FrancophonIA/ELRC3.0 huggingface dataset:
English: ≥ 2 gm / 24 hours
Maltese: ≥ 2 g/24 siegħa
English: Resolves to Grade 0, 1 or 2.
Maltese: Tfieq sa Grad 0, 1 jew 2.
English: Reactions that occurred at an incidence of ≥0.75% above placebo were: epistaxis (11.9%), haematuria (6.5%), contusion (4.6%), gingival bleeding (2.3%), haematochezia (2.3%), rectal haemorrhage (1.5%), haematoma (1.1%), haemorrhoidal haemorrhage (1.1%), laryngeal haemorrhage (1.1%), petechiae (1.1%), and intracranial tumour haemorrhage (0.8%).
Maltese: Reazzjonijiet li seħħew b'inċidenza ta' ≥0.75% fuq il-plaċebo kienu: epistassi (11.9%), ematurija (6.5%), kontużjoni (4.6%), ħruġ ta' demm mill-ħanek (2.3%), ematokeżija (2.3%), emorraġija mirrektum (1.5%), ematoma (1.1%), emorraġija mill-murliti (1.1%), emorraġija larinġeali (1.1%), tikek żgħar vjola fuq il-ġilda (1.1%), u emorraġija minn tumur intrakranjali (0.8%).
English: • Uncommon (≥1/1,000 to <1/100)
Maltese: (≥1/1,000 sa <1/100)
English: See detailed guidance in Table 3 in section 4.4.
Maltese: Ara l-gwida dettaljata f'Tabella 3 f'sezzjoni 4.4.
English: • The capsules come in blisters of polyamide/aluminium/PVC with a push through aluminium foil lidding in cartons of 30, 60 or 90 hard capsules.
Maltese: • Il-kapsuli jiġu f'folji tal-polyamide/aluminium/PVC b'kisja ta' folji tal-aluminju push through f'kaxxi tal-kartun ta' 30, 60 jew 90 kapsula iebsa.
English: Amongst 1,166 patients treated with lenvatinib, there were 5 cases (0.4%) of arterial thromboembolisms (3 cases of myocardial infarction and 2 cases of cerebrovascular accident) with a fatal outcome.
Maltese: Fost 1,166 pazjent li ġew ttratti b'lenvatinib, kien hemm 5 każijiet (0.4%) ta' tromboemboliżmi arterjali (3 każijiet ta' infart mijokardijaku u 2 każijiet ta' inċident ċerebrovaskulari) b'riżultat fatali.
English: Table 1
Maltese: Tabella 5
English: Reactions that occurred at an incidence of ≥2.0% were: epistaxis (22.6%), haematuria (4.8%), haematoma (3.2%), and gastric haemorrhage (3.2%).
Maltese: Reazzjonijiet li seħħew b'inċidenza ta' ≥2.0% fuq il-plaċebo kienu: epistassi (22.6%), ematurija (4.8%), ematoma (3.2%), u emorraġija gastrika (3.2%).
English: Similarly, no induction of P-gp mRNA expression was observed.
Maltese: Bl-istess mod, ma ġiet osservat l-ebda induzzjoni tal-espressjoni P-gp mRNA.
English: Paediatric population See section 4.2 for information on paediatric use.
Maltese: Popolazzjoni pedjatrika Ara sezzjoni 4.2) għal informazzjoni dwar l-użu pedjatriku.
English: Gastrointestinal and abdominal painsf
Maltese: Uġigħ gastrointestinali u addominalif
English: Duration of response, months, median (95% CI)
Maltese: Tul ta' rispons, xhur, medjan (95%
English: Please see distribution section.
Maltese: Jekk jogħġbok ara sezzjoni tad-distribuzzjoni.
English: Impaired healing***.
Maltese: Fejqan indebolit***
English: Oral inflammation includes: aphthous ulcer, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Maltese: Infjammazzjoni orali tinkludi: ulċera aftuża, stomatite, glossite, ulċerazzjoni fil-ħalq, u infjammazzjoni mukożali.
English: The treatment effect of the combination on PFS and ORR was also supported by a post-hoc retrospective independent blinded review of scans.
Maltese: L-effett tal-kura tal-kombinazzjoni fuq PFS u ORR kien appoġġjat ukoll minn reviżjoni blinded indipendenti retrospettiva post-hoc tal-iscans.
English: Progression-free survival (PFS)a by Investigator Assessment
Maltese: Sopravivenza Ħielsa mill-Progressjoni (PFS)a minn Evalwazzjoni tal-Investigatur
English: In the DTC study (see Lenvima SmPC), the most commonly reported liver-related adverse reactions were hypoalbuminaemia (9.6% lenvatinib vs. 1.5% placebo) and elevations of liver enzyme levels, including increases in alanine aminotransferase (7.7% lenvatinib vs. 0 placebo), aspartate aminotransferase (6.9% lenvatinib vs. 1.5% placebo), and blood bilirubin (1.9% lenvatinib vs. 0 placebo).
Maltese: Fl-istudju DTC (ara l-SmPC ta' Lenvima), l-iktar reazzjonijiet avversi relatati mal-fwied li ġew irrappurtati b'mod komuni kienu ipoalbuminemija (9.6% lenvatinib vs 1.5% plaċebo) u żidiet fillivelli tal-enzimi fil-fwied, li jinkludu żidiet f'alanine aminotransferase (7.7% lenvatinib vs. 0 plaċebo), aspartate aminotransferase (6.9% lenvatinib vs. 1.5% plaċebo), u bilirubina fid-demm (1.9% lenvatinib vs. 0 plaċebo).
English: Blood thyroid stimulating hormone increased (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction) (see section 4.4)
Maltese: Indeboliment ta' soppressjoni talormon li jistimula t-tirojde/Disfunzjoni tat-tirojde) (ara sezzjoni 4.4)
English: Lenvatinib exposure, based on AUC0-inf data, was 101%, 90%, and 122% of normal for subjects with mild, moderate, and severe renal impairment, respectively.
Maltese: L-esponiment għal lenvatinib, ibbażat fuq dejta dwar AUC0-inf kien ta' 101%, 90%, u 122% tannormal għal individwi b'indeboliment ħafif, moderat, u sever tal-kliewi, rispettivament.
English: Number of capsules
Maltese: Qoxra tal-kapsula
English: In vitro studies indicate that lenvatinib is a substrate for P-gp and BCRP.
Maltese: Studji in vitro jindikaw li lenvatinib hu substrat għal P-gp u BCRP.
English: The requirements for submission of periodic safety update reports for this medicinal product are set out in the list of Union reference dates (EURD list) provided for under Article 107c(7) of Directive 2001/83/EC and any subsequent updates published on the European medicines web-portal.
Maltese: PSURs għal dan il-prodott mediċinali huma mniżżla fil-lista tad-dati ta' referenza tal-Unjoni (lista EURD) prevista skont l-Artikolu 107c(7) tad-Direttiva 2001/83/KE u kwalunkwe aġġornament sussegwenti ppubblikat fuq il-portal elettroniku Ewropew tal-mediċini.
English: A total of 62 patients received the combination of lenvatinib and everolimus at the recommended dose.
Maltese: Total ta' 62 pazjent irċivew il-kombinazzjoni ta' lenvatinib u everolimus fid-doża rakkomandata.
English: In human liver microsomes, the demethylated form of lenvatinib (M2) was identified as the main metabolite.
Maltese: F'mikrosomi tal-fwied tal-bniedem, il-forma demethylated ta' lenvatinib (M2) ġiet identifikata bħala l-metabolit ewlieni.
English: GI perforation or fistula Grade 3
Maltese: Perforazzjoni GI jew Grad 3
English: INFORMATION IN BRAILLE Kisplyx 4 mg
Maltese: Kisplyx 4 mg
English: Amongst 1,166 patients treated with lenvatinib, Grade 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.3%) had a Grade 4 haemorrhage and 5 patients (0.4%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial tumour haemorrhage, haemoptysis and tumour haemorrhage.
Maltese: Fost 1,166-il pazjent li ġew ttratti b'lenvatinib, Grad 3 jew aktar ġiet irrappurtata fi 2% tal-pazjenti, 3 pazjenti (0.3%) kellhom emorraġija ta' Grad 4, u 5 pazjenti (0.4%) kellhom reazzjoni ta' Grad 5 li tinkludi emorraġija arterjali, aċċessjoni emorraġika, emorraġija minn tumur intrakranjali, emoptisi u emorraġija tat-tumur.
English: In the RCC study (see section 5.1), 1.6% of patients in the lenvatinib plus everolimus-treated group reported arterial thromboembolic events.
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), 1.6% tal-pazjenti fil-grupp ttratt b'lenvatinib flimkien ma' everolimus irrappurtaw avvenimenti tromboemboliċi arterjali.
English: There are limited data on patients of age ≥75 years with RCC.
Maltese: Hemm dejta limitata dwar pazjenti li jkollhom ≥75 sena b'RCC.
English: Other medicines and Kisplyx
Maltese: Mediċini oħra u Kisplyx
English: INFORMATION IN BRAILLE Kisplyx 10 mg
Maltese: Kisplyx 10 mg
English: In the DTC study (see Lenvima SmPC), haemorrhage was reported in 34.9% (1.9% were Grade ≥ 3) of lenvatinib-treated patients versus 18.3% (3.1% were Grade ≥ 3) of placebo-treated patients.
Maltese: Fl-istudju DTC (ara l-SmPC ta' Lenvima), emorraġija ġiet irrappurtata f'34.9% (1.9% kienu ta' Grad ≥ 3) tal-pazjenti ttratti b'lenvatinib u fi 18.3% (3.1% kienu ta' Grad ≥ 3) tal-pazjenti ttratti bi plaċebo.
English: Liver-related reactions led to dose interruptions and reductions in 4.6% and 2.7% of patients, respectively, and to permanent discontinuation in 0.4%.
Maltese: Reazzjonijiet relatati mal-fwied wasslu għal interruzzjonijiet fid-doża u tnaqqis f'4.6% u 2.7% tal-pazjenti, rispettivament, u għal twaqqif permanenti f'0.4%.
English: Haemorrhaged, †,‡ Hypertensione,‡ Hypotension
Maltese: Il-benefiċċju-riskju f'dawn il-pazjenti ma ġiex evalwat.
English: Fatigue Asthenia Oedema peripheral
Maltese: Għejja Astenija Edema periferali
English: The most frequently reported adverse reactions in the RCC and DTC patient populations (occurring in ≥30% of patients) were diarrhoea (80.6%), hypertension (70.1%)*, fatigue (59.7%), decreased appetite (53.7%), weight decreased (52.6%)*, vomiting (48.4%), nausea (45.2%), proteinuria (38.9%)*, stomatitis (36.9%)*, headache (35.8%)*, dysphonia (35.6%)*, palmar-plantar erythrodysaesthesia syndrome (PPE) (34.1%)*, peripheral oedema (33.9%), and hypercholesterolemia (30.6%).
Maltese: 1%)*, għejja (59.7%), tnaqqis fl-aptit (53.7%), tnaqqis fil-piż (52.6%)*, rimettar (48.4%), dardir (45.2%), proteinurija (38.9%)*, stomatite (36.9%)*, uġigħ ta' ras (35.
English: Kisplyx 4 mg hard capsules Kisplyx 10 mg hard capsules lenvatinib
Maltese: Kisplyx 4 mg kapsuli ibsin Kisplyx 10 mg kapsuli ibsin lenvatinib
English: The adverse reactions presented in this section are based on the combined safety data of 62 RCC patients (see section 5.1) and 458 DTC patients (see Lenvima SmPC).
Maltese: Ir-reazzjonijiet avversi ppreżentati f'din is-sezzjoni huma bbażati fuq id-dejta ta' sigurtà kombinata ta' 62 pazjent b'RCC (ara sezzjoni 5.1) u 458 pazjent b'DTC (ara l-SmPC ta' Lenvima).
English: The final dose level in the combination arm was 18 mg for 29% of patients, 14 mg for 31% of patients, 10 mg for 23% of patients, 8 mg for 16% of patients and 4 mg for 2% of patients.
Maltese: Il-livell tad-doża finali fil-parti tal-istudju dwar il-kombinazzjoni tad-doża kien ta' 18 mg għal 29% tal-pazjenti, 14 mg għal 31% tal-pazjenti, 10 mg għal 23% tal-pazjenti, 8 mg għal 16% tal-pazjenti u 4 mg għal 2% tal-pazjenti.
English: 8 mg orally once daily Two 4 mg capsules a Limited data are available for doses below 8 mg
Maltese: 8 mg mill-ħalq darba kuljum Żewġ kapsuli ta'10mg a Data limitata hi disponibbli għal dożi taħt 8 mg
English: Hepatic failure and acute hepatitis (<1%; see section 4.8, Description of selected adverse reactions) have been reported in patients treated with lenvatinib.
Maltese: Insuffiċjenza tal-fwied u epatite akuta (<1%; ara sezzjoni 4.8 Deskrizzjoni ta' reazzjonijiet avversi magħżula) ġew irrappurtati f'pazjenti ttratti b'lenvatinib.
English: In the DTC study, 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: Fl-istudju DTC, avvenimenti ta' perforazzjoni gastrointestinali jew fistula ġew irrappurtati f'1.9% talpazjenti ttratti b'lenvatinib u f'0.8% tal-pazjenti fil-grupp ttratt bi plaċebo.
English: Leave for at least 10 minutes then stir for at least 3 minutes to dissolve the capsule shells.
Maltese: Ħalli mill-inqas 10 minuti u mbagħad ħawwad għal mill-inqas 3 minuti biex tħoll il-qxur talkapsuli.
English: In the DTC study (see Lenvima SmPC), proteinuria was reported in 33.7% of lenvatinib-treated patients and 3.1% of patients in the placebo-treated group.
Maltese: Fl-istudju DTC (ara l-SmPC ta' Lenvima), il-proteinurija ġiet irrappurtata fi 33.7% tal-pazjenti ttratti b'lenvatinib u fi 3.1% tal-pazjenti fil-grupp ttratti bi plaċebo.
English: When systolic BP ≤150 mmHg, diastolic BP ≤95 mmHg, and patient has been on a stable dose of antihypertensive therapy for at least 48 hours, resume lenvatinib at a reduced dose (see section 4.2)
Maltese: Meta BP sistolika tkun ta' ≤150 mmHg, BP dijastolika ta' ≤95 mmHg, u l-pazjent kien fuq doża stabbli ta' terapija kontra l-pressjoni għolja għal millinqas 48 siegħa, kompli lenvatinib f'doża mnaqqsa (ara sezzjoni 4.2).
English: Blood alkaline phosphatase increased Hepatic function abnormal Gamma-glutamyltransferase increasedk Blood bilirubin increased‡
Maltese: Żieda f'alkaline phosphatase Funzjoni anormali talfwied Żieda f'gammaglutamyltransferasek
English: In the RCC study (see section 5.1), haemorrhage was reported in 38.7% (8.1% were Grade ≥ 3) of patients in the lenvatinib plus everolimus-treated group.
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), emorraġija ġiet irrappurtata fi 38.7% (8.1% kienu ta' Grad ≥ 3) tal-grupp ta' pazjenti ttratti b'lenvatinib flimkien ma' everolimus.
English: In the DTC study (see Lenvima SmPC), arterial thromboembolic events were reported in 5.4% of lenvatinib-treated patients and 2.3% of patients in the placebo group.
Maltese: Fl-istudju dwar DTC (ara l-SmPC ta' Lenvima), avvenimenti tromboemboliċi arterjali ġew irrappurtati f'5.4% tal-pazjenti ttratti b'lenvatinib u fi 2.3% tal-pazjenti fil-grupp ttratt bi plaċebo.
English: Median PFS in months (95% CI) Hazard Ratio (95% CI)b lenvatinib + everolimus vs everolimus
Maltese: PFS medjan f'xhur (95% CI) Proporzjon ta' Periklu (95% C
English: In the DTC study (see Lenvima SmPC), QT/QTc interval prolongation was reported in 8.8% of lenvatinibtreated patients and 1.5% of patients in the placebo group.
Maltese: Fl-istudju DTC (ara l-SmPC ta' Lenvima), titwil fl-intervall tal-QT/QTc ġie rrappurtat fi 8.8% talpazjenti ttratti b'lenvatinib u f'1.5% tal-pazjenti fil-grupp ttratt bi plaċebo.
English: Gastrointestinal and abdominal pain includes: abdominal discomfort, abdominal pain, lower abdominal pain, upper abdominal pain, 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: Liver-related reactions led to dose interruptions and reductions in 1.6% and 1.6% of patients, respectively, and to permanent discontinuation in 3.2% of patients.
Maltese: Reazzjonijiet relatati mal-fwied wasslu għal interruzzjonijiet fid-doża u tnaqqis f'1.6% u 1.6% talpazjenti, rispettivament, u għall-waqfien permanenti fi 3.2% tal-pazjenti.
English: ANNEX III LABELLING AND PACKAGE LEAFLET
Maltese: Tabella 4 Reazzjonijiet avversi rrappurtati f'pazjenti ttratti b'lenvatinib
English: In the RCC study (see section 5.1), there was 1 event of PRES (Grade 3) in the lenvatinib-treated group, occurring after 18.4 weeks of treatment.
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), kien hemm avveniment wieħed ta' PRES (Grad 3) fil-grupp ttratt b'lenvatinib, li seħħ wara 18.4 ġimgħat ta' kura.
English: Memorial Sloan Kettering Cancer Centre (MSKCC) poor risk was observed in 39% of patients in the lenvatinib plus everolimus arm, 44% in the lenvatinib arm and 38% in the everolimus arm. International mRCC Database Consortium (IMDC) poor risk was observed in 20% of patients in the lenvatinib plus everolimus arm, 23% in the lenvatinib arm, and 24% in the everolimus arm.
Maltese: Riskju ta' pronjosi batuta ta' Memorial Sloan Kettering Cancer Center (MSKCC) ġie osservat f'39% tal-pazjenti fil-parti tal-istudju dwar lenvatinib flimkien ma' everolimus, 44% fil-parti tal-istudju dwar lenvatinib u 38% fil-parti tal-istudju dwar everolimus.
English: The most common adverse reactions (≥5%) resulting in dose reductions in the lenvatinib plus everolimus treated group were diarrhoea (21.0%), thrombocytopenia (6.5%), and vomiting (6.5%).
Maltese: L-aktar reazzjonijiet avversi komuni (≥5%) li rriżultaw fi tnaqqis fid-doża fil-grupp li kien qed jiġi ttratt b'lenvatinib flimkien ma' everolimus kienu dijarea (21.0%), tromboċitopenija (6.5%), u rimettar (6.5%).
English: Patients were randomly allocated to one of 3 arms: 18 mg of lenvatinib plus 5 mg of everolimus, 24 mg of lenvatinib or 10 mg of everolimus using a 1:1:1 ratio.
Maltese: Il-pazjenti ntgħażlu b'mod każwali f'wieħed mit-3 partijiet tal-istudju: 18 mg ta' lenvatinib flimkien ma' 5 mg ta' everolimus, 24 mg ta' lenvatinib jew 10 mg ta' everolimus bl-użu ta' proporzjon ta' 1:1:1.
English: The study consisted of a Phase 1b dose finding and a Phase 2 portion.
Maltese: L-istudju kien jikkonsisti minn sejba ta' doża ta' Fażi 1b u porzjon ta' Fażi 2.
English: In the DTC study (see Lenvima SmPC), hypertension (including hypertension, hypertensive crisis, blood pressure diastolic increased, and blood pressure increased) was reported in 72.8% of lenvatinib-treated patients and 16.0% of patients in the placebo-treated group.
Maltese: Fl-istudju DTC (ara l-SmPC ta' Lenvima), pressjoni għolja (li tinkludi pressjoni għolja, kriżi ipertensiva, żieda fil-pressjoni dijastolika tad-demm, u żieda fil-pressjoni tad-demm), ġew irrappurtati fi 72.8% tal-pazjenti ttratti b'lenvatinib u f'16.0% tal-pazjenti fil-grupp ttratt bi plaċebo.
English: Of the 153 patients randomly allocated, 73% were male, the median age was 61 years, 37% were 65 years or older, 7% were 75 years or older, and 97% were Caucasian.
Maltese: Mill-153 pazjent allokati b'mod każwali, 73% kienu rġiel, l-età medjana kienet ta' 61 sena, 37% kellhom 65 sena jew aktar, 7% kellhom 75 sena jew aktar, u 97% kienu Kawkasi.
English: • Kisplyx 10 mg hard capsule: 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: • Kisplyx 10 mg kapsula iebsa: 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: Kisplyx 4 mg hard capsules
Maltese: Kisplyx 4 mg kapsuli ibsin
English: Renal failure includes: acute prerenal failure, renal failure, acute kidney injury, and renal tubular necrosis.
Maltese: Insuffiċjenza tal-kliewi jinkludu: insuffiċjenza prerenali akuta, insuffiċjenza tal-kliewi, ferita akuta tal-kliewi, u nekrożi tubulari tal-kliewi.
English: The median time from diagnosis to first dose was 32 months in the lenvatinib plus everolimus-treatment arm, 33 months in the lenvatinib arm and 26 months in the everolimus arm. All patients had been treated with 1 prior VEGF-inhibitor; 65% with sunitinib, 23% with pazopanib, 4% with tivozanib, 3% with bevacizumab, and 2% each with sorafenib or axitinib.
Maltese: Il-pazjenti kollha kienu ġew ttratti b'1 inibitur ta' VEGF fil-passat; 65% b'sunitinib, 23% b'pazopanib, 4% b'tivozanib, 3% b'bevacizumab, u 2% kull wieħed b'sorafenib jew b'axitinib.
English: Although not studied directly, the MOA for the worsening of diarrhoea with the combination is postulated to be mediated by the impairment of intestinal function related to the MOAs for the individual agentsVEGF/VEGFR and c-KIT inhibition by lenvatinib coupled with mTOR/NHE3 inhibition by everolimus.
Maltese: Għalkemm mhux studjat b'mod dirett, l-MOA għall-aggravament tad-dijarea bil-kombinazzjoni hu postulat li jiġi medjat mill-indeboliment tal-funzjoni intestinali relatata mal-MOAs għall-mediċini individwali - VEGF/VEGFR u inibizzjoni ta' c-KIT minn lenvatinib flimkien ma' inibizzjoni ta' mTOR/NHE3 minn everolimus.
English: There are limited data on patients with body weight <60 kg in RCC.
Maltese: Hemm dejta limitata dwar pazjenti b'piż tal-ġisem ta' <60 kg f'RCC.
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 tal-kura.
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, magħrufa wkoll bħala RPLS, ġiet irrappurtata f'pazjenti ttratti b'lenvatinib (<1%; ara sezzjoni 4.8, Deskrizzjoni ta' reazzjonijiet avversi magħżula).
English: Each carton contains 30, 60, or 90hard capsules.Not all pack sizes may be marketed.
Maltese: Kull pakkett fih 30, 60 jew 90 kapsula iebsa.
English: Periodic monitoring of ECG and electrolytes (magnesium, potassium and calcium) should be considered during treatment.
Maltese: Monitoraġġ perjodiku tal-ECG u elettroliti (magnesium, potassium u calcium) għandhom jiġu kkunsidrati matul il-kura.
English: Nongastrointestinal fistulak
Maltese: Azzjoni rakkomandata
English: The most important serious adverse reactions were renal failure and impairment (11.3%), arterial thromboembolisms (3.9%)*, cardiac failure (1.6%), cerebral haemorrhage (1.6%), intracranial tumour haemorrhage (0.7%)*, PRES / RPLS (0.2%)*, and hepatic failure (0.2%)* (the asterisked frequencies are from the DTC patient population).
Maltese: L-aktar reazzjonijiet avversi serji importanti kienu insuffiċjenza u indeboliment tal-kliewi (11.3%), tromboemboliżmi arterjali (3.9%)*, insuffiċjenza kardijaka (1.6%), emorraġija ċerebrali (1.6%), emorraġija minn tumur intrakranjali (0.
English: Lenvatinib and its metabolites are excreted in rat milk (see section 5.3).
Maltese: Lenvatinib u l-metaboliti tiegħu jiġu eliminati fil-ħalib tal-firien (ara sezzjoni 5.3).
English: • The recommended daily dose of Kisplyx is 18 mg once a day (one 10 mg capsule and two 4 mg capsules) in combination with one 5 mg tablet of everolimus once a day.
Maltese: • Id-doża rakkomandata ta' kuljum ta' Kisplyx hi ta' 18 mg darba kuljum (kapsula waħda ta' 10 mg u żewġ kapsuli ta' 4 mg) flimkien ma' kapsula waħda ta' 5 mg ta' everolimus darba kuljum.
English: • other types of fistulae (an abnormal connection between different organs in the body or from the skin to an underlying structure such as throat and windpipe).
Maltese: • tipi oħrajn ta' fistuli (konnessjoni mhux normali bejn organi differenti fil-ġisem jew mill-ġilda għal struttura sottostanti bħal gerżuma u l-passaġġ tan-nifs).
English: In the RCC study (see section 5.1), decreased ejection fraction/cardiac failure was reported in 4.8% of patients (3.2% were Grade ≥ 3) in the lenvatinib plus everolimus treated group, and 4.0% in the everolimus group (2.0% were Grade ≥ 3).
Maltese: Fl-istudju dwar RCC (ara sezzjoni 5.1), porzjon ta' tfigħ 'il barra mnaqqas/insuffiċjenza kardijaka ġew irrappurtati f'4.8% tal-pazjenti (3.2% kienu ta' Grad ≥ 3) fil-grupp li ġie ttratt b'lenvatinib flimkien ma' everolimus, u 4.0% fil-grupp ta' everolimus (2.0% kienu Grad ≥ 3).
English: Amongst 1,166 patients treated with lenvatinib, there were 3 cases (0.3%) of hepatic failure, all with a fatal outcome.
Maltese: Fost 1,166-il pazjenti ttratti b'lenvatinib, kien hemm 3 każijiet (0.3%) ta' insuffiċjenza tal-fwied, kollha b'riżultat fatali.
English: All patients had a baseline ECOG PS of either 0 (55%) or 1 (45%) with similar distribution across the 3 treatment arms.
Maltese: Il-pazjenti kollha kellhom ECOG PS fil-linja bażi jew ta' 0 (55%) jew ta' 1 (45%), b'distribuzzjoni simili fit-3 gruppi ta' kura.
English: Number of deaths, n (%) Median OS in months (95% CI) Hazard Ratio (95% CI) b lenvatinib + everolimus vs everolimus Objective Response Rate n (%) by Investigator Assessment Complete responses
Maltese: Numru ta' mwiet, n (%) OS medjan f'xhur (95% CI) Proporzjon ta' Periklu (95% C
English: Kisplyx 10 mg hard capsules
Maltese: Kisplyx 10 mg kapsuli ibsin
English: In the DTC study (see Lenvima SmPC), hypocalcaemia was reported in 12.6% of lenvatinib-treated patients vs. no cases in the placebo arm.
Maltese: Fl-istudju DTC (ara l-SmPC ta' Lenvima), l-ipokalċemija ġiet irrappurtata fi 12.6% tal-pazjenti ttratti b'lenvatinib kontra l-ebda każijiet fil-parti tal-istudju dwar il-plaċebo.
English: Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Maltese: Yellow iron oxide (E172)
English: The following information is derived from the clinical experience on single agent lenvatinib in patients with differentiated thyroid cancer (DTC; see Lenvima SmPC).
Maltese: L-informazzjoni li ġejja nkisbet mill-esperjenza klinika dwar il-mediċina lenvatinib waħidha f'pazjenti b'kanċer tat-tirojde differenzjat (DTC, differentiated thyroid cancer; ara l-SmPC ta' Lenvima).