FrancophonIA/ELRC3.0 huggingface dataset:
English: One subject (0.2%) discontinued lenvatinib due to hypertension.
Slovenian: Pri 1 bolniku (0,2 %) je hipertenzija povzročila trajno ukinitev zdravljenja z lenvatinibom.
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.
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) je bil en dogodek PRES (stopnje 2) v skupini, zdravljeni z lenvatinibom, v skupini s placebom pa niso poročali o nobenem primeru.
English: <60 kg BW 8 mg (two 4 mg capsules orally once daily)
Slovenian: < 60 kg TM 8 mg (dve 4 mg kapsuli peroralno enkrat na dan)
English: Capsule shell Hypromellose Titanium dioxide (E171) Yellow iron oxide (E172) Red iron oxide (E172)
Slovenian: Ovojnica kapsule hipromeloza, titanov dioksid (E171), rumeni železov oksid (E172), rdeči železov oksid (E172).
English: Liver cancer
Slovenian: Rak ščitnice
English: Patients of age ≥75 years were more likely to experience Grade 3 or 4 hypertension, proteinuria, decreased appetite, and dehydration.
Slovenian: Pri bolnikih, starih ≥ 75 let, so bile verjetnejše hipertenzija, proteinurija, zmanjšan apetit in dehidracija stopnje 3 ali 4.
English: Management of adverse reactions may require dose interruption, adjustment, or discontinuation of lenvatinib therapy (see section 4.4).
Slovenian: Zaradi obvladovanja neželenih učinkov utegnejo biti potrebne prekinitev odmerjanja, prilagoditev odmerka ali ukinitev zdravljenja z lenvatinibom (glejte poglavje 4.4).
English: Cases of fistula formation or enlargement that involve areas of the body other than stomach or intestines were observed in clinical trials and in post-marketing experience (e.g. tracheal, tracheo-oesophageal, oesophageal, cutaneous, female genital tract fistulae).
Slovenian: V kliničnih preskušanjih in izkušnjah po prihodu zdravila na trg so opazili primere nastanka ali zvečanja fistul, ki so zajeli druge dele telesa, ne želodca ali črevesja (npr. trahealne, traheo-ezofagealne, ezofagealne, kožne fistule in fistule ženskih spolovil).
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.
Slovenian: Z jetri povezani neželeni učinki stopnje 3 ali višje stopnje (vključno z 1 primerom odpovedi jeter stopnje 5) so nastopili pri 5,4 % bolnikov, zdravljenih z lenvatinibom, in pri 0,8 % bolnikov, ki so prejemali placebo.
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.
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o podaljšanju intervala QT/QTc pri 8,8 % bolnikov, zdravljenih z lenvatinibom, in pri 1,5 % bolnikov v skupini s placebom.
English: Grade 4 (despite medical management)
Slovenian: Izboljša se na stopnjo 0-1 ali v izhodišče stopnja 4 (kljub medicinski obravnavi)
English: Hypothyroidism Increased blood thyroid stimulating hormone ‡
Slovenian: Bolezni endokrinega sistema hipotiroidizem zvišan tirotropni hormon v krvi‡
English: If urine dipstick proteinuria ≥2+ is detected, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Slovenian: Če z urinskim testnim lističem odkrijemo proteinurijo ≥ 2+, bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
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%.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o hipertenziji (vključno s hipertenzijo, zvišanim krvnim tlakom, zvišanim diastoličnim krvnim tlakom in ortostatsko hipertenzijo) pri 44,5 % bolnikov, zdravljenih z lenvatinibom.
English: LENVIMA
Slovenian: Driska
English: Lenvatinib should be discontinued following an arterial thrombotic event.
Slovenian: Po arterijskem trombotičnem dogodku je treba lenvatinib ukiniti.
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%).
Slovenian: Neželeni učinki, ki so se pojavili z incidenco, za ≥ 0,75 % večjo kot pri placebu, so bili: epistaksa (11,9 %), hematurija (6,5 %), kontuzija (4,6 %), gingivalna krvavitev (2,3 %), hematohezija (2,3 %), rektalna krvavitev (1,5 %), hematom (1,1 %), krvavitev iz hemoroidov (1,1 %), laringealna krvavitev (1,1 %), petehije (1,1 %) in krvavitev v znotrajlobanjski tumor (0,8 %).
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.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o krvavitvah pri 24,6 %, in 5,0 % jih je bilo stopnje ≥ 3.
English: The available data do not allow for a dosing recommendation for patients with HCC and severe renal impairment.
Slovenian: Razpoložljivi podatki pri bolnikih s HCC in hudo okvaro ledvic ne zadostujejo za priporočilo glede odmerjanja.
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.
Slovenian: Neželeni učinki, ki so najpogosteje privedli do sprememb odmerka (pri ≥ 5 % bolnikov), so bili zmanjšan apetit, driska, proteinurija, hipertenzija, utrujenost, PPE in zmanjšano število trombocitov.
English: LENVIMA 4 mg hard capsules LENVIMA 10 mg hard capsules lenvatinib
Slovenian: LENVIMA 4 mg trde kapsule LENVIMA 10 mg trde kapsule lenvatinib
English: Hazard ratioa, b (95% CI)
Slovenian: Razmerje ogroženostia, b (95-odstotni IZ)
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.
Slovenian: Bolniki z izhodiščno okvaro ledvic so imeli večjo incidenco hipertenzije, proteinurije, utrujenosti, stomatitisa, perifernih edemov, trombocitopenije, dehidracije, podaljšanega intervala QT, hipotiroidizma, hiponatriemije, zvišanega tirotropnega hormona v krvi in pljučnice stopnje 3 ali 4 v primerjavi s preiskovanci z normalno funkcijo ledvic.
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.
Slovenian: Med 1166 bolniki, zdravljenimi z lenvatinibom v monoterapiji za druge indikacije kot HCC, so poročali o krvavitvi stopnje ≥ 3 ali višje stopnje pri 2 % bolnikov, 3 bolniki (0,2 %) so imeli krvavitve stopnje 4, 8 bolnikov (0,6 %) pa je imelo neželeni učinek stopnje 5, vključno z arterijsko krvavitvijo, hemoragično možgansko kapjo, znotrajlobansko krvavitvijo, krvavitvijo v znotrajlobanski tumor, hematemezo, meleno, hemoptizo in krvavitvijo v tumor.
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).
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o driski pri 38,7 % bolnikov, zdravljenih z lenvatinibom (4,2 % jih je bilo stopnje ≥ 3).
English: The majority of cases recovered following dose interruption or reduction, which occurred in 3.6% and 3.4% of patients respectively.
Slovenian: V večini primerov je prišlo do okrevanja po prekinitvi ali zmanjšanju odmerjanja, kar se je zgodilo pri 3,6 % oziroma 3,4 % bolnikov.
English: Adverse reactions that most commonly led to discontinuation of lenvatinib were proteinuria, asthenia, hypertension, cerebrovascular accident, diarrhoea, and pulmonary embolism.
Slovenian: Neželeni učinki, ki so najpogosteje povzročili ukinitev lenvatiniba, so bili proteinurija, astenija, hipertenzija, cerebrovaskularni insult, driska in pljučna embolija.
English: The majority of cases had an outcome of recovered or resolved following dose interruption or reduction, which occurred in 16.9% and 10.7% of patients, respectively.
Slovenian: V večini primerov je prišlo do ozdravitve ali okrevanja po prekinitvi ali zmanjšanju odmerka, kar se je zgodilo pri 16,9 % oziroma 10,7 % bolnikov.
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).
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o zmanjšani iztisni frakciji/popuščanju srca pri 6,5 % bolnikov (1,5 % jih je bilo stopnje ≥ 3) v skupini, zdravljeni z lenvatinibom, in pri 2,3 % v skupini s placebom (nobeden ni bil stopnje ≥ 3).
English: 24 mg orally once daily Two 10 mg capsules plus one 4 mg capsule
Slovenian: 24 mg peroralno enkrat na dan dve 10 mg kapsuli in ena 4 mg kapsula
English: The majority of cases recovered following dose interruption or reduction, which occurred in 6.9% and 2.5% of patients respectively.
Slovenian: V večini primerov je prišlo do okrevanja po prekinitvi ali zmanjšanju odmerka, kar se je zgodilo pri 6,9 % oziroma 2,5 % bolnikov.
English: • feeling sick and being sick, constipation, diarrhoea, abdominal pain, indigestion
Slovenian: • slabost in bruhanje, zaprtje, driska, bolečina v trebuhu, prebavne motnje,
English: Table 3 Adverse reactions requiring dose modification of lenvatinib in DTC and HCC Adverse reaction Severity
Slovenian: Preglednica 3 Neželeni učinki pri DTC in HCC, pri katerih je potrebna sprememba odmerka lenvatiniba Neželeni učinek Resnost
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.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o dogodkih gastrointestinalne perforacije ali fistule pri 1,9 % bolnikov, zdravljenih z lenvatinibom.
English: Quartiles are estimated by the Kaplan-Meier method, and the 95% CIs are estimated with a generalized Brookmeyer and Crowley method f.
Slovenian: e Kvartili so ocenjeni s Kaplan-Meierjevo metodo; 95-odstotni IZ so bili ocenjeni s posplošeno
English: Interrupt until resolved to Grade 0-1 or baselined
Slovenian: prekinite, dokler se ne izboljša na stopnjo 0-1 ali izhodiščed
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.
Slovenian: Izrazi za krvavitev, ki so se pojavili pri 5 ali več preiskovancih z DTC, so bili: epistaksa, hemoptiza, hematurija, kontuzija, hematohezija, krvavitev iz dlesni, petehije, krvavitev v pljučih, rektalna krvavitev, prisotnost krvi v urinu, hematom in vaginalna krvavitev.
English: 4 mg (one 4 mg capsule) orally every other day
Slovenian: 4 mg (ena 4 mg kapsula) peroralno vsak drugi dan
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).
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o driski pri 67,4 % bolnikov v skupini, zdravljeni z lenvatinibom (9,2 % jih je bilo stopnje ≥ 3), in pri 16,8 % bolnikov v skupini s placebom (nobeden ni bil stopnje ≥ 3).
English: LENVIMA 4 mg hard capsules
Slovenian: LENVIMA 4 mg trde kapsule
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.
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o krvavitvah pri 34,9 % (1,9 % jih je bilo stopnje ≥ 3) bolnikov, zdravljenih z lenvatinibom, in pri 18,3 % (3,1 % jih je bilo stopnje ≥ 3) bolnikov, ki so prejemali placebo.
English: LENVIMA 10 mg hard capsules
Slovenian: LENVIMA 10 mg trde kapsule
English: In the Phase 3 REFLECT trial (see section 5.1), 7.1% of lenvatinib-treated patients developed a renal failure/impairment event.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) se je pri 7,1 % bolnikov, zdravljenih z lenvatinibom, pojavil dogodek odpovedi ali okvare ledvic.
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.
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o arterijskih trombemboličnih dogodkih pri 5,4 % bolnikov, zdravljenih z lenvatinibom, in pri 2,3 % bolnikov v skupini s placebom.
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.
Slovenian: Pri mladih podganah so opazili tudi upočasnitev rasti, sekundarno zakasnitev telesnega razvoja in lezije, ki jih lahko pripišemo farmakološkim učinkom (sekalci, stegnenica [epifizna rastna plošča], ledvice, nadledvičnice in dvanajstnik).
English: • feeling dizzy
Slovenian: • okvara jeter
English: Any grade
Slovenian: katera koli stopnja prekinite
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.
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o dogodkih gastrointestinalne perforacije ali fistule pri 1,9 % bolnikov, zdravljenih z lenvatinibom, in pri 0,8 % bolnikov v skupini s placebom.
English: Lenvatinib impairs exogenous thyroid suppression (see section 4.8, Description of selected adverse reactions).
Slovenian: Lenvatinib oslabi eksogeno supresijo ščitnice (glejte poglavje 4.8 Opis izbranih neželenih učinkov).
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.
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o proteinuriji pri 33,7 % bolnikov, zdravljenih z lenvatinibom, in pri 3,1 % bolnikov v skupini, ki je prejemala placebo.
English: The majority of cases recovered or resolved following dose interruption or reduction, which occurred in 13.0% and 13.4% of patients, respectively.
Slovenian: V večini primerov je prišlo do ozdravitve ali okrevanja po prekinitvi ali zmanjšanju odmerjanja, kar se je zgodilo pri 13,0 % oziroma 13,4 % bolnikov.
English: Arterial thromboembolisms (see section 4.4)
Slovenian: Arterijske trombembolije (glejte poglavje 4.4)
English: Renal impairment Increased blood creatinine Increased blood urea
Slovenian: okvara ledvic zvišan kreatinin v krvi zvišana sečnina v krvi nefrotični sindrom
English: Initiate medical management for nausea, vomiting, or diarrhoea prior to interruption or dose reduction.
Slovenian: Pred prekinitvijo ali zmanjšanjem odmerka uvedite ukrepe za obvladovanje navzee, bruhanja ali driske.
English: The median time to first onset in lenvatinib-treated patients was 10.1 weeks.
Slovenian: Mediani čas do prvega nastopa pri bolnikih, zdravljenih z lenvatinibom, je bil 10,1 tedna.
English: PRES, also known as RPLS, has been reported in patients treated with lenvatinib (<1%; see section 4.8, Description of selected adverse reactions).
Slovenian: O sindromu posteriorne reverzibilne encefalopatije (PRES, znan tudi kot RPLS) so poročali pri bolnikih, zdravljenih z lenvatinibom (< 1 %; glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: 10 mg orally once dailya One 10mg capsule a:
Slovenian: 10 mg peroralno enkrat na dana ena 10 mg kapsula a:
English: In the case of a gastrointestinal perforation or fistula, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Slovenian: V primeru gastrointestinalne perforacije ali fistule bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
English: The median time to onset of liver reactions in lenvatinib-treated patients was 12.1 weeks.
Slovenian: Mediani čas do nastopa z jetri povezanih neželenih učinkov pri bolnikih, zdravljenih z lenvatinibom, je bil 12,1 tedna.
English: 8 mg (two 4 mg capsules) orally once daily
Slovenian: 8 mg (dve 4 mg kapsuli) peroralno enkrat na dan
English: The median time to first onset in lenvatinibtreated patients was 11.1 weeks.
Slovenian: Mediani čas do prvega nastopa pri bolnikih, zdravljenih z lenvatinibom, je bil 11,1 tedna.
English: Oral inflammation includes: aphthous stomatitis, aphthous ulcer, gingival erosion, gingival ulceration, oral mucosal blistering, stomatitis, glossitis, mouth ulceration, and mucosal inflammation.
Slovenian: Vnetje v ustih vključuje: aftozni stomatitis, aftozni ulkus, gingivalno erozijo, razjede dlesni, mehurje na ustni sluznici, stomatitis, glositis, razjede v ustih in vnetje sluznice.
English: In patients with signs or symptoms of PRES, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Slovenian: Pri bolnikih z znaki ali simptomi PRES bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
English: • loss of appetite or weight loss
Slovenian: • izguba teka ali hujšanje,
English: • have a history of heart problems or stroke
Slovenian: • ste v preteklosti imeli težave s srcem ali ste doživeli možgansko kap;
English: Discontinue Do not resume
Slovenian: Zdravljenja ne začnite znova
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).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o arterijskih trombembolijah (cerebrovaskularni insult, tranzitorna ishemična ataka (TIA) in miokardni infarkt) (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: In the patient populations enrolled in the HCC study no dose adjustments were required on the basis of hepatic function in those patients who had mild hepatic impairment (Child-Pugh A).
Slovenian: V populacijah bolnikov z blago jetrno okvaro (Child-Pugh A), vključenih v študijo HCC, prilagoditev odmerka na podlagi jetrne funkcije ni bila potrebna.
English: In the case of hepatotoxicity, dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Slovenian: V primeru hepatotoksičnosti bodo morda potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
English: In patients with severe (Child-Pugh C) hepatic impairment, the recommended starting dose is 14 mg taken once daily.
Slovenian: Pri bolnikih s hudo (Child-Pugh C) okvaro jeter je priporočeni začetni odmerek 14 mg enkrat na dan. Na podlagi prenašanja posameznega bolnika utegnejo biti potrebne nadaljnje prilagoditve odmerka.
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.
Slovenian: V ključnem preskušanju 3. faze SELECT (glejte poglavje 5.1) so poročali o hipokalciemiji pri 12,6 % bolnikov, zdravljenih z lenvatinibom, in pri nobenem bolniku v kraku s placebom.
English: 4 mg (one 4 mg capsule) orally once daily
Slovenian: 4 mg (ena 4 mg kapsula) peroralno enkrat na dan
English: Reactions of Grade 3 or 4 severity occurred in 5.0% of lenvatinibtreated vs 0 placebo-treated patients.
Slovenian: Neželeni učinki stopnje 3 ali 4 so nastopili pri 5,0 % bolnikov, zdravljenih z lenvatinibom, in pri nobenem od bolnikov, ki so prejemali placebo.
English: • liver damage
Slovenian: • težave s celjenjem ran
English: In the case of bleeding, dose interruptions, adjustments, or discontinuation may be required (see Section 4.2, Table 3).
Slovenian: V primeru krvavitve bodo mogoče potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2, preglednica 3).
English: Proteinuria‡
Slovenian: Bolezni sečil proteinurija‡
English: In the Phase 3 REFLECT trial (see section 5.1), arterial thromboembolic events were reported in 2.3% of patients treated with lenvatinib.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o arterijskih trombemboličnih dogodkih pri 2,3 % bolnikov, zdravljenih z lenvatinibom.
English: Lenvatinib should be discontinued in the event of nephrotic syndrome.
Slovenian: V primeru nefrotičnega sindroma je treba lenvatinib ukiniti.
English: Pneumothorax
Slovenian: pnevmotoraks
English: Dose interruptions, adjustments, or discontinuation may be necessary (see section 4.2).
Slovenian: Morda bodo potrebne prekinitve, prilagoditve ali ukinitev odmerjanja (glejte poglavje 4.2).
English: Baseline hypertension
Slovenian: Izhodiščna hipertenzija
English: INFORMATION IN BRAILLE LENVIMA 4 mg
Slovenian: LENVIMA 4 mg
English: Patients may be at increased risk for the development of fistulae when treated with lenvatinib.
Slovenian: Kadar se bolniki zdravijo z lenvatinibom, se lahko pri njih zveča tveganje nastanka fistul.
English: Hypothyroidism has been reported in patients treated with lenvatinib (see section 4.8, Description of selected adverse reactions).
Slovenian: Pri bolnikih, zdravljenih z lenvatinibom, so poročali o hipotiroidizmu (glejte poglavje 4.8, Opis izbranih neželenih učinkov).
English: Myocardial infarctionc,†
Slovenian: Srčne bolezni miokardni infarktc,†
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%.
Slovenian: V preskušanju 3. faze REFLECT (glejte poglavje 5.1) so poročali o hipokalciemiji pri 1,1 % bolnikov.
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
Slovenian: Pred začetkom zdravljenja bolnikov z jetrno cirozo z lenvatinibom je treba v skladu s standardom oskrbe opraviti pregled glede prisotnosti ezofagealnih varic in njihovo zdravljenje.
English: Figure 2
Slovenian: DRUGI PODATKI
English: Per independent radiology review retrospective analysis.
Slovenian: Odziv (popolni ali delni odziv) g Glede na retrospektivno analizo neodvisnega radiološkega pregleda.
English: Name and address of the manufacturer responsible for batch release Eisai Manufacturing Ltd
Slovenian: Ime in naslov proizvajalca, odgovornega za sproščanje serij
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).
Slovenian: IME ZDRAVILA LENVIMA 4 mg trde kapsule lenvatinib NAVEDBA ENE ALI VEČ UČINKOVIN Ena trda kapsula vsebuje 4 mg lenvatiniba (v obliki lenvatinibijevega mesilata).
English: What LENVIMA contains
Slovenian: Kaj vsebuje zdravilo LENVIMA
English: Palmar-plantar erythrodysaesthesia syndrome Rash Alopecia
Slovenian: Bolezni kože in podkožja sindrom palmarnoplantarne eritrodizestezije izpuščaj alopecija hiperkeratoza
English: Oral pain includes: oral pain, glossodynia, gingival pain, oropharyngeal discomfort, oropharyngeal pain and tongue discomfort.
Slovenian: Bolečina v ustih vključuje: bolečino v ustih, glosodinijo, bolečino v dlesnih, nelagodje v ustih in žrelu, orofaringealno bolečino in nelagodje na jeziku.