FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients with a baseline Child Pugh (CP) score of 6 (about 20% patients in the REFLECT study) had a higher incidence of decreased appetite, fatigue, proteinuria, hepatic encephalopathy and hepatic failure compared to patients with a baseline CP score of 5.
Maltese: Pazjenti b'punteġġ ta' Child Pugh (CP) tal-linja bażi ta' 6 (madwar 20% tal-pażjenti fl-istudju REFLECT) kellhom inċidenza ogħla ta' tnaqqis fl-aptit, għejna, proteinurija, enċefalopatija tal-fwied u insuffiċjenza tal-fwied meta mqabbel ma' pazjenti b'punteġġ CP tal-linja bażi ta' 5.
English: Proteinuria led to permanent treatment discontinuation in 0.6% of patients.
Maltese: Il-proteinurija wasslet għal twaqqif permanenti tal-kura f'0.6% tal-pazjenti.
English: Patients with ≥50% liver occupation, clear invasion into the bile duct or a main branch of the portal vein (Vp4) on imaging were also excluded.
Maltese: Pazjenti b'okkupazzjoni tal-fwied ta' ≥50%, invażjoni ċara fil-kanal tal-bili jew f'fergħa ewlenija talvina portali (Vp4) fuq l-immaġni, ġew esklużi wkoll.
English: • changes in blood test results for magnesium (low), cholesterol (high) and thyroid stimulating hormone (high)
Maltese: • tibdil fir-riżultati tat-testijiet tad-demm tal-magnesium fid-demm (baxx), kolesterol (għoli) u ormon li jistimula t-tirojde (għoli)
English: The clinical efficacy and safety of lenvatinib have been evaluated in an international, multicenter, open-label, randomised phase 3 study (REFLECT) in patients with unresectable hepatocellular carcinoma (HCC).
Maltese: L-effikaċja klinika u s-sigurtà ta' lenvatinib ġew evalwati fi studju internazzjonali, multiċentriku, open-label u li fih il-parteċipanti ntgħażlu b'mod każwali, ta' Fażi 3 (REFLECT) f'pazjenti b'karċinoma epatoċellolari (HCC) li ma jistax jitneħħa.
English: In the Phase 3 -REFLECT trial (see section 5.1), hypertension (including hypertension, increased blood pressure, increased diastolic blood pressure and orthostatic hypertension) was reported in 44.5% of lenvatinib-treated patients and Grade 3 hypertension occurred in 23.5%.
Maltese: Fil-prova ta' Fażi 3 - REFLECT (ara sezzjoni 5.1), pressjoni għolja (inkluż pressjoni għolja, żieda filpressjoni tad-demm, żieda fil-pressjoni diastolika tad-demm u pressjoni ortostatika għolja) kienet irrappurtata f'44.5% tal-pazjenti ttratti b'lenvatinib, u pressjoni għolja ta' Grad 3 seħħet fi 23.5%.
English: * Identified from post-marketing use of lenvatinib
Maltese: Naqqas id-doża u kompli lenvatinib
English: There was a higher incidence of decreased neutrophil count in patients with HCC (8.7% on lenvatinib than in other nonHCC tumour types (1.4%)), which was not associated with infection, sepsis or bacterial peritonitis.
Maltese: Kien hemm inċidenza akbar ta' tnaqqis fl-għadd ta' newtofili f'pazjenti b'HCC (8.7% fuq lenvatinib meta mqabbel ma' tipi oħra ta' tumur li mhux HCC (1.4%)), li ma kienx assoċjat ma' infezzjoni, sepsis jew peronite batterjali.
English: Further dose reductions should be considered on an individual patient basis as limited data are available for doses below 10 mg.
Maltese: Tnaqqis addizzjonali fid-doża għandu jiġi kkunsidrat fuq bażi ta' pazjent individwali għax id-dejta disponibbli għal dożi taħt 10 mg hi limitata.
English: In the lenvatinib arm, median OS was 19.5 months (95% CI: 15.7, 23.0) for subjects who received post-treatment anticancer therapy (43%) and 10.5 months (95% CI: 8.6, 12.2) for those who did not.
Maltese: Fil-fergħa ta' lenvatinib, l-OS medjan kien ta' 19.5 xhur (95% CI: 15.7, 23.0) għal individwi li rċevew terapija ta' kontra l-kanċer wara l-kura (43%) u ta' 10.
English: There was no statistically significant difference in overall survival between the treatment groups at the time of the primary efficacy analysis (HR=0.73; 95% CI: 0.50, 1.07, p=0.1032).
Maltese: Ma kien hemm l-ebda differenza statistikament sinifikanti fis-sopravivenza globali bejn il-gruppi tal-kura filħin tal-analiżi tal-effikaċja primarja (HR=0.73; 95% CI: 0.50, 1.07, p=0.1032). L-OS medjan ma ntlaħaqx la għall-grupp ta' lenvatinib u lanqas għall-grupp tal-plaċebo crossover.
English: The incidence of QT interval prolongation of greater than 500 ms was 2% in the lenvatinib-treated patients compared to no reports in the placebo group.
Maltese: Linċidenza tat-titwil fl-intervall tal-QT ta' aktar minn 500 ms kienet ta' 2% fil-pazjenti ttratti b'lenvatinib meta mqabbla ma' l-ebda rapporti fil-grupp tal-plaċebo.
English: The recommended daily dose of lenvatinib is 24 mg (two 10 mg capsules and one 4 mg capsule) once daily.
Maltese: Id-doża rakkomandata ta' kuljum ta' lenvatinib hija ta' 24 mg (żewġ kapsuli ta' 10 mg u kapsula waħda ta' 4 mg) darba kuljum.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), 5.0% of patients developed renal failure and 1.9% developed renal impairment (3.1% of patients had a Grade ≥ 3 event of renal failure or impairment).
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), 5.0% tal-pazjenti żviluppaw insuffiċjenza tal-kliewi u 1.9% żviluppaw indeboliment tal-kliewi (3.1% tal-pazjenti kellhom avveniment ta' Grad ≥ 3 ta' insuffiċjenza jew indeboliment tal-kliewi).
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules lenvatinib
Maltese: LENVIMA 4 mg kapsuli ibsin lenvatinib
English: The Rac in HCC subjects with mild and moderate liver impairment was similar to that reported for other solid tumours.
Maltese: L-RAC f'individwi b'HCC b'indeboliment tal-fwied ħafif u moderat kien simili għal dak irrappurtat għal tumuri solidi oħra.
English: Myocardial infarction includes myocardial infarction and acute myocardial infarction.
Maltese: Infart mijokardijaku jinkludi infart mijokardijaku u infart mijokardijaku akut.
English: Based on a population pharmacokinetic analysis of patients receiving up to 24 mg lenvatinib once daily, age, sex, weight, and race (Japanese vs. other, Caucasian vs. other) had no significant effects on clearance (see section 4.2).
Maltese: Ibbażat fuq analiżi farmakokinetika tal-popolazzjoni ta' pazjenti li kienu qed jirċievu sa 24 mg lenvatinib darba kuljum, l-età, is-sess tal-persuna, il-piż, u r-razza (Ġappuniżi vs. razza oħra, Kawkasi vs oħrajn), ma kellhom l-ebda effetti sinifikanti fuq it-tneħħija (ara sezzjoni 4.2).
English: Increased blood bilirubin j, ‡ Hypoalbuminaemiaj
Maltese: Żieda fil-bilirubina tad-demm j, ‡
English: Adverse reactions observed in clinical trials in DTC and HCC and reported from post-marketing use of lenvatinib are listed in Table 5.
Maltese: Reazzjonijiet avversi osservati fil-provi kliniċi għal DTC u HCC u rrappurtati mill-użu ta' wara ttqegħid fis-suq ta' lenvatinib huma elenkati f'Tabella 5.
English: Hepatotoxicity (see section 4.4)
Maltese: Ipokalċemija (ara sezzjoni 4.4
English: • loss of body fluids (dehydration)
Maltese: • telf ta' fluwidu mill-ġisem (deidratazzjoni)
English: One subject (0.2%) discontinued lenvatinib due to hypertension.
Maltese: Individwu wieħed (0.2%) waqqaf lenvatinib minħabba pressjoni għolja.
English: There were 17 (3.6%) deaths due to hepatotoxicity events in the lenvatinib arm and 4 (0.8%) deaths in the sorafenib arm. Hepatotoxicity adverse reactions led to dose interruptions and reductions in 12.2% and 7.4% of lenvatinib-treated patients respectively, and to permanent discontinuation in 5.5%.
Maltese: Reazzjonijiet avversi relatati mal-fwied wasslu għal interruzzjonijiet u tnaqqis fid-doża fi 12.2% u 7.4% tal-pazjenti ttratti b'lenvatinib rispettivament, u għal twaqqif permanenti f'5.5%.
English: HCC patients other than those with moderate and severe hepatic impairment or severe renal impairment should initiate treatment at the recommended starting dose of 8 mg (two 4 mg capsules) for body weight < 60 kg and 12 mg (three 4 mg capsules) for body weight ≥ 60 kg, following which the dose should be further adjusted on the basis of individual tolerability.
Maltese: Pazjenti b'HCC minbarra dawk b'indeboliment tal-fwied moderat u sever jew b'indeboliment talkliewi sever għandhom jibdew il-kura bid-doża tal-bidu rakkomandata ta' 8 mg (żewġ kapsuli ta' 4 mg) għal piż tal-ġisem ta' < 60 kg u ta' 12 mg (tliet kapsuli ta' 4 mg) għal piż tal-ġisem ta' ≥ 60 kg, u wara d-doża għandha tiġi aġġustata sussegwentement fuq il-bażi tat-tollerabbiltà individwali.
English: Accidental medication errors resulting in single doses of 40 to 48 mg have occurred in clinical trials.
Maltese: Żbalji aċċidentali talmedikazzjoni li rriżultaw f'dożi waħidhom ta' 40 sa 48 mg seħħew fil-provi kliniċi.
English: The most frequently reported adverse reactions (occurring in ≥30% of patients) are hypertension (44.0%), diarrhoea (38.1%), decreased appetite (34.9%), fatigue (30.6%), and decreased weight
Maltese: L-aktar reazzjonijiet avversi rrappurtati b'mod frekwenti (li seħħew fi ≥30% tal-pazjenti) huma lpressjoni għolja (44.0%), dijarea (38.1%), tnaqqis fl-aptit (34.9%), għeja (30.
English: Patients with baseline hypertension had a higher incidence of Grade 3 or 4 hypertension, proteinuria, diarrhoea, and dehydration, and experienced more serious cases of dehydration, hypotension, pulmonary embolism, malignant pleural effusion, atrial fibrillation, and GI symptoms (abdominal pain, diarrhoea, vomiting).
Maltese: Pazjenti bi pressjoni għolja fil-linja bażi kellhom inċidenza ogħla ta' pressjoni għolja, proteinurija, dijarea, u deidratazzjoni, u kellhom każijiet aktar serji ta' deidratazzjoni, pressjoni baxxa, emboliżmu pulmonari, effużjoni plewlari malinna, fibrillazzjoni atrijali, u sintomi GI (uġigħ addominali, dijarea, rimettar) ta' Grad 3 jew 4.
English: Number of capsules
Maltese: Doża ta' kuljum Numru ta' kapsuli
English: These findings indicate that lenvatinib has a teratogenic potential, likely related to the pharmacologic activity of lenvatinib as an antiangiogenic agent.
Maltese: Dawn ir-riżultati jindikaw li lenvatinib għandu potenzjal teratoġeniku, li x'aktarx hu relatat malattività farmakoloġika ta' lenvatinib bħala aġent antianġjoġeniku.
English: In human liver cytosol, lenvatinib did not inhibit aldehyde oxidase activity.
Maltese: F'cytosol tal-fwied uman, lenvatinib ma inibixxix l-attività ta' oxidase aldeide.
English: The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively.
Maltese: Il-maġġoranza tal-każijiet irkupraw jew fiequ wara l-interruzzjoni jew it-tnaqqis tad-doża, li seħħew fi 13.0% u 13.4% talpazjenti, rispettivament.
English: • feeling dizzy
Maltese: • puplesija żgħira
English: Data from a human mass balance/excretion study indicate lenvatinib is extensively metabolised in humans.
Maltese: Dejta minn studju dwar il-bilanċ tal-massa fil-bniedem u l-eliminazzjoni tindika li lenvatinib jiġi metabolizzat b'mod estensiv fil-bniedem.
English: Hepatotoxicity events and haemorrhage events also occurred at a higher incidence in CP score 6 patients compared to CP score 5 patients.
Maltese: Avvenimenti epatotossiċi u ta' emorraġija seħħew ukoll b'inċidenza ogħla f'pazjenti b'punteġġ CP ta' 6 meta mqabbel ma' pazjenti b'punteġġ CP ta' 5.
English: Lenvatinib is mainly eliminated via the liver and exposure might be increased in these patient populations.
Maltese: Lenvatinib u l-metaboliti tiegħu jiġu eliminati fil-ħalib tal-firien.
English: Consider resuming at reduced dose if resolves to Grade 0-1.
Maltese: Ikkunsidra li terġa' tibda b'doża mnaqqsa jekk jitjieb għal Grad 0-1.
English: LENVIMA blocks the action of proteins called receptor tyrosine kinases (RTKs), which are involved in the development of new blood vessels that supply oxygen and nutrients to cells and help them to grow.
Maltese: LENVIMA jimblokka l-azzjoni ta' grupp ta' proteini li jissejħu receptor tyrosine kinases (RTKs), li huma involuti fl-iżvilupp ta' vini ġodda li jissupplixxu ossiġnu u nutrijenti liċ-ċelluli u jgħinuhom jikbru.
English: Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Maltese: Uġigħ fid-dahar Artralġja Mijalġja Uġigħ flestremitajiet Uġigħ muskoloskeletriku
English: A statistically significant prolongation in PFS was demonstrated in lenvatinib-treated patients compared with those receiving placebo (p<0.0001) (see figure 1).
Maltese: Intwera titwil statistikament sinifikanti fil-PFS f'pazjenti ttratti b'lenvatinib meta mqabbla ma' dawk li kienu qed jirċievu plaċebo (p<0.
English: Patients should be monitored for clinical symptoms or signs of cardiac decompensation, as dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Maltese: Il-pazjenti għandhom jiġu mmonitorjati għal sintomi jew sinjali kliniċi ta' dikumpensazzjoni kardijaka, għax interruzzjonijiet, aġġustamenti, jew it-twaqqif tad-doża jistgħu jkunu meħtieġa (ara sezzjoni 4.2).
English: Constipation Dyspepsia Dry mouth
Maltese: Sess tal-persuna
English: Renal impairment and renal failure have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Maltese: Avvenimenti ta' indeboliment tal-kliewi u insuffiċjenza tal-kliewi ġew irrappurtati f'pazjenti ttratti b'lenvatinib (ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Baseline hypertension
Maltese: GĦAMLA KWALITATTIVA
English: Lenvatinib and its metabolites are excreted in rat milk.
Maltese: u Pgp) ma nbidlux meta ntuża lenvatinib.
English: The SELECT study was a multicentre, randomised, double-blind, placebo-controlled trial that was conducted in 392 patients with radioiodine-refractory differentiated thyroid cancer with independent, centrally reviewed, radiographic evidence of disease progression within 12 months (+1 month window) prior to enrolment.
Maltese: L-istudju SELECT kienet prova multiċentrika, li fiha l-parteċipanti ntgħażlu b'mod każwali, doubleblind, ikkontrollata bi plaċebo, li twettqet fuq 392 pazjent b'kanċer tat-tirojde differenzjat u refrattorju għal radioiodine, b'evidenza indipendenti, evalwata ċentralment, radjografika tal-progressjoni talmarda, fi żmien 12-il xahar (perjodu ta' +1 xahar) qabel ir-reġistrazzjoni.
English: Haemorrhage terms that occurred in 5 or more subjects with HCC were: epistaxis, haematuria, gingival bleeding, haemoptysis, oesophageal varices haemorrhage, haemorrhoidal haemorrhage, mouth haemorrhage, rectal haemorrhage and upper gastrointestinal haemorrhage.
Maltese: It-termini tal-emorraġija li seħħew f'5 individwi jew aktar b'HCC kienu: epistassi, ematurija, ħruġ ta' demm mill-ħanek, emorraġija mill-variċi tal-esofagu, emorraġija tal-murliti, emorraġija tal-ħalq, emorraġija mir-rektum u emorraġija ġastrointestinali tan-naħa ta' fuq.
English: Number of objective responders (%) (95% CI)
Maltese: Numru ta' dawk li rrispondew b'mod oġġettiv (%) (95% CI)
English: • liver failure
Maltese: • infjammazzjoni fil-marrara
English: Haemorrhaged, †,‡ Hypertensione,‡ Hypotension
Maltese: Kif għandek tieħu LENVIMA Effetti sekondarji possibbli
English: Malaise
Maltese: Azzjoni
English: Hypertension (see section 4.4)
Maltese: Dijarea (ara sezzjoni 4.4)
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 10 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg lenvatinib (as mesilate).
Maltese: LENVIMA 10 mg kapsuli ibsin lenvatinib DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: LENVIMA is indicated as monotherapy for the treatment of adult patients with advanced or unresectable hepatocellular carcinoma (HCC) who have received no prior systemic therapy (see section 5.1).
Maltese: LENVIMA hu indikat bħala monoterapija għall-kura ta' pazjenti adulti b'karċinoma epatoċellulari avvanzata jew li ma tistax titneħħa (hepatocellular carcinoma, HCC) li ma rċevew l-ebda terapija sistemika qabel (ara sezzjoni 5.1).
English: P-value is for the superiority test of lenvatinib versus sorafenib.
Maltese: d Il-valur-p huwa għat-test ta' superjorità ta' lenvatinib kontra sorafenib.
English: Table 1 Dose modifications from recommended lenvatinib daily dose in DTC patientsa
Maltese: Tabella 1 Modifikazzjonijiet tad-doża mid-doża rakkomandata ta' lenvatinib ta' kuljum f'pazjenti b'DTCa
English: • The 4 mg capsule is a yellowish red body and yellowish red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Maltese: • Il-kapsula ta' 4 mg hi korp safrani-aħmar u għatu safrani-aħmar, b'tul ta' madwar 14.3 mm, immarkat b'linka sewda b'“Є” fuq l-għatu, u “LENV 4 mg” fuq il-korp.
English: Most reactions resolved following supportive treatment, without dose interruption or reduction, which occurred in 1.5% and 1.1% of patients, respectively; 1 patient with Grade 4 hypocalcaemia discontinued treatment permanently.
Maltese: Il-biċċa l-kbira tar-reazzjonijiet fiequ wara kura ta' appoġġ, mingħajr interruzzjoni jew tnaqqis tad-doża, li seħħew f'1.5% u 1.1% tal-pazjenti, rispettivament; pazjent b'ipokalċemija ta' Grad 4 waqqaf il-kura b'mod permanenti.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), diarrhoea was reported in 67.4% of patients in the lenvatinib-treated group (9.2% were Grade ≥ 3) and in 16.8% of patients in the placebo group (none were Grade ≥ 3).
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), id-dijarea ġiet irrappurtata f'67.4% tal-pazjenti fil-grupp li kien ttratt b'lenvatinib (9.2% kienu ta' Grad ≥ 3) u f'16.
English: Increased blood thyroid stimulating hormone (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction)
Maltese: Indeboliment ta' soppressjoni talormon li jistimula t-tirojde/Disfunzjoni tat-tirojde)
English: Excluding laboratory abnormalities judged to be nonlife-threatening, which should be managed as Grade 3.
Maltese: Bl-esklużjoni tal-anormalitajiet tal-laboratorju meqjusa li mhumiex ta' periklu għall-ħajja, li għandhom jiġu immaniġġjati bħala Grad 3.
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 10 mg hard capsules lenvatinib
Maltese: LENVIMA 10 mg kapsuli ibsin lenvatinib
English: In HCC patients treated with lenvatinib in the REFLECT trial, liver-related adverse reactions including hepatic encephalopathy and hepatic failure (including fatal reactions) were reported at a higher frequency (see Section 4.8) compared to patients treated with sorafenib .
Maltese: F'pazjenti b'HCC ittratti b'lenvatinib fil-prova REFLECT, ir-reazzjonijiet avversi relatati mal-fwied inkluż enċefalopatija tal-fwied u insuffiċjenza tal-fwied (inkluż reazzjonijiet fatali) kienu rrappurtati bi frekwenza akbar (ara Sezzjoni 4.8) meta mqabbla ma' pazjenti ttratti b'sorafenib.
English: A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
Maltese: Korp isfar u għatu safrani-aħmar, b'tul ta' madwar 14.3 mm, immarkat b'linka sewda b'“Є” fuq lgħatu, u “LENV 10 mg” fuq il-korp.
English: Haemorrhage (see section 4.4)
Maltese: Epatotossiċità (ara sezzjoni 4.4)
English: • The recommended dose of LENVIMA is usually 24 mg once a day
Maltese: • Id-doża rakkomandata ta' LENVIMA normalment hi ta' 24 mg darba kuljum (2 kapsuli ta'
English: In post-marketing surveillance, serious and fatal carotid artery haemorrhages were seen more frequently in patients with anaplastic thyroid carcinoma (ATC) than in DTC or other tumour types.
Maltese: Fis-sorveljanza ta' wara t-tqegħid fis-suq, emorraġiji serji u fatali tal-arterja karotide ġew osservati b'mod aktar frekwenti f'pazjenti b'karċinoma anaplastika tat-tirojde (ATC, anaplastic thyroid carcinoma) milli f'DTC jew tipi oħrajn ta' tumuri.
English: In addition, lenvatinib had selective, direct antiproliferative activity in hepatocellular cell lines dependent on activated FGFR signalling, which is attributed to the inhibition of FGFR signalling by lenvatinib.
Maltese: Flimkien ma' dan, lenvatinib kellu attività ta' kontra l-proliferazzjoni selettiva u diretta f'razez ta' ċelluli epatoċellulari dipendenti fuq is-senjalizzazzjoni FGFR, li hija attribwita għall-inibizzjoni tassenjalizzazzjoni FGFR minn lenvatinib.
English: The adverse reaction frequency category represents the most conservative estimate of frequency from the two individual populations.
Maltese: Il-kategorija tal-frekwenza tar-reazzjonijiet avversi tirrappreżenta l-aktar stima konservattiva ta' frekwenza miż-żewġ popolazzjonijiet individwali.
English: 8 mg (two 4 mg capsules) orally once daily
Maltese: 8 mg (żewġ kapsuli ta' 4 mg) mill-ħalq darba kuljum
English: The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhoea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE.
Maltese: L-aktar reazzjonijiet avversi tal-mediċina osservati b'mod frekwenti f'dawn id-dożi kienu pressjoni għolja, dardir, dijarea, għeja, stomatite, proteinurija, uġigħ ta' ras, u aggravament ta' PPE.
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules
Maltese: LENVIMA 4 mg kapsuli ibsin LENVIMA 10 mg kapsuli ibsin
English: Hypertension and proteinuria tend to occur early during lenvatinib treatment (see sections 4.4 and 4.8, Description of selected adverse reactions).
Maltese: Il-pressjoni għolja u lproteinurija għandhom tendenza li jseħħu kmieni matul il-kura b'lenvatinib (ara sezzjonijiet 4.4 u 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: • chest pain or pressure, pain in your arms, back, neck or jaw, being short of breath, rapid or irregular heart rate, coughing, bluish colour to lips or fingers, feeling very tired - these may be signs of a heart problem, a blood clot in your lung or a leak of air from your lung into your chest so your lung cannot inflate.
Maltese: • uġigħ jew pressjoni fis-sider, uġigħ f'dirgħajk, fid-dahar, fl-għonq jew fix-xedaq, qtugħ ta' nifs, rata mgħaġġla jew irregolari ta' taħbit tal-qalb, sogħla, kulur kaħlani fix-xufftejn jew fis-swaba', tħossok għajjien ħafna - dawn jistgħu jkunu sinjali ta' problema tal-qalb, embolu tad-demm filpulmun tiegħek jew tnixxija ta' arja mill-pulmun tiegħek għal ġo sidrek li twaqqaf il-pulmun tiegħek milli jintefaħ.
English: Since lenvatinib is mainly eliminated by hepatic metabolism, an increase in exposure in patients with moderate to severe hepatic impairment is expected.
Maltese: Peress li lenvatinib jiġi eliminat permezz tal-metaboliżmu tal-fwied, żieda fl-esponiment filpazjenti b'indeboliment tal-fwied moderat sa sever hija mistennija.
English: Dizziness Headache Dysgeusia
Maltese: Sturdament Uġigħ ta' ras Indeboliment fissens tat-togħma
English: • need to have a surgical procedure.
Maltese: • għandek bżonn proċedura kirurġika.
English: • have a history of abnormal connections (known as a fistula) between different organs in the body or from an organ to the skin
Maltese: • ikollhom storja medika ta' konnessjonijiet mhux normali (magħrufa bħala fistula) bejn organi differenti fil-ġisem jew minn organu lejn il-ġilda
English: Data in HCC patients with moderate hepatic impairment (Child-Pugh B) are very limited and there are currently no data available in HCC patients with severe hepatic impairment (Child-Pugh C).
Maltese: Dejta f'pazjenti b'HCC b'indeboliment tal-fwied moderat (Child-Pugh B) hija limitata ħafna u attwalment m'hemmx dejta disponibbli għal pazjenti b'HCC b'indeboliment tal-fwied sever (ChildPugh C).
English: Proteinuria has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Maltese: Proteinurija ġiet irrappurtata f'pazjenti ttratti b'lenvatinib; normalment din isseħħ kmieni fil-kors talkura (ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheo-oesophageal fistulae.
Maltese: Dejta limitata hi disponibbli dwar l-użu f'pazjenti li jkollhom ≥75 sena (ara wkoll sezzjoni 4.8, Popolazzjonijiet speċjali oħra).
English: • you are allergic to lenvatinib or any of the other ingredients of this medicine (listed in section 6).
Maltese: • inti allerġiku għal lenvatinib jew għal xi sustanza oħra ta' din il-mediċina (elenkati fis sezzjoni 6).
English: Biotransformation
Maltese: Modifikazzjoni
English: The effects of LENVIMA in people younger than 18 years old are not known.
Maltese: L-effetti ta' LENVIMA f'persuni li jkollhom inqas minn 18-il sena mhumiex magħrufa.