FrancophonIA/ELRC3.0 huggingface dataset:
English: For the full list of all side effects reported with Daronrix, see the Package Leaflet.
Maltese: Għal-lista sħiħa ta' l-effetti sekondarji rrapportati b'Daronrix, ara l-Fuljett ta' Tagħrif.
English: Why has Daronrix been approved?
Maltese: Għaliex ġie approvat Daronrix?
English: Daronrix is a vaccine that can only be used once a flu ‘pandemic' has been officially declared by the World Health Organization (WHO) or European Union (EU).
Maltese: Daronrix huwa vaċċin li jista' jintuża biss ladarba tkun ġiet iddikjarata b'mod uffiċjali, pandemija ta' l-influwenza mill-Organizzazzjoni Dinjija tas-Saħħa (WHO) jew mill-Unjoni Ewropea (UE).
English: 21 days after the second injection, 70.8% of the people receiving the vaccine had levels of antibodies that would protect them against H5N1.
Maltese: L-istudju wera li Daronrix li fih 15-il mikrogramm ta' haemagglutinin u l-adjuvant ipproduċa rispons ta' antikorpi li jissodisfa dawn il-kriterji. 21 jum wara t-tieni injezzjoni, 70.8% tan-nies li rċevew ilvaċċin kellhom livelli ta' antikorpi li setgħu jgħinuhom kontra H5N1.
English: The virus is whole, but it has been inactivated (killed) so that it does not cause disease.
Maltese: Il-virus huwa wieħed sħiħ, madankollu ġie magħmul inattiv (inqatel) sabiex ma jikkawżax il-marda.
English: Other information about Daronrix:
Maltese: Tagħrif ieħor dwar Daronrix:
English: What is the risk associated with Daronrix?
Maltese: X'inhu r-riskju assoċjat ma' Daronrix?
English: A flu pandemic occurs when a new type (strain) of flu virus emerges that can spread easily from person to person because people have no immunity (protection) against it. A pandemic can affect most countries and regions around the world.
Maltese: Pandemija ta' l-influwenza sseħħ meta jfeġġ tip (razza) ġdid(a) ta' virus ta' l-influwenza li jista' jittieħed minn persuna għall-oħra minħabba li n-nies ma għandhomx immunità (protezzjoni) kontrih.
English: The effects of Daronrix were first tested in experimental models before being studied in humans.
Maltese: L-effetti ta' Daronrix ġew ittestjati l-ewwel f'mudelli esperimentali qabel ma ġie studjat fuq ilbniedem.
English: The study showed that Daronrix containing 15 micrograms of haemagglutinin and the adjuvant produced an antibody response that satisfies these criteria.
Maltese: Imbagħad is-sistema immunitarja tkun tista' tipproduċi antikorpi aktar malajr meta tkun esposta għall-virus mill-ġdid.
English: Daronrix has been authorised under “Exceptional Circumstances”.
Maltese: Daronrix ġie awtorizzat taħt “Ċirkustanza ta' Eċċezzjoni”.
English: If a pandemic starts, the virus strain in Daronrix will be replaced by the strain causing the pandemic before the vaccine can be used.
Maltese: Jekk tibda l-pandemija, irrazza tal-virus f'Daronrix tiġi sostitwita bir-razza li tikkawża l-pandemija qabel jintuża l-vaċċin.
English: How has Daronrix been studied?
Maltese: Kif ġie studjat Daronrix?
English: The most common side effects with Daronrix (seen in more than 1 in 10 people) are headache, pain and redness at the site of the injection, and fatigue (tiredness).
Maltese: L-aktar effetti sekondarji komuni b'Daronrix (li dehru f'aktar minn persuna 1 minn kull 10) huma uġigħ ta' ras, uġigħ u ħmurija fil-post ta' l-injezzjoni, u għeja.
English: When a person is given the vaccine, the immune system recognises the inactivated virus as ‘foreign' and makes antibodies against it.
Maltese: Meta persuna tingħata l-vaċċin, is-sistema immunitarja tagħraf il-virus magħmul inattiv bħala ‘barrani' u tifforma antikorpi kontrih.
English: The Member States should ensure that all conditions or restrictions with regard to the safe and effective use of the medicinal product described below are implemented:
Maltese: L-Istati Membri għandhom jiżguraw li l-kundizzjonijiet jew restrizzjonijiet fir-rigward ta' l-użu sigur u effettiv tal-prodott mediċinali deskritti hawn taħt huma implimentati:
English: Conditions or restrictions with regard to the safe and effective use of the medicinal product to be implemented by the Member States
Maltese: Kundizzjonijiet jew Restrizzjonijiet fir-rigward ta' l-użu sigur u effettiv tal-prodott mediċinali li għandhom jiġu implimentati mill-Istati Membri
English: The full EPAR for Entecavir Mylan can be found on the Agency's website: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
Maltese: ema.europa.eu/Find medicine/Human medicines/European public assessment reports.
English: Children weighing 32.6 kg and above can be given the 0.5 mg tablets, while an oral solution of entecavir should be used for children weighing less than 32.6 kg. For further information, see the package leaflet.
Maltese: Tfal li jiżnu 32.6 kg u aktar jistgħu jingħataw il-pilloli ta' 0.5 mg, filwaqt li għal tfal li jiżnu inqas minn 32.6 kg, għandha tintuża soluzzjoni orali ta' entecavir.
English: The active substance in Entecavir Mylan, entecavir, is an antiviral belonging to the class of the nucleoside analogues.
Maltese: Is-sustanza attiva f'Entecavir Mylan, l-entecavir, hija antivirali li tappartjeni għall-klassi tal-analogi nukleosidiċi.
English: Entecavir Mylan is a medicine used to treat chronic (long-term) hepatitis B (an infectious disease of the liver, caused by the hepatitis B virus).
Maltese: Entecavir Mylan huwa mediċina li tintuża biex tikkura l-epatite B kronika (fit-tul) (marda infettiva talfwied, ikkawżata mill-virus tal-epatite B).
English: Entecavir Mylan contains the active substance entecavir and is a ‘generic medicine'.
Maltese: Entecavir Mylan fih is-sustanza attiva entecavir u huwa ‘mediċina ġenerika'.
English: Entecavir Mylan can only be obtained with a prescription and is available as tablets (0.5 mg and 1 mg).
Maltese: Entecavir Mylan jista' jinkiseb biss b'riċetta ta' tabib u jiġi bħala pilloli (0.5 mg u 1 mg).
English: This is a summary of the European public assessment report (EPAR) for Entecavir Mylan.
Maltese: Dan huwa sommarju tar-rapport pubbliku Ewropew ta' valutazzjoni (EPAR) għal Entecavir Mylan.
English: Studies on the benefits and risks of the active substance in the approved uses have already been carried out with the reference medicine, Baraclude, and do not need to be repeated for Entecavir Mylan.
Maltese: Diġà saru studji dwar il-benefiċċji u r-riskji tas-sustanza attiva fl-użi approvati bil-mediċina ta' referenza, Baraclude, u ma għandhomx għalfejn jiġu ripetuti għal Entecavir Mylan.
English: Other information about Entecavir Mylan
Maltese: Informazzjoni oħra dwar Entecavir Mylan
English: For adults with compensated liver disease, the dose depends on whether or not the patient has been previously treated with a medicine in the same group as Entecavir Mylan (a nucleoside analogue, such as lamivudine).
Maltese: Għal adulti b'mard tal-fwied ikkumpensat, id-doża tiddependi minn jekk il-pazjent ġiex ikkurat qabel jew le b'mediċina fl-istess grupp ta' Entecavir Mylan (analogu nukleosidiku, bħal lamivudine).
English: What are the benefits and risks of Entecavir Mylan?
Maltese: X'inhuma l-benefiċċji u r-riskji ta' Entecavir Mylan?
English: Because Entecavir Mylan is a generic medicine and is bioequivalent to the reference medicine, its benefits and risks are taken as being the same as the reference medicine's.
Maltese: Peress li Entecavir Mylan huwa mediċina ġenerika u huwa bijoekwivalenti għall-mediċina ta' referenza, il-benefiċċji u r-riskji tiegħu jitqiesu l-istess bħal dawk tal-mediċina ta' referenza.
English: Why is Entecavir Mylan approved?
Maltese: Għaliex ġie approvat Entecavir Mylan?
English: The Agency recommended that Entecavir Mylan be approved for use in the EU.
Maltese: L-Aġenzija rrakkomandat li Entecavir Mylan ikun approvat għall-użu fl-UE.
English: This means that Entecavir Mylan contains the same active substance and works in the same way as a ‘reference medicine' already authorised in the European Union (EU) called Baraclude.
Maltese: Dan ifisser li Entecavir Mylan fih l-istess sustanza attiva u jaħdem bl-istess mod bħal ‘mediċina ta' referenza' diġà awtorizzata fl-Unjoni Ewropea (UE) li jisimha Baraclude.
English: The European Medicines Agency concluded that, in accordance with EU requirements, Entecavir Mylan has been shown to have comparable quality and to be bioequivalent to Baraclude.
Maltese: L-Aġenzija Ewropea għall-Mediċini kkonkludiet li, b'mod konformi mar-rekwiżiti tal-UE, Entecavir Mylan wera li għandu kwalità komparabbli u huwa bijoekwivalenti għal Baraclude.
English: Treatment with Entecavir Mylan should be started by a doctor with experience in the management of chronic hepatitis B.
Maltese: Il-kura b'Entecavir Mylan għandha tinbeda minn tabib li jkollu esperjenza fil-ġestjoni tal-epatite B kronika.
English: How is Entecavir Mylan used?
Maltese: Kif jaħdem Entecavir Mylan?
English: It can also be considered for children aged from 2 to 18 years but only in those with compensated liver disease.
Maltese: Dan jista' jiġi kkunsidrat ukoll għal tfal li għandhom bejn 2 sa 18-il sena iżda f'dawk li għandhom mard tal-fwied ikkumpensat biss.
English: How has Entecavir Mylan been studied?
Maltese: Kif ġie studjat Entecavir Mylan?
English: Entecavir stops the virus making DNA, and prevents it from multiplying and spreading.
Maltese: L-entecavir twaqqaf lill-virus milli jipproduċi DNA, u tipprevjenih milli jimmultiplika ruħu u jinfirex.
English: As for every medicine, the company provided studies on the quality of Entecavir Mylan.
Maltese: Bħal kull mediċina oħra, il-kumpanija pprovdiet studji dwar il-kwalità ta' Entecavir Mylan.
English: Difference in proportion (95% C.I.)
Maltese: Differenza fil-proporzjon (95% C.I.)
English: Angina pectoris, bradycardia
Maltese: Anġina pectoris, bradikardija
English: Elderly (≥65 years)
Maltese: Anzjani (≥ 65 sena)
English: ATC code: M04AA51
Maltese: M04AA51
English: Clinical outcomes - renal events
Maltese: Riżultati kliniċi - avvenimenti renali
English: Opaque (PVC/PVdC/Aluminium) blister.
Maltese: Folja opaka (PVC/PVdC/Aluminium).
English: 6-mercaptopurine and azathioprine
Maltese: 6-mercaptopurine u azathioprine
English: Hypersensitivity*
Maltese: Sensittività eċċessiva**
English: Coumarin anticoagulants
Maltese: Antikoagulanti ta' coumarin
English: EU/1/18/1300/001 EU/1/18/1300/002 EU/1/18/1300/003 EU/1/18/1300/004 EU/1/18/1300/005 EU/1/18/1300/006
Maltese: EU/1/18/1300/001 EU/1/18/1300/002 EU/1/18/1300/003 EU/1/18/1300/004
English: Mean (SE) Serum Uric Acid (mg/dL)
Maltese: Medja (SE) ta' Uric Acid fis-Serum (mg/dL)
English: Tumour lysis syndrome or Lesch-Nyhan syndrome.
Maltese: Sindrome tal-lisi tat-tumur jew sindrome Lesch-Nyhan.
English: Renal clearance is 25.6 mL/min (coefficient of variation CV=56%).
Maltese: L-eliminazzjoni mill-kliewi hija ta' 25.6 mL/min (koeffiċjent ta' varjazzjoni CV= 56%).
English: Renal failure***, renal impairment, nephrolithiasis
Maltese: Insuffiċjenza renali***, indeboliment renali, nefrolitijasi
English: Clinical outcomes - cardiovascular safety
Maltese: Riżultati kliniċi - sigurtà kardjovaskulari
English: Agranulocytosis*, aplastic anaemia*, thrombocytopenia*
Maltese: Agranuloċitożi*, anemija aplastika*, tromboċitopenija*
English: Cataract, vision disorders (visual impairment and blurred vision), maculopathy
Maltese: Katarretti, disturbi fil-vista (indeboliment tal-vista u vista mċajpra), makulopatija
English: Diabetes mellitus, hyperlipidaemia
Maltese: Dijabete mellitus, iperlipidemija
English: • people of Han Chinese, Thai or Korean origin
Maltese: • persuni ta' oriġini Ċiniża tal-Han, Tajlandiża jew Koreana
English: *** Includes the terms: renal failure, renal failure chronic and renal failure acute.
Maltese: *** Tinkludi t-termini: insuffiċjenza renali, insuffiċjenza renali kronika u insuffiċjenza renali akuta.
English: Male infertility, erectile dysfunction, gynaecomastia
Maltese: Infertilità fl-irġiel, disfunzjoni erettili, ginekomastija
English: --o-- Placebo + Allopurinol,
Maltese: Grupp ta' Trattament:--o-- Plaċebo + Allopurinol,
English: Grunenthal Sweden AB Tel: +46 (0)86434060
Maltese: Tel: + 46 (0)86434060
English: Lesinurad is not an in vitro inhibitor of P-glycoprotein, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1, MATE2-K and BSEP.
Maltese: Lesinurad mhuwiex inibitur in vitro tal-glikoproteina-P, BCRP, OATP1B3, MRP2, MRP4, OCT2, MATE1, MATE2-K u BSEP.
English: Zamenhof, 36 E-28027 Madrid Tel: +34 (91) 301 93 00
Maltese: Grünenthal Pharma, S.A. C/Dr. Zamenhof, 36 E-28027 Madrid Tel: + 34 (91) 301 93 00
English: Frequency categories are defined according to the following conventions: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1000 to <1/100), rare (≥1/10000 to <1/1000) and very rare
Maltese: Il-kategoriji ta' frekwenza huma ddefiniti skont il-konvenzjonijiet li ġejjin: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1000 sa < 1/100), rari (≥ 1/10000 sa < 1/1000) u rari ħafna (< 1/10,000).
English: Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production.
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet kontra l-gotta, preparazzjonijiet li jinibixxu l-produzzjoni ta' uric acid.
English: Haematuria, azotemia
Maltese: Ematurja, ażotemija
English: In addition, lesinurad is an in vitro inducer of CYP2B6 and CYP3A via constitutive androstane receptor (CAR)/pregnane X receptor (PXR).
Maltese: Barra minn hekk, lesinurad huwa inibitur in vitro ta' CYP2B6 u CYP3A permezz ta' riċettur kostituttiv ta' androstane (CAR, constitutive androstane receptor)/riċettur ta' pregnane X (PXR, pregnane X receptor).
English: Other metabolites of allopurinol include allopurinol-riboside and oxypurinol-7-riboside.
Maltese: Metaboliti oħra ta' allopurinol jinkludu allopurinol-riboside u oxypurinol-7-riboside.
English: A specific antidote is unknown.
Maltese: Antidotu speċifiku mhux magħruf.
English: Lesinurad is extensively bound to proteins in plasma (greater than 98%), mainly to albumin.
Maltese: Lesinurad jeħel ħafna ma' proteini fil-plażma (aktar minn 98%), l-aktar mal-albumina.
English: In vitro, lesinurad is an inhibitor of OATP1B1, OAT1, OAT3, OAT4 and OCT1 at clinically relevant plasma concentrations.
Maltese: In vitro, lesinurad huwa inibitur ta' OATP1B1, OAT1, OAT3, OAT4 u OCT1 f'konċentrazzjonijiet fil-plażma klinikament rilevanti.
English: Epoxide hydrolase inhibitors (e.g. valproic acid, valpromide) Inhibitors of microsomal Epoxide Hydrolase (mEH) (e.g. valproic acid, valpromide) may interfere with the metabolism of lesinurad.
Maltese: Inibituri ta' epoxide hydrolase (eż valproic acid, valpromide) L-inibituri ta' Epoxide Hydrolase mikrożomali (mEH, microsomal Epoxide Hydrolase) (eż. valproic acid, valpromide) jistgħu jinterferixxu mal-metaboliżmu ta' lesinurad.
English: The frequency of the HLA-B*5801 allele varies widely between ethnic populations: up to 20% in Han Chinese population, 8-15% in the Thai, about 12% in the Korean population and 1-2% in individuals of Japanese or European origin.
Maltese: Il-frekwenza tal-allele HLA-B*5801 tvarja ħafna bejn il-popolazzjonijiet etniċi: sa 20% fil-popolazzjoni Ċiniża tal-Han, 8-15% f'dik Tajlandiża, madwar 12% fil-popolazzjoni Koreana u 1-2% f'individwi ta' oriġini Ġappuniża jew Ewropea.
English: Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with allopurinol (5.8%) in a long term open label extension study.
Maltese: Valuri miżjudin tat-TSH (> 5.5 μIU/mL) ġew osservati f'pazjenti fuq trattament fit-tul b'allopurinol (5.8%) fi studju ta' estensjoni open label fuq terminu twil.
English: The safety of lesinurad 200 mg was evaluated in the Phase 3 combination therapy clinical trials (including extension studies).
Maltese: Is-sigurtà ta' lesinurad 200 mg ġiet evalwata fi provi kliniċi ta' terapija kkombinata ta' Fażi 3 (inklużi studji ta' estensjoni).
English: The HLA-B*5801 allele has been shown to be associated with the risk of developing allopurinol related hypersensitivity syndrome and SJS/TEN.
Maltese: L-allele HLA-B*5801 intweriet li hija assoċjata mar-riskju li tiżviluppa sindrome ta' sensittività eċċessiva u SJS/TEN relatati ma' allopurinol.
English: The absolute bioavailability of lesinurad is approximately 100%.
Maltese: Il-bijodisponibbiltà assoluta ta' lesinurad hija ta' madwar 100%.
English: Furuncle
Maltese: Furunklu
English: The other ingredients are: - tablet core: hydroxypropylcellulose, microcrystalline cellulose, lactose monohydrate, crospovidone, magnesium stearate - film-coating: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), iron oxide red (E172)
Maltese: crospovidone, magnesium stearate - kisja tar-rita: hypromellose, titanium dioxide (E171), triacetin, iron oxide yellow (E172), iron oxide red (E172)
English: Lesinurad 200 mg vs. placebo
Maltese: Lesinurad 200 mg kontra plaċebo
English: Other medicines and Duzallo
Maltese: Mediċini oħra u Duzallo
English: At the 400 mg dose, when compared with extensive CYP2C9 metabolisers (CYP2C9 *1/*1 [N=41]), increased lesinurad exposures were observed in intermediate CYP2C9 metabolisers (CYP2C9 *1/*3 [N=4], approximately 22% increase in AUC) and in poor CYP2C9 metabolisers (CYP2C9 *3/*3 [N=1], approximately 111% increase in AUC) accompanied with higher lesinurad renal excretion.
Maltese: Fid-doża ta' 400 mg, meta mqabbel ma' metabolizzaturi estensivi ta' CYP2C9 (CYP2C9 *1/*1 [N= 41]), ġiet osservata żieda fl-espożizzjonijiet għal lesinurad fil-metabolizzaturi intermedji ta' CYP2C9 (CYP2C9 *1/*3 [N= 4], żieda ta' madwar 22% fl-AUC) u f'metabolizzaturi dgħajfa ta' CYP2C9 (CYP2C9 *3/*3 [N= 1], żieda ta' madwar 111% fl-AUC) akkumpanjati b'eliminazzjoni renali ogħla ta' lesinurad.
English: Lesinurad is administered as a 50:50 mixture of lesinurad atropisomers.
Maltese: Lesinurad jingħata bħala taħlita 50:50 ta' atropisomers ta' lesinurad.
English: Elimination of allopurinol is mainly by metabolic conversion to oxypurinol by xanthine oxidase and aldehyde oxidase, with less than 10% of the unchanged active substance excreted in the urine.
Maltese: L-eliminazzjoni ta' allopurinol hija l-aktar permezz tal-konverżjoni metabolika għal oxypurinol minn xanthine oxidase u aldehyde oxidase, b'inqas minn 10% tas-sustanza attiva mhux mibdula li tiġi eliminata fl-awrina.
English: Hypersensitivity syndrome, Stevens-Johnson-Syndrome (SJS ) and toxic epidermal necrolysis (TEN)
Maltese: Sindrome ta' sensittività eċċessiva, Sindrome ta' Stevens-Johnson (SJS, Stevens-Johnson Syndrome) u nekroliżi epidermika tossika (TEN, toxic epidermal necrolysis)
English: The main metabolite of allopurinol is oxypurinol.
Maltese: Il-metabolit prinċipali ta' allopurinol huwa oxypurinol.
English: Table 1 Adverse reactions by System Organ Class and frequency
Maltese: Tabella 1 Reazzjonijiet avversi skont is-Sistema tal-Klassifika tal-Organi u l-frekwenza
English: Recurrent haematemesis, steatorrhoea, stomatitis, changed stool frequency
Maltese: Ematemeżi rikorrenti, steatorrea, stomatite, bidla fil-frekwenza tal-ippurgar
English: Rare - may affect up to 1 in 1000 people - disorder of the liver (hepatitis).
Maltese: Rari - jistgħu jaffettwaw sa persuna 1 minn kull 1000 - disturb tal-fwied (epatite).
English: Stevens-Johnson syndrome, toxic epidermal necrolysis, angioedema, medicinal product eruption, alopecia, hair colour changes
Maltese: Sindrome ta' Stevens-Johnson, nekroliżi epidermika tossika, anġjoedema, eruzzjoni tal-prodott mediċinali, alopeċja, tibdil fil-kulur tax-xagħar
English: Mild to moderate induction of CYP3A by lesinurad may reduce plasma exposures of co-administered medicinal products that are sensitive substrates of CYP3A.
Maltese: Induzzjoni ħafifa sa moderata ta' CYP3A minn lesinurad tista' tnaqqas l-espożizzjonijiet fil-plażma ta' prodotti mediċinali mogħtija flimkien li huma sottostrati sensittivi ta' CYP3A.
English: Each film-coated tablet contains 128.3 mg of lactose (as monohydrate).
Maltese: Kull pillola miksija b'rita fiha 128.3 mg ta' lattożju (bħala monohydrate).
English: Following administration of a single dose of lesinurad to individuals with renal impairment compared to those with normal renal function lesinurad Cmax and AUC, respectively, were 36% and 30% higher (200 mg) in patients with mild renal impairment (eCrCL 60 to 89 mL/min), 20% and 73% higher (200 mg) and 3% and 50% higher (400 mg) in patients with moderate renal impairment (eCrCL 30 to 59 mL/min), and 13% higher and 113% higher (400 mg) in patients with severe renal impairment (eCrCL <30 mL/min).
Maltese: Wara għoti ta' doża waħda ta' lesinurad lil individwi b'indeboliment renali meta mqabbla ma' dawk b'funzjoni renali normali, is-Cmax u l-AUC ta' lesinurad, rispettivament, kienu 36% u 30% ogħla (200 mg) f'pazjenti b'indeboliment renali ħafif (eCrCL ta' 60 sa 89 mL/min), 20% u 73% ogħla (200 mg) u 3% u 50% ogħla (400 mg) f'pazjenti b'indeboliment renali moderat (eCrCL ta' 30 sa 59 mL/min), u 13% ogħla u 113% ogħla (400 mg) f'pazjenti b'indeboliment renali sever (eCrCL ta' < 30 mL/min).
English: Lesinurad undergoes oxidative metabolism mainly via cytochrome P450 (CYP) 2C9 to intermediate metabolite M3c (not detected in vivo) and is subsequently metabolised by microsomal epoxide hydrolase (mEH) to metabolite M4; there is minimal contribution from CYP1A1, CYP2C19, and CYP3A to the metabolism of lesinurad.
Maltese: Lesinurad jgħaddi minn metaboliżmu ossidattiv prinċipalment permezz ta' cytochrome P450 (CYP) 2C9 għall-metabolit intermedju M3c (mhux misjub in vivo) u huwa sussegwentement metabolizzat minn microsomal epoxide hydrolase (mEH) għall-metabolit M4; hemm kontribuzzjoni minima minn CYP1A1, CYP2C19, u CYP3A għall-metaboliżmu ta' lesinurad.
English: Reported values for the elimination half-life range from 13.6 hours to 29 hours.
Maltese: Il-valuri rrapportati għall-half-life ta' eliminazzjoni jvarjaw minn 13.6 sigħat għal 29 siegħa.
English: Following administration of a single dose of lesinurad at 400 mg in patients with mild (Child-Pugh class A) or moderate (Child-Pugh class B) hepatic impairment, lesinurad Cmax was comparable and lesinurad AUC was 7% and 33% higher, respectively, compared to individuals with normal hepatic function.
Maltese: Wara l-għoti ta' doża waħda ta' lesinurad ta' 400 mg f'pazjenti b'indeboliment epatiku ħafif (Child-Pugh klassi A) jew moderat (Child-Pugh klassi B), is-Cmax ta' lesinurad kienet komparabbli u l-AUC ta' lesinurad kienet 7% u 33% ogħla, rispettivament, meta mqabbla ma' individwi b'funzjoni epatika normali.
English: The ratio of atropisomer 1 to atropisomer 2 AUC(0-24) was 44:56 because atropisomer 1 undergoes more extensive metabolism than atropisomer 2, causing atropisomer 1 to have lower plasma exposure than atropisomer 2.
Maltese: Il-proporzjon ta' AUC(0-24) ta' atropisomer 1 ma' atropisomer 2 kien ta' 44:56 peress li atropisomer 1 jgħaddi minn metaboliżmu iktar estensiv minn atropisomer 2, u dan iwassal biex atropisomer 1 ikollu espożizzjoni fil-plażma iktar baxxa minn atropisomer 2.
English: An interaction between allopurinol and coumarins has been seen under experimental conditions.
Maltese: Interazzjoni bejn allopurinol u coumarins ġiet osservata taħt kundizzjonijiet sperimentali.
English: EU/1/18/1300/003 30 film-coated tablets EU/1/18/1300/004 100 film-coated tablets EU/1/18/1300/006 10 film-coated tablets
Maltese: EU/1/18/1300/003 30 pillola miksijin b'rita EU/1/18/1300/004 100 pillola miksijin b'rita EU/1/18/1300/006 10 pillola miksijin b'rita
English: Post-hoc analyses in a subgroup of patients with high cardiovascular risk at baseline (as defined by transient ischemic attack, angina pectoris, heart failure, myocardial infarction, peripheral vascular disease and/or stroke), showed that the incidence of MACE was 0/39 for placebo and 2/43 for lesinurad 200 mg.
Maltese: Analiżijiet post-hoc f'sottogrupp ta' pazjenti b'riskju kardjovaskulari għoli fil-linja bażi (kif iddefinit minn attakk iskemiku temporanju, anġina pectoris, insuffiċjenza tal-qalb, infart mijokardijaku, mard vaskulari periferali u/jew puplesija), urew li l-inċidenza ta' MACE kienet 0/39 għal plaċebo u 2/43 għal lesinurad 200 mg.
English: Allopurinol has a plasma half-life of about 0.5 to 1.5 hours.
Maltese: Allopurinol għandu half-life fil-plażma ta' madwar 0.5 sa 1.5 sigħat.