FrancophonIA/ELRC3.0 huggingface dataset:
English: Demographics and baseline disease characteristics were comparable between the sorafenib and the placebo group with regard to ECOG status (status 0: 54 % vs. 54 %; status 1: 38 % vs. 39 %; status 2: 8 % vs. 7 %), TNM stage (stage I: <1 % vs. <1 %; stage II: 10.4 % vs. 8.3 %; stage III: 37.8 % vs. 43.6 %; stage IV: 50.8 % vs. 46.9 %), and BCLC stage (stage B: 18.1 % vs. 16.8 %; stage C: 81.6 % vs. 83.2 %; stage D: < 1 % vs. 0 %).
Maltese: Demografika u linja bażi talkaratteristiċi tal-marda kienu komparabbli bejn il-grupp ta' sorafenib u tal-plaċebo fir-rigward ta' listat ECOG (stat 0: 54 % vs. 54 %; stat 1: 38 % vs. 39 %; stat 2: 8 % vs. 7 %), stadju TNM (stadju I: < 1 % vs. < 1 %; stadju II: 10.4 % vs. 8.3 %; stadju III: 37.8 % vs. 43.6 %; stadju IV: 50.8 % vs. 46.9 %), u stadju BCLC (stadju B: 18.1 % vs. 16.8 %; stadju C: 81.6 % vs. 83.2 %; stadju D: < 1 % vs. 0 %).
English: Majority of patients had papillary carcinoma (56.8%), followed by follicular (25.4%) and poorly differentiated carcinoma (9.6%).
Maltese: Il-maġġoranza tal-pazjenti kellhom karċinoma papillari (56.8%), segwita minn karċinoma follikulari (25.4%) u karċinoma differenzjata b'mod batut (9.6%).
English: Sorafenib inhibits the activity of targets present in the tumour cell (CRAF, BRAF, V600E BRAF, c-KIT, and FLT-3) and in the tumour vasculature (CRAF, VEGFR-2, VEGFR-3, and PDGFR-ß).
Maltese: Sorafenib jinibixxi l-attività ta' miri preżenti fiċ-ċellola tat-tumur (CRAF, BRAF, V600E BRAF, c-KIT, u FLT-3) u fil-vaskulatura tat-tumur (CRAF, VEGFR-2, VEGFR-3, u PDGFR-ß).
English: Sorafenib accounts for approximately 70 - 85 % of the circulating analytes in plasma at steady state.
Maltese: Sorafenib jirrappreżenta madwar 70 - 85 % ta' l-analiti preżenti fl-plażma fi stat stabbli.
English: Dogs showed tubular degeneration in the testes and oligospermia.
Maltese: Klieb urew deġenerazzjoni tubolari fit-testikoli u oligospermja.
English: Table 3: Efficacy results from study 3 (study 100554) in hepatocellular carcinoma
Maltese: Tabella 3: Riżultati ta' effikaċja minn studju 3 (studju 100554) dwar karċinoma epatoċellulari
English: Nexavar contains sodium
Maltese: Nexavar fih sodium
English: Sorafenib (N=299)
Maltese: (N=299)
English: P-gp-substrates
Maltese: Substrati ta' P-gp
English: Lipase increased * Common Terminology Criteria for Adverse Events (CTCAE), version 3.0 ** The aetiology of hypophosphatemia associated with sorafenib is not known.
Maltese: Żieda fil-lipase * Common Terminology Criteria for Adverse Events (CTCAE), verżjoni 3.0 ** L-etjoloġija ta' ipofosfatemija assoċjata ma' sorafenib mhijiex magħrufa.
English: When administered with irinotecan, whose active metabolite SN-38 is further metabolised by the UGT1A1 pathway, there was a 67 - 120 % increase in the AUC of SN-38 and a 26 - 42 % increase in the AUC of irinotecan.
Maltese: irinotecan, li l-metabolita attiv tiegħu SN-38 jiġi mmetabolizzat aktar mir-rotta UGT1A1, kien hemm żjieda ta' 67 - 120 % fl-AUC ta' SN-38 u żjieda ta' 26 - 42 % fl-AUC ta' irinotecan.
English: CYP3A4, CYP2D6 and CYP2C19 substrates
Maltese: Substrati ta' CYP3A4, CYP2D6 u CYP2C19
English: Environmental Risk Assessment information is available in the EPAR of this medicine (see section 6.6).
Maltese: Informazzjoni dwar Stima tar-Riskju Ambjentali hi disponibbli fl-EPAR ta' din il-mediċina (ara sezzjoni 6.6).
English: Median PFS time was 10.8 months in the sorafenib group compared to 5.8 months in the placebo group (HR=0.587; 95% Confidence Interval (CI): 0.454, 0.758; one-sided p <0.0001).
Maltese: 8 xhur fil-grupp ta' sorafenib meta mqabbel ma' 5.8 xhur filgrupp tal-plaċebo (HR=0.587; Intervall ta' kunfidenza (CI - Confidence Interval) ta' 95%: 0.454, 0.758; one-sided p < 0.0001).
English: Infections and infestations infection folliculitis
Maltese: Infezzjonijiet u infestazzjoniji et infezzjoni follikulite
English: This OS analysis showed a statistically significant advantage for sorafenib over placebo for OS (HR: 0.69, p = 0.00058, see table 3).
Maltese: Din l-analiżi ta' OS wriet vantaġġ statistikament sinifikanti għal sorafenib fuq plaċebo għal OS (HR: 0.69, p = 0.00058, ara tabella 3).
English: Hypocalcaemia grade 3 and 4 occurred in 6.8% and 3.4% of sorafenib-treated patients with DTC (see section 4.8).
Maltese: Ipokalċemija ta' grad 3 u 4 seħħet f'6.8% u 3.4% tal pazjenti kkurati b'sorafenib li kellhom DTC (ara sezzjoni 4.8).
English: Bayer AG
Maltese: Bayer AB
English: The recommended dose of Nexavar in adults is 400 mg sorafenib (two tablets of 200 mg) twice daily (equivalent to a total daily dose of 800 mg).
Maltese: Id-doża rakkomandata ta' Nexavar fl-adulti hija 400 mg sorafenib (żewġ pilloli ta' 200 mg) darbtejn kuljum (ekwivalenti għal doża totali ta' kuljum ta' 800 mg).
English: INR abnormal, prothrombin level abnormal
Maltese: livell anormali ta' prothrombin
English: Differentiated thyroid cancer (DTC)
Maltese: Karċinoma differenzjata tat-tirojde (DTC)
English: CYP2B6, CYP2C8 and CYP2C9 substrates
Maltese: Substrati ta' CYP2B6, CYP2C8 u CYP2C9
English: In case of symptomatic hypoglycaemia, sorafenib should be temporarily interrupted.
Maltese: ipogliċemija sintomatika, sorafenib għandu jiġi interrott temporanjament.
English: Typical changes consisted of signs of degeneration and retardation in testes, epididymides, prostate, and seminal vesicles of rats.
Maltese: Tibdiliet tipiċi ikkonsistew f'sinjali ta' deġenerazzjoni u ritardazzjoni fit-testikoli, epididimi, prostata, u l-bużżieqa seminali tal-firien.
English: Frequencies are defined as: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1,000 to <1/100), rare (≥1/10,000 to <1/1,000), not known (cannot be estimated from the available data).
Maltese: Il frekwenzi huma mniżżla bħala: komuni ħafna (≥ 1/10), komuni (≥ 1/100 sa < 1/10), mhux komuni (≥ 1/1,000 sa < 1/100), rari (≥ 1/10,000 sa < 1/1,000), mhux magħruf (ma tistax tittieħed stima middata disponibbli).
English: Nexavar is indicated for the treatment of hepatocellular carcinoma (see section 5.1).
Maltese: Nexavar huwa indikat għall-kura ta' karċinoma epatoċellulari (ara sezzjoni 5.1).
English: In an overall survival analysis conducted 9 months after the data cut-off for the final PFS analysis there was no statically significant difference in overall survival between the treatment groups (HR=0.884; 95% CI: 0.633, 1.236, one-sided p value of 0.236).
Maltese: F'analiżi globali tas-sopravivenza li twettaq 9 xhur wara li waqfet tinġabar id-data għall-analiżi finali tal-PFS ma kien hemm l-ebda differenza statistikament sinifikanti fis-sopravivenza globali bejn ilgruppi tal-kura (HR=0.884; CI ta' 95%: 0.633, 1.236, valur p one-sided ta' 0.236).
English: Sorafenib has been shown to prolong the QT/QTc interval (see section 5.1), which may lead to an increased risk for ventricular arrhythmias.
Maltese: Sorafenib intwera li jtawwal l-intervall QT/QTc (ara sezzjoni 5.1), u dan jista' jwassal għal riskju akbar ta' arritmiji ventrikulari.
English: The PFS analysis was conducted at 342 events in 769 patients.
Maltese: L-analiżi ta' PFS kienet kondotta fuq 342 episodju f'769 pazjent.
English: Caution is recommended when administering sorafenib with compounds that are metabolised/eliminated predominantly by the UGT1A1 (e.g. irinotecan) or UGT1A9 pathways (see section 4.5).
Maltese: Kawtela hija rakkomandata meta sorafenib jiġi mogħti ma' prodotti li huma metabolizzati/eliminati prinċipalment mir-rotot UGT1A1 (e.ż. irinotecan) jew UGT1A9 (ara sezzjoni 4.5).
English: In vitro, sorafenib has been shown to inhibit the transport protein p-glycoprotein (P-gp).
Maltese: In vitro, sorafenib intwera li jinibixxi l-ġarr tal-proteina p-glycoprotein (P-gp).
English: Placebo (N=303)
Maltese: (N=303)
English: In two randomised trials investigating patients with Non-Small Cell Lung Cancer in the subgroup of patients with squamous cell carcinoma treated with sorafenib as add-on to paclitaxel/carboplatin, the HR for overall survival was found to be 1.81 (95% CI 1.19; 2.74) and as add-on to gemcitabine/cisplatin 1.22 (95% CI 0.82; 1.80).
Maltese: F'żewġ provi randomised li nvestigaw pazjenti b'kanċer taċ-ċelluli mhux żgħar tal-pulmun fis-sottogrupp ta' pazjenti b'karċinoma taċ-ċelluli skwamużi kkurati b'sorafenib bħala kura addizzjonali ma' paclitaxel/carboplatin, l-HR għal sopravivenza globali instab li kien 1.81 (95% CI 1.19; 2.74) u bħala kura addizzjonali ma' gemcitabine/cisplatin kien ta' 1.22 (95% CI 0.82; 1.80).
English: CI=Confidence interval, HR=Hazard ratio (sorafenib over placebo) * statistically significant as the p-value was below the prespecified O'Brien Fleming stopping boundary of 0.0077 ** independent radiological review
Maltese: CI=Intervall ta' Kunfidenza, HR=Proporzjon ta' Periklu (sorafenib fuq plaċebo) * statistikament sinifikanti minħabba li l-valur p kien inqas mil-livell ta' waqfien O'Brien Fleming speċifikat minn qabel ta' 0.0077 ** analiżi radjoloġika indipendenti
English: Warfarin co-administration
Maltese: Amministrazzjoni flimkien ma' warfarin
English: The steady-state concentrations of sorafenib administered at 400 mg twice daily were evaluated in DTC, RCC and HCC patients.
Maltese: Il-konċentrazzjonijiet ta' sorafenib fi stat fiss mogħti f'doża ta' 400 mg darbtejn kuljum ġew evalwati f'pazjenti b'DTC, RCC u HCC.
English: Hypocalcaemia was reported in 35.7% of sorafenib treated patients compared to 11.0% of placebo patients.
Maltese: Ipokalċemija ġiet irrappurtata f'35.7% tal-pazjenti kkurati b'sorafenib meta mqabbla ma' 11.0% talpazjenti fuq plaċebo.
English: Laboratory test abnormalities in DTC patients (study 5)
Maltese: Anormalitajiet fit-testijiet tal-laboratorju f'pazjenti b'DTC (studju 5)
English: 112 film-coated tablets (4 x 28) in transparent (PP/Aluminium) blister packs.
Maltese: In-natura tal-kontenitur u ta' dak li hemm ġo fih 112-il pillola miksija b'rita (4 x 28) ġo folji trasparenti (PP/Aluminium).
English: Progression-free survival in patients with RCC was significantly longer in the sorafenib group (163 days) than in the placebo group (41 days) (p = 0.0001, HR = 0.29).
Maltese: Sopravivenza bla progressjoni f'pazjenti b'RCC kienet sinifikatament itwal fil grupp b'sorafenib (163 ġurnata) milli fil-ġrupp bil-plaċebo (41 ġurnata) (p = 0.0001, HR = 0.29).
English: Study 2 was a Phase II, discontinuation study in patients with metastatic malignancies, including RCC.
Maltese: II b'waqfien fil-kura f'pazjenti b'tumuri malinni metastatiċi, inkluż RCC.
English: Furthermore, the sorafenib batch tested in the standard genotoxicity battery included 0.34 % PAPE.
Maltese: Barra minn hekk, il-lott ta' sorafenib ittestjat fil-batterija ġenotossika stàndard inkluda 0.34 % ta' PAPE.
English: One intermediate in the manufacturing process, which is also present in the final active substance (< 0.15 %), was positive for mutagenesis in an in vitro bacterial cell assay (Ames test).
Maltese: Intermedjarju wieħed fil-proċess ta' manifattura, li huwa preżenti ukoll fis-sustanza attiva finali (< 0.15 %), kien pożittiv għall-mutaġenisi f'analiżi in vitro f'ċelloli tal-batterja (Ames test).
English: Sorafenib inhibited CYP2B6, CYP2C8 and CYP2C9 in vitro with similar potency.
Maltese: In vitro sorafenib inibixxa CYP2B6, CYP2C8 u CYP2C9 b'qawwa simili.
English: Croscarmellose sodium Microcrystalline cellulose Hypromellose Sodium laurilsulfate Magnesium stearate
Maltese: Croscarmellose sodium Microcrystalline cellulose Hypromellose
English: Hypocalcaemia was reported in 12% and 26.5% of sorafenib treated patients compared to 7.5% and 14.8% of placebo patients in study 1 and study 3, respectively.
Maltese: Ipokalċimija kienet irrappurtata fi 12% u f'26.5% tal-pazjenti kkurati b'sorafenib meta mqabbel ma' 7.5% u 14.8% tal-pazjenti fuq plaċebo fi studju 1 u studju 3, rispettivament.
English: The median duration of response was 309 days (95% CI: 226,505 days) in sorafenib treated patients who experienced a PR.
Maltese: It-tul medjan tar-rispons kien ta' 309 ijiem (CI ta' 95%: 226,505 ijiem) f'pazjenti kkurati b'sorafenib li kellhom PR.
English: Common:
Maltese: Rari:
English: This metabolite comprises approximately 9 - 16 % of circulating analytes at steady state.
Maltese: Dan il-metabolita jammonta għal madwar 9 - 16 % ta' l-analiti li qed jiċċirkolaw fi stat stabbli.
English: Sorafenib had no clinically relevant effect on the pharmacokinetics of gemcitabine, cisplatin, carboplatin, oxaliplatin or cyclophosphamide.
Maltese: Sorafenib ma kellu l-ebda effett ta' rilevanza klinika fuq il-farmakokinetika ta' gemcitabine, cisplatin, carboplatin, oxaliplatin jew cyclophosphamide.
English: In studies 1 and 3 decreased potassium was observed in 5.4% and 9.5% of sorafenib-treated patients compared to 0.7% and 5.9% of placebo patients, respectively.
Maltese: Fi studji 1 u 3 ġie osservat tnaqqis fil-livell ta' potassium f'5.4 % u 9.5 % tal-pazjenti kkurati b'sorafenib meta mqabbel ma' 0.7 % u 5.9 % tal-pazjenti kkurati bi plaċebo, rispettivament.
English: When given with a high-fat meal sorafenib absorption was reduced by 30 % compared to administration in the fasted state.
Maltese: 30 % meta mqabbel ma' amministrazzjoni fi stat sajjem.
English: In company sponsored clinical trials congestive heart failure was reported as an adverse event in 1.9% of patients treated with sorafenib (N= 2276).
Maltese: Fi provi kliniċi sponsorjati mill-kumpanija, insuffiċjenza tal-qalb konġestiva kienet irrapportata bħala avveniment avvers f'1.9% tal-pazjenti kkurati b'sorafenib (N= 2276).
English: Clinical pancreatitis was reported in 2 of 451 sorafenib treated patients (CTCAE Grade 4) in study 1, 1 of 297 sorafenib treated patients in study 3 (CTCAE Grade 2), and 1 of 451 patients (CTCAE Grade 2) in the placebo group in study 1.
Maltese: Pakrejatite klinika kienet irrappurtata f'2 minn 451 pazjent kkurat b'sorafenib (CTCAE ta' Grad 4) f'studju 1, 1 minn 297 tal-pazjenti kkurati b'sorafenib f'studju 3 (CTCAE ta' Grad 2), u 1 minn 451 pazjent (CTCAE ta' Grad 2) fil-grupp tal-plaċebo ta' studju 1.
English: Reproductive system and breast disorders erectile dysfunction gynaecomastia
Maltese: Disturbi fis sistema riproduttiva u tas-sider disfunzjoni erettili ginekomastja
English: Date of first authorisation: 19 July 2006 Date of latest renewal: 21 July 2011
Maltese: Data tal-aħħar tiġdid: 21 ta' Lulju 2011
English: Docetaxel (75 or 100 mg/m2 administered once every 21 days) when co-administered with sorafenib (200 mg twice daily or 400 mg twice daily administered on Days 2 through 19 of a 21-day cycle with a 3-day break in dosing around administration of docetaxel) resulted in a 36-80 % increase in docetaxel AUC and a 16-32 % increase in docetaxel Cmax.
Maltese: Docetaxel (75 jew 100 mg/m2 mogħti darba kull 21 ġurnata) meta jingħata flimkien ma' sorafenib (200 mg darbtejn kuljum jew 400 mg darbtejn kuljum mogħtija fi Ġranet 2 sa 19 minn ċiklu ta' 21ġurnata b'pawża ta' 3-ijiem fid-dożaġġ waqt l-għoti ta' docetaxel) wassal għall-żjieda ta' 36 - 80 % flAUC ta' docetaxel AUC u żjieda ta' 16 - 32 % f'Cmax ta' docetaxel.
English: The median survival was 19.3 months for patients randomised to sorafenib compared to 15.9 months for placebo patients (HR = 0.77; 95 % CI: 0.63 - 0.95; p = 0.015).
Maltese: 9 xhur għall-pazjenti fuq il plaċebo (HR = 0.77; 95 % CI: 0.63 - 0.95; p = 0.015).
English: Ketoconazole, a potent inhibitor of CYP3A4, administered once daily for 7 days to healthy male volunteers did not alter the mean AUC of a single 50 mg dose of sorafenib.
Maltese: Ketoconazole, inibitur potenti ta' CYP3A4, mogħti darba kuljum għal 7 ijiem lill-volontiera rġiel f'saħħithom ma biddilx l-AUC medja ta' doża waħda ta' sorafenib ta' 50 mg.
English: Severe hypocalcaemia should be corrected to prevent complications such as QT-prolongation or torsade de pointes (see section QT prolongation).
Maltese: Ipokalċemija severa għandha tiġi kkoreġuta biex jiġu evitati komplikazzjonijiet bħal titwil tal-QT jew torsade de pointes (ara sezzjoni titwil tal-QT).
English: The pharmacokinetics (PK) of sorafenib in Child-Pugh A and B non-HCC patients were similar to the PK in healthy volunteers.
Maltese: Il-farmakokinetika (PK) ta' sorafenib f'pazjenti b'Child-Pugh A jew B li m'għandhomx HCC kienet simili għal PK f'voluntiera b'saħħithom.
English: Hypocalcaemia in DTC
Maltese: Ipokalċemija f'DTC
English: dyspepsia dysphagia gastro oesophageal reflux disease pancreatitis gastritis gastrointestinal perforations*
Maltese: Disturbi gastrointestinali dijarrea tqalligħ rimettar stitikezza stomatitie (inkluż ħalq xott u glossodinja) dispepsja disfaġija marda ta' rifluss gastroesofagali pankrejatite gastrite perforazzjoni gastrointestinali*
English: Other medicines and Nexavar
Maltese: Mediċini oħra u Nexavar
English: anaphylactic reaction angioedema
Maltese: reazzjoni anafilattika anġjoedima
English: Age, MSKCC prognostic group, ECOG PS and prior therapy did not affect the treatment effect size.
Maltese: Eta', grupp pronjostiku MSKCC, ECOG PS u terapija minn qabel ma affettwatx id-daqs ta' l-effett tal-kura.
English: In study 11213 (RCC) adverse events consistent with congestive heart failure were reported in 1.7% of patients treated with sorafenib and 0.7% receiving placebo.
Maltese: Fi studju 11213 (RCC) avvenimenti avversi konsistenti ma' insuffiċjenza tal-qalb konġestiva kienu irrapportati f'1.7% ta' dawk ikkurati b'sorafenib u f'0.7% li rċevew plaċebo.
English: The most common adverse reactions were diarrhoea, fatigue, alopecia, infection, hand foot skin reaction (corresponds to palmar plantar erythrodysaesthesia syndrome in MedDRA) and rash.
Maltese: L-aktar effetti avversi komuni kienu dijarrea, għeja, alopeċja, infezzjoni, reazzjoni tal-ġilda tal-id u ssieq (li jikkorrespondi għas-sindromu ta' eritrodisasteżija palmari-plantari f'MedDRA) u raxx.
English: Gastrointestinal perforation
Maltese: emorraġġija gastrointestinali*,
English: Renal and urinary disorders renal failure proteinuria nephrotic syndrome
Maltese: Disturbi filkliewi u fis sistema urinarja insuffiċjenza renali proteina fl awrina sindrome nefrotiku
English: Nexavar 200 mg tablets sorafenib
Maltese: Pilloli Nexavar 200 mg sorafenib
English: Paclitaxel/carboplatin o Administration of paclitaxel (225 mg/m2) and carboplatin (AUC = 6) with sorafenib (≤ 400 mg twice daily), administered with a 3-day break in sorafenib dosing (two days prior to and on the day of paclitaxel/carboplatin administration), resulted in no significant effect on the pharmacokinetics of paclitaxel.
Maltese: Paclitaxel/carboplatin o L-għoti ta' paclitaxel (225 mg/m2) u carboplatin (AUC = 6) ma' sorafenib (≤ 400 mg darbtejn kuljum), mogħti b'waqfien ta' 3 ijiem fid-dożaġġ ta' sorafenib (jumejn qabel u fil-ġurnata talgħoti ta' paclitaxel/carboplatin), ma wassal għall-ebda effett sinifikanti fuq il-farmakokinetika ta' paclitaxel.
English: Metastases were present in the lungs in 86%, lymph node in 51% and bone in 27% of the patients.
Maltese: Metastasi kienet preżenti fil-pulmun f'86%, fil-glandoli tal-limfa f'51% u fl-għadam f'27% talpazjenti.
English: How to take Nexavar The recommended dose of Nexavar in adults is 2 x 200 mg tablets, twice daily.
Maltese: Id-doża rakkomandata ta' Nexavar fl-adulti hija ta' 2 x 200 mg pilloli, darbtejn kuljum.
English: Progression-free survival (PFS) as evaluated by a blinded independent radiological review using RECIST criteria was the primary endpoint of the study.
Maltese: Sopravivenza mingħajr progressjoni (PFS - progression-free survival) kif evalwata minn evalwazzjoni radjoloġika indipendenti blinded bl-użu tal-kriterji RECIST kienet il-punt finali primarju tal-istudju.
English: Metabolism and nutrition disorders anorexia hypophosphataemia hypocalcaemia hypokalaemia hyponatraemia hypoglycaemia dehydration
Maltese: Disturbi filmetaboliżmu u nnutrizzjoni anoressija ipofosfatimja ipokalċimija ipokalimja iponatrimja ipogliċemija diżidratazzjoni
English: CTCAE Grade 3 or 4 lipase elevations occurred in 11 % and 9 % of patients in the sorafenib group in study 1 (RCC) and study 3 (HCC), respectively, compared to 7 % and 9 % of patients in the placebo group.
Maltese: L-elevazzjonijiet tal-lipase CTCAE ta' Grad 3 jew 4 seħħew f'11 % u f'9 % tal-pazjenti fil-grupp ta' sorafenib fi studji 1 (RCC) u f'studju 3 (HCC), rispettivament, meta mqabbla ma' 7 % u ma' 9 % tal-pazjenti fil-grupp tal-plaċebo.
English: All Grades*
Maltese: Kollha*
English: However, in clinical pharmacokinetic studies, concomitant administration of sorafenib 400 mg twice daily with cyclophosphamide, a CYP2B6 substrate, or paclitaxel, a CYP2C8 substrate, did not result in a clinically meaningful inhibition.
Maltese: Madankollu, fi studji farmakokinetiċi kliniċi, l-għoti ta' sorafenib 400 mg darbtejn kuljum flimkien ma' cyclophosphamide, substrat ta' CYP2B6, jew paclitaxel, substrat ta' CYP2C8, ma rriżultax f'inibizzjoni ta' sinifikanza klinika.
English: The adverse events observed at this dose were primarily diarrhoea and dermatological events.
Maltese: L-effetti avversi osservati f'din id-doża kienu primarjament dijarrea u episodji dermatoloġiċi.
English: Rash and hand foot skin reaction are usually CTC (Common Toxicity Criteria) Grade 1 and 2 and generally appear during the first six weeks of treatment with sorafenib.
Maltese: Raxx u reazzjoni tal-ġilda fl-id u s-sieq normalment huma CTC (Kriterji ta' Tossiċità Komuni) ta' Grad 1 u 2 u ġeneralment jidru waqt lewwel sitt ġimgħat tal-kura b'sorafenib.
English: The main circulating metabolite of sorafenib in plasma, the pyridine N-oxide, shows in vitro potency similar to that of sorafenib.
Maltese: Il-metabolita prinċipali ta' sorafenib li qed jiċċirkola fil-plażma, pyridine N-oxide, juri potenza in vitro simili għal dik ta' sorafenib.
English: After administration of sorafenib tablets the mean relative bioavailability is 38 - 49 % when compared to an oral solution.
Maltese: Wara amministrazzjoni ta' pilloli sorafenib il-biodisponibiltà relattiva medja hija ta' 38 - 49 % meta mqabbla ma' soluzzjoni li tittieħed mill-ħalq.
English: The HR of progression free survival was 0.39 (95% CI: 0.21 - 0.72) for patients with symptoms at baseline and 0.60 (95% CI: 0.45 - 0.81) for patients without symptoms at baseline.
Maltese: L-HR ta' sopravivenza mingħajr progressjoni kien ta' 0.39 (CI ta' 95%: 0.21 - 0.72) għall-pazjenti b'sintomi fil-linja bażi u ta' 0.60 (CI ta' 95%: 0.45 - 0.81) għall-pazjenti mingħajr sintomi fil-linja bażi.
English: Musculoskeletal and connective tissue disorders arthralgia myalgia muscle spasms rhabdomyolysis
Maltese: Disturbi muskolu skeletriċi u tat-tessuti konnettivi artralġja mijalġja spażmi tal muskoli rabdomijolisi
English: Nexavar is a so-called multikinase inhibitor.
Maltese: Nexavar huwa 'l hekk msejjaħ inibitur ta' multikinase.
English: This study, conducted in China, Korea and Taiwan confirmed the findings of Study 3 with respect to the favourable benefit-risk profile of sorafenib (HR (OS): 0.68, p = 0.01414).
Maltese: Dan l-istudju, li twettaq fiċ-Ċina, Koreja u Taiwan ikkonferma s-sejbiet ta' Studju 3 rigward il-profil favorevoli tal-benefiċċju-riskju ta' sorafenib (HR (OS): 0.68, p = 0.01414).
English: The absolute bioavailability is not known.
Maltese: Il-biodisponibilità assoluta mhux magħrufa.
English: In a randomised, placebo-controlled, double-blind study (study 1, see section 5.1) the incidence of treatment-emergent cardiac ischaemia/infarction events was higher in the sorafenib group (4.9 %) compared with the placebo group (0.4 %).
Maltese: Fi studju randomised, ikkontrollat bil-plaċebo u double-blind (studju 1, ara sezzjoni 5.1), l-inċidenza ta' episodji ta' iskemija/infart tal-qalb li dehru waqt il-kura kienet għola fil-grupp ta' sorafenib (4.9 %) meta mqabbel mal-grupp ta' plaċebo (0.4 %).
English: Endocrine disorders hypothyroidism hyperthyroidism
Maltese: Disturbi fis sistema endokrinarja ipotirojdiżmu ipertirojdiżmu
English: The overall response rate (CR + partial response (PR) per independent radiological assessment was higher in the sorafenib group (24 patients, 12.2%) than in the placebo group (1 patient, 0.5%), one-sided p<0.0001.
Maltese: Ir-rata ta' rispons globali (CR + rispons parzjali (PR - partial response) għal kull evalwazzjoni radjoloġika indipendenti kienet ogħla fil-grupp ta' sorafenib (24 pazjent, 12.2%) milli fil-grupp tal-plaċebo (pazjent wieħed, 0.5%),