako 500/mm Liečba pri PV sa má prerušiť aj vtedy, ak sú hodnoty hemoglobínu nižšie ako 8 g/dl.
English: Jakavi 10 mg tablets ruxolitinib
Slovak: Jakavi 10 mg tablety ruxolitinib
English: Jakavi 15 mg tablets ruxolitinib
Slovak: Jakavi 15 mg tablety ruxolitinib
English: Each tablet contains 20 mg ruxolitinib (as phosphate).
Slovak: Každá tableta obsahuje 20 mg ruxolitinibu (ako fosfátu).
English: 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.
Slovak: % u pacientov randomizovaných na placebo; HR 0,687; 95 % IS 0,459 - 1,029; p=0,0668.
English: Positive (N=110) n (%)
Slovak: Pozitívn y (N=110)
English: Each tablet contains 5 mg ruxolitinib (as phosphate).
Slovak: Každá tableta obsahuje 5 mg ruxolitinibu (ako fosfátu).
English: Each tablet contains 15 mg ruxolitinib (as phosphate).
Slovak: Každá tableta obsahuje 15 mg ruxolitinibu (ako fosfátu).
English: 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.
Slovak: % u pacientov randomizovaných na najlepšiu dostupnú liečbu (BAT); HR 0,48; 95 % IS 0,28 - 0,85; p=0,009.
English: 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.
Slovak: Jednorazová dávka 20 mg alebo dve dávky po 10 mg s 12 hodinovým odstupom sa odporúčajú pre pacientov s MF s počtom doštičiek > 200 000/mm
English: Each tablet contains 10 mg ruxolitinib (as phosphate).
Slovak: Každá tableta obsahuje 10 mg ruxolitinibu (ako fosfátu).
English: In COMFORT-II
Slovak: V štúdii COMFORT
English: BAT was selected by the investigator on a patient-bypatient basis and included hydroxyurea (59.5%), interferon/pegylated interferon (11.7%), anagrelide (7.2%), pipobroman (1.8%) and observation (15.3%).
Slovak: %), interferón/pegylovaný interferón (11,7
English: Novartis Pharma B.V. Tel: +31 88 04 52 111
Slovak: Tel: +31 88 04 52 111
English: Do not breast-feed while taking Jakavi.
Slovak: Počas liečby s Jakavi nedojčite.