FrancophonIA/ELRC3.0 huggingface dataset:
English: Inform your doctor as soon as possible if you develop symptoms suggesting a problem with your liver (like feeling sick without explanations, vomiting, stomach ache, tiredness, loss of appetite and/or dark urine) as your liver function should be checked.
Maltese: Ghid lit-tabib tiegħek minnufih jekk ikollok sinjali li juru li jista jkun hemm problema bil-fwied tieghek (bħal ħass ħażin mingħajr raġuni, rimettar, uġigħ fl-istonku, għeja, nuqqas ta' aptit, u/jew awrina skura) għax il-funzjoni tal-fwied tkun trid tiġi iċċekkjata.
English: Blurred vision due to swelling (or fluid) at the back of the eye (macular oedema) has also been reported in patients taking Tandemact (frequency cannot be estimated from the available data).
Maltese: Vista mċajpra minħabba nefħa (jew fluwidu) fil-parti ta' wara tal-għajn (edema makulari) ġiet irrappurtata ukoll f'pazjenti li hadu Tandemact (ma tistax tittieħed stima tal-frekwenza mid-data disponibbli).
English: Tandemact is indicated as second line treatment of adult patients with type 2 diabetes mellitus who show intolerance to metformin or for whom metformin is contraindicated and who are already treated with a combination of pioglitazone and glimepiride.
Maltese: Tandemact huwa indikat bħala kura sekondarja ta' pazjenti adulti b'dijabete mellitus tat-tip 2 li juru ntolleranza għal metformin jew għal dawk li metformin huwa kontra-indikat u li diġà huma kkurati b'taħlita ta' pioglitazone u glimepiride.
English: Mean dominant serum half-life, which is of relevance for the serum concentrations under multiple-dose conditions, is about 5 to 8 hours.
Maltese: Il-medja tal-half-life dominanti fis-serum, li hija ta' rilevanza għall-konċentrazzjonijiet fis-serum f'kundizzjonijiet ta' dożi multipli, hija ta' madwar 5 sa 8 sigħat.
English: There is a linear relationship between dose and both Cmax and AUC (area under the time/concentration curve).
Maltese: Hemm relazzjoni lineari bejn id-doża u kemm Cmax u l-AUC (erja taħt il-kurva ta'
English: Post-marketing reports of new-onset or worsening diabetic macular oedema with decreased visual acuity have been reported with thiazolidinediones, including pioglitazone.
Maltese: Rapporti ta' wara t-tqegħid fis-suq ta' żvilupp ġdid jew irkadar ta' edema makulari dijabetika bi tnaqqis fl-akutezza viżiva kienu rrappurtati b'thiazolidinediones, inkluż pioglitazone.
English: quinolones, clarithromycin (to treat bacterial or fungal infections)
Maltese: - barbiturates (biex jittrattaw nervi u problemi fl-irqad)
English: Tandemact contains pioglitazone and glimepiride which are anti-diabetic medicines, used to control blood sugar level.
Maltese: phenytoin, diazoxide, glucagon, barbiturates u rifampicin.
English: Pioglitazone should be used with caution during concomitant administration of cytochrome P450 2C8 inhibitors (e.g. gemfibrozil) or inducers (e.g. rifampicin).
Maltese: Dan isir primarjament permeżż taċ-ċitokromju P450 2C8, għalkemm isoformi oħra jistgħu jkunu involuti f'ammont inqas.
English: Other medicines and Tandemact
Maltese: Mediċini oħra u Tandemact
English: NAME OF THE MEDICINAL PRODUCT Tandemact 30 mg/2 mg tablets
Maltese: Pilloli Tandemact 30 mg/2 mg
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: • Rapporti Perjodiċi Aġġornati dwar is-Sigurtà Ir-rekwiżiti biex jigu ppreżentati rapporti perjodiċi aġġornati dwar is-sigurtà għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont lArtikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunke aġġornament sussegwenti ppubblikat fuq ilportal elettroniku Ewropew tal-mediċini.
English: Cross allergenicity with sulphonylureas, sulphonamides or related substances is possible.
Maltese: Allerġeniċità ma' sulphonylureas,
English: Blood and lymphatic system disorders changes in haematology1
Maltese: Disturbi tad-demm u tas-sistema limfatika bidliet fl'ematoloġija1
English: This finding is based on conventional safety pharmacology, repeated dose toxicity, genotoxicity, carcinogenicity, and reproduction toxicity studies.
Maltese: Din is-sejba hija bbażata fuq studji konvenzjonali ta' sigurtà farmakoloġika, effett tossiku minn dożi ripetuti, effett tossiku fuq il-ġeni, riskju ta' kanċer u effett tossiku fuq is-sistema riproduttiva.
English: MAO-inhibitors quinolone antibiotics probenecid miconazole pentoxyfylline (high dose parenteral) tritoqualine fluconazole
Maltese: Cellulose microcrystalline Croscarmellose sodium Hydroxypropylcellulose Lattosju monohydrate Magnesium stearate Polysorbate 80
English: Linearity/non-linearity Single dose studies demonstrate linearity of pharmacokinetics in the therapeutic dose range.
Maltese: Studji ta' doża waħda juru linearita' farmakokinetika fil-medda tad-doża terapewtika.
English: Pharmacotherapeutic group: Drugs used in diabetes, combinations of oral blood glucose lowering drugs; ATC code: A10BD06.
Maltese: Minħabba f'hekk, prodotti mediċinali oħra għandhom jittieħdu ma' Tandemact biss b'kunsens (jew b'riċetta) tat-tabib.
English: Treatment with Tandemact therefore requires regular haematological monitoring (especially leucocytes and platelets).
Maltese: Għalhekk kura b'Tandemact tinħtieġ sorveljanza ematoloġika regolari (speċjalment il-lewkoċiti u l-plejtlits).
English: If large quantities have been ingested, gastric lavage is indicated, followed by activated charcoal and sodium-sulphate.
Maltese: Jekk ittieħdu kwantitajiet kbar, tlaħliħ ta' l-istonku huwa ndikat, segwit minn faħam attivat u sodium-sulphate.
English: Jens Ersboll (Denmark)
Maltese: Jens Ersbøll (Danimarka)
English: Company responses provided on: 6 April 2009, 11 September 2009, 14 January 2010 and 19 March 2010
Maltese: 6 ta' April 2009, 11 ta' Settembru 2009, 14 ta' Jannar 2010 u 19 ta' Marzu 2010
English: Martina Weise (Germany)
Maltese: Martina Weise (Ġermanja)
English: Penciclovir is an antiviral.
Maltese: Penciclovir huwa antivirali.
English: Famvir is also available in the EU under other trade names: Famciclovir-Sandoz, Famciclovir-SB, Famciclovir-SB Zoster, Famvir Zoster and Oravir.
Maltese: Famvir huwa disponibbli wkoll fl-UE taħt ismijiet kummerċjali oħrajn: Famciclovir-Sandoz, FamciclovirSB, Famciclovir-SB Zoster, Famvir Zoster u Oravir.
English: What is Famvir?
Maltese: X'inhu Famvir?
English: Famvir is an antiviral medicine that contains the active substance famciclovir.
Maltese: Famvir hija mediċina antivirali li fiha s-sustanza attiva famciclovir.
English: The European Medicines Agency has completed a review of Famvir.
Maltese: L-Aġenzija Ewropea għall-Mediċini lestiet reviżjoni ta' Famvir.
English: The active substance in Famvir, famciclovir, is converted in the body into a substance called penciclovir.
Maltese: Is-sustanza attiva f'Famvir, famciclovir, tinqeleb fil-ġisem f'sustanza msejħa penciclovir.
English: • treatment of recurrent episodes of genital herpes in immunocompromised adults;
Maltese: • il-kura ta' episodji rikorrenti ta' ħerpes ġenitali f'adulti immunokompromessi;
English: • the treatment of herpes zoster in immunocompromised adults (reduced activity of the immune system);
Maltese: • il-kura ta' ħerpes zoster f'adulti immunokompromessi (attività mnaqqsa tas-sistema immuni);
English: Famvir was identified as needing harmonisation by the Co-ordination Group on the Mutual and Decentralised Procedures - Human (CMD(h)).
Maltese: Famvir ġie identifikat bħala li jeħtieġ armonizzazzjoni mill-Grupp ta' Koordinazzjoni dwar il-Proċeduri Konġunti u Deċentralizzati - tal-Bniedem (CMD(h)).
English: Recurrent episodes should be treated with 125 mg twice a day for five days.
Maltese: Episodji rikorrenti għandhom jiġu kkurati b'125 mg darbtejn kuljum għal ħamest ijiem.
English: For the suppression of the recurrence of genital herpes, the recommended dose is 250 mg twice a day in immunocompetent adults and 500 mg twice a day in immunocompromised adults.
Maltese: Għat-trażżin tar-rikorrenza ta' ħerpes ġenitali, id-doża rakkomandata hija 250 mg darbtejn kuljum f'adulti immunokompetenti u 500 mg darbtejn kuljum f'adulti immunokompromessi.
English: It is used to treat infection with herpes viruses including varicella zoster which causes shingles, and herpes simplex (HSV) which can cause cold sores or genital herpes.
Maltese: Tintuża biex tikkura infezzjoni bilvirusijiet tal-ħerpes inkluż varicella zoster li tikkawża l-ħruq ta' Sant' Antnin, u ħerpes simplex (HSV) li jista' jikkawża selħiet minħabba kesħa jew ħerpes ġenitali.
English: The company that markets these medicines is Novartis.
Maltese: Il-kumpanija li tikkummerċjalizza dawn il-mediċini hija Novartis.
English: On 27 November 2008, the European Commission referred the matter to the CHMP in order to harmonise the marketing authorisations for Famvir and associated names in the EU.
Maltese: Fis-27 ta' Novembru 2008, il-Kummissjoni Ewropea irreferiet il-kwistjoni lis-CHMP sabiex jiġu armonizzati l-awtorizzazzjonijiet għat-tqegħid fis-suq għal Famvir u l-ismijiet assoċjati fl-UE.
English: For recurrent genital herpes in immunocompromised adults, the recommended dose is 500 mg twice a day for seven days.
Maltese: Għal ħerpes ġenitali rikorrenti f'adulti immunokompromessi, id-doża rakkomandata hija 500 mg darbtejn kuljum għal sebat ijiem.
English: • the treatment of herpes zoster (shingles) and ophthalmic zoster (shingles around the eye) in immunocompetent adults (patients with an immune system that works normally);
Maltese: • il-kura ta' ħerpes zoster (il-ħruq ta' Sant' Antnin) u zoster oftalmiku (il-ħruq ta' Sant' Antnin madwar l-għajn) f'adulti immunokompetenti (pazjenti b'sistema immuni li taħdem b'mod normali);
English: For herpes zoster, the recommended dose is 500 mg three times a day, for seven days in immunocompetent adults and for ten days in immunocompromised adults.
Maltese: Għal ħerpes zoster, id-doża rakkomandata hija 500 mg tliet darbiet kuljum, għal sebat ijiem f'adulti immunokompetenti u għal għaxart ijiem f'adulti immunokompromessi.
English: Why was Famvir reviewed?
Maltese: Għaliex ġie rivedut Famvir?
English: Other sections harmonised include the sections on special warnings, pregnancy and lactation and side effects.
Maltese: Taqsimiet oħrajn armonizzati jinkludu s-sezzjonijiet dwar twissijiet speċjali, tqala u treddigħ u effetti sekondarji.
English: Famvir is authorised in the EU via national procedures.
Maltese: Famvir huwa awtorizzat fl-UE permezz ta' proċeduri nazzjonali.
English: For genital herpes in immunocompetent adults, the recommended dose for the first episode is 250 mg three times a day for five days.
Maltese: Għal ħerpes ġenitali f'adulti immunokompetenti, id-doża rakkomandata għall-ewwel episodju hija 250 mg tliet darbiet kuljum għal ħamest ijiem.
English: It works by blocking the production of DNA by herpes viruses.
Maltese: Jaħdem billi jimblokka l-produzzjoni ta' DNA minn virusijiet tal-ħerpes.
English: The CHMP agreed that Famvir should be used for:
Maltese: Is-CHMP qabel li Famvir għandu jintuża għal:
English: • treatment of first and recurrent episodes of genital herpes in immunocompetent adults;
Maltese: • il-kura ta' episodji li seħħew għall-ewwel darba u rikorrenti ta' ħerpes ġenitali f'adulti immunokompetenti;
English: The Agency's Committee for Medicinal Products for Human Use (CHMP) has concluded that there is a need to harmonise the prescribing information for Famvir in the European Union (EU).
Maltese: Il-Kumitat għall-Mediċini għall-Użu millBniedem tal-Aġenzija (CHMP) ikkonkluda li jeħtieġ li l-informazzjoni tal-preskrizzjoni għal Famvir tiġi armonizzata fl-Unjoni Ewropea (UE).
English: Subcutaneous use pre-filled syringe (glass) in prefilled pen (VarioJect)
Maltese: Soluzzjoni għall-injezzjoni siringa mimlija għal-lest (ħġieġ) f'pinna mimlija għallest (VarioJect)
English: BLISTER (PVC/PVDC/PVC//Alu)
Maltese: FOLJA (PVC/PVDC/PVC//Alu)
English: Agency http://www.ema.europa.eu.
Maltese: Mediċini http://www.ema.europa.eu.
English: Date of first authorisation: 28 March 2019
Maltese: Data tal-ewwel awtorizzazzjoni: 28 Marzu 2019
English: Iron oxide, yellow (E172)
Maltese: Talc Iron oxide, yellow (E172)
English: Excipient(s) with known effect - lactose: 73 mg
Maltese: Eċċipjent(i) b'effett magħruf: - lactose: 73 mg
English: * p < 0.001 vs allopurinol, # p < 0.001 vs 80 mg
Maltese: # p < 0.001 vs 80 mg
English: Excipient(s) with known effect - lactose: 109 mg
Maltese: Eċċipjent(i) b'effett magħruf: - lactose: 109 mg
English: Febuxostat Krka contains lactose.
Maltese: Krka fih lactose.
English: Blister (PVC/PVDC/PVC//Alu): 14, 28, 56 or 84 film-coated tablets, in a box.
Maltese: Folja (PVC/PVDC/PVC//Alu): 14, 28, 56, jew 84 pillola miksija b'rita f'kaxxa.
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 febuxostat and allopurinol respectively.
Maltese: L-inċidenza globali ta' sinjali u sintomi li jitfaċċaw waqt it-trattament u reazzjonijiet avversi tal-mediċina kienu 67.6% vs 64.7% u 6.4% vs 6.4% b'febuxostat u allopurinol rispettivament.
English: See section 2 "Febuxostat Krka contains lactose and sodium".
Maltese: Ara sezzjoni 2 “Febuxostat Krka fih lactose u sodium”.
English: Pharmacotherapeutic group: Antigout preparations, preparations inhibiting uric acid production; ATC code: M04AA03.
Maltese: Kategorija farmakoterapewtika: Preparazzjonijiet kontra l-gotta, preparazzjonijiet li jinibixxu lproduzzjoni ta' uric acid, Kodiċi ATC:
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: concentrations febuxostat does not inhibit other enzymes involved in purine or pyrimidine metabolism, namely, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase or purine nucleoside phosphorylase.
Maltese: F'konċentrazzjonijiet terapewtiċi febuxostat ma jinibixxix enżimi oħra involuti fil-metaboliżmu ta' purine jew ta' pyrimidine, jiġifieri, guanine deaminase, hypoxanthine guanine phosphoribosyltransferase, orotate phosphoribosyltransferase, orotidine monophosphate decarboxylase jew purine nucleoside phosphorylase.
English: Renal failure, nephrolithiasis, haematuria, pollakiuria, proteinuria
Maltese: Insuffiċjenza renali, nefrolitajasi, ematurja, pollakurja, protejnurja Rari
English: Toxic epidermal necrolysis*, Stevens-Johnson Syndrome*, angioedema*, drug reaction with eosinophilia and systemic symptoms*, generalized rash (serious)*, erythema, exfoliative rash, rash follicular, rash vesicular, rash pustular, rash pruritic*, rash erythematous, rash morbillifom, alopecia, hyperhidrosis Musculoskeletal and connective tissue disorders Uncommon Arthralgia, arthritis, myalgia, musculoskeletal pain, muscle weakness, muscle spasm, muscle tightness, bursitis
Maltese: Nekrolisi epidermali tossika*, Sindrome Stevens-Johnson*, anġjoedema*, reazzjoni għall-mediċina b'eosinofilja u sintomi sistemiċi*, raxx mal-ġisem kollu (serju)*, ħmura, raxx bil-qxur, raxx follikulari, raxx vesikulari, raxx pustulari, raxx bil-ħakk*, raxx bi ħmura, raxx morbilliforme, alopeċja, iperidrożi
English: With regard to secondary endpoints, no significant difference was detected in terms of incidence of laboratory TLS (8.1% and 9.2% in febuxostat 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 febuxostat 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: Febuxostat Krka contains lactose and sodium
Maltese: Krka fih lactose u sodium
English: hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica and magnesium stearate in the tablet core and poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172) - only for 120 mg film-coated tablets and red iron oxide (E172) - only for 80 mg film-coated tablets in the film coating.
Maltese: - Is-sustanzi l-oħra huma: lactose monohydrate, microcrystalline cellulose, hydroxypropylcellulose, croscarmellose sodium, colloidal hydrated silica u magnesium stearate fil-qalba tal-pillola u poly(vinyl alcohol), macrogol 3350, titanium dioxide (E171), talc, yellow iron oxide (E172) - għall-pilloli miksija b'rita tal-120 mg u red iron oxide (E172) - għall-pilloli miksija b'rita ta' 80 mg fil-qoxra tal-pillola.
English: Increased TSH values (>5.5 μIU/mL) were observed in patients on long-term treatment with febuxostat (5.5%) and patients with allopurinol (5.8%) in the long term open label extension studies (see section 4.4).
Maltese: Kienu osservati valuri miżjuda ta' TSH (>5.5 µIU/mL) f'pazjenti fuq kura fit-tul b'febuxostat (5.5%) u f'pazjenti b'allopurinol (5.8%) fl-istudji ta' estensjoni open label fit-tul (ara sezzjoni 4.4).
English: Tablet dimension: approximatelly 16 mm × 8 mm.
Maltese: Id-dimensjoni tal-pillola: 16 mm x 8 mm.
English: Tablet dimension: approximatelly 19 mm × 8 mm.
Maltese: Id-dimensjoni talpillola: 19 mm x 8 mm.
English: Febuxostat Krka is for adults.
Maltese: Krka huwa għall-adulti.
English: In vitro studies with human liver microsomes showed that those oxidative metabolites were formed primarily by CYP1A1, CYP1A2, CYP2C8 or CYP2C9 and febuxostat glucuronide was formed mainly by UGT 1A1, 1A8, and 1A9.
Maltese: Studji in vitro b'mikrożomi tal-fwied uman urew li dawk il-metaboliti ossidattivi ġew iffurmati primarjament minn CYP1A1, CYP1A2, CYP2C8 jew CYP2C9 u febuxostat glucuronide kien iffurmat primarjament minn UGT 1A1, 1A8, u 1A9.
English: No significant difference in mean serum creatinine change (%) occurred between febuxostat 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 febuxostat 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 ; 8.8406]; p=0.0903).
English: One thousand and seventy-two (1072) patients were randomized: placebo (n=134), febxuostat 80 mg QD (n=267), febuxostat 120 mg QD (n=269), febuxostat 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: Elf u tnejn u sebgħin (1072) pazjent kienu randomised: plaċebo (n=134), febuxostat 80 mg QD (n=267), febuxostat 120 mg QD (n=269), febuxostat 240 mg QD (n=134) jew allopurinol (300 mg QD [n=258] għall-pazjenti 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: 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 ttqegħid fis-suq
English: A total of 1,086 patients were enrolled: febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) and allopurinol 300/100 mg QD (n=145).
Maltese: Totali ta' 1086 pazjent kienu ingaġġati: febuxostat 80 mg QD (n=649), febuxostat 120 mg QD (n=292) u allopurinol 300mg/100mg QD (n=145).
English: Febuxostat Krka 80 mg tablets febuxostat
Maltese: Krka 80 mg pilloli febuxostat
English: Film coating
Maltese: Riżultati Kombinati
English: Febuxostat Krka 120 mg tablets febuxostat
Maltese: Krka 120 mg pilloli febuxostat
English: Skin and subcutaneous tissue disorders
Maltese: Disturbi muskolu-skeltrali u talconnective tissue
English: 14 film-coated tablets 28 film-coated tablets 56 film-coated tablets 84 film-coated tablets
Maltese: 14-il pillola miksija b'rita 28 pillola miksija b'rita 56 pillola miksija b'rita 84 pillola miksija b'rita
English: Febuxostat Krka is indicated for the prevention and treatment of hyperuricaemia in adult patients undergoing chemotherapy for haematologic malignancies at intermediate to high risk of Tumor Lysis Syndrome (TLS).
Maltese: Krka hu indikat għal prevenzjoni u trattament ta' iperuriċemija f'pazjenti adulti fuq kimoterapija għal malinni ematoloġiċi f'riskju intermedjarju sa għoli ta' Sindrome ta' Lisi ta' Tumur (Tumor Lysis Syndrome, TLS).
English: Table 2 Proportion of Patients with Serum Uric Acid Levels <6.0 mg/dL (357 μmol/L) Last Three Monthly Visits
Maltese: Tabella 2 Proporzjon ta' Pazjenti b'Livelli ta' Uric Acid fis-Serum <6.0 mg/dL (357µmol/L)
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: L-AUC totali medja ta' febuxostat żdiedet b'madwar 1.8 darbiet minn 7.5 gh/mL fil-grupp b'funzjoni renali normali għal 13.2 g.h/mL fil-grupp b'indeboliment renali severi.
English: The APEX study showed statistically significant superiority of both the febuxostat 80 mg QD and the febuxostat 120 mg QD treatment arms versus the conventionally used doses of allopurinol 300 mg (n = 258) /100 mg (n = 10) treatment arm in reducing the sUA below 6 mg/dL (357 μmol/L) (see Table 2 and Figure 1).
Maltese: L-istudju APEX wera superjorità statistikament sinifikanti taż-żewġ gruppi ta' kura ta' febuxostat 80 mg QD u ta' febuxostat 120 mg QD versus il-grupp ta' kura ta' dożi konvenzjonali ta' allopurinol 300 mg (n = 258) /100 mg (n = 10), biex inaqqsu l-sUA taħt 6 mg/dL (357 µmol/L) (ara Tabella 2 u Figura 1).
English: The proportion of patients with serum urate levels of < 6.0 mg/dL (357 μmol/L) at the final visit, was 45% for 40 mg febuxostat, 67% for febuxostat 80 mg and 42% for allopurinol 300/200 mg, respectively.
Maltese: Il-proporzjon ta' pazjenti b'livelli ta' urate fis-serum ta' < 6.0 mg/dL (357 μmol/L) fl-aħħar żjara, kien 45% għal 40 mg febuxostat, 67% għal febuxostat 80 mg u 42% għal allopurinol 300/200 mg, rispettivament.
English: Rare (may affect up to 1 in 1,000 people): - muscle damage, a condition which on rare occasions can be serious.
Maltese: Rari (jistgħu jaffettwaw sa'1 f'kull 1,000 persuna): - ħsara fil-muskoli, kundizzjoni li f'każijiet rari tista' tkun serja.
English: Clabeled febuxostat, approximately 49% of the dose was recovered in the urine as unchanged febuxostat (3%), the acyl glucuronide of the active substance (30%), its known oxidative metabolites and their conjugates (13%), and other unknown metabolites (3%).
Maltese: C, madwar 49% tad-doża kienet irkuprata fl-awrina bħala febuxostat mhux mibdul (3%), l-acyl glucuronide tas-sustanza attiva (30%), il-metaboliti ossidattivi magħrufa tiegħu u l-konjugati tagħhom (13%), u metaboliti mhux magħrufa oħra (3%).
English: Febuxostat Krka 80 mg film-coated tablets Febuxostat Krka 120 mg film-coated tablets febuxostat
Maltese: Krka 80 mg pilloli miksija b'rita Febuxostat Krka 120 mg pilloli miksija b'rita febuxostat
English: Rare reports of serious allergic/hypersensitivity reactions, including life-threatening Stevens-Johnson Syndrome, Toxic epidermal necrolysis and acute anaphylactic reaction/shock, have been collected in the post-marketing experience.
Maltese: Rapporti rari ħafna ta' reazzjonijiet serji ta' allerġija/sensittività eċċessiva, inkluża s-Sindrome Stevens-Johnson, nekrolisi epidermali tossika, li kienu ta' theddida għall-ħajja u reazzjoni anafilattika akuta/ xokk, kienu miġbura waqt l-esperjenza ta' wara t-tqegħid fis-suq.