FrancophonIA/ELRC3.0 huggingface dataset:
English: Concomitant administration of sorafenib and midazolam, dextromethorphan or omeprazole, which are substrates for cytochromes CYP3A4, CYP2D6 and CYP2C19 respectively, did not alter the exposure of these agents.
Maltese: L-għoti ta' sorafenib flimkien ma' midazolam, dextromethorphan jew omeprazole, li huma substrati għal ċitokromji CYP3A4, CYP2D6 u CYP2C19 rispettivament, ma biddilx l-espożizzjoni ta' dawn issustanzi.
English: CTCAE grade 3 hypocalcaemia (6.0 - 7.0 mg /dL) occurred in 1.1% and 1.8% of sorafenib treated patients and 0.2% and 1.1% of patients in the placebo group, and CTCAE grade 4 hypocalcaemia (< 6.0 mg/dL) occurred in 1.1% and 0.4% of sorafenib treated patients and 0.5% and 0% of patients in the placebo group in study 1 and 3, respectively.
Maltese: Ipokalċimija ta' CTCAE ta' grad 3 (6.0 - 7.0 mg/dL) seħħet f'1.1% u f'1.8% tal-pazjenti kkurati b'sorafenib u f'0.2% u f'1.1% talpazjenti fil-grupp tal-plaċebo, u ipokalċimija ta' CTCAE ta' grad 4 (< 6.0 mg/dL) seħħet f'1.1% u f'0.4% tal-pazjenti kkurati b'sorafenib u f'0.5% u f'0% tal-pazjenti fil-grupp tal-plaċebo fi studju 1 u
English: If any bleeding event necessitates medical intervention it is recommended that permanent discontinuation of sorafenib should be considered (see section 4.8).
Maltese: Jekk xi episodju ta' fsada jinħtieġ intervent mediku huwa rakkomandat li jiġi kkunsidrat twaqqif permanenti ta' sorafenib (ara sezzjoni 4.8).
English: Amylase increased
Maltese: Żieda fl-amylase
English: Nexavar is indicated for the treatment of patients with progressive, locally advanced or metastatic, differentiated (papillary/follicular/Hürthle cell) thyroid carcinoma, refractory to radioactive iodine.
Maltese: Nexavar hu indikat għall-kura ta' pazjenti b'karċinoma differenzjata tat-tirojde, progressiva, avanzata lokalment jew metastatika (papillari/follikulari/ċelluli ta' Hürthle), refrattarja għal iodine radjuattiv.
English: Adverse reactions reported in multiple clinical trials or through post-marketing use are listed below in table 1, by system organ class (in MedDRA) and frequency.
Maltese: Reazzjonijiet avversi rrappurtati fi provi kliniċi multipli jew minn użu ta' wara t-tqegħid fis-suq huma mniżżla f'tabella 1 isfel, skont is-sistema tal-klassifikazzjoni tal-organi (f'MedDRA) u l-frekwenza.
English: Most reports of hypokalaemia were low grade (CTCAE Grade 1).
Maltese: Il-biċċa lkbira tar-rapporti ta' ipokalimja kienu ta' grad baxx (CTCAE Grad 1).
English: In hepatocellular carcinoma (HCC) patients with Child-Pugh A or B (mild to moderate) hepatic impairment, exposure values were comparable and within the range observed in patients without hepatic impairment.
Maltese: F'pazjenti b'karċinoma epatoċellolari (HCC) b'indeboliment epatiku Child-Pugh A jew B (ħafif sa moderat), il-valuri ta' espożizzjoni kienu komparabbli u fil-firxa osservata f'pazjenti mingħajr indeboliment epatiku.
English: In a clinical pharmacology study (single dose of 400 mg sorafenib), no relationship was observed between sorafenib exposure and renal function in subjects with normal renal function, mild, moderate or severe renal impairment.
Maltese: Fi studji kliniku farmakoloġiku (doża waħda ta' 400 mg ta' sorafenib), ma kienet osservata l-ebda relazzjoni bejn l-esponiment ta' sorafenib u l-funzjoni renali f'individwi b'funzjoni renali normali, indeboliment renali ħafif, moderat jew sever.
English: CTCAE Grade 3 hypophosphataemia (1 - 2 mg/dl) in study 1 occurred in 13 % of sorafenib treated patients and 3 % of patients in the placebo group, in study 3 in 11 % of sorafenib treated patients and 2 % of patients in the placebo group.
Maltese: Ipofosfatemija CTCAE ta' Grad 3 (1 - 2 mg/dl) f'studju 1 seħhet fi 13 % tal-pazjenti kkurati b'sorafenib u 3 % tal-pazjenti fil-grupp tal-plaċebo, f'studju 3 11 % tal-pazjenti kkurati b'sorafenib u 2 % tal-pazjenti fil-grupp plaċebo.
English: The most important serious adverse reactions were myocardial infarction/ischaemia, gastrointestinal perforation, drug induced hepatitis, haemorrhage, and hypertension/hypertensive crisis.
Maltese: L-aktar reazzjonijiet avversi serji importanti kienu infart/iskemija mijokardijaka, perforazzjoni gastro intestinali, epatite ikkawżata mill-mediċina, emorraġija, u pressjoni għolja/kriżi ipertensiva.
English: - If you have poor kidney function.
Maltese: - Jekk għandek funzjoni tal-kliewi ħażina.
English: Nexavar is used to treat thyroid cancer (differentiated thyroid carcinoma).
Maltese: Kanċer differenzjat tat-tirojde (DTC - differentiated thyroid cancer)
English: Infrequent bleeding events or elevations in the International Normalised Ratio (INR) have been reported in some patients taking warfarin while on sorafenib therapy.
Maltese: Episodji infrekwenti ta' fsada jew elevazzjonijiet fil-Proporzjon Normalizzat Internazzjonali (INR) ġew irrappurtati f'xi pazjenti li qed jieħdu warfarin waqt terapija b'sorafenib.
English: Other clinically relevant laboratory abnormalities observed in the study 5 are shown in table 2.
Maltese: Anormalitajiet tal-laboratorju oħrajn li kienu klinikament rilevanti li ġew osservati fi studju 5 qed jintwerew f'tabella 2.
English: o Co-administration of paclitaxel (225 mg/m2, once every 3 weeks) and carboplatin (AUC=6) with sorafenib (400 mg twice daily, without a break in sorafenib dosing) resulted in a 47% increase in sorafenib exposure, a 29% increase in paclitaxel exposure and a 50% increase in 6OH paclitaxel exposure.
Maltese: o L-għoti ta' paclitaxel (225 mg/m2, darba kull 3 ġimgħat) u carboplatin (AUC=6) flimkien ma' sorafenib (400 mg darbtejn kuljum, mingħajr waqfien fid-dożaġġ ta' sorafenib) wassal għal żjieda ta' 47% fl-esponiment għal sorafenib, żjieda ta' 29% fl-esponiment għal paclitaxel u żjieda ta' 50% fl-esponiment għal 6-OH paclitaxel.
English: Cardiac disorders congestive heart failure* myocardial ischaemia and infarction*
Maltese: iskemija u infart mijokardijaku*
English: There are limited data from this study in patients with Child Pugh B liver impairment and only one patient with Child Pugh C had been included.
Maltese: Hemm tagħrif limitat minn dan l-istudju f'pazjenti b'indeboliment tal-fwied Child Pugh B u kien inkluż pażjent wieħed biss b'Child Pugh C.
English: After one 28-day treatment cycle, at the time of maximum concentration of sorafenib, QTcB was prolonged by 4 ±19 msec and QTcF by 9 ±18 msec, as compared to placebo treatment at baseline.
Maltese: Wara ċiklu wieħed ta' 28 jum ta' kura, fil-ħin ta' konċentrazzjoni massima ta' sorafenib, QTcB kien imtawwal b'4 ± 19 msec u QTcF b'9 ± 18 msec, meta mqabbel ma' kura bil-plaċebo fil-linja bażi.
English: System organ class
Maltese: Sistema talklassifikazzjo ni tal-organi
English: In study 5 (see section 5.1), increases in TSH levels above 0.5mU/L were observed in sorafenib treated patients.
Maltese: Fi studju 5 (ara sezzjoni 5.1), żidiet fil-livelli ta' TSH għal iktar minn 0.5 mU/L ġew osservati f'pazjenti kkurati b'sorafenib.
English: Co-administration of capecitabine (750-1050 mg/m2 twice daily, Days 1-14 every 21 days) and sorafenib (200 or 400 mg twice daily, continuous uninterrupted administration) resulted in no significant change in sorafenib exposure, but a 15-50% increase in capecitabine exposure and a 0-52% increase in 5-FU exposure.
Maltese: L-għoti ta' capecitabine (750-1050 mg/m2 darbtejn kuljum, Ġranet 1-14 kull 21 ġurnata) flimkien ma' sorafenib (200 jew 400 mg darbtejn kuljum, għoti kontinwu u mhux imwaqqaf) ma wassal għall-ebda bidla sinifikanti fl-esponiment għal sorafenib, iżda wassal għal żjieda ta' 15-50% fl-esponiment għal capecitabine u żjieda ta' 0-52% fl-esponiment għal 5-FU.
English: A second Phase III, international, multi-centre, randomised, double blind, placebo-controlled study (Study 4, 11849) evaluated the clinical benefit of sorafenib in 226 patients with advanced hepatocellular carcinoma.
Maltese: III (Studju 4, 11849) ivvaluta l-benefiċċju kliniku ta' sorafenib f'226 pazjent b'karċinoma epatoċellulari avvanzata.
English: Most reports of hypocalcaemia were low grade (CTCAE Grade 1 and 2).
Maltese: Il-biċċa l-kbira tarrapporti ta' ipokalċimija kienu ta' grad baxx (CTCAE ta' Grad 1 u 2).
English: Overall Survival (OS) [median, weeks (95%
Maltese: Sopravvivenza Globali (OS) [medjan,
English: The median OS was not reached in the sorafenib arm and was 36.5 months in the placebo arm. One hundred fifty seven (75%) patients randomised to placebo and 61 (30%) patients randomised to sorafenib received open-label sorafenib.
Maltese: Mija u sebgħa u ħamsin (75%) pazjent randomised għal plaċebo u 61 (30%) pazjent randomised għal sorafenib irċevew sorafenib open-label.
English: In clinical studies sorafenib has been administered with a variety of other anti-neoplastic agents at their commonly used dosing regimens including gemcitabine, cisplatin, oxaliplatin, paclitaxel, carboplatin, capecitabine, doxorubicin, irinotecan, docetaxel and cyclophosphamide.
Maltese: Taħlita ma' sustanzi anti-neoplastiċi oħra Fi studji kliniċi, sorafenib ingħata ma' varjetà ta' sustanzi anti-neoplastiċi fil-korsijiet ta' dożaġġ li ġeneralment jiġu wżati, inkluż gemcitabine, cisplatin, oxaliplatin, paclitaxel, carboplatin, capecitabine,
English: Effects of other antibiotics have not been studied, but will likely depend on their ability to interfere with microorganisms with glucuronidase activity.
Maltese: antibijotiċi oħra ma kienux studjati, iżda x'aktarx li jiddependu fuq l-abilità tagħhom li jinterferu ma' mikro-organiżmi li għandhom attività ta' glucuronidase.
English: Thus, also the risk for a clinically relevant in vivo inhibition of CYP2C9 by sorafenib may be expected to be low.
Maltese: Għalhekk, in vivo r-riskju ta' inibizzjoni ta' rilevanza klinika ta' CYP2C9 minn sorafenib ukoll jista' jkun mistenni li jkun baxx.
English: CYP1A2 and CYP3A4 activities were not altered after treatment of cultured human hepatocytes with sorafenib, indicating that sorafenib is unlikely to be an inducer of CYP1A2 and CYP3A4.
Maltese: L-attivitajiet ta' CYP1A2 u CYP3A4 ma nbidlux wara kura ta' epatoċiti umani kkultivati b'sorafenib.
English: In some cases this was not associated with apparent intra-abdominal tumour.
Maltese: F'ċertu każijiet dan ma kienx assoċjat ma' tumur intra-addominali apparenti.
English: Table 2: Treatment-emergent laboratory test abnormalities reported in DTC patient (study 5) double blind period
Maltese: Tabella 2: Anormalitajiet fit-testijiet tal-laboratorju li żviluppaw mill-kura, irrappurtati f'pazjenti b'DTC (studju 5) fil-perjodu double blind
English: The median duration of therapy in the double-blind period was 46 weeks (range 0.3-135) for patients receiving sorafenib and 28 weeks (range 1.7-132) for patients receiving placebo.
Maltese: It-tul medjan tat-terapija fil-perjodu double-blind kien ta' 46 ġimgħa (firxa 0.3-135) għal pazjenti li kienu qed jirċievu sorafenib, u 28 ġimgħa (firxa 1.7-132) għal pazjenti li kienu qed jirċievu plaċebo.
English: Only patients with clear cell renal carcinoma and low and intermediate risk MSKCC (Memorial Sloan Kettering Cancer Center) were included.
Maltese: Kienu nklużi biss pazjenti b'karċinoma taċ-ċelloli renali ċara u b'riskju MSKCC (Memorial Sloan Kettering Cancer Center) baxx u intermedju.
English: No subject showed a QTcB or QTcF >500 msec during the post-treatment ECG monitoring (see section 4.4).
Maltese: L-ebda individwu ma wera QTcB jew QTcF ta' > 500 msec matul ilmonitoraġġ ta' ECG ta' wara l-kura (ara sezzjoni 4.4).
English: PFS was evaluated by blinded independent radiological review using RECIST criteria.
Maltese: PFS kien evalwat skond kriterji RECIST minn reviżjoni radjoloġika indipendenti għamja.
English: Sorafenib therapy should be discontinued (see section 4.8).
Maltese: Kura b'sorafenib għanda titwaqqaf (ara sezzjoni 4.8).
English: A post-hoc subgroup analysis by maximum tumour size showed a treatment effect for PFS in favour of sorafenib over placebo for patients with maximum tumour size of 1.5 cm or larger (HR 0.54 (95% CI: 0.41 - 0.71)) whereas a numerically lower effect was reported in patients with a maximum tumour size of less than 1.5 cm (HR 0.87 (95% CI: 0.40 - 1.89).
Maltese: Analiżi post-hoc ta' sottogrupp skont id-daqs massimu tat-tumur uriet effett tal-kura għal PFS favur sorafenib fuq il-plaċebo għal pazjenti b'daqs massimu tat-tumur ta' 1.5 ċm jew ikbar (HR 0.54 (CI ta' 95%: 0.41 - 0.71)) filwaqt li effett numerikament iktar baxx ġie rrappurtat f'pazjenti b'daqs massimu tat-tumur ta' inqas minn 1.5 ċm (HR 0.
English: They come in calendar packs of 112 tablets: four transparent blister packs of 28 tablets each.
Maltese: Jiġu f'pakketti li juru l-ġranet tal-ġimgħa li fihom 112-il pillola: erba' folji trasparenti ta' 28 pillola kull wieħed.
English: Patients taking concomitant warfarin or phenprocoumon should be monitored regularly for changes in prothrombin time, INR or clinical bleeding episodes (see sections 4.5 and 4.8).
Maltese: Pazjenti li qed jieħdu warfarin jew phenprocoumon fl-istess waqt għandhom jiġu sorveljati regolarment għal tibdil fil-ħin prothrombin, INR jew episodji ta' fsada kliniċi (ara sezzjoni 4.5 u 4.8).
English: Skin and subcutaneous tissue disorders dry skin rash alopecia hand foot skin reaction** erythema pruritus keratoacanthoma/ squamous cell cancer of the skin dermatitis exfoliative acne skin desquamation hyperkeratosis eczema erythema multiforme radiation recall dermatitis StevensJohnson syndrome leucocytoclastic vasculitis toxic epidermal necrolysis*
Maltese: Disturbi filgilda u fittessuti ta' taħt il-gilda ġilda xotta raxx alopeċja reazzjoni tal ġilda tal-id u s-sieq** eritema ħakk keratoakantoma/ kanċer taċ-ċelluli skwamużi talġilda dermatite li titqaxxar akne tqaxxir tal-ġilda iperkeratożi ekżema eritema multiform dermatite radiation recall sindrome
English: There are no clinically relevant differences in pharmacokinetics between Caucasian and Asian subjects.
Maltese: Ma hemm l-ebda differenzi klinikament rilevanti fil-farmakokinetika bejn individwi Kawkasi u Asjatiċi.
English: Haemorrhage in DTC
Maltese: Emorraġija f'DTC
English: Management of dermatological toxicities may include topical therapies for symptomatic relief, temporary treatment interruption and/or dose modification of sorafenib, or in severe or persistent cases, permanent discontinuation of sorafenib (see section 4.8).
Maltese: L-immaniġġjar ta' tossiċitajiet dermatoloġiċi jista' jinkludi terapiji topikali għas-serħan tas-sintomi, waqfien temporanju tal-kura u/jew modifikazzjoni tad-doża ta' sorafenib, jew f'każijiet severi jew persistenti, twaqqif permanenti ta' sorafenib (ara sezzjoni 4.8).
English: In study 5 (see section 5.1), 37% of subjects had dose interruption and 35% had dose reduction already in cycle 1 of sorafenib treatment.
Maltese: Fi studju 5 (ara sezzjoni 5.1), 37% talindividwi diġà kellhom interruzzjoni tad-doża u 35% diġà kellhom tnaqqis fid-doża f'ċiklu 1 ta' kura b'sorafenib.
English: Sorafenib conjugates may be cleaved in the gastrointestinal tract by bacterial glucuronidase activity, allowing reabsorption of unconjugated active substance.
Maltese: Konjugati ta' Sorafenib jistgħu jinqasmu fl-apparat gastrointestinali permezz ta' l-attività ta' glucuronidase tal-batterja, u dan jippermetti assorbiment mill-ġdid tas-sustanza attiva mhux konjugata.
English: These data suggest that sorafenib at the recommended dose of 400 mg twice daily may not be an in vivo inhibitor of CYP2B6 or CYP2C8.
Maltese: Din id-data tissuġġerixxi li sorafenib fid-doża rrakkomandata ta' 400 mg darbtejn kuljum jista' ma jkunx inibitur in vivo ta' CYP2B6 jew CYP2C8.
English: Study 1 (study 11213) was a Phase III, multi-centre, randomised, double blind, placebo-controlled study in 903 patients.
Maltese: III, f'iktar minn sit wieħed, randomised, double blind u kkontrollat bil-plaċebo f'903 pazjent.
English: hypertension flushing hypertensive crisis*
Maltese: ipertensjoni fwawar kriżi ipertensiva*
English: Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.4).
Maltese: Kawtela hija rrakkomandata meta sorafenib jingħata flimkien ma' docetaxel (ara sezzjoni 4.4).
English: CTCAE Grade 3 or 4 laboratory abnormalities occurring in ≥ 5 % of sorafenib treated patients included lymphopenia and neutropenia.
Maltese: Anomaliji tal-laboratorju ta' CTCAE ta' Grad 3 jew 4 seħhew f'≥ 5 % tal-pazjenti kkurati b'sorafenib inkluż limfopenja u newtropenja.
English: There were no reports of hypokalaemia CTCAE grade 4.
Maltese: Ma kien hemm l-ebda rapporti ta' ipokalimja ta' CTCAE grad 4.
English: The European Medicines Agency has waived the obligation to submit the results of studies, in all subsets of the paediatric population, in kidney and renal pelvis carcinoma (excluding nephroblastoma, nephroblastomatosis, clear cell sarcoma, mesoblastic nephroma, renal medullary carcinoma and rhabdoid tumour of the kidney) and liver and intrahepatic bile duct carcinoma (excluding hepatoblastoma) and differentiated thyroid carcinoma (see section 4.2 for information on paediatric use).
Maltese: L-Aġenzija Ewropea għall-Mediċini irrinunzjat għall-obbligu li jiġu ppreżentati r-riżultati tal-istudji f'kull sett tal-popolazzjoni pedjatrika, f'karċinoma tal-kliewi u tal-pelvi tal-kliewi (minbarra nefroblastoma, nefroblastomatożi, sarkoma taċ-ċellula ċara, nefroma meżoblastika, karċinoma talmedulla tal-kliewi u tumur rabdojd tal-kliewi) u karċinoma tal-fwied u tal-kanal intra-epatiku tal-bili (minbarra epatoblastoma) u karċinoma differenzjata tat-tirojde (ara sezzjoni 4.2 għal informazzjoni dwar l-użu pedjatriku).
English: The clinical safety and efficacy of sorafenib have been studied in patients with hepatocellular carcinoma (HCC), in patients with advanced renal cell carcinoma (RCC) and in patients with differentiated thyroid carcinoma (DTC).
Maltese: L-effikaċja u s-sigurtà klinika ta' sorafenib ġew studjati f'pazjenti b'karċinoma epatoċellulari (HCC), f'pazjenti b'karċinoma avvanzat taċ-ċellula renali (RCC) u f'pazjenti b'karċinoma differenzjata tattirojde (DTC).
English: Nervous system disorders peripheral sensory neuropathy dysgeusia reversible posterior leukoencephalopathy*
Maltese: Disturbi fis sistema nervuża newropatija sensittività periferali indeboliment fis sens tat-togħma lewkoenċelopa tija posterjuri riversibbli*
English: Bayer Austria Ges.
Maltese: Bayer Austria Ges.m.b.H.
English: Hypophosphataemia was a very common laboratory finding, observed in 45 % and 35 % of sorafenib treated patients compared to 12 % and 11 % of placebo patients in study 1 and study 3, respectively.
Maltese: Ipofosfatimja kienet sejba tal-laboratorju komuni ħafna, osservata f'45 % u f'35 % tal-pazjenti kkurati b'sorafenib meta mqabbla ma' 12 % u ma' 11 % tal-pazjenti bil-plaċebo fi studju 1 u studju 3
English: Female rats showed central necrosis of the corpora lutea and arrested follicular development in the ovaries.
Maltese: Firien nisa wrew nekrożi ċentrali talcorpora lutea u twaqqif fl-iżvilupp follikolari fl-ovarji.
English: Caution is recommended when sorafenib is co-administered with docetaxel (see section 4.5).
Maltese: Kawtela hija rakkomandata meta sorafenib jingħata flimkien ma' docetaxel (ara sezzjoni 4.5).
English: In a clinical pharmacology study, QT/QTc measurements were recorded in 31 patients at baseline (pre-treatment) and post-treatment.
Maltese: Fi studju farmakoloġiku kliniku, il-kejl ta' QT/QTc kien iddokumentat f'31 pazjent fil-linja bażi
English: Aneurysms and artery dissections
Maltese: anewriżmi u dissezzjonijiet tal-arterji
English: aneurysms and artery dissections
Maltese: Anewriżmi u dissezzjonijiet tal-arterji
English: Study 5 (study 14295) was a Phase III, international, multi-centre, randomised, double blind, placebocontrolled trial in 417 patients with locally advanced or metastatic DTC refractory to radioactive iodine.
Maltese: III, internazzjonali, multiċentrika, randomised, double blind, ikkontrollata bi plaċebo, li saret fuq 417-il pazjent b'DTC avanzata lokalment jew metastatika, refrattarja għal iodine radjuattiv.
English: In cases of severe or persistent hypertension, or hypertensive crisis despite institution of antihypertensive therapy, permanent discontinuation of sorafenib should be considered (see section 4.8).
Maltese: F'każ ta' ipertensjoni severa jew persistent, jew kriżi ipertensiva minkejja l-istituzzjoni ta' kura anti-ipertensiva, għandu jiġi kkunsidrat twaqqif permanenti ta' sorafenib (ara sezzjoni 4.8).
English: These data suggest that clinical pharmacokinetic interactions of sorafenib with CYP3A4 inhibitors are unlikely.
Maltese: Dan it-tagħrif jissuġġerixxi li nterazzjonijiet farmakokinetiċi kliniċi ta' sorafenib ma' inibituri ta' CYP3A4 mhumiex probabbli.
English: Study 3 (study 100554) was a Phase III, international, multi-centre, randomised, double blind, placebo-controlled study in 602 patients with hepatocellular carcinoma.
Maltese: III, internazzjonali, b'ħafna ċentri, randomised, double blind u kkontrollat bil-plaċebo f'602 pazjent b'karċinoma epatoċellulari.
English: TSH suppression in DTC
Maltese: Trażżin ta' TSH f'DTC
English: Nexavar may increase the effects and, in particular, the side effects of these medicines.
Maltese: Nexavar jista' jżid l-effetti, speċjalment l-effetti sekondarji ta' dawn il-mediċini.
English: Kaiser-Wilhelm-Allee 51368 Leverkusen Germany
Maltese: Detentur tal-Awtorizzazzjoni għat-Tqegħid fis-Suq Bayer AG 51368 Leverkusen
English: Pharmacotherapeutic group: Antineoplastic agents, protein kinase inhibitors, ATC code: L01XE05 Sorafenib is a multikinase inhibitor which has demonstrated both anti-proliferative and antiangiogenic properties in vitro and in vivo.
Maltese: Sorafenib huwa inibitur ta' multikinase li in vitro u in vivo wera kemm kwalitajiet anti-proliferattivi kif ukoll anti-anġjoġeniċi.
English: Each film-coated tablet contains 200 mg sorafenib (as tosylate).
Maltese: DIKJARAZZJONI TAS-SUSTANZA ATTIVA Kull pillola fiha 200 mg ta' sorafenib (bħala tosylate).
English: Hypertension
Maltese: ipersesittività
English: Nexavar 200 mg film-coated tablets are red and round with the Bayer cross on one side and “200” on the other side.
Maltese: Kif jidher Nexavar u l-kontenut tal-pakkett Pilloli miksija b'rita ta' Nexavar 200 mg huma ħomor u tondi, bis-salib ta' Bayer fuq naħa u “200” fuq in-naħa l-oħra.
English: No single cause of death dominated, but higher incidence of respiratory failure, hemorrhages and infectious adverse events were observed in patients treated with sorafenib as add-on to platinum-based chemotherapies.
Maltese: Ma ddominat l-ebda kawża waħdanija ta' mewt, iżda inċidenza ogħla ta' insuffiċjenza respiratorja, emorraġiji u avvenimenti avversi infettivi kienu osservati f'pazjenti kkurati b'sorafenib bħala kura addizzjonali ma' kimoterapiji bbażata fuq platinum.
English: An interim analysis (second interim analysis) for overall survival was conducted at 367 deaths in 903 patients.
Maltese: Analiżi fl-intervall (it-tieni analiżi fl-intervall) għas-sopravivenza totali kien kondott fuq 367 mewt f'903 pazjent.
English: CI)]
Maltese: (iperbilirubinimja)
English: Sorafenib was not genotoxic in the Ames test or in the in vivo mouse micronucleus assay.
Maltese: Sorafenib ma kienx ġenotossiku fit-test Ames jew fl-analiżi in vivo tal-mikronukleju tal-ġrieden.
English: In healthy volunteers treated with a 5-day regimen of neomycin the average exposure to sorafenib decreased by 54%.
Maltese: F'voluntiera b'saħħithom ikkurati b'kors ta' 5 ijiem ta' neomycin l-esponiment medju għal sorafenib naqas b'54%.
English: DTC refractory to RAI was defined as having a lesion without iodine uptake on a RAI scan, or receiving cumulative RAI ≥ 22.2 GBq, or experiencing a progression after a RAI treatment within 16 months of enrollment or after two RAI treatments within 16 months of each other.
Maltese: DTC refrattarja għal RAI ġiet definita bħala li individwu jkollu leżjoni mingħajr assorbiment ta' iodine fuq skan ta' RAI, jew li rċieva RAI kumulattiv ta' ≥22.2 GBq, jew li jkollu progressjoni wara kura b'RAI fi żmien 16-il xahar mir-reġistrazzjoni jew wara żewġ kuri b'RAI b'intervall ta' żmien ta' 16-il xahar bejniethom.