FrancophonIA/ELRC3.0 huggingface dataset:
English: In the RCC study (see section 5.1), adverse reactions led to dose reductions in 67.7% of patients and 18 (29.0%) patients discontinued the treatment.
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), ir-reazzjonijiet avversi wasslu għal tnaqqis fid-doża f'67.7% tal-pazjenti, u 18-il (29.0%) pazjent ma komplewx il-kura.
English: In the DTC study (see Lenvima SmPC), 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: Fl-istudju dwar DTC (ara l-SmPC ta' Lenvima), id-dijarea ġiet irrappurtata fi 67.4% tal-pazjenti filgrupp li kien ttratt b'lenvatinib (9.2% kienu ta' Grad ≥ 3) u f'16.8% tal-pazjenti fil-grupp ttratt bilplaċebo (l-ebda wieħed ma kien ta' Grad ≥ 3).
English: Do not take Kisplyx if:
Maltese: Tiħux Kisplyx jekk:
English: Lenvatinib should not be started in patients with fistulae 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: In DTC, patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged electrocardiogram QT, hypothyroidism, hyponatraemia, blood thyroid stimulating hormone increased, pneumonia compared with subjects with normal renal function.
Maltese: F'DTC, pazjenti b'indeboliment tal-kliewi fil-linja bażi kellhom inċidenza ogħla ta' pressjoni għolja ta' Grad 3 jew 4, proteinurija, għejja, stomatite, edema periferali, tromboċitopenija, deidratazzjoni, QT imtawwal fuq l-elettrokardjogramm, ipotirojdiżmu, iponatremija, żieda fl-ormon li jistimula t-tirojde tad-demm, pnewmonja meta mqabbla ma' individwi b'funzjoni normali tal-kliewi.
English: In the DTC study (see Lenvima SmPC), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group and no reports in the placebo group.
Maltese: Fl-istudju dwar DTC (ara l-SmPC ta' Lenvima), kien hemm 1 avveniment ta' PRES (Grad 2) fil-grupp ttratt b'lenvatinib, u l-ebda rapporti fil-grupp tal-plaċebo.
English: Kisplyx is indicated in combination with everolimus for the treatment of adult patients with advanced renal cell carcinoma (RCC) following one prior vascular endothelial growth factor (VEGF)-targeted therapy.
Maltese: Kisplyx huwa indikat flimkien ma' everolimus għall-kura ta' pazjenti adulti b'karċinoma avvanzata taċ-ċelluli tal-kliewi (RCC, renal cell carcinoma) wara terapija waħda fil-passat immirata b'fattur tattkabbir endoteljali vaskulari (VEGF, vascular endothelial growth factor).
English: Kisplyx 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Maltese: Kisplyx 4 mg kapsuli ibsin - Kull kapsula iebsa fiha jew 4 mg ta' lenvatinib (bħala mesilate).
English: In the RCC study (see section 5.1), QTc interval increases greater than 60 ms were reported in 11% of patients in the lenvatinib plus everolimus-treated group.
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), żidiet fl-intervall tal-QTc li kienu akbar minn 60 ms, ġew irrappurtati fi 11% tal-pazjenti fil-grupp ttratt b'lenvatinib flimkien ma' everolimus.
English: The lenvatinib plus everolimus arm showed a statistically significant and clinically meaningful improvement in PFS compared with the everolimus arm (see Table 5 and Figure 1).
Maltese: Il-parti tal-istudju dwar lenvatinib flimkien ma' everolimus wriet titjib statistikament sinifikanti u klinikament sinifikanti fil-PFS meta mqabbel mal-parti tal-istudju dwar everolimus (ara Tabella 5 u Figura 1).
English: In the RCC study (see section 5.1), proteinuria was reported in 30.6% of patients in the lenvatinib plus everolimus-treated group (8.1% were Grade ≥ 3) and 14.0% of patients in the everolimus-treated group (2.0% were Grade ≥3).
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), proteinurija ġiet irrappurtata fi 30.6% tal-pazjenti fil-grupp li kien qed jiġi ttratt b'lenvatinib flimkien ma' everolimus (8.1% kienu ta' Grad 3) u 14.0% tal-pazjenti fil-grupp li kien qed jiġi ttratt b'everolimus (2.0% kienu ta' Grad 3).
English: The incidence of QTc interval greater than 500 ms was 6% in the lenvatinib plus everolimus-treated group.
Maltese: L-inċidenza ta' intervall tal-QTc akbar minn 500 ms kien ta' 6% tal-pazjenti fil-grupp ttratt b'lenvatinib flimkien ma' everolimus.
English: In the DTC study (see Lenvima SmPC), 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: Fl-istudju dwar DTC (ara l-SmPC ta' Lenvima), 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: Withhold lenvatinib
Maltese: Kif taħżen Lenvatinib
English: Data cut-off date = 13 Jun 2014
Maltese: L-evalwazzjoni tat-tumur kienet ibbażata fuq kriterji ta' RECIST 1.1. Data sa meta nġabret id-dejta = 13 ta' Ġunju, 2014
English: Gastrointestinal perforation or fistulae have been reported in patients treated with lenvatinib (see section 4.8).
Maltese: Perforazzjoni gastrointestinali u l-formazzjoni ta' fistula Perforazzjoni gastrointestinali jew fistuli ġew irrappurtati f'pazjenti ttratti b'lenvatinib (ara sezzjoni 4.8).
English: Results for ORR were consistent with that of the investigators' assessments, 35.3% in the lenvatinib plus everolimus arm, with one complete response and 17 partial responses; no subject had an objective response in the everolimus arm (P < 0.0001) in favour of the lenvatinib plus everolimus arm.
Maltese: Ir-riżultati għal ORR kienu konsistenti ma' dawk talevalwazzjonijiet tal-investigaturi, 35.3% fil-parti tal-istudju dwar lenvatinib flimkien ma' everolimus, b'rispons komplet wieħed u 17-il rispons parzjali; l-ebda individwu ma kellu rispons oġġettiv fil-parti tal-istudju dwar everolimus (P < 0.0001) favur il-parti tal-istudju dwar lenvatinib flimkien ma' everolimus.
English: The recommended daily dose of lenvatinib is 18 mg (one 10 mg capsule and two 4 mg capsules) once daily in combination with 5 mg of everolimus once daily.
Maltese: Id-doża rakkomandata ta' kuljum ta' lenvatinib hija ta' 18 mg (kapsula waħda ta' 10 mg u żewġ kapsuli ta' 4 mg) meħuda darba kuljum flimkien ma' 5 mg ta' everolimus darba kuljum.
English: Caution should be taken in patients receiving agents acting on the renin-angiotensin aldosterone system given a potentially higher risk for acute renal failure with the combination treatment.
Maltese: Għandu jkun hemm kawtela f'pazjenti li jkunu qed jirċievu mediċini li jaġixxu fuq is-sistema renin-angiotensin aldosterone minħabba riskju potenzjalment ogħla għal insuffiċjenza akuta tal-kliewi bil-kura kombinata.
English: In the DTC study (see Lenvima SmPC), 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: Fl-istudju dwar DTC (ara l-SmPC ta' Lenvima), 5.0% tal-pazjenti żviluppaw insuffiċjenza tal-kliewi u 1.9% żviluppaw indeboliment tal-kliewi (3.1% tal-pazjenti kellhom avveniment ta' Grad ≥ 3 f'każ ta' insuffiċjenza jew indeboliment tal-kliewi).
English: The effects of Kisplyx in people younger than 18 years old are not known.
Maltese: L-effetti ta' Kisplyx f'persuni li jkollhom inqas minn 18-il sena mhumiex magħrufa.
English: However, in DTC, patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Maltese: Madankollu f'DTC, pazjenti li kellhom ≥75 sena kienu aktar probabbli li jkollhom pressjoni għolja ta' Grad 3 jew 4, proteinurija, tnaqqis fl-aptit, u deidratazzjoni.
English: Amongst 1,166 patients treated with lenvatinib, there were 4 cases (0.3%) of PRES (0.3% were Grade 3 or 4), all of which resolved after treatment and/or dose interruption, or permanent discontinuation.
Maltese: Fost 1,166-il pazjent ttratt b'lenvatinib, kien hemm 4 każijiet (0.3%) ta' PRES (0.3% kienu ta' Grad 3 jew 4), li kollha fiequ wara l-kura/jew interruzzjoni tad-doża, jew twaqqif permanenti.
English: In the RCC study (see section 5.1), the most commonly reported liver-related adverse reactions in the lenvatinib plus everolimus-treated group were elevations of liver enzyme levels, including increases in alanine aminotransferase (9.7%), aspartate aminotransferase (4.8%), alkaline phosphatase (4.8%), and blood bilirubin (3.2%).
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), l-iktar reazzjonijiet avversi relatati mal-fwied li ġew irrappurtati b'mod komuni fil-grupp li kien qed jiġi ttratt b'lenvatinib flimkien ma' everolimus kienu żidiet tal-livelli tal-enzimi fil-fwied, li jinkludu żidiet f'alanine aminotransferase (9.7%), aspartate aminotransferase (4.8%), alkaline phosphatase (4.8%), u bilirubina fid-demm (3.2%).
English: Absolute bioavailability has not been determined in humans; however, data from a mass-balance study suggests 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 jissuġġerixxi li hi ta' madwar 85%.
English: Kisplyx 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Maltese: Kisplyx 10 mg kapsuli ibsin - Kull kapsula iebsa fiha jew 10 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 it-twaqqif (0.4% vs. 0) taddoża.
English: • Do not use this medicine after the expiry date which is stated on the carton and blister after ‘EXP'.
Maltese: • Tużax din il-mediċina wara d-data ta' meta tiskadi, li tidher fuq il-kaxxa tal-kartun u folja wara ‘EXP'.
English: Median PFS in months (95% CI) Hazard Ratio (95% CI)b lenvatinib + everolimus vs everolimus P Value lenvatinib + everolimus vs everolimus Overall Survivalc
Maltese: I)b lenvatinib + everolimus vs everolimus valur P lenvatinib + everolimus vs everolimus
English: Thrombocytopeniaa
Maltese: Pnewmotoraċi
English: Hypertension and proteinuria tend to occur early during lenvatinib treatment (see sections 4.4 and 4.8, Description of selected adverse reactions; the asterisked frequencies are from the DTC patient population).
Maltese: Il-pressjoni għolja u l-proteinurija għandhom tendenza li jseħħu kmieni matul il-kura b'lenvatinib (ara sezzjonijiet 4.4 u 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula; il-frekwenzi b'asterisk huma mill-popolazzjoni ta' pazjenti b'DTC).
English: Lenvatinib shows minimal or no inhibitory activities toward P-gp mediated and BCRP mediated transport activities.
Maltese: Lenvatinib juri attivitajiet inibitorji minimi jew l-ebda attivitajiet inibitorji lejn attivitajiet tat-trasport medjati minn P-gp u medjati minn BCRP.
English: The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhea, 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, għejja, stomatite, proteinurija, uġigħ ta' ras, u aggravament ta' PPE.
English: In patients with severe renal impairment, the recommended starting dose is 10 mg of lenvatinib with 5 mg of everolimus taken once daily.
Maltese: F'pazjenti b'indeboliment sever tal-kliewi, id-doża rakkomandata tal-bidu hija ta' 10 mg ta' lenvatinib ma' 5 mg ta' everolimus meħuda darba kuljum.
English: Baseline hypertension
Maltese: Potassium hydroxide
English: Kisplyx 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: Kisplyx 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 għaċ-ċelluli u jgħinuhom jikbru.
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 uAUC) żdied fi proporzjon dirett għad-doża mogħtija fuq il-medda ta' 3.2 sa 32 mg darba kuljum.
English: The median time to onset of liver events was 6.7 weeks (any grade) and 14.2 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Maltese: Iż-żmien medjan għall-bidu ta' avvenimenti fil-fwied f'pazjenti kien ta' 6.7 ġimgħat (kwalunkwe grad) u 14.2 ġimgħat (Grad ≥ 3) fil-grupp li kien qed jiġi ttratt b'lenvatinib flimkien ma' everolimus.
English: Wound Healing Complications
Maltese: Sopravivenza Mingħajr Progressjoni
English: In the RCC study (see section 5.1), 1.6% of cases of perforated appendicitis (of Grade 3) occurred in the lenvatinib plus everolimus-treated group; there were no reports in the lenvatinib or everolimus groups.
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), 1.6% tal-każijiet ta' appendiċite perforata (ta' Grad 3) filgrupp ttratt b'lenvatinib flimkien ma' everolimus; ma kien hemm l-ebda rapporti fil-grupp ttratt b'lenvatinib jew b'everolimus.
English: Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction Hypothyroidism has been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Maltese: Indeboliment ta' soppressjoni tal-ormon li jistimula t-tirojde/Disfunzjoni tat-tirojde L-ipotirojdiżmu ġie rrappurtat f'pazjenti ttratti b'lenvatinib (ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: How to store Kisplyx
Maltese: X'inhu Kisplyx
English: Mild to moderate adverse reactions (e.g., Grade 1 or 2) generally do not warrant interruption of the combination, unless intolerable to the patient despite optimal management.
Maltese: Reazzjonijiet avversi minn ħfief sa moderati (eż., Grad 1 jew 2) ġeneralment ma jkunux jeħtieġu l-interruzzjoni tal-kombinazzjoni, ħlief jekk ikunu intollerabbli għall-pazjent minkejja li jkun qed jingħata kura ottimali.
English: 18 mg orally once daily One 10 mg capsule plus two 4 mg capsules
Maltese: 18 mg mill-ħalq darba kuljum Kapsula waħda ta' 10 mg u żewġ kapsuli ta' 4mg
English: Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Maltese: Uġigħ fid-dahar Artralġja Mijalġja Uġigħ fl-estremitajiet Uġigħ muskoloskeletriku
English: Renal failure and impairment
Maltese: Ħsara epatoċellulari/epatitei
English: However, in DTC Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and blood thyroid stimulating hormone increased.
Maltese: Madankollu, f'DTC, pazjenti Asjatiċi kellhom inċidenza ogħla minn pazjenti Kawkasi ta' edema periferali, pressjoni għolja, għejja, PPE, proteinurija, tromboċitopenija, u żieda fl-ormon li jistimula t-tirojde tad-demm.
English: Liver-related adverse reactions most commonly reported in patients treated with lenvatinib included increases in alanine aminotransferase, increases in aspartate aminotransferase, and increases in blood bilirubin.
Maltese: Reazzjonijiet avversi relatati mal-fwied, l-aktar irrappurtati b'mod komuni f'pazjenti ttratti b'lenvatinib, kienu jinkludu żidiet f'alanine aminotransferase, żidiet f'aspartate aminotransferase, u żidiet fil-bilirubina fid-demm.
English: The median time to onset of hypocalcaemia was 28.3 weeks (any grade) and 45.9 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Maltese: Iż-żmien medjan għall-bidu ta' ipokalċemija kien ta' 28.3 ġimgħat (kwalunkwe grad) u 45.9 ġimgħat (Grad ≥ 3) filgrupp ttratt b'lenvatinib flimkien ma' everolimus.
English: Overall survival was longer in the lenvatinib plus everolimus arm (see Table 5 and Figure 2).
Maltese: Is-sopravivenza globali kienet itwal fil-parti tal-istudju dwar lenvatinib flimkien ma' everolimus (ara Tabella 5 u Figura 2).
English: No reports of QTc interval prolongation greater than 500 ms or increases greater than 60 ms occurred in the everolimus-treated group.
Maltese: Ma kien hemm l-ebda rapporti ta' titwil tal-intervall tal-QTc akbar minn 500 ms jew ta' żidiet akbar minn 60 ms li seħħew fil-grupp ttratt b'everolimus.
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% talpazjenti, rispettivament; 1 pazjent b'ipokalċemija ta' Grad 4 waqqaf il-kura b'mod permanenti.
English: In the RCC study (see section 5.1), 8.1% of patients in the lenvatinib plus everolimus treated group developed renal failure and 3.2% developed renal impairment, (9.7% of patients had a Grade 3 event of renal failure or impairment).
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), 8.1% tal-pazjenti fil-grupp li kien qed jiġi ttratt b'lenvatinib u everolimus, żviluppaw insuffiċjenza tal-kliewi, u 3.2% żviluppaw indeboliment tal-kliewi (9.7% talpazjenti kellhom avveniment ta' indeboliment jew insuffiċjenza tal-kliewi ta' Grad 3).
English: The Phase 1b portion included 11 patients who received the combination of 18 mg of lenvatinib plus 5 mg of everolimus.
Maltese: Il-porzjon ta' Fażi 1b kien jinkludi 11-il pazjent li rċivew il-kombinazzjoni ta' 18 mg ta' lenvatinib flimkien ma' 5 mg ta' everolimus.
English: Dizziness Headache Dysgeusia
Maltese: Sturdament Uġigħ ta' ras Indeboliment fis-sens tattogħma
English: The combination of lenvatinib and everolimus showed increased antiangiogenic and antitumour activity as demonstrated by decreased human endothelial cell proliferation, tube formation, and VEGF signalling in vitro and tumour volume in mouse xenograft models of human renal cell cancer greater than each drug alone.
Maltese: Il-kombinazzjoni ta' lenvatinib u everolimus wriet żieda fl-attività antianġjoġenika u antitumorika, kif muri mit-tnaqqis talproliferazzjoni taċ-ċelluli endoteljali tal-bniedem, formazzjoni ta' tubi, u senjalazzjoni VEGF in vitro u volum tat-tumur f'mudelli xenograft tal-ġrieden ta' kanċer taċ-ċelluli tal-kliewi bniedem, akbar minn kull mediċina waħidha.
English: There are limited data on Asian patients with RCC.
Maltese: Hemm dejta limitata dwar pazjenti Asjatiċi b'RCC.
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules lenvatinib
Maltese: Kisplyx 4 mg kapsuli ibsin lenvatinib
English: Accidental medication errors resulting in single doses of 40 to 48 mg have also occurred in clinical trials.
Maltese: Żbalji aċċidentali talmedikazzjoni li rriżultaw f'dożi waħidhom ta' 40 sa 48 mg seħħew ukoll fil-provi kliniċi.
English: Consider resuming at reduced dose if resolves to Grade 0-1.
Maltese: Ikkunsidra li terġa' tibda b'doża mnaqqsa jekk ifieq sa Grad 0-1.
English: Proteinuria led to permanent treatment discontinuation in 4.8% of patients.
Maltese: Il-proteinurija wasslet għal twaqqif permanenti tal-kura f'4.8% tal-pazjenti.
English: In DTC, 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: F'DTC, 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: • Do not breast-feed if you are taking Kisplyx.
Maltese: • Treddax jekk qed tkun tieħu Kisplyx.
English: In patients with a normal TSH at baseline, an elevation of TSH level was observed post baseline in 60.5% of lenvatinib plus everolimus-treated patients as compared with none in patients receiving everolimus alone.
Maltese: F'pazjenti b'TSH normali fil-linja bażi, ġiet osservata żieda fil-livell ta' TSH wara l-linja bażi f'60.5% tal-pazjenti ttratti b'lenvatinib flimkien ma' everolimus meta mqabbla ma' xejn f'pazjenti ttratti li kienu qed jirċievu everolimus waħdu.
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 4 mg lenvatinib (as mesilate).
Maltese: Kisplyx 4 mg kapsuli ibsin lenvatinib DIKJARAZZJONI TAS-SUSTANZA(I) ATTIVA(I)
English: Hepatocellular damage and hepatitis includes: drug-induced liver injury, hepatic steatosis, and cholestatic liver injury.
Maltese: Ħsara epatoċellulari u epatite jinkludu: ferita fil-fwied ikkaġunata mill-mediċina, steatożi talfwied, u ferita kolestatika fil-fwied.
English: OTHER
Maltese: CI)
English: 14 mg orally once daily One 10 mg capsule plus one 4 mg capsule
Maltese: 14 mg mill-ħalq darba kuljum Kapsula waħda ta' 10 mg u kapsula waħda ta' 4 mg
English: What Kisplyx is
Maltese: X'fih Kisplyx
English: The safety profile of lenvatinib in combination with everolimus is based on data from 62 subjects, allowing characterisation only of common adverse drug reactions in RCC patients.
Maltese: Il-profil tas-sigurtà ta' lenvatinib flimkien ma' everolimus hu bbażat fuq dejta minn 62 individwu, li ppermettiet il-karatterizzazzjoni biss ta' reazzjonijiet avversi komuni tal-mediċina f'pazjenti b'RCC.
English: Black iron oxide (E172) Potassium hydroxide Propylene glycol
Maltese: • tħossok minfuħ jew ikollok il-gass fl-imsaren
English: Hypothyroidism** Blood thyroid stimulating hormone increased‡**
Maltese: (baxxi), kolesterol (għoli) u ormon li jistimula t-tirojde (għoli)
English: The median time to onset of decreased ejection fraction and cardiac failure was 15.7 weeks (any grade) and 32.8 weeks (Grade ≥ 3) in the lenvatinib plus everolimus-treated group.
Maltese: 7 ġimgħat (kwalunkwe grad), u 32.8 ġimgħa (Grad ≥ 3) fil-grupp ttratt b'lenvatinib flimkien ma' everolimus.
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 4 mg hard capsules Kisplyx 10 mg hard capsules
Maltese: Kisplyx 4 mg kapsuli ibsin Kisplyx 10 mg kapsuli ibsin
English: • high levels of protein in the urine and urinary infections (increased frequency in urination and pain in passing urine)
Maltese: • livelli għoljin ta' proteina fl-awrina u infezzjonijiet urinarji (żieda fil-frekwenza meta tagħmel l awrina u wġigħ meta tagħmel l-awrina)
English: Lenvatinib is for oral use.
Maltese: Lenvatinib hu għal użu orali.
English: Hypokalaemia Decreased appetite Weight decreased
Maltese: Insuffiċjenza u indeboliment tal-kliewi
English: NAME OF THE MEDICINAL PRODUCT Kisplyx 10 mg hard capsules lenvatinib
Maltese: Kisplyx 10 mg kapsuli ibsin lenvatinib