FrancophonIA/ELRC3.0 huggingface dataset:
English: 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)
Maltese: ras persistenti, titrix, tnemnim, dgħufija jew paraliżi (komuni) - kull sinjal ta' fsada fl-istonku jew l-imsaren, bħalma huma li tgħaddi ppurgar iswed jew imċappas bid-demm, jew tirremetti d-demm (komuni) - tbenġil u/jew fsada bla mistenni, għeja mhux tas-soltu, qtugħ ta' nifs inti u tagħmel l-eżerċizzju jew meta tkun mistrieħ, ġilda bajda mhux tas-soltu, jew infezzjonijiet ta' spiss (sintomi possibbli ta' disturbi fid-demm) (komuni ħafna) - raxx fil-ġilda bl-infafet u l-uġigħ (sintomi possibbli ta' ħruq ta' Sant'Antnin (herpes zoster))
English: 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.
Maltese: Waqt studji kliniċi pivotali f'fażi 3 fuq pazjenti b'MF kien hemm żieda fil-pressjoni sistolika taddemm ta' 20 mmHg jew aktar mil-linja bażi f'31.5% tal-pazjenti f'mill-inqas viżta waħda mqabbla ma' 19.5% tal-pazjenti mogħtija trattament ikkontrollat.
English: Substances transported by P-glycoprotein or other transporters Ruxolitinib may inhibit P-glycoprotein and breast cancer resistance protein (BCRP) in the intestine.
Maltese: Sustanzi ttrasportati bil-glikoproteina-P jew trasportaturi oħrajn Ruxolitinib jista' jinibixxi l-glikoproteina-P u l-proteina li tirreżisti l-kanċer tas-sider (BCRP) flimsaren.
English: Dose proportionality was demonstrated in the single and multiple dose studies.
Maltese: Il-proporzjonalità tad-doża dehret fi studji dwar doża singola u multipla.
English: In COMFORT-I and COMFORT-II, patient baseline demographics and disease characteristics were comparable between the treatment arms.
Maltese: F'COMFORT-I u COMFORT-II, id-demografiċi u l-karatteristiċi fil-linja bażi tal-marda tal-pazjenti kienu komparabbli bejn iż-żewġ gruppi ta' trattament.
English: It has been observed that patients with low platelet counts (<200,000/mm 3) at the start of therapy are more likely to develop thrombocytopenia during treatment.
Maltese: Ġie osservat li pazjenti b'ammonti baxxi ta' plejtlits (<200,000/mm 3) fil-bidu tat-terapija għandhom aktar ċans li jiżviluppaw tromboċitopenija matul it-trattament.
English: Intracranial bleeding
Maltese: Fsada intrakranjali
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
Maltese: 200,000/mm qabel ma ngħata ruxolitinib kellhom frekwenza ogħla ta' tromboċitopenija jiġifieri grad 3 jew 4 mqabbel ma' pazjenti bl-ammont ta' plejtlits ta' >200,000/mm
English: - The recommended starting dose in polycythaemia vera is 10 mg twice daily.
Maltese: - Id-doża tal-bidu rrakkomandata f'poliċitemija vera hija ta' 10 mg darbtejn kuljum.
English: There are no human data on the effect of ruxolitinib on fertility.
Maltese: Ma dehru l-ebda effetti fuq il-fertilità.
English: Vascular disorders Hypertensiona
Maltese: Disturbi gastro-intestinali
English: 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.
Maltese: F'pazjenti b'saħħithom l-għoti flimkien ta' ruxolitinib (doża singola ta'10 mg) ma' 500 mg erythromycin darbtejn kuljum għal erbat ijiem wassal biex is-Cmax u l-AUC ta' ruxolitinib kienu ħarira ogħla bi 8% u 27%, rispettivament, milli kienu b'ruxolitinib waħdu.
English: 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.
Maltese: Studju tal-effikaċja wara l-awtorizzazzjoni li jipprovdi informazzjoni dwar leffikaċja u s-sigurtà fit-tul ta' ruxolitinib, inklużi l-kisba (tard) ta' reazzjoni, it-tul ta' (diversi) reazzjonijiet, kif ukoll l-inċidenza ta' AEs, inklużi t-trasformazzjoni ematoloġika u tumuri malinni sekondarji mill-istudju B2301.
English: The three most frequent non-haematological adverse reactions were dizziness (9.2%), constipation (8.7%) and hypertension (6.5%).
Maltese: L-aktar tliet reazzjonijiet avversi mhux ematoloġiċi frekwenti għall-mediċina kienu l-isturdament (9.2%), l-istitikezza (8.7%) u pressjoni għolja (6.5%).
English: Jakavi is indicated for the treatment of adult patients with polycythaemia vera who are resistant to or intolerant of hydroxyurea.
Maltese: Jakavi hu indikat għat-trattament ta' pazjenti adulti b'poliċitemija vera li huma reżistenti jew intolleranti għall-hydroxyurea.
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.
Maltese: F'suġġetti b'saħħithom l-għoti flimkien ta' ruxolitinib (doża waħda ta' 10 mg) mal-inibitur doppju ta' CYP2C9 u CYP3A4, fluconazole, wassal biex is-Cmax u l-AUC ta' ruxolitinib ikunu ogħla b'47% u 232%, rispettivament, milli b'ruxolitinib waħdu.
English: Patients should be assessed for the risk of developing serious infections.
Maltese: Il-pazjenti għandhom ikunu evalwati għar-riskju li jiżviluppaw infezzjonijiet serji.
English: Parent compound is the predominant entity in human plasma, representing approximately 60% of the drug-related material in circulation.
Maltese: Il-kompost ewlieni hu l-entità predominanti fil-plażma umana, li jirrappreżenta madwar 60% tal-materjal fiċ-ċirkulazzjoni b'rabta mal-mediċina.
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.
Maltese: Hu maħsub li l-bażi għal din id-disregulazzjoni tinkludi livelli għolja ta' ċitokini ċirkulatorji li jattivaw il-mogħdija ta' JAK-STAT, il-mutazzjonijiet tal-kisba tal-funzjoni bħalma huma JAK2V617F, u t-trażżin ta' mekkaniżmi regulatorji negattivi.
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%).
Maltese: 1%), żieda flalanina aminotransferasi (22.3%) u iperkolesterolemija (20.7%).
English: - Each 20 mg Jakavi tablet contains 20 mg of ruxolitinib.
Maltese: - Kull pillola Jakavi tal-20 mg fiha 20 mg ruxolitinib.
English: However, patients should be closely monitored for cytopenias when initiating therapy with a moderate CYP3A4 inhibitor.
Maltese: Madanakollu, il-pazjenti għandhom ikunu mmonitorjati minħabba ċitopeniji malli tinbeda t-terapija b'inibitur moderat ta' CYP3A4.
English: Frequency is based on laboratory values.
Maltese: Il-frekwenza tissejjes fuq valuri tal-laboratorju.
English: Jakavi 20 mg tablets ruxolitinib
Maltese: Jakavi 20 mg pilloli ruxolitinib
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.
Maltese: Il-probabbiltà li jinżamm ir-rispons tal-milsa (≥35% tnaqqis) fuq Jakavi għal mill-inqas 24 ġimgħa kienet ta' 89% f'COMFORT-I u 87% f'COMFORT-II; 52% tal-pazjenti żammew ir-rispons tal-milsa għal mill-inqas 48 ġimgħa f'COMFORT-II.
English: The safety and efficacy of Jakavi in children and adolescents aged up to 18 years have not been established.
Maltese: Is-sigurtà u l-effikaċja ta' Jakavi fit-tfal u l-adolexxenti b'età sa 18-il sena għadhom ma ġewx determinati s'issa.
English: 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.
Maltese: Fl-istudju randomizzat COMFORT-I, ikkontrollat bi plaċebo 60.6% tal-pazjenti b'MF ikkurati b'Jakavi u 37.7% tal-pazjenti b'MF ttrattati bi plaċebo ngħataw trasfużjonijiet ta' ċelloli ħomor taddemm matul it-trattament ta' randomizzazzjoni.
English: Jakavi must not be used during breast-feeding (see section 4.3) and breast-feeding should therefore be discontinued when treatment is started.
Maltese: Jakavi m'għandux jintuża waqt it-treddigħ (ara sezzjoni 4.3) u għaldaqstant wieħed għandu jieqaf iredda' meta jinbeda t-trattament.
English: 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.
Maltese: Fil-perjodu randomizzat tal-istudju pivotali fuq pazjenti b'MF, il-medja tal-pressjoni sistolika taddemm żdiedet b'0.65 mmHg fil-kura b'ruxolitinib kontra tnaqqis ta' 2 mmHg fil-kura b'BAT.
English: Any CTCAE
Maltese: U L-UŻU
English: The exposure of ruxolitinib active metabolites was unchanged.
Maltese: L-espożizzjoni tal-metabolit attiv ruxolitinib ma nbidlitx.
English: Each tablet contains 20 mg ruxolitinib (as phosphate).
Maltese: Kull pillola fiha 20 mg ruxolitinib (bħala fosfat).
English: 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).
Maltese: L-endpoint tal-effikaċja primarja kien proporzjonali għall-pazjenti li kisbu ≥35% tnaqqis mil-linja bażi fil-volum tal-milsa fl-24 ġimgħa kif imkejjel permezz tal-Immaġini ta' Reżonanza Manjetika (MRI) jew tat-Tomografija Kkomputata (CT).
English: It is important that you tell your doctor if you have ever had hepatitis B. - if you have any kidney problems.
Maltese: Huwa importanti li tgħid lit-tabib tiegħek jekk qatt kellek l-epatite B. - jekk għandek xi problemi fil-kliewi.
English: Bruising
Maltese: UŻU
English: Jakavi contains lactose.
Maltese: - jekk qatt kellek kanċer tal-ġilda.
English: 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).
Maltese: Kien osservat tnaqqis fit-tkabbir tal-għadam b'dożi ta' ≥5 mg/kg/jum meta t-trattament inbeda fis-7 jum wara t-twelid (imqabbel ma' tarbija tat-twelid umana) u ta' ≥15 mg/kg/jum meta t-trattament beda fl-14 jew il-21 jum wara t-twelid (imqabbel ma' tarbija umana ta' bejn sena u 3 snin).
English: The concomitant use of cytoreductive therapies and ruxolitinib has not been studied.
Maltese: L-użu konkomitanti ta' terapiji ċitoreduttivi u ruxolitinib ma ġiex studjat.
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.
Maltese: F'pazjenti b'saħħithom l-għoti flimkien ta' ruxolitinib (doża singola ta' 10 mg) ma' inibitur qawwi ta' CYP3A4, ketoconazole, wassal biex is-Cmax u l-AUC ta' ruxolitinib kienu ħarira ogħla bi 33% u 91%, rispettivament, milli kienu b'ruxolitinib waħdu.
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.
Maltese: Pilloli tondi kkurvati bojod għal kważi bojod b'dijametru ta' madwar 9.3 mm b'“NVR” imnaqqxa fuq naħa minnhom u “L10” mnaqqxa fuq in-naħa l-oħra.
English: Therapeutic drug monitoring (TDM) or clinical monitoring of the affected substance is advised.
Maltese: Huwa ssuġġerit li jkun hemm monitoraġġ tal-mediċina terapewtika (TDM) jew monitoraġġ kliniku tas-sustanza affettwata.
English: The three most frequent non-haematological adverse drug reactions were bruising (21.3%), dizziness (15.3%) and headache (14.0%).
Maltese: L-aktar tliet reazzjonijiet avversi mhux ematoloġiċi frekwenti għall-mediċina kienu t-tbenġil (21.3%), l-isturdament (15.
English: Jakavi 5 mg tablets ruxolitinib
Maltese: Jakavi 5 mg pilloli ruxolitinib
English: Fractures and early termination of rats were observed at doses ≥30 mg/kg/day when treatment was started on postnatal day 7.
Maltese: Kienu osservati ksur u tmiem tal-firien b'dożi ta'≥30 mg/kg/jum meta t-trattament inbeda fis-7 jum.
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.
Maltese: x 7.0 mm b'“NVR” imnaqqxa fuq naħa minnhom u “L15” imnaqqxa fuq in-naħa l-oħra.
English: MF patients did not become refractory to the pharmacodynamic effects of ruxolitinib treatment over time.
Maltese: Ma dehru l-ebda effetti fl-evalwazzjoni tal-effetti newrofarmakoloġiċi ta' ruxolitinib.
English: Jakavi 5 mg tablets Each tablet contains 5 mg ruxolitinib (as phosphate).
Maltese: Jakavi 5 mg pilloli Kull pillola fiha 5 mg ruxolitinib (bħala fosfat).
English: Jakavi 15 mg tablets ruxolitinib
Maltese: Jakavi 15 mg pilloli ruxolitinib
English: Jakavi can help reduce the risk of serious blood or vascular complications.
Maltese: Jakavi jista' jgħinek tnaqqas ir-riskju ta' kumplikazzjonijiet tad-demm jew vaskulari serji.
English: Jakavi 10 mg tablets ruxolitinib
Maltese: Jakavi 10 mg pilloli ruxolitinib
English: Jakavi tablets are supplied in blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets
Maltese: Il-pilloli Jakavi huma jiġu fi pakketti b'folji li fihom 14 jew 56 pillola jew pakketti b'ħafna li fihom 168 (3 pakketti ta' 56) pillola.
English: The median duration of exposure to Jakavi during the randomised study periods was 7.85 months (range 0.03 to 7.85 months).
Maltese: It-tul medjan ta' espożizzjoni għal Jakavi waqt il-perjodi randomised tal-istudju kien ta' 7.85 xhur (firxa 0.03 sa 7.85 xhur).
English: Haemodialysis is not expected to enhance the elimination of ruxolitinib.
Maltese: Mhux mistenni li l-emodijaliżi ssaħħaħ l-eliminazzjoni ta' ruxolitinib.
English: Final CSR: December 2019
Maltese: April 2017
English: Myelosuppression
Maltese: Mjelofibrożi
English: Phlebotomy eligibility was defined as a confirmed HCT of >45%, i.e. at least 3 percentage points higher than the HCT obtained at baseline or a confirmed HCT of >48%, depending on which was lower.
Maltese: L-eliġibbiltà tal-flebotomija kienet definita bħala HCT ikkonfermat ta' >45%, jiġifieri mill-inqas 3 punti perċentwali ogħla mill-HCT miksub fil-linja bażi jew HCT ikkonfermat ta' >48%, skont liema jkun l-aktar baxx.
English: Ruxolitinib is a Biopharmaceutical Classification System (BCS) class 1 compound, with high permeability, high solubility and rapid dissolution characteristics.
Maltese: Ruxolitinib hu kompost ta' klassi 1 fis-Sistema ta' Klassifikazzjoni Bijofarmaċewtika (BCS), b'porużità għolja, solubbiltà għolja u b'karatteristiċi li jinħall malajr.
English: Positive (N=49) n (%)
Maltese: Pożittiv (N=49) n (%)
English: Other interactions to be considered affecting ruxolitinib
Maltese: Interazzjonijiet minħabba tnaqqis tad-doża ta' ruxolitinib
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.
Maltese: F'COMFORT-II, wara segwitu medju ta' 34.7 xhur, ir-rata tal-mewt f'pazjenti randomizzati għal ruxolitinib kienet ta' 19.9% kontra 30.1% f'pazjenti randomizzati għall-aħjar trattament disponibbli (BAT);
English: When adjusted for exposure, the adverse events rates were generally comparable with those observed during the comparative periods of the randomised studies.
Maltese: Meta aġġustati għall-esponiment, ir-rati ta' avvenimenti avversi ġeneralment kienu komparabbli ma' dawk osservati matul il-perjodi komparattivi tal-istudji randomised.
English: The potential risk for humans is unknown.
Maltese: Ir-riskju għat-tfal imreddgħa mhux eskluż.
English: Each tablet contains 15 mg ruxolitinib (as phosphate).
Maltese: Kull pillola fiha 15 mg ruxolitinib (bħala fosfat).
English: Other bleeding (including epistaxis, post-procedural haemorrhage and haematuria)
Maltese: Fsada oħra (inkluż epistassi, emorrarġija wara operazzjonijiet u ematurja)
English: 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.
Maltese: Wara l-għoti ta' doża singola ta' 25 mg ruxolitinib, l-espożizzjoni ta' ruxolitinib kienu jixxiebhu bejn il-pazjenti bi gradi varji ta' indeboliment tal-kliewi u dawk b'funzjoni normali tal-kliewi.
English: 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.
Maltese: C] f'pazjenti adulti b'saħħithom, l-eliminazzjoni kienet fil-biċċa l-kbira tagħha mill-metaboliżmu, b'74% tar-radjuattività mneħħija mal-awrina u 22% mal-ippurgar.
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.
Maltese: Fil-perjodu randomizzat tal-istudju pivotali fuq pazjenti b'PV, ġiet irrapportata infezzjoni waħda filpassaġġ urinarju (0.5%) ta' CTCAE fil-grad 3 u ma ġiet irrapportata ebda waħda fil-grad 4.
English: Dose reductions should be considered if the platelet count decreases below 100,000/mm
Maltese: Pazjenti b'ammont tal-plejtlits ta' bejn 100,000/mm u
English: A dose reduction of approximately 50% is recommended for patients with hepatic impairment (see section 4.2).
Maltese: Huwa rrakkomandat tnaqqis fid-doża ta' madwar 50% f'każ ta' pazjenti b'indeboliment tal-fwied (ara sezzjoni 4.2).
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.
Maltese: L-endpoints sekondarji kienu jinkludu proporzjon ta' pazjenti li kisbu ≥35% tnaqqis tal-volum talmilsa mil-linja bażi fl-24 ġimgħa u dewmien tal-manutenzjoni ta' ≥35% tnaqqis mill-volum tal-milsa fil-linja bażi.
English: Each tablet contains 5 mg ruxolitinib (as phosphate).
Maltese: Kull pillola fiha 5 mg ruxolitinib (bħala fosfat).
English: Thus, medicinal products inhibiting these enzymes can give rise to increased ruxolitinib exposure.
Maltese: Għalhekk, prodotti mediċinali li jinibixxu dawn l-enzimi jistgħu jwasslu għal żieda fl-espożizzjoni ta' ruxolitinib.
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.
Maltese: Il-pilloli Jakavi tal-15 mg huma pilloli ovali bojod jew kważi bojod b'“NVR” imbuzzata fuq naħa waħda u b'“L15” mbuzzata fuq in-naħa l-oħra.
English: - Each 15 mg Jakavi tablet contains 15 mg of ruxolitinib.
Maltese: - Kull pillola Jakavi tal-15 mg fiha 15 mg ruxolitinib.
English: Best available therapy
Maltese: L-aħjar terapija possibbli
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.
Maltese: Pilloli tondi kkurvati bojod għal kważi bojod b'dijametru ta' madwar 7.5 mm b'“NVR” imnaqqxa fuq naħa minnhom u “L5” mnaqqxa fuq in-naħa l-oħra.
English: Each tablet contains 10 mg ruxolitinib (as phosphate).
Maltese: Kull pillola fiha 10 mg ruxolitinib (bħala fosfat).
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.
Maltese: Il-pilloli Jakavi tal-10 mg huma pilloli tondi bojod jew kważi bojod b'“NVR” imnaqqxa fuq naħa waħda u b'“L10” imnaqqxa fuq in-naħa l-oħra.
English: - Each 5 mg Jakavi tablet contains 5 mg of ruxolitinib.
Maltese: - Kull pillola Jakavi tal-5 mg fiha 5 mg ruxolitinib.
English: Hypertriglyceridaemia b
Maltese: Ipertrigliċeridemija b
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).
Maltese: It-tibdil medju fl-istat tas-saħħa globali fl-24 ġimgħa, kif imkejjel minn EORTC QLQ C30, kien +12.3 għal Jakavi u -3.4 għall-plaċebo (p<0.
English: Jakavi contains lactose (milk sugar).
Maltese: Jakavi fih il-lattosju (zokkor tal-ħalib).
English: Myelofibrosis
Maltese: Il-Ġermanja
English: - Cimetidine, a medicine to treat heartburn.
Maltese: - Cimetidine, mediċina biex tittratta l-aċdu fl-istonku.
English: There is limited information to recommend a starting dose for patients with platelet counts between 50,000/mm and <100,000/mm 3.
Maltese: M'hemmx biżżejjed informazzjoni biex wieħed jissuġġerixxi xi doża inizjali għal pazjenti bl-ammont tal-plejtlits ta' bejn 50,000/mm u <100,000/mm
English: Ruxolitinib is mainly eliminated through metabolism.
Maltese: Ruxolitinib jitneħħa primarjament mill-metaboliżmu.
English: - Each 10 mg Jakavi tablet contains 10 mg of ruxolitinib.
Maltese: - Kull pillola Jakavi tal-10 mg fiha 10 mg ruxolitinib.
English: Doses were then adjusted in individual patients based on tolerability and efficacy with a maximum dose of 25 mg twice daily.
Maltese: Id-dożi mbagħad ġew aġġustati f'pazjenti individwali skont it-tollerabbiltà u leffikaċja b'doża massima ta' 25 mg darbtejn kuljum.
English: Time point After 24 weeks
Maltese: Data tal-aħħar tiġdid: 24
English: Frequency category for MF patients
Maltese: Il-kategorija tal-frekwenza għall-pazjenti b'MF
English: There was one report of CTCAE grade 3 post-herpetic neuralgia amongst the PV patients.
Maltese: Kien hemm rapport wieħed ta' newralġija post-erpetika ta' CTCAE fil-grad 3 fost il-pazjenti b'PV.
English: The safety assessment was based on a total of 982 patients (with MF or PV) receiving Jakavi in phase 2 and 3 studies.
Maltese: Il-valutazzjoni tas-sigurtà kienet ibbażata fuq total ta' 982 pazjent (b'MF jew PV) li rċevew Jakavi filfażijiet 2 u 3 tal-istudji.
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.
Maltese: L-endpoint kompost primarju kien il-proporzjon ta' pazjenti li kisbu kemm assenza ta' eliġibbiltà talflebotomija (kontroll HCT) kif ukoll tnaqqis ta' ≥35% fil-volum tal-milsa mil-linja bażi fit-32 ġimgħa.
English: Thrombocytopenia is generally reversible and is usually managed by reducing the dose or temporarily withholding Jakavi (see sections 4.2 and 4.8).
Maltese: Ġeneralemnt it-tromboċitopenija hi riversibbli u normalment tkun immaniġġjata billi titnaqqas id-doża jew jitwaqqaf għal ftit Jakavi (ara sezzjonijiet 4.2 u 4.8).
English: - The maximum dose is 25 mg twice daily.
Maltese: - L-ogħla doża hi ta' 25 mg darbtejn kuljum.