FrancophonIA/ELRC3.0 huggingface dataset:
English: Why has Jakavi been approved?
Maltese: Għaliex ġie approvat Jakavi?
English: • polycythaemia vera in adults who are resistant or intolerant to treatment with the medicine hydroxyurea.
Maltese: • adulti b'poliċitemija li jirreżistu jew ma jittollerawx il-kura bil-mediċina hydroxyurea.
English: The second study compared Jakavi with the best available treatment, which included different types of medicines such as anti-cancer agents, hormones and immunosuppressants.
Maltese: It-tieni studju qabbel lil Jakavi mal-aħjar kura disponibbli, li kienet tinkludi tipi differenti ta' mediċini bħal aġenti kontra l-kanċer, ormoni u immunosuppressanti.
English: In polycythaemia vera, the recommended starting dose is 10 mg twice a day.
Maltese: Fil-poliċitemija, id-doża inizjali rakkomandata hija 10 mg darbtejn kuljum.
English: In polycythaemia vera, Jakavi was studied in one main study which involved 222 patients who were resistant or intolerant to treatment with hydroxyurea.
Maltese: Fil-poliċitemija vera, Jakavi ġie studjat fi studju ewlieni wieħed li involva 222 pazjent li rreżistew jew ma ttollerawx il-kura b'hydroxyurea.
English: In the second study, the target reduction in spleen size was achieved in 29% of patients treated with Jakavi (41 out of 144) compared with 0% of patients receiving the best available treatment (0 out of 72).
Maltese: Fit-tieni studju, it-tnaqqis fil-mira fid-daqs tal-milsa tal-pazjenti nkiseb f'29% tal-pazjenti kkurati b'Jakavi (41 minn 144) meta mqabbel ma' 0% tal-pazjenti li rċevew l-aħjar kura disponibbli (0 minn
English: What is Jakavi?
Maltese: X'inhu Jakavi?
English: In polycythaemia vera, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), bleeding, bruising, hypercholesterolaemia (high blood cholesterol levels), hypertriglyceridemia (high blood fat levels), dizziness, raised liver enzyme levels and high blood pressure.
Maltese: Fil-poliċitemija vera, l-effetti sekondarji l-aktar komuni b'Jakavi (li dehru f'aktar minn pazjent 1 minn kull 10) huma tromboċitopenija (għadd baxx ta' pjastrini tad-demm), anemija (għaxx baxx ta' ċelloli tad-demm ħomor), fsada, tbenġil, iperkolesterolemija (livelli għoljin ta' kolesterol fid-demm), ipertrigliċeridemija (livelli għolja ta' xaħam fid-demm), sturdament, livelli ogħla ta' enzimi fil-fwied.
English: In myelofibrosis, the most common side effects with Jakavi (seen in more than 1 patient in 10) are thrombocytopenia (low blood platelet counts), anaemia (low red blood cell counts), neutropenia (low levels of neutrophils), urinary tract infections (infection of the structures that carry urine), bleeding, bruising, weight gain, hypercholesterolaemia (high blood cholesterol levels), dizziness, headache and raised liver enzyme levels.
Maltese: L-effetti sekondarji l-aktar komuni b'Jakavi (li dehru f'aktar minn pazjent 1 minn kull 10) huma tromboċitopenija (għadd baxx ta' pjastrini tad-demm), anemija (għadd baxx ta' ċelloli tad-demm ħomor), newtropenija (livelli baxxi ta' newtrofili), infezzjonijiet fl-apparat tal-awrina (infezzjoni talistrutturi li jġorru l-awrina), fsada, tbenġil, żieda fil-piż, iperkolesterolemija (livelli għoljin ta' kolesterol fid-demm), sturdament, uġigħ ta' ras u livelli ogħla ta' enzimi fil-fwied.
English: What is the risk associated with Jakavi?
Maltese: X'inhu r-riskju assoċjat ma' Jakavi?
English: The European Commission granted a marketing authorisation valid throughout the European Union for Jakavi on 23 August 2012.
Maltese: Il-Kummissjoni Ewropea tat awtorizzazzjoni għat-tqegħid fis-suq għal Jakavi valida fl-Unjoni Ewropea kollha fis-23 ta' Awwissu 2012.
English: If the treatment is not considered effective enough, the dose can be increased by 5 mg up to 25 mg twice a day.
Maltese: Jekk il-kura titqies li ma tkunx effettiva biżżejjed, id-doża tista' tiżdied b'5 mg sa 25 mg darbtejn kuljum.
English: The active substance in Jakavi, ruxolitinib, works by blocking a group of enzymes known as Janus kinases (JAKs), which are involved in the production and growth of blood cells.
Maltese: Is-sustanza attiva f'Jakavi, ir-ruksolitinib, taħdem billi timblokka grupp ta' enzimi magħrufin bħala kinażi Janus (JAKs), li huma involuti fil-produzzjoni u t-tkabbir ta' ċelloli tad-demm.
English: In myelofibrosis the CHMP considered that the reduction in spleen size and symptoms seen in patients taking Jakavi is clinically important.
Maltese: Is-CHMP ikkunsidra li t-tnaqqis fid-daqs tal-milsa u s-sintomi li kien hemm f'pazjenti li ħadu Jakavi huwa klinikament importanti.
English: In myelofibrosis and polycythaemia vera, there is too much JAK activity, leading to the abnormal production of blood cells.
Maltese: Fil-majelofibrożi u l-poliċitemija vera, hemm wisq attività JAK, li twassal għal produzzjoni anormali taċ-ċelloli tad-demm.
English: The first study compared Jakavi with placebo (a dummy treatment).
Maltese: L-ewwel studju qabbel lil Jakavi ma' plaċebo (kura finta).
English: Jakavi can be used in three types of the disease: primary myelofibrosis (also known as chronic idiopathic myelofibrosis, where the cause is unknown), post-polycythaemia vera myelofibrosis (where the disease is linked to an overproduction of red blood cells) and postessential thrombocythaemia myelofibrosis (where the disease is linked to an overproduction of platelets, components that help the blood to clot).
Maltese: Jakavi jista' jintuża fi tliet tipi tal-marda: majelofibrożi primarja (magħrufa wkoll bħala majelofibrożi idjopatika kronika, fejn il-kawża ma tkunx magħrufa), majelofibrożi ta' wara poliċitemija vera (fejn il-marda hija marbuta ma' produzzjoni eċċessiva ta' ċelloli ħomor taddemm) u majelofibrożi ta' wara tromboċitemija essenzjali (fejn il-marda hija marbuta ma' produzzjoni eċċessiva ta' pjastrini, komponenti li jgħinu sabiex id-demm jagħqad).
English: In myelofibrosis, Jakavi was investigated in two main studies involving 528 patients.
Maltese: Fil-majelofibrożi, Jakavi ġie investigat f'żewġ studji ewlenin li kienu jinvolvu 528 pazjent.
English: In myelofibrosis, the recommended starting dose is up to 20 mg twice a day depending on the platelet count.
Maltese: Fil-majelofibrożi, id-doża inizjali rakkomandata hija 20 mg darbtejn kuljum skont l-għadd tal-pjastrini.
English: In myelofibrosis, Jakavi was more effective than placebo and the best available treatment at reducing the size of the spleen.
Maltese: Fil-majelofibrożi, Jakavi kien aktar effettiv mill-plaċebo u l-aħjar kura disponibbli biex inaqqas id-daqs tal-milsa.
English: For the full list of all side effects and restrictions with Jakavi, see the package leaflet.
Maltese: Għal-lista sħiħa tal-effetti sekondarji u r-restrizzjonijiet kollha b'Jakavi, ara l-fuljett ta' tagħrif.
English: In polycythaemia vera the CHMP considered that Jakavi is of benefit to patients who do not respond or are intolerant to treatment with hydroxyurea, while the safety profile is acceptable.
Maltese: Fil-poliċitemija vera, is-CHMP ikkunsidra li Jakavi huwa ta' benefiċċju għall-pazjenti li ma jirrispondux jew ma jittollerawx il-kura b'hydroxyurea, filwaqt li l-profil ta' sigurtà huwa aċċettabbli.
English: How has Jakavi been studied?
Maltese: Kif ġie studjat Jakavi?
English: In polycythaemia vera, the company will extend the main study to provide long-term data on the safety and effectiveness of Jakavi.
Maltese: Filpoliċitemija vera, il-kumpanija se testendi l-istudju ewlieni biex tipprovdi dejta fit-tul dwar is-sigurtà u l-effikaċja ta' Jakavi.
English: By blocking JAKs, Jakavi reduces the abnormal production of blood cells, thereby reducing the symptoms of the diseases.
Maltese: Billi jimblokka JAKs, Jakavi jnaqqas il-produzzjoni anormali taċ-ċelloli tad-demm, u b'hekk inaqqas is-sintomi talmard.
English: Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu France or
Maltese: Patheon France 40 boulevard de Champaret 38300 Bourgoin Jallieu Franza jew
English: Patheon France 40 Boulevard de Champaret FR-38300 Bourgoin Jallieu France or
Maltese: Patheon France 40 Boulevard de Champaret FR-38300 Bourgoin Jallieu Franza jew
English: Mean (±SEM) Serum Uric Acid Level (mg/dL)
Maltese: Serum Uric Acid Level (mg/dL)
English: Tumor Lysis Syndrome
Maltese: (Tumor Lysis Syndrome, TLS) .
English: Film-coating: Opadry II yellow, 85F42129 containing: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide yellow (E172)
Maltese: Opadry II isfar, 85F42129 li fih: polyvinyl alcohol, titanium dioxide (E171), macrogols 3350, talc, iron oxide isfar (E172)
English: ADENURIC is indicated in adults.
Maltese: ADENURIC huwa indikat fl-adulti.
English: ADENURIC contains lactose
Maltese: ADENURIC fih lactose
English: Each tablet contains 76.50 mg of lactose (as monohydrate)
Maltese: Kull pillola fiha 76.50 mg ta' lactose (bħala monohydrate)
English: Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Maltese: Menarini International Operations Luxembourg S.A. 1, Avenue de la Gare, L-1611 Luxembourg Il-Lussemburgu
English: Date of first authorisation: 21 April 2008 Date of latest renewal: 20 December 2012
Maltese: Data tal-aħħar tiġdid: 20 Diċembru 2012
English: Prophylaxis against gout flares was obligatory over the 26-week period.
Maltese: Profilassi kontra laggravar tal-gotta kien obbligatorju fuq il-perijodu ta' 26-ġimgħa.
English: Incidence of overall treatment-emergent signs and symptoms and adverse drug reactions was 67.6% vs 64.7% and 6.4% vs 6.4% with ADENURIC and allopurinol respectively.
Maltese: 64.7% u 6.4% vs 6.4% b'ADENURIC u allopurinol rispettivament.
English: Clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
Maltese: Folja ċara (Aclar/PVC/Aluminju jew PVC/PE/PVDC/Aluminju) ta' 14-il pillola.
English: After single or multiple oral 80 and 120 mg once daily doses, Cmax is approximately 2.8-3.2 µg/mL, and 5.0-5.3 µg/mL, respectively.
Maltese: Wara doża waħda jew dożi multipli orali kuljum ta' 80 u 120 mg, Cmax ikun madwar 2.8-3.2 µg/mL, u 5.0-5.3 µg/mL, rispettivament.
English: MINIMUM PARTICULARS TO APPEAR ON BLISTERS OR STRIPS PVC/ACLAR/ALUMINIUM OR PVC/PE/PVDC/ALUMINIUM BLISTER
Maltese: FOLJA PVC/ACLAR/ALUMINJU JEW PVC/PE/PVDC/ALUMINJU
English: ADENURIC tablets contain lactose (a type of sugar).
Maltese: Pilloli ADENURIC fihom lactose (tip ta' zokkor).
English: Tablet core: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica.
Maltese: Qalba tal-pillola: lactose monohydrate, microcrystalline cellulose, magnesium stearate, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica.
English: With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.875 [95% confidence interval: 0.4408 ; 1.7369]; p=0.8488) nor of clinical TLS (1.7% and 1.2% in ADENURIC and allopurinol arm, respectively; relative risk: 0.994 [95% confidence interval: 0.9691 ; 1.0199]; p=1.0000).
Maltese: Fir-rigward ta' punti aħħarin sekondarji, ma ġiet osservata l-ebda differenza sinifikanti f'termini ta' inċidenza ta' TLS tal-laboratorju (8.1% u 9.2% fil-grupp ta' Febuxostat u Allopurinol, rispettivament; riskju relattiv: 0.875 [95% intervall ta' kunfidenza : 0.4408: 1.7369]; p=0.8488u lanqas ta' TLS kliniku (1.7% u 1.2% fil-gruppi ta' Febuxostat u Allopurinol rispettivament; riskju relattiv: 0.994 [95% intervall ta' kunfidenza 0.9691; 1.0199]; p=1.0000).
English: Plasma protein binding of the active metabolites ranges from about 82% to 91%.
Maltese: It-twaħħil mal-proteini fil-plażma tal-metaboliti attivi jvarja minn madwar 82% sa 91%.
English: Febuxostat tablets contain lactose.
Maltese: Pilloli febuxostat fihom lactose.
English: Marketing Authorisation Holder: Menarini International O. L. S.A. 1, Avenue de la Gare, L-1611 Luxembourg Luxembourg
Maltese: Menarini International O. L. S. A. 1, Avenue de la Gare, L-1611 Luxembourg Il-Lussemburgu
English: Population pharmacokinetic/pharmacodynamic analyses were conducted in 211 patients with hyperuricaemia and gout, treated with ADENURIC 40-240 mg QD.
Maltese: Saru analiżi tal-farmakokinetika/farmakodinamika tal-popolazzjoni f'211-il pazjent b'iperuriċimja u gotta, kkurati b'ADENURIC 40-240 mg QD.
English: 14 film-coated tablets 28 film-coated tablets 42 film-coated tablets 56 film-coated tablets 84 film-coated tablets 98 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 42 pillola miksija b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita 98 pillola miksija b'rita
English: Tabulated list of adverse reactions Common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100) and rare (≥1/10,000 to <1/1,000)
Maltese: Reazzjonijiet avversi komuni (≥1/100 sa <1/10), mhux komuni (≥1/1,000 sa <1/100) u rari (≥1/10,000 sa <1/1000) li seħħew f'pazjenti ikkurati b'febuxostat huma mniżżla hawn taħt.
English: Febuxostat is extensively metabolized by conjugation via uridine diphosphate glucuronosyltransferase (UDPGT) enzyme system and oxidation via the cytochrome P450 (CYP) system.
Maltese: Biotrasformazzjoni Febuxostat huwa metabolizzat b'mod estensiv permezz ta' konjugazzjoni permezz tas-sistema tal enżima uridine diphosphate glucuronosyltransferase (UDPGT) u ta' ossidazzjoni permezz tas-sistema taċ-ċitokromju P450 (CYP).
English: The APEX Study evaluated efficacy in 40 patients with renal impairment (i.e., baseline serum creatinine > 1.5 mg/dL and ≤2.0 mg/dL).
Maltese: L-Istudju APEX ivvaluta l-effikaċja f'40 pazjent b'indeboliment renali (i.e., linja bażi tal-krejatinina fis-serum > 1.5 mg/dL u ≤2.0 mg/dL).
English: Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated
Maltese: Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated
English: ADENURIC 80 mg is available in pack sizes of 14, 28, 42, 56, 84 and 98 film-coated tablets.
Maltese: ADENURIC 80 mg huwa disponibbli f'daqsijiet tal-pakkett ta' 14, 28, 42, 56, 84 u 98 pillola miksija b'rita.
English: The incidence of investigator-reported cardiovascular APTC events in the combined Phase 3 studies (APEX, FACT and CONFIRMS studies) was 0.7 vs. 0.6 events per 100 PYs.
Maltese: Il-frekwenzi ta' episodji APTC kardjovaskulari irrappurtati mill-investigatur fl istudji ta' Fażi 3 kombinati (studji APEX, FACT u CONFIRMS) kienu 0.7 kontra 0.6 episodju kull
English: Each tablet contains 114.75 mg of lactose (as monohydrate)
Maltese: Kull pillola fiha 114.75 mg ta' lactose monohydrate
English: Combined Results
Maltese: Kombinati
English: Other medicines and ADENURIC
Maltese: Mediċini oħra u ADENURIC
English: Cardio-vascular disorders
Maltese: Disturbi gastro-intestinali
English: Lactose monohydrate Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated
Maltese: Qalba tal-pillola Lactose monohydrate Microcrystalline cellulose Magnesium stearate Hydroxypropylcellulose Croscarmellose sodium Silica, colloidal hydrated
English: The apparent steady state volume of distribution (Vss/F) of febuxostat ranges from 29 to 75 L after oral doses of 10-300 mg.
Maltese: Distribuzzjoni Il-volum ta' distribuzzjoni apparenti fi stat stabbli (Vss/F) ta' febuxostat ivarja minn 29 sa 75 l wara dożi orali ta' 10-300 mg.
English: EU/1/08/447/003 EU/1/08/447/004 EU/1/08/447/009 EU/1/08/447/010 EU/1/08/447/011 EU/1/08/447/012 EU/1/08/447/019 EU/1/08/447/020 EU/1/08/447/021 EU/1/08/447/022 EU/1/08/447/023 EU/1/08/447/024
Maltese: EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008 EU/1/08/447/019 EU/1/08/447/020 EU/1/08/447/021 EU/1/08/447/022 EU/1/08/447/023 EU/1/08/447/024
English: ADENURIC 80 mg and 120 mg is packed in clear (Aclar/PVC/Aluminium or PVC/PE/PVDC/Aluminium) blister of 14 tablets.
Maltese: ADENURIC 80 mg u 120 mg jiġu f'pakketti b'folja ċara (Aclar/PVC/Aluminju jew
English: EU/1/08/447/001 EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008 EU/1/08/447/013 EU/1/08/447/014 EU/1/08/447/015
Maltese: EU/1/08/447/001 EU/1/08/447/002 EU/1/08/447/005 EU/1/08/447/006 EU/1/08/447/007 EU/1/08/447/008
English: Pharmacotherapeutic group: Antigout preparation, preparations inhibiting uric acid production, ATC code: M04AA03
Maltese: Preparazzjoni kontra l-gotta, preparazzjonijiet li jinibixxu l produzzjoni ta' uric acid, Kodiċi ATC:
English: Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 µmol/L)
Maltese: Tabella 2 Proporzjon ta' Pazjenti b'Livelli ta' Uric Acid fis-Serum <6.0 mg/dL (357µmol/L)
English: Should you experience allergic reactions to ADENURIC, stop taking this medicine (see also section 4).
Maltese: Jekk ikollok reazzjonijiet allerġiċi għal ADENURIC, waqqaf din il-mediċina (ara wkoll sezzjoni 4).
English: Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria Rare
Maltese: Insuffiċjenza renali, nefrolitajasi, ematurja, pollakurja, protejnurja
English: Following multiple oral doses of ADENURIC, the Cmax and AUC were 24% and 12% higher in females than in males, respectively.
Maltese: Wara dożi orali multipli ta' ADENURIC, Cmax u l-AUC kienu 24% u 12% ogħla fin-nisa milli fl-irġiel,
English: One thousand and seventy-two (1072) patients were randomized: placebo (n=134), ADENURIC 80 mg QD (n=267), ADENURIC 120 mg QD (n=269), ADENURIC 240 mg QD (n=134) or allopurinol (300 mg QD [n=258] for patients with a baseline serum creatinine ≤1.5 mg/dL or 100 mg QD [n=10] for patients with a baseline serum creatinine >1.5 mg/dL and ≤2.0 mg/dL).
Maltese: 120 mg QD (n=269), ADENURIC 240 mg QD (n=134) jew allopurinol (300 mg QD [n=258] għallpazjenti b'linja bażi ta' krejatinina fis-serum ≤1.5 mg/dL jew 100 mg QD [n=10] għall-pazjenti b'linja bażi ta' krejatinina fis-serum >1.5 mg/dL u ≤2.0 mg/dL).
English: During the combined phase 3 clinical studies, mild liver function test abnormalities were observed in patients treated with febuxostat (5.0%).
Maltese: Waqt studji kliniċi kombinati ta' fażi 3, kienu osservati anormalitajiet ħfief fit-test tal-funzjoni tal fwied f'pazjenti kkurati b'febuxostat (5.0%).
English: Gout flares during the last 4 weeks of the study (Weeks 24-28) were observed in 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) and 20% (placebo) of subjects.
Maltese: (Ġimgħat 24-28) deher fi 15% (febuxostat 80, 120 mg), 14% (allopurinol 300 mg) u 20% (plaċebo) tal-individwi.
English: The efficacy and safety of ADENURIC in the prevention and treatment of Tumor Lysis Syndrome was evaluated in the FLORENCE (FLO-01) study.
Maltese: L-effikaċja u s-sigurtà ta' ADENURIC fil-prevenzjoni u t-trattament ta' Sindrome tal-Lisi tat-Tumur kienu murija fl-istudju FLORENCE (FLO-01).
English: ADENURIC 120 mg tablets Febuxostat
Maltese: Pilloli ADENURIC 120 mg Febuxostat
English: Seven hundred sixty (760) patients were randomized: ADENURIC 80 mg QD (n=256), ADENURIC 120 mg QD (n=251), or allopurinol 300 mg QD (n=253).
Maltese: ADENURIC 80 mg QD (n=256), ADENURIC 120 mg QD (n=251), jew allopurinol 300 mg QD (n=253).
English: Gout flares during the last 4 weeks of the study (Weeks 49-52) were observed in 6-8% (febuxostat 80 mg, 120 mg) and 11% (allopurinol 300 mg) of subjects.
Maltese: (Ġimgħat 49-52) deher f'6-8% (febuxostat 80 mg, 120 mg) u 11% (allopurinol 300 mg) tal-individwi.
English: No significant difference in mean serum creatinine change (%) occurred between ADENURIC and allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 respectively; least square means difference: 4.0970 [95% confidence interval: -0.6467 ; 8.8406]; p=0.0903).
Maltese: Ma kienx hemm ebda differenza sinifikanti fil-bidla medja (%) ta' kreatinina fis-serum bejn ADENURIC u allopurinol (-0.83 ± 26.98 vs -4.92 ± 16.70 rispettivament; l-inqas kwadru jfisser differenza ta': 4.0970 [95% intervall ta' kunfidenza: -0.6467 ;
English: Overall, 346 patients with haematological malignancies undergoing chemotherapy and at intermediate / high risk of Tumor Lysis Syndrome were included.
Maltese: Globalment, 346 pazjent b'malinni ematoloġiċi li jkunu qed jieħdu kimoterapija u f'riskju intermedjarju / għoli għal Sindrome tal-Lisi tat-Tumur kienu inklużi.
English: ADENURIC achieved the primary efficacy endpoint in 44% (80 mg QD), 45% (120 mg QD), and 60% (240 mg QD) of patients compared to 0% in the allopurinol 100 mg QD and placebo groups.
Maltese: ADENURIC laħaq il-mira primarja tal-effikaċja f'44% (80 mgQD), 45% (120 mg QD), u 60% (240 mg QD) tal-pazjenti meta mqabbel ma' 0% filgruppi ta' allopurinol 100 mg QD u tal-plaċebo.
English: Table 1: Adverse reactions in combined phase 3, long-term extension studies and post-marketing experience
Maltese: Tabella 1: Reazzjonijiet avversi kombinati fil-Fazi 3 fl-istudji estiżi fit-tul u esperjenza ta' wara t tqegħid fis-suq
English: ADENURIC 80 mg tablets Febuxostat
Maltese: Pilloli ADENURIC 80 mg Febuxostat
English: Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Maltese: Pazjenti bi problemi ereditarji rari ta' intolleranza għal galactose, defiċjenza Lapp lactase, jew assorbiment ħażin ta' glucose-galactase, m'għandhomx jieħdu din ilmediċina.
English: The mean total AUC of febuxostat increased by approximately 1.8-fold from 7.5 µg⋅h/mL in the normal renal function group to 13.2 µg.h/mL in the severe renal dysfunction group.
Maltese: totali medja ta' febuxostat żdiedet b'madwar 1.8 darbiet minn 7.5 µg⋅h/mL fil-grupp b'funzjoni renali normali għal 13.2 µg.h/mL fil-grupp b'indeboliment renali severi. Cmax u l-AUC tal-metaboliti attivi żdiedu sa darbtejn u 4 darbiet, rispettivament.
English: Following multiple doses of 80 mg of ADENURIC in patients with mild, moderate or severe renal impairment, the Cmax of febuxostat did not change, relative to subjects with normal renal function.
Maltese: Wara dożi multipli ta' 80 mg ta' ADENURIC f'pazjenti b'indeboliment renali ħafif, moderata jew severa, Cmax ta' febuxostat ma nbidilx, relattivament għall-individwi b'funzjoni renali normali.
English: Note: 509 patients received allopurinol 300 mg QD; 10 patients with serum creatinine >1.5 and ≤2.0 mg/dL were dosed with 100 mg QD.
Maltese: Nota: 509 pazjent irċievew allopurinol 300 mg QD; 10 pazjenti bi krejatinina fis-serum >1.5 u ≤2.0 mg/dL kienu dożati b'100 mg QD. (10 pazjenti minn 268 fl-istudju APEX).
English: The ability of ADENURIC to lower serum uric acid levels was prompt and persistent.
Maltese: Il-ħila ta' ADENURIC biex ibaxxi l-livelli ta' uric acid fis-serum kienet immedjata u persistenti.
English: Detailed information on this medicine is available on the European Medicines Agency website http://www.ema.europa.eu.
Maltese: Sorsi oħra ta' informazzjoni Informazzjoni dettaljata dwar din il-mediċina tinsab fuq il-website tal-Aġenzija Ewropeja dwar il-Mediċini http://www.ema.europa.eu.
English: • rash (including various types of rash, please see below under “uncommon” and “rare” sections)
Maltese: • uġigħ ta' ras raxx (inklużi tipi differenti ta' raxx, jekk jogħġbok ara hawn taħt fis-sezzjonijiet “mhux komuni” u “rari”)
English: Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis
Maltese: Artralġja, artrite, mijalġja, bugħawwieġ, djgħufija fil-muskoli,
English: Pale yellow to yellow, film-coated, capsule shaped tablets, engraved with “120” on one side
Maltese: Pilloli forma ta' kapsula, sofor ċari sa sofor, miksija b'rita, minquxa b'“120” fuq naħa waħda.
English: Primary endpoint in the sub-group of patients with renal impairment
Maltese: Il-mira primarja fis-sottogrupp ta' pazjenti b'indeboliment renali
English: Opadry II, Yellow, 85F42129 containing: Polyvinyl alcohol
Maltese: Kisja tal-pillola Opadry II, Isfar, 85F42129 fih: Polyvinyl alcohol Titanium dioxide(E171) Macrogols 3350