FrancophonIA/ELRC3.0 huggingface dataset:
English: Chemotherapeutic agents
Croatian: Kemoterapijski lijekovi
English: Hazard ratio (95% CI)b, e P-value b, e
Croatian: Omjer hazarda (95% CI)b, e P-vrijednostb, e
English: PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions).
Croatian: U bolesnika liječenih lenvatinibom zabilježen je PRES, poznat i kao RPLS (<1%; vidjeti dio 4.8, Opis odabranih nuspojava).
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.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), produljenje QT/QTc intervala zabilježeno je u 8,8% bolesnika liječenih lenvatinibom i 1,5% bolesnika u skupini koja je primala placebo.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), diarrhoea was reported in 67.4% of patients in the lenvatinib-treated group (9.2% were Grade ≥ 3) and in 16.8% of patients in the placebo group (none were Grade ≥ 3).
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), proljev je zabilježen u 67,4% bolesnika u skupini liječenoj lenvatinibom (9,2% bilo je ≥3. stupnja) i u 16,8% bolesnika u skupini koja je primala placebo (nijedan slučaj ≥3. stupnja).
English: In the pivotal Phase 3 SELECT trial (see section 5.1), proteinuria was reported in 33.7% of lenvatinibtreated patients and 3.1% of patients in the placebo-treated group.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), proteinurija je bila zabilježena u 33,7% bolesnika liječenih lenvatinibom i 3,1% bolesnika u skupini koja je primala placebo.
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%.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), proteinurija je zabilježena u 26,3% bolesnika liječenih lenvatinibom, a nuspojave 3. stupnja zabilježene su u 5,9%.
English: The median time to onset of liver reactions in lenvatinib-treated patients was 12.1 weeks.
Croatian: Medijan vremena do nastupa jetrenih nuspojava u bolesnika liječenih lenvatinibom iznosio je 12,1 tjedana.
English: Posterior reversible encephalopathy syndrome Monoparesis Transient ischaemic attack
Croatian: Poremećaji živčanog sustava omaglica glavobolja disgeuzija cerebrovaskularni inzult sindrom posteriorne reverzibilne encefalopatije monopareza tranzitorna ishemijska ataka
English: Arterial thromboembolisms (cerebrovascular accident, transient ischaemic attack, and myocardial infarction) have been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Croatian: U bolesnika liječenih lenvatinibom zabilježena je arterijska tromboembolija (cerebrovaskularni inzult, tranzitorna ishemijska ataka i infarkt miokarda) (vidjeti dio 4.8, Opis odabranih nuspojava).
English: No dose adjustments are required on the basis of renal function in patients with mild or moderate renal impairment.
Croatian: Nije potrebna prilagodba doze na temelju funkcije bubrega u bolesnika s blagim ili umjerenim oštećenjem funkcije bubrega.
English: Adverse reactions that most commonly led to discontinuation of lenvatinib were hepatic encephalopathy, fatigue, increased blood bilirubin, proteinuria and hepatic failure.
Croatian: Nuspojave koje su najčešće dovele do trajnog prekida liječenja lenvatinibom bile su hepatička encefalopatija, umor, povišene razine bilirubina u krvi, proteinurija i zatajenje jetre.
English: Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Croatian: Jedna tvrda kapsula sadrži 4 mg lenvatiniba (u obliku lenvatinibmesilata).
English: Adverse reactions that most commonly led to discontinuation of lenvatinib were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea, and pulmonary embolism.
Croatian: Nuspojave koje su najčešće dovele do prestanka primjene lenvatiniba bile su proteinurija, astenija, hipertenzija, cerebrovaskularni inzult, proljev i plućna embolija.
English: Impaired wound healing has been reported in patients receiving lenvatinib.
Croatian: Zabilježeno je smanjeno cijeljenje rana kod bolesnika koji primaju lenvatinib.
English: Hepatic encephalopathy occurred at more than twice the incidence in patients aged ≥75 years (17.2%) than in those <75 years (7.1%).
Croatian: ≥75 godina (17,2%) u odnosu na bolesnike u dobi
English: Renal impairment Increased blood creatinine Increased blood urea
Croatian: oštećenje funkcije bubrega povišen kreatinin u krvi povišena ureja u krvi nefrotski sindrom
English: Haemorrhage terms that occurred in 5 or more subjects with DTC were: epistaxis, haemoptysis, haematuria, contusion, haematochezia, gingival bleeding, petechial, pulmonary haemorrhage, rectal haemorrhage, blood urine present, haematoma and vaginal haemorrhage.
Croatian: Hemoragijski pojmovi koji su se javili u 5 ili više ispitanika sa DTC-om bili su: epistaksa, hemoptiza, hematurija, kontuzija, hematohezija, krvarenje iz desni, petehije, plućno krvarenje, rektalno krvarenje, prisutnost krvi u mokraći, hematom i vaginalno krvarenje.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), 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.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), krvarenje je bilo zabilježeno u 34,9% bolesnika liječenih lenvatinibom (1,9% bilo je ≥3. stupnja) naspram 18,3% bolesnika koji su primali placebo (3,1% bilo je ≥3. stupnja).
English: In the Phase 3 REFLECT trial (see section 5.1), haemorrhage was reported in 24.6% of patients and 5.0% were Grade ≥ 3.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), krvarenje je zabilježeno u 24,6% bolesnika, a 5,0% bilo je ≥3.stupnja.
English: In the pivotal Phase 3 SELECT trial (see section 5.1), arterial thromboembolic events were reported in 5.4% of lenvatinib-treated patients and 2.3% of patients in the placebo group.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), događaji arterijske tromboembolije zabilježeni su u 5,4% bolesnika liječenih lenvatinibom i 2,3% bolesnika u skupini koja je primala placebo.
English: Dose reduce and resume lenvatinib
Croatian: Što poduzeti Sniženje doze i nastavak primjene lenvatiniba
English: Microcrystalline cellulose Hydroxypropylcellulose Low-substituted hydroxypropylcellulose Talc
Croatian: Sadržaj kapsule kalcijev karbonat manitol celuloza, mikrokristalinična hidroksipropilceluloza hidroksipropilceluloza, nisko supstituirana talk
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.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), događaji gastrointestinalne perforacije ili fistule zabilježeni su u 1,9% bolesnika liječenih lenvatinibom i 0,8% bolesnika u skupini koja je primala placebo.
English: In the Phase 3 REFLECT trial (see section 5.1), arterial thromboembolic events were reported in 2.3% of patients treated with lenvatinib.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), arterijski tromboembolijski događaji zabilježeni su u 2,3% bolesnika liječenih lenvatinibom.
English: LENVIMA 4 mg hard capsules
Croatian: LENVIMA 4 mg tvrde kapsule
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).
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), smanjena ejekcijska frakcija/zatajenje srca zabilježeno je u 6,5% bolesnika (1,5% bilo je ≥3. stupnja) u skupini liječenoj lenvatinibom i 2,3% u skupini liječenoj placebom (nijedan slučaj nije bio ≥3. stupnja).
English: Secondary efficacy outcome measures included overall response rate and overall survival.
Croatian: Response Evaluation Criteria in Solid Tumours, RECIST) 1.1. Sekundarne mjere ishoda za djelotvornost uključivale su stopu ukupnog odgovora i ukupno preživljenje.
English: LENVIMA 10 mg hard capsules
Croatian: LENVIMA 10 mg tvrde kapsule
English: In the Phase 3 REFLECT trial (see section 5.1), events of gastrointestinal perforation or fistula were reported in 1.9% of lenvatinib-treated patients.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), slučajevi gastrointestinalne perforacije ili fistule zabilježeni su u 1,9% bolesnika liječenih lenvatinibom.
English: Hypothyroidism Increased blood thyroid stimulating hormone ‡
Croatian: Endokrini poremećaji hipotireoza povišen tireotropin u krvi‡
English: Lenvatinib impairs exogenous thyroid suppression (see section 4.8, Description of selected adverse reactions).
Croatian: Lenvatinib narušava egzogenu supresiju štitnjače (vidjeti dio 4.8, Opis odabranih nuspojava).
English: Quartiles are estimated by the Kaplan-Meier method, and the 95% CIs are estimated with a generalized Brookmeyer and Crowley method f.
Croatian: e Kvartili procijenjeni Kaplan-Meierovom metodom, a 95% CI procijenjeni su generaliziranom
English: Palmar-plantar erythrodysaesthesia syndrome Rash Alopecia
Croatian: Poremećaji kože i potkožnog tkiva sindrom palmarno-plantarne eritrodizestezije osip alopecija hiperkeratoza
English: In the Phase 3 REFLECT trial (see section 5.1), there was 1 event of PRES (Grade 2) in the lenvatinib-treated group.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), zabilježen je 1 događaj PRES-a (2.stupnja) u skupini liječenoj lenvatinibom.
English: NE (16.8, NE)
Croatian: NP (16,8, NP)
English: • feeling sick and being sick, constipation, diarrhoea, abdominal pain, indigestion
Croatian: • mučnina i povraćanje, zatvor, proljev, bol u trbuhu, probavne tegobe
English: Hypocalcaemia‡ Hypokalaemia Decreased weight Decreased appetite
Croatian: Poremećaji metabolizma i prehrane hipokalcemija‡ hipokalemija smanjena tjelesna težina smanjen apetit dehidracija hipomagnezemijab hiperkolesterolemijab
English: In the case of bleeding, dose interruptions, adjustments, or discontinuation may be required (see Section 4.2, Table 3).
Croatian: U slučaju krvarenja može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2, tablica 3).
English: Discontinue Do not resume
Croatian: Trajno prekinuti
English: Patients with baseline renal impairment had a higher incidence of fatigue, hypothyroidism, dehydration, diarrhoea, decreased appetite, proteinuria and hepatic encephalopathy.
Croatian: Bolesnici koji su na početku imali oštećenje bubrega imali su veću incidenciju umora, hipotireoze, dehidracije, proljeva, smanjenog apetita, proteinurije i hepatičke encefalopatije.
English: Hepatotoxicity (see section 4.4)
Croatian: Hepatotoksičnost (vidjeti dio 4.4)
English: In patients with signs or symptoms of PRES, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Croatian: U bolesnika sa znakovima ili simptomima PRES-a može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2).
English: Hypothyroidism has been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Croatian: Hipotireoza je zabilježena u bolesnika liječenih lenvatinibom (vidjeti dio 4.8, Opis odabranih nuspojava).
English: Renal failure cases includes: acute prerenal failure, renal failure, renal failure acute, acute kidney injury and renal tubular necrosis.
Croatian: Slučajevi zatajenja bubrega uključuju: akutno prerenalno zatajenje, zatajenje bubrega, akutno zatajenje bubrega, akutno oštećenje bubrega i bubrežnu tubularnu nekrozu.
English: Table 5 Adverse reactions reported in patients treated with lenvatinib System Organ
Croatian: Tablica 5 Nuspojave zabilježene u bolesnika liječenih lenvatinibom Klasifikacija organskih sustava (MedDRA terminologija*)
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.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1) hipokalcemija je bila zabilježena u 12,6% bolesnika liječenih lenvatinibom naspram nula slučajeva u skupini koja je primala placebo.
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules
Croatian: NAZIV LIJEKA LENVIMA 4 mg tvrde kapsule LENVIMA 10 mg tvrde kapsule
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.
Croatian: U ključnom ispitivanju faze 3 pod nazivom SELECT (vidjeti dio 5.1), zabilježen je 1 događaj PRES-a (2. stupnja) u skupini liječenoj lenvatinibom, a u skupini liječenoj placebom nije bilo takvih događaja.
English: Gastrointestinal perforation or fistulae have been reported in patients treated with lenvatinib (see section 4.8).
Croatian: U bolesnika liječenih lenvatinibom zabilježeni su gastrointestinalna perforacija ili fistule (vidjeti dio 4.8).
English: • Not known
Croatian: Nepoznato
English: Black iron oxide (E172) Potassium hydroxide Propylene glycol
Croatian: Tinta za označavanje šelak željezov oksid, crni (E172) kalijev hidroksid propilenglikol
English: Non-Gastrointestinal fistulae (see section 4.4)
Croatian: Fistule koje nisu gastrointestinalne (vidjeti dio 4.4)
English: chills, nausea and vomiting (splenic farction)
Croatian: mučninom i povraćanjem (infarkt slezene)
English: • feeling unwell
Croatian: • opće loše osjećanje
English: You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.
Croatian: Nuspojave možete prijaviti izravno putem nacionalnog sustava prijave nuspojava: navedenog u Dodatku V.
English: In the Phase 3 REFLECT trial (see section 5.1), 7.1% of lenvatinib-treated patients developed a renal failure/impairment event.
Croatian: U ispitivanju REFLECT faze 3 (vidjeti dio 5.1), u 7,1% bolesnika liječenih lenvatinibom došlo je do zatajenja/oštećenja funkcije bubrega.
English: 8 mg (two 4 mg capsules) orally once daily
Croatian: 8 mg (dvije kapsule od 4 mg) peroralno jedanput dnevno
English: • have liver or kidney problems
Croatian: • imate tegobe s jetrom ili bubrezima
English: What LENVIMA is
Croatian: Što je LENVIMA
English: Non-Gastrointestinal fistula
Croatian: Fistula koja nije gastrointestinalna
English: 4 mg (one 4 mg capsule) orally once daily
Croatian: 4 mg (jedna kapsula od 4 mg) peroralno jedanput dnevno
English: Adverse reactions observed in clinical trials in DTC and HCC and reported from post-marketing use of lenvatinib are listed in Table 5.
Croatian: Nuspojave opažene u kliničkim ispitivanjima DTC-a i HCC-a i zabilježene pri primjeni lenvatiniba nakon stavljanja lijeka u promet navedene su u Tablici 5. Kategorija učestalosti nuspojava predstavlja najkonzervativniju procjenu učestalosti iz dviju pojedinačnih populacija.
English: In the case of a gastrointestinal perforation or fistula, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Croatian: U slučaju gastrointestinalne perforacije ili fistule može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2).
English: Myocardial infarctionc,†
Croatian: Srčani poremećaji infarkt miokardac,†
English: The majority of cases recovered following dose interruption or reduction, which occurred in 6.9% and 2.5% of patients respectively.
Croatian: U većini slučajeva došlo je do oporavka nakon privremenog prekida doziranja (6,9%) ili smanjenja doze (2,5%).
English: The median time to first onset in lenvatinibtreated patients was 11.1 weeks.
Croatian: Medijan vremena do prvog nastanka hipokalcemije u bolesnika liječenih lenvatinibom iznosio je 11,1 tjedana.
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).
Croatian: NAZIV LIJEKA LENVIMA 4 mg tvrde kapsule lenvatinib NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 4 mg lenvatiniba (u obliku lenvatinibmesilata).
English: Figure 1
Croatian: Prva pojavac
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.
Croatian: • Kapsula od 10 mg ima žuto tijelo i žućkasto-crvenu kapicu, duljine je približno 14,3 mm, s oznakom “Є” otisnutom crnom tintom na kapici, a“LENV 10 mg” na tijelu.
English: Median was estimated with the Kaplan-Meier method and the 95% confidence interval was constructed with a generalised Brookmeyer and Crowley method.
Croatian: Medijan je procijenjen Kaplan-Meierovom metodom, a 95%-tni interval pouzdanosti procijenjen je generaliziranom Brookmeyerovom i Crowleyevom metodom HR je procijenjen prema Coxovom modelu proporcionalnog hazarda s liječenjem kao neovisnom varijablom i stratificiran IxRS stratifikacijskim čimbenicima.
English: OR
Croatian: Ili
English: Asian patients had a higher incidence than Caucasian patients of peripheral oedema, hypertension, fatigue, PPE, proteinuria, thrombocytopenia, and increased blood thyroid stimulating hormone.
Croatian: U usporedbi s bijelcima, azijatski bolesnici imali su višu incidenciju perifernog edema, hipertenzije, umora, PPE-a, proteinurije, trombocitopenije i povišenog tireotropina u krvi.
English: The median time to onset was 6.7 weeks.
Croatian: Medijan vremena do nastupa proteinurije iznosio je 6,7 tjedana.
English: In the case of hepatotoxicity, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Croatian: U slučaju hepatotoksičnosti može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2).
English: The median time to first onset in lenvatinib-treated patients was 10.1 weeks.
Croatian: Medijan vremena do prvog nastanka krvarenja u bolesnika liječenih lenvatinibom iznosio je 10,1 tjedana.
English: Impairment of thyroid stimulating hormone suppression/ Thyroid dysfunction
Croatian: Narušena supresija tireotropina / disfunkcija štitnjače
English: NAME OF THE MEDICINAL PRODUCT LENVIMA 10 mg hard capsules lenvatinib STATEMENT OF ACTIVE SUBSTANCE(S) Each hard capsule contains 10 mg lenvatinib (as mesilate).
Croatian: NAZIV LIJEKA LENVIMA 10 mg tvrde kapsule lenvatinib NAVOĐENJE DJELATNE(IH) TVARI Jedna tvrda kapsula sadrži 10 mg lenvatiniba (u obliku lenvatinibmesilata).
English: Second dose reduction 14 mg orally once daily One 10mg capsuleplus one 4 mg capsule Third dose reduction
Croatian: Drugo sniženje doze 14 mg peroralno jedanput na dan
English: LENVIMA 4 mg hard capsules: - Each hard capsule contains 4 mg of lenvatinib (as mesylate).
Croatian: LENVIMA 4 mg tvrde kapsule: jedna tvrda kapsula sadrži 4 mg lenvatiniba (u obliku lenvatinibmesilata)
English: For previously normotensive subjects, monotherapy with one of the classes of antihypertensives should be started when elevated BP is observed.
Croatian: Kad se opazi povišen krvni tlak u prethodno normotenzivnih osoba, potrebno je započeti monoterapiju jednom od skupina antihipertenziva.
English: Withhold lenvatinib
Croatian: Nemojte davati lenvatinib
English: There were 17 (3.6%) deaths due to hepatotoxicity events in the lenvatinib arm and 4 (0.8%) deaths in the sorafenib arm. Hepatotoxicity adverse reactions led to dose interruptions and reductions in 12.2% and 7.4% of lenvatinib-treated patients respectively, and to permanent discontinuation in 5.5%.
Croatian: Nuspojave hepatotoksičnosti dovele su do privremenog prekida doziranja u 12,2% bolesnika liječenih lenvatinibom, do smanjenja doze u 7,4%, a do trajnog prekida liječenja u 5,5%.
English: Hepatic failure includes: hepatic failure, acute hepatic failure and chronic hepatic failure.
Croatian: Zatajenje jetre uključuje: zatajenje jetre, akutno zatajenje jetre i kronično zatajenje jetre.
English: LENVIMA 10 mg
Croatian: Dvije kapsule od 10 mg
English: Response rate (complete or partial response)
Croatian: Broj potpunih odgovora
English: How LENVIMA works
Croatian: Kako LENVIMA djeluje
English: LENVIMA
Croatian: Doziranje
English: Overall Survival Number of deaths (%) Median OS in months (95% CI)
Croatian: Medijan OS u mjesecima (95% CI)
English: A yellow body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 10 mg” on the body.
Croatian: Žuto tijelo i žućkasto-crvena kapica, približne duljine 14,3 mm, s oznakom “Є” otisnutom crnom tintom na kapici, i “LENV 10 mg” na tijelu.
English: The following side effects may happen with this medicine.
Croatian: Uz ovaj lijek mogu se pojaviti nuspojave opisane u nastavku.
English: The majority of cases recovered following dose interruption or reduction, which occurred in 3.6% and 3.4% of patients respectively.
Croatian: U većini slučajeva došlo je do oporavka nakon privremenog prekida doziranja (3,6%) ili smanjenja doze (3,4%).
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).
Croatian: U bolesnika liječenih lenvatinibom zabilježeni su zatajenje srca (<1%) i smanjena ejekcijska frakcija lijeve klijetke (vidjeti dio 4.8, Opis odabranih nuspojava).
English: Diarrhoea has been reported frequently in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Croatian: Proljev je često zabilježen u bolesnika liječenih lenvatinibom, a obično se javlja rano u tijeku liječenja (vidjeti dio 4.8, Opis odabranih nuspojava).
English: Splenic infarction
Croatian: • moždani udar
English: Thrombocytopenia includes thrombocytopenia and decreased platelet count.
Croatian: Trombocitopenija uključuje trombocitopeniju i smanjeni broj trombocita.
English: Not adjusted for crossover effect.
Croatian: Bez prilagodbe za utjecaj prelaska s placeba na lenvatinib.
English: LENVIMA 10 mg hard capsules: - Each hard capsule contains 10 mg of lenvatinib (as mesylate).
Croatian: LENVIMA 10 mg tvrde kapsule: jedna tvrda kapsula sadrži 10 mg lenvatiniba (u obliku lenvatinibmesilata)
English: Thrombocytopeniaa Leukopeniaa Neutropeniaa
Croatian: Poremećaji krvi i limfnog sustava trombocitopenijaa leukopenijaa neutropenijaa limfopenijaa infarkt slezene
English: Back pain Arthralgia Myalgia Pain in extremity Musculoskeletal pain
Croatian: Poremećaji mišićno-koštanog sustava i vezivnog tkiva bol u leđima artralgija mijalgija bol u udovima mišićno-koštani bol
English: Hypertension has been reported in patients treated with lenvatinib, usually occurring early in the course of treatment (see section 4.8, Description of selected adverse reactions).
Croatian: U bolesnika liječenih lenvatinibom zabilježena je hipertenzija koja obično nastaje rano u tijeku liječenja (vidjeti dio 4.8, Opis odabranih nuspojava).
English: Resolves to Grade 0-1 or baseline.
Croatian: Povlači se na 0., 1. ili 2. stupanj.
English: Renal failure and impairment (see section 4.4)
Croatian: Zatajenje i oštećenje funkcije bubrega (vidjeti dio 4.4)
English: Dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Croatian: Može biti potrebno privremeno prekinuti doziranje, prilagoditi dozu ili trajno prekinuti primjenu (vidjeti dio 4.2).
English: A yellowish-red body and yellowish-red cap, approximately 14.3 mm in length, marked in black ink with “Є” on the cap, and “LENV 4 mg” on the body.
Croatian: Žućkasto-crveno tijelo i žućkasto-crvena kapica, približne duljine 14,3 mm, s oznakom “Є” otisnutom crnom tintom na kapici, i “LENV 4 mg” na tijelu.
English: • wound healing problems
Croatian: • problemi sa cijeljenjem rana
English: 10 mg orally once dailya One 10mg capsule a:
Croatian: Jedna kapsula od 10 mg a: