FrancophonIA/ELRC3.0 huggingface dataset:
English: Patients of age ≥75 years, of Asian race, with comorbidities (such as hypertension, and hepatic or renal impairment), or body weight below 60 kg appear to have reduced tolerability to lenvatinib (see section 4.8, Other special populations).
Maltese: Pazjenti li jkollhom ≥75 sena, ta' razza Asjatika, b'komorbiditajiet (bħal pressjoni għolja, u indeboliment tal-fwied jew tal-kliewi), jew b'piż tal-ġisem ta' inqas minn 60 kg, jidhru li għandhom tollerabilità mnaqqsa għal lenvatinib (ara sezzjoni 4.8, Popolazzjonijiet speċjali oħra).
English: In patients with solid tumours administered single and multiple doses of lenvatinib once daily, exposure to lenvatinib (Cmax and AUC) increased in direct proportion to the administered dose over the range of 3.2 to 32 mg once-daily.
Maltese: F'pazjenti b'tumuri solidi li ngħataw dożi waħidhom u multipli ta' lenvatinib darba kuljum, lesponiment għal lenvatinib (Cmax u AUC) żdied fi proporzjon dirett għad-doża mogħtija fuq il-medda ta' 3.2 sa 32 mg darba kuljum.
English: If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Maltese: Jekk id-dipstick ta' proteinurija fl-awrina jindika livell ta' ≥2+, interruzzjonijiet, aġġustamenti, jew it-twaqqif tad-doża jistgħu jkunu meħtieġa (ara sezzjoni 4.2).
English: Radioiodine-refractory was defined as one or more measurable lesions either with a lack of iodine uptake or with progression in spite of radioactive-iodine (RAI) therapy, or having a cumulative activity of RAI of >600 mCi or 22 GBq with the last dose at least 6 months prior to study entry.
Maltese: Refrattorju għal radioiodine ġie definit bħala leżjoni waħda jew aktar li jistgħu jitkejlu, jew b'nuqqas ta' iodine jew bi progressjoni minkejja terapija b'iodine radjuattiv (RAI), jew li jkun hemm attività kumulattiva ta' RAI ta' >600 mCi jew 22 GBq bl-aħħar doża li tkun ingħatat mill-inqas 6 xhur qabel ma l-pazjent ikun daħal flistudju.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients and 0.8% of patients in the placebo group.
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), ġew irrappurtati avvenimenti ta' perforazzjoni gastrointestinali jew fistula f'1.9% tal-pazjenti ttratti b'lenvatinib u f'0.8% tal-pazjenti fil-grupp tal-plaċebo.
English: QT interval prolongation (see section 4.4)
Maltese: Titwil tal-intervall tal-QT (ara sezzjoni 4.4)
English: Pneumothorax
Maltese: Pnewmotoraċi
English: Data cut-off date: 13 Nov 2016. a.
Maltese: DATA TA' REVIŻJONI TAT-TEST 18 ta' Settembru 2019
English: Serious complications of poorly controlled hypertension, including aortic dissection, have been reported.
Maltese: Ġew irrappurtati kumplikazzjonijiet serji ta' pressjoni għolja mhux ikkontrollata tajjeb, inkluż id-dissezzjoni tal-aorta.
English: Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, abdominal pain lower, abdominal pain upper, abdominal tenderness, epigastric discomfort, and gastrointestinal pain.
Maltese: Uġigħ gastrointestinali u addominali jinkludi: skumdità addominali, uġigħ addominali, uġigħ fil-parti addominali t'isfel, uġigħ fil-parti addominali ta' fuq, sensittività addominali, skonfort epigastriku, u wġigħ gastrointestinali.
English: Adverse reactions that most commonly led to discontinuation of lenvatinib were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea, and pulmonary embolism.
Maltese: Reazzjonijiet avversi li bl-aktar mod komuni wasslu għat-twaqqif ta' lenvatinib kienu proteinurija, astenija, pressjoni għolja, inċident ċerebrovaskulari, dijarea, u emboliżmu pulmonari.
English: In plasma samples collected up to 24 hours after administration, lenvatinib constituted 97% of the radioactivity in plasma radiochromatograms while the M2 metabolite accounted for an additional 2.5%.
Maltese: F'kampjuni tal-plażma miġbura sa 24 siegħa wara l-għoti, lenvatinib ammonta għal 97% tarradjuattività f'radjukromatogrammi tal-plażma, filwaqt li l-metabolit M2 ammonta għal 2.5% addizzjonali.
English: The median duration of objective response was 7.3 (95% CI 5.6, 7.4) months in the lenvatinib arm and 6.2 (95% CI 3.7, 11.2) months in the sorafenib arm.
Maltese: It-tul medjan tar-rispons oġġettiv kien ta' 7.3 (95%CI 5.6, 7.4) xhur fil-fergħa tal-istudju dwar lenvatinib, u 6.2 (95%CI 3.7, 11.2) xhur fil-fergħa tal-istudju dwar sorafenib.
English: The objective response rate (complete response [CR] plus partial response [PR]) per independent radiological review was significantly (p<0.0001) higher in the lenvatinib-treated group (64.8%) than in the placebo-treated group (1.5%).
Maltese: 0001) fil-grupp ttratt b'lenvatinib (64.8%) milli fil-grupp ttratt bil-plaċebo (1.5%).
English: Across clinical studies in which 1327 patients received lenvatinib monotherapy in indications other than HCC, hepatic failure (including fatal events) was reported in 4 patients (0.3%), liver injury in 2 patients (0.2%), acute hepatitis in 2 patients (0.2%), and hepatocellular injury in 1 patient (0.1%).
Maltese: Fl-istudji kliniċi li fihom 1327 pazjent irċevew monoterapija b'lenvatinib għal indikazzjonijiet li ma kinux HCC, insuffiċjenza tal-fwied (inkluż avvenimenti fatali) kienet irrappurtata f'4 pazjenti (0.3%), ħsara tal-fwied f'2 pazjenti (0.2%), u epatite akuta f'2 pazjenti (0.2%), u ħsara epatoċellulari f'pazjent 1 (0.1.%).
English: Hepatocellular Carcinoma
Maltese: Il-kontenut tal-kapsula Calcium carbonate
English: Table 2 Dose modifications from recommended lenvatinib daily dose in HCC patients Starting Dose
Maltese: Tabella 2 Modifikazzjonijiet tad-doża mid-doża rakkomandata ta' kuljum ta' lenvatinib f'pazjenti b'HCC
English: Lenvatinib showed minimal or no inhibitory activities toward P-gp-mediated and breast cancer resistance protein (BCRP)-mediated transport activities.
Maltese: Lenvatinib wera attivitajiet inibitorji minimi jew l-ebda attivitajiet inibitorji lejn attivitajiet tat-trasport medjati minn P-gp u medjati minn proteina ta' reżistenza għall-kanċer tas-sider (breast cancer resistance protein, BCRP).
English: Pharmacotherapeutic group: antineoplastic agents, protein kinase inhibitors, ATC code: L01XE29
Maltese: Kategorija farmakoterapewtika: aġenti antineoplastiċi, inibituri ta' proteina kinase;
English: Perineal abscess
Maltese: Axxess perineali
English: LENVIMA 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Maltese: LENVIMA 4 mg kapsuli ibsin: - Kull kapsula iebsa fiha 4 mg ta' lenvatinib (bħala mesilate).
English: Class (MedDRA terminology*)
Maltese: Organi (Terminoloġija
English: Histologically, 66.1% had a confirmed diagnosis of papillary thyroid cancer and 33.9% had follicular thyroid cancer which included Hürthle cell 14.8% and clear cell 3.8%.
Maltese: Istoloġikament, 66.1% kellhom dijanjosi kkonfermata ta' kanċer tat-tirojde papillari, u 33.9% kellhom kanċer tat-tirojde follikulari li kien jinkludi ċelluli Hürthle 14.8% u ċelluli ċari 3.8%.
English: The recommended daily dose of lenvatinib is 8 mg (two 4 mg capsules) once daily for patients with a body weight of < 60 kg and 12 mg (three 4 mg capsules) once daily for patients with a body weight of ≥ 60 kg.
Maltese: Id-doża rakkomandata ta' kuljum ta' lenvatinib hija ta' 8 mg (żewġ kapsuli ta' 4 mg) darba kuljum għall-pazjenti b'piż tal-ġisem ta' < 60 kg u 12 mg (tliet kapsuli ta' 4 mg) darba kuljum għall-pazjenti b'piż tal-ġisem ta' ≥ 60 kg.
English: LENVIMA 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Maltese: LENVIMA 10 mg kapsuli ibsin: - Kull kapsula iebsa fiha 10 mg ta' lenvatinib (bħala mesilate).
English: Of the 392 patients randomised, 76.3% were naïve to prior VEGF/VEGFR-targeted therapies, 49.0% were female, 49.7% were European, and the median age was 63 years.
Maltese: Mit-392 pazjent li ntgħażlu b'mod każwali, 76.3% qatt ma kienu rċivew kura permezz ta' terapiji mmirati VEGF/VEGFR fil-passat, 49.0% kienu nisa, 49.7% kienu Ewropej, u l-età medjana kienet ta' 63 sena.
English: Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggest that it is in the order of 85%.
Maltese: Il-bijodisponibilità assoluta ma ġietx stabbilita fil-bnedmin; madankollu, dejta minn studju dwar il-massa-bilanċ tissuġġerixxi li hi ta' madwar 85%.
English: Lenvatinib should not be started in patients with fistula to avoid worsening and lenvatinib should be permanently discontinued in patients with oesophageal or tracheobronchial tract involvement and any Grade 4 fistula (see section 4.2); limited information is available on the use of dose interruption or reduction in management of other events, but worsening was observed in some cases and caution should be taken.
Maltese: Lenvatinib m'għandux jinbeda f'pazjenti b'fistula, biex jiġi evitat id-deterjorament, u lenvatinib għandu jitwaqqaf b'mod permanenti f'pazjenti b'involviment esofagali jew tal-passaġġ trakeobronkjali u kwalunkwe fistula ta' Grad 4 (ara sezzjoni 4.2); informazzjoni limitata hi disponibbli dwar l-użu ta' interruzzjoni tad-doża jew it-tnaqqis flimmaniġġjar ta' avvenimenti oħrajn, iżda aggravament ġie osservat f'xi każijiet, u għandu jkun hemm kawtela.
English: Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and increased blood thyroid stimulating hormone.
Maltese: Pazjenti Asjatiċi kellhom inċidenza ogħla minn pazjenti Kawkasi ta' edema periferali, pressjoni għolja, għeja, PPE, proteinurija, tromboċitopenija, u żieda fl-ormon li jistimula t-tirojde tad-demm.
English: Withhold lenvatinib
Maltese: 4.1 Indikazzjonijiet terapewtiċi
English: Lenvatinib showed minimal or no inhibitory effect on OATP1B3 and MATE2-K. Lenvatinib weakly inhibits MATE1.
Maltese: Lenvatinib wera effett minimu jew l-ebda effett inibitorju fuq OATP1B3 u MATE2-K.
English: In the Phase 3 REFLECT trial (see section 5.1), proteinuria was reported in 26.3% of lenvatinibtreated patients and Grade 3 reactions occurred in 5.9%.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), proteinurija ġiet irrappurtata f'26.3% tal-pazjenti ttratti b'lenvatinib, u reazzjonijiet ta' Grad 3 seħħew f'5.9%.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), QT/QTc interval prolongation was reported in 8.8% of lenvatinib-treated patients and 1.5% of patients in the placebo group.
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), titwil tal-intervall tal-QT ġie rrappurtat fi 8.8% tal-pazjenti ttratti b'lenvatinib, u f'1.5% tal-pazjenti fil-grupp tal-plaċebo.
English: Impaired healing*
Maltese: Fejqan indebolit*
English: Gastrointestinal perforation and fistula formation
Maltese: Perforazzjoni gastrointestinali u l-formazzjoni ta' fistula
English: In this trial, there was 1 case of fatal intracranial haemorrhage among 16 patients who received lenvatinib and had CNS metastases at baseline.
Maltese: F'din il-prova, kien hemm każ wieħed ta' emorraġija intrakranjali fatali fost 16-il pazjent li rċivew lenvatinib u li kellhom metastasi tas-CNS fil-linja bażi.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), hypocalcaemia was reported in 12.6% of lenvatinib-treated patients vs. no cases in the placebo arm.
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), ipokalċemija ġiet irrappurtata fi 12.6% tal-pazjenti ttratti b'lenvatinib vs. l-ebda każijiet fil-parti tal-istudju dwar il-plaċebo.
English: In the Phase 3 REFLECT trial (see section 5.1), 89.6% of patients had a baseline TSH level of less than the upper limit of normal.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), 89.6% tal-pazjenti kellhom livell ta' TSH fil-linja bażi li kien inqas mil-limitu ta' fuq tan-normal.
English: Not applicable.
Maltese: Ipokalċemija‡
English: A single 32-mg dose of lenvatinib did not prolong the QT/QTc interval based on results from a thorough QT study in healthy volunteers; however, QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see sections 4.4 and 4.8).
Maltese: Doża waħda ta' 32 mg ta' lenvatinib ma tawlitx l-intervall tal-QT/QTc ibbażat fuq riżultati minn studju bir-reqqa dwar il-QT li sar fuq voluntiera f'saħħithom; madankollu, titwil tal-intervall talQT/QTc ġie rrappurtat f'inċidenza ogħla f'pazjenti ttratti b'lenvatinib milli f'pazjenti ttratti bi plaċebo (ara sezzjonijiet 4.4 u sezzjoni 4.8).
English: Metastases were present in 99% of the patients: lungs in 89.3%, lymph nodes in 51.5%, bone in 38.8%, liver in 18.1%, pleura in 16.3%, and brain in 4.1%.
Maltese: Metastasi kienu preżenti f'99% tal-pazjenti: fil-pulmun f'89.3%, fl-għoqod tal-limfa f'51.5%, fl-għadam 38.8%, fil fwied fi 18.1%, fil-plewra f'16.3%, u fil-moħħ f'4.1%.
English: Lenvatinib was non-inferior for OS to sorafenib with HR = 0.92 [95% CI of (0.79, 1.06)] and a median OS of 13.6 months vs 12.3 months (see Table 7 and Figure 2).
Maltese: Medjan (xhur) (95% CI) Lenvatinib 18.3 (15.1, NE) Plaċebo 3.6 (2.2, 3.7) HR (99% CI): 0.21 (0.14, 0.31) Long-rank Test P<0.0001
English: In the pivotal Phase 3 SELECT trial (see section 5.1), decreased ejection fraction/cardiac failure was reported in 6.5% of patients (1.5% were Grade ≥ 3) in the lenvatinib treated group, and 2.3% in the placebo group (none were Grade ≥ 3).
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), porzjon ta' tfigħ 'il barra mnaqqas/insuffiċjenza kardijaka ġie rrappurtat f'6.5% tal-pazjenti (1.5% kienu ta' Grad ≥ 3) fil-grupp li kien ttratt b'lenvatinib, u 2.3% fil-grupp tal-plaċebo (l-ebda wieħed ma kien ta' Grad ≥ 3).
English: • The 10 mg capsule is 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: • Il-kapsula ta' 10 mg hi korp isfar u għatu safrani-aħmar, b'tul ta' madwar 14.3 mm, immarkat b'linka sewda b'“Є” fuq l-għatu, u “LENV 10 mg” fuq il-korp.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group.
Maltese: Fil-prova importanti ħafna ta' Fażi 3, SELECT, (ara sezzjoni 5.1), kien hemm avveniment wieħed ta' PRES (Grad 2) fil-grupp ttratt b'lenvatinib, u l-ebda rapporti fil-grupp tal-plaċebo.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), hypertension (including hypertension, hypertensive crisis, increased diastolic blood pressure , and increased blood pressure) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group.
Maltese: Fil-prova importanti ħafna ta' Fażi 3 SELECT (ara sezzjoni 5.1), pressjoni għolja (li tinkludi pressjoni għolja, kriżi ipertensiva, żieda fil-pressjoni dijastolika tad-demm, u żieda fil-pressjoni tad-demm), ġiet irrappurtata fi 72.8% tal-pazjenti ttratti b'lenvatinib u f'16.0% tal-pazjenti fil-grupp li kien qed jiġi ttratt bi plaċebo.
English: • wound healing problems
Maltese: • problemi tal-fejqan tal-feriti
English: Number of complete responses Number of partial responses Median time to objective response,d months (95% CI) Duration of response,d months, median (95% CI)
Maltese: Numru ta' risponsi kompleti Numru ta' risponsi parzjali Żmien medjan għal rispons oġġettiv, d xhur (95%
English: However, testicular and ovarian toxicity has been observed in rats, dogs, and monkeys (see section 5.3).
Maltese: Madankollu, ġiet osservata tossiċità testikulari u fl-ovarji fil-firien, fil-klieb u fix-xadini (ara sezzjoni 5.3).
English: Radioiodine-refractory differentiated thyroid cancer
Maltese: Kanċer tat-tirojde differenzjat u refrattorju għal radioiodine
English: In those patients with a normal TSH at baseline, elevation of TSH level above 0.5 mU/L was observed post baseline in 57% of lenvatinib-treated patients as compared with 14% of placebo-treated patients.
Maltese: F'dawk il-pazjenti b'TSH normali fil-linja bażi, ġiet osservata żieda fil-livell ta' TSH 'il fuq minn 0.5 mU/L wara l-linja bażi f'57% tal-pazjenti ttratti b'lenvatinib meta mqabbla ma' 14% tal-pazjenti ttratti bil-plaċebo.
English: Administration of lenvatinib during organogenesis resulted in embryolethality and teratogenicity in rats (foetal external and skeletal anomalies) at exposures below the clinical exposure (based on AUC) at the maximum tolerated human dose, and rabbits (foetal external, visceral or skeletal anomalies) based on body surface area; mg/m2 at the maximum tolerated human dose.
Maltese: L-għoti ta' lenvatinib matul l-organoġenesi, irriżulta f'embrijoletalità u teratoġeniċità fil-firien (anomaliji esterni u skeletriċi tal-fetu) f'livelli ta' esponiment taħt l-esponiment kliniku (ibbażat fuq lAUC) fid-doża massima ttollerata fil-bniedem, u fil-fniek (anomaliji esterni, vixxerali jew skeletriċi tal-fetu) ibbażat fuq l-erja tas-superfiċje tal-ġisem; mg/m2 fid-doża massima ttollerata fil-bniedem.
English: The majority of cases recovered following dose interruption or reduction, which occurred in 3.6% and 3.4% of patients respectively.
Maltese: Il-maġġoranza tal-każijiet irkupraw wara interruzzjoni jew tnaqqis tad-doża, li seħħew fi 3.6% u 3.4% tal-pazjenti, rispettivament.
English: Dehydration Hypomagnesaemiab Hypercholesterolaemia b
Maltese: Deidratazzjoni Ipomanjesemijab Iperkolesterolemijab
English: Patients with low body weight (<60 kg) had a higher incidence of PPE, proteinuria, of Grade 3 or 4 hypocalcaemia and hyponatraemia, and a trend towards a higher incidence of Grade 3 or 4 decreased appetite.
Maltese: Pazjenti b'piż baxx tal-ġisem (<60 kg) kellhom inċidenza ogħla ta' PPE, proteinurija ta' Grad 3 jew 4, ipokalċemija u iponatremija, u tendenza lejn inċidenza ogħla ta' tnaqqis fl-aptit ta' Grad 3 jew 4.
English: Serious tumour related bleeds, including fatal haemorrhagic events have occurred in clinical trials and have been reported in post-marketing experience (see section 4.8, Description of selected adverse reactions).
Maltese: Ħruġ ta' demm serju relatat mat-tumur, li jinkludi avvenimenti emorraġiċi fatali, seħħ fil-provi kliniċi u ġie rrappurtat fl-esperjenza ta' wara t-tqegħid fis-suq (ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Cardiac failure (<1%) and decreased left ventricular ejection fraction have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Maltese: Insuffiċjenza kardijaka (<1%) u tnaqqis fil-porzjon ta' tfigħ 'il barra ventrikulari tax-xellug, ġew irrappurtati f'pazjenti ttratti b'lenvatinib (ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Maltese: Pazjenti li kellhom ≥75 sena kienu aktar probabbli li jkollhom pressjoni għolja ta' Grad 3 jew 4, proteinurija, tnaqqis fl-aptit, u deidratazzjoni.
English: The adverse reactions presented in this section are based on safety data of both DTC and HCC patients (see section 5.1).
Maltese: Ir-reazzjonijiet avversi ppreżentati f'din is-sezzjoni huma bbażati fuq id-dejta ta' siġurtà ta' pazjenti b'DTC u b'HCC (ara sezzjoni 5.1).
English: • joint or muscle pain
Maltese: • Mhux komuni
English: Discontinue Do not resume *Grade 4 laboratory abnormalities judged to be non-life-threatening, may be managed as severe reactions (e.g., Grade 3)
Maltese: Tkomplix *Anormalitajiet tal-laboratorju ta' Grad 4 li jkunu ġġudikati li mhumiex ta' theddida għall-ħajja, jistgħu jiġu mmaniġġjati bħala reazzjonijiet severi (eż., Grad 3).
English: The pharmacokinetics of lenvatinib following a single 24-mg dose were evaluated in 6 subjects each with mild, moderate, and severe renal impairment, and compared with 8 healthy, demographically matched subjects.
Maltese: Il-farmakokinetika ta' lenvatinib wara doża waħda ta' 24 mg ġiet evalwata f'6 individwi, li kull wieħed minnhom kellu indeboliment ħafif, moderat, u sever tal-kliewi, u pparaguna tmien individwi b'saħħithom, li ġew imqabbla demografikament.
English: In 1.1% of patients, hypertension led to permanent treatment discontinuation.
Maltese: F'1.1% tal-pazjenti, il-pressjoni għolja wasslet għat-twaqqif permanenti talkura.
English: • Demographic and baseline disease characteristics were similar between the lenvatinib and the sorafenib groups and are shown below for all 954 randomised patients:
Maltese: • Il-karatteristiċi demografiċi u fil-linja bażi tal-marda kienu simili bejn il-gruppi ta' lenvatinib u sorafenib, u qed jintwerew hawn taħt għad-954 pazjent kollha li ntgħażlu b'mod każwali:
English: Non-gastrointestinal fistula includes cases of fistula occurring outside of the stomach and intestines such as tracheal, tracheo-oesophageal, oesophageal, female genital tract fistula, and cutaneous fistula.
Maltese: Fistula mhux gastrointestinali tinkludi każijiet ta' fistula li sseħħ barra mill-istonku u l-imsaren, bħal fistula trakeali, fistula trakeoesofagali, fistula esofagali, fistula tal-passaġġ ġenitali talmara, u fistula tal-ġilda.
English: Patients with HCC should be monitored for worsening liver function including hepatic encephalopathy.
Maltese: Pazjenti b'HCC għandhom jiġu mmonitorjati għal deterjorament tal-funzjoni talfwied, inkluż enċefalopatija tal-fwied.
English: Objective Response Ratea
Maltese: Reazzjoni avversa Severità
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg lenvatinib (as mesilate).
Maltese: U KWANTITATTIVA LENVIMA 4 mg kapsuli ibsin Kull kapsula iebsa fiha 4 mg ta' lenvatinib (bħala mesilate).
English: No differences between lenvatinib- and placebo-treated patients were observed in the incidences of serious reactions (3.4% vs. 3.8%), reactions leading to premature discontinuation (1.1% vs. 1.5%), or reactions leading to dose interruption (3.4% vs. 3.8%) or reduction (0.4% vs. 0).
Maltese: Ma ġew osservati l-ebda differenzi bejn pazjenti ttratti b'lenvatinib u pazjenti ttratti bi plaċebo, fl-inċidenzi ta' reazzjonijiet avversi serji (3.4% vs 3.8%), reazzjonijiet li wasslu għal twaqqif prematur (1.1% vs 1.5%), jew reazzjonijiet li wasslu għall-interruzzjoni (3.4% vs. 3.8%) jew ittwaqqif (0.4% vs. 0) tad-doża.
English: PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions).
Maltese: PRES - posterior reversible encephalopathy syndrome, magħruf ukoll bħala RPLS, ġiet irrappurtata f'pazjenti ttratti b'lenvatinib (<1%; ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: In the Phase 3 REFLECT trial (see section 5.1), 7.1% of lenvatinib-treated patients developed a renal failure/impairment event.
Maltese: Fil-prova ta' Fażi 3 REFLECT, (ara sezzjoni 5.1), 7.1% tal-pazjenti ttratti b'levantinib żviluppaw avveniment ta' insuffiċjenza/indeboliment tal-kliewi.
English: Limited data are available for patients of ethnic origin other than Caucasian or Asian, and in patients aged ≥75 years.
Maltese: Dejta limitata hi disponibbli għal pazjenti ta' oriġini etnika li ma tkunx Kawkasa jew Asjatika, u f'pazjenti li jkollhom ≥75 sena.
English: The degree of tumour invasion/infiltration of major blood vessels (e.g. carotid artery) should be considered because of the potential risk of severe haemorrhage associated with tumour shrinkage/necrosis following lenvatinib therapy.
Maltese: Il-grad ta' invażjoni/infiltrazzjoni tat-tumur ta' vini/arterji maġġuri (eż. arterja karotide) għandu jiġi kkunsidrat minħabba r-riskju potenzjali ta' emorraġija severa assoċjata mat-tnaqqis fid-daqs tat-tumur/nekrożi wara t-terapija b'lenvatinib.
English: Lenvatinib displays minimimal accumulation at steady state.
Maltese: Lenvatinib juri akkumulazzjoni minima fl-istat fiss.