FrancophonIA/ELRC3.0 huggingface dataset:
English: 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.
Maltese: Fil-programm ta' studju kliniku l-gravità tar-reazzjonijiet avversi tal-mediċina kienu evalwati skont ilCTCAE, li jiddefinixxu grad 1 = ħafif, grad 2 = moderat, grad 3 = gravi u grad 4 = theddida għallħajja.
English: 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).
Maltese: Proporzjon ta' pazjenti bil-bosta akbar fil-grupp mogħti Jakavi kisbu ≥35% tnaqqis mil-linja bażi filvolum tal-milsa (Tabella 2) indipendentament mill-preżenza jew nuqqas tagħha tal-mutazzjoni JAK2V617F jew tas-sottotip tal-marda (MF primarja, MF post-poliċitemija vera, MF posttromboċitemija essenzjali).
English: 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.
Maltese: Fil-fażi 3 tal-istudji kliniċi f'MF, ma ġiet osservata ebda iperkolesterolemija fil-grad 3 jew 4 ta' CTCAE, żieda fl-aspartat aminotransferasi jew żieda fl-alanina aminotransferasi fil-grad 4 ta' CTCAE.
English: - St. John's wort (Hypericum perforatum), a herbal product used to treat depression.
Maltese: John's Wort (Hypericum perforatum), prodott mill-ħxejjex użat biex jittratta d-dipressjoni.
English: Constipation a
Maltese: Gass a
English: Stopping Jakavi
Maltese: Kif jaħdem Jakavi
English: 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).
Maltese: Il-proporzjon ta' pazjenti li kisbu remissjoni ematoloġika kompleta kien ta' 23.6% fuq Jakavi, imqabbel ma' 8.0% fuq BAT (p=0.0013) u lproporzjon ta' pazjenti li kisbu rispons primarju durabbli fit-48 ġimgħa kien ta' 20% fuq Jakavi u 0.9% fuq BAT.(p<0.0001).
English: Effects of ruxolitinib on other medicinal products
Maltese: L-effetti ta' ruxolitinib fuq prodotti mediċinali oħrajn
English: Gastrointestinal bleeding was reported in 5.0% of patients exposed to ruxolitinib compared to 3.1% exposed to reference treatments.
Maltese: Kienet irrappurtata fsada gastrointestinali f'5.0% tal-pazjenti esposti għal ruxolitinib mqabbla ma' 3.1% esposti għal trattamenti ta' referenza.
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).
Maltese: Kontroll haematocrit (HCT) inkiseb f'60% tal-pazjenti mogħtija Jakavi, imqabbla ma' 18.8% tal-pazjenti mogħtija BAT u nkiseb tnaqqis ta' ≥35% fil-volum tal-milsa f'40% tal-pazjenti mogħtija Jakavi, imqabbla ma' 0.9% ta' dawk mogħtija BAT (il-Figura 1).
English: Jakavi can relieve the symptoms, reduce spleen size and the volume of red blood cells produced in patients with polycythaemia vera by selectively blocking enzymes called Janus Associated Kinases (JAK1 and JAK2), thus potentially reducing the risk of serious blood or vascular complications.
Maltese: Jakavi jista' jtaffi s-sintomi u jnaqqas id-daqs tal-milsa u l-volum taċ-ċelloli ħomor prodotti f'pazjenti b'poliċitemija vera billi jimblokka b'mod selettiv enzimi msejħa Janus Associated Kinases (JAK1 u JAK2), sabiex b'hekk potenzjalment inaqqas ir-riskju ta' kumplikazzjonijiet vaskulari jew tad-demm serji.
English: Jakavi 20 mg tablets
Maltese: Jakavi 20 mg pilloli
English: - Mibefradil or diltiazem, medicines to treat hypertension and chronic angina pectoris.
Maltese: - Mibefradil jew diltiazem, mediċini biex jittrattaw il-pressjoni għolja u l-angina pectoris kronika.
English: 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.
Maltese: F'pazjenti b'saħħithom mogħtija ruxolitinib (doża singola ta' 50 mg) wara l-induttur potenti ta' CYP3A4 rifampicin (doża ta' 600 mg kuljum għal 10 ijiem), l-AUC ta' ruxolitinib kienu 70% anqas, rispettivament, milli wara li ngħata ruxolitinib waħdu.
English: In the phase 3 pivotal studies in MF, grade 3 or 4 urinary tract infection was reported in 1.0% of patients, herpes zoster in 4.3% and tuberculosis in 1.0%.
Maltese: Fl-istudji pivotali f'fażi 3 fuq pazjenti b'MF, kienu irrappurtati infezzjoni fil-passaġġ urinarju fi grad 3 jew 4 f'1.0% tal-pazjenti, herpes zoster f'4.3% u tuberkolożi f'1.0%.
English: 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)
Maltese: Tabella 2 Perċentwali ta' pazjenti b'≥35% tnaqqis mil-linja bażi fil-volum tal-milsa fl24 ġimgħa f'COMFORT-I u fit-48 ġimgħa f'COMFORT-II (ITT)
English: Positive (N=121) n (%)
Maltese: Pożittiv (N=121) n (%)
English: Table 3 Percentage of patients with ≥35% reduction from baseline in spleen volume by JAK mutation status (safety set)
Maltese: Tabella 3 Perċentwali ta' pazjenti b'≥35% tnaqqis mil-linja bażi fil-volum tal-milsa skont listat ta' mutazzjoni JAK (sett ta' sigurtà)
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.
Maltese: Fl-istudju COMFORT-II ir-rata ta' trasfużjonijiet ippakkjati ta' ċelloli ħomor tad-demm kienet ta' 53.4% fost il-pazjenti mogħtija Jakavi u ta' 41.1% fost il-pazjenti fl-aħjar terapija disponibbli.
English: Ruxolitinib was not carcinogenic in the Tg.rasH2 transgenic mouse model.
Maltese: Ruxolitinib ma kienx karċinoġeniku fil-mudell transġeniku tal-ġurdien Tg.rasH2.
English: These were all CTCAE grade 1 and 2 with the exception of one CTCAE grade 3 raised alanine aminotransferase event.
Maltese: Dawn kienu kollha fil-grad 1 u 2 ta' CTCAE, bl-eċċezzjoni ta' avveniment wieħed ta' żieda fl-alanina aminotransferasi fil-grad 3 ta' CTCAE.
English: Treatment with Jakavi can cause haematological adverse drug reactions, including thrombocytopenia, anaemia and neutropenia.
Maltese: It-trattament b'Jakavi jista' jikkawża reazzjonijiet avversi ematoloġiċi minħabba l-mediċina, inkluż tromboċitopenija, u anemija newtropenija.
English: Jakavi 5 mg tablets Jakavi 10 mg tablets Jakavi 15 mg tablets Jakavi 20 mg tablets ruxolitinib
Maltese: Informazzjoni għall-pazjent Jakavi 5 mg pilloli Jakavi 10 mg pilloli Jakavi 15 mg pilloli Jakavi 20 mg pilloli ruxolitinib
English: Other bleeding events (including events such as epistaxis, post-procedural haemorrhage, gingival bleeding) were reported in 8.7% of patients treated with ruxolitinib, 6.3% of patients treated with best available therapy in RESPONSE study and 6.7% of patients treated with best available therapy in RESPONSE 2 study.
Maltese: Ġew irrappurtati avvenimenti ta' fsada oħrajn (inklużi avvenimenti bħal epistassi, emorrarġija wara operazzjonijiet, fsada fil-ħanek) fi 8.7% tal-pazjenti kkurati b'ruxolitinib, 6.3% talpazjenti kkurati bl-aħjar terapija disponibbli fl-istudju RESPONSE u f'6.7% tal-pazjenti ttrattati blaħjar terapija disponibbli fl-istudju RESPONSE 2.
English: Frequency is based on all patients exposed to ruxolitinib in clinical studies (N=4755)
Maltese: Il-frekwenza hija bbażata fuq il-pazjenti kollha esposti għal ruxolitinib fl-istudji kliniċi (N=4755)
English: Haematocrit control without phlebotomy
Maltese: Kontroll ematokrit mingħajr flebotomija
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.
Maltese: Pilloli tawwalin bojod għal kważi bojod ta' madwar 16.5 x 7.4 mm b'“NVR” imnaqqxa fuq naħa minnhom u “L20” imnaqqxa fuq in-naħa l-oħra.
English: 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).
Maltese: Jekk Jakavi għandu jingħata flimkien ma' inibituri qawwija ta' CYP3A4 jew inibituri doppji ta' enzimi ta' CYP3A4 u CYP2C9 (eż. fluconazole), id-doża tal-unità ta' Jakavi għandha titnaqqas b'madwar 50%, u tingħata darbtejn kuljum (għall-frekwenza ta' monitoraġġ ara sezzjonijiet 4.2 u 4.5).
English: Symptom burden was assessed using the MPN-SAF total symptom score (TSS) electronic patient diary, which consisted of 14 questions.
Maltese: Il-piż tas-sintomi kien evalwat permezz tad-djarju elettroniku tal-pazjenti bi skor sintomatiku totali (TSS) tal-MPN-SAF, li kien jikkonsisti f'14-il mistoqsija.
English: Thrombocytopenia b
Maltese: Tromboċitopenija b
English: Negative (N=35) n (%)
Maltese: Negattiv (N=35) n (%)
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.
Maltese: Wara l-għoti ta' doża singola ta' 25 mg ruxolitinib f'pazjenti bi gradi differenti ta' indeboliment talfwied l-AUC medju għal ruxolitinib żdied f'pazjenti b'indeboliment tal-fwied ħafif, moderat u gravi b'87%, bi 28% u b'65%, rispettivament, imqabbel ma' pazjenti b'funzjoni normali tal-fwied.
English: Baseline elevations in inflammatory markers associated with constitutional symptoms such as TNFα, IL-6 and CRP in subjects with MF were decreased following treatment with ruxolitinib.
Maltese: Żidiet fil-linja bażi f'markaturi infjammatorji assoċjati ma' sintomi kostituzzjonali bħlma huma TNFα, IL-6 u CRP f'pazjenti b'MF tnaqqsu wara trattament b'ruxolitinib.
English: Frequency category for PV patients
Maltese: Il-kategorija tal-frekwenza għall-pazjenti b'PV
English: Mild or moderate CYP3A4 inhibitors (such as, but not limited to, ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine)
Maltese: (bħalma huma, imma mhux biss, ciprofloxacin, erythromycin, amprenavir, atazanavir, diltiazem, cimetidine)
English: Week 24
Maltese: Dublin 4
English: 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.
Maltese: Ittneħħija orali mbassra kienet ta' 17.7 l/h fin-nisa u ta' 22.1 l/h fl-irġiel, b'varjabbiltà bejn il-pazjenti b'MF ta' 39%.
English: Serious bacterial, mycobacterial, fungal, viral and other opportunistic infections have occurred in patients treated with Jakavi.
Maltese: Infezzjonijiet batteriċi, mikrobatteriċi, fungali, virali u opportunistiċi oħrajn serji seħħew f'pazjenti ttrattati b'Jakavi.
English: Figure 1 Patients achieving the primary endpoint and components of the primary endpoint at week 32
Maltese: Figura 1 Pazjenti li kisbu l-endpoint primarju u l-komponenti tal-endpoint primarju fit32 ġimgħa
English: Adverse drug reactions from clinical studies (Table 1) are listed by MedDRA system organ class.
Maltese: Ir-reazzjonijiet avversi tal-mediċina minn studji kliniċi (Tabella 1) huma elenkati skont is-sistema ta' klassifika tal-organi.
English: - Keep this leaflet.
Maltese: Perċentwali ta' pazjenti
English: Ruxolitinib was not mutagenic or clastogenic.
Maltese: Ruxolitinib ma kienx mutoġeniku jew klastoġeniku.
English: 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).
Maltese: Skont dejta dwar is-sigurtà fit-tul miksuba minn żewġ studji pivotali f'fażi 3 li evalwaw 457 pazjent b'MF li kienu ttrattati b'ruxolitinib, li kienu jinkludu pazjenti magħżula għall-ewwel b'mod randomizzat għal ruxolitinib (n=301 pazjent; espożizzjoni ta' 0.3-68.1 xhur, b'espożizzjoni medjana ta' 33.4 xhur) u pazjenti li ngħataw ruxolitinib wara li nqalbu mit-trattamenti ta' kontroll (n=156; espożizzjoni: 0.5-59.8 xhur, b'espożizzjoni medjana ta' 25.
English: MF and PV are myeloproliferative neoplasms known to be associated with dysregulated JAK1 and JAK2 signalling.
Maltese: MF u PV huma neoplażmi mjeloproliferattivi magħrufa li huma assoċjati ma' disregulazzjoni tassinjali ta' JAK1 u JAK2.
English: A single dose of 15 mg is recommended for MF patients with platelet count between 100,000/mm and 200,000/mm
Maltese: Doża waħda ta' 15 mg hija rrakkomandata għal pazjenti ta' MF bl-ammont tal-plejtlits ta' bejn 100,000/mm u 200,000/mm
English: Target organs associated with the pharmacological action of ruxolitinib in repeated dose studies include bone marrow, peripheral blood and lymphoid tissues.
Maltese: L-organi mmirati assoċjati mal-azzjoni farmakoloġika ta' ruxolitinb fi studji dwar dożi ripetuti jinkludu l-mudullun, id-demm periferali u t-tessuti limfatiċi.
English: Higher than recommended repeat doses are associated with increased myelosuppression including leukopenia, anaemia and thrombocytopenia.
Maltese: Dożi ripetuti ogħla minn dawk irrakkomandati huma assoċjati ma' żieda fil-mjelosuppressjoni inkluż lewkopenijia, anemija u tromboċitopenija.
English: With these updated data, therapy discontinuation due to adverse events was observed in 27.4% of patients treated with ruxolitinib.
Maltese: B'din id-dejta aġġornata, it-twaqqif għal kollox tat-terapija minħabba reazzjonijiet avversi kien osservat f'27.4% tal-pazjenti ttrattati b'ruxolitinib.
English: At clinically relevant concentrations of ruxolitinib, binding to plasma proteins in vitro is approximately 97%, mostly to albumin.
Maltese: F'konċentrazzjonijiet relevanti klinikament ta' ruxolitinib, it-twaħħil mal-proteini tal-plażma in vitro hu ta' madwar 97%, l-aktar minħabba l-albumina.
English: Avoid the concomitant use of ruxolitinib with fluconazole doses greater than 200 mg daily.
Maltese: Evita l-użu flimkien ta' ruxolitinib ma' dożi ta' fluconazole akbar minn 200 mg kuljum.
English: Single doses up to 200 mg have been given with acceptable acute tolerability.
Maltese: Ingħataw dożi singoli sa 200 mg b'tollerrabbiltà akuta aċċettabbli.
English: Non-melanoma skin cancers (NMSCs), including basal cell, squamous cell, and Merkel cell carcinoma, have been reported in patients treated with ruxolitinib.
Maltese: Ġew irrapportati kanċers tal-ġilda non-melanoma (NMSCs), inkluż karċinoma taċ-ċellula bażi, karċinoma taċ-ċellula skwamuża u karċinoma taċ-ċellula Merkel, f'pazjenti kkurati b'ruxolitinib.
English: Positive (N=113) n (%)
Maltese: Pożittiv (N=113) n (%)
English: 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).
Maltese: Il-punt finali primarju definit bħala l-proporzjon ta' pazjenti li kisbu kontroll tal-HCT (nuqqas ta' eliġibilità għall-flebotomija) f'ġimgħa 28 intlaħaq (62.2% fil-grupp ta' Jakavi kontra 18.7% fil-grupp ta' BAT).
English: Negative (N=27) n (%)
Maltese: Negattiv (N=27) n (%)
English: Jakavi 10 mg tablets
Maltese: Jakavi 10 mg pilloli
English: Negative (N=20) n (%)
Maltese: Negattiv (N=20) n (%)
English: Negative (N=40) n (%)
Maltese: Negattiv (N=40) n (%)
English: Jakavi 5 mg tablets
Maltese: Jakavi 5 mg pilloli
English: 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.
Maltese: F'COMFORT-I, wara segwitu medju ta' 61.7 xhur, ir-rata tal-mewt f'pazjenti randomizzati għall-kura b'ruxolitinib kienet ta' 44.5% (69 minn 155 pazjent) kontra 53.2% (82 minn 154) f'pazjenti randomizzati għall-plaċebo.
English: Jakavi is indicated for the treatment of disease-related splenomegaly or symptoms in adult patients with primary myelofibrosis (also known as chronic idiopathic myelofibrosis), post polycythaemia vera myelofibrosis or post essential thrombocythaemia myelofibrosis.
Maltese: Jakavi hu indikat għat-trattament ta' splenomegalija jew sintomi relatati mal-marda f'pazjenti adulti b'mjelofibrożi primarja (magħrufa wkoll bħala mjelofibrożi idjopatika kronika), mjelofibrożi postpoliċitemija vera jew mjelofibrożi posttromboċitemija essenzjali.
English: Juvenile rats are more sensitive than adult rats to ruxolitinib toxicity.
Maltese: Il-firien mhux adulti huma aktar sensittivi għat-tossiċità ta' ruxolitinib mill-firien adulti.
English: In COMFORT-I, 45.9% subjects in the Jakavi group achieved a ≥50% improvement from baseline in the week 24 total symptom score (measured using MFSAF diary v2.0), as compared to 5.3% in the placebo group (p<0.0001 using chi-square test).
Maltese: F'COMFORT-I, 45.9% tal-pazjenti fil-grupp Jakavi kisbu a ≥50% titjib fl-iskor sintomatiku totali millinja bażi fl-24 ġimgħa (imkejjel permezz tal-MFSAF djarju v2.0), imqabbel ma' 5.3% fil-grupp talplaċebo (p<0.
English: 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.
Maltese: Ġew irrapportati żidiet ta' tagħbija virali tal-epatite B (HBV-DNA titre), bi u mingħajr elevazzjonijiet assoċjati f'alanina aminotransferasi u aspartat aminotransferasi, f'pazjenti b'infezzjonijiet kroniċi ta' HBV li jieħdu Jakavi.
English: Jakavi 15 mg tablets
Maltese: Jakavi 15 mg pilloli
English: PVC/PCTFE/Aluminium blister packs containing 14 or 56 tablets or multipacks containing 168 (3 packs of 56) tablets.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih Pakketti b'foji tal-PVC/PCTFE/Aluminju li fihom 14 jew 56 pillola jew pakketti b'ħafna li fihom 168 (3 pakketti ta' 56) pillola.
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.
Maltese: Endpoints sekondarji kienu jinkludu d-dewmien tal-manutenzjoni ta' ≥35% tnaqqis mil-linja bażi filvolum tal-milsa, proporzjon tal-pazjenti li kellhom ≥50% tnaqqis tal-iskor sintomatiku totali, bidliet fliskors sintomatiċi totali mil-linja bażi sal-24 ġimgħa, kif imkejjel bil-Formula ta' Evalwazzjoni tasSintomu tal-MF (MFSAF) djarju v2.0, u s-sopravivenza totali.
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).
Maltese: F'COMFORT-II, wara segwitu medju ta' 55.9 xhur, ir-rata tal-mewt f'pazjenti randomizzati għal ruxolitinib kienet ta' 40.4% (59 minn 146 pazjent) kontra 47.
English: Gastrointestinal disorders Flatulence a
Maltese: Disturbi vaskulari Pressjoni għolja a
English: Positive (N=110) n (%)
Maltese: Pożittiv (N=110) n (%)
English: The half-life was prolonged from 3.7 to 6.0 hours with concurrent ketoconazole administration.
Maltese: Il-half-life kien imtawwal minn 3.7 għal 6.0 sigħat blgħoti flimkien ma' ketoconazole.
English: 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.
Maltese: Simulazzjonijiet farmakokinetiċi/farmakodinamiċi bbażati fuq informazzjoni disponibbli f'din il-popolazzjoni tissuġġerixxi li d-doża inizjali għal pazjenti ta' MF b'ESRD li qegħdin fuq emodijaliżi hi doża waħda ta' 15-20 mg jew żewġ dożi ta' 10 mg mogħtija 12-il siegħa bogħod minn xulxin, li għandhom jingħataw wara d-dijalisi u dakinhar tal-emodijaliżi biss.
English: This can include medical history, possible previous contact with tuberculosis, and/or appropriate screening such as lung x-ray, tuberculin test and/or interferon-gamma release assay, as applicable.
Maltese: Dan jista' jinkludi storja medika, kuntatt possibbli minn qabel ma' tuberkulosi, u/jew screening adattat bħal x-ray tal-pulmun, test għat-tuberculin u/jew analiżi tar-rilaxx ta' interferon-gamma, kif applikabbli.
English: A second randomised, open label, active-controlled phase 3b study (RESPONSE 2) was conducted in 149 PV patients who were resistant to, or intolerant of, hydroxyurea but without palpable splenomegaly.
Maltese: Twettaq studju ieħor ta' fażi 3b randomised, open label, ikkontrollat b'attiv (RESPONSE 2) f'149 pazjent b'PV li kienu reżistenti għal, jew intolleranti għal, hydroxyurea iżda mingħajr splenomegalija palpabbli.
English: This medicine is not intended for use by children or adolescents aged below 18 years because it has not been studied in this age group.
Maltese: Din il-mediċina mhix maħsuba għall-użu fi tfal jew adolexxenti ta' età anqas minn 18-il sena peress li ma ġietx studjata f'dan il-grupp ta' età.
English: 50% dose reduction should be considered when using medicinal products which are dual inhibitors of CYP2C9 and CYP3A4 enzymes (e.g. fluconazole).
Maltese: 50% tat-tnaqqis tad-doża għandu jikkunsidra tnaqqis tad-doża meta jintużaw prodotti mediċinali li huma inibituri doppji ta' enzimi ta' CYP2C9 u CYP3A4
English: 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.
Maltese: Id-doża inizjali rrakkomandata ta' ruxolitinib f'MF hi ta' 15 mg darbtejn kuljum għal pazjenti li għandhom l-ammont tal-plejtlits ta' bejn 100,000/mm u 200,000/mm u ta' 20 mg darbtejn kuljum għal pazjenti li għandhom l-ammont tal-plejtlits >200,000/mm
English: A study in healthy subjects indicated that ruxolitinib did not inhibit the metabolism of the oral CYP3A4 substrate midazolam.
Maltese: Studju fuq individwi f'saħħithom indika li ruxolitinib ma inibixxiex il-metaboliżmu tas-sottostrat orali ta' CYP3A4 midazolam.
English: 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.
Maltese: Is-sigurtà fit-tul kienet evalwata permezz ta' data minn żewġ studji ta' fażi 3 inkluża data minn pazjenti inizjalment randomised għal ruxolitinib (n=184; esponiment 0.03 sa 43.5 xhur, esponiment medjan ta' 18.9 xhur) u pazjenti li rċevew ruxolitinib wara li qalbu minn trattamenti ta' kontroll (n=149; esponiment: