FrancophonIA/ELRC3.0 huggingface dataset:
English: Your doctor may consider stopping LENVIMA if you will be undergoing a major surgical procedure as LENVIMA may affect wound healing.
Croatian: vaš liječnik može razmotriti prekid davanja LENVIME jer taj lijek može utjecati na cijeljenje rana.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), 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).
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), najčešće zabilježene nuspojave povezane s jetrom bile su hipoalbuminemija (9,6% lenvatinib naspram 1,5% placebo) i povišenje razine jetrenih enzima, uključujući povišenje razina alanin aminotransferaze (7,7% lenvatinib naspram 0 placebo), aspartat aminotransferaze (6,9% lenvatinib naspram 1,5% placebo) i bilirubina u krvi (1,9% lenvatinib naspram 0 placebo).
English: It has been determined that plasma protein binding in plasma from renally impaired subjects was similar to the respective matched healthy subjects and no concentration dependency was observed.
Croatian: Utvrđeno je da je vezanje za proteine plazme u ispitanika s oštećenjem funkcije bubrega slično odgovarajućim podudarnim zdravim ispitanicima te nije uočena ovisnost o koncentraciji.
English: The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively.
Croatian: Većina nuspojava se popravila ili povukla nakon privremenog prekida primjene ili sniženja doze, što se dogodilo u 13,0% odnosno 13,4% bolesnika.
English: NAME AND ADDRESS OF THE MARKETING AUTHORISATION HOLDER Eisai GmbH
Croatian: 11. NAZIV I ADRESA NOSITELJA ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eisai GmbH
English: Hazard ratioa, b (95% CI)
Croatian: Omjer hazardaa, b (95% CI)
English: Some cases of bleeding have occurred secondarily to tumour shrinkage and fistula formation, e.g. tracheo-oesophageal fistulae.
Croatian: Neki slučajevi krvarenja dogodili su se kao posljedica smanjenja veličine tumora i stvaranja fistule, npr. traheoezofagealne fistule.
English: Adjusted Doseb (≥60 kg BW)
Croatian: Prilagođena dozab (≥60 kg tjelesne težine)
English: Reactions of Grade 3 or higher (including 1 reaction of Grade 4) occurred in 44.4% of lenvatinib-treated patients compared with 3.8% of placebo-treated patients.
Croatian: Nuspojave 3. ili višeg stupnja (uključujući jednu nuspojavu 4. stupnja) nastale su u 44,4% bolesnika liječenih lenvatinibom u usporedbi s 3,8% bolesnika koji su primali placebo.
English: ≥60 kg BW 12 mg (three 4 mg capsules orally once daily)
Croatian: ≥60 kg tjelesne težine 12 mg (tri kapsule od 4 mg peroralno jedanput dnevno)
English: In human liver microsomes, the demethylated form of lenvatinib (M2) was identified as the main metabolite.
Croatian: Demetilirani oblik lenvatiniba (M2) bio je utvrđen kao glavni metabolit u mikrosomima ljudske jetre.
English: The printing ink contains shellac, black iron oxide (E172), potassium hydroxide, propylene glycol.
Croatian: Boja za označavanje sadrži šelak, crni željezov oksid (E172), kalijev hidroksid, propilenglikol.
English: Increased blood thyroid stimulating hormone (see section 4.4 Impairment of thyroid stimulating hormone suppression / Thyroid dysfunction)
Croatian: Povišen tireotropin u krvi (vidjeti dio 4.4, Narušena supresija tireotropina / disfunkcija štitnjače)
English: The most frequently observed adverse drug reactions at these doses were hypertension, nausea, diarrhoea, fatigue, stomatitis, proteinuria, headache, and aggravation of PPE.
Croatian: Najčešće opažene nuspojave pri tim dozama bile su hipertenzija, mučnina, proljev, umor, stomatitis, proteinurija, glavobolja i pogoršanje PPE-a.
English: In the Phase 3 REFLECT trial (see section 5.1), cardiac dysfunction (including congestive cardiac failure, cardiogenic shock, and cardiopulmonary failure) was reported in 0.6% of patients (0.4% were Grade ≥ 3) in the lenvatinib-treated group.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), srčana disfunkcija (uključujući kongestivno zatajenje srca, kardiogeni šok i kardiopulmonalno zatajenje) prijavljena je u 0,6% bolesnika (0,4% bilo je ≥ 3.stupnja) u skupini liječenoj lenvatinibom.
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.
Croatian: Izloženost lenvatinibu, temeljena na podacima o AUC0-inf, u ispitanika s blagim, umjerenim i teškim oštećenjem funkcije bubrega iznosila je 101%, 90% odnosno 122% normalne izloženosti.
English: Table 2 Dose modifications from recommended lenvatinib daily dose in HCC patients Starting Dose
Croatian: Tablica 2 Prilagodbe doze u odnosu na preporučenu dnevnu dozu lenvatiniba u bolesnika s HCC-om
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%.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), hipertenzija (uključujući hipertenziju, povišen krvni tlak, povišen dijastolički krvni tlak i ortostatsku hipertenziju) je zabilježena u 44,5% bolesnika koji su liječeni lenvatinibom, a hipertenzija 3.stupnja zabilježena je u 23,5%.
English: QT/QTc interval prolongation has been reported at a higher incidence in patients treated with lenvatinib than in patients treated with placebo (see section 4.8, Description of selected adverse reactions).
Croatian: Produljenje QT/QTc intervala zabilježeno je s većom incidencijom u bolesnika liječenih lenvatinibom nego u bolesnika koji su primali placebo (vidjeti dio 4.8, Opis odabranih nuspojava).
English: Patients of age ≥75 years were more likely to experience hypertension, proteinuria, decreased appetite, asthenia, dehydration, dizziness, malaise, peripheral oedema, pruritus and hepatic encephalopathy.
Croatian: Kod bolesnika u dobi od ≥75 godina postojala je veća vjerojatnost pojave hipertenzije, proteinurije, smanjenog apetita, astenije, dehidracije, omaglice, malaksalosti, perifernog edema, pruritusa i hepatičke encefalopatije.
English: No adjustment of starting dose is required on the basis of renal function in patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba početne doze na temelju funkcije bubrega u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: GI perforation or fistula
Croatian: Gastroinestinalna perforacija ili fistula
English: In the Phase 3 REFLECT trial (see section 5.1), the most commonly reported hepatotoxicity adverse reactions were increased blood bilirubin (14.9%), increased aspartate aminotransferase (13.7%), increased alanine aminotransferase (11.1%), hypoalbuminaemia (9.2%), hepatic encephalopathy (8.0%), increased gamma-glutamyltransferase (7.8%) and increased blood alkaline phosphatase (6.7%).
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), najčešće zabilježene nuspojave hepatotoksičnosti bile su porast bilirubina u krvi (14,9%), porast aspartat aminotransferaze (13,7%), porast alanin aminotransferaze (11,1%), hipoalbuminemija (9,2%), hepatička encefalopatija (8,0%), porast gamaglutamiltransferaze (7,8%) i porast alkalne fosfataze u krvi (6,7%).
English: In the Phase 3 REFLECT trial (see section 5.1), QT/QTc interval prolongation was reported in 6.9% of lenvatinib-treated patients.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), produljenje QT/QTc intervala zabilježeno je u 6,9% bolesnika liječenih lenvatinibom.
English: The most important serious adverse reactions were renal failure and impairment (2.4%), arterial thromboembolisms (3.9%), cardiac failure (0.7%), intracranial tumour haemorrhage (0.7%), PRES / RPLS (0.2%), hepatic failure (0.2%), and arterial thromboembolisms (cerebrovascular accident (1.1%), transient ischaemic attack (0.7%), and myocardial infarction (0.9%).
Croatian: Najvažnije ozbiljne nuspojave bile su zatajenje i oštećenje funkcije bubrega (2,4%), arterijska tromboembolija (3,9%), zatajenje srca (0,7%), krvarenje intrakranijalnog tumora (0,7%), PRES / RPLS (0,2%), zatajenje jetre (0,2%) i arterijska tromboembolija (cerebrovaskularni inzult (1,1%), tranzitorna ishemijska ataka (0,7%) i infarkt miokarda (0,9%)).
English: Across clinical studies in which 1,327 patients received lenvatinib monotherapy in indications other than HCC, Grade ≥ 3 or greater haemorrhage was reported in 2% of patients, 3 patients (0.2%) had a Grade 4 haemorrhage and 8 patients (0.6%) had a Grade 5 reaction including arterial haemorrhage, haemorrhagic stroke, intracranial haemorrhage, intracranial tumour haemorrhage, haematemesis, melaena, haemoptysis and tumour haemorrhage.
Croatian: U kliničkim ispitivanjima u kojima je 1327 bolesnika primilo monoterapiju lenvatiniba u indikacijama osim HCC-a, krvarenje ≥ 3.stupnja zabilježeno je u 2% bolesnika, 3 bolesnika (0,2%) imalo je krvarenje 4. stupnja, a 8 bolesnika (0,6%) imalo je nuspojavu 5. stupnja koja je uključivala arterijsko krvarenje, hemoragijski moždani udar, intrakranijalno krvarenje, krvarenje intrakranijalnog tumora, hematemezu, melenu, hemoptizu i krvarenje tumora.
English: NE (20.3, NE)
Croatian: NP (20,3, NP)
English: How long to take LENVIMA You will usually carry on taking this medicine as long as you are getting benefit.
Croatian: Obično ćete uzimati ovaj lijek sve dok od toga imate kliničku korist.
English: A haemorrhage event led to dose interruption or reduction in 3.2% and 0.8% patients respectively and to treatment discontinuation in 1.7% of patients.
Croatian: Slučaj krvarenja doveo je do privremenog prekida doziranja u 3,2% bolesnika ili do smanjenja doze u 0,8% bolesnika, a do trajnog prekida liječenja u 1,7% bolesnika.
English: Patients were eligible to participate if they had a liver function status of Child-Pugh class A and Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0 or 1.
Croatian: A i ocjenu općeg stanja prema ECOG (Eastern Cooperative Oncology Group) 0 ili 1.
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).
Croatian: Kod bolesnika je potrebno pratiti kliničke simptome ili znakove dekompenzacije srca jer može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2).
English: Marketing Authorisation Holder Eisai GmbH
Croatian: NOSITELJ ODOBRENJA ZA STAVLJANJE LIJEKA U PROMET Eisai GmbH
English: Grade 3 reactions occurred in 3.4%, Grade 4 reactions in 0.2% and 7 patients (1.5%) had a grade 5 reaction including cerebral haemorrhage, upper gastrointestinal haemorrhage, intestinal haemorrhage and tumour haemorrhage.
Croatian: Nuspojave 3.stupnja javile su se u 3,4%, nuspojave 4.stupnja u 0,2%, a 7 bolesnika (1,5%) imalo je nuspojave 5.stupnja, uključujući cerebralno krvarenje, krvarenje u gornjem dijelu gastrointestinalnog sustava, intestinalno krvarenje i krvarenje tumora.
English: Oral inflammation includes: aphthous stomatitis, aphthous ulcer, gingival erosion, gingival ulceration, oral mucosal blistering, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Croatian: Oralna upala uključuje: aftozni stomatitis, aftozni ulkus, gingivalnu eroziju, gingivalnu ulceraciju, mjehuriće na sluznici usne šupljine, stomatitis, glositis, ulceracije u ustima i upalu sluznice.
English: Pneumothorax
Croatian: pneumotoraks
English: Adjusted Doseb (<60 kg BW)
Croatian: Prilagođena dozab (<60 kg tjelesne težine)
English: • heart palpitations
Croatian: • osjećaj lupanja srca (palpitacije)
English: Oral pain includes: oral pain, glossodynia, gingival pain, oropharyngeal discomfort, oropharyngeal pain and tongue discomfort.
Croatian: Oralni bol uključuje: oralni bol, glosodiniju, gingivalni bol, orofaringealnu nelagodu, orofaringealni bol i nelagodu jezika.
English: In the Phase 3 REFLECT trial (see section 5.1), hypocalcaemia was reported in 1.1% of patients, with grade 3 reactions occurring in 0.4%.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), hipokalcemija je prijavljena u 1,1% bolesnika, a nuspojave 3.stupnja zabilježene su u 0,4%.
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.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), hipertenzija (koja uključuje hipertenziju, hipertenzivnu krizu, povišen dijastolički krvni tlak i povišen krvni tlak) zabilježena je u 72,8% bolesnika liječenih lenvatinibom i 16,0% bolesnika u skupini koja je primala placebo.
English: The median time to onset in lenvatinib-treated patients was 16 days.
Croatian: Medijan vremena do nastupa hipertenzije u bolesnika liječenih lenvatinibom iznosio je 16 dana.
English: Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinibtreated vs 0 placebo-treated patients.
Croatian: Nuspojave 3. ili 4. stupnja težine nastale su u 5,0% bolesnika liječenih lenvatinibom naspram 0 bolesnika koji su primali placebo.
English: Close monitoring of the overall safety is recommended in patients with mild or moderate hepatic impairment (see also sections 4.2 and 5.2).
Croatian: U bolesnika s blagim ili umjerenim oštećenjem funkcije jetre preporučuje se pomno praćenje ukupnog sigurnosnog profila (vidjeti također dijelove 4.2 i 5.2).
English: • feeling very tired or weak
Croatian: • osjećaj velikog umora ili slabosti
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).
Croatian: Bolesnici s hipertenzijom na početku ispitivanja imali su višu incidenciju 3. ili 4. stupnja hipertenzije, proteinurije, proljeva i dehidracije te su imali ozbiljnije slučajeve dehidracije, hipotenzije, plućne embolije, malignog pleuralnog izljeva, atrijske fibrilacije i gastrointestinalnih simptoma (abdominalni bol, proljev, povraćanje).
English: Hypertension and proteinuria tend to occur early during lenvatinib treatment (see sections 4.4 and 4.8, Description of selected adverse reactions).
Croatian: Hipertenzija i proteinurija imaju tendenciju nastajanja rano u tijeku liječenja lenvatinibom (vidjeti dijelove 4.4 i 4.8 Opis odabranih nuspojava).
English: The most important serious adverse reactions were hepatic failure (2.8%), hepatic encephalopathy (4.6%), oesophageal varices haemorrhage (1.4%), cerebral haemorrhage (0.6%), arterial thromboembolic events (2.0%) including myocardial infarction (0.8%), cerebral infarction (0.4%) and cerebrovascular accident (0.4%) and renal failure/impairment events (1.4%).
Croatian: Najvažnije ozbiljne nuspojave bile su zatajenje jetre (2,8%), hepatička encefalopatija (4,6%), krvarenje varikoziteta jednjaka (1,4%), cerebralno krvarenje (0,6%), arterijski tromboembolijski događaji (2,0%) uključujući infarkt miokarda (0,8%), moždani udar (0,4%) i cerebrovaskularni inzult (0,4%) te zatajenje/oštećenje funkcije bubrega (1,4%).
English: Electrolytes (magnesium, potassium and calcium) should be monitored periodically during treatment.
Croatian: Tijekom liječenja potrebno je razmotriti potrebu povremenog praćenja elektrolita (magnezija, kalija i kalcija).
English: Asian patients had a higher incidence than Caucasian patients of proteinuria, decreased neutrophil count, decreased platelet count, decreased white blood count and PPE syndrome, while Caucasian patients had a higher incidence of fatigue, hepatic encephalopathy, acute kidney injury, anxiety, asthenia, nausea, thrombocytopenia and vomiting.
Croatian: Kod bolesnika azijskog podrijetla postojala je veća incidencija nego kod bolesnika bijele rase što se tiče proteinurije, smanjenog broja neutrofila, smanjenog broja trombocita, smanjenog broja bijelih krvnih stanca i PPE sindroma, dok je kod bolesnika bijele rase bila veća incidencija umora, hepatičke encefalopatije, akutnog oštećenja bubrega, tjeskobe, astenije, mučnine, trombocitopenije i povraćanja.
English: Patients with baseline hepatic impairment had a higher incidence of hypertension and PPE, and a higher incidence of Grade 3 or 4 hypertension, asthenia, fatigue, and hypocalcaemia compared with patients with normal hepatic function.
Croatian: Bolesnici s oštećenjem funkcije jetre na početku ispitivanja imali su višu incidenciju hipertenzije i PPE-a, kao i višu incidenciju 3. ili 4. stupnja hipertenzije, astenije, umora i hipokalcemije u usporedbi s bolesnicima s normalnom funkcijom jetre.
English: • changes in urine tests for protein (high) and urinary infections (increased frequency in urination and pain in passing urine)
Croatian: • promjene u nalazu pretrage mokraće na bjelančevine (povišene) i mokraćne infekcije (povećana učestalost mokrenja i bolno mokrenje)
English: Hypomagnesaemia includes hypomagnesaemia and decreased blood magnesium.
Croatian: Hipomagnezemija uključuje hipomagnezemiju i sniženi magnezij u krvi.
English: Adverse reactions that most commonly led to dose reductions (in ≥5% of patients) were hypertension, proteinuria, diarrhoea, fatigue, PPE, decreased weight, and decreased appetite.
Croatian: Nuspojave koje su najčešće dovele do sniženja doze (u ≥5% bolesnika) bile su hipertenzija, proteinurija, proljev, umor, PPE, smanjena tjelesna težina i smanjeni apetit.
English: Consider resuming at reduced dose if resolves to Grade 0-1.
Croatian: Ako se povuče na 0.-1. stupanj, razmisliti o nastavku primjene u sniženoj dozi.
English: Hazard ratio (95% CI)b,c
Croatian: Omjer hazarda (95% CI)b,c
English: If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Croatian: Ako se urinskom test-trakom otkrije proteinurija ≥2+, može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili prestati s primjenom (vidjeti dio 4.2).
English: Liver-related reactions of Grade 3 or higher (including 1 Grade 5 case of hepatic failure) occurred in 5.4% of lenvatinib-treated patients compared with 0.8% in placebo-treated patients.
Croatian: Nuspojave 3. ili višeg stupnja povezane s jetrom (uključujući jedan slučaj zatajenja jetre 5. stupnja) nastale su u 5,4% bolesnika liječenih lenvatinibom u usporedbi s 0,8% bolesnika koji su primali placebo.
English: CI, confidence interval; NE, not estimable; OS, overall survival; PFS, progression-free survival; RPSFT, rank preserving structural failure time model; VEGF/VEGFR, vascular endothelial growth factor / vascular endothelial growth factor receptor.
Croatian: CI, interval pouzdanosti; NP, ne može se procijeniti; OS, ukupno preživljenje; PFS, preživljenje bez progresije bolesti; RPSFT model (engl.
English: LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules lenvatinib
Croatian: LENVIMA 4 mg tvrde kapsule LENVIMA 10 mg tvrde kapsule lenvatinib
English: Hazard ratio (99% CI)b,c P-valueb
Croatian: Omjer hazarda (99% CI)b,c P-vrijednostb
English: Adverse reactions that most commonly led to dose modifications (in ≥5% of patients) were decreased appetite, diarrhoea, proteinuria, hypertension, fatigue, PPE and decreased platelet count.
Croatian: Nuspojave koje su najčešće dovele do prilagodbe doze (u ≥5% bolesnika) bile su smanjen apetit, proljev, proteinurija, hipertenzija, umor, PPE i smanjen broj trombocita.
English: Growth retardation, secondary delay of physical development, and lesions attributable to pharmacologic effects (incisors, femur [epiphyseal growth plate], kidneys, adrenals, and duodenum) were also observed in juvenile rats.
Croatian: U mladih štakora također su bili opaženi zastoj u rastu, posljedično usporen fizički razvoj i lezije koje su se mogle pripisati farmakološkim učincima (sjekutići, femur [epifizna ploča rasta], bubrezi, nadbubrežne žlijezde i duodenum).
English: 4 mg (one 4 mg capsule) orally every other day
Croatian: 4 mg (jedna kapsula od 4 mg) peroralno svaki drugi dan
English: In the Phase 3 REFLECT trial (see section 5.1), diarrhoea was reported in 38.7% of patients treated with lenvatinib (4.2% were Grade ≥ 3).
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), proljev je zabilježen u 38,7% bolesnika liječenih lenvatinibom (4,2% bilo je ≥3.stupnja).
English: Hazard ratio is for lenvatinib vs. sorafenib, based on a Cox model including treatment group as a factor.
Croatian: Zaključni datum prikupljanja podataka: 13.11.2016. a Omjer hazarda za lenvatinib naspram sorafeniba, na temelju Coxovog modela koji uključuje terapijsku skupinu kao čimbenik.
English: Cardiac dysfunction (see section 4.4)
Croatian: Srčana disfunkcija (vidjeti dio 4.4)
English: Patients with baseline renal impairment had a higher incidence of Grade 3 or 4 hypertension, proteinuria, fatigue, stomatitis, oedema peripheral, thrombocytopenia, dehydration, prolonged QT, hypothyroidism, hyponatraemia, increased blood thyroid stimulating hormone, pneumonia compared with subjects with normal renal function.
Croatian: Bolesnici s oštećenjem funkcije bubrega na početku ispitivanja imali su višu incidenciju 3. ili 4. stupnja hipertenzije, proteinurije, umora, stomatitisa, perifernog edema, trombocitopenije, dehidracije, produljenog QT intervala, hipotireoze, hiponatremije, povišenog tireotropina u krvi i pneumonije u usporedbi s ispitanicima s normalnom funkcijom bubrega.
English: (1 capsule of 10 mg and 1 capsule of 4 mg).
Croatian: kapsula od 10 mg i 1 kapsula od 4 mg).
English: Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy (see section 4.4).
Croatian: Zbog zbrinjavanja nuspojava možda će biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili prestati s primjenom lenvatiniba (vidjeti dio 4.4).
English: Screening for and subsequent treatment of oesophageal varices in patients with liver cirrhosis should be performed as per standard of care before starting treatment with lenvatinib
Croatian: Potrebno je provesti probir na varikozitete jednjaka u bolesnika s cirozom jetre i provesti naknadno liječenje u skladu sa standardnom skrbi prije početka primjene lenvatiniba.
English: Arterial thromboembolisms (see section 4.4)
Croatian: Arterijska tromboembolija (vidjeti dio 4.4)
English: The dose is usually 12 mg once a day (3 capsules of 4 mg) if you weigh 60 kg or more and 8 mg once a day (2 capsules of 4 mg) if you weigh less than 60kg.
Croatian: Doza je obično 12 mg jedanput dnevno (3 kapsule od 4 mg) ako težite 60 kg ili više i
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%).
Croatian: Nuspojave čija je incidencija nastanka bila ≥0,75% viša od one kod placeba bile su: epistaksa (11,9%), hematurija (6,5%), kontuzija (4,6%), krvarenje iz desni (2,3%), hematohezija (2,3%), rektalno krvarenje (1,5%), hematom (1,1%), hemoroidalno krvarenje (1,1%), laringealno krvarenje (1,1%), petehije (1,1%) krvarenje intrakranijalnog tumora (0,8%).
English: • have a history of heart problems or stroke
Croatian: • ste imali srčane tegobe ili moždani udar
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).
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1) 5,0% bolesnika razvilo je zatajenje bubrega, a 1,9% oštećenje funkcije bubrega (3,1% bolesnika imalo je zatajenje ili oštećenje funkcije bubrega ≥3. stupnja).